PEO - Product Experience Observation Segment

Details related to a particular clinical experience or event are embodied in the PEO segment. This segment can be used to characterize an event which might be attributed to a product to which the patient was exposed. Products with a possible causal relationship to the observed experience are described in the following PCR (possible causal relationship) segments. The message format was designed to be robust and includes many optional elements which may not be required for a particular regulatory purpose but allow a complete representation of the drug experience if needed.

A PEX message can contain multiple PEO segments if the patient experienced more than one event but must contain at least one PEO segment.

HL7 Attribute Table - PEO - Product Experience Observation Segment

Seq#	Data Element Name	DataType	Usage	Vocabulary	Cardinality	Item #	Length	C.LEN	Flags
PEO
1	Event Identifiers Used	CWE	O	0678	[0..*]	01073
2	Event Symptom/Diagnosis Code	CWE	O	0679	[0..*]	01074
3	Event Onset Date/Time	DTM	R		[1..1]	01075
4	Event Exacerbation Date/Time	DTM	O		[0..1]	01076
5	Event Improved Date/Time	DTM	O		[0..1]	01077
6	Event Ended Data/Time	DTM	O		[0..1]	01078
7	Event Location Occurred Address	XAD	O		[0..*]	01079
8	Event Qualification	ID	O	0237(R) Event Qualification(Required)	[0..*]	01080	[1..1]
9	Event Serious	ID	O	0238(R) Event Seriousness(Required)	[0..1]	01081	[1..1]
10	Event Expected	ID	O	0239(R) Event Expected(Required)	[0..1]	01082	[1..1]
11	Event Outcome	ID	O	0240(R) Event Consequence(Required)	[0..*]	01083	[1..1]
12	Patient Outcome	ID	O	0241(R) Patient Outcome(Required)	[0..1]	01084	[1..1]
13	Event Description from Others	FT	O		[0..*]	01085		600	#
14	Event Description from Original Reporter	FT	O		[0..*]	01086		600	#
15	Event Description from Patient	FT	O		[0..*]	01087		600	#
16	Event Description from Practitioner	FT	O		[0..*]	01088		600	#
17	Event Description from Autopsy	FT	O		[0..*]	01089		600	#
18	Cause Of Death	CWE	O	0680	[0..*]	01090
19	Primary Observer Name	XPN	O		[0..*]	01091
20	Primary Observer Address	XAD	O		[0..*]	01092
21	Primary Observer Telephone	XTN	O		[0..*]	01093
22	Primary Observer's Qualification	ID	O	0242(R) Primary Observer's Qualification(Required)	[0..1]	01094	[1..1]
23	Confirmation Provided By	ID	O	0242(R) Primary Observer's Qualification(Required)	[0..1]	01095	[1..1]
24	Primary Observer Aware Date/Time	DTM	O		[0..1]	01096
25	Primary Observer's identity May Be Divulged	ID	O	0243(R) Identity May Be Divulged(Required)	[0..1]	01097	[1..2]

PEO-1: Event Identifiers Used (CWE) 01073

Definition: This field may be used to transmit the event identifier used by other entities for this event. The entry would typically contain a unique alphanumeric identifier assigned by an entity with the text component null or repeating the unique alphanumeric identifier followed by the organization's identifier. An event identifier might be GB1234^GB1234^PharmaGiant for example. Refer to Table 0678 - Event Identifiers Used in Chapter 2C for valid values.

PEO-2: Event Symptom/Diagnosis Code (CWE) 01074

Definition: This field is the coded diagnosis or problem description which best describes the event. A text representation of the coded item should routinely be included. MEDDRA and WHO-ART are examples of appropriate coding schemes, as are the patient and device codes included in the FDA Center for Devices and Radiologic Health's coding manual for Form 3500A. Refer to Table 0679 - Event Symptom/Diagnosis Code in Chapter 2C for valid values.

PEO-3: Event Onset Date/Time (DTM) 01075

Definition: This field contains a report or best estimate of the date/time of onset of the event. The date/time can be recorded to any level of precision it is known (hour, day, month, year).

PEO-4: Event Exacerbation Date/Time (DTM) 01076

Definition: This field identifies the best estimate of the date/time the event was exacerbated.

PEO-5: Event Improved Date/Time (DTM) 01077

Definition: This field identifies the best estimate of the date/time the event improved.

PEO-6: Event Ended Data/Time (DTM) 01078

Definition: This field identifies the best estimate of the date/time the event resolved.

PEO-7: Event Location Occurred Address (XAD) 01079

Definition: This field identifies the location at which the event started. Often this will specify only the country in which the event started.

PEO-8: Event Qualification (ID) 01080

Definition: This field is contains a classification of the type of product experience this event is considered to represent. Refer to HL7 Table 0237 - Event Qualification for valid values.

Unexpected beneficial effects would not often be reported but are required by certain countries.

PEO-9: Event Serious (ID) 01081

Definition: This field indicates whether the event was judged as serious. If the event did not meet the criteria for seriousness but the sender judges the event significant on other grounds, the event can be identified as significant [but not serious]. Refer to HL7 Table 0238 - Event Seriousness for valid values.

PEO-10: Event Expected (ID) 01082

Definition: This field indicates whether the observed event was expected or unexpected as judged. Refer to HL7 Table 0239 - Event Expected for valid values.

PEO-11: Event Outcome (ID) 01083

Definition: This field identifies the consequence of the event on the patient. If the consequence of the event is not understood or not available, the patient outcome element may be used although neither is required. May be repeated if more than one is appropriate. Refer to HL7 Table 0240 - Event Consequence for valid values.

PEO-12: Patient Outcome (ID) 01084

When an event specific outcome is not available, the patient outcome element may be used to represent the patient's overall outcome if that information is known. Refer to HL7 Table 0241 - Patient Outcome for valid values.

PEO-13: Event Description from Others (FT) 01085

Definition: This field contains a summary narrative text description of the event that occurred written by the sender. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative. By representing clinical information in OBX segments rather than in the narrative, these data become much more useful and flexible.

PEO-14: Event Description from Original Reporter (FT) 01086

Definition: This field contains a summary narrative text description of the event provided by the original reporter. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

PEO-15: Event Description from Patient (FT) 01087

Definition: This field contains a summary narrative text description of the event obtained directly from the patient. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative, which will allow the data to be more readily represented and manipulated.

PEO-16: Event Description from Practitioner (FT) 01088

Definition: This field contains a summary narrative text description of the event provided by the practitioner most familiar with the event. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

PEO-17: Event Description from Autopsy (FT) 01089

Definition: This field contains a summary narrative text description of the autopsy results. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.

PEO-18: Cause Of Death (CWE) 01090

Definition: This field identifies the coded cause of death. May be repeated as necessary to list multiple contributing causes. A text description can be included by including text but no code or coding system. For example, if the cause of death is to be determined at autopsy but results are not yet available, the cause of death element could be ^Pending autopsy^. The date/time of death can be sent in the PID and the autopsy results sent in the event description from autopsy element of the PEO segment. Refer to Table 0680 - Cause Of Death in Chapter 2C for valid values.

PEO-19: Primary Observer Name (XPN) 01091

Definition: This field identifies the name of the person who initially described the event.

PEO-20: Primary Observer Address (XAD) 01092

Definition: This field identifies the address of the person who initially described the event.

PEO-21: Primary Observer Telephone (XTN) 01093

Definition: This field identifies the telephone number of the person who initially described the event.

PEO-22: Primary Observer's Qualification (ID) 01094

Definition: This field contains the qualification of the primary observer which may assist in assessing the validity of the observations. Refer to HL7 Table 0242 - Primary Observer's Qualification for valid values.

PEO-23: Confirmation Provided By (ID) 01095

Definition: This field contains the qualification of the health professional who confirmed the observation if the primary observer was not a health professional. Refer to HL7 Table 0242 - Primary Observer's Qualification for valid values.

PEO-24: Primary Observer Aware Date/Time (DTM) 01096

Definition: This field identifies the date/time the primary observer became aware of event.

PEO-25: Primary Observer's identity May Be Divulged (ID) 01097

Definition: Indicates whether or not the primary observer, if known to the sender, grants permission to disclose his or her identity to the product manufacturer for the purpose of further investigating the event. If the element is absent, the assumption should be made that permission is not granted. Refer to HL7 Table 0243 - Identity May Be Divulged for valid values.