20.11.1 Observation Reporting (99.1.6)

ANSI/HL7 V2.9-2019

12/9/2019

21 .Observation Reporting (7)

7

Co-Chair:

Rob HausamHausam Consulting

J.D. NolenChildren’s Mercy Hospital

Co-Chair:	Hans BuitendijkCerner Corporation
Co-Chair:	David BurgessLabCorp
Co-Chair:	Lorraine ConstableConstable Consulting Inc.
Co-Chair:	Patrick LoydICode Solutions
Co-Chair:	Ken McCaslinAccenture Federal
Co-Chair:	Riki MerrickVernetzt, LLC
Co-Chair:
Editor:	Hans BuitendijkCerner Corporation
Sponsoring Workgroup:	Orders & Observations
List Server:	ord@lists.hl7.org

21.1 CHAPTER 7 CONTENTS (7.1)

21.2 Purpose (7.2)

This chapter describes the transaction set required for sending structured patient-oriented clinical data from one computer system to another. A common use of these transaction sets will be to transmit observations and results of diagnostic studies from the producing system (e.g., clinical laboratory system, EKG system) (the filler), to the ordering system (e.g., HIS order entry, physician's office system) (the placer). Observations can be sent from producing systems to clinical information systems (not necessarily the order placer) and from such systems to other systems that were not part of the ordering loop, e.g., an office practice system of the referring physician for inpatient test results ordered by an inpatient surgeon. This chapter also provides mechanisms for registering clinical trials and methods for linking orders and results to clinical trials and for reporting experiences with drugs and devices.

These transaction sets permit the transmission of clinical observations including (but not limited to) clinical laboratory results, measures of patient status and condition, vital signs, intake and output, severity and/or frequency of symptoms.

If the observation being reported meets one or more of the following criteria, then the content would qualify as a medical document management message (MDM) rather than an observation message (ORU). The reader is referred to the MDM message type in Chapter 9.

• Documents/reports that require succession management to reflect the evolution of both document addenda and replacement documents. Succession management is described in Chapter 9.

• Documents/reports where the Sender wants to indicate the availability of the report for use in patient care using the availability status present in the TXA segment, as described in Chapter 9.

Additional considerations that may affect the appropriateness of using an MDM message:

• Documents/reports where the whole requires a signature as part of the message. While the ORU message does not support the inclusion of signature or authentication, some document content forms support these requirements. Of particular note, CDA documents provide for the inclusion of originator/signature. Thus, if a CDA document requires a signature but does not require succession management or report availability (as described above), then an ORU message may be appropriate. However, if the CDA document requires succession management or report availability, then an MDM message is required.

• Documents/reports where the whole requires authentication as part of the message. As described for signatures, authentication may exist within the document content form. Again, CDA documents provide for the identification of an authenticator. Thus if a CDA document does not require succession management or report availability, then an ORU message may be appropriate. If succession management or report availability are necessary, then an MDM message is required.

• Documents/reports where the content as a whole requires special confidentiality protection using the confidentiality status present in the TXA segment, as described in Chapter 9.

• Documents/reports where document storage status is useful for archival and purging purposes using the storage status present in the TXA segment, as described in Chapter 9.

Using these criteria, the following examples of documents/reports would typically qualify as medical document management (MDM) messages. Note that as clinical content, the following documents/reports typically require succession management and/or report availability thus would require an MDM message even if the payload utilizes CSA.

• History and Physical

• Consultation reports

• Discharge summaries

• Surgical/anatomic pathology reports

• Diagnostic imaging reports

• Cardio-diagnostic reports

• Operative reports

• As an international example, microbiology reports may include clinical interpretation and require authentication. This may not be the case in all jurisdictions, but is an example that the use or requirement of MDM messages may be influenced by local considerations.

Usage Notes:

Transcription is not a defining quality for the selection of an MDM or ORU message. In an MDM message, the document/report is typically dictated or transcribed, but not always. Machine-generated or automated output is an example of a document/report that is appropriate to the MDM but is not transcribed.

Observations may be transmitted in a solicited (in response to a query) or unsolicited mode. In the solicited mode, a user requests a set of observations according to criteria transmitted by the user. The sending system responds with existing data to satisfy the query (subject to access controls). Queries do not elicit new observations by the target system, they simply retrieve old observations. (See Chapter 5 for full discussion of the query transmission.)

The unsolicited mode is used primarily to transmit the values of new observations. It is the mode used by producing services to return the values of observations requested by an ordering system. A laboratory system, for example, would usually send the results of an AM electrolytes to the ordering HIS via the unsolicited mode. An intensive care system would send the blood pressures to the same HIS by the same mode. Calling such transactions unsolicited may sound like a misnomer, but is not. The placing service solicits the producing service to make the observation. It could also (through a query) solicit the value of that observation after it has been made. However, such an approach would demand continuous polling of the producing system until the result was produced. Using the unsolicited mode, the producing service returns the value of an observation as soon as it is available. The unsolicited mode can also be used to transmit new results to a system (e.g., an archival medical record system) that did not order the observation. The transactions that define these modes are more fully described in Section 7.3, "General Trigger Events & Message Definitions."

Observations are usually ordered and reported as sets (batteries) of many separate observations. Physicians order electrolytes (consisting of sodium, potassium, chloride, bicarbonate) or vitals (consisting of diastolic blood pressure, systolic blood pressure, pulse, and temperature). Moreover, tests that we may think of as single entity, e.g., cardiac echo, usually yield multiple separate measurements, e.g., left ventricular diameter, left atrial diameter, etc. Moreover, observations that are usually reported as text (e.g., the review of systems from the history and physical) can also be considered a set of separately analyzable units (e.g., cardiac history, pulmonary history, genito-urinary history, etc.). We strongly suggest that all text clinical reports be broken down into such separate analyzable entities and that these individual entities be transmitted as separate OBX segments. Because many attributes of a set of observations taken at one time will be identical, one OBR segment serves as a header for the report and carries the information that applies to all of the individual observations in the set. In the case of ordered observations, the OBR segment is a "turn-around document" like the manual request forms it replaces. It carries information about the order to the producing service; a copy of the OBR with additional fields completed is returned with the observations to the requesting service. Alternately, text documents can be encoded as a CDA document and sent within a single OBX.

Not all observations are preceded by an order. However, all observations whether explicitly ordered or initiated without an order are reported with an OBR segment as the report header.

The major segments (OBR, OBX) defined in this chapter, their fields, and the code tables have been defined in collaboration with ASTM E31.11 with the goal of keeping HL7 observation transmission the same as ASTM E1238 in pursuit of the goals of ANSI HISPP and the Message Standards Developers Subcommittee. (Some sections of this chapter have been taken with permission directly from the E1238-91 document and vice versa in pursuit of those goals).

The OBR segment provides information that applies to all of the observations that follow. It includes a field that identifies a particular battery (or panel or set) of observations (e.g., electrolytes, vital signs or Admission H&P). For simplicity we will refer to the observation set as the battery. The battery usually corresponds to the entity that is ordered or performed as a unit. (In the case of a query, observation sets may be a more arbitrary collection of observations.) The OBX segment provides information about a single observation, and it includes a field that identifies that single observation (e.g., potassium, diastolic blood pressure or admission diagnosis). Both of these fields assume master tables that define coding systems (the universe of valid identifying codes) for batteries and observations, respectively. These tables will usually be part of the producing and sending services application and (usually) include many other useful pieces of information about the observation or battery. Segments for transmitting such master file information between systems that produce and systems that use clinical information are described in Chapter 8.

This Standard does not require the use of a particular coding system to identify either batteries or single observations In the past, local institutions tended to invent their own unique code systems for identifying test and other clinical observations because standard codes were not available. Such local code systems sufficed for transmitting information within the institutions but presented high barriers to pooling data from many sources for research or for building medical record systems. However, standard code systems such as LOINC® for observation IDs (OBX-3) and SNOMED for coding categorical observations now exist for many of these purposes, and we strongly encourage their use in observation reporting. These codes can be sent either as the only code or they can be sent along with the local historic code as the second code system in a CWE or CNE coded field.

LOINC® codes exist for most laboratory tests and many common clinical variables and codes for reporting observations from the laboratory, 12-lead EKG, cardiac echoes, obstetrical ultrasounds, radiology reports, history and physical findings, tumor registries, vital signs, intake and outputs, UCUM units of measure references and/or answer lists depending on the data type, and descriptions for most variables. Translations of LOINC® descriptions are provided for more than 14 languages. The most recent version of the LOINC® database, which includes records for more than 70,000 observations and includes codes, names, synonyms and other attributes (such as the molecular weights of chemical moieties) for each observation, the LOINC database and a downloadable browser and mapping tool are available at no cost from the Regenstrief Institute at http://loinc.org/. A web browser for LOINC is available at https://search.loinc.org. Codes for Neurophysiologic variables (EEG, EMG, Evoked potentials) are provided in Appendix X2 of ASTM E1467. Some parts of this document (the discussion and tables defining units, the discussion of the rules of mapping observations to OBX segments, and some of the examples at the end of the chapter) have been copied (with permission) from ASTM E1238.

As is true throughout this Standard, the emphasis should be on the abstract messages, defined without regard to the encoding rules. The example messages, however, are based upon the HL7 encoding rules.

21.2.1 Snapshot Mode (7.2.1)

Chapter 2, Section 2.10.4 defines the meaning of snapshot mode updates and indicates that each chapter or related implementation guides may further refine this definition. The following guidance applies to results messages:

• In some instances there are tests that have a precise relationship between the parent and child to assist the clinician in understanding to which OBX in the parent OBR the child is connected. In those instances the ORDER_OBSERVATION segment groups of the parent and other children should be included in the snapshot rather than sending the child's ORDER_OBSERVATION segment group (including the OBR/OBX set) by itself. Example: OBRs of the parent OBR (example would be microbiology with culture and Sensitivity Panels (Sensi-Panels)), unless advised otherwise by trading partners, would be included in the snapshot reporting. 

21.2.2 Preface (organization of this chapter) (7.2.2)

Following this Purpose and general information section, the remainder of this chapter is organized into four main subject areas; General, Clinical Trials, Product Experience and Waveform. Sections 7.1 to 7.5 document the trigger events, message definitions, segment definitions and examples for general observation reporting. Sections 7.6 to 7.9 include all information related to Clinical Trials. Sections 7.10 to 7.13 include all information related to Product Experience messaging, and sections 7.14 to 7.17 include Waveform messaging information. Large tables can be found in section 7.18 and outstanding issues are listed in section 7.19.

21.2.3 Glossary (7.2.3)

21.2.3.1 hiddentext (7.2.3.0)

21.2.3.2 Placer: (7.2.3.1)

Person or service that requests (places order for) an observation battery, e.g., the physician, the practice, clinic, or ward service, that orders a lab test, X-ray, vital signs, etc. The meaning is synonymous with, and used interchangeably with, requestor. See ORC-2-placer order number, Chapter 4, section 4.5.1.2, "Placer order number."

21.2.3.3 Filler: (7.2.3.2)

Person, or service, who produces the observations (fills the order) requested by the requestor. The word is synonymous with "producer" and includes diagnostic services and clinical services and care providers who report observations about their patients. The clinical laboratory is a producer of lab test results (filler of a lab order), the nursing service is the producer of vital signs observations (the filler of orders to measure vital signs), and so on. See ORC-3-filler order number, Chapter 2, section 4.5.1.3, "Filler order number."

21.2.3.4 Battery: (7.2.3.3)

A set of one or more observations identified as by a single name and code number, and treated as a shorthand unit for ordering or retrieving results of the constituent observations. In keeping with the mathematical conventions about set, a battery can be a single observation. Vital signs, electrolytes, routine admission tests, and obstetrical ultrasound are all examples. Vital signs (conventionally) consist of diastolic and systolic blood pressure, pulse, and respiratory rate. Electrolytes usually consist of Na+, K+, Cl-, and HCO3-. Routine admission tests might contain CBC, Electrolytes, SMA12, and Urinalysis. (Note that the elements of a battery for our purposes may also be batteries.) Obstetrical ultrasound is a battery made up of traditional component measurements and the impression, all of which would be returned as separate results when returned to the requestor. A test involving waveform recording (such as an EKG) can be represented as a battery comprised of results of many categories, including digital waveform data, labels and annotations to the data, measurements, and the impression

The word battery is used in this specification synonymously with the word profile or panel. The individual observation elements within a battery may be characteristic of a physiologic system (e.g., liver function tests), or many different physiologic systems.

21.2.3.5 Observation: (7.2.3.4)

A measurement of a single variable or a single value derived logically and/or algebraically from other measured or derived values. A test result, a diastolic blood pressure, and a single chest X-ray impression are examples of observations. In certain circumstances, tracings and images may be treated by HL7 as individual observations and sent as a single OBX. These include waveform data described in section 7.15, "Waveform - Trigger Events & Message Definitions," and encapsulated data aggregates using the ED data type described in Chapter 2A, section 2.A.24, "ED - encapsulated data," (which can represent actual images, audio data, etc.).

21.2.3.6 Clinical Document Architecture (CDA): (7.2.3.5)

The Health Level 7 Specification (ANSI/HL7 CDA R1.0-2000) for encoding and encapsulating clinical documents.

21.2.4 Narrative Reports as Batteries with Many OBX (7.2.4)

Narrative reports from services such as Radiology usually consist of a number of subcomponents (e.g., a chest X-ray report may consist of a description, an impression, and a recommendation). Other studies, such as echocardiograms, contain analogous components, as well as numeric observations (e.g., left ventricular and diastolic diameter). Surgical pathology reports may contain information about multiple specimens and reports: the anatomic source, the gross description, the microscopic description, and a diagnostic impression for each specimen.

The current Standard treats each component of a narrative report as a separate "test" or observation. Just as a CHEM12 is transmitted as an order segment (OBR) plus 12 OBX segments, a chest X-ray would be transmitted as an order (OBR) segment plus three OBX segments, one for the description, one for the impression, and one for the recommendations. Similarly, an EKG report would be transmitted as an order segment (OBR), two OBX segments for the impression and recommendation, and additional OBX segments for each EKG measurement, e.g., the PR interval, QR interval, QRS axis, and so on.

21.2.5 Suffixes for Defining Observation IDs for Common Components of Narrative Reports (7.2.5)

Retained for backwards compatability only as of V2.7 and withdrawn as of v2.9, in favor of using LOINC codes that pre-coordinate the appropriate identifiers with the suffices. See Chapter 2.8.4.c.

21.3 General Trigger Events & Message Definitions (7.3)

The triggering events that follow are all served by the ORU (Unsolicited Observation Message, Unsolicited Point-of-Care Observation Message, Unsolicited Alert Observation Message), the OUL (Observational Report - Automated Lab), or the OPU (Observational Report - Population) messages in combination with ACK and ORA (Observational Report - Application Acknowledgement). Each triggering event is listed below, along with the messages exchanged, and the segments that comprise the messages. The notation used to describe the sequence, optionality, and repeating of segments is described in Chapter 2, "Format for defining abstract messages."

21.3.1 ORU - Unsolicited Observation Message (Event R01) (7.3.1)

The ORU message is for transmitting observational results, including lab, clinical or other observations, to other systems.. The OUL message is designed to accommodate the laboratory processes of laboratory automation systems.

With the segment (OBX) defined in this chapter, and the OBR defined in Chapter 4, one can construct almost any clinical report as a multi-level hierarchy, with the PID segment defined in Chapter 3 at the upper level, an order record (OBR) at the next level with one or more observation records (OBX), followed by the specimen information (SPM) and one or more observations (OBX) directly associated with the specimen.

One result segment (OBX) is transmitted for each component of a diagnostic report, such as an EKG or obstetrical ultrasound or electrolyte battery.

The CTD segment in this trigger is used to transmit temporary patient contact details specific to this order.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

Many report headers (OBR) may be sent beneath each patient segment, with many separate observation segments (OBX) related to the order / observation request beneath each OBR. OBX segments that are related to specimens immediately follow the SPM segments. Note segments (NTE) may be inserted at different locations in the message. The note segment applies to the entity that immediately precedes it, i.e., the patient if it follows the PID segment, the observation request if it follows the OBR segment, and the individual result if it follows the OBX segment.

There is not supposed to be an Application Level acknowledgement to an Application Level Acknowledgement message. In Enhanced Mode, MSH-16 SHALL always be set to NE (Never).

21.3.2 OUL - Unsolicited Laboratory Observation Message (Event R21) (7.3.2)

Attention: Retained for backwards compatibility only as of v 2.5 and withdrawn as of v 2.7.  

21.3.3 QRY/ORF - Query for Results of Observation (Events R02, R04) (7.3.3)

Attention: Retained for backwards compatibility only as of v 2. .and withdrawn as of v 2.7.

21.3.4 ORU - Unsolicited Point-Of-Care Observation Message without Existing Order - Place an Order (Event R30) (7.3.4)

This event trigger instructs the receiving system to create a new order for the observation(s) contained in the message.

One example of this trigger's use case occurs when a Doctor verbally instructs a nurse to perform a test. Looking at this use case from an information management perspective, one might expect that, the nurse would enter an order into laboratory information or ordering system before performing the test. However, there usually isn't time for order entry in these use cases. In fact, it is highly desirable for the POC measurement process to become automated so that the only action a user needs to take is to make a measurement on the POC Device, with all other processes for generating an order and tying it in to the observation handled by the "machines."

In order to allow for the passing of specific information relating to the Patient, responsible Doctor, placing doctor, patient location, etc., there is a requirement for the inclusion of a PV1 and PD1 segment in the ORU message type. One example of this trigger's use case occurs when a Doctor at a remote site without a shared Patient index instructs a nurse to perform a test. The testing is carried out without prior entry of a request into the LIS. Once performed, the results, along with the patient information are transmitted to the LIS. In some circumstances, the LIS may add clinical interpretation to this and report it back to the placing system and/or another system. In order to allow for this to take place, the requester, location, etc., information is required.

To allow the sending system to correlate every result with its associated order, the receiving system will return the placer order number in the ORC segment of the ORA^R33 message. If the receiving system cannot place an order it must returning an application level error description in the Application Acknowledgement Message MSA Text Message field.

The sending system must return a commit-level acknowledgement in response to the ORA^R33 message.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

There is not supposed to be an Application Level acknowledgement to an Application Level Acknowledgement message. In Enhanced Mode, MSH-16 SHALL always be set to NE (Never).

21.3.5 ORU - Unsolicited New Point-Of-Care Observation Message - Search for an Order (Event R31) (7.3.5)

This event trigger instructs the receiving system to search for an existing order for the observation(s) contained in the message.

In this case, the sending system does not know if an order has been placed. This transaction instructs the receiving system to search for an existing order for the associated results. If the receiver finds an existing order, it should return the Placer ID to the sender in the ORC segment of an OML^O21 message. This information allows the Observation Reviewer to correlate every result with its associated order.

The institution's business rules will determine what the receiving system does if it can't find a matching order. Possibilities include automatically placing an order (as in trigger event R30), or returning an application level error description in the Application Acknowledgement MSA Text Message field..

If it is necessary to pass specific information related to the Patient, responsible Doctor, placing doctor, patient location etc, there is a requirement for the inclusion of a PV1 and PD1 segment in the ORU message type (see also ORU^R30 for description).

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

There is not supposed to be an Application Level acknowledgement to an Application LevelAcknowledgement message. In Enhanced Mode, MSH-16 SHALL always be set to NE (Never).

21.3.6 ORU - Unsolicited Pre-Ordered Point-Of-Care Observation (Event R32) (7.3.6)

This event trigger instructs the receiver to place the result with the order information included in the message.

From a traditional clinical laboratory perspective, this event trigger's use case is probably the predominant (if not exclusive) one. However, in the POC environment, it is actually uncommon to have an order already generated when a test is performed. It does happen sometimes, though. If it is necessary to pass specific information related to the Patient, responsible Doctor, placing doctor, patient location, etc., there is a requirement for the inclusion of a PV1 and PD1 segment in the ORU message type (see also ORU^R30 for description).

If the receiving system accepts both the order and the result, it will return an ORA^R33 Application Acknowledgement message with the acknowledgement code of AA. A comment may be included in the Acknowledgement Message MSA Text Message field.

If the receiving system is unable to accept both the order and the result, no order or result should be placed and an ACK^33 Application Acknowledgement message must be returned to the sender with the error identified in the MSA Text Message field.

The sending system must return a commit-level acknowledgement in response to the ORA^R33 message.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

There is not supposed to be an Application Level acknowledgement to an Application Level Acknowledgement message. In Enhanced Mode, MSH-16 SHALL always be set to NE (Never).

21.3.7 ORA - Observation Report Acknowledgement (Event R33) (7.3.7)

This message enables a response to the ORU^R30 message to provide an application level acknowledgement that may include a placer order number.

There is not supposed to be an Application Level acknowledgement to an Application Level Acknowledgement message. In Enhanced Mode, MSH-16 SHALL always be set to NE (Never).

21.3.8 OUL - Unsolicited Specimen Oriented Observation Message (Event R22 ) (7.3.8)

This message was designed to accommodate specimen oriented testing. It should be applicable to container-less testing (e.g., elephant on a table) and laboratory automation systems requiring container.

Generally this construct allows transfer of multiple results related to a specimen from a patient, where this specimen has been in none, one, or multiple containers.

In addition to the patient results themselves it permits the communication of the following kinds of information:

• Analysis results of a non patient related sample (e.g., environmental) - patient related segments (e.g., PID, PD1, PV1, PV2) are optional.

• Analysis results to a particular container with QC sample and the lot and manufacturer information about this sample (SAC-INV segments) - however for this purpose the "Unsolicited Specimen Container Oriented Observation Message" (OUL^R23) is recommended due to explicit relation between the observation and the container.

• Basic identification data (lot, manufacturer, etc.) of the reagents and other substances involved in the generation of analysis results (TCD-SID segments).

Refer to Chapter 13 Laboratory Automation for additional examples of usage of SAC.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

21.3.9 OUL - Unsolicited Specimen Container Oriented Observation Message (Event R23) (7.3.9)

This message was designed to accommodate specimen oriented testing. It should be applicable to, for example, laboratory automation systems requiring container.

Generally this construct allows transfer of multiple results related to one or more specific containers with one or more specimens from a patient.

In addition to the patient results themselves it permits the communication of the following kinds of information:

• Analysis results of a non patient related sample (e.g., environmental) - patient related segments (e.g., PID, PD1, PV1, PV2) are optional.

• Analysis results to a particular container with QC sample and the lot and manufacturer information about this sample (SAC-INV segments).

• Basic identification data (lot, manufacturer, etc.) of the reagents and other substances involved in the generation of analysis results (TCD-SID segments).

Refer to Chapter 13 Laboratory Automation for additional examples of usage of SAC.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

21.3.10 OUL - Unsolicited Order Oriented Observation Message (Event R24) (7.3.10)

This message was designed to accommodate multi-specimen oriented testing. It should be applicable to, e.g., laboratory automation systems requiring container.

Generally this construct allows transfer of multiple results, each one related to none, one or more specific containers with one or more specimens from a patient. (Example: Creatinine Clearance result with detailed information about the urine and serum specimens and their containers.)

In addition to the patient results themselves it permits the communication of the following kinds of information:

• Analysis results of a non patient related sample (e.g., environmental) - patient related segments (e.g., PID, PD1, PV1, PV2) are optional.

• Analysis results to a particular container with QC sample and the lot and manufacturer information about this sample (SAC-INV segments).

• Basic identification data (lot, manufacturer, etc.) of the reagents and other substances involved in the generation of analysis results (TCD-SID segments).

Refer to Chapter 13 Laboratory Automation for additional examples of usage of SAC.

The Device segment (DEV) provides additional device information for a device referenced in one or more of the PRT segments in the message (using PRT-10 Participation Device to match DEV-2 Unique Device Identifier or PRT-22 Participation Device Type using DEV-3 Device Type).

21.3.11 OPU - Unsolicited Population/Location-Based Laboratory Observation Message (Event R25) (7.3.11)

This message supports unsolicited population or location-based surveillance reporting to a central repository where the accession / visit may contain references to multiple patients, multiple specimens, non-patient specimens, and multiple orders per specimen.

This message structure represents the way most submissions to veterinary laboratories occur. There is a multi-tier hierarchy in which a single individual (for example, a veterinarian or an owner of a production facility) submits one or more specimen samples from one or more animals or non-living entity, such as environmental specimens or feed. This grouped submission of specimens from multiple animal 'patients' is usually referred to as an 'accession' which can be considered analogous to a 'visit' in the veterinary laboratory context. This is what accounts for the unusual structure where the PV1 segment precedes a repeatable ACCESSION_DETAIL group.

Since specimens can originate from non-patients the PATIENT group is optional. This allows for specimens that are both associated with patients as well as those associated with non-patients to be included under the same accession (visit). Each specimen may have one or more orders assigned, each of which may have one or more individual results.

The OBX segment at the visit level provides the reason for submission. The repeatable PRT segment at the visit level represents the person(s) or organization submitting the request and other interested parties and locations who (that) play a role in the disposition of the accession/visit.

The NK1 segment contains owner and/or responsible party information for the patient and/or specimen.

21.3.12 ORU - Unsolicited Alert Observation Message (Event R40) (7.3.12)

The R40 trigger event is used for observation reports that include an alertable condition, i.e., for which some timely human or application intervention in patient care may be indicated by the findings. The ORA^R41 provides the application level response to the ORU^R40.

The ORU^R40 message is outside of the order-fulfilling cycle of the ORU and OUL messages with other trigger events, and is supplemental to those order-fulfilling observations. As such, the results conveyed in the ORU^R40 do not replace, edit, or override the results of messages with other trigger events.

The ORU^R40 message represents a unitary alert, which is to be acknowledged as a whole by an ORA message. Multiple alerts requiring separate acknowledgement must be sent as individual messages.

The ORDER_OBSERVATION Segment Group which has OBR-49 value A (Alert provider when abnormal) conveys the alert observation(s). One or more OBX segments in this Segment Group will typically have OBX-8 Interpretation Codes value of LL. HH, or AA. At least one OBR segment shall have OBR-49 value A. Other ORDER_OBSERVATION Segment Groups within the message shall be considered supporting information for the alert observation(s).

An alert observation report may simply replicate observations conveyed in another observation message, e.g., sent in an ORU^R01 (the source observation). In such an instance the ORDER_OBSERVATION Segment Group shall replicate the OBR (and ORC, if present) of the source observation.

An alert observation reporting application may also derive a new alertable observation, e.g., from a combination of other observations from multiple orders, processed by a clinical decision support rule set. In this case, the ORDER_OBSERVATION Segment Group with the alertable observation may use an OBR representing the "order" for clinical decision support, with this instance uniquely identified in the OBR-51 Observation Group ID. Supporting source observations may be conveyed in subsequent ORDER_OBSERVATION Segment Groups in the message using their original OBR information.

If the reporting application can identify a preferred recipient for the alert, that may be conveyed in the PRT segment related to the OBR or OBX (with PRT-4 value RCT "Results Copies To"). This recipient may not be the same as the recipient(s) identified in a source observation. There is no expectation that the reporting application will a priori know a preferred recipient, nor that the receiving application will deliver the alert to the identified recipient (e.g., it may be delivered to an "on-call" clinician in lieu of the identified recipient).

21.3.13 ORA - Observation Report Alert Acknowledgement (Event R41) (7.3.13)

This message enables application level acknowledgements in response to the ORU^R40 alert observation message.

The R41 trigger event is used to indicate that the alert observation has been delivered to, and acknowledged by, a clinical user. If the clinical user can be identified, that identity can be conveyed in the PRT segment (with PRT-4 value AAP Alert Acknowledging Provider).

Considering that the alerts may be received by multiple providers, multiple acknowledgements may be returned. The behavior associated with the user acknowledgement may be specified in a local implementation agreement or implementation guide and may be indicated in MSH-21 Message Profile Identifier.

21.3.14 ORU - Unsolicited Device Event Observation Message (Event R42) (7.3.14)

The R42 trigger event is used for observation reports that identify a device-sourced event (e.g., transition on an infusion pump between primary and secondary modes of operation) that is relevant to clinical workflow but that does not require a response from a clinician or clinical management system (in which case, an R40 alert message should be used). These events are episodic (vs. periodic), require low latency and appropriate prioritized handling (i.e., should be communicated immediately after the event is signaled), and typically require low transmission bandwidth. R42 messages do not need to provide for an application level response, as does the ORU^R40 message (via the ORA^R41 message).

Use examples of this message include:

Electronic medication administration record (eMAR) systems that record the pre-programmed transition event of an infusion pump between primary and secondary operational modes, or when it is manually paused and then restarted;

Clinical decision support systems (CDSS) that track a patient’s progress by monitoring, among other events, ventilator transitions from the primary operational mode to a backup mode (e.g., patient triggered to fully mechanical breaths);

Clinical information systems that note an event when a patient’s physiological monitor is placed into Standby Mode;

Computerized Maintenance Management Systems (CMMS) records usage events and technical (non-alert) maintenance events to determine when a piece of equipment should be evaluated for proper operation.

In contrast to ORU^R42, the ORU^R01 message is typically used to periodically report “bulk” or full-disclosure device data that may include event information, albeit not reported in a timely manner and in a way that requires more processing to identify. As mentioned, the ORU^R40 message supports a class of episodic events, but focuses on those alerts and alarms that require some level of clinical response to resolve. The ORU^R42 message explicitly does not require clinical action to be taken in response to receipt of the message.

The OBX-8 field for these messages should be left blank or set to “N” for normal. Any abnormal or other non-normal indications should result in usage of the ORU^R40 message.

The ORU^R40 message is outside of the order-fulfilling cycle of the ORU and OUL messages with other trigger events, and is supplemental to those order-fulfilling observations. As such, the results conveyed in the ORU^R40 message do not replace, edit, or override the results of messages with other trigger events.

21.3.15 ORU - Unsolicited Patient-Device Association Observation Message (Event R43) (7.3.15)

The R43 trigger event is used for observation reports that indicate the association of one patient to one or more health care devices. This includes both patient-device association as well as disassociation when a device is removed from active use with a patient. Other messages may be utilized for this purpose (e.g., ADT); however, this message was chosen given the general use of ORU-style messages to communicate device data, including unique device identifiers (e.g., PRT-10 and UDI components), and the possible need to include additional device data such as hardware / software configuration. The R43 trigger provides indication of the specialized usage of this message. Note that OBX-3 Observation Identifier, PRT-4 Participation, and OBX-11 Observation Result Status represent the purpose of the association of the device and the status of that association as further defined through the appropriate implementation guides and/or profiles.

Use cases that this message supports include:

Simple patient-device association where a system that integrates a bar code or RFID reader is used to capture patient and device identifiers at the point of care and then communicate those to other devices and systems that process device data associated with the same patient.

When one or more devices are no longer associated with a patient, this message can be used to communicate this change of status

Systems may not only perform the identifier acquisition from patients and devices, but may also authenticate the identifiers and support cross-referencing (e.g., when there are multiple patient identifiers)

In the latter use case, this message can be used to establish a “source of truth” for patient-device associations. There are many systems in and supportive of the point of care that make associations between patients and health care devices, all of which need to be coordinated to ensure there are no mis-matches between information sources and the patients to which they are associated.

The message shall identify a patient with optional location information, and one or more device observations, each including a unique device identifier along with an indication of whether the device is being associated or disassociated with the specified patient. In addition, a single observation can be specified to disassociate all devices for a given patient.

The event type will be carried in the message header segment.

21.3.16 CRM - Clinical Study Registration Message (Events C01-C08) (7.7.1)

The data are entered in a clinical trials or other patient data system and broadcast to other facility systems such as order entry, pharmacy, accounting, and nursing systems. They can be transmitted in batch mode or broadcast to outside-facility computer systems, including diagnostic and patient management systems. It is assumed that proper routing and security mechanisms are in place.

The general acknowledgement message as defined in Chapter 2 should be used for any acknowledgements.

	Event		Description
	C01		Register a patient on a clinical trial
	C02		Cancel a patient registration on clinical trial (for clerical mistakes since an intended registration should not be canceled)
	C03		Correct/update registration information
	C04		Patient has gone off a clinical trial
	C05		Patient enters phase of clinical trial
	C06		Cancel patient entering a phase (clerical mistake)
	C07		Correct/update phase information
	C08		Patient has gone off phase of clinical trial

21.3.17 CSU - Unsolicited Study Data Message (Events C09-C12) (7.7.2)

Data are entered in the clinical trials system or may reside in laboratory, pathology, radiology, pharmacy and/or other clinical applications. Most clinical trials data - clinical observations and study variables - will be communicated in OBR and OBX segments. The CSR, CSP, and CSS segments will identify the specific association these OBR and OBX have to the clinical trial. Data can be broadcast or transmitted in batch mode to study sponsors or the data management center for collaborative studies.

The general acknowledgement message as defined in Chapter 2 should be used for any acknowledgements.

	Event		Description
	C09		Automated time intervals for reporting, like monthly
	C10		Patient completes the clinical trial
	C11		Patient completes a phase of the clinical trial
	C12		Update/correction of patient order/result information

21.4 Clinical Trials - Examples of use (7.9)

21.4.1 CRM - Message When Patient Registered on a Clinical Trial (7.9.1)

MSH|^~\&|PDMS|MDACC|ORDER ENTRY|MDACC|200006021649||CRM^C01^CRM_C01|...

PID|1||2222||Everywoman^Eve^E||19530117|...

CSR|DM94-004^MDACC||MDACC|3||19941013||342^^^^^^^PDMS| |||||1005^^^^^^^MDACC|19941013|Y^Meets All Requirements^PDMS|...

21.4.2 CRM - Message When Patient Begins a Phase of a Clinical Trial (7.9.2)

MSH|^~\&|PDMS|MDACC|PHARM|MDACC|200006050925||CRM^C05^CRM_C05|...

PID|1||2222||Everywoman^Eve^E||19230213|...

CSR|ID91-025^MDACC||MDACC|301||19941005||342^^^^^^^PDMS |||19941201|2^blind^PDMS| 12^Smoker,Stage II,<60^PDMS|...

CSP|2^Treatment^PDMS|19941201|...

21.4.3 CSU - Message Reporting Monthly Patient Data Updates to the Sponsor (7.9.3)

MSH|^~\&|PDMS|MDACC|CTMS|NCI|200006050927||CSU^C09^CRM_C09|...

PID|1||235925||J^F^M||19350616|...[note:anonymous]

CSR|T93-080^NCI|ID93-030^^MDACC|MDACC|14||19941205|...

CSS|^Prestudy|19941204|C^compliant^NCI

OBR|1|1234|1234|3^EligibilChecklist^StudyFormsList|||19941205|...

Note: The clinical trials section probably needs its own definition of OBR. OBR-2&3 have condition rules indicating that the placer and filler numbers must be present in either the ORC or the OBR. Since an ORC is not present, then these fields must be populated in the OBR. My guess is that clinical trials aren't interested in the placer and filler number.

OBX|1|CWE|ELIG1^Elig Crit 1^NCI|Text Elig Crit 1|Y|...

OBX|2|CWE|ELIG2^Elig Crit 2^NCI||Y|...

OBR|2|1235|1235|4^Prestudy Form^StudyFormsList|||19941205|...

OBX|1|CWE|QOL^Quality of Life^NCI||2\T\3\T\2\T\4\T\2^SPITZER|...

OBX|2|CWE|PRICHEM^Prior Chemo^NCI||Yes|...

OBX|3|CWE|PRIBIOL^Prior Biologics^NCI||No|...

OBX|4|NM|NUMREM^Number Prior Remissions^NCI||2|...

OBR|3|932^OE|243789^LAB|88304^SURG PATH REPORT|||19940101|...

OBX|1|CWE|88304&ANT|1|9999^PANCREAS^SNM|...

OBX|2|CWE|88304&IMP|2|9999^ADENOCARCINOMA^SNM|...

OBR|4|933^OE|243790^LAB|85022^CBC|||199412050800|...

OBX|1|NM|718-7^HEMOGLOBIN:^LN||13.4|GM/DL|14-18|N||S|F|19860522|...

[cbc values]

OBX|2|NM|4544-3^HEMATOCRIT:^LN||40.3|%|42-52|L||S|F|19860522|...

OBX|3|NM|789-8^ERYTHROCYTES:^LN||4.56|10*6/ml|4.7-6.1|L||S|F|19860522|...

OBX|4|NM|787-22^ERYTHROCYTE MEAN CORPUSCULAR VOLUME:^LN||88|fl |80-94|N||S|F|19860522|...

OBX|5|NM|785-6^ERYTHROCYTE MEAN CORPUSCULAR HEMOGLOBIN:^LN||29.5|pg |27-31|N||N|F|19860522|...

OBX|6|NM|786-4^ERYTHROCYTE MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION:^LN||33|%|33-37|N||N|F|19860522|...

OBX|7|NM|6690-2^LEUKOCYTES:^LN||10.7|10*3/ml|4.8-10.8|N||N|F|19860522|...

OBX|8|NM|764-1^NEUTROPHILS BAND FORM/100 LEUKOCYTES:^LN||2|%|||||F|...

OBX|9|NM|769-0^NEUTROPHILS SEGMENTED/100 LEUKOCYTES:^LN||67|%|||||F |...

OBX|10|NM|736-9^LYMPHOCYTES/100 LEUKOCYTES:^LN||29|%|||||F|...

OBX|11|NM|5905-5^MONOCYTES/100 LEUKOCYTES:^LN||1|%|||||F|...

OBX|12|NM|713-8^EOSINOPHILS/100 LEUKOCYTES:^LN||2|%|||||F|...

OBR|5|934^OE|243791^LAB|80004^ELECTROLYTES|||199412050800|...

OBX|1|NM|2947-0^SODIUM:^LN||150|mmol/l|136-148|H||A|F|19850301 |...

OBX|2|NM|2823-3^POTASSIUM:^LN||4.5|mmol/l|3.5-5|N||N|F|19850301|...

[electrolytes values]

OBX|3|NM|2069-3^CHLORIDE:^LN||102|mmol/l|94-105|N||N|F|19850301|...

OBX|4|NM|2028-9^CARBON DIOXIDE.TOTAL:^LN||27|mmol/l|24-31|N||N|F |19850301|...

CSP|^Course 1|19941205|19950120|Y^Toxicity and Response^NCI |...

CSS|^Course Completion|19950120|...

OBR|1|935^OE|243791^LAB|2039-6^CARCINOEMBRYONIC AG:^LN|||19941008|...

OBX|1|NM|2039-6^CARCINOEMBRYONIC AG:^LN||15.2|IU |...

OBR|2|1236|1236|10^Course Completion Form^StudyPhaseFormsList|||19950120 |...

OBX|1|CWE|CRSRESP^Course Response^NCI||4^Partial Response|...

OBX|2|NM|DRUGDISP^Capsules Dispensed^NCI||60|...

OBX|3|NM|DRUGRETN^Capsules Returned^NCI||5|...

OBX|4|ID|DXCOMP^Diagnostic Tests Compliance^NCI||Y|...

OBX|5|CWE|PERSTAT^Performance Status^NCI||3^ZUBRODS|...

OBR|3|1237|1237|9999^Adverse Events|...

OBX|1|CWE|9999&EVENT|1|45^Vomiting^NCI|...

OBX|2|DT|9999&ONSET|1|19941215|...

OBX|3|DT|9999&RESOLUTION|1|19941217|...

OBX|4|CWE|9999&GRADE|1|M^MODERATE|...

OBX|5|CWE|9999&RELATION_TO_RX|1|L^LIKELY|...

OBX|6|CWE|9999&EVENT|2|303^Dyspnea^NCI|...

OBX|7|DT|9999&ONSET|2|19941231|...

OBX|8|DT|9999&RESOLUTION|2|...

OBX|9|CWE|9999&GRADE|2|MI^MILD|...

OBX|10|CWE|9999&RELATION_TO_RX|2|U^UNLIKELY|...

[Note: Needs to maintain compatibility with ongoing product experience message efforts.]

[Note2: There are other possible OBX suffixes defined by FDA: APEX/ NADIR, ACTION, THERAPY, OUTCOME, RECHALLENGE.]

21.5 Product Experience (7.10)

Patients experience symptoms, manifest signs or develop diseases or syndromes while exposed to medical devices and/or drugs. Evidence suggests that some of these symptoms, signs, diseases or syndromes may develop as a consequence of the products used. Examples include the development of clear cell adenocarcinoma of the vagina in the daughters of mothers treated with diethylstilbestrol during pregnancy and gastrointestinal bleeding in patients treated with non-steroidal anti-inflammatory drugs. While it is difficult to prove causality, strong evidence exists in many cases.

It is important to document such experiences during the development and testing of products to identify potential adverse effects but also during routine use of the product to identify serious adverse effects which occur infrequently. The latter is the realm of pharmacoepidemiology and post-marketing surveillance.

Adverse events are important for product manufacturers as signal generating hypotheses concerning drug kinetics or dynamics, often in special populations of patients. Adverse events are important for regulators in ensuring that manufacturers protect the public health in assessments of risk and benefits, including special populations, and that they promptly and thoroughly investigate individual events and clusters of events. Adverse events are especially important for practitioners and patients who always deal with a special population of one individual who may be having an event and a practitioner seeking information about related events seen with the same or similar products.

Reporting has usually focused on serious and unexpected events. Serious, if defined unambiguously, focuses attention on those events of most importance to the patient and practitioner. Expected events are those which prior experience has demonstrated to be probabilistically linked to the product and are generally included in product labeling.

Because of the risks associated with the uses of drugs and medical devices, a system of surveillance has been established in most developed countries. With globalization of the marketplace, the need to share this information across national boundaries has increased. Currently most reporting is performed using a series of forms, including CIOMS, yellow cards, the FDA's 1639 and MedWatch forms and the Japanese form, which are sent:

• from identified reporting sources to regulatory bodies

• from identified reporting sources to product manufacturers

• between regulatory bodies

• within product manufacturers

• within regulatory bodies

• from product manufacturers to regulatory bodies

• from regulatory bodies to the WHO Collaborative Drug Surveillance Center

Figure 7-6. - Flow of product experience information

Regardless of who originates a drug experience report, documentation of the experience eventually reaches the regulatory agencies. The manufacturer is mandated to alert the regulatory agency.

Electronic interchange of these data would reduce errors, decrease costs and speed communications.

21.5.1 Glossary (7.10.1)

21.5.1.1 hiddentext (7.10.1.0)

21.5.1.2 Drug: (7.10.1.1)

Any chemical compound that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiological condition (Dorland's Illustrated Medical Dictionary 27th edition).

21.5.1.3 Medical device: (7.10.1.2)

Something contrived for or used in the diagnosis (vascular catheters), treatment (thermotherapy units) or prevention of disease or other abnormal condition, for the relief of pain or suffering or to control or improve any physiologic condition, including instrumentation and implanted devices (prosthetic cardiac valves, pacemakers, hip prostheses).

21.5.1.4 Product: (7.10.1.3)

A drug or medical device.

21.5.1.5 Non-proprietary (generic) name: (7.10.1.4)

Drug name that is not protected by a trademark, usually descriptive of its chemical structure; sometimes called a public name. In the US, most generic drug names are assigned by the US Adopted Name Council (USAN). Other generic names in common use are the National Formulary (NF) and the US Pharmacopoeia (USP) names. Figure 7-3 lists other available drug coding systems.

21.5.1.6 Trade (brand) name: (7.10.1.5)

Proprietary names that are registered to protect the name for the sole use of the manufacturer holding the trademark.

21.5.1.7 Adverse event/adverse experience: (7.10.1.6)

• Pre-marketing: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

• Post-marketing/European Union: Any undesirable experience occurring to a patient treated with a pharmaceutical product whether or not considered related to the medicinal product.

• Post-marketing/US: Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose; an adverse event occurring from drug withdrawal; and any failure of expected pharmacologic action.

• WHO: Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this product.

21.5.1.8 Adverse drug reaction: (7.10.1.7)

• Pre-marketing: All noxious and unintended responses to a medicinal product related to any dose.

• Post-marketing/WHO: A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function

• Post-marketing/European Union: A reaction which is harmful and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis, or treatment of disease or the modification of physiological function.

• Post-marketing/US: Any undesirable effect reasonably associated with the use of the drug that may occur as part of the pharmacological action of the drug or may be unpredictable.

21.5.1.9 Causation: (7.10.1.8)

An exposure which truly does increase or decrease the probability of a certain outcome.

21.5.1.10 Causal relationship: (7.10.1.9)

When an event occurs a product may be suspected as causing the event but rarely can it be proven particularly at an early stage of the product's life. Certain information about the relationship between the product and the event can reinforce the belief in a causal relationship between the product and the event while others can decrease the probability that there is a causal relationship.

21.5.1.11 Regulatory agency: (7.10.1.10)

Many geopolitical entities have established agencies/authority responsible for regulating products used in health care. The agencies are collectively referred to as regulatory agencies.

21.5.1.12 Product manufacturer: (7.10.1.11)

The organization which is responsible for the manufacture of a product. This will usually be the entity, which holds the marketing authorization for the product.

21.5.1.13 Holder of marketing authorization: (7.10.1.12)

The organization which holds the authority to market a product. This will often be the organization, which manufactures the product.

21.5.1.14 Serious adverse product reaction: (7.10.1.13)

An adverse product reaction which:

• is fatal (results in death)

• is life threatening

• requires hospitalization or prolongation of a hospitalization

• results in persistent or significant disability/incapacity

• results in a congenital anomaly/birth defect.

Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life threatening or result in hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These should also be considered serious.

21.5.1.15 Expected adverse product reaction: (7.10.1.14)

Expected events are those which prior experience has demonstrated to be probabilistically linked to the product and are generally included in product labeling.

Pre-marketing: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product).

Post-marketing/European Union: This relates to an adverse reaction which is not mentioned in any EC summary of product characteristics (SPC). In the absence of any European SPC, an international document prepared by the marketing authorization holder containing all relevant safety information which the marketing authorization holder considers should be listed for the medicinal product in all countries where the medicinal product is marketed (Care Data Sheet).

Post-marketing/US current: Unexpected means an adverse drug experience that is not listed in the current labeling for the drug product and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling but differs from the event because of greater severity or specificity.

Post-marketing/US (proposed): The applicant's core safety data sheet shall be a document prepared by the applicant that contains all relevant safety information, including adverse drug experiences, which the applicant believes should e listed for the drug in all countries where the drug is marketed. It may be used by the applicant as the reference document by which an adverse drug experience is judged to be expected or unexpected for purposes of this post-marketing periodic report.

Post-marketing/WHO: An adverse reaction, the nature or severity of which is not consistent with domestic labeling or market authorization, or expected from characteristics of the drug.

21.5.2 References (7.10.2)

Gabrielli ER. Standard specification for drug therapy documentation. ASTM Committee E31.12 July (1993).

Kessler DA. Introducing MEDWatch. JAMA 269: 2765-2768(1993).

Kurata JH, Overhage JM, Gabrielli E, Jones JK. International Data Standards for Hospital-based Drug Surveillance. M.D. Computing 12(1) 50-57 (1995).

Moore N, Montera d, Coulson R, DeAbajo F, Kreft-Jais C, Biron A, Monteaugudo J. The single case format: proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance. Pharmacoepidemiology and Drug Safety 3: 157-162 (1994)

Thompson WL. A modest proposal for enhancing the safety and effectiveness of use of human drugs, biologics and devices and animal health products with human health implications through cost-effective health informatics tools supporting a global database of safety reports as a joint ICH E2, M1 and M2 initiative. Private communication. March (1995)

21.6 Product Experience - Examples of use (7.13)

MSH|^-&|SAP||RAP||200006051512||PEX^P07|...

EVN|...

PID||1||A^A^A||19230616|F|||||||||||||||||Y|...

Note:This section probably needs to have its own definition of the PID. PID-3 is a required field in chapter 3, but in the context of this section probably shouldn't be required. I also removed PID-23, Birthplace (19950710). A date is not a birthplace.

PES|MakeADrug, Inc||Manufacturer Mall^^Ann Arbor^MI^99999|| GB95070448A|0|||19950704|19950710|10D|...

PEO||^Awaiting results of autopsy|19950704||||^^^^^GBR||S|N|D~H~O||Patient admitted via casualty with increased shortness of breath and left sided chest pain on 04 JUL 95 for assessment.~11-JUL-95 Patient admitted 09-JUL-95 at 11:30 PM with an 18 hour history of diarrhoea followed by collapse. On admission, patient was exhausted and dehydrated. She had a rash on both breasts and abdomen. Patient found to have deteriorating renal function. Patient commenced IV fluid, however patient was found dead on 10-JUL-95 morning. Query vomited and aspirated. Post mortem requested. Events possibly related to study drug.|...

PCR|xxxxx^Wonder Drug 1^ATC|N|^antineoplastic|||||||^NON SMALL CELL LUNG CANCER|...

RXE|1^^^19950629^19950710|xxxxx^Wonder Drug 1^ATC|1||TAB|||||||||||||||||M1|3||||NON SMALL CELL LUNG CANCER|...

RXR|PO|...

PRB|AD|19950704|705^DYSPNEA^MEDR|...

PRB|AD|19950710|20143^DEATH^MEDR|...

PRB|AD|19950704|18330^CHEST PAIN^MEDR|...

PRB|AD|19950709|21197^DIARRHEA^MEDR|...

PRB|AD|19950709|6432^SYNCOPE^MEDR|...

PRB|AD|19950709|4966^DEHYDRATION^MEDR|...

PRB|AD|19950709|20544^KIDNEY FUNCTION ABNORMAL^MEDR|...

OBX|1|NM|804-5^lEUKOCYTES^LN||2300|10*3/ml|||||F|19940704|...

OBX|2|NM|770-8^NEUTROPHILS/100 LEUKOCYTES^LN||1.9|%|||||F|19950704|...

OBX|3|NM|6299-2^UREA NITROGEN^LN||22.3|mg%|||||F|19950709|...

OBX|4|NM|2160-0^CREATININE^LN||247|mmole|||||F|19950709|...

NTE|||Additional details must be obtained from the affiliate in order to assess causality. A three day alert phone call was made to the FDA on 12-JUL-95|...

21.7 Waveform (7.14)

Retained for backwards compatibility only in v 2.7 and withdrawn as of v2.9. Implementers are encouraged to use other V2 guidance (e.g., IHE's PCD profile) or V3 constructs to support waveform messages.

21.8 Waveform - Trigger Events & Message Definitions (7.15)

Retained for backwards compatibility only in v 2.7 and withdrawm as of v2.9. Implementers are encouraged to use other V2 guidance (e.g., IHE's PCD profile) or V3 as it expands its use cases in this space, while using older V2 versions until that point.

21.9 Specimen Shipment Manifest (7.16)

21.9.1 OSM - Unsolicited Specimen Shipment Manifest Message (Event R26) (7.16.1)

The OSM^R26 Unsolicited Specimen Shipment Manifest message is used to communicate the contents of a specimen shipment to a specimen receiver (typically a laboratory). The message documents details regarding the following:

• Shipment information including sender, receiver, shipper, shipping container, etc.;

• Specimens in the shipment;

• Specimen containers; and,

• Identification of persons/places/things associated with the specimens.

21.9.1.1 Segment Notes (7.16.1.0)

The Participation (PRT) segment following the Shipment (SHP) segment is used to document participants in a shipment. A minimum of one Participation segment is required for documenting the destination of the shipment. Other participants including shipment originator, shipment packer, shipment waypoints, etc. can also be documented using the Participation segment.

The Observation/Result (OBX) segment in the SHIPPING_OBSERVATION segment group is used to carry any additional shipping information or observations that are not carried in the Shipment segment.

The Participation (PRT) segment following the Specimen (SPM) segment is used to identify the person(s) who collected the specimen.

The Observation/Result (OBX) segment in the SPECIMEN_OBSERVATION segment group is used to document any additional shipping information that is not conveyed in the Specimen (SPM) segment.

The Container (SAC) segment is used to document the containers for a specimen. If it is necessary to document where in a package a particular specimen container is found, use SAC-11 (Position in Carrier) to convey this position. SAC-10 (Carrier Identifier) can be used to carry the identifier of the package within which the specimen container is located.

The Observation/Result (OBX) segment in the CONTAINER_OBSERVATION segment group is used to document observations regarding the specimen container.

The SUBJECT_PERSON/ANIMAL_IDENTIFICATION segment group is used to associate a specimen with the person or animal the specimen was obtained from. If the subject of the testing is something other than a person, the Next of Kin/Associated Parties (NK1) segment will document the person or organization responsible or owning the subject. For patients who are persons, the NK1 segment documents the next of kin of the patient.

If the specimen was obtained from a population of animals or a location then the SUBJECT_POPULATION/LOCATION_IDENTIFICATION segment group should be used instead. The Patient Identification (PID) segment in this segment group is used to carry the species, breed and strain information for a population. The Next of Kin (NK1) segment in this segment group is used to convey information regarding the owner or responsible party for a population of animals or a location.

The Patient Visit (PV1) segment is used to provide basic information about a patient encounter where the specimen was taken.

The Observation/Result (OBX) segment in the PATIENT_VISIT_OBSERVATION segment group is used to document observations regarding the visit.

21.9.1.2 Actors (7.16.1.1)

21.9.1.2.1 Specimen Shipper (7.16.1.1.1)

The Specimen Shipper actor is an application capable of sending specimen shipments and transmitting the specimen shipment manifest message.

21.9.1.2.2 Specimen Shipment Receiver (7.16.1.1.2)

The Specimen Shipment Receiver actor is an application capable of receiving specimen shipments as well as specimen shipment manifest messages. Typically this application is associated with a Laboratory.

21.9.1.3 Activity Diagram (7.16.1.2)

The following activity diagram illustrates the usage of this message. The message is initially sent from the Specimen Shipper at the point the specimen is shipped. The actual point of transmission of the message could occur as soon as all the contents of the shipment have been identified, and the transporters shipment id has been assigned to the shipment. The specimen shipment receiver will send back transaction using the Specimen Shipment Manifest message indicating the specimen shipment has been accepted or rejected. This normally will occur after the shipment has been physically received and evaluated. Note that this response back is not considered an application acknowledgment, and is certainly not required. Its purpose is to update the shipper with the status of the shipment.

21.9.2 SHP - Shipment Segment (7.16.2)

The intent of this segment is to describe the information associated with the transportation of the shipment.

HL7 Attribute Table - SHP - Shipment

21.9.2.1 SHP Field Definitions (7.16.2.0)

21.9.2.2 SHP-1 Shipment ID (EI) 02317 (7.16.2.1)

Definition: The shipment id is the identifier assigned by the shipment transportation provider that uniquely identifies this shipment from all other shipments by the same provider. The addressee for the shipment should be able to use this identifier to match a physical shipment with the electronic manifest for the shipment.

21.9.2.3 SHP-2 Internal Shipment ID (EI) 02318 (7.16.2.2)

Definition: The internal shipment id is an identifier assigned to the shipment by the sender or addressee of the shipment. The field repeats allowing multiple identifiers to be transmitted.

21.9.2.4 SHP-3 Shipment Status (CWE) 02319 (7.16.2.3)

Definition: The shipment status specifies where in the shipment process the package is at the time of messaging. Refer to HL7 Table 0905 - Shipment Status for specific values:

21.9.2.5 SHP-4 Shipment Status Date/Time (DTM) 02320 (7.16.2.4)

Definition: The shipment status date/time carries the date and time the status in SHP-3 Shipment Status occurred.

21.9.2.6 SHP-5 Shipment Status Reason (TX) 02321 (7.16.2.5)

Definition: The shipment status reason is used to document the reason for the status in SHP-3 Shipment Status. This reason field is of particular importance when a shipment is rejected.

21.9.2.7 SHP-6 Shipment Priority (CWE) 02322 (7.16.2.6)

Definition: The shipment priority documents the priority the shipment has been given by the sender. Refer to HL7 Table 0906 - ActPriority for specific values.

21.9.2.8 SHP-7 Shipment Confidentiality (CWE) 02323 (7.16.2.7)

Definition: The shipment confidentiality documents any confidentiality that may be associated with this particular shipment. Refer to HL7 Table 0907 - Confidentiality for specific values.

21.9.2.9 SHP-8 Number of Packages in Shipment (NM) 02324 (7.16.2.8)

Definition: The number of packages in shipment field documents the total number of separate packages that are contained in the shipment. This total should not include packages that are nested inside of one another. For instance if a shipment consisted of 3 separate boxes, this field would contain the value

"…|3|…".

21.9.2.10 SHP-9 Shipment Condition (CWE) 02325 (7.16.2.9)

Definition: The shipment condition field allows the receiver of the shipment to document the condition of the shipment when it was received. Refer to HL7 Table 0544 - Container Condition for suggested values. Many of the values found in Table 0544 are associated with values found in Table 0376 (Special Handling Codes). Values from Table 0376 have had an X placed in front of them, and the meaning of the code has been changed to indicate that the type of handling has failed during shipment. For instance if a handling code indicated that the shipment was to be kept at body temperature (C37), and the shipment arrived at some other temperature, the XC37 condition code would be used to indicate the shipment arrived with a temperature outside the range indicated by the handling code.

21.9.2.11 SHP-10 Shipment Handling Code (CWE) 02326 (7.16.2.10)

Definition: This describes how the shipment needs to be handled during transport. Refer to User-defined Table 0376 - Special Handling Code for suggested values.

21.9.2.12 SHP-11 Shipment Risk Code (CWE) 02327 (7.16.2.11)

Definition: This field contains any known or suspected hazards associated with this shipment, e.g., exceptionally infectious agent or blood from a hepatitis patient. Refer to User-defined Table 0489 - Risk Codes for suggested values.

21.9.2.13 SHP-12 Action Code (ID) 00816 (7.16.2.12)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when SHP-1 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

21.9.3 PAC - Shipment Package Segment (7.16.3)

The intent of this segment is to describe the information associated with the shipping package specimens are sent in.

HL7 Attribute Table - PAC - Shipment Package

21.9.3.1 PAC Field Definitions (7.16.3.0)

21.9.3.2 PAC-1 Set Id – PAC (SI) 02350 (7.16.3.1)

Definition: This field contains the sequence number. This field is used to identify PAC segment instances in message structures where the PAC segment repeats

21.9.3.3 PAC-2 Package ID (EI) 02351 (7.16.3.2)

Definition: The Package ID uniquely identifies this package from all other packages within its shipment.

Condition: If SHP-8 Number of Packages in Shipment is greater then 1, then Package ID must be valued.

21.9.3.4 PAC-3 Parent Package ID (EI) 02352 (7.16.3.3)

Definition: The parent package id identifies the package which contains this package. This is used to link a nested set of packages. For instance a shipping container may itself contain several smaller packages. These contained packages would identify the shipping container as their parent package. Multiple layers of nested packaging can be documented in this fashion.

21.9.3.5 PAC-4 Position in Parent Package (NA) 02353 (7.16.3.4)

Definition: The position in parent package field is used when it is important to communicate specifically where in the parent package this package resides. Each position is identified with a position number. The NA (numeric array) data type is used to allow, if necessary, to transfer multiple axis information, e.g., 2-dimensional tray (X^Y).

21.9.3.6 PAC-5 Package Type (CWE) 02354 (7.16.3.5)

Definition: The package type field identifies the type of container. See User-defined Table 0908 - Package Type for values.

21.9.3.7 PAC-6 Package Condition (CWE) 02355 (7.16.3.6)

Definition: The package condition field describes the condition of the package at the time of the message. Refer to HL7 Table 0544 - Container Condition for suggested values.

21.9.3.8 PAC-7 Package Handling Code (CWE) 02356 (7.16.3.7)

Definition: This describes how the package needs to be handled during transport. Refer to User-defined Table 0376 - Special Handling Code for suggested values.

21.9.3.9 PAC-8 Package Risk Code (CWE) 02357 (7.16.3.8)

Definition: This field contains any known or suspected hazards associated with this package, e.g., exceptionally infectious agent or blood from a hepatitis patient. Refer to User-defined Table 0489 - Risk Codes for suggested values.

21.9.3.10 PAC-9 Action Code (ID) 00816 (7.16.3.9)

Definition: This field reveals the intent of the message. Refer to HL7 Table 0206 - Segment Action Code for valid values.

The action code can only be used when PAC-2 is valued in accordance with the guidance in Chapter 2, Section 2.10.4.2.

21.10 Tables Listings (7.17)

21.10.1 Common ISO Derived Units & ISO+ Extensions (7.17.1)

Figure 7-10. Common ISO derived units and ISO+ extensions

	Code/Abbr.		Name
	/(arb_u)		*1 / arbitrary unit
	/iu		*1 / international unit
	/kg		*1 / kilogram
	/L		1 / liter
	1/mL		*1 / milliliter
	10.L/min		*10 x liter / minute
	10.L /(min.m2)		*10 x (liter / minute) / meter2 = liter / (minute ? meter2)
	10*3/mm3		*103 / cubic millimeter (e.g., white blood cell count)
	10*3/L		*103 / Liter
	10*3/mL		*103 / milliliter
	10*6/mm3		*106 / millimeter3
	10*6/L		*106 / Liter
	10*6/mL		*106 / milliliter
	10*9/mm3		*109 / millimeter3
	10*9/L		*109 / Liter
	10*9/mL		*109 / milliliter
	10*12/L		*1012 / Liter
	10*3(rbc)		*1000 red blood cells†
	a/m		Ampere per meter
	(arb_u)		*Arbitrary unit
	bar		Bar (pressure; 1 bar = 100 kilopascals)
	/min		Beats or Other Events Per Minute
	bq		Becquerel
	(bdsk_u)		*Bodansky Units
	(bsa)		*Body surface area
	(cal)		*Calorie
	1		*Catalytic Fraction
	/L		Cells / Liter
	cm		Centimeter
	cm_h20		* Centimeters of water =H20 (pressure)
	cm_h20.s/L		Centimeters H20 / (liter / second) = (centimeters H20 ? second) / liter (e.g., mean pulmonary resistance)
	cm_h20/(s.m)		(Centimeters H20 / second) / meter = centimeters H20 / (second ? meter) (e.g., pulmonary pressure time product)
	(cfu)		*Colony Forming Units
	m3/s		Cubic meter per second
	d		Day
	db		Decibels
	dba		*Decibels a Scale
	cel		Degrees Celsius
	deg		Degrees of Angle
	(drop)		Drop
	10.un.s/cm5		Dyne ? Second / centimeter5 (1 dyne = 10 micronewton = 10 un) (e.g., systemic vascular resistance)
	10.un.s/(cm5.m2)		((Dyne ? second) / centimeter5) / meter2 = (Dyne ? second) / (centimeter5 ? meter2) (1 dyne = 10 micronewton = 10 un) (e.g., systemic vascular resistance/body surface area)
	ev		Electron volts (1 electron volt = 160.217 zeptojoules)
	eq		Equivalent
	f		Farad (capacitance)
	fg		Femtogram
	fL		Femtoliter
	fmol		Femtomole
	/mL		*Fibers / milliliter
	g		Gram
	g/d		*Gram / Day
	g/dL		Gram / Deciliter
	g/hr		Gram / Hour
	g/(8.hr)		*Gram / 8 Hour Shift
	g/kg		Gram / Kilogram (e.g., mass dose of medication per body weight)
	g/(kg.d)		(Gram / Kilogram) / Day = gram / (kilogram ? day) (e.g., mass dose of medication per body weight per day)
	g/(kg.hr)		(Gram / Kilogram) / Hour = gram / (kilogram ? hour) (e.g., mass dose of medication per body weight per hour)
	g/(8.kg.hr)		(Gram / Kilogram) /8 Hour Shift = gram / (kilogram ? 8 hour shift) (e.g., mass dose of medication per body weight per 8 hour shift)
	g/(kg.min)		(Gram / Kilogram) / Minute = gram / (kilogram ? minute) (e.g., mass dose of medication per body weight per minute)
	g/L		Gram / Liter
	g/m2		Gram / Meter2 (e.g., mass does of medication per body surface area)
	g/min		Gram / Minute
	g.m/(hb)		Gram ? meter / heart beat (e.g., ventricular stroke work)
	g.m/((hb).m2)		(Gram ? meter/ heartbeat) / meter2 = (gram ? meter) / (heartbeat ? meter2)	(e.g., ventricular stroke work/body surface area, ventricular stroke work index)
	g(creat)		*Gram creatinine
	g(hgb)		*Gram hemoglobin
	g.m		Gram meter
	g(tot_nit)		*Gram total nitrogen
	g(tot_prot)		*Gram total protein
	g(wet_tis)		*Gram wet weight tissue
	gy		Grey (absorbed radiation dose)
	hL		Hectaliter = 102 liter
	h		Henry
	in		Inches
	in_hg		Inches of Mercury (=Hg)
	iu		*International Unit
	iu/d		*International Unit / Day
	iu/hr		*International Unit / Hour
	iu/kg		International Unit / Kilogram
	iu/L		*International Unit / Liter
	iu/mL		*International Unit / Milliliter
	iu/min		*International Unit / Minute
	j/L		Joule/liter (e.g., work of breathing)
	kat		*Katal
	kat/kg		*Katal / Kilogram
	kat/L		*Katal / Liter
	k/watt		Kelvin per watt
	(kcal)		Kilocalorie (1 kcal = 6.693 kilojoule)
	(kcal)/d		*Kilocalorie / Day
	(kcal)/hr		*Kilocalorie / Hour
	(kcal)/(8.hr)		*Kilocalorie / 8 Hours Shift
	kg		Kilogram
	kg(body_wt)		* kilogram body weight
	kg/m3		Kilogram per cubic meter
	kh/h		Kilogram per hour
	kg/L		Kilogram / liter
	kg/min		Kilogram per minute
	kg/mol		Kilogram / mole
	kg/s		Kilogram / second
	kg/(s.m2)		(Kilogram / second)/ meter2 = kilogram / (second ? meter2)
	kg/ms		Kilogram per square meter
	kg.m/s		Kilogram meter per second
	kpa		Kilopascal (1 mmHg = 0.1333 kilopascals)
	ks		Kilosecond
	(ka_u)		King-Armstrong Unit
	(knk_u)		*Kunkel Units
	L		Liter
	L/d		*Liter / Day
	L/hr		Liter / hour
	L/(8.hr)		*Liter / 8 hour shift
	L/kg		Liter / kilogram
	L/min		Liter / minute
	L/(min.m2)		(Liter / minute) / meter2 = liter / (minute ? meter2)	(e.g., cardiac output/body surface area = cardiac index)
	L/s		Liter / second (e.g., peak expiratory flow)
	L.s		Liter / second / second2 = liter ? second
	lm		Lumen
	lm/m2		Lumen / Meter2
	(mclg_u)		*MacLagan Units
	mas		Megasecond
	m		Meter
	m2		Meter2 (e.g., body surface area)
	m/s		Meter / Second
	m/s2		Meter / Second2
	ueq		*Microequivalents
	ug		Microgram
	ug/d		Microgram / Day
	ug/dL		Microgram / Deciliter
	ug/g		Microgram / Gram
	ug/hr		*Microgram / Hour
	ug(8hr)		Microgram / 8 Hour Shift
	ug/kg		Microgram / Kilogram
	ug/(kg.d)		(Microgram / Kilogram) /Day = microgram / (kilogram ? day) (e.g., mass dose of medication per patient body weight per day)
	ug/(kg.hr)		(Microgram / Kilogram) / Hour = microgram / (kilogram ? hours) (e.g., mass dose of medication per patient body weight per hour)
	ug/(8.hr.kg)		(Microgram / Kilogram) / 8 hour shift = microgram / (kilogram ? 8 hour shift)	(e.g., mass dose of medication per patient body weight per 8 hour shift)
	ug/(kg.min)		(Microgram / Kilogram) / Minute = microgram / (kilogram ? minute)	(e.g., mass dose of medication per patient body weight per minute)
	ug/L		Microgram / Liter
	ug/m2		Microgram / Meter2 (e.g., mass dose of medication per patient body surface area)
	ug/min		Microgram / Minute
	uiu		*Micro international unit
	ukat		*Microkatel
	um		Micrometer (Micron)
	umol		Micromole
	umol/d		Micromole / Day
	umol/L		Micromole / Liter
	umol/min		Micromole / Minute
	us		Microsecond
	uv		Microvolt
	mbar		Millibar (1 millibar = 100 pascals)
	mbar.s/L		Millibar / (liter / second) =(millibar ? second) / liter (e.g., expiratory resistance)
	meq		*Milliequivalent
	meq/d		*Milliequivalent / Day
	meq/hr		*Milliequivalent / Hour
	meq/(8.hr)		Milliequivalent / 8 Hour Shift
	meq/kg		Milliequivalent / Kilogram (e.g., dose of medication in milliequivalents per patient body weight)
	meq/(kg.d)		(Milliequivalents / Kilogram) / Day = milliequivalents / (kilogram ? day) (e.g., dose of medication in milliequivalents per patient body weight per day)
	meq/(kg.hr)		(Milliequivalents / Kilogram) / Hour = milliequivalents / (kilogram ? hour) (e.g., dose of medication in milliequivalents per patient body weight per hour)
	meq/(8.hr.kg)		(Milliequivalents / Kilogram) / 8 Hour Shift = milliequivalents / (kilogram ? 8 hour shift) (e.g., dose of medication in milliequivalents per patient body weight per 8 hour shift)
	meq/(kg.min)		(Milliequivalents / Kilogram) / Minute = milliequivalents / (kilogram ? minute) (e.g., dose of medication in milliequivalents per patient body weight per minute)
	meq/L		Milliequivalent / Liter
		Milliequivalent / Meter2 (e.g., dose of medication in milliequivalents per patient body surface area)
	meq/min		Milliequivalent / Minute
	mg		Milligram
	mg/m3		Milligram / Meter3
	mg/d		Milligram / Day
	mg/dL		Milligram / Deciliter
	mg/hr		Milligram / Hour
	mg/(8.hr)		Milligram / 8 Hour shift
	mg/kg		Milligram / Kilogram
	mg/(kg.d)		(Milligram / Kilogram) / Day = milligram / (kilogram ? day) (e.g., mass dose of medication per patient body weight per day)
	mg/(kg.hr)		(Milligram / Kilogram) / Hour = milligram/ (kilogram ? hour) (e.g., mass dose of medication per patient body weight per hour)
	mg/(8.hr.kg)		(Milligram / Kilogram) /8 Hour Shift = milligram / (kilogram ? 8 hour shift) (e.g., mass dose of medication per patient body weight per 8 hour shift)
	mg/(kg.min)		(Milligram / Kilogram) / Minute = milligram / (kilogram ? minute) (e.g., mass dose of medication per patient body weight per hour)
	mg/L		Milligram / Liter
	mg/m2		Milligram / Meter2 (e.g., mass dose of medication per patient body surface area)
	mg/min		Milligram / Minute
	mL		Milliliter
	mL/cm_h20		Milliliter / Centimeters of Water (H20) (e.g., dynamic lung compliance)
	mL/d		*Milliliter / Day
	mL/(hb)		Milliliter / Heart Beat (e.g., stroke volume)
	mL/((hb).m2)		(Milliliter / Heart Beat) / Meter2 = Milliliter / (Heart Beat ? Meter2) (e.g., ventricular stroke volume index)
	mL/hr		*Milliliter / Hour
	mL/(8.hr)		*Milliliter / 8 Hour Shift
	mL/kg		Milliliter / Kilogram (e.g., volume dose of medication or treatment per patient body weight)
	mL/(kg.d)		(Milliliter / Kilogram) / Day = milliliter / (kilogram ? day) (e.g., volume dose of medication or treatment per patient body weight per day)
	mL/(kg.hr)		(Milliliter / Kilogram) / Hour = milliliter / (kilogram ? hour) (e.g., volume dose of medication or treatment per patient body weight per hour)
	mL/(8.hr.kg)		(Milliliter / Kilogram) / 8 Hour Shift = milliliter / (kilogram ? 8 hour shift) (e.g., volume dose of medication or treatment per body weight per 8 hour shift)
	mL/(kg.min)		(Milliliter / Kilogram) / Minute = milliliter / (kilogram ? minute) (e.g., volume dose of medication or treatment per patient body weight per minute)
	mL/m2		Milliliter / Meter2 (e.g., volume of medication or other treatment per patient body surface area)
	mL/mbar		Milliliter / Millibar (e.g., dynamic lung compliance)
	mL/min		Milliliter / Minute
	mL/(min.m2)		(Milliliter / Minute) / Meter2 = milliliter / (minute ? meter2) (e.g., milliliters of prescribed infusion per body surface area; oxygen consumption index)
	mL/s		Milliliter / Second
	mm		Millimeter
	mm(hg)		*Millimeter (HG) (1 mm Hg = 133.322 kilopascals)
	mm/hr		Millimeter/ Hour
	mmol/kg		Millimole / Kilogram (e.g., molar dose of medication per patient body weight)
	mmol/(kg.d)		(Millimole / Kilogram) / Day = millimole / (kilogram ? day) (e.g., molar dose of medication per patient body weight per day)
	mmol/(kg.hr)		(Millimole / Kilogram) / Hour = millimole / (kilogram ? hour) (e.g., molar dose of medication per patient body weight per hour)
	mmol/(8.hr.kg)		(Millimole / Kilogram) / 8 Hour Shift = millimole / (kilogram ? 8 hour shift) (e.g., molar dose of medication per patient body weight per 8 hour shift)
	mmol/(kg.min)		(Millimole / Kilogram) / Minute = millimole / (kilogram ? minute) (e.g., molar dose of medication per patient body weight per minute)
	mmol/L		Millimole / Liter
	mmol/hr		Millimole / Hour
	mmol/(8hr)		Millimole / 8 Hour Shift
	mmol/min		Millimole / Minute
	mmol/m2		Millimole / Meter2 (e.g., molar dose of medication per patient body surface area)
	mosm/L		*Milliosmole / Liter
	ms		Milliseconds
	mv		Millivolts
	miu/mL		*Milliunit / Milliliter
	mol/m3		Mole per cubic meter
	mol/kg		Mole / Kilogram
	mol/(kg.s)		(Mole / Kilogram) / Second = mole / (kilogram ? second)
	mol/L		Mole / Liter
	mol/s		Mole / Second
	ng		Nanogram
	ng/d		Nanogram / Day
	ng/hr		*Nanogram / Hour
	ng/(8.hr)		Nanogram / 8 Hour shift
	ng/L		Nanogram / Liter
	ng/kg		Nanogram / Kilogram (e.g., mass dose of medication per patient body weight)
	ng/(kg.d)		(Nanogram / Kilogram) / Day = nanogram / (kilogram ? day) (e.g., mass dose of medication per patient body weight per day)
	ng/(kg.hr)		(Nanogram / Kilogram) / Hour = nanogram / (kilogram ? hour) (e.g., mass dose of medication per patient body weight per hour)
	ng/(8.hr.kg)		(Nanogram / Kilogram) / 8 Hour Shift = nanogram / (kilogram ? 8 hour shift) (e.g., mass dose of medication per patient body weight per 8 hour shift)
	ng/(kg.min)		(Nanogram / Kilogram) / Minute = nanogram / (kilogram ? minute) (e.g., mass dose of medication per patient body weight per minute)
	ng/m2		Nanogram / Meter2 (e.g., mass dose of medication per patient body surface area)
	ng/mL		Nanogram / Milliliter
	ng/min		*Nanogram / Minute
	ng/s		*Nanogram / Second
	nkat		*Nanokatel
	nm		Nanometer
	nmol/s		Nanomole / Second
	ns		Nanosecond
	n		Newton (force)
	n.s		Newton second
	(od)		*O.D. (optical density)
	ohm		Ohm (electrical resistance)
	ohm.m		Ohm meter
	osmol		Osmole
	osmol/kg		Osmole per kilogram
	osmol/L		Osmole per liter
	/m3		*Particles / Meter3
	/L		*Particles / Liter
	/(tot)		*Particles / Total Count
	(ppb)		*Parts Per Billion
	(ppm)		*Parts Per Million
	(ppth)		Parts per thousand
	(ppt)		Parts per trillion (10^12)
	pal		Pascal (pressure)
	/(hpf)		*Per High Power Field
	(ph)		*pH
	pa		Picoampere
	pg		Picogram
	pg/L		Picogram / Liter
	pg/mL		Picogram / Milliliter
	pkat		*Picokatel
	pm		Picometer
	pmol		*Picomole
	ps		Picosecond
	pt		Picotesla
	(pu)		*P.U.
	%		Percent
	dm2/s2		Rem (roentgen equivalent man) = 10-2 meter2 / second2 = decimeter2 / second2 Dose of ionizing radiation equivalent to 1 rad of x-ray or gamma ray) [From Dorland's Medical Dictionary]
	sec		Seconds of arc
	sie		Siemens (electrical conductance)
	sv		Sievert
	m2/s		Square meter / second
	cm2/s		Square centimeter / second
	t		Tesla (magnetic flux density)
	(td_u)		Todd Unit
	v		Volt (electric potential difference)
	1		Volume Fraction
	wb		Weber (magnetic flux)
	*Starred items are not genuine ISO, but do not conflict.	†This approach to units is discouraged by IUPAC. We leave them solely for backward compatibility

21.10.2 External Units of Measure Examples (7.17.2)

Figure 7-11. ISO single case units abbreviations

	Units		Abbreviation		Units		Abbreviation		Units		Abbreviation
	Base units code/abbreviations
	Ampere		a		kelvin		K		meter		m
	Candela		cd		Kilogram		Kg		mole		mol
					second		s
	Derived units with specified name and abbreviation
	coulomb		c		hour		Hr		pascal		pal
	day		d		joule		J		volt		v
	degree Celsius		cel		minute (ti)		Min		watt		w
	farad		f		newton		N		weber		wb
	hertz		hz		ohm		Ohm		year		ann
	Other units
	atomic mass unit		u		grey		gy		minute of arc		mnt
	Bel		b		henry		h		radian		rad
	Decibel		db		liter		l		siemens		sie
	Degree		deg		lumen		Lm		steradian		sr
	Gram		g		lux		Lx		tesla		t
	See ISO 2955-1983 for full set

Figure 7-12. ANSI+ unit codes for some U.S. customary units

	Units		Abbreviation		Units		Abbreviation		Units		Abbreviation
	LENGTH		VOLUME		TIME
	Inch		In		cubic foot		Cft		Year		yr
	Foot		Ft		cubic inch		Cin		Month		mo
	Mile (statute)		Mi		cubic yard		Cyd		Week		wk
	nautical mile		Nmi		tablespoon		Tbs		Day		d
	Rod		Rod		teaspoon		Tsp		Hour		hr
	Yard		Yd		pint		Pt		minute		min
			quart		Qt		second		sec
			gallon		Gal
			ounce (fluid)		Foz
	AREA		MASS
	square foot		Sqf		dram		Dr
	square inch		Sin		grain		gr (avoir)
	square yard		Syd		ounce (weight)		Oz
			pound		Lb
	Other ANSI units, derived units, and miscellaneous
	**British thermal unit		Btu		**degrees Fahrenheit		Degf		**millirad		mrad
	cubic feet/minute		cft/min		**feet/minute		ft/min		**RAD		rad
	Note:The abbreviations for conventional U.S. units of time are the same as ISO, except for year. ISO = ANN, AMSI = yr. The metric units in X3.50 are the same as ISO, except for: pascal ("pa" in ANSI, "pal" in ISO); ANSI uses "min" for both time and arc while ISO uses "mnt" for minutes of arc; and in ISA seconds are abbreviated "s", in ANSI, "sec".
	Caution: Because the ANS+ specification includes both ISO and US customary units, as well as miscellaneous non-metric units, some of the abbreviations are ambiguous. Although there should be little confusion, in the context of a particular observation, this ambiguity is a good reason for a voiding ANS+ unit codes when possible.
	This list is not exhaustive. Refer to ANSI X3.50-1986, Table 1, for other metric and standard U.S. units.
	**Non-metric units not explicitly listed in ANSI

The ISO abbreviations for multiplier prefixes are given in Figure 7-13. Prefixes ranging from 10-24 (1/billion billionth) to 1024 (a billion billion) are available. The single case abbreviation for kilo (x1000) is k. A unit consisting of 1000 seconds would be abbreviated as ks, 1000 grams as kg, 1000 meters as km, and so on. Some prefixes share the abbreviation of a base unit. Farad and femto, for example, (10-18) both have the abbreviation of f. To avoid confusion, ISO forbids the use of solitary prefixes. It also deprecates the use of two prefixes in one complex unit. Thus, f always means farad, ff would mean 1 million billionth of a farad. Compound prefixes are not allowed.

A unit can be raised to an exponential power. Positive exponents are represented by a number immediately following a unit's abbreviation, i.e., a square meter would be denoted by m2. Negative exponents are signified by a negative number following the base unit, e.g., 1/m2 would be represented as m-2. Fractional exponents are expressed by a numeric fraction in parentheses: the square root of a meter would be expressed as m(1/2). The multiplication of units is signified by a period (.) between the units, e.g., meters X seconds would be denoted m.s. Notice that spaces are not permitted. Division is signified by a slash (/) between two units, e.g. meters per second would be denoted as m/s. Algebraic combinations of ISO unit abbreviations constructed by dividing, multiplying, or exponentiating base ISO units, are also valid ISO abbreviations units. Exponentiation has precedence over multiplication or division. For example, microvolts squared per hertz (a unit of spectral power) would be denoted uv2/hz and evaluated as uv 2/hz while microvolts per square root of hertz (a unit of spectral amplitude) would be denoted uv/hz(1/2) and evaluated as uv/hz½. If more than one division operator is included in the expression the associations should be parenthesized to avoid any ambiguity, but the best approach is to convert a/(b/c) to a.c/b or a.c.b-1 to simplify the expression.

Figure 7-13. Single case ISO abbreviations for multiplier prefixes

	Prefix			Code		Prefix			Code
	yotta*		1024		ya		yocto		10-24		Y
	zetta*		1021		za		zepto		10-21		Z
	exa		1018		ex		atto		10-18		A
	peta		1015		pe		femto		10-15		F
	tera		1012		t		pico		10-12		p
	giga		109		g		nano		10-9		n
	mega		106		ma		micro		10-6		u
	kilo		103		k		milli		10-3		m
	hecto		102		h		centi		10-2		c
	deca		101		da		deci		10-1		d
	*These abbreviations are not defined in the ISO specification for single case abbreviations.

Figure 7-9 lists the abbreviations for common ISO derived units. It also includes standard unit abbreviations for common units, e.g., Milliequivalents, and international units, mm(Hg), and for counting per which we denote by a division sign, a denominator, but no numerator, e.g., /c, that are not part of the above referenced ISO standards. We have extended the units table to better accommodate drug routes and physiologic measures, and otherwise fill in gaps in v2.2.

We have generally followed the IUPAC 1995 Silver Book2 in the definitions of units. However, IUPAC specifies standards for reporting or displaying units and employs 8-bit data sets to distinguish them. This Standard is concerned with the transmission of patient information. Therefore, we have restricted ourselves to case insensitive alphabetic characters and a few special characters (e.g., ".", "/", "(", ")", "*", and "_") to avoid any possible confusion in the transmission. Therefore, we use ISO 2955-1983 (Information processing -- representation of SI and other units in systems with limited character sets) and ANSI X3.50-1986 (Representations for U.S. customary, SI, and other units to be used in systems with limited character sets) case insensitive units abbreviations where they are defined. This means that in some cases, IUPAC abbreviations have different abbreviations in ISO+ even when the IUPAC abbreviations use only standard alphabetic characters. For example, Pascal is abbreviated Pa in IUPAC but PAL in ISO+ (following ISO 2955) because Pa in a case insensitive context also means Picoampere. However, the requirements for transmission do not preclude usage of IUPAC standards for presentation on paper or video display reports to end-users.

All unit abbreviations are case insensitive. One could write milliliters as ML, ml, or mL. In this table we have used lower case for all of the abbreviations except for the letter L which we represent in upper case so that readers will not confuse it with the numeral one (1). This is just a change in presentation, not a change in the Standard. Systems should continue to send the codes as upper or lower case as they always have.

21.11 Outstanding Issues (7.18)

None.