PCR - Possible Causal Relationship Segment

The PCR segment is used to communicate a potential or suspected relationship between a product (drug or device) or test and an event with detrimental effect on a patient. This segment identifies a potential causal relationship between the product identified in this segment and the event identified in the PEO segment.

More than one PCR segment can be included in the message if more than one product is possibly causally related to the event.

HL7 Attribute Table - PCR - Possible Causal Relationship Segment

Seq#	Data Element Name	DataType	Usage	Vocabulary	Cardinality	Item #	Length	C.LEN	Flags
PCR
1	Implicated Product	CWE	R	0670	[1..1]	01098
2	Generic Product	IS	O	0249 Generic Product	[0..1]	01099		1	#
3	Product Class	CWE	O	0671	[0..1]	01100
4	Total Duration Of Therapy	CQ	O		[0..1]	01101
5	Product Manufacture Date	DTM	O		[0..1]	01102
6	Product Expiration Date	DTM	O		[0..1]	01103
7	Product Implantation Date	DTM	O		[0..1]	01104
8	Product Explantation Date	DTM	O		[0..1]	01105
9	Single Use Device	CWE	O	0244 Single Use Device	[0..1]	01106
10	Indication For Product Use	CWE	O	0672	[0..1]	01107
11	Product Problem	CWE	O	0245 Product Problem	[0..1]	01108
12	Product Serial/Lot Number	ST	O		[0..3]	01109		199	#
13	Product Available For Inspection	CWE	O	0246 Product Available for Inspection	[0..1]	01110
14	Product Evaluation Performed	CWE	O	0673	[0..1]	01111
15	Product Evaluation Status	CWE	O	0247(R) Status of Evaluation(Required)	[0..1]	01112
16	Product Evaluation Results	CWE	O	0674	[0..1]	01113
17	Evaluated Product Source	ID	O	0248(R) Product Source(Required)	[0..1]	01114	[1..1]
18	Date Product Returned To Manufacturer	DTM	O		[0..1]	01115
19	Device Operator Qualifications	ID	O	0242(R) Primary Observer's Qualification(Required)	[0..1]	01116	[1..1]
20	Relatedness Assessment	ID	O	0250(R) Relatedness Assessment(Required)	[0..1]	01117	[1..1]
21	Action Taken In Response To The Event	ID	O	0251(R) Action Taken in Response to the Event(Required)	[0..6]	01118	[1..2]
22	Event Causality Observations	ID	O	0252(R) Causality Observations(Required)	[0..6]	01119	[2..2]
23	Indirect Exposure Mechanism	ID	O	0253(R) Indirect Exposure Mechanism(Required)	[0..3]	01120	[1..1]

PCR-1: Implicated Product (CWE) 01098

Definition: This field contains the coded identity of the product (drug, device, etc.) which is possibly causally related to the event. Includes the product identity number such as NDC, model or catalogue numbers. If a coded value is not available for the product a text description can be included as the second component of the CWE data. See Chapter 2 for a listing of some recognized coding systems for drugs and devices. Refer to Table 0670 - Implicated Product in Chapter 2C for valid values.

PCR-2: Generic Product (IS) 01099

Definition: This field indicates whether the product used was a generic or a branded product. Refer to User-defined Table 0249 – Generic Product for suggested values.

PCR-3: Product Class (CWE) 01100

Definition: This field contains the coded classification of the implicated product. For drugs, this would usually be the drug class - calcium channel blocking agents for nifedipine, for example. For other products it would be the generic type of device, e.g., urinary catheter, cardiac pacemaker. If a coded value is not available for the class, a text description can be included. Refer to Table 0671 - Product Class in Chapter 2C for valid values.

PCR-4: Total Duration Of Therapy (CQ) 01101

Definition: This field represents the total duration of therapy with product listed. The treatment at the current dose and schedule are indicted in the quantity timing attribute of the RXE segment but the patient may have been treated for some time previously at a different dose or on a different schedule. The quantity in the second component of the CQ should be a time quantity.

PCR-5: Product Manufacture Date (DTM) 01102

Definition: This field indicates the date the product was manufactured.

PCR-6: Product Expiration Date (DTM) 01103

Definition: This field contains the expiration date indicated on the product packaging.

PCR-7: Product Implantation Date (DTM) 01104

Definition: If an implantable medical device, this field identifies the date device was implanted.

PCR-8: Product Explantation Date (DTM) 01105

Definition: If an implantable medical device and it was removed, the field identifies the date it was removed.

PCR-9: Single Use Device (CWE) 01106

Definition: This field indicates whether the product was designed for a single use. Refer to User-defined Table 0244 – Single Use Device for suggested values.

PCR-10: Indication For Product Use (CWE) 01107

Definition: This field contains coded representation of the problem or diagnosis for which the product was used. See Chapter 2 for some coding systems which might be chosen to transmit diagnoses or problems. Refer to Table 0672 - Indication For Product Use in Chapter 2C for valid values.

PCR-11: Product Problem (CWE) 01108

Definition: A product problem would exist if a product malfunction could lead to death or serious injury. Refer to User-defined Table 0245 - Product Problem for suggested values.

PCR-12: Product Serial/Lot Number (ST) 01109

Definition: This field is an alphanumeric descriptor which identifies the specific item or lot of drug. This descriptor would normally be obtained from the package labeling or item itself.

PCR-13: Product Available For Inspection (CWE) 01110

Definition: This field indicates that the product is available for analysis. User-defined Table 0246 -Product Available for Inspection is used as the HL7 identifier for the user-defined table of values for this field. If the product was returned to the manufacturer, this would be indicated by including the date it was returned in the date product returned to manufacturer element.

PCR-14: Product Evaluation Performed (CWE) 01111

Definition: This field indicates the type of product evaluation performed. The evaluation codes listed in SubPart B of the Coding Manual for FDA Form 3500A, "Type of Evaluation Performed," may be used. If no codes are available, text may be sent in the second component of the field. Refer to Table 0673 - Product Evaluation Performed in Chapter 2C for valid values.

PCR-15: Product Evaluation Status (CWE) 01112

Definition: This field identifies the status of product evaluation. Subpart A Item H.3 of the Coding Manual for FDA Form 3500A may also be used. If no codes are available, text may be sent in the second component of the field. Refer to HL7 Table 0247 - Status of Evaluation for valid values.

PCR-16: Product Evaluation Results (CWE) 01113

Definition: This field contains the results of the product evaluation. Refer to Table 0674 - Product Evaluation Results in Chapter 2C for valid values.

PCR-17: Evaluated Product Source (ID) 01114

Definition: This field contains the source of the product evaluated. Refer to HL7 Table 0248 - Product Source for valid values.

PCR-18: Date Product Returned To Manufacturer (DTM) 01115

Definition: If the product was returned to the manufacturer, this field contains the date it was returned.

PCR-19: Device Operator Qualifications (ID) 01116

Definition: This field identifies the qualification of the person operating the device when the event occurred. Refer to HL7 Table 0242 - Primary Observer's Qualification for valid values.

PCR-20: Relatedness Assessment (ID) 01117

Definition: This field represents the assessment of relatedness of the product to the event. Refer to HL7 Table 0250 - Relatedness Assessment for valid values.

PCR-21: Action Taken In Response To The Event (ID) 01118

Definition: This field indicates the action taken as a result of the event. Segment may repeat if multiple categories of evidence are relevant. Refer to HL7 Table 0251 - Action Taken in Response to the Event for valid values.

PCR-22: Event Causality Observations (ID) 01119

Definition: This field contains observations made about the event which may bear on causality. Refer to HL7 Table 0252 - Causality Observations for valid values. Segment may repeat if multiple categories of evidence are relevant.

PCR-23: Indirect Exposure Mechanism (ID) 01120

Definition: The patient identified in the PID segment, who experienced the event, might have been exposed to the potential causal product via an intermediary, e.g., a child might be exposed to a product through the placenta or in breast milk, or a transfusion recipient might be exposed via a blood product. If this is the case, the mechanism of product transmission is identified in this field, using the valid values in HL7 Table 0253 - Indirect Exposure Mechanism. If this field is populated, the identity of the person through whom the product was transmitted is contained in NK1 and RXE segments which follow.