2014 product catalogue

2014 Product Catalogue

www.rcpaqap.com.au

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

ContentsRCPA 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 ..... 24

Haematology Discipline ........................................ 24

Quality Assurance Programs ................................. 24

HAEMATOLOGY & TRANSFUSION GROUP ..... 31

Transfusion Discipline ........................................... 31


INFECTIOUS DISEASES & IMMUNOLOGY GROUP ........................................................... 33

Biosecurity Discipline ............................................ 33

2014 Programs ..................................................... 33


INFECTIOUS DISEASES & IMMUNOLOGY GROUP ........................................................... 35

Immunology Discipline ......................................... 35

2014 Programs ..................................................... 35

Quality Assurance Programs................................. 35

INFECTIOUS DISEASES & IMMUNOLOGY GROUP .......................................................... 42

Microbiology Discipline ........................................ 42



Serology Discipline ............................................... 46



Synovial Fluid Discipline ....................................... 51


TISSUE & CELLULAR PATHOLOGY GROUP ..... 52

Anatomical Pathology DisciplineError! Bookmark not defined.

Diagnostic Profiency ProgramsError! Bookmark not defined.

TISSUE & CELLULAR PATHOLOGY GROUP ..... 57

Cytopathology Discipline ...................................... 57


MOLECULAR UNIT ......................................... 58

Molecular Genetics Program ................................ 58

Molecular Diagnostics Program ............................ 60

VIRTUAL MICROSCOPY UNIT......................... 61

NON-ANALYTICAL PROGRAMS UNIT............. 62

Key Incident Monitoring & ................................... 62

Management Systems (KIMMS) ........................... 62


Data collection ..................................................... 62

Qualified privilege ................................................ 62

POINT-OF-CARE TESTING .............................. 63



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


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.

Further information on our Privacy Policy can be found at: www.rcpaqap.com.au

http://www.rcpaqap.com.au/�


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 www.rcpaqap.com.au to 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.

http://www.rcpaqap.com.au/�


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.

More info: www.bpay.com.au


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 [email protected]

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: [email protected]

Australia phone: 1300 78 29 20 fax: 1300 78 29 21

International phone: +61 2 9045 6000 fax: +61 2 9356 2003

mailto:[email protected]�



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.

http://www.rcpaqap.com.au/chempath

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.

http://www.rcpaqap.com.au/chempath�


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 T3 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

Trace Elements – Blood Cobalt, Chromium, Thallium added


Quality Assurance Programs

Alcohol / Ammonia Program

Analytes Samples /Survey

Surveys/ Year Sample Type

Alcohol Ammonia 2 12 Serum

Bile Acids Program


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



Haemoglobin Oxyhaemoglobin 2 12 Bovine

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

BNP Program



B-type Natriuretic Peptide (BNP) 2 12 Serum

N-terminal Prohormone B-type Natriuretic Peptide (NT – pro BNP)


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 Sample /Survey


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

CSF and Matching

Serum Interpretive Comment

Endocrine Program



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



Total PSA Free PSA 2 12 Serum


Endocrine Red Cell Folate Program



Red Cell Folate 2 12 Whole Blood

Endocrine ACE Program



Angiotensin Converting Enzyme (ACE) 2 12 Serum

Faecal Occult Blood Program

Analytes Samples /survey


Faecal Occult Blood (qualitative) 2 12 Human Blood

Note: Suitable for immunological methods only.


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.


Glycohaemoglobin Lyophilised Program Analytes Samples

/Survey Surveys

/Year Sample

Type

HbA1c 2 12 Lyophilised blood

Glycohaemoglobin Whole Blood Program


Surveys /Year

Sample Type

HbA1c 2 3 Fresh Blood

IGF-1/C Peptide Program


Surveys /Year

Sample Type

IGF-1 C Peptide IGF-BP3 2 12 Serum


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



Amphetamine Cocaine metabolites

1 12 Urine Methamphetamine Cannabis metabolites

Benzodiazepines Opiates


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



Metanephrine

Normetanephrine 2 12 Plasma

3-Methoxythyramine

Point-of-Care Testing Blood Gases Program



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


Surveys /Year

Sample Type

Albumin Bilirubin Conj Glucose Sodium

2 12


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.

Abbott i-STAT are recommended to enrol in the PocT Blood Gases Program.

Point-of-Care Testing Troponin Program




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



Urine Total Porphyrin Urine ALA

Quantitative Porphobilinogen Urine Porphyrin Components 2 12 Urine Qualitative Porphobilinogen

Porphyrins Plasma Program



Plasma Total Porphyrin Plasma Porphyrin Components 2 12 Plasma

Porphyrins Faeces Program



Faecal Dry Weight

Faecal Total Porphyrin 2 12 Faeces

Faecal Porphyrin Components

Porphyrins Whole Blood Program



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.


Special Drugs Program



Amiodarone Tricyclic Antidepressants Amikacin

2 12 Serum Clozapine (Qualitative) Gentamicin

Methotrexate Amitriptyline Tobramycin

Mycophenolate Nortriptyline Vancomycin

Immunosuppressants Program



Cyclosporin Tacrolimus 2 12 Whole Blood Sirolimus

Special Lipids Program



Cholesterol Apolipoprotein A1

2 12 Serum HDL Cholesterol Apolipoprotein B

LDL Cholesterol Lipoprotein (a)

Triglyceride

Sweat Electrolytes Program



Sodium Sweat Conductivity 2 12 Aqueous Chloride Clinical Evaluation


Trace Elements Serum Program



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



Arsenic Magnesium*

2 12 Frozen Human 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 Frozen Human Blood

Cadmium Mercury

Cobalt* Selenium

Chromium* Thallium

Lead Zinc

Magnesium*

*New analytes for 2014


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



Noradrenaline HVA

3 (2 Linear, 1 Patient)

12 Urine

5HIAA 3-Methoxytyramine

Adrenaline Metanephrine

Dopamine Normetanephrine

HMMA Serotonin Clinical Evaluation


Urine Pregnancy Program Analytes Samples

/Survey Surveys

/Year Sample Type

hCG (qualitative) 2 6 Urine

Urine Toxicology Program



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



Vitamin B1 2 12 Whole

Blood Vitamin B2

Vitamin B6

Vitamin C Program



Vitamin C 2 12 Serum


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

Lyophilised Serum and Matching

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


Basic Serum Chemistry Program Analytes include Samples

/Survey Surveys

/Year Sample Type

Amylase Calcium Protein (Total)

2 6

Lyophilised Serum and Matching

Diluent

Albumin Cholesterol Sodium Alkaline Phosphatase Creatinine Kinase Triglycerides

ALT Creatinine Urate

AST Glucose Urea

Bicarbonate HDL Cholesterol

Bilirubin-Total Potassium Note: Suitable for very small laboratories doing a limited range of testing.


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.

http://www.rcpaqap.com.au/haematology/

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 Stabilised whole blood

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

Thrombin Time TT

http://www.rcpaqap.com.au/haematology/�


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

Morphology Educational DVD – Virtual Images DVD


Paediatric Morphology – Virtual Microscopy Program

Tests Surveys/Year Samples/Survey Sample Type

Description & Diagnostic Interpretation of paediatric blood films 2 2 Virtual images-

supplied on DVD

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

Module 2 StaRRsed users ONLY


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 Lyophilised haemolysate

Glucose-6-phosphate G6PD Assay


dehydrogenase Assay


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

Module 8 PML:RARa 1 3 RNA


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.


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.

http://www.rcpaqap.com.au/transfusion/


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) - Anti-D Titre

4 1 Plasma

http://www.rcpaqap.com.au/transfusion/�


Blood Grouping and Antibody Screen Program – (B Program)

Module Surveys/Year Samples/Survey Sample Type

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

Whole blood

Individual Assessment Program - (I Program)


Individual Assessment Program (up to 3 participants results can be submitted per survey) 6 2

EDTA Whole blood

Foetal Maternal Haemorrhage Estimation - (F Program)


Foetal Maternal Haemorrhage Estimation 4 2 EDTA

Whole blood

Snake Venom Detection- (SV Program)


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 units


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. http://www.health.gov.au/SSBA#list

All enquiries regarding the content and cost of the RCPAQAP Biosecurity program should be directed to [email protected]

After consultation with the RCPAQAP Biosecurity team, enrolments for the program should be arranged through the RCPAQAP Enrolment office, [email protected].

2014 Programs

New Modules

eLearning Module and Simulated Exercise Module

http://www.health.gov.au/SSBA#list�




Quality Assurance Programs 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 material: http://www.rcpaqap.com.au/biosecurity/

http://www.rcpaqap.com.au/biosecurity/�


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.

http://www.rcpaqap.com.au/immunology/


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

Prealbumin Transthyretin

http://www.rcpaqap.com.au/immunology/�


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


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 Anti-Nuclear Antibodies titre ANA titre


Rheumatic Disease Serology Program

Analytes include

Abbreviation

Samples /Survey


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


Deamidated Gliadin IgG and IgA 1 8

Serum Tissue transglutaminase IgG and IgA tTG Endomysial antibodies EMA Skin antibodies (intercellular substance, basement membrane) ICS, BMZ 4 1


Tissue Antibodies Program

Analytes include

Abbreviation

Samples /Survey


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


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


Acetylcholine Receptor Antibodies Myasthenia Gravis Ab; AChR 1 4 Serum

Myositis Specific and Scleroderma Antibodies Program

Analytes include

Abbreviation

Samples /Survey


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

IgE (Total) Program

Analytes

Abbreviation

Samples /Survey


Immunoglobulin E IgE 2 12 Serum


Tryptase Program

Analytes

Abbreviation

Samples /Survey


Tryptase Mast Cell Tryptase 1 8 Serum

Bee Venom IgE Program



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

Food Allergy Program



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

1 8 Serum

Inhalant Allergens Program



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

1 8 Serum


Fungal & Avian Antibodies Program Analytes include Samples

/Survey Surveys

/Year Sample Type

IgG antibodies to Aspergillus fumigatus IgG antibodies to Budgie IgG antibodies to Pigeon

1 4 Serum

HLA B27 Status Program

Analytes

Abbreviation

Samples /Survey


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



Lymphocytes of the following phenotypes (percentages): CD3+

, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+, CD3-CD56+, CD3-CD16+CD56+, Alpha-Beta, Gamma-Delta

2

8

Lithium Heparin

whole blood diluted with

media

Lymphocytes of the following phenotypes (absolute numbers);CD3+, CD3+CD4+, CD3+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.


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.


INFECTIOUS DISEASES & IMMUNOLOGY 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.

http://www.rcpaqap.com.au/microbiology



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 sites D 8 1 Lyophilised sample

http://www.rcpaqap.com.au/microbiology�


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


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

Serotyping of S. pneumoniae 4 6 Lyophilised sample


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 Lyophilised

simulated sample

Clostridium difficile Laboratory Diagnosis Program

Tests Surveys /Year

Samples/Survey Sample Type

Testing for Clostridium difficile antigen and toxin. 2 4 Lyophilised simulated sample


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.


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

http://www.rcpaqap.com.au/serology/


Quality Assurance Programs Antenatal Program

Modules Samples/Survey Surveys/Year Sample Type

Rubella serology 2 4 Serum/Plasma

Syphilis serology 2 4 Serum/Plasma

http://www.rcpaqap.com.au/serology/�


Bacterial Program

Hepatitis Program


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


Infectious Mononucleosis 2 6 Serum/Plasma

Lymphadenopathy Program


Cytomegalovirus serology 2 4 Serum/Plasma

Epstein Barr Virus serology 2 4 Serum/Plasma

Toxoplasma serology 2 4 Serum/Plasma


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 Streptococcal serology 2 2 Serum/Plasma




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


HIV PoCT ONLY 2 4 Whole blood or Serum/Plasma

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

lysate

RSV Antigen PoCT ONLY 2 4 Inactivated viral culture

lysate


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


HIV serology (comprehensive) 2 6 Serum/Plasma

HTLV serology 2 6 Serum/Plasma

Vaccine Preventable Program


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


Alphavirus serology 2 2 Serum/Plasma

Flavivirus serology 2 2 Serum/Plasma

Herpes simplex serology 2 2 Serum/Plasma

Parvovirus serology 2 2 Serum/Plasma


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.


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.

http://www.rcpaqap.com.au/synovial/



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.

http://www.rcpaqap.com.au/synovial/�


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.

https://anatomical.rcpaqap.com.au/

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


Oral Pathology 2 10 DVD-ROM and available via the website.

https://anatomical.rcpaqap.com.au/�


Dermatopathology Module


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

Forensic Pathology Module


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

Gynaecology Module


Specialist Gynaecological Pathology


Paediatrics Module


Specialist Paediatric Pathology


Urology Module


Specialist Urological Pathology



Neuropathology Module Tests Surveys/Year Cases/Survey Survey Material

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

HER2 BRISH (Breast) Module


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

HER2 BRISH (Gastric) Module


HER-2 BRISH Gastric techniques 2 30 Unstained slides. Formalin fixed paraffin wax sections.

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


Frozen sections 1 1 Stained section provided by participant


Neuropathology Immunohistochemistry & Technical


Neuropathology Immunohistochemistry and Technical

1 2 Unstained slides. Formalin fixed paraffin wax sections

Immunohistochemistry Technical Markers Routine IHC


Routine Immunohistochemistry


Immunohistochemistry Questionnaire Internal Audit


Included with Immunohistochemistry Breast marker Module

1 1 Breast marker audit of cases reported by participant

Immunohistochemistry Breast Markers


Breast Immunohistochemistry


Immunohistochemistry Lymphoma Markers


Lymphoma Immunohistochemistry



IMMUNOHISTOCHEMISTRY ISH / MOLECULAR PROGRAMS Immunohistochemistry EBV-ISH


EBV-ISH Immunohistochemistry


Immunohistochemistry HPV-ISH


HPV-ISH Immunohistochemistry


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 and available via the website.


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.

http://www.rcpaqap.com.au/cytopathology/


Quality Assurance Programs Gynaecological Cytopathology

Module Abbrev. Surveys/Year Cases/ Survey 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 2 Collection of data for NPAAC Performance

Measures

* Australian Laboratories Only

Non-gynaecological Cytopathology

Module Abbrev. Surveys/Year Cases/ Survey Survey Material

Non-gynaecological General GEN 4 2 One glass slide and one virtual case

Non-gynaecological Fine needle Aspiration FNA 4 2 One glass slide and one

virtual case

http://www.rcpaqap.com.au/cytopathology/�


MOLECULAR UNIT Molecular Genetics Program The RCPAQAP Molecular Genetics in association with the Human Genetics Society of Australasia provides a range of quality assurance products for an array of inherited disorders and molecular genetics techniques.

There is a comprehensive panel of programs on offer from the European Molecular Genetics Quality Network (EMQN), Cystic Fibrosis European Network (CF Network) and the RCPAQAP Molecular Genetics.

For further information on the EMQN and CF Network quality assurance programs on offer, please visit their websites:

http://www.emqn.org/emqn/Home and http://cf.eqascheme.org/

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

Quality Assurance Programs Provider - RCPAQAP Molecular Genetics

Module Code Surveys /Year

Samples /Survey

Survey Material

BRAF mutation screening BRAF 2 3 FFPE Tissue

EGFR mutation screening EGFR 2 3 FFPE Tissue

Fragile X PCR screening FXPCR 1 5 Purified genomic DNA

KRAS mutation screening KRAS 2 3 FFPE Tissue

Maternal Cell Contamination MCC 1 5 Purified genomic DNA

Mitochondrial Myopathy MM 1 5 Purified genomic DNA

Sanger DNA sequencing DSEQ 1 3 PCR products

Module Code Survey Material

Cystic Fibrosis CFSUP Supplementary report

Duchenne & Becker Muscular Dystrophy DMDSUP Supplementary report

Fragile X syndrome FXSUP Supplementary report

Hereditary Non-Polyposis Colon Cancer HNPSUP Supplementary report

Prader-Willi & Angelman Syndromes PWASUP Supplementary report

Spinal Muscular Atrophy SMASUP Supplementary report

Spinocerebellar Ataxia SCASUP Supplementary report

http://www.emqn.org/emqn/Home�

http://cf.eqascheme.org/�


Provider - Cystic Fibrosis European Network (CF Network)

Module Code Surveys /Year

Samples /Survey

Survey Material

Cystic Fibrosis CF 1 5 Extracted genomic DNA

Provider - European Molecular Genetics Quality Network (EMQN)

Module Code Surveys

/Year Samples /Survey

Survey Material

aCGH/Microarray EQA CGH

1

2 DNA

Aicardi-Goutieres Syndrome (pilot) AGS 3 Lyophilised DNA

BRAF: Molecular testing in Melanoma MELANOMA 10

Rolled sections of FFPE materials designed to simulate a real patient

sample. Charcot Marie Tooth Disease CMT 3 Lyophilised DNA

Congenital Adrenal Hypoplasia CAH 3 Lyophilised DNA

Diagnostic Mutation Database DMuDB N/A N/A DNA-Sequencing EQA scheme – Data Assessment only DNAPS N/A Lyophilised and/or wet

DNA (in TE) DNA-Sequencing EQA scheme – Full version DNAF N/A Lyophilised and/or wet

DNA (in TE) Duchenne & Becker Muscular Dystrophy DMD 3 Lyophilised DNA

EGFR: Molecular testing in Lung Cancer (NSCLC) NSCLC 10

Rolled sections of FFPE materials designed to simulate a real patient

sample. Familial Adenomatous Polyposis Colon Cancer FAP 3 Lyophilised DNA

Familial Breast Cancer – Full version BRCA 3 Lyophilised DNA

Familial Breast Cancer – Genotyping only BRCAG 3 Lyophilised DNA

Fragile X syndrome – Full version FRAX 3 DNA in TE Buffer

Fragile X syndrome – Pre-screening FRAXPS 3 Lyophilised DNA

Friedrich’s Ataxia FRDA 3 Lyophilised DNA

Hereditary Deafness – GJB2/GJB6 DFNB1 3 Lyophilised DNA Hereditary Haemochromatosis HFE 3 Lyophilised DNA


Hereditary Non-Polyposis Colon Cancer HNPCC

1

3 Lyophilised DNA

Hereditary Recurrent fevers HRF 4 Lyophilised DNA

Huntington Disease HD 3 Lyophilised DNA

Monogenic Diabetes MD 3 Lyophilised DNA

Multiple Endocrine Neoplasia Type 2 MEN2 3 Lyophilised DNA

Myotonic Dystrophy DM 3 Lyophilised DNA

NextGen (2012) – pilot EQA scheme NG N/A Genomic DNA from cell lines

Osteogenesis imperfecta OI 3 Lyophilised and/or wet DNA (in TE)

Phenylketonuria PKU 3 Lyophilised DNA

Porphyria POR 3 Lyophilised DNA

Prader-Willi & Angelman Syndromes PWAS 3 Lyophilised DNA

Retinoblastoma RB 3 Lyophilised DNA Short Stature Homeobox Gene Testing SHOX 3 Lyophilised and/or wet

DNA (in TE) Spinal Muscular Atrophy SMA 3 Lyophilised DNA Spinocerebellar Ataxia SCA 3 Lyophilised DNA

Von Hippel Lindau Syndrome VHL 3 Lyophilised DNA

Wilson disease WIL 3 Lyophilised DNA

Y chromosome microdeletions AZF 3 Lyophilised DNA


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 Thalassemia beta Thalassemia alpha 1 3 DNA

Module 7 Jak 2 2 5 DNA Module 8 PML:RARa 1 3 RNA PLEASE NOTE: bcl-1 / bcl-2 module is no longer available.


VIRTUAL MICROSCOPY UNIT

The RCPA Quality Assurance Programs Pty Limited is committed to providing services to enhance education, training and continuous professional development in pathology. One such service is the use of the Aperio® ScanScope® to convert glass slides to high resolution digital images and these are now being used for:

• RCPAQAP Anatomical Pathology diagnostic modules, • Some RCPAQAP Cytopathology non-gynaecological surveys, • Enhancement of the RCPAQAP Haematology morphology program, • Provision of the paediatric morphology program and • Provision of the malaria parasite program

For more information please consult the RCPAQAP virtual microscopy unit website or contact us by using the websites’ contact us form.

http://www.rcpaqap.com.au/virtual.microscopy/

The RCPAQAP Virtual Microscopy Unit also offers a scanning service for individuals or organisations. Contact us for an obligation free quote.

RCPAQAP Virtual Microscopy Unit

Phone +61 2 9045 6080 Fax +61 2 9356 2003 Email [email protected]

http://www.rcpaqap.com.au/cytopathology/�

http://www.rcpaqap.com.au/virtual.microscopy/�

http://www.rcpaqap.com.au/vm/contactform.cfm�



NON-ANALYTICAL PROGRAMS UNIT Key Incident Monitoring &

Management Systems (KIMMS)

The Key Incident Monitoring & Management Systems (KIMMS) project was initiated by the Quality Assurance Scientific and Education Committee (QASEC) of the Royal College of Pathologists of Australasia (RCPA). KIMMS aims to monitor the pre- and post-analytical phase of the laboratory quality system and is designed to provide pathology practices with the tools for continuous measurement and monitoring of key incident quality indicators. Please consult the RCPAQAP website for more detailed information on this program.

http://www.rcpaqap.com.au/kimms/



KIMMS Program Parameters Runs/Year Survey Material

Pre-analytical & post- analytical incidents 4 Online submission of data

Data collection Pathology practices are requested to collect data and return to RCPAQAP KIMMS within specified dates. Identification and evaluation of incidents will provide valuable data to each practice to enable measurement, monitoring and improvement of these incidents and ultimately improve patient safety.

Qualified privilege RCPA Quality Assurance Programs was granted Qualified Privilege from the Department of Health & Ageing, Australia and in New Zealand by the NZ Government

http://www.rcpaqap.com.au/kimms/�


POINT-OF-CARE TESTING The RCPAQAP recognises that PoCT is increasingly being used and that it is essential that the quality of the results generated by a PoCT device is of sufficient quality for patient care. International standards and guidelines recommend that where available, participation in an external quality assurance scheme is recommended for each test.

Please refer to the discipline -specific sections in this Catalogue or the discipline-specific Participant Handbooks for more information on these PoCT modules.

Alternatively please visit our website: http://www.rcpaqap.com.au/poct/


Chemical Pathology Serology Haematology PoCT Chemistry PoCT HIV PoCT INR PoCT Troponin PoCT Influenza A & B PoCT Blood Gases PoCT RSV Ag Microbiology Urine Pregnancy Brucella Urine Dipstick Chemistry Glycohaemoglobin – Chlamydia trachomatis Lyophilised and Fresh Dengue Transfusion Whole Blood Helicobacter pylori Snake Venom Detection Hepatitis B surface Antigen (HBsAg) Hepatitis C Antibodies (HCV Ab) Hepatitis E lgM (HEV lgM) Hydatid Infectious Mononucleosis Legionella Urinary Antigen Leptospira lgM

Syphilis

http://www.rcpaqap.com.au/poct�


Quality Assurance Programs Point-of-Care Testing Blood Gases Program



pH Sodium Glucose Ionised Calcium

2 12 Aqueous pCO2 Potassium Haemoglobin* Haematocrit*

pO2 Chloride Lactate Creatinine

Urea

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

Point-of-Care Testing Chemistry Program


Surveys /Year

Sample Type

Albumin Bilirubin Conj Glucose Sodium

2 12


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. Abbott i-STAT are recommended to enrol in the PocT Blood Gases Program.

Point-of-Care Testing Troponin Program



Troponin I Troponin T (semi-quantitative) 2 12 Serum Note: Suitable for devices such as Abbott i-STAT and Roche cobas h232


On-Site Urine Toxicology Screening Program Analytes include Samples

/Survey Surveys

/Year Sample Type

Amphetamine Cocaine metabolites 1 12 Urine Methamphetamine Cannabis metabolites

Benzodiazepines Opiates

Urine Pregnancy Program Analytes include Samples

/Survey Surveys

/Year Sample Type

hCG (qualitative) 2 6 Urine

Serology 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

RSV Antigen PoCT ONLY 2 4 Inactivated viral culture lysate

Antenatal Program


Syphilis serology 2 4 Serum/Plasma

Bacterial Program


Brucella serology 2 2 Serum/Plasma Chlamydia trachomatis Antigen EIA 2 2 Culture supernatant Helicobacter pylori serology 2 2 Serum/Plasma Legionella Urinary Antigen 2 2 Urine


Hepatitis Program


Hepatitis B serology 2 6 Serum/Plasma

Hepatitis C serology 2 6 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

Parasite & Spirochaete Program Modules Samples/Survey Surveys/Year Sample Type

Hydatid serology 2 2 Serum/Plasma Leptospiral serology 2 2 Serum

Viral Program Tests Samples/Survey Survey/Year Sample Type

Flavivirus serology (including Dengue) 2 2 Serum/Plasma

Point-of-Care – INR Program Tests Surveys/Year Samples/

Survey Sample Type

International Normalised Ratio 5 2 Lyophilised plasma + water + calcium


Urine Dipstick Chemistry Program Tests include Surveys/Year Samples/Survey Sample Type

Leukocyte esterase blood glucose protein nitrite


Snake Venom Detection- (SV Program)

Module Surveys/Year Samples/Survey Sample Type Snake Venom Detection 1 1 Swab

RCPA Quality Assurance Programs

Suite 201, Level 2, 8 Herbert Street St Leonards NSW 2065

Phone +61 2 9045 6000 Fax +61 2 9356 2003 ABN 32 003 520 072

www.rcpaqap.com.au

©2013 RCPA Quality Assurance Programs Pty Ltd. All rights reserved.

2014 product catalogue

Documents

immunology discipline

haematology discipline

transfusion discipline

chemical pathology group

haematology transfusion

chemical pathology discipline

biosecurity discipline

microbiology discipline