sop mrrb dataentry 30092010 · 2010-11-09 · version 2.0 sop-rru-co05-3 date: 21/06/2010 created...

National Renal Registry

Malaysian Society of Nephrology

Version 2.0 SOP-RRU-CO05-3 Date: 21/06/2010

Created by NRR on 21/06/2010

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Standard Operating Procedure for Data Entry Malaysian Registry of Renal

Biopsy (MRRB)

Document name: Standard Operation Procedure

SOP Number: SOP-RRU-CO05-3 (MRRB)

Current version: 2.0

Version date: 21/06/2010

File name and

location:

Q:\eMRRB\UserManual\ver2_Final\SOP_MRRB_DataEntry_30092010.doc

Uploaded to web: 08/11/2010

Track version:

Version 1.0 Dated 21/07/2006

File name and

location:

P:\GN Registry\System\Manual\22092006_SOP_DataEntry.doc





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CONTENTS

1. Introduction and Purpose .....................................................................................3

2. Scope....................................................................................................................3

3. Applicable guidelines and regulations................................................................4

3.1 Verify a New Patient...........................................................................................4

3.1.1 How to verify a patient before data entry?.........................................................5

3.1.1 b) The search choices available are flexible, the similar patient found will be

listed for manual/visual verification of possible typo error. Please search all possible

fields and search selection choice to minimize duplicate record. ..................................5

3.1.1 c) Manual/visual verification is performed to minimized duplication or double

patient registration .........................................................................................................5

3.1.1 d) For more details about the patient, click at [Action] click [View]. Any

correction / update required please inform [email protected] ....................................6

3.2 How to register a “New Patient”?........................................................................6

3.2.1 Patient Registration Rule ....................................................................................6

3.2.2 Patient registration post verification. ..................................................................7

3.2.3 Compulsory field ................................................................................................8

3.3 Add New Biopsy Notification record to existing patient ...................................8

3.3.1 How to register “New Biopsy Notification”? .....................................................8

3.3.2 Add new biopsy type for registered patient ........................................................9

3.3.3 Add new biopsy Notification ..............................................................................9

4. How to complete data entry for the biopsy registered according to kidney type?

......................................................................................................................................10

These compulsory fields have the value entered. Please complete the rest of the......10

fields in the forms.........................................................................................................10

4.1 Native kidney biopsy – complete data entry as follows: ...................................10

4.2 Graft kidney biopsy – complete data entry as follows:......................................13

5 How to notify an ‘Outcome Event’?..................................................................16

5.1 Outcome Notification Rules: .............................................................................16

5.2 Perform search/verify to get the patient’s record...............................................17

5.3 Notify outcome event.......................................................................................17

5.3.1 Notify an Outcome event to patient with no outcome record..........................17

5.3.2 Notify an Outcome event to patient with an outcome record ...........................17

5.4 Data entry for Outcome events .........................................................................18

5.4.1 Death .................................................................................................................18

5.4.2 Moved to other centre .......................................................................................18

5.4.3 Lost to follow up...............................................................................................19

5.4.4 ESRF.................................................................................................................20

6. Biopsy Procedure Form ....................................................................................20

6.1 How to add Biopsy Procedure?.........................................................................20

7 Request delete ...................................................................................................21

8. Responsibility .........................................................................................................22

Appendix:.....................................................................................................................23

1. Patient Registration Post Verification Process Flowchart .......................................24

2. Add New Biopsy Notification record to existing patient Process Flowchart ..........25

3. Add Biopsy Procedure Process flowchart (refer 6.1) ..............................................26

4. Add Outcome Event Process flowchart (refer 5.1)..................................................27





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1. Introduction and Purpose

The data accuracy is a paramount important in a registry. To ensure that a

patient is not registered more than once, the patient’s unique identifiable

variables like Mykad/Mykid (IC New), IC Old, name must be accurate and

correct. A registered patient will than be given a unique [Patient ID].

Every biopsy episode is reported using a MRRB Notification Form (Native

Kidney Biopsy/Graft Kidney Biopsy). It is norm that patient often may have

more than one biopsy. Thus a patient can only have one [Pt ID] (Patient ID) but

multiple [RB ID} (Renal Biopsy ID).

This SOP describes the steps and techniques to systematically verify a patient’s

CRF for accurate data entry. It is utmost important to verify a patient’s unique

identifiable variables and the critical variable [Date Biopsy] before any

registration.

All the SDP authorized staff has the access right to the system. He/she is able to

[View], [Add], [Update], and [Save] a record. The [Delete] buttons are disabled

to save guard the data integrity.

2. Scope

This SOP applies to the activities within the SDP. The verification process is

performed based on the patient’s source documents.

Source documents:

• Patient record- patient’s case notes are the source document.

• Biopsy Report and Laboratory results

• The MRRB forms if the centre chooses to capture the patient’s information

in CRF then transcript it to the system.

(CRF printed from the system is not a source document)

The result search field(s) will be able to identify the patient status; e.g. current

patient, new patient, current centre, current biopsy record, number of biopsy

performed and patient and treatment outcome.

Verification of source document will assist the user to decide the subsequent

needful procedures like registration, editing and data entry.





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3. Applicable guidelines and regulations

3.1 Verify a New Patient

Verification Rule 1:

• Before registering a Patient, Notification or CUSUM, please verify that patient has

not been registered in the system before.

• Select Search under the Patient toolbar. In the Search section, enter the patient’s

MyKad / MyKid No.

• If patient exists (i.e. Patient is shown in the patient list), DO NOT register patient.

At the [Action] click [View] to confirmed that this is NOT the same patient before

‘Register Patient’

• If patient doesn't exist (i.e. Patient is NOT shown in the patient list), select [ADD]

according to the type of renal biopsy to ‘Register Patient’.

Patient registration is at this screen [Search] with [Patient List]

Click here





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3.1.1 How to verify a patient before data entry?

3.1.1 a) Perform patient verification at the {Search Screen}

• [Participating Centre] always at default (blank)

• Recommended search fields are [Mykad/Mykid], [Patient Name] and [Other

Document No.]

3.1.1 b) The search choices available are flexible, the similar patient found will be

listed for manual/visual verification of possible typo error. Please search all possible

fields and search selection choice to minimize duplicate record.

• The default is ‘Contain (*S*)’ this is recommended as it provide wider search. But

you need to perform visual check for the record.

• If you need more specific/ exact match you may change to “whole word (S)”.

• You may also used ‘Begin with (S*)’ as user needs to type only a portion of the

information. But you need to perform visual check for the record.

3.1.1 c) Manual/visual verification is performed to minimized duplication or double

patient registration

• If record found as shown in the [Patient List], verify that name and date biopsy and

type biopsy before you add a new patient or new notification.

• If confirmed NOT the same patient / biopsy, then click [ADD] not otherwise.

Search all the possible fields to avoid

duplicate record





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3.1.1 d) For more details about the patient, click at [Action] click [View]. Any

correction / update required please inform [email protected] .

3.2 How to register a “New Patient”?

3.2.1 Patient Registration Rule

Before register a patient, please ensure that patient has not been registered in the system

before to avoid duplication / double reporting.

Register a new patient post verified.

• Compulsory variables must be entered:

• [Name]

• Identification Card Number e.g. [MyKad / MyKid], [Old IC] or [Other Document]

• [Date Biopsy] in section 5 (Native Biopsy) or section 4 (Graft Biospy)

Patient’s [Name] data entering standardization to minimized duplication

• Name as in the patient identification document

2. Click one of this [ADD] icon to

register new native / graft patient.

See item 3.2 below

1. If this patient the same patient as

the CRF that or if there is no record

shown, please proceed to step 2

4. If this patient is the same patient you intended to update, click the icon(s) to view

previous biopsy record. ‘0’ beside the icon indicate no record.

before add new biopsy record. See item 3.3 below

3. Click this icon to view

more information about the

patient.

See the screen below





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• Muslim name with ‘Bin’ and ‘Binti’ enter as ‘B’ and ‘Bt’ respectively.

• Name with ‘Anak’ enter as ‘A/K’

• Indian name enter as ‘A/L’ and ‘A/P’

Patient’s National Register Identification Card (NRIC) number data entering

standardisation

• Mykad/Mykid for patients who has NRIC

• Other Document identification number for those patients who DO NOT has NRIC.

Please specify document type accordingly.

• Old IC to be complete 7 digits (if patient with 6 digit please add ‘0’ in front) and

with the alphabet if there is.

• For paediatric patient who uses parent’s NRIC, please enter twice; i.e. at [NRIC

Mykad/Mykid] and [Other Document]. Patient actual NRIC should be updated

once he/she has attained it.

3.2.2 Patient registration post verification.

3.2.2 a) Register a patient if record NOT found

• Record NOT found the [Patient List] will be empty.

• Click [ADD] (Register patient) to register new patient according to biopsy type.

• Complete the compulsory fields then click [Save] and [Confirmed].

• Registration failed if the compulsory fields shown in red after click [Save] is not

being completed.

Native kidney biopsy - incomplete Graft kidney biopsy - incomplete

Take note of the PTID and RBID to facilitate subsequent data entry.





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3.2.3 Compulsory field

Native kidney biopsy - compulsory fields must be entered before [Save]

o Item C: Date Biopsy (dd-mm-yyyy)

o Section 1.1: Patient Name

o Section 1.3: Identification Card Number

o Section 1.5: Date of Birth

o Section 1.6: Gender

o Section 1.7: Ethnic group

o Section 2.1 a): Date at presentation

o Section 2.1 b): Date seen by first Nephorologist

o Section 4.3 d): Creatinine at biopsy (please provide the value. If not please tick

[Not available])

Graft kidney biopsy - compulsory fields must be entered before [Save]

o Item C : Date Biopsy (dd-mm-yyyy)

o Section 1.1: Patient Name

o Section 1.3: Identification Card Number

o Section 1.5: Date of Birth

o Section 1.6: Gender

o Section 1.7: Ethnic group

o Section 2.1 b): Date of Transplant

o Section 3.4 d): Creatinine at biopsy (please provide the value. If not please tick

[Not available])

3.3 Add New Biopsy Notification record to existing patient

3.3.1 How to register “New Biopsy Notification”?

Always perform search/verify before any registration.

• Record found shown in the [Patient List] after “Search”.

• The number of renal biopsy reported is indicated beside the [Notification] icon.

• To add [Native Kidney Notification] / [Graft Kidney Notification], click the

relevant [Notification] icon to access to forms.

• Always check the [Date Biopsy] before [Add] new biopsy record to avoid

duplication.

• If confirmed NOT the same record(s), click [ADD] (Add new xxxx xxx ) and not

otherwise.

Click here to add new graft biopsy. To add

new biopsy type see item 3.3.2 below.





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3.3.2 Add new biopsy type for registered patient

• Record found the name of patient is shown in the [Patient List].

• But the biopsy type need to be updated shown ‘0’ confirmed new biopsy.

• Click [ADD] (Add new xxxx xxx) and not otherwise

3.3.3 Add new biopsy Notification

• Record found the name of patient is shown in the [Patient List].

• List of biopsy notified shown.

• Verify the [Date of biopsy] to ensure that the record to be updated is confirm new

notification

• Click [ADD] (Add new xxxx xxx) and not otherwise.

Click here to see the list of biopsy reported. To add

new notification to the same biopsy type, see item

3.3.3 below.

.

Click here to add new notification

Click here to add new notification

Click here to update new notification after confirm

Click here to update new notification after confirm





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4. How to complete data entry for the biopsy registered according to kidney type?

These compulsory fields have the value entered. Please complete the rest of the

fields in the forms.

4.1 Native kidney biopsy – complete data entry as follows:

SECTION 2: Please complete item 2 - 4

Click each tab to go to another

page until you complete all the

pages

SECTION 1: Please complete the address





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SECTION 3: Applicable to SLE patient only

SECTION 4: Please complete





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SECTION 5: Please complete all





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4.2 Graft kidney biopsy – complete data entry as follows:

After completed Data Entry

session, please click [Save] and

[Confirmed save]

SECTION 5: HPE Data (Q5-Q6)

SECTION 1: Please complete the address

Click each tab to go to another

page until you complete all the

pages





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SECTION 3: Please complete

SECTION 2: Please complete item 1 - 5





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SECTION 4: Please complete all





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5 How to notify an ‘Outcome Event’?

Outcome event required reporting are:

o Death

o Move centre – This allow record sharing

o Lost to follow-up

o ESRF – where native or graft kidney failed.

5.1 Outcome Notification Rules:

• Outcome is by patient not biopsy record. Thus a patient can have more than one

outcome record according to the outcome event.

• Outcome event updated can be edited within the same record.

After completed Data Entry

session, please click [Save] and

[Confirmed save] SECTION 5: HPE Data (Q5-Q6)





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5.2 Perform search/verify to get the patient’s record

• Record found is shown in the [Patient List] upon “Search”.

• The number of outcome events that were reported is indicated in the [Outcome]

column.

• Click the [Outcome] icon to view the detail of the event.

5.3 Notify outcome event

5.3.1 Notify an Outcome event to patient with no outcome record

Outcome Notification = 0

• Click here to notify the outcome event.

5.3.2 Notify an Outcome event to patient with an outcome record

Outcome Notification = 1, 2…

• Ensure that the [Outcome Event] and [Date Outcome] is NOT same as record

shown.

• At the [Patient Outcome] page click [Add].

Example: This patient has 1

outcome event as shown here

Example: This patient

has more than 1

outcome event, the

screen as shown the

event and the dates

Click here





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5.4 Data entry for Outcome events

• Click the appropriate outcome event to access to the related page for data entry

• Complete the data entry as required

5.4.1 Death

5.4.2 Moved to other centre

If this patient has being transferred to your centre, you may add an outcome event =

[move]. By doing this, you are able to share the information; accessible to this patients

forms and HPE report.

Vice versa for patient transferred out from your centre.

Click the appropriate

outcome event to

access to the related

page for data entry

Please tick the

appropriate information

to be reported

Click here after

confirmed reporting

required.





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5.4.3 Lost to follow up

Please provide

reason in the text

box

Patient in more than 1

centre





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5.4.4 ESRF

6. Biopsy Procedure Form

• Biopsy Procedure form is tied to the Patient Norification form according to the date

biopsy.

• Perform search/verify to get the patient’s record.

• Select the appropriate biopsy notification before adding the ‘Biopsy Procedure

Form’

6.1 How to add Biopsy Procedure?

• Add Biopsy Procedure to current [Notification]

• Click [ADD] (Add Biopsy) and try to complete as much information as possible.

• Nephrology trainee needs to enter your name in the item “ 7 aii)” to facilitate

CUSUM charting. (Please check for complete in reporting of biopsy performed in

the CUSUM. You can update the missing biopsy via MRRB only)

Click here

Please select appropriate [RRT

modality]. Provide the centre

name if possible





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7 Request delete

You may request a form to be deleted once you confirmed that it is not

relevant/incorrect/duplicate. Please request it through the system.

• Click on the icon at the form and provide the reasons for the request.

Examples of request delete icons for all the forms:

• The reason for request delete is located above all the page tabs

Please complete all





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8. Responsibility

This SOP for all data entry users

CRM to continue monitor the database patient records

Detect double registration of patient and notification

Check the SDP activity and the latest biopsy reported by month





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Appendix:

FLOW CHARTS

1. Patient Registration Post Verification Process Flowchart .......................................24

2. Add New Biopsy Notification record to existing patient Process Flowchart ..........25

3. Add Biopsy Procedure Process flowchart (refer 6.1) ..............................................26

4. Add Outcome Event Process flowchart (refer 5.1)..................................................27





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1. Patient Registration Post Verification Process Flowchart

Register a patient if record NOT found (refer 3.2.2 9a) & 3.3.1)

Compulsory field Native kidney biopsy Graft kidney biopsy

• Item C: Date Biopsy (dd-mm-yyyy)

• Section 1.1: Patient Name

• Section 1.3: Identification Card Number

• Section 1.5: Date of Birth

• Section 1.6: Gender

• Section 1.7: Ethnic group

• Section 2.1 a): Date at presentation

• Section 2.1 b): Date seen by first Nephorologist

• Section 4.3 d): Creatinine at biopsy (please provide

the value. If not please tick [Not available])

• Item C : Date Biopsy (dd-mm-yyyy)

• Section 1.1: Patient Name

• Section 1.3: Identification Card Number

• Section 1.5: Date of Birth

• Section 1.6: Gender

• Section 1.7: Ethnic group

• Section 2.1 b): Date of Transplant

• Section 3.4 d): Creatinine at biopsy (please

provide the value. If not please tick [Not

available])

Start

End

Patient found?

Register patient accordingly Click either:

or

Verified patient

by MyKad/Mykid, IC Old, Name

No

No

Yes

Complete the compulsory fields

Compulsory Information

Complete?

Save

Go to: Add new biopsy type

for registered patient (refer

3.3.2 & 3.3.3)

Yes

Confirm Save





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2. Add New Biopsy Notification record to existing patient Process Flowchart

Add new biopsy type for registered patient (refer 3.3.2 & 3.3.3)

Start

End

Patient found

Register patient

accordingly

Click either:

or

Check [Biopsy

Date]

Verified patient


Access more information / forms

or

Check information

completeness

Click

or

To complete the

information

Click

Perform DE

Add new notification

Click or

Different

Different

Same

Same

Native/Graft Biopsy

Save

Confirm Save

Information

complete

Yes

No





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3. Add Biopsy Procedure Process flowchart (refer 6.1)

Start

End

Native/Graft Biopsy

Register patient

accordingly

Click either:

or

[Biopsy Date]?

Verified patient



Click or

Perform DE

Add [Biopsy Procedure]

Click

Same

Different

Same

Different

Check information

completeness

Click

or

To complete the

information

Click

Patient found

Save

Confirm Save

Information

complete

No

Yes





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4. Add Outcome Event Process flowchart (refer 5.1)

Start

End

Register patient

accordingly

Click either:

or

Check [Outcome

Event and Date]

Verified patient



Click

Perform DE

Same

No

Yes

Different

Confirm Save

Information

complete

Check information

completeness

Click

or

To complete the

information

Click

Add [Outcome Notification]

Click

No

Patient found?

Yes Save

sop mrrb dataentry 30092010 · 2010-11-09 · version 2.0 sop-rru-co05-3 date: 21/06/2010 created...

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