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- RCPAQAP Transfusion TRANSFUSION GENERAL TRANSFUSION PROGRAMS General Compatibility Module: Blood Grouping, DAT, Antibody Screen, Antibody Identification, Phenotyping and Compatibility Basic Compatibility Module: Blood Grouping, DAT, Antibody Screen and Compatibility Phenotyping Module: Extended Antigen Testing Antibody Titre Module: Anti-D Titration INFORMATION BOOKLET 2013 BEFORE 1 JULY 2013 RCPAQAP TRANSFUSION PO Box 2074 KELVIN GROVE QLD 4059 AUSTRALIA Tel: +61 7 3129 8450 Fax: +61 7 3838 9413 E-mail: [email protected] Website: www.rcpaqap.com.au/transfusion/ AFTER 1 JULY 2013 RCPAQAP CENTRE OF EXCELLENCE Suite 201, 8 Herbert Street ST LEONARDS NSW 2065 AUSTRALIA Tel: +61 2 9045 6000 Fax: +61 2 9356 2003 E-mail: [email protected] Website: www.rcpaqap.com.au/transfusion/

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Page 1: GENERAL TRANSFUSION PROGRAMS - RCPAQAPdataentry.rcpaqap.com.au/transfusion/GT Program Booklet.pdf · RCPAQAP TRANSFUSION OFFICE The RCPAQAP Transfusion is currently located at the

- RCPAQAP Transfusion

TRANSFUSION

GENERAL TRANSFUSION PROGRAMS General Compatibility Module: Blood Grouping, DAT, Antibody Screen, Antibody Identification,

Phenotyping and Compatibility

Basic Compatibility Module: Blood Grouping, DAT, Antibody Screen and Compatibility

Phenotyping Module: Extended Antigen Testing

Antibody Titre Module: Anti-D Titration

INFORMATION BOOKLET 2013

BEFORE 1 JULY 2013 RCPAQAP TRANSFUSION

PO Box 2074 KELVIN GROVE QLD 4059

AUSTRALIA

Tel: +61 7 3129 8450 Fax: +61 7 3838 9413

E-mail: [email protected] Website: www.rcpaqap.com.au/transfusion/

AFTER 1 JULY 2013 RCPAQAP CENTRE OF EXCELLENCE

Suite 201, 8 Herbert Street ST LEONARDS NSW 2065

AUSTRALIA

Tel: +61 2 9045 6000 Fax: +61 2 9356 2003

E-mail: [email protected] Website: www.rcpaqap.com.au/transfusion/

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TRANSFUSION General Transfusion Programs

CONTENTS

TOPIC PAGE

Program Contact Information 1

General Information

RCPAQAP Transfusion Advisory Committee 2

RCPAQAP Transfusion Office 2

RCPAQAP Certificates 2

General & Basic Compatibility Module Result Sheets 3

Phenotyping & Anti-D Titre Module Result Sheets 3

QAP Survey Samples 3

RCPAQAP Transfusion Scope of Accreditation 4

General Transfusion Program Information

General Compatibility Module Details 4

Basic Compatibility Module Details 4

General & Basic Compatibility Module Reports and Assessment 5

Phenotyping Module Details 5

Phenotyping Module Reports and Assessment 5

Antibody Titre Module Details 5

Antibody Titre Module Reports and Assessment 5

General Transfusion Program Despatch & Result Due Dates 6

General and Basic Compatibility Modules - Performance Assessment

Performance Assessment System 6

Performance Levels 6

Performance Monitoring in Transfusion 7

Cumulative Performance Levels 7

What Tests Results are Considered Critical? 7

Transfusion QAP Criteria 7

Example of Performance Assessment 8

Transfusion QAP Framework 8

Participant Feedback 8

General Transfusion Program Method Sheets and Result Sheets Examples & Explanations

General Transfusion Program Method Classification Sheet Example 10

General & Basic Compatibility Result Sheets Example 12

Phenotyping Module Result Sheet Example 14

Antibody Titre Module Result Sheet Example 15

General Transfusion Program User Registration and Data Entry Instructions

User Registration for General Transfusion Programs via the Website 17

Data Entry for General Transfusion Program Results via the Website 20

Important Points - General Transfusion Program 23

General Transfusion Program Report Examples & Explanations

General and Basic Compatibility Module Reports 25

Phenotyping Module Report 27

Antibody Titre Module Report 29

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TRANSFUSION General Transfusion Programs

Page 1

PROGRAM CONTACT INFORMATION

Before 1 July 2013 RCPAQAP Transfusion PO Box 2074 Kelvin Grove Qld 4059 Australia

Telephone No: Fax No: E-mail:

+61 7 3129 8450 +61 7 3838 9413 [email protected]

RCPAQAP Transfusion Chair Dr Bronwyn Williams Haematology Department Royal Brisbane Hospital Herston Qld 4029 Australia

Telephone No: Fax No: E-mail:

+61 7 3636 8068 +61 7 3252 1324 [email protected]

RCPAQAP Transfusion Program Manager Mr Neville Herrmann

Telephone No: Fax No: E-mail:

+61 7 3129 8451 +61 7 3838 9413 [email protected]

RCPAQAP Transfusion Program Second in Charge Ms Cathy Hughes

Telephone No: Fax No: E-mail:

+61 7 3129 8452 +61 7 3838 9413 [email protected]

RCPAQAP Transfusion Website www.rcpaqap.com.au/transfusion/

After 1 July 2013 RCPAQAP Centre of Excellence Suite 201, 8 Herbert Street St Leonards NSW 2065 Australia

Telephone No: Fax No:

E-mail:

+61 2 9045 6000 +61 2 9356 2003 [email protected]

RCPAQAP Transfusion Program Manager Mr Friend Maviza

E-mail: [email protected]

RCPAQAP Transfusion Website www.rcpaqap.com.au/transfusion/

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TRANSFUSION General Transfusion Programs

Page 2

GENERAL INFORMATION RCPAQAP TRANSFUSION ADVISORY COMMITTEE The RCPAQAP Transfusion is under the guidance of an Advisory Committee. The RCPAQAP Transfusion Advisory Committee is as follows:

Dr Bronwyn Williams QAP Chair / Consultant Haematologist, Royal Brisbane Hospital, Queensland Mr Arthur Joyce Scientist in Charge, Blood Bank, Mater Health Services, Queensland Mr Geoff Magrin Supervising Scientist, The Alfred Hospital, Victoria Mrs Elizabeth Lennox Transfusion Medicine Scientist, Australian Red Cross Blood Service, Queensland Mrs Cheryl Kann Supervising Scientist, Blood Bank, The Prince Charles Hospital, Queensland Dr Anne Haughton Haematologist, Sullivan Nicolaides Pathology, Queensland Mr Tony Greenfield Scientist in Charge, Blood Bank, Liverpool Hospital, New South Wales Mr Neville Herrmann Program Manager Ms Cathy Hughes Program Second in Charge

RCPAQAP TRANSFUSION OFFICE The RCPAQAP Transfusion is currently located at the Australian Red Cross Blood Service - Queensland. The office is responsible for the day-to-day delivery of all aspects of the QA programs from design of surveys, sample selection and preparation, to summary reports and assessment.

The QAP staff will provide a prompt and friendly service to all enquiries with scientific support from the Chair and Advisory Committee. The Transfusion QAP endeavours to provide consultative services to all participants and the profession. The identity to all participants is kept confidential and details will not be released without the written permission of the participant. The Transfusion QAP will however consider all reasonable requests for information and support when requested.

The QAP is managed by a full-time Program Manager and a full-time Second in Charge with the support and consultation of the QAP Advisory Committee. The QAP welcomes all feedback from participants. If participants have a query, please contact the QAP by e-mail, phone or fax. The QAP has a voicemail service so if we are unable to take your call, please leave a message and we will get back to you as soon as possible.

RCPAQAP CERTIFICATES

Enrolment Certificates

Enrolment certificates for the RCPAQAP Transfusion are processed and issued by the RCPAQAP Enrolment Office after payment has been received. Enrolment office is located at RCPAQAP Centre of Excellence, Suite 201, Level 2, 8 Herbert St, St. Leonards NSW 2065. Enrolment contacts: Ph: +61 2 9045 6010, F: +61 2 9356 2006 or E-mail: [email protected]

Participation Certificates

Participation certificates are processed and issued by the Transfusion QAP office. A participation certificate is issued to participants for each program your laboratory is enrolled in. Certificates are provided after the final survey for the year has been analysed and assessed by the Advisory Committee.

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TRANSFUSION General Transfusion Programs

Page 3

GENERAL TRANSFUSION PROGRAM RESULT SHEETS

GENERAL AND BASIC COMPATIBILITY MODULE RESULT SHEETS

Request forms and Result Sheets for the General and Basic Compatibility modules will be supplied to participants with the survey samples. Result sheet composition will vary from survey to survey depending on the scenario and participant results can be returned to the QAP via the Transfusion website, mail, fax or e-mail.

PHENOTYPING & ANTIBODY TITRE MODULE RESULT SHEETS The QAP provides participants with a generic result sheet for the Phenotyping and Antibody Titre modules. Instructions for Phenotyping and Antibody Titre modules are supplied to participants with survey samples.

Participant results can be returned to the RCPAQAP Transfusion via mail, fax or using the direct data entry via the Transfusion QAP website. All result sheets supplied by the QAP have participant numbers printed on them.

QAP SURVEY SAMPLES SAMPLE TRANSPORT

The RCPAQAP Transfusion survey samples are transported at ambient temperature.

SAMPLE TESTING

All Transfusion QAP survey samples issued are non-reactive for the following markers: - HbsAg and HBV DNA - Antibodies to HIV-1 and HIV-2, HIV-1 RNA - Antibodies to HCV and HCV RNA - Antibodies to HTLV-1 - Syphilis

In keeping with safe laboratory practices, the RCPAQAP Transfusion recommends that all samples are handled as potentially infectious and appropriate personal protective equipment is recommended.

The RCPAQAP Transfusion is NATA accredited and all survey samples issued by the QAP have been selected and prepared in accordance with NATA recommended guidelines ISO/IEC 17043:2010.

All survey samples issued by the RCPAQAP Transfusion have been packaged and distributed in accordance with IATA packing instruction 650 regulations.

SAMPLE SPECIFICS

General and Basic Compatibility Modules - Type and Volume of Samples Provided Patient Samples:

Donor Unit Samples:

Separate plasma sample - 4mL EDTA provided - sample contains CelpresolTM and EDTA

Separate cell sample - 2mL EDTA provided - sample contains CelpresolTM and EDTA

Cell sample only - 2mL EDTA provided - samples contain CelpresolTM and EDTA

Phenotyping & Antibody Titre Modules - Type and Volume of Samples Provided Phenotyping Samples: Anti-D Titre Samples:

Cell sample - 6mL EDTA provided - sample contains CelpresolTM and EDTA Plasma sample - 2mL provided - sample contains EDTA and NaN3

SAMPLE INTEGRITY

Stability testing is performed on all survey samples as follows: Two (2) sets of samples are placed in temperature conditions of 2-8oC and 22oC for four (4) days and two (2) sets of samples are placed at 38oC for 8 hours and then at 30oC for the remainder of the four day duration. Four (4) days is the average time the QAP has determined for delivery of QAP samples. After 4 days the samples are then placed at 2-8oC until closing date. Stability samples are tested by the QAP staff and results reviewed by the Program Manager or Second in Charge.

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TRANSFUSION General Transfusion Programs

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RCPAQAP TRANSFUSION SCOPE OF ACCREDITATION

The RCPAQAP Transfusion is NATA accredited for the provision of a proficiency testing scheme under guidelines ISO/IEC 17043:2010. Following is the scope which the QAP is accredited.

SCOPE OF PROFICIENCY TESTING PROVIDER FOR: MEDICAL TESTING 10.20 Immunohaematology .01 Blood grouping including ABO and RhD .03 Blood group antibody .04 Identification of blood group antibodies .05 Determination of compatibility of donation units using appropriate techniques including the investigation of transfusion reactions .06 Red cell phenotyping .99 Miscellaneous testing Foetal maternal haemorrhage estimation, Direct Antiglobulin Test, Antibody Titration, Snake Venom Detection by ELISA

GENERAL TRANSFUSION PROGRAM INFORMATION

GENERAL COMPATIBILITY MODULE DETAILS The General Compatibility Module comprises Blood Grouping, DAT, Antibody Screen, Antibody Identification, Phenotyping and Compatibility testing.

This module is designed for laboratories that routinely prepare blood for transfusion for patients with or without allo-antibodies. Laboratories in this module will be expected to carry out all the testing including antibody identification and phenotyping mandated for the safe transfusion of blood. Any specific tests that are outside the scope of the laboratory and would normally be referred to a central or reference laboratory will not affect the performance assessment provided the appropriate responses for the survey have been reported.

Only those tests required for the transfusion of compatible units will be assessed. For example, only phenotyping for antigens corresponding to the allo-antibodies detected in the patient will be assessed. For extended phenotyping assessment, participants may consider enrolling in the Phenotyping Module (outlined next page) in order to achieve assessment of overall phenotyping performance.

There are six (6) surveys per year with a varying number of red cell and plasma samples for patients and donation units. Surveys are despatched on a bi-monthly basis. In addition, customer satisfaction questionnaires are distributed every two or three years to provide the QAP with participant feedback.

BASIC COMPATIBILITY MODULE DETAILS The Basic Compatibility Module comprises Blood Grouping, DAT, Antibody Screen and Compatibility testing.

This module is designed for laboratories not performing antibody identification or phenotyping. Laboratories that refer antibody identification and compatibility testing to a central or reference laboratory when an allo-antibody is detected in the patient’s plasma should enrol in this module. In the absence of allo-antibodies, laboratories enrolled in this module may perform compatibility testing by IAHG crossmatch, computer crossmatch, immediate spin or similar techniques.

There are six (6) surveys per year with a varying number of red cell and plasma samples for patients and donation units. Surveys are despatched on a bi-monthly basis. In addition, customer satisfaction questionnaires are distributed every two or three years to provide the QAP with participant feedback.

The General and Basic Compatibility modules are designed to challenge laboratories with different scenarios such as antenatal/neonatal complications, post transplantation, transfusion reactions & patients with multiple antibodies.

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TRANSFUSION General Transfusion Programs

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GENERAL AND BASIC COMPATIBILITY MODULE REPORTS AND ASSESSMENT The General and Basic Compatibility module targets and acceptable responses are determined by consensus. The final acceptable responses are at the discretion of the Transfusion Advisory Committee. Each response is allocated a score which is shown on the report as well as a pointer indicating your result.

Reports will show a table of all responses by method with your response highlighted. A corresponding double bar graph shows how may laboratories supplied results for each method.

Performance assessment is based on a numerical scoring system and the final page of the report indicates the number of points accrued by the laboratory compared to the target score. The scoring system for the general and basic compatibility modules has a maximum number of possible points and participants will lose points for errors. Report features for the basic compatibility module are an Assessment Summary, Cumulative Summary and Assessment scores obtained for each previous survey in the cycle. Report features for the general compatibility module are an Assessment Summary, Performance Level indicator and Assessment score obtained for each previous survey in the cycle.

The General Compatibility and Basic Compatibility modules are assessed separately and reports are designed for prompt identification of areas requiring corrective action.

PHENOTYPING MODULE DETAILS This module is designed for laboratories testing both a limited or extended range of antigens. Laboratories requiring performance assessment for a full range of antigens are encouraged to participate in this module.

There are four (4) surveys per year with one (1) red cell sample per survey for extended phenotyping. Only perform routine phenotyping for antisera held in your institution. In addition, customer satisfaction questionnaires are distributed every two or three years to provide the QAP with participant feedback regarding the QA programs. PHENOTYPING MODULE REPORTS AND ASSESSMENT The Phenotyping module targets and acceptable responses are determined by consensus. The final acceptable responses are at the discretion of the Transfusion Advisory Committee.

Reports show a double bar graph indicating how may laboratories supplied results and the acceptable response for each analyte with your method highlighted in black. A table indicating your response and method classification is shown as well as a summary data table for each analyte indicating laboratory result and target for each survey.

Other features of the report is an Analysis of Results for the current survey, a Summary table indicating survey id, total number of errors, total results submitted, percentage of errors for each survey and a summary of results outside the allowable limits.

ANTIBODY TITRE MODULE DETAILS This module is designed for laboratories that routinely perform anti-D titrations. There are four (4) surveys per year with one (1) plasma sample per survey of varying strengths for anti-D titration.

ANTIBODY TITRE MODULE REPORTS AND ASSESSMENT The Antibody Titre module targets and acceptable range is determined by consensus. The final acceptable target is at the discretion of the Transfusion Advisory Committee. In the case when a clear consensus cannot be demonstrated, the target value and acceptable range will be set by the committee. Deviation of a survey target and acceptable range will be clearly enunciated on the survey report.

Reports show a table indicating your result and method and a graph indicating the target value and range with your response highlighted and a pointer indicating your result. A breakdown of your method is also provided as well as a summary data table indicating your laboratory result and target for each survey.

The report also shows an Analysis of Results for the current survey and an Analysis of Results Outside the Acceptable Limits.

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TRANSFUSION General Transfusion Programs

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GENERAL TRANSFUSION PROGRAM - SAMPLE DESPATCH & RESULT DUE DATES

General Compatibility Module: Blood Grouping, DAT, Antibody Screen and Identification, Phenotyping and Compatibility

Basic Compatibility Module: Blood Grouping, DAT, Antibody Screen and Compatibility Module Identification Survey Despatch Date Results Due

AGAB2013-1 14/01/2013 01/02/2013 AGAB2013-2 11/03/2013 29/03/2013 AGAB2013-3 13/05/2013 31/05/2013 AGAB2013-4 12/08/2013 30/08/2013 AGAB2013-5 23/09/2013 11/10/2013 AGAB2013-6 04/11/2013 22/11/2013

Phenotyping Module: Limited and Extended Antigen Testing Antibody Titre Module: Anti-D Titration

Module Identification Survey Despatch Date Results Due *AP2013-1 & *AA2013-1 11/03/2013 29/03/2013 *AP2013-2 & *AA2013-2 13/05/2013 31/05/2013 *AP2013-3 & *AA2013-3 12/08/2013 30/08/2013 *AP2013-4 & *AA2013-4 23/09/2013 11/10/2013

* Please note: Phenotyping (AP) and Antibody Titre (AA) module samples are despatched with the AG/AB survey samples and are supplied in AG/AB survey 2, AG/AB survey 3, AG/AB survey 4 and AG/AB survey 5.

GENERAL & BASIC COMPATIBILITY MODULES - PERFORMANCE ASSESSMENT SYSTEM

Survey Component Points per Component (if applicable) Total Points Patient Identification 5 points 20 points

Patient Blood Group* 2 points per mandatory reaction

60 points 50 points for blood group*

Patient DAT 20 points Patient Antibody Screen* 50 points Patient Antibody Identification 20 points Phenotyping 5 points per assessed result Variable

Donor Grouping* 2 point per mandatory reaction

56 points per donor unit 50 points for blood group*

Compatibility - Crossmatch Reaction* 50 points per donor unit 55 points per donor unit - Transfuse Unit? 5 points per donor unit * Indicates the critical areas of the Transfusion QAP surveys.

GENERAL COMPATIBILITY MODULE - PERFORMANCE ASSESSMENT LEVELS

Category Level Total Points Loss for Level

Reference 100 Level Corresponds to a loss of 0 points

Reference 99 Level Corresponds to a loss of 1-19 points (minor errors)

Operational Level Corresponds to a loss of 20-49 points (minor errors)

Review Level Corresponds to a loss of 50-99 points (1 critical error)

Unsatisfactory Level Corresponds to a loss of ≥ 100 points (2 critical errors)

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TRANSFUSION General Transfusion Programs

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PERFORMANCE MONITORING IN TRANSFUSION

GENERAL COMPATIBILITY MODULE In 2012, the Transfusion QAP will be introducing a pilot for Performance Monitoring in the General Compatibility module. Details of the performance monitoring system are outlined below: Cumulative Performance Levels Calculation

Cumulative performance level (CPL) is calculated from a six survey cycle regardless of year. Each performance level is weighted and used in the calculation. Survey Performance Level Weighting:

Reference 100 Level weighting = 1 Reference 99 Level weighting = 2 Operational Level weighting = 3 Review Level weighting = 4 Unsatisfactory Level weighting = 5

Cumulative performance level = ∑ (survey performance level for last 6 surveys) _______________________________________ 6

then rounded up to the closest performance level Exceptions:

Unsatisfactory Survey Performance Level defaults to Unsatisfactory CPL Review Survey Performance Level defaults to Review CPL On the 3rd consecutive Ref 100 Survey Performance Level, the CPL resets to Ref 100

What Test Results are Considered Critical? Blood Groups (Patient and Donor Units) Antibody Screen Crossmatch Reaction

Transfusion QAP Criteria When participants fall outside the following criteria, results will be referred to the Transfusion Advisory Committee. A letter of notification and the committee report will be issued to the participant. Letter Notification of Unsatisfactory Performance

- Letter 1: equivalent of 2 critical errors - Letter 2: equivalent of 3 critical errors - Letter 3: equivalent of 4 critical errors

- Letter 1: letter and report sent to participant. The decision to send this letter will be at the discretion of

the advisory committee. Participant results will be monitored for 12 months. - Letter 2: letter and report sent to participant and immediate supervisor. - Letter 3: and letter and report sent to participant, immediate supervisor and Directory of Pathology.

Note: Non-return of survey results correlates to Unsatisfactory Performance.

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TRANSFUSION General Transfusion Programs

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EXAMPLE OF PERFORMANCE ASSESSMENT

The following is a mock up of a laboratories performance in 2012 and the how the scoring, performance levels and letter notifications will interact.

Participant Number: WXYZ

Survey Id 2012-1 2012-2 2012-3 2012-4 2012-5 2012-6

Target Score 600 600 600 600 600 600

Your Score 595 400 600 550 590 550

Survey Performance Level Reference 99 Unsatisfactory Reference 100 Review Reference 99 Review

Cumulative Performance Level Reference 99 Unsatisfactory Operational Review Operational Review

1st Letter 2nd Letter 3rd Letter

From this example, it can be seen that laboratory (WXYZ) has made 4 critical errors that has resulted in letters being sent to the laboratory supervisor initially and finally to the laboratory director. Clearly a laboratory achieving these results needs to be reviewed and perhaps a single staff member may be responsible and require training. This is an extreme example and lab performance such as this would be most unusual. From the aspect of patient safety, it’s important that supervisors at all levels are made aware of these types of laboratory failures.

Transfusion QAP Framework

Participant Feedback

The RCPAQAP Transfusion would like to inform participants of the following:

1. If you disagree with an assessment of your laboratory’s performance, you can appeal to the Transfusion QAP for an amendment if you have appropriate evidence relating to the amendment.

2. If you’re not satisfied with the response by the Transfusion QAP, you are entitled to make a final appeal to the Program Chair. Ultimately, the Chair’s decision is final regarding amendments to participant results.

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GENERAL TRANSFUSION PROGRAMS

General Compatibility Module (AG - Blood Grouping, DAT, Antibody Screen & Id, Phenotyping and Compatibility)

Basic Compatibility Module (AB - Blood Grouping, DAT, Antibody Screen and Compatibility)

Phenotyping Module (AP - Extended Phenotyping)

Antibody Titre Module (AA - Anti-D Titration)

METHOD CLASSIFICATION SHEETS AND RESULT SHEETS

EXAMPLES AND EXPLANATIONS

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TRANSFUSION General Transfusion Programs

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GENERAL TRANSFUSION PROGRAM METHOD SHEETS - EXAMPLE AND EXPLANATION

METHOD CLASSIFICATION SHEET No.1

Method Changes Apply From Survey: 2013-

Participant Number: 99997 (AG,AP,AA,I)

ANALYTE / TEST CATEGORY - Please record Codes using the supplied Method Master List

1. Method 2. Instrument 3. Reagent 4. Clonality Example A 99A 350 A

Patient Blood Group Anti-A

Anti-B

Anti-A,B

Anti-D

A1 Cells

Reagent cells N/A

A2 Cells

Reagent cells N/A B Cells

Reagent cells N/A

O Cells

Reagent cells N/A Patient Blood Group - Confirmatory Testing

Anti-A

Anti-B

Anti-D

Donor Unit Blood Group Anti-A

Anti-B

Anti-A,B

Anti-D

Neonatal Blood Group

Anti-A

Anti-B

Anti-A,B

Anti-D

Neonatal Blood Group - Confirmatory Testing Anti-A

Anti-B

Anti-D

DAT Adult

Polyspecific

IgG Specific

C3d Specific

DAT Neonatal Polyspecific

IgG Specific

C3d Specific

Antibody Screen

Cell panel N/A

If any of the classifications above are "other" please complete the section below

Analyte/Test Category Description

CHECK & COMPLETE

- Complete Survey number if requesting method changes during the year

- Check Participant Number

- Complete appropriate Method Codes - Refer to the Method Classification Master List

- For ‘Other - @’ methods, indicate manufacturer to assist QAP with assigning correct method code

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TRANSFUSION General Transfusion Programs

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GENERAL TRANSFUSION PROGRAM - EXAMPLE AND EXPLANATION

METHOD CLASSIFICATION SHEET No.2

Method Changes Apply From Survey: 2013-

Participant Number: 99997 (AG,AP,AA,I)

ANALYTE / TEST CATEGORY - Please record Codes using the supplied Method Master List

1. Method 2. Instrument 3. Reagent 4. Clonality Example A 99A 350 A

Phenotyping Anti-C

Anti-c

Anti-E

Anti-e

Anti-K

Anti-k

Anti-Kpa

Anti-Kpb

Anti-Fya

Anti-Fyb

Anti-Jka

Anti-Jkb

Anti-M

Anti-N

Anti-S

Anti-s

Anti-P1

Anti-Lea

Anti-Leb

Anti-Lua

Anti-Lub

Anti-Cw

Anti-D Titre 1. Method 2. Instrument 3. Diluent 4. Indicator Cells

If any of the classifications above are "other" please complete the section below

ANALYTE/TEST Category Description

CHECK & COMPLETE

- Complete Survey number if requesting method changes during the year

- Check Participant Number

- Complete appropriate Method Codes - Refer to the Method Classification Master List

- For ‘Other - @’ methods, indicate manufacturer to assist QAP with assigning correct method code

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TRANSFUSION General Transfusion Programs

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GENERAL & BASIC COMPATIBILITY RESULT SHEET - EXAMPLE AND EXPLANATION

Survey Id: AG/AB2013-1 Participant Number: 99997 (AG,AP,AA,I) Date Samples Received: Results Due Date: 03 / 02 / 2013 1. Patient ID & Blood Group (Pre Transfusion) Total Score = 80

Surname:

Given Name: Patient ID = 20 points

D.O.B: (dd/mm/yyyy)

UR Number:

Anti-A }

Anti-B }

Anti-A,B }

Anti-D } Enter Reaction Strength

A1 Cells } 0 WK 1 2 3 4 MF Mandatory Reactions = 10 points

A2 Cells }

B Cells }

O Cells }

Anti-A Confirm }

Anti-B Confirm }

Anti-D Confirm }

Blood Group Result: (circle response)

OPos ONeg APos ANeg BPos BNeg ABPos ABNeg IND Blood Group Result = 50points

2. Patient DAT Total Score = 20 Polyspecific } Enter Reaction Strength

IgG Specific }

C3d Specific } 0 WK 1 2 3 4 MF

DAT Result: POS NEG IgG Specific IgG+C3d C3d Specific

3. Patient Elution Studies (General Compatibility Module Only) Optional = Not Scored *Acceptable Method Codes [A=Heat] [B=Freeze/Thaw] [C=Acid Glycine] [D=Citric Acid] [E=Chloroform] Eluate Antibody Screen: POS NEG * Method (circle one) A B C D E (circle responses - maximum 7) Eluate A B D C c E c CW K k FYA FYB JKA IS IS = Insufficient sample

NS=No Specificity

REF=Refer for further testing

Antibody Id: JKB M N S s P1 LEA LEB LUA LUB KPA KPB COB NS xD xC xc xE xc xCW xK xk xFYA xFYB xJKA xJKB

x = cannot exclude xM xN xS xs xP1 xLEA xLEB xLUA xLUB xKPA xKPB xCOB REF

4. Antibody Screen (Pre Transfusion) Total Score = 50 Antibody Screen: POS NEG (circle response)

5. Antibody Identification (Pre Transfusion) (General Compatibility Module Only) Total Score = 20 (circle responses - maximum 7) A B D C c E c CW K k FYA FYB JKA

X = cannot exclude REF only is not an acceptable response

JKB M N S s P1 LEA LEB LUA LUB KPA KPB COB xD xC xc xE xc xCW xK xk xFYA xFYB xJKA xJKB xM xN xS xs xP1 xLEA xLEB xLUA xLUB xKPA xKPB xCOB REF

CHECK - Check Survey Identification (Eg. AG/AB2013-1 : Survey Type - General&Basic, Year - 2013 & Despatch Number - 1) - Check Participant Number and Results Due Date

MANDATORY

- Date Samples Received (Must record - checks prompt delivery of participant samples) - Patient Details (Must record Surname, Given Name, Date of Birth & UR Number) - Patient ABO/RhD Group Reactions (Must record cell group anti-A, anti-B, anti-D and serum group A1 & B cells) - Patient Blood Group Result (Must circle ABO/Rh group an acceptable response) - Patient DAT Result (Must circle DAT acceptable response) - Antibody Screen and Identification (if applicable) (Must record an acceptable response)

OPTIONAL - ABO & Rh(D) Grouping Reactions (Cell group anti-A,B and serum group A2 & O cells) - ABO & Rh(D) Grouping Reactions (Cell group anti-A confirm, anti-B confirm and anti-D confirm)

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Survey Id: AG/AB2013-1 Participant Number: 99997 (AG,AP,AA,I)

6. Phenotyping (General Compatibility Module Only) Total Score = Variable Only test antigens corresponding to the antibodies identified above including antibodies not excluded. (5 points per reaction)

Antigen: C c E e K Fya Fyb Jka Jkb M N S s Enter Phenotyping Code

Patient P Positive Donor Unit1:

N Negative

1111111 RT Refer for Testing Donor Unit2:

NT Not Tested; not pertinent to outcome

2222222 NTX Not Tested; crossmatch incompatible Donor Unit3:

3333333

7. Blood Group - Donation Units (Pre Transfusion) Total Score = 56 points per unit

Donor Unit 1: Donor Unit 2: Donor Unit 3: Donor Unit No: 1111111 2222222 3333333

Anti-A } Anti-B } Enter Reaction Strength

Anti-A,B } 0 WK 1 2 3 4 MF Anti-D }

Blood Group Result: Enter: OPOS ONEG APOS ANEG BPOS BNEG ABPOS ABNEG

Mandatory Reactions = 2 points per reaction per unit Blood Group Results = 50 points per unit

8. Compatibility Testing (Pre Transfusion) Total Score = 55 points per unit * Method Codes [A=Tube-IAHG] [ B=CAT-Gel] [C=CAT-glass bead] [D=Computer] [ E=Immed. Spin] [ F=Ab. Screen neg] [ G=By Phenotype] Donor Unit 1: 1111111 - A RhD Positive

U1 Crossmatch Reaction: 0 WK 1 2 3 4 DSEL * Method (circle one) A B C D E F G

Transfuse Unit 1? Y N YEH YP NS NP Crossmatch reaction = 50 points; Transfuse decision = 5 points

Donor Unit 2: 2222222 - A RhD Positive

U2 Crossmatch Reaction: 0 WK 1 2 3 4 DSEL * Method (circle one) A B C D E F G

Transfuse Unit 2? Y N YEH YP NS NP Crossmatch reaction = 50 points; Transfuse decision = 5 points

Donor Unit 3: 3333333 - A RhD Positive

U3 Crossmatch Reaction: 0 WK 1 2 3 4 DSEL * Method (circle one) A B C D E F G

Transfuse Unit 3? Y N YEH YP NS NP Crossmatch reaction = 50 points; Transfuse decision = 5 points

Sample Quality (please circle) Acceptable Unacceptable CODE EXPLANATION PLEASE TICK ()

If ‘Unacceptable’ is indicated please select 1 or 2 comments from the following options in the sample comment list

BAD One or more samples unacceptable - survey unable to be tested PAT Patient sample grossly haemolysed PATP Patient plasma of doubtful quality U1 Unit 1 sample grossly haemolysed

U2 Unit 2 sample grossly haemolysed U3 Unit 3 sample grossly haemolysed U4 Unit 4 sample grossly haemolysed

Tested by: Date: Reviewed by: (if applicable) Date:

CHECK - Check Survey Identification (Eg. AG/AB2013-1 : Survey Type - General&Basic, Year - 2013 & Despatch Number - 1) - Check Donation Unit Numbers and Blood Group against QAP samples provided

MANDATORY

- Phenotyping Results relating to antibodies reported (if applicable) (Must record an acceptable response) - Donation Units ABO & Rh(D) Grouping Reactions (Must record cell group anti-A, anti-B & anti-D) - Donation Units Blood Group Result (Must record ABO/RhD group result for all donation units) - Donation Units Crossmatching Results (Must record an acceptable response for all donation units) - Complete Operator id, date tested, Reviewed by and date reviewed (Recommended for your laboratory records)

OPTIONAL - Circle the Quality of the Survey Samples - If ‘Unacceptable’, tick or select reason from sample comment list - Provide comments and feedback if needed

*Note: Participants performing the basic compatibility module are not required to record results in the antibody identification or phenotyping sections of the result sheets.

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PHENOTYPING MODULE RESULT SHEET - EXAMPLE AND EXPLANATION

Survey: AP2013- Participant No: 99997 (AG,AP,AA,I)

SAMPLE INFORMATION AND STORAGE CONDITIONS QAP samples should be stored at 2-8oC upon receipt and kept at 2-8oC when not in use to maintain optimal condition of the samples. Cells are approx. 20% suspension in CelpresolTM. All samples are negative for HBsAg, anti-HIV and anti-HCV; however, samples should be regarded as potentially infectious and handled accordingly.

Use this Section to Record Changes to Method Classification Codes Antigen Result (please tick) Method Instrument Reagent Clonality

C Negative Positive

c Negative Positive

E Negative Positive

e Negative Positive

K Negative Positive

k Negative Positive

Kpa Negative Positive

Kpb Negative Positive

Fya Negative Positive

Fyb Negative Positive

Jka Negative Positive

Jkb Negative Positive

M Negative Positive

N Negative Positive

S Negative Positive

s Negative Positive

P1 Negative Positive

Lea Negative Positive

Leb Negative Positive

Lua Negative Positive

Lub Negative Positive

Cw Negative Positive

Tested by (initials): Date:

CHECK & COMPLETE

- Check Participant Number - Complete Operator Id Initials and Date of Testing - Complete for Method Code changes (not required for each survey if methods have been provided and are unchanged)

MANDATORY - Complete Survey Identification (Eg. AP2013-1 : Survey Type - Phenotyping, Year - 2013 & Despatch Number - 1) - Antigen ‘Negative or Positive’ Results (Must tick acceptable response for appropriate antigens tested in your laboratory)

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ANTI-D TITRE MODULE RESULT SHEET - EXAMPLE AND EXPLANATION

SAMPLE INFORMATION AND STORAGE CONDITIONS QAP samples should be stored at 2-8oC upon receipt and should be kept at 2-8oC when not in use to maintain the optimal condition of the samples. All samples are negative for HBsAg, anti-HIV and anti-HCV; however, samples should be regarded as potentially infectious and handled accordingly. The plasma sample contains EDTA and Sodium Azide (NaN3). Caution: Sample contains 0.1% Sodium Azide as a preservative. Sodium Azide is harmful if swallowed (R22). Wear suitable protective clothing (S36). If swallowed seek medical advice immediately and show them container or label (S46). Contact with acid liberates very toxic gas (R32). Azide compounds should be flushed with large volumes of water during disposal to avoid deposits in lead or copper plumbing where explosive conditions can develop.

Survey: AA2013- Participant No: 99997 (AG,AP,AA,I)

Please Circle End Point Result

Result Options

1 2 4 8 16 32 64 128 256 512 1024

Use this Section to Record Changes to Method Classification Codes

Method Instrument Diluent Indicator Cells

Tested by (initials): Date:

CHECK & COMPLETE

- Check Participant Number

- Complete Operator Id Initials and Date of Testing

- Complete for Method Code changes (not required for each survey if methods have been provided and are unchanged)

MANDATORY - Complete Survey Identification (Eg. AP2013-1 : Survey Type - Phenotyping, Year - 2013 & Despatch Number - 1)

- Indicate End Point Result for the titre sample (Must circle an acceptable end point response)

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GENERAL TRANSFUSION PROGRAMS

General Compatibility Module (AG - Blood Grouping, DAT, Antibody Screen & Id, Phenotyping and Compatibility)

Basic Compatibility Module (AB - Blood Grouping, DAT, Antibody Screen and Compatibility)

Phenotyping Module (AP - Extended Phenotyping)

Antibody Titre Module (AA - Anti-D Titration)

USER REGISTRATION AND ONLINE

RESULT ENTRY VIA TRANSFUSION QAP WEBSITE

INSTRUCTIONS

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USER REGISTRATION FOR GENERAL TRANSFUSION PROGRAMS VIA THE WEBSITE

Enter the RCPAQAP Transfusion website on address: www.rcpaqap.com.au/Transfusion/ and click on the ‘Member Log in’ button. This will display the ‘Member Services’ pages.

On the Member Services page, select the radio button ‘Online data entry for General Transfusion Program’

The system will display the On-line Registration Screen.

When accessing the system the first time, click on ‘Register Here’ to register as a user and to set up a user id and to receive a password via the nominated email address.

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After clicking ‘Register Here’, the system will display the online registration information and Terms and Conditions for using the website online data entry system. Please read the terms and then select the ‘Accept’ button on the bottom of the screen.

The system will display the ‘Online Registration - User Identification’ page. Participants can enter a user id and must enter the participant/laboratory number. Click ‘Next’ to proceed.

The system will display the ‘Online Registration - Laboratory Details’ page. Enter your laboratory details for all fields marked with a red asterisk and then click ‘Next” to proceed.

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The system will display the ‘Online Registration - Secret Question & Answer’ page. This provides the system with additional security to verify your identity if you forget or lose your password. Participants should keep a record of the secret question and answer submitted to the system.

The system will display the ‘Online Registration Complete’ page. This page informs participants that registration has been completed and indicates the email address of the user. Participants will receive an email detailing the user id and password.

If at any stage a user forgets or loses the password, the user can select ‘Click here’ on the Log in screen. The system will ask the user to enter their user id, click ‘Next’. The system will display the users’ secret question and will ask for the secret answer. Enter the secret answer and click ‘Next’. The system will e-mail the user password to the nominated e-mail address.

Congratulations and Welcome to the RCPAQAP Transfusion Online Data Entry Participants have now successfully completed the Online Registration for their laboratory and can now proceed with the online data entry for the General Transfusion Modules for which the laboratory is enrolled in.

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DATA ENTRY FOR THE GENERAL TRANSFUSION PROGRAM RESULTS VIA THE WEBSITE

After a participant has been registered and received the password e-mail, result entry pages can be accessed. Enter your participant number, user id and password and click the ‘Login’ button to proceed.

The system will display the ‘Welcome’ page. It is recommended that first time users check to see if their computer configuration meets minimum requirements for accessing the system. Select ‘Click here’ to test your computer. From the blue bar on the left of the screen, select ‘Data Entry’ to begin the data entry process.

The system will display the Data Entry options. There are four (4) tabs across the top. To view lab enrolments and due dates for all General Transfusion modules, select the ‘Enrolment/What’s Due’ tab. To begin data entry, select the ‘Data Entry’ tab.

The system will display a page indicating several tabs across the top. Tabs relating to the General Transfusion Program are: “Antibody Titre Module”, “General Transfusion Program” and “Phenotyping Module”.

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Antibody Titre Module - Website Result Entry

The tab labelled ‘Antibody Titre Module’ will display a screen as above. The analyte name and specimen identification is displayed. This result sheet page requires participants to select the anti-D titre result using the ellipse ‘...’ button to select an acceptable response in the pop up box.

Please note: Your laboratory method classification is indicated next to each analyte on the right hand side of the screen. Participants can change method codes as required by clicking on the ellipse ‘...’ button next to the method code displayed.

Phenotyping Module - Website Result Entry

The tab labelled ‘Phenotyping Module’ will display a screen as above. The analyte name and specimen identification is displayed. In the centre area are ‘Negative’ and ‘Positive’ tick boxes. Participants are required to tick the ‘Negative’ or ‘Positive’ box next to the analyte for each antigen tested within the laboratory.

Please note: Your laboratory method classification is indicated next to each analyte on the right hand side of the screen. Participants can change method codes as required by clicking on the ellipse ‘...’ button next to the method code displayed.

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General & Basic Compatibility Module - Result Entry Pages

Click the tab ‘General Transfusion Program’ tab and the system will load the data entry options for your laboratory. Please note: the system will only display the General Transfusion program tabs for which your laboratory is enrolled. Eg. If your laboratory is enrolled in the basic compatibility module, the system will not display the phenotyping or antibody id tabs.

Result entry TABS are displayed across the top of the screen and are unique to each scenario. Responses are indicated in the ellipse ‘...’ button next to each appropriate analyte. Select the ellipse ‘...’ button and then click on the required response option. A message will be displayed if too many options are selected. As a rule, only one response is allowed however the exception to this is the antibody identification which allows the selection of up to seven (7) responses.

Responses are allocated a score to achieve final assessment. All mandatory responses are given a score unless otherwise indicated on the result sheet or if deemed not assessable by the Advisory Committee.

‘Save’ Result Entry Data

After selecting ‘Save’, the system displays a review box indicating all results entered and asks ‘Are these values correct?’. If ‘Yes’ is selected, the results will be saved . If the results need amending, select ‘No’ and the system will go back to the data entry pages for result amendment. ‘Save’ after results have been amended.

A message may appear indicating, not all mandatory fields completed. Check all results and method codes in the orange buff areas; enter any further results or method codes and select ‘Save’.

After ‘Saving’ the results, the system will advise participants that ‘General Transfusion Program data entry values were saved successfully. An email has been sent to the registered e-mail address. Select the Print button below to print the saved results”. It is recommended the saved results be printed or the email be retained until after the survey report has been received.

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IMPORTANT POINTS - GENERAL & BASIC COMPATIBILITY MODULES

• Select the ‘...’ icon in the method classification box to add or make changes to your methods at any

time during the data entry stage. Methods are saved through to the end of the cycle year. • Provide the QAP with method codes for all testing areas for your laboratory. This will assist with

saving results online. • Check your method codes each time data is entered and update methods regularly.

• ‘Crossmatch reaction’ method codes must be entered for each survey. This can be variable

depending on the scenario and requires participants to select a method code on a survey by survey basis. For example a unit may be excluded from crossmatching based on phenotyping results. Enter the method by selecting the ellipse button ‘...’ and selecting the ‘Method’. That is, one alpha character e.g. ‘A’ if you perform crossmatching by Tube-IAHG.

• ‘REF’ only in the antibody identification is unacceptable for laboratories in the General Compatibility module. It is expected that participants enrolled in the general compatibility module make a reasonable attempt to identify antibodies. The ‘x’ (cannot exclude) antibody listing is provided to report antibodies unable to be excluded.

• Result sheets are provided for each survey and composition varies according to the survey

scenario. Result sheets must be returned to the QAP for data entry if participants do not have access to web entry. Result sheets contain all information required including acceptable responses.

• Update email addresses with the QAP regularly - when enrolling or if email address changes.

• Participants entering results via the web may choose to use the result sheets supplied or enter

results from in-house result sheets. Please do not return result sheets to the QAP if you have entered your results via the web.

• Phone or email the QAP for assistance if required - staff and the RCPA IT department are happy to

assist participants. Ph: +61 7 3129 8450 (Transfusion QAP office) Fax: +61 7 3838 9413 E-mail: [email protected]/

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GENERAL TRANSFUSION PROGRAMS

General Compatibility Module (AG - Blood Grouping, DAT, Antibody Screen & Id, Phenotyping and Compatibility)

Basic Compatibility Module (AB - Blood Grouping, DAT, Antibody Screen and Compatibility)

REPORT EXAMPLES & EXPLANATIONS FOR:

GENERAL AND BASIC

COMPATIBILITY MODULES PHENOTYPING MODULE

ANTIBODY TITRE MODULE

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GENERAL & BASIC COMPATIBILITY MODULE REPORT EXAMPLE AND EXPLANATION

1 Analyte name(s) and Survey Id (appears on all result pages)

2 Results Due Date (appears on all result pages)

3 Participant Number (appears on all result pages)

4 Your Patient Identification Results and ID Score

5 Target Patient Identification and Target ID Score

6 Your Data - Table & Graphs: Patient Grouping Results & Method Codes

7 Indicates total no. of labs & number using your method (black section)

8 Diamond indicates your result.

9 Reactions + Blood Group Score Your Score & Target Score

6

1 2

5

4

6

7 8

9

3

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GENERAL & BASIC COMPATIBILITY MODULE REPORT EXAMPLE AND EXPLANATION

1 Assessment Summary Graph for current survey

2 Assessment Summary Graph displays Survey Scores & Your Score Indicator

3 Your Total Score & Total Possible Score for current survey

4 Performance Level Graph displays your Cumulative Performance Level

5 Your Score & Performance Level for each Survey in Current Cycle

6 Reviewed by (Provided for Supervisor Comments, Actions & Signature)

1

2 3

4 5

6

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PHENOTYPING MODULE REPORT EXAMPLE AND EXPLANATION

1 Module name and Survey Id (appears on all result pages)

2 Analyte name

3 Graph showing Expected Value, Your Result Indicator & Method Code

4 Your Data - Table indicating Your Antigen Result & Method Code

Summary Data - Table indicates Your

Result & Target Result for each Survey for the individual Analyte

5

6 Analysis of Current Survey Results (All Errors, Total Submitted & % of Errors)

Summary Table indicating Survey Id,

Total Errors, Total Results Submitted, Errors % for each Survey and Total Cycle Analysis

7

8 Reviewed by (Provided for Supervisor Comments, Actions & Signature)

1

2

3 4

5

6 7

8

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PHENOTYPING MODULE REPORT EXAMPLE AND EXPLANATION

1 Cycle Id, Date Range and Summary of Results Outside Allowable Limits

Indicates Reported Antigen Results

during Cycle that were Outside Allowable Limits

2

3 Indicates Total Number of Results for the Cycle for each Analyte Listed

4 Indicates the Number of Errors for each listed Analyte

5 Indicates the Current Survey Errors (Errors from previous surveys are listed)

6 Review section for recording Action Taken regarding Incorrect Responses

1

2

3

99997

4 5

6

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ANTIBODY TITRE MODULE REPORT EXAMPLE AND EXPLANATION

1 Module name and Survey Id (appears on all result pages)

2 Your Data - Table indicating Your Titre Result & Method Code

3 Graph for Target Titre Value, Acceptable Range & Your Result Indicator

4 Graphs for Method Classification Breakdown indicating Your Result

Summary Data - Table indicates Your

Result, Target Result and Method Code for each Survey Result

5

Result Comments indicates an Analysis

of Survey Results and Analysis of Results Outside Acceptable Limits

6

7 Reviewed by (Provided for Supervisor Comments, Actions & Signature)

1

2 3

4

5

6

7

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ANTIBODY TITRE MODULE REPORT EXAMPLE AND EXPLANATION

1 Cycle Id, Date Range and Summary of Results Outside Allowable Limits

2 Indicates Module Name

3 Indicates Total Number of Results Received for the Cycle (Eg. 2010)

4 Indicates the number of Low and High Results for the current Cycle

5 Indicates the number of Low and High Results for the Current Survey

6 Review is for recording Action Taken for Results Outside Allowable Limits

1

2

3

99997

4 5 6