2014 Product Catalogue.

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2014

Product

Catalogue

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1 | P a g e 2 0 1 4 P r o d u c t C a t a l o g u e

Contents

RCPA Quality Assurance Programs Pty Ltd ... 2

Company accreditation ... 2 Company structure ... 2 Privacy policy ... 3

ENROLMENT OFFICE ... 4

Overview ... 4 Enrolment period ... 4

Online enrolment via myQAP ... 4

Payment ... 4

Terms of Trade ... 5

Refund policy ... 6

Enrolment office contact details ... 6

CHEMICAL PATHOLOGY GROUP ... 7

Chemical Pathology Discipline ... 7

Enrolment ... 7

2014 Programs ... 8

Quality Assurance Programs ... 9

HAEMATOLOGY & TRANSFUSION GROUP .... 23

Haematology Discipline ... 23

HAEMATOLOGY & TRANSFUSION GROUP .... 29

Transfusion Discipline ... 29

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP ... 31

Biosecurity Discipline ... 31

2014 Programs ... 31

GROUP ... 33

Immunology Discipline ... 33

2014 Programs ... 33

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP ... 40

Microbiology Discipline... 40

GROUP ... 44

Serology Discipline ... 44

GROUP ... 49

Synovial Fluid Discipline ... 49

TISSUE & CELLULAR PATHOLOGY GROUP ... 50

Anatomical Pathology Discipline ... 50

TISSUE & CELLULAR PATHOLOGY GROUP ... 55

Cytopathology Discipline ... 55

MOLECULAR UNIT ... 56

Molecular Genetics Program ... 56

Molecular Diagnostics Program ... 58

VIRTUAL MICROSCOPY UNIT ... 59

NON-ANALYTICAL PROGRAMS UNIT ... 60

Key Incident Monitoring & ... 60

Management Systems (KIMMS) ... 60

Data collection ... 60

Qualified privilege ... 60

POINT-OF-CARE TESTING ... 61

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RCPA Quality Assurance Programs Pty Ltd

RCPA Quality Assurance Programs Pty Ltd (RCPAQAP) was formed in 1988 by the Royal College of Pathologists of Australasia (RCPA) and has evolved to become one of the world’s leading external quality assurance (EQA) providers to pathology laboratories in Australia and globally. Programs are provided for all disciplines of pathology.

All Programs have been developed with assistance from a number of professional bodies and with significant input from participating laboratories.

In line with our company’s philosophy all Programs are intended to continually improve the practice and standards of pathology services and health of patients.

Company accreditation

The company overall is accredited to AS/NZS ISO 9001:2008-Quality Management Systems. NATA Accredited Proficiency Testing Scheme Provider

Number: 14863

Accredited for compliance with ISO/IEC 17043:2010

Company structure

Discipline-related Programs are clustered into business groups consisting of individual business units, each representing a pathology discipline or Program. The Groups are:

Chemical Pathology Group

Haematology & Transfusion Group Infectious Diseases & Immunology Group

Tissue and Cellular Pathology Group Molecular Unit

Non-Analytical Programs Unit Virtual Microscopy Unit

Chemical Pathology

Haematology & Transfusion

Biosecurity, Immunology, Microbiology, Serology & Synovial Fluid

Anatomical Pathology & Cytopathology

Molecular Genetics & Molecular Diagnostics (Haematology) KIMMS

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Privacy policy

RCPAQAP respects the rights of individuals to privacy and the confidentiality of information about individuals it deals with.

RCPAQAP is bound by the National Privacy Principles ("Principles") contained in the Privacy Amendment Act 2000 ("Privacy Act"). The Principles are designed to protect the confidentiality of personal information and the privacy of individuals by regulating the way personal information is managed. Information gathered in the course of RCPAQAP administered programs, which identifies the laboratory participating in those programs (Identifying Information), is strictly confidential, except as detailed below. RCPAQAP keeps all participant details confidential. Such details will not be disclosed to a third party, unless required by legislation, without the prior written consent of the participant.

In the course of administering its programs, Identifying Information is only made available to the employees of the specific discipline Program, except where written permission for its release to a third party has been sought and given by a participant laboratory. In addition, where RCPAQAP administers programs in co-operation with the Federal government, RCPAQAP may be required by the Federal government, its delegates or employees to release Identifying Information to NATA.

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ENROLMENT OFFICE

Overview

The Enrolment Office provides a single point of contact for all enrolment enquiries.

Enrolments must be completed online using myQAP. For any enquiries or issues with myQAP, please contact the Enrolment Office.

Enrolment period

Programs offered by the RCPAQAP are organised over a calendar year from January to December.

Whilst the key time for participants to enrol is September to December of the preceding year, the majority of RCPAQAPs will offer enrolment throughout the year depending on sample availability and dispatch dates.

Online enrolment via myQAP

Participants must enrol via myQAP for the 2014 subscription, please visit access myQAP. Hard copy enrolment forms will not be available for 2014 enrolments onwards.

Payment

On completion of enrolment via myQAP, a Tax Invoice is generated and participants are then provided the option to:

Pay by BPAY Payment may be made immediately online via BPAY (Australia only) or credit card (worldwide) by clicking on the Pay Now option in the myInvoice tab in the customer portal.

Pay by Electronic Transfer of Funds (EFT)

If a participant does not wish to pay online, payment may be made via EFT (Electronic Funds Transfer) or cheque

Notice: When paying by EFT or cheque, remittance advice must be supplied before payment can be processed

Purchase Order

If participants have a PO number available before generating an invoice, the PO number can be entered into myQAP when checking out. If a tax invoice is generated before a PO number can be referenced, please contact your accounts payable department.

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Terms of Trade

Payment should be received within 30 days of issue of an Invoice.

Failure to pay within these terms will result in the cessation of delivery of material and reports to the participant.

WHEN PAYING BY EFT

Company Name: RCPA Quality Assurance Programs Pty Limited

Account Name: RCPA Quality Assurance Programs Pty Limited- Enrolment Account Bank: Westpac Bank

Branch: Sydney BSB No: 032-000 Swift code: WPAC AU2S Account No: 186614 WHEN PAYING BY CHEQUE

Please make cheques payable to “RCPA QUALITY ASSURANCE PROGRAMS PTY LTD” and return together with the remittance advice to:

Enrolment Office

RCPA Quality Assurance Programs Pty Ltd Suite 201, Level 2, 8 Herbert Street St Leonards NSW 2065

AUSTRALIA

TELEPHONE AND INTERNET BANKING -– BPAY®

Contact your bank or financial institution to make this payment from your cheque, savings, debit, credit card or transaction account.

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6 | P a g e 2 0 1 4 P r o d u c t C a t a l o g u e WHEN PAYING BY CREDIT CARD

Please indicate for prompt processing.

Credit Card: (Amex not accepted) __Visa __Mastercard Card No: _______ _______ _______ _______

Expiry Date...

Cardholder's Name... Cardholder's Signature...

To avoid a delay in the processing of your payment and to ensure the allocation of payment to the correct invoice please forward your remittance advice to

Refund policy

Full refunds will be issued to participants if the Enrolment Office is notified of the request to withdraw prior to the supply of services from the RCPAQAP.

If any materials or paperwork have been dispatched to the participant, then the refund will be reduced, or not applicable, and these policies are discipline specific. Refunds for withdrawals will not be applicable after 30th_{June 2014.}

Enrolment office contact details

Suite 201, Level 2, 8 Herbert Street St Leonards NSW 2065 AUSTRALIA email: Australia phone: 1300 78 29 20 fax: 1300 78 29 21 International phone: +61 2 9045 6000 fax: +61 2 9356 2003

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CHEMICAL PATHOLOGY GROUP

Chemical Pathology Discipline

The RCPAQAP Chemical Pathology is run in association with the Australasian Association of Clinical Biochemists (AACB) whose members provide expertise and assistance in many specialised working parties, setting target values, providing expert opinion for reports and collecting and preparing quality assurance material.

Please consult the RCPAQAP website for more detailed information on this program.

Enrolment

Program prices are listed in the RCPAQAP myQAP online enrolment customer portal.

•

Full Program

– the standard enrolment The Full Program is made up of two components:

• Data Management - Includes result entry, data management, Interim, End-of-Cycle and KPI reports and supplied paperwork. A Participant Handbook and Schedule are supplied.

• Material - a set of material containing all the samples to be analysed for the full year. The material is lyophilised unless indicated otherwise.

Only one method code is permitted per analyte. If a participant wishes to report more than one per analyte, a new Participant Number is required and an additional Data Management enrolment may be purchased. Log a request on the RCPAQAP myQAP online enrolment customer portal, or contact the Enrolment Office to set up a new Participant Number.

•

Data Management Only

Purchasing a Data Management enrolment is useful when the material from the Full Program can be shared with a second instrument or a satellite/branch laboratory.

Note: a Participant Number may have either a Full Program OR a Data Management enrolment, not both.

•

Modules

Previously some programs had multiple modules e.g. Blood Gases and Co-oximetry could be purchased as Blood Gases only, Co-oximetry only, or the combined module Blood Gases and Co-oximetry. In 2014 each of these modules will only be available separately.

•

Options

Additional material - laboratories may purchase an additional set of materials if the volume supplied in each vial is insufficient for the number of analytes the laboratory will test.

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2014 Programs

New Programs

Endocrine <10 Analytes

General Urine Chemistry <5 Analytes

PoCT Blood Gases

For all Abbott i-STAT and Alere epoc devices

Changes in Programs

Programs with multiple modules

Each module only offered individually

Basic Urine Chemistry

Renamed General Urine Chemistry

General Serum Chemistry

Total T

3

no longer available

Special Drugs

Special Therapeutic Drugs and Antibiotics offered as one

program

Urine Toxicology

Creatinine added

PoCT Chemistry

Albumin, ALP, Amylase, Total Bilirubin, Conjugated

Bilirubin, GGT, Magnesium, LD, Protein, Urate added.

Liquid Serum Chemistry

Anion Gap, Corrected Calcium, eGFR, Osmolar Gap

added.

Trace Elements – Serum

Lithium, Magnesium, Thallium, Vanadium added.

Trace Elements – Urine

Iron, Magnesium added

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Quality Assurance Programs

Alcohol / Ammonia Program

Analytes Samples /Survey Surveys/ Year Sample Type

Alcohol

Ammonia 2 12 Serum

Bile Acids Program

Analytes Samples /Survey Surveys/Year Sample Type

Total Bile Acids 2 12 Serum

Blood Gases Program

Analytes include Samples /Survey Surveys /Year Sample Type

pH Potassium Ionised Calcium

2 12 Aqueous

pCO2 Chloride Urea

pO2 Glucose Creatinine

Sodium Lactate

Note: Abbott i-STAT and Alere epoc devices should enrol in the PoCT Blood Gases Program.

Co-oximetry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Haemoglobin Oxyhaemoglobin

2 12 _HaemoglobinBovine

Carboxyhaemoglobin Methaemoglobin Note: this program is not suitable for Abbott i-STAT devices.

BNP Program

Analytes include Samples /Survey Surveys /Year Sample Type

B-type Natriuretic Peptide (BNP)

2 12 Serum

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CSF Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Total Protein Immunoglobulin G

2 12 CSF

Glucose Xanthochromia Screen – Bilirubin _{(absorbance, concentration & qualitative)} Lactate Xanthochromia Screen – Haemoglobin _{(absorbance & qualitative)} Albumin

CSF Oligoclonal Bands

Analytes include /Survey Sample Surveys /Year Sample Type

Oligoclonal Banding (CSF) Oligoclonal Banding (serum) ₂ ₁₂ CSF and Matching

Serum Interpretive Comment

Endocrine Program

Analytes include Samples /Survey Surveys /Year Sample Type

AFP Growth Hormone PTH

2 12 Serum

Aldosterone hCG SHBG

Androstenedione Homocysteine Testosterone CA 125 17-Hydroxyprogesterone TSH

CEA Insulin Free T3

Cortisol LH Total T3

DHEA Sulphate Oestradiol Free T4

Ferritin Oestriol (Unconjugated) Total T4

Folate Progesterone Vitamin B12

FSH Prolactin Vitamin D3

Note: A discounted pricing option is available for <10 analytes

Endocrine PSA Program

Analytes include Samples /Survey Surveys /Year Sample Type

(12)

Endocrine Red Cell Folate Program

Analytes Samples /Survey Surveys /Year Sample Type

Red Cell Folate 2 12 Whole _Blood

Endocrine ACE Program

Analytes Samples /Survey Surveys /Year Sample Type

Angiotensin Converting Enzyme (ACE) 2 12 Serum

Faecal Occult Blood Program

Analytes Samples /survey Surveys /Year Sample Type

Faecal Occult Blood (qualitative) 2 12 Human _Blood

(13)

General Serum Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Albumin Protein (Total) TSH

2 24

Lyophilised Serum and Matching

Diluent

Bicarbonate Sodium Free T3

Bilirubin-Total Urate hCG (quantitative)

Bilirubin-Conjugated Urea hCG (qualitative)

Calcium Iron Enzymes

Chloride TIBC ALT

Creatinine Transferrin Alkaline Phosphatase

Fructosamine Ferritin Amylase

Glucose Troponin I _{(quantitative)} AST

Lactate Troponin T _{(quantitative)} Cholinesterase

Lithium Troponin T (semi- qualitative) Roche

Cardiac Reader only Creatine Kinase

Magnesium Endocrine CK-MB

Osmolality Cortisol GGT

Phosphate (Inorganic) Thyroxine Lactate _{Dehydrogenase}

Potassium Free T4 Lipase

Phenobarbitone Phenytoin

Lipids Drugs Salicylate

Cholesterol Carbamazepine Theophylline

Triglyceride Digoxin Valproate

HDL Cholesterol Paracetamol Gentamicin

Vancomycin

Note 1. Discounted pricing options available for: 31 – 40 analytes 21 – 30 analytes 11 – 20 analytes <10 analytes Note 2. Troponin T (semi-qualitative) on Roche Instruments

Participants using the Roche Cardiac Reader should enrol in the General Serum Chemistry Program. Participants with Roche cobas h232 should enrol in the PoCT Troponin Program. This is due to the different cut-offs, standardisation and units of these 2 instruments.

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Glycohaemoglobin Lyophilised Program

Analytes Samples /Survey Surveys /Year Sample Type

HbA1c 2 12 Lyophilised _blood

Glycohaemoglobin Whole Blood Program

Analytes Samples /Survey Surveys /Year Sample Type

HbA1c 2 3 _BloodFresh

IGF-1/C Peptide Program

Analytes include Samples /Survey Surveys /Year Sample Type

(15)

Liquid Serum Chemistry Program

Analytes including Lipids, Endocrine & Enzyme Samples /Survey Surveys /Year Sample Type

Albumin Protein (Total) GGT

2 1 Fresh Frozen _Serum Bicarbonate Sodium Lactate _{Dehydrogenase}

Bilirubin-Total Urate Lipase

Bilirubin-

Conjugated Urea Cholesterol

Calcium Iron Triglyceride

Chloride TIBC HDL Cholesterol

Creatinine Transferrin Cortisol

Fructosamine Ferritin TSH

Glucose ALT Free T4

Lactate Alkaline _Phosphatase Free T3

Magnesium Amylase Anion Gap*

Osmolality AST Corrected _Calcium* Phosphate

(Inorganic) Cholinesterase eGFR*

Potassium Creatine Kinase Osmolar Gap*

*New analytes for 2014. Please note this program is not offered to overseas participants.

Neonatal Bilirubin Program

Analytes include Samples /Survey Surveys /Year Sample Type

Total Bilirubin Conjugated Bilirubin 2 12 Serum

On-Site Urine Toxicology Screening Program

Analytes include Samples /Survey Surveys /Year Sample Type

Amphetamine Cocaine metabolites

1 12 Urine

Methamphetamine Cannabis metabolites

(16)

Patient Report Comments Program

A program for commenting on patient biochemistry results. A set of patient results is provided to participants. Participants are asked to provide comments they would typically add to the report or give verbally. Ten cases are provided per year. Enrolment is for an individual person. Samples are not issued with this program.

Plasma Metanephrines Program

Analytes include Samples /Survey Surveys /Year Sample Type

Metanephrine

Normetanephrine 2 12 Plasma

3-Methoxythyramine

Point-of-Care Testing Blood Gases Program

Analytes include Samples /Survey Surveys /Year Sample Type

pH Sodium Glucose Ionised

Calcium

2 12 Aqueous

pCO2 Potassium Haemoglobin* Haematocrit*

pO2 Chloride Lactate Creatinine

Urea

* Optimised for the Abbott i-STAT and Alere epoc devices.

Point-of-Care Testing Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Albumin Bilirubin Conj Glucose Sodium

2 12

Diluent ALP Calcium HDL _Cholesterol Triglycerides

ALT Chloride Magnesium Urate

Amylase Cholesterol LD

AST CK Phosphate

Bicarbonate Creatinine Potassium Bilirubin Total GGT Protein

Note: This program is designed specifically for PoCT instruments such as the Samsung LABGEO, Roche Reflotron, Abaxis Piccolo, Ortho Clinical Diagnostics DT60, Cholestech Dx etc.

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Point-of-Care Testing Troponin Program

Analytes include Samples /Survey Surveys /Year Sample Type

Troponin I Troponin T (semi-quantitative) 2 12 Serum

Note: Suitable for devices such as Abbott i-STAT and Roche cobas h232

Porphyrins Urine Program

Analytes include Samples /Survey Surveys /Year Sample Type

Urine Total Porphyrin Urine ALA

Quantitative Porphobilinogen Urine Porphyrin Components 2 12 Urine Qualitative Porphobilinogen

Porphyrins Plasma Program

Analytes include Samples /Survey Surveys /Year Sample Type

Plasma Total Porphyrin Plasma Porphyrin Components 2 12 Plasma

Porphyrins Faeces Program

Analytes include Samples /Survey Surveys /Year Sample Type

Faecal Dry Weight

Faecal Total Porphyrin 2 12 Faeces

Faecal Porphyrin Components

Porphyrins Whole Blood Program

Analytes include Samples /Survey Surveys /Year Sample Type

Whole Blood Total Porphyrin

2 12 Whole _Blood Whole Blood Total Porphyrin Clinical Evaluation

Whole Blood Porphyrin Fractions

Porphyrin Patient Report Comments

Three clinical cases are offered each year. A set of patient porphyrin results is provided to participants. Participants are asked to provide comments they would typically add to the report or give verbally. Participation is from individuals rather than a laboratory. Multiples individuals from the same laboratory can return comments. A report is generated for each individual. There is no extra charge for participation.

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Special Drugs Program

Analytes include Samples /Survey Surveys /Year Sample Type

Amiodarone Tricyclic Antidepressants Amikacin

2 12 Serum

Clozapine (Qualitative) Gentamicin Methotrexate Amitriptyline Tobramycin Mycophenolate Nortriptyline Vancomycin

Immunosuppressants Program

Analytes include Samples /Survey Surveys /Year Sample Type

Cyclosporin Tacrolimus ₂ ₁₂ Whole

Blood Sirolimus

Special Lipids Program

Analytes include Samples /Survey Surveys /Year Sample Type

Cholesterol Apolipoprotein A1

2 12 Serum

HDL Cholesterol Apolipoprotein B LDL Cholesterol Lipoprotein (a) Triglyceride

Sweat Electrolytes Program

Analytes include Samples /Survey Surveys /Year Sample Type

Sodium Sweat Conductivity ₂ ₁₂ _Aqueous

(19)

Trace Elements Serum Program

Analytes include Samples /Survey Surveys /Year Sample Type

Aluminium Lithium* 2 12 Frozen Bovine Serum Chromium Magnesium* Cobalt Selenium Copper Thallium* Vanadium* Zinc

Note: The RCPAQAP will be joining the Occupational and Environmental Laboratory Medicine Trace Elements Program (OELM) for serum, urine and blood trace elements. This is a federation of 6 countries and the advantage of this will be a much larger peer group. This program will run from April to March. Result entry will be electronic only. OELM and RCPAQAP style reports will be available.

*New analytes for 2014

Trace Elements Urine Program

Analytes include Samples /Survey Surveys /Year Sample Type

Arsenic Magnesium* 2 12 Human Frozen Urine Cadmium Manganese Chromium Mercury Cobalt Nickel Copper Selenium Iron Thallium Lead Vanadium Zinc *New analytes for 2014

Trace Elements Whole Blood Program

Analytes include Samples /Survey Surveys /Year Sample Type

Arsenic Manganese 2 12 Human Frozen Blood Cadmium Mercury Cobalt* Selenium Chromium* Thallium Lead Zinc Magnesium*

(20)

Tumour Markers Program

Analytes include Samples /Survey Surveys /Year Sample Type

ACTH CA 125 NSE

2 12 Serum

Alpha-fetoprotein CA 15-3 Total PSA Beta-2-Microglobulin CA 19-9 Prolactin

Calcitonin Gastrin Thyroglobulin

CEA hCG

General Urine Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Albumin Magnesium 2 12 Urine ACR N-Telopeptides Calcium Osmolality Chloride Phosphate Cortisol Potassium Creatinine Sodium

Free Deoxypyridinoline Total Protein

Glucose Urate

hCG-Qualitative Urea

hCG-Quantitative

Note: A discounted pricing option is available for <5 analytes.

Biogenic Amines Program

Analytes include Samples /Survey Surveys /Year Sample Type

Noradrenaline HVA 3 (2 Linear, 1 Patient) 12 Urine 5HIAA 3-Methoxytyramine Adrenaline Metanephrine Dopamine Normetanephrine HMMA Serotonin Clinical Evaluation

(21)

Urine Pregnancy Program

Analytes Samples /Survey Surveys /Year Sample Type

hCG (qualitative) 2 6 Urine

Urine Toxicology Program

Analytes include Samples /Survey Surveys /Year Sample Type

Qualitative drug Screening Creatinine* 1 12 Urine

Note: 10 mLs of lyophilised sample is provided. Laboratories using non-immunoassay methodology may need to purchase additional set of material.

Vitamins Plasma Program

Analytes include Samples /Survey Surveys /Year Sample Type

Vitamin A 2 12 Plasma Vitamin E β-carotene Total Carotenoids Plasma Vitamin B6

Vitamins Whole Blood Program

Analytes include Samples /Survey Surveys /Year Sample Type

Vitamin B1

2 12 Whole _Blood Vitamin B2

Vitamin B6

Vitamin C Program

Analytes Samples /Survey Surveys /Year Sample Type

(22)

The following programs are only available to participants outside Australia and New Zealand

Condensed Serum Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Albumin Phosphate (Inorganic) Enzymes

2 24

Diluent

Bicarbonate Potassium ALT

Bilirubin-Total Protein (Total) Alkaline Phosphatase

Bilirubin-Conjugated Sodium Amylase

Calcium Urate AST

Chloride Urea Cholinesterase

Creatinine Iron Creatine Kinase

Fructosamine TIBC CK-MB

Glucose Transferrin GGT

Lactate Ferritin Lactate Dehydrogenase

Lithium Troponin I _{(quantitative)} Lipase

Magnesium Troponin T _{(quantitative)} Drugs

Osmolality Troponin T (semi- qualitative) Roche

Cardiac Reader only Carbamazepine

Lipids Endocrine Digoxin

Cholesterol Cortisol Paracetamol

Triglyceride Thyroxine Phenobarbitone

HDL Cholesterol Free T4 Phenytoin

TSH Salicylate

Total T3 Theophylline

Free T3 Valproate

hCG (quantitative) Gentamicin

hCG (qualitative) Vancomycin

Note: Discounted pricing options for: 31 – 40 analytes 21 – 30 analytes 11 – 20 analytes <10 analytes

(23)

Basic Serum Chemistry Program

Analytes include Samples /Survey Surveys /Year Sample Type

Amylase Calcium Protein (Total)

2 6

Diluent

Albumin Cholesterol Sodium

Alkaline

Phosphatase Creatinine Kinase Triglycerides

ALT Creatinine Urate

AST Glucose Urea

Bicarbonate HDL Cholesterol Bilirubin-Total Potassium

(24)

HAEMATOLOGY & TRANSFUSION GROUP

Haematology Discipline

Thirteen surveys are dispatched each year with a wide range of samples for both routine and specialist haematology testing. For more information on these please consult the Haematology Participant Handbook or the RCPAQAP haematology website for more details.

Prices for participation are listed in the RCPAQAP myQAP online enrolment customer portal.

Full Blood Count Program (FBC)

Tests include Abbreviation Surveys/Year Samples/Survey Sample Type

White Blood Cells WBC

12 2 _{whole blood}Stabilised

Red Blood Cells RBC

Hemoglobin Hb

Haematocrit HCT

Mean Cell Volume MCV

Platelet PLT

Haemostasis Program

Tests include Abbreviation Surveys/Year Samples/Survey Sample Type

International Normalised Ratio INR

8 2 Lyophilised _plasma

Activated Partial

Thromboplastin Time APTT

Fibrinogen Fib

(25)

Additional Factors Program

Tests include Abbreviation Surveys/ Year Samples/ Survey Sample Type

Module 1

Factor VIII FVIII ₆ ₂ Lyophilised

plasma Factor IX FIX Module 2 Factor II FII 3 2 Lyophilised _plasma Factor V FV

Factor VII FVII

Factor XI FXI

Factor XII FXII

D-Dimer Program

Tests Abbreviation Surveys/Year Samples/ Survey Sample Type

Module 1 D-Dimer – fully

quantitative fibrin degradation fragment 4 2 Lyophilised plasma Module 2

D-Dimer – semi quantitative /

qualitative fibrin degradation fragment 4

2 Lyophilised _plasma

Haemoglobinopathy Program

Tests Abbreviation Surveys/Year Samples/ Survey Sample Type

Haemoglobin A2 Hb A2

4 1 Lyophilised _{red cells}

Haemoglobin F Hb F

Variant Haemoglobin Variant

Morphology/Manual Differential Program

Tests Surveys/Year Samples/ Survey Sample Type

Morphology Program 4 3 Blood Film

Blood Film Differential Count 12 1 Blood Film

(26)

Paediatric Morphology – Virtual Microscopy Program

Tests Surveys/Year Samples/Survey Sample Type

Description & Diagnostic Interpretation of

paediatric blood films 2 2 supplied on DVD Virtual images-

Reticulocyte Program

Tests Abbreviation Surveys/Year Samples/Survey Sample Type

Reticulocyte

count Retic count 4 2

Stabilised whole blood Program

Module Compatible Instrument/Method Module 1 Manual Reticulocyte counting

Module 2

Beckman Coulter (STKS, MAXM, HmX)

Sysmex Corporation: XT2000i, XE2100, XE5000, XT4000i, RAM-1) Abbott (Cell Dyn 3200/Ruby, 3500, 3700, 4000/Sapphire Siemens ADVIA Manual Reticulocyte counting

Module 3 Beckman Coulter (Gen.S, LH500, _{LH750, LH755 & UniCell DxH 800)}

ESR Program

Tests Abbreviation Surveys/Year Samples/Survey Sample Type

Erythrocyte

Sedimentation Rate ESR 4 2 Stabilised whole blood

Program Module Compatible _{Instrument/Method} Module 1 All methods excluding _{StaRRsed users}

(27)

Automated Differential Program

Tests Abbreviation Surveys/Year Samples/Survey Sample Type

WBC

Differential WCC, Neut/Gran, Lymph, Mono, Eos, Baso 4 2

Stabilised whole

blood Program

Module Compatible Instrument

Module 1 Sysmex Corporation: XT1800i, XT2000i, XT4000i, XE2100, XE5000, XS1000i, XS800i, XN series

Module 2 Abbott Laboratories: Cell-Dyn 3000, _{3200/Ruby, 3500, 3700, 4000/Sapphire} Module 3 Beckman Coulter: Act 5 Diff, ABX Pentra 60C+ Module 4 Bayer Diagnostics: ADVIA 120/2120, _{Technicon H Systems}

Module 5 Sysmex Corporation: K-1000, KX-21, K-4500, PocH100i NO LONGER AVAILABLE AS A MODULE

Module 6

Abbott Laboratories: Cell-Dyn 1200,1300,1600,1700,1800

Beckman Coulter: Act/Act Diff, T series, JT series JS,JR,ST, Onyx, MD series

ABX Diagnostics: Micros 60, MINOS, ABX Argos

Nihon Kohden: Celltac Bayer Diagnostics: ADVIA 60

Module 7 Beckman Coulter: STKS, MaxM, HMX, LH _{500/750/755/780, GENS} Module 8 Sysmex Corporation: SE9500, SE9000, SF3000 _{NO LONGER AVAILABLE AS A MODULE}

PLEASE NOTE - If the instrument used is not listed in the above table, please contact the RCPAQAP Haematology office for selection of the correct module.

G6PD Program

Tests Abbreviation Surveys/Year Samples/ Survey Sample Type

Glucose-6-phosphate dehydrogenase

Screen G6PD Screen 2 2 _haemolysateLyophilised

Glucose-6-phosphate

(28)

Paediatric Morphology – Virtual Microscopy Program

Tests Surveys/Year Case studies / _Survey Sample Type

Descriptive and Diagnostic Interpretation of

paediatric blood films 2 2

Virtual images- supplied on

DVD

Malarial Parasite – Virtual Microscopy Program

Tests Surveys/Year Case studies/ Survey Sample Type

Malarial Parasite identification of thin and thick

blood films. 2 2

Virtual images- supplied on

DVD

Point-of-Care – INR Program

Tests Abbreviation Surveys/Year Samples/ Survey Sample Type

International Normalised

Ratio INR 5 2

Lyophilised plasma + water

+ calcium

Molecular Diagnostics Program

Program Module Assays Surveys/Year Samples/ Survey Sample Type

Module 1 Factor V Leiden MTHFR (Ala677Val)

Prothrombin gene G20210A mutation

2 5 DNA Module 2 Hereditary Haemochromatosis Cys282Tyr Hereditary Haemochromatosis His63Asp 2 5 DNA

Module 3 bcr-abl for CML _{bcr-abl for ALL} 1 5 RNA

Module 4 T cell receptor gene _{Immunoglobulin heavy chain gene} 1 5 DNA

Module 5 Chimerism 1 5 DNA

Module 6 Thalassaemia beta _{Thalassaemia alpha} 1 3 DNA

Module 7 Jak 2 1 5 DNA

(29)

Oncology Immunophenotyping Program

Program

Module Assays Surveys /Year Samples/Survey Sample Type

Module 1 _{Oncology Immunophenotyping –} (AML, T and B cell ALL and

LPD-Diagnostic Interpretation)

4 1 case study Stabilised PB/BM mononuclear cells Module 2

PNH Testing (not included in

scope of accreditation) 2 2

Stabilised PB/BM mononuclear

cells

CD34+ Program

Tests Surveys/Year Samples/Survey Sample Type

WCC

3 2 Stabilised whole _blood %CD34

Total CD34/uL

Specialised Haemostasis Program

Program Module Assays Surveys/Year Samples/Survey Sample Type

Program A Lupus Anticoagulant _{additional dispatch in 2013} 3 2 Lyophilised _plasma

Program B Protein C

2 2 Lyophilised _plasma

Program B Protein S

Program B Antithrombin

Program B APC resistance

Program C von Willebrand Factor 2 2 Lyophilised _plasma

Program D FVIII Inhibitor 2 2 Lyophilised _plasma

Program E PFA-100 analysis 2 2 Lyophilised _plasma

Program F Heparin Monitoring 2 2 Lyophilised _plasma

Module 1 Unfractionated Heparin Module 2 Low Molecular Weight _Heparin

PLEASE NOTE

- Laboratories enrolling in the Heparin Monitoring module must enrol in both modules if monitoring unfractionated and low molecular weight heparin.

(30)

HAEMATOLOGY & TRANSFUSION GROUP

Transfusion Discipline

The General Transfusion program covers all routine tests performed in a pre-transfusion testing laboratory including clinical decision making on given scenarios. The Individual Assessment program is designed to assist laboratory supervisors maintain and assess individual staff competencies while also enabling individual staff to meet EQA participation requirements as stipulated by the guidelines. The Foetal Maternal Haemorrhage Estimation program is for assessing laboratories on methods used in estimating foetal red cells in maternal samples.

All programs are specifically arranged so laboratories of all sizes may participate. For more information on these please consult the transfusion discipline handbook or the RCPAQAP Transfusion website for more details.

Quality Assurance Programs

General Transfusion Program - (GT Program)

Modules Surveys/Year Samples/Survey Sample Type

General Compatibility (AG Module) – Tests include blood grouping, antibody screen and identification, crossmatch/ compatibility testing, phenotyping, DAT, and elution studies.

6 Varied EDTA whole blood _{and Red cells}

Basic Compatibility Module (AB module) - Includes all tests in the AG module except antibody identification, phenotyping and elution studies.

6 Varied EDTA whole blood _{and Red cells}

Phenotyping Module (AP module) -

Extended Red Cell Antigen Phenotyping 4 1 Red cell sample

Antibody Titre Module (AA module) -

(31)

Blood Grouping and Antibody Screen Program –

(B Program)

Module Surveys/Year Samples/Survey Sample Type

Blood grouping (Antibody Screen/Identification – Optional) 6 2 Whole EDTA blood

Individual Assessment Program - (I Program)

Module Surveys/Year Samples/Survey Sample Type

Individual Assessment Program (up to 3 participants

results can be submitted per survey) 6 2

EDTA Whole

blood

Foetal Maternal Haemorrhage Estimation - (F Program)

Module Surveys/Year Samples/Survey Sample _Type

Foetal Maternal Haemorrhage Estimation 4 2 Whole EDTA

blood

Snake Venom Detection- (SV Program)

Module Surveys/Year Samples/Survey Sample Type

Snake Venom Detection 1 1 Swab

Transfusion Competency Program- (ST Program)

Module includes Surveys/Year Samples/Survey Sample Type

Blood Grouping ₆ ₃ EDTA Whole blood Weak D testing DAT 6 ₁ Antibody Screen Antibody identification

Phenotyping (Rh/ K antigens only) 6 3

Crossmatching/ Compatibility Testing 6 2

2 red cell donor

(32)

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP

Biosecurity Discipline

In 2008 the Australian Government established a two-tiered list of Security Sensitive Biological Agents (SSBA) as part of the SSBA Regulatory Scheme for the control of select agents. The program now offers surveys for SSBA, other potential agents and communicable disease threats to Australia with a view to building and enhancing laboratory capacity and capability to detect, analyse, identify and report on these agents.

Refer to the Australian Government Department of Health and Ageing (DoHA) website for current

Security Sensitive Biological Agents Lists.

All enquiries regarding the content and cost of the RCPAQAP Biosecurity program should be directed to

After consultation with the RCPAQAP Biosecurity team, enrolments for the program should be arranged

through the RCPAQAP Enrolment office,

2014 Programs

New Modules

(33)

Sample Modules

Modules - Available to Australian laboratories that require the capability to test for Security Sensitive Biological Agents, other potential agents and communicable disease threats. These include Bacteria Virus & Toxins

Bacterial modules

• Clinical or environmental analytes

• Derivations of vaccine strains

• Genetic material

• Inactivated material

• Surrogate organisms Viral modules

• Genetic material

• In vitro RNA Transcripts

• Plasmids

• Surrogate organisms Toxin modules

• Non-toxic subunits

• Inactivated toxins

• Non-toxin producing strains

Virtual Module

Modules - Available to all laboratories within Australia and approved international laboratories.

eLearning Module

Modules - Available to all laboratories within Australia and approved international laboratories.

Simulated Exercises in Biopreparedness

Modules - Available to selected laboratories within Australia

Simulated exercises in a controlled environment to test the biopreparedness of selected laboratories. Please refer to Biosecurity Participant Handbook or the website for further details on annual survey

(34)

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP

Immunology Discipline

Participating laboratories may select from a group of RCPAQAP Immunology program modules that comprehensively cover the assays performed in Clinical Immunology. For more detailed information please refer to our website or Immunology Participant Handbook.

2014 Programs

New Programs

Food Allergy Program

Myositis Specific and Scleroderma Antibodies Program

Specific Proteins Program

Analytes include Abbreviation Samples/Survey Surveys/Year Sample Type

Immunoglobulin G IgG 2 12 Serum Immunoglobulin A IgA Immunoglobulin M IgM Complement component 3 C3 Complement component 4 C4

α-1-antitrypsin A1AT, AAT

C1 esterase inhibitor C1-inh

Haptoglobin Hp

Caeruloplasmin Caeruloplasmin

(35)

Rheumatoid Factor Program

Analytes include Abbreviation Samples/Survey Surveys/Year Sample Type

Rheumatoid Factor RF

2 12 Serum

Cyclic citrullinated peptide

antibody CCP

C Reactive Protein Program

Analytes include Abbreviation Samples/ Survey Surveys/Year Sample Type

C-reactive Protein CRP

2 12 Serum

High-sensitivity C-reactive protein hsCRP

Paraprotein Program

Analytes include Samples/ Survey Surveys/Year Sample Type

Paraprotein identification serum

1 8

Serum

Paraprotein identification urine Urine

Paraprotein concentration serum Serum

Paraprotein concentration urine Urine

Serum free light chains Serum

IgG Subclasses Program

Analytes include Samples /Survey Surveys /Year Sample Type

IgG1 IgG2 IgG3 IgG4

Calculated subclass sum Total IgG

1 8 Serum

Anti-Nuclear Antibodies Program

Analytes include Abbreviation Samples /Survey Surveys /Year Sample Type

Anti-Nuclear Antibodies pattern ANA pattern ₂ ₁₂ _Serum

(36)

Rheumatic Disease Serology Program

Analytes include Abbreviation Samples /Survey Surveys /Year Sample Type

Extractable Nuclear Antigen ENA

1 each for ENA, DNA, phospholipid

antibodies

8 Serum

Anti-double stranded DNA dsDNA antibodies

Nucleosome antibodies AnuA

Cardiolipin IgG and IgM

antibodies Antiphospholipid Abs

β2GP1 IgG antibodies Anti β2 Glycoprotein 1 _{IgG Ab}

Vasculitis Serology Program

Analytes include Abbreviation Samples /Survey Surveys/Year Sample Type

Antineutrophil Cytoplasmic Antibodies ANCA

1 8 Serum

Myeloperoxidase Antibodies MPO-ANCA

Proteinase 3 Antibodies PR3-ANCA

Anti-glomerular basement membrane GBM

Coeliac Serology Program

Analytes include Abbrev. Samples /Survey Surveys /Year Sample Type

Deamidated Gliadin IgG and IgA

1 8

Serum Tissue transglutaminase IgG and IgA tTG

Endomysial antibodies EMA

Skin antibodies (intercellular substance,

(37)

Tissue Antibodies Program

Analytes include Abbreviation Samples /Survey Surveys /Year Sample Type

Gastric Parietal Cell antibodies APC

1 8

Serum

Smooth Muscle antibodies ASM

F-Actin antibodies F-actin

Mitochondrial antibodies AMA

Liver/Kidney Microsome antibodies LKM

Intrinsic Factor antibodies IF

Thyroglobulin antibodies TgAb

1 8

Thyroid microsome antibodies TPO

Thyroid receptor antibodies TRAb

Type I Diabetes Antibodies Program

Analytes include Abbreviation Samples /Survey Surveys /Year Sample Type

Islet cell antibodies ICA

1 8 Serum

Glutamic Acid Decarboxylase antibodies GAD Insulinoma-associated-2 autoantibodies IA2 antibodies

Myasthenia Gravis Antibodies Program

Analytes Abbreviation Samples /Survey Surveys /Year Sample Type

Acetylcholine Receptor Antibodies Myasthenia Gravis Ab; _AChR 1 4 Serum

Myositis Specific and Scleroderma Antibodies Program

Analytes include Abbreviation Samples _/Survey Surveys _/Year Sample Type

Myositis and scleroderma

antibodies Mi-2, Ku, RNA Pol III 1 4 Serum

IgE (Total) Program

Analytes Abbreviation Samples /Survey Surveys /Year Sample Type

(38)

Tryptase Program

Analytes Abbreviation Samples /Survey Surveys /Year Sample Type

Tryptase Mast Cell Tryptase 1 8 Serum

Bee Venom IgE Program

Analytes Samples /Survey Surveys /Year Sample Type

Specific IgE to Bee Venom (Apis mellifera) 1 8 Serum

Food Allergy Program

Analytes include Samples /Survey Surveys /Year Sample Type

Specific IgE to: Prawn Peanut Cashew Cow’s Milk Egg Sesame Seed Soy Wheat Grain 1 8 Serum

Inhalant Allergens Program

Analytes include Samples /Survey Surveys /Year Sample Type

Cat epithelium/dander Rye grass pollen Bermuda grass House dust mite

(Dermatophagoides pteronyssinus) Latex

Aspergillus fumigatus Alternaria alternata/tenuis

Grass Pollen mix Animal Epithelium mix Mould mix

House Dust Mite mix

(39)

Fungal & Avian Antibodies Program

Analytes include Samples /Survey Surveys /Year Sample Type

IgG antibodies to Aspergillus fumigatus

IgG antibodies toBudgie IgG antibodies toPigeon

1 4 Serum

HLA B27 Status Program

Analytes Abbreviation Samples /Survey Surveys /Year Sample Type

Human Leukocyte Antigen B27 HLA B27 2 8

Lithium Heparin Whole blood

diluted with media The material assayed in the HLA B27 program is fresh whole blood, which quickly deteriorates under normal transport conditions and should be tested within 3-4 days of dispatch. For reasons beyond our control, it may take longer than this to deliver samples to some centres outside Australia and New Zealand and in these cases we are unable to guarantee the quality of the material received or provide replacements. Please consider carefully before ordering this program and contact us if you wish to discuss your individual situation.

Immunophenotyping - Immunodeficiency Program

Analytes include Samples /Survey Surveys /Year Sample Type

Lymphocytes of the following phenotypes (percentages): CD3+ , CD3+CD4+, CD3+CD8+, CD19+, CD3-_CD16+_{, CD}3-_CD56+_{, CD}3-_CD16+_CD56+_{, Alpha-Beta, Gamma-Delta} 2 8 Lithium Heparin whole blood diluted with media Lymphocytes of the following phenotypes (absolute

numbers);CD3+_{, CD}3+_CD4+_{, CD}3+_CD8+_,_CD19+

The material assayed in the Immunophenotyping program is fresh whole blood, which quickly deteriorates under normal transport conditions and should be tested within 3-4 days of despatch. For reasons beyond our control, it may take longer than this to deliver samples to some centres outside Australia and New Zealand and in these cases we are unable to guarantee the quality of the material received or provide replacements. Please consider carefully before ordering this program and contact us if you wish to discuss your individual situation.

(40)

HLA B*57 (in conjunction with APHIA) Program

Analytes Abbreviation Samples /Survey Surveys /Year Sample Type

Human Leukocyte Antigen

B*57 HLA B*57 5 3 DNA

Case Study Program

A program of Immunology clinical case studies. This is a paperwork program only and no samples are provided. Five clinical cases are provided per year.

(41)

GROUP

Microbiology Discipline

The RCPAQAP Microbiology discipline has been developed and evolved under the guidance of the RCPAQAP Microbiology Advisory Committee. For detailed information on Microbiology programs please consult the Microbiology participant handbook or the RCPAQAP microbiology website for more details.

Quality Assurance Programs

Bacteriology Extensive Program

Tests include Abbrev. Surveys/Year Samples/Survey Sample Type

Urine U 8 _7-8 Lyophilised sample Skin/Ear/Eye/Throat/Nose S Faecal F Respiratory R Genital Swabs/Anaerobes G

Mycobacteriology M Lyophilised samples and _slides

Difficult/Blood Culture/Sterile sites D 1 Lyophilised sample

Bacteriology Limited Program

Tests include Abbrev. Surveys/Year Samples/Survey Sample Type

Urine U 4 2 Lyophilised sample

Skin/Ear/Eye/Throat/Nose _S ₄ ₂ Lyophilised sample

Faecal F 4 2 Lyophilised sample

Respiratory R 4 2 Lyophilised sample

Genital Swabs/Anaerobes _G ₄ ₂ Lyophilised sample

Mycobacteriology M 4 2 Lyophilised samples and _Slides

Difficult/Blood Culture/Sterile

(42)

Mycology Program

Tests Include Surveys/Year Samples/Survey Sample Type

Dermatophytes, systemic mycotic pathogens, clinically significant yeast and contaminants of interest.

4 3 Lyophilised _sample

Parasitology Program

Tests Include Surveys/Year Samples/Survey Sample Type

Protozoa, helminths and samples containing faecal

artefacts. 4 2

Fixed smears /faecal suspensions.

Urine Dipstick Chemistry Program

Tests include Surveys/Year Samples/Survey Sample Type

Leukocyte esterase blood glucose protein nitrite 4 2 Lyophilised _sample

Stat Microscopy Program

Tests include Surveys/Year Samples /Survey Sample Type

Includes urine cell counts and Gram stains of

samples. 4 2

Lyophilised samples and

smears

Pneumococcal Serotyping Program

Tests include Surveys/Year Samples/Survey Sample Type

(43)

Molecular Diagnostics Program

Tests - Nucleic acid amplification testing (NAT)

Tests include Surveys _/Year Samples _/Survey Sample Type Bordetella pertussis

2 6-8 Lyophilised sample

Chlamydia trachomatis* and Neisseria gonorrhoeae**

Cytomegalovirus Enterovirus

Herpes simplex virus 1 and 2 MRSA mecA/nuc genes

Mycobacterium tuberculosis and Mycobacterium avium

complex

Varicella zoster virus

Neisseria meningitidis

* Note - the Chlamydia trachomatis samples are not suitable for immunofluorescence or EIA assays. ** Note - the Neisseria gonorrhoeae samples are not suitable for detection by RNA methods.

Vancomycin-Resistant Enterococci (VRE) Program

Tests include Surveys _/Year Samples_/Survey Sample Type

VRE testing including screening, phenotypic testing and/or

Molecular testing. 2 4 simulated sample Lyophilised

Clostridium

difficile

Laboratory Diagnosis Program

Tests Surveys _/Year Samples_/Survey Sample Type

(44)

Microbiological Surveillance Culture Program

Tests Surveys/Year Samples/Survey Sample Type

Microbiological Surveillance Culture for

endoscopes and bronchoscopes 2 8

Lyophilised simulated sample sample

Paperwork Only Program

This module is designed for manufacturers and sponsors (distributors) of kits. Participants enrolled in the Paperwork Only do not receive samples.

(45)

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP

Serology Discipline

Key features of the program include;

• One sample dispatch per year;

• All methodologies accepted;

• Comprehensive assessment of over 50 analytes;

• Detection of antibodies, antigens, DNA & RNA;

• Direct data entry via website;

• Final Generic reports reviewed by experts in the field;

• Individualised Participant Assessment Reports available within one week of the survey due date, showing year-to-date cumulative scores and graphical analysis of results;

• Trend analysis with a minimum of 2 surveys/year (for most analytes);

• Archived survey material including the relevant reports are available for participants to purchase for validation studies

Quality Assurance Programs

Antenatal Program

Modules Samples/Survey Surveys/Year Sample Type

Rubella serology 2 4 Serum/Plasma

(46)

Bacterial Program

Hepatitis Program

Modules Samples/Survey Surveys/Year Sample Type

Hepatitis A serology 2 6 Serum/Plasma

Hepatitis B serology 2 6 Serum/Plasma

Hepatitis C serology 2 6 Serum/Plasma

Hepatitis D serology 2 1 Serum/Plasma

Hepatitis E serology 2 1 Serum/Plasma

Infectious Mononucleosis Program

Modules Samples/Survey Surveys/Year Sample Type

Infectious Mononucleosis

2

6

Serum/Plasma

Lymphadenopathy Program

Modules Samples/Survey Surveys/Year Sample Type

Cytomegalovirus serology 2 4 Serum/Plasma

Epstein Barr Virus serology 2 4 Serum/Plasma

Toxoplasma serology 2 4 Serum/Plasma

Modules Samples/Survey Surveys/Year Sample Type

Brucella serology 2 2 Serum/Plasma

Chlamydia pneumoniae serology 2 2 Serum/Plasma

Chlamydia trachomatis Antigen EIA 2 2 Culture supernatant

Chlamydia trachomatis Antigen IFA 2 2 Slide

Chlamydia trachomatis Antigen NAT 2 2 Culture Supernatant

Helicobacter pylori serology 2 2 Serum/Plasma

Legionella serology 2 2 Serum

Legionella Urinary Antigen 2 2 Urine

Mycoplasma serology 2 2 Serum/Plasma

QuantiFERON®_{-TB Gold (detection}

only) 2 2 Lyophilised Serum/Plasma

Rickettsial serology 2 2 Serum/Plasma

(47)

Molecular Diagnostics Program

Modules Samples/Survey Surveys/Year Sample Type

Alphavirus & Flavivirus NAT 3 3 Inactivated viral culture _lysate* Hepatitis B DNA (Qualitative/

Quantitative) 3 4 Plasma*

Hepatitis C RNA (Qualitative/

Quantitative) 3 4 Plasma*

Hepatitis C Genotyping 3 4 Plasma*

HIV-1 RNA (Quantitative) 3 4 Plasma*

Human Papillomavirus DNA 4 3 PreservCyt® Solution.

Influenza 6 3 Inactivated viral culture _lysate

*Sent on dry ice

Point-of-Care Program

Modules Samples/Survey Surveys/Year Sample Type

HIV PoCT ONLY 2 4 Whole blood or _Serum/Plasma

Influenza A & B Antigen PoCT ONLY 2 4 Inactivated viral culture _lysate

(48)

Parasite & Spirochaete Program

Modules Samples/Survey Surveys/Year Sample Type

Cryptococcal Antigen 2 2 Serum or culture _supernatant

Entamoeba serology 2 2 Serum/Plasma

Hydatid serology 2 2 Serum/Plasma

Leptospiral serology 2 2 Serum

Schistosomiasis serology 2 2 Serum/Plasma

Retroviral Program

Modules Samples/Survey Surveys/Year Sample Type

HIV serology (comprehensive) 2 6 Serum/Plasma

HTLV serology 2 6 Serum/Plasma

Vaccine Preventable Program

Modules Samples/Survey Surveys/Year Sample Type

Bordetella pertussis serology 2 2 Serum/Plasma

Influenza A & B Antibody serology 2 2 Serum/Plasma

Measles serology 2 2 Serum/Plasma

Mumps serology 2 2 Serum/Plasma

Q fever serology 2 2 Serum/Plasma

Varicella zoster serology 2 2 Serum/Plasma

Viral Program

Modules Samples/Survey Surveys/Year Sample Type

Alphavirus serology 2 2 Serum/Plasma

Flavivirus serology 2 2 Serum/Plasma

Herpes simplex serology 2 2 Serum/Plasma

(49)

Specimen-Free Program

In 2014, three surveys each consisting of two case studies or scenarios will be issued to participants enrolled in the Specimen-free module. This module is not ‘scored’ and is designed as an educational tool for staff, presenting case studies and scenarios that may be encountered in serological and molecular testing laboratories. Although not scored, report reviewers are encouraged to grade participant responses to the questions posed in the case-study or scenario as satisfactory or unsatisfactory.

Paper Work Only Program

Participants enrolled in the Paperwork-Only module do not receive samples, they receive access to the Final Generic Report library and are able to access and download these reports as required. This module is designed for manufacturers and sponsors (distributors) of kits.

(50)

INFECTIOUS DISEASES & IMMUNOLOGY

GROUP

Synovial Fluid Discipline

The RCPAQAP Synovial Fluid assesses the ability of laboratories to detect the key disease-related crystals (urate, calcium pyrophosphate) and to differentiate those from other crystalline structures such as corticosteroid, cholesterol and cartilage that may be found in synovial fluid. For detailed information please consult our website.

Quality Assurance Programs

Synovial Fluid Program

Tests - Detection & Identification in Synovial Fluid Surveys /Year Samples /Survey Sample Type

Monosodium Urate Monohydrate (Urate) Crystals

2 3 synovial fluid

Calcium Pyrophosphate Dihydrate (CPPD) Crystals Cholesterol Crystals

Synthetic Corticosteroid Crystals

Non-crystalline inclusions (cartilage, fibrin, rice bodies) Artefacts (starch, talc)

Two surveys, each containing 3 capillary tips per survey are dispatched annually.

Participants also receive a DVD/CD of three to five microscopic examinations of synovial fluid to report. A second DVD/CD with the same images, but with a commentary, is sent after the results have been received.

(51)

TISSUE & CELLULAR PATHOLOGY GROUP

Anatomical Pathology Discipline

The RCPAQAP Anatomical Pathology offers modules in the areas of diagnostic and technical proficiency of histopathology laboratories.

Diagnostic survey cases are selected to demonstrate either classical histological features of a disease process, common disease processes observed in routine pathology laboratories or critical disease processes of educational value to participants.

Technical survey cases are selected on similar criteria of classical, common or critical features to be demonstrated by routine methods in the laboratory.

For more details please consult the Anatomical Pathology website.

Prices for participation are listed in the RCPAQAP myQap online enrolment customer portal. The diagnostic proficiency programs offered are for laboratories (collective response) and individual pathologists. Laboratories requiring participation in an external proficiency testing program for Australian accreditation may enrol in the technical and immunohistochemistry programs.

Diagnostic Proficiency Programs

General Module

Tests Surveys/Year Cases/Survey Survey Material

Routine Anatomical

Pathology 3 10

DVD-ROM and available via the website.

Breast Pathology Module

Tests Surveys/Year Cases/Survey Survey Material

Breast Pathology 3 10 DVD-ROM and available via the _website.

Oral Pathology Module

Tests Surveys/Year Cases/Survey Survey Material

(52)

Dermatopathology Module

Tests Surveys/Year Cases/Survey Survey Material

Specialist Dermatopathology 1 10 DVD-ROM and available via the _website.

Forensic Pathology Module

Tests Surveys/Year Cases/Survey Survey Material

Specialist Forensic Pathology 1 10 DVD-ROM and available via the _website.

Gynaecology Module

Tests Surveys/Year Cases/Survey Survey Material

Specialist Gynaecological

Pathology 1 10

Paediatrics Module

Tests Surveys/Year Cases/Survey Survey Material

Specialist Paediatric

Pathology 1 10

Urology Module

Tests Surveys/Year Cases/Survey Survey Material

Specialist Urological

Pathology 1 10

(53)

Neuropathology Module

Tests Surveys/Year Cases/Survey Survey Material

Neuropathology 1 10 DVD-ROM and available via the _website.

HER

2

BRISH (Breast) Module

Tests Surveys/Year Cases/Survey Survey Material

HER-2BRISH Breast techniques 2 30 Unstained slides. Formalin fixed _{paraffin wax sections}

HER

2

BRISH (Gastric) Module

Tests Surveys/Year Cases/Survey Survey Material

(54)

TECHNICAL & TECHNICAL

IMMUNOHISTOCHEMISTRY PROGRAMS

Technical Module

Tests Surveys/Year Cases/Survey Survey Material

Routine Anatomical

Pathology 3 1-2

Unstained slides. Formalin fixed paraffin wax sections

Technical Frozen Module

Tests Surveys/Year Cases/Survey Survey Material

Frozen sections 1 1 Stained section provided by _participant

Neuropathology Immunohistochemistry & Technical

Tests Surveys/Year Cases/Survey Survey Material

Neuropathology

Immunohistochemistry and Technical

1 2 Unstained slides. Formalin fixed _{paraffin wax sections}

Immunohistochemistry Technical Markers Routine IHC

Routine

Immunohistochemistry 2 2

Immunohistochemistry Questionnaire Internal Audit

Included with

Immunohistochemistry Breast marker Module

(55)

Immunohistochemistry Breast Markers

Tests Surveys/Year Cases/Survey Survey Material

Breast

Immunohistochemistry Lymphoma Markers

Tests Surveys/Year Cases/Survey Survey Material

Lymphoma

COMBINED DIAGNOSTIC & TECHNICAL PROGRAMS

Electron Microscopy

Tests Surveys/Year Cases/Survey Survey Material

Electron microscopy 1 4

Technical exercise Lab Practice Questionnaire 2 x diagnostic exercises on DVD-ROM

(56)

TISSUE & CELLULAR PATHOLOGY GROUP

Cytopathology Discipline

The RCPAQAP Cytopathology offers external quality assurance modules that encompass both gynaecological and non-gynaecological Cytopathology practice. Surveys comprise glass slides, DVDs containing virtual cases, staining exercises and questionnaires on laboratory practice. Laboratories may enrol in any or all of the modules.

Gynaecological Cytopathology

Module Abbrev. Surveys/Year Survey Cases/ Survey Material

Conventional gynaecological GYN

4 5

Conventional cervical smears Liquid-based ThinPrep gynaecological THP Liquid- based cervical

smears Liquid-based Surepath gynaecological SUP

Module Abbrev. Surveys/Year Survey Material

Performance Measures * PM