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Setting Up Codes


Codes allow you to codify many aspects of the AECM process. For example, codes are used to categorize the service request that triggers the adverse event or complaint, and codes are used to categorize the corrective actions initiated at the end of a complaint's life cycle.

Multiple codes and sometimes codes of multiple types can be specified in one code field.

Think carefully when designing and setting up your code system. Codes are used as search criteria for service requests and product issues.

According to your business needs, you may decide to use:

  • Industry codes such as FDA patient, device, method, results, and conclusion codes required for the MedWatch 3500A form
  • Company-specific codes
  • A combination of industry and company-specific codes

Table 41 lists where code fields appear in the Siebel AECM module.

Table 41. Code Fields in the Siebel AECM Module
Screen
View
Field Name
Notes

Service Requests

More Info

Codes

 

Product Issues

More Info

Codes

Copied from the service request when a product issue is created.

Codes from the service request record are copied to this field when a product issue is created from a service request.

Corrective Actions

Codes

Typically, codes of type Corrective Action are entered in this field, although any type of code can be entered.

Investigation

Method Codes

Only codes of type Method can be entered.

Result Codes

Only codes of type Result can be entered.

Conclusion Codes

Only codes of type Conclusion can be entered.

Non-Evaluation Codes

Only codes of type Non-Evaluation can be entered.

Importer

MDV

Patient Codes

Only codes of type Patient can be entered.

Device Codes

Only codes of type Device can be entered.

Repairs

More Info

Codes

Typically, codes of type Product Analysis are entered in this field, although any type of code can be entered.

Corrective Actions

More Info

Codes

Typically, codes of type Corrective Action are entered in this field, although any type of code can be entered.

Regulatory Reports

More Info

Method Codes

Only codes of type Method can be entered.

Copied from the product issue when a regulatory report is populated.

Result Codes

Only codes of type Result can be entered.

Copied from the product issue when a regulatory report is populated.

Conclusion Codes

Only codes of type Conclusion can be entered.

Copied from the product issue when a regulatory report is populated.

Non-Evaluation Codes

Only codes of type Non-Evaluation can be entered.

Copied from the product issue when a regulatory report is populated.

Regulatory Reports

Importer

MDV

Patient Codes

Only codes of type Patient can be entered.

Copied from the product issue when a regulatory report is populated.

Device Codes

Only codes of type Device can be entered.

Copied from the product issue when a regulatory report is populated.

Activities

Items

Code

Single value field.

An Example

When you set up codes, you can enter values for Product, Product Line, Category, Type, Area, and Sub Area that are associated with the code. Call center agents can use these values to search for and identify the correct code for a service request.

Table 42 is an example of the field values used to describe one code.

Table 42. Example Fields for a Code Classifying a Pump Error on a Blood Analyzer
Field
Example Value

Name

Error 333

Description

Blood analyzer pump overflow.

Code Type

Device

Product

Blood Analyzer Model 350, Blood Analyzer Model 373 1

Product Line

Blood analyzer, Dialysis system 1

Category

Nephrology

Type

Potential Complaint

Area

Software

Sub Area

Pump timing

1Field can have multiple values.

How to Set Up Codes

Create the codes needed to classify your company's adverse events and complaints.

Codes are needed for the procedures in this chapter and for procedures in the following AECM chapters.

This task is a step in Process of Capturing and Escalating Adverse Events and Complaints.

To set up codes

  1. Navigate to Service Administration screen > Code Administration view.
  2. In the Code Admin list, create a new record and complete the necessary fields.

    Some fields are described in the following table.

    Field
    Comments

    Name

    Enter the name for the code. Typically this is a number or a letter number combination.

    Code Type

    Examples are: Method, Result, Conclusion, Device, Patient.

    Product

    Multiple products can be associated with a code.

    Product Line

    Multiple product lines can be associated with a code.

    Category

    A grouping of products. Only one category can be associated to a code. To set up categories, see Siebel Order Management Guide.

    Type

    Use to categorize the type of service request, for example, as a potential complaint. This is the same LOV used in service request and product issue records.

    Area

    The Type field constrains this drop-down list.

    Sub Area

    The Area field constrains this drop-down list.

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