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7.11.1 PES - product experience sender segment

Figure 7-20. PES attributes

SEQ

LEN

DT

OPT

RP/ #

TBL #

ITEM #

ELEMENT NAME

1

80

XON

O



01059

Sender Organization Name

2

60

XCN

O

Y


01060

Sender Individual Name

3

200

XAD

O

Y


01062

Sender Address

4

44

XTN

O

Y


01063

Sender Telephone

5

75

EI

O



01064

Sender Event Identifier

6

2

NM

O



01065

Sender Sequence Number

7

600

FT

O

Y


01066

Sender Event Description

8

600

FT

O



01067

Sender Comment

9

26

TS

O



01068

Sender Aware Date/Time

10

26

TS

R



01069

Event Report Date

11

3

ID

O

Y/2

0234

01070

Event Report Timing/Type

12

1

ID

O


0235

01071

Event Report Source

13

1

ID

O

Y

0236

01072

Event Reported To

7.11.1.0 PES - field definitions

7.11.1.1 Sender organization name (XON) 01059

Components: <organization name (ST)>^ <organization name type code (IS)> ^<ID Number (NM)> ^ <check digit (NM)> ^ <code identifying the check digit scheme employed (ID)> ^ <assigning authority (HD)> ^ <identifier type code (IS)> ^ <assigning facility ID (HD)>

Subcomponents of assigning authority: <namespace ID (IS)> & <universal ID (ST)> * <universal ID type (ID)>

Subcomponents of assigning facility: <namespace ID (IS)> & <universal ID (ST)> * <universal ID type (ID)>

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.

7.11.1.2 Sender individual name (XCN) 01060

Components: <ID number (ST)> ^<family name (ST)> ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^<assigning authority (HD)> ^<name type (ID)> ^<identifier check digit (ST)> ^ <code identifying the check digit scheme employed (ID)> ^ <identifier type code (IS)> ^ <assigning facility ID (HD)>

Subcomponents of assigning authority: <namespace ID (IS)> & <universal ID (ST)> & <univerwsal ID type (ID)>

Subcomponents of assigning facility ID: <namespace ID (IS)> & <universal ID (ST)> & <univerwsal ID type (ID)>

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.

7.11.1.3 Sender address (XAD) 01062

Components: <street address (ST)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or province (ST)> ^ <zip or postal code(ST)> ^ <country (ID)> ^ < address type (ID)> ^ <other geographic designation (ST)>^ <county/parish code (IS)> ^ <census tract (IS)>

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

7.11.1.4 Sender telephone (XTN) 01063

Components: [NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^ phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>

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.

7.11.1.5 Sender event identifier (EI) 01064

Components: <entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>

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 an 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").

7.11.1.6 Sender sequence number (NM) 01065

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.

7.11.1.7 Sender event description (FT) 01066

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.

7.11.1.8 Sender comment (FT) 01067

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

7.11.1.9 Sender aware date/time (TS)

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

7.11.1.10 Event report date (TS) 01069

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

7.11.1.11 Event report timing type (ID) 01070

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

Table 0234 - Report timing

Value

Description

CO

Correction

AD

Additional information

RQ

Requested information

DE

Device evaluation

PD

Periodic

3D

3 day report

7D

7 day report

10D

10 day report

15D

15 day report

30D

30 day report

7.11.1.12 Event report source (ID) 01071

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.

Table 0235 - Report source

Value

Description

C

Clinical trial

L

Literature

H

Health professional

R

Regulatory agency

D

Database/registry/poison control center

N

Non-healthcare professional

P

Patient

M

Manufacturer/marketing authority holder

E

Distributor

O

Other

7.11.1.13 Event reported to (ID) 01072

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.

Table 0236 - Event reported to

Value

Description

M

Manufacturer

L

Local facility/user facility

R

Regulatory agency

D

Distributor

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