HL7 - REFACTORED

18.8.118 PES - Product Experience Sender Segment (7.12.1)

HL7 Attribute Table - PES - Product Experience Sender

Segment (new)
(base framework)
Segment (new)
(w/o profiles)
Segment (new)
(w/ profiles)
Segment (classic)
(w/ profiles)
Segment (classic)
(w/o profiles)
FHIR
Structure Definition
v2.xml
XSD

Base Framework
	Seq#	Data Element	Description	Flags	Implement	Cardinality	Length	C.LEN	Vocabulary	Data Type
PES
	1	01059	Sender Organization Name		MAY	[0..*]				XON Extended Composite Name and Identification Number for Organizations
	2	01060	Sender Individual Name		MAY	[0..*]				XCN Extended Composite ID Number and Name for Persons
	3	01062	Sender Address		MAY	[0..*]				XAD Extended Address
	4	01063	Sender Telephone		MAY	[0..*]				XTN Extended Telecommunication Number
	5	01064	Sender Event Identifier		MAY	[0..1]				EI Entity Identifier
	6	01065	Sender Sequence Number	= Truncation not allowed!	MAY	[0..1]		16		NM Numeric
	7	01066	Sender Event Description	= Truncation not allowed!	MAY	[0..*]		600		FT Formatted Text Data
	8	01067	Sender Comment	= Truncation not allowed!	MAY	[0..1]		600		FT Formatted Text Data
	9	01068	Sender Aware Date/Time		MAY	[0..1]				DTM Date/Time
	10	01069	Event Report Date		SHOULD	[1..1]				DTM Date/Time
	11	01070	Event Report Timing/Type		MAY	[0..2]	[2..3]		univ: ReportTiming (CD) hl7VS-reportTiming (VS) reportTiming (CS)	ID Coded Value for HL7 Defined Tables
	12	01071	Event Report Source		MAY	[0..1]	[1..1]		univ: ReportSource (CD) hl7VS-reportSource (VS) reportSource (CS)	ID Coded Value for HL7 Defined Tables
	13	01072	Event Reported To		MAY	[0..*]	[1..1]		univ: EventReportedTo (CD) hl7VS-eventReportedTo (VS) eventReportedTo (CS)	ID Coded Value for HL7 Defined Tables

	Seq#	Data Element	Description	Flags	Implement	Cardinality	Length	C.LEN	Vocabulary	Data Type
PES
	1	01059	Sender Organization Name		MAY	[0..*]				XON Extended Composite Name and Identification Number for Organizations
	2	01060	Sender Individual Name		MAY	[0..*]				XCN Extended Composite ID Number and Name for Persons
	3	01062	Sender Address		MAY	[0..*]				XAD Extended Address
	4	01063	Sender Telephone		MAY	[0..*]				XTN Extended Telecommunication Number
	5	01064	Sender Event Identifier		MAY	[0..1]				EI Entity Identifier
	6	01065	Sender Sequence Number	= Truncation not allowed!	MAY	[0..1]		16		NM Numeric
	7	01066	Sender Event Description	= Truncation not allowed!	MAY	[0..*]		600		FT Formatted Text Data
	8	01067	Sender Comment	= Truncation not allowed!	MAY	[0..1]		600		FT Formatted Text Data
	9	01068	Sender Aware Date/Time		MAY	[0..1]				DTM Date/Time
	10	01069	Event Report Date		SHALL	[1..1]				DTM Date/Time
	11	01070	Event Report Timing/Type		MAY	[0..2]	[2..3]		univ: ReportTiming (CD) hl7VS-reportTiming (VS) reportTiming (CS)	ID Coded Value for HL7 Defined Tables
	12	01071	Event Report Source		MAY	[0..1]	[1..1]		univ: ReportSource (CD) hl7VS-reportSource (VS) reportSource (CS)	ID Coded Value for HL7 Defined Tables
	13	01072	Event Reported To		MAY	[0..*]	[1..1]		univ: EventReportedTo (CD) hl7VS-eventReportedTo (VS) eventReportedTo (CS)	ID Coded Value for HL7 Defined Tables

Base Framework											Base Standard Profile
	Seq#	Data Element	Description	Flags	Implement	Cardinality	Length	C.LEN	Vocabulary	Data Type	Implement	Vocabulary
PES
	1	01059	Sender Organization Name		MAY	[0..*]				XON Extended Composite Name and Identification Number for Organizations	MAY
	2	01060	Sender Individual Name		MAY	[0..*]				XCN Extended Composite ID Number and Name for Persons	MAY
	3	01062	Sender Address		MAY	[0..*]				XAD Extended Address	MAY
	4	01063	Sender Telephone		MAY	[0..*]				XTN Extended Telecommunication Number	MAY
	5	01064	Sender Event Identifier		MAY	[0..1]				EI Entity Identifier	MAY
	6	01065	Sender Sequence Number	= Truncation not allowed!	MAY	[0..1]		16		NM Numeric	MAY
	7	01066	Sender Event Description	= Truncation not allowed!	MAY	[0..*]		600		FT Formatted Text Data	MAY
	8	01067	Sender Comment	= Truncation not allowed!	MAY	[0..1]		600		FT Formatted Text Data	MAY
	9	01068	Sender Aware Date/Time		MAY	[0..1]				DTM Date/Time	MAY
	10	01069	Event Report Date		SHOULD	[1..1]				DTM Date/Time	SHALL
	11	01070	Event Report Timing/Type		MAY	[0..2]	[2..3]		univ: ReportTiming (CD) hl7VS-reportTiming (VS) reportTiming (CS)	ID Coded Value for HL7 Defined Tables	MAY
	12	01071	Event Report Source		MAY	[0..1]	[1..1]		univ: ReportSource (CD) hl7VS-reportSource (VS) reportSource (CS)	ID Coded Value for HL7 Defined Tables	MAY
	13	01072	Event Reported To		MAY	[0..*]	[1..1]		univ: EventReportedTo (CD) hl7VS-eventReportedTo (VS) eventReportedTo (CS)	ID Coded Value for HL7 Defined Tables	MAY

Base Framework											Base Standard Profile
	Seq#	Data Element	Description	Flags	Optionality	Repetition	Length	C.LEN	Table	Data Type	Optionality	Table
PES
	1	01059	Sender Organization Name		O	Y				XON Extended Composite Name and Identification Number for Organizations
	2	01060	Sender Individual Name		O	Y				XCN Extended Composite ID Number and Name for Persons
	3	01062	Sender Address		O	Y				XAD Extended Address
	4	01063	Sender Telephone		O	Y				XTN Extended Telecommunication Number
	5	01064	Sender Event Identifier		O					EI Entity Identifier
	6	01065	Sender Sequence Number		O			16=		NM Numeric
	7	01066	Sender Event Description		O	Y		600=		FT Formatted Text Data
	8	01067	Sender Comment		O			600=		FT Formatted Text Data
	9	01068	Sender Aware Date/Time		O					DTM Date/Time
	10	01069	Event Report Date		O					DTM Date/Time	R
	11	01070	Event Report Timing/Type		O	Y/2	[2..3]			ID Coded Value for HL7 Defined Tables		(0234)
	12	01071	Event Report Source		O		[1..1]			ID Coded Value for HL7 Defined Tables		(0235)
	13	01072	Event Reported To		O	Y	[1..1]			ID Coded Value for HL7 Defined Tables		(0236)

	Seq#	Data Element	Description	Optionality	Repetition	Length	C.LEN	Table	Data Type
PES
	1	01059	Sender Organization Name	O	Y				XON Extended Composite Name and Identification Number for Organizations
	2	01060	Sender Individual Name	O	Y				XCN Extended Composite ID Number and Name for Persons
	3	01062	Sender Address	O	Y				XAD Extended Address
	4	01063	Sender Telephone	O	Y				XTN Extended Telecommunication Number
	5	01064	Sender Event Identifier	O					EI Entity Identifier
	6	01065	Sender Sequence Number	O			16=		NM Numeric
	7	01066	Sender Event Description	O	Y		600=		FT Formatted Text Data
	8	01067	Sender Comment	O			600=		FT Formatted Text Data
	9	01068	Sender Aware Date/Time	O					DTM Date/Time
	10	01069	Event Report Date	R					DTM Date/Time
	11	01070	Event Report Timing/Type	O	Y/2	[2..3]		(0234)	ID Coded Value for HL7 Defined Tables
	12	01071	Event Report Source	O		[1..1]		(0235)	ID Coded Value for HL7 Defined Tables
	13	01072	Event Reported To	O	Y	[1..1]		(0236)	ID Coded Value for HL7 Defined Tables

18.8.118.1 PES - field definitions (7.12.1.0)

18.8.118.2 PES-1 Sender Organization Name (XON) 01059 (7.12.1.1)

Definition: This field contains the name of the organization sending the message. Coded lists of manufacturers such as that from the World Health Organization database might be used in the component of the coded name to identify the source code type. If sent from an individual, this field may not be sent.

18.8.118.3 PES-2 Sender Individual Name (XCN) 01060 (7.12.1.2)

Definition: This field contains the name of the contact individual. If sent by an organization, the individuals in the organization who serve as primary contact points correspondence regarding this event.

18.8.118.4 PES-3 Sender Address (XAD) 01062 (7.12.1.3)

Definition: This field contains the postal address of the message sender to which correspondence regarding the experience being reported should be directed.

18.8.118.5 PES-4 Sender Telephone (XTN) 01063 (7.12.1.4)

Definition: This field contains the telephone number of the message sender to which telephone communications regarding the experience being reported should be directed. An electronic mail address can be specified in this field.

18.8.118.6 PES-5 Sender Event Identifier (EI) 01064 (7.12.1.5)

Definition: The first component of this field contains the product manufacturer's unique alphanumeric identifier for this specific event. This identifier will be used on all subsequent communications regarding this event. For events reported to the FDA, the identifier is: the FDA assigned manufacturer or distributor number; a hyphen; the 4-digit year; a hyphen; and a consecutive 5-digit sequence number for each report filled by the sender that year. For example, the event identifier for the third event reported in 1996 by a manufacturer whose FDA-assigned registration number is 1234567 would be 1234567-1993-3. Organizations without a FDA-assigned registration number should use 0000000 until assigned a number. Reports from other facilities should use the 10-digit HCFA number left padded with zeros in place of the FDA-assigned registration number. The second through fourth components are defined in exactly the same way as the three components of the hierarchic designator (HD) data type (Section 2.8.18, "HD - hierarchic designator").

18.8.118.7 PES-6 Sender Sequence Number (NM) 01065 (7.12.1.6)

Definition: This field contains sequentially assigned integer values which distinguish messages which share the same sender event identification element. 0 for initial report, 1 for second, and so on.

18.8.118.8 PES-7 Sender Event Description (FT) 01066 (7.12.1.7)

Definition: This field contains the summary narrative text description of the event that occurred written by the sender, which may include a description of the nature of the event, how the product was involved, any environmental conditions that may have influenced the event, and patient follow-up or required treatment. 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.

18.8.118.9 PES-8 Sender Comment (FT) 01067 (7.12.1.8)

Definition: This field contains the text commentary regarding the report being made, such as disclaimers, which is not necessarily part of the report.

18.8.118.10 PES-9 Sender Aware Date/Time (DTM) 01068 (7.12.1.9)

Definition: This field identifies the date the sender became aware of the event.

18.8.118.11 PES-10 Event Report Date (DTM) 01069 (7.12.1.10)

Definition: This field contains the date the message was originally sent to the regulatory agency.

18.8.118.12 PES-11 Event Report Timing/Type (ID) 01070 (7.12.1.11)

Definition: This field contains the timing type of report as required by regulatory agency. Refer to HL7 Table 0234 - Report Timing for valid values.

18.8.118.13 PES-12 Event Report Source (ID) 01071 (7.12.1.12)

Definition: This field identifies the source from which the sender learned about the event. Multiple sources may be reported by repeating the element.

If the source of the report is a clinical trial, the CSR and CSP segments can be included to define the study. Refer to HL7 Table 0235 - Report Source for valid values.

18.8.118.14 PES-13 Event Reported To (ID) 01072 (7.12.1.13)

Definition: This field indicates all the entities to whom the entity submitting the report has reported the event. Repeat the element if the report was submitted to more than one entity. Refer to HL7 Table 0236 - Event reported to for valid values.