Appendix A

Programs, Analytes and Allowable Limits of Performance

ALCOHOL/AMMONIA ± 10% > 500 nmol/day CSF
Alcohol ± 2.2 ≤ 21.7 mmol/L Normetanephrine ± 1.0 ≤ 3.0 µmol/day Albumin ± 0.10 ≤ 1.00 g/L
± 10% > 21.7mmol/L ± 33% > 3.0 µmol/day ± 10% > 1.0 g/L
Ammonia ± 3 ≤ 30 µmol/L Serotonin ± 0.3 ≤ 1.0 µmol/day Glucose ± 1.0 ≤ 10 mmol/L
± 10% > 30 µmol/L ± 30% > 1.0 µmol/day ± 10% > 10 mmol/L
Immunoglobulin G ± 0.1 ≤ 1.00 g/L
± 10% > 1.00 g/L
ANTIBIOTICS BLOOD GASES Lactate ± 1.0 ≤ 10 mmol/L
Chloride ± 3.0 mmol/L ± 10% > 10.0 mmol/L
Amikacin ± 2.0 ≤ 20.0 mg/L
± 10% > 20.0 mg/L Glucose ± 1.0 ≤ 10.0 mmol/L Total Protein ± 0.10 ≤ 1.0 g/L
± 10% > 10.0 mmol/L ± 10% > 1.00 g/L
Gentamicin ± 0.5 ≤ 5.0 mg/L
± 10% > 5.0 mg/L Ionised Calcium ± 0.05 mmol/L
Tobramycin ± 0.5 ≤ 5.0 mg/L Lactate ± 1.0 ≤ 10.0 mmol/L
± 10% > 5.0 mg/L ± 10% > 10.0 mmol/L ENDOCRINE
Vancomycin ± 2.0 ≤ 20.0 mg/L pH ± 0.04 AFP ± 5 ≤ 25 kIU/L
± 10% > 20.0 mg/L pCO2 ± 2.0 ≤ 25.0 mm Hg ± 20% > 25 kIU/L
± 8% > 25.0 mm Hg Androstenedione ± 2.0 nmol/L
pO2 ± 5 ≤ 100 mm Hg CA125 ± 10 ≤ 50 kU/L
± 5% > 100 mm Hg ± 20% > 50 kU/L
BIOGENIC AMINES Potassium ± 0.2 mmol/L
Adrenaline ± 50 ≤ 150 nmol/day
CEA ± 2.0 ≤ 10.0 µg/L
Sodium ± 3.0 mmol/L ± 20% > 10.0 µg/L
± 33% > 150 nmol/day
Dopamine ± 0.25 ≤ 1.0 µmol/day Cortisol ± 30 ≤ 200 nmol/L
± 25% > 1.0 µmol/day ± 15% > 200 nmol/L
CO-OXIMETRY 11-Deoxycortisol ± 30.0 ≤ 200.0 nmol/L
5HIAA ± 20 ≤ 100 µmol/day
Haemoglobin Concentration ± 3 ≤ 100 g/L ± 15% > 200.0 nmol/L
± 20% > 100 µmol/day
± 3% > 100 g/L DHEA Sulphate ± 1.0 ≤ 10.0 µmol/L
HMMA ± 20 ≤ 100 µmol/day Fractional Oxyhaemoglobin ± 3 ≤ 75.0% ± 10% > 10.0 µmol/L
± 20% > 100 µmol/day ± 4% > 75.0% Ferritin ± 6.0 ≤ 40.0 µg/L
HVA ± 8 ≤ 32 µmol/day Fractional ± 2.0% ± 15% > 40.0 µg/L
± 25% > 32 µmol/day Carboxyhaemoglobin Folate ± 1.0 ≤ 4.0 nmol/L
Metanephrine ± 0.5 ≤ 1.5 µmol/day Fractional Methaemoglobin ± 1.0 ≤ 10.0% ± 25% > 4.0 nmol/L
± 33% > 1.5µmol/day ± 10% > 10% FSH ± 4.0 ≤ 20.0 IU/L
Noradrenaline ± 50 ≤ 500 nmol/day
± 20% > 20.0 IU/L

© RCPA-AACB Chemical Pathology Quality Assurance Programs Group – Appendix A – Page 26

Gastrin ± 25 ≤ 250 pmol/L Free PSA ± 1.5 ≤ 10 µg/L CK-MB ± 6 ≤ 40 U/L & µg/L
± 10% > 250 pmol/L ± 15% > 10 µg/L ± 15% > 40 U/L & µg/L
Growth Hormone ± 2 ≤ 10m U/L Aldosterone ± 75.0 ≤ 500.0 pmol/L Cortisol ± 30 ≤ 200 nmol/L
± 20% > 10 mU/L ± 15% > 500.0 pmol/L ± 15% > 200 nmol/L
HCG ± 3 ≤ 20 IU/L PTH ± 2.5 ≤ 10.0 pmol/L Creatinine ± 0.010 ≤ 0.100 mmol/L
± 15% > 20 IU/L ± 25% > 10.0 pmol/L ± 10% > 0.100 mmol/L
17-Hydroxyprogesterone ± 3.0 ≤ 15.0 nmol/L Plasma Renin Activity ± 1.0 ≤ 4.0 ng/mL/hr Ferritin ± 6.0 ≤ 40 µg/L
± 20% > 15.0 nmol/L ± 25% > 4.0 ng/mL/hr ± 15% > 40 µg/L
IgE ± 4.0 ≤ 20.0 IU/L Active Renin ± 1.0 ≤ 4.0 µU/mL Fructosamine ± 30 ≤ 300 µmol/L
± 20% > 20.0 IU/L ± 25% > 4.0 µU/mL ± 10% > 300 µmol/L
Insulin ± 5.0 ≤ 20.0 mU/L Glucose ± 0.5 ≤ 5.0 mmol/L
± 25% > 20.0 mU/L ± 10% > 5.0 mmol/L
LH ± 2.0 ≤ 10.0 IU/L GGT ± 8 ≤ 60 U/L
± 20% > 10.0 IU/L ± 15% > 60 U/L
Oestradiol ± 100 ≤ 500 pmol/L GENERAL SERUM CHEMISTRY hCG-quantitative ± 3.0 ≤ 20.0I U/L
± 20% > 500 pmol/L Acid Phos (Total) ± 1.5 ≤ 10.0 U/L & ± 15% > 20.0 IU/L
Oestriol(Total) ± 20 ≤ 200 nmol/L µg/L hCG-qualitative neg. ≤ 20 IU/L
± 10% > 200 nmol/L ± 15% > 10.0 U/L & pos. > 30 IU/L
Oestriol(Unconjugated) ± 5.0 ≤ 25.0 nmol/L µg/L HDL Cholesterol ± 0.20 ≤ 2.00 mmol/L
± 20% > 25.0 nmol/L Acid Phos (Pros) ± 1.5 ≤ 10.0 U/L&µg/L ± 10% > 2.00 mmol/L
Progesterone ± 2 ≤ 10 nmol/L ± 15% > 10.0 U/L&µg/L Iron ± 5.0 µmol/L
± 25% > 10 nmol/L Albumin ± 2.0 ≤ 20.0 g/L Lactate Dehydrogenase ± 30 ≤ 200 U/L
Prolactin ± 20 ≤ 100 mIU/L ± 10% > 20.0 g/L ± 15% > 200 U/L
± 20% > 100 mIU/L Alkaline Phosphatase ± 15 ≤ 100 U/L Lactate ± 1.0 ≤ 10.0 mmol/L
SHBG ± 5 ≤ 50 nmol/L ± 15% > 100 U/L ± 10% > 10.0 mmol/L
± 10% > 50 nmol/L ALT ± 8 ≤ 60 U/L Lipase ± 40 ≤ 200 U/L
Testosterone ± 0.5 ≤ 2.5 nmol/L ± 15% > 60 U/L ± 20% > 200 U/L
± 20% > 2.5 nmol/L Amylase ± 15 ≤ 100 U/L Lithium ± 0.20 mmol/L
TSH ± 0.6 ≤ 4.0 mU/L ± 15% > 100 U/L
Magnesium ± 0.12 mmol/L
± 15% > 4.0 mU/L AST ± 8 ≤ 60 U/L
± 15% > 60 U/L Osmolality ± 8 mmol/kg
Free T3 ± 3 pmol/L
Free T4 ± 1.5 ≤ 10 pmol/L Bicarbonate ± 2.0 ≤ 20.0 mmol/L Phosphate ± 0.10 ≤ 1.00 mmol/L
± 15% > 10 pmol/L ± 10% > 20.0 mmol/L ± 10% > 1.00 mmol/L
Total T3 ± 0.3 ≤ 1.5 nmol/L Bilirubin-Total ± 5 ≤ 50 µmol/L Potassium ± 0.2 mmol/L
± 20% > 1.5 nmol/L ± 10% > 50 µmol/L Protein (Total) ± 5.0 g/L
Total T4 ± 8 ≤ 50 nmol/L Bilirubin Conjugated ± 10 ≤ 50 µmol/L Sodium ± 3 mmol/L
± 15% > 50 nmol/L ± 20% > 50 µmol/L Total T3 ± 0.3 ≤ 2.0 nmol/L
Vitamin B12 ± 20 ≤ 100 pmol/L Calcium ± 0.10 mmol/L ± 15% > 2.0 nmol/L
± 20% > 100 pmol/L Chloride ± 3 mmol/L Free T3 ± 3.0 pmol/L
Vitamin D3 ± 5 ≤ 20 nmol/L Cholesterol ± 0.50 ≤ 10.00 mmol/L Free T4 ± 3.0 ≤ 20.0 pmol/L
± 15 > 20 nmol/L ± 5% > 10.00 mmol/L ± 15% > 20.0 pmol/L
Total PSA ± 1.5 ≤ 10.0 µg/L Creatine Kinase ± 15 ≤ 100 U/L TSH ± 0.6 ≤ 4.0 mU/L
± 15% > 10.0 µg/L ± 15% > 100 U/L ± 15% > 4.0 mU/L

© RCPA-AACB Chemical Pathology Quality Assurance Programs Group – Appendix A – Page 27

Thyroxine ± 8 ≤ 100 nmol/L GLYCOHAEMOGLOBIN hCG-qualitative neg. ≤ 20 IU/L
± 15% > 100 nmol/L Haemoglobin A1c ± 0.5 ≤ 10.0% pos. > 30 IU/L
TIBC ± 10.0 µmol/L ± 5% > 10.0% HDL Cholesterol ± 0.20 ≤ 2.00 mmol/L
Transferrin ± 0.50 g/L ± 10% > 2.00 mmol/L
Triglyceride ± 0.20 ≤ 2.00 mmol/L Lactate Dehydrogenase ± 30 ≤ 200 U/L
± 10% > 2.00 mmol/L ± 15% > 200 U/L
IGF-1 / C PEPTIDE Magnesium ± 0.12 mmol/L
Troponin I ± 0.2 ≤ 2.0 ng/mL
± 10% > 2.0 ng/mL IGF-1 ± 3 ≤ 20 nmol/L Potassium ± 2.0 mmol/L
Troponin T ± 0.10 ≤ 1.0 ng/mL ± 15% > 20 nmol/L Protein (Total) ± 5.0 g/L
± 10% > 1.0 ng/mL C Peptide ± 1.0 ≤ 10 nmol/L Sodium ± 3 mmol/L
Urate ± 0.050 mmol/L ± 10% > 10 nmol/L Triglyceride ± 0.20 ≤ 2.00 mmol/L
Urea ± 1.0 ≤ 10.0 mmol/L ± 10% > 2.00 mmol/L
± 10% > 10.0 mmol/L Urate ± 0.050 mmol/L
NEAR PATIENT TESTING Urea ± 1.0 ≤ 10.0 mmol/L
Albumin ± 2.0 ≤ 20.0 g/L ± 10% > 10.0 mmol/L
± 10% > 20.0 g/L
GENERAL THERAPEUTIC DRUGS Alkaline Phosphatase ± 15 ≤ 100 U/L
Carbamazepine ± 2.0 ≤ 20.0 µmol/L ± 15% > 100 U/L NEONATAL BILIRUBIN
± 10% > 20.0 µmol/L ALT ± 8 ≤ 60 U/L
Total Bilirubin ± 15 ≤ 150 µmol/L
Digoxin ± 0.2 ≤ 2.0 nmol/L ± 15% > 60 U/L
± 10% > 150 µmol/L
± 10% > 2.0 nmol/L Amylase ± 15 ≤ 100 U/L
Conjugated Bilirubin ± 10 ≤ 50 µmol/L
Gentamicin ± 0.5 ≤ 5.0 mg/L ± 15% > 100 U/L
± 10% > 5.0 mg/L AST ± 8 ≤ 60 U/L ± 20% > 50 µmol/L
Paracetamol ± 20 ≤ 200 µmol/L ± 15% > 60 U/L
± 10% > 200 µmol/L Bicarbonate ± 2.0 ≤ 20.0 mmol/L
Phenobarbitone ± 3.0 ≤ 30.0 µmol/L ± 10% > 20.0 mmol/L PORPHYRINS
± 10% > 30.0 µmol/L Bilirubin ± 5 ≤ 50 µmol/L Urine ALA ± 5 ≤ 20 µmol/L
Phenytoin ± 3.0 ≤ 30.0 µmol/L ± 10% > 50 µmol/L ± 25% > 20 µmol/L
± 10% > 30.0 µmol/L Calcium ± 0.10 mmol/L Urine Porphobilinogen ± 5 ≤ 25 µmol/L
Quinidine ± 2.0 ≤ 20.0 µmol/L Chloride ± 3 mmol/L (Quantitative) ± 20% > 25 µmol/L
± 10% > 20.0 µmol/L Cholesterol ± 0.50 ≤ 10.00 mmol/L Urine Porphobilinogen neg ≤ 10 µmol/L
Salicylate ± 0.10 ≤ 1.00 mmol/L ± 5% > 10.00 mmol/L (Qualitative) + 10-50 µmol/L
± 10% > 1.00 mmol/L Creatine Kinase ± 15 ≤ 100 U/L ++ 51-100 µmol/L
Theophylline ± 3 ≤ 30 µmol/L ± 15% > 100 U/L +++ > 100 µmol/L
± 10% > 30 µmol/L Creatinine ± 0.010 ≤ 0.100 mmol/L Urine Total Porphyrin ± 15 ≤ 100 nmol/L
Valproate ± 25 ≤ 250 µmol/L ± 10% > 0.100 mmol/L ± 15% > 100 nmol/L
± 10% > 250 µmol/L Glucose ± 0.5 ≤ 5.0 mmol/L Faecal Percent Dry Weight ± 1 ≤ 10%
Vancomycin ± 2.0 ≤ 20.0 mg/L ± 10% > 5.0 mmol/L ± 10% > 10%
± 10% > 20.0 mg/L GGT ± 8 ≤ 60 U/L Faecal Total Porphyrin ± 15 ≤ 100 µmol/kg
± 15% > 60 U/L ± 15% > 100 µmol/kg
hCG-quantitative ± 3.0 ≤ 20.0 IU/L Plasma Total Porphyrin ± 3 ≤ 20 nmol/L
± 15% > 20.0 IU/L ± 15% > 20 nmol/L

© RCPA-AACB Chemical Pathology Quality Assurance Programs Group – Appendix A – Page 28

RBC Total Porphyrin ± 0.3 ≤ 2.0 µmol/L rc Chloride ± 2 ≤ 20 mmol/L DPD (Total) ± 15 ≤ 80 nmol/L
± 15% > 2.0 µmol/L rc ± 10% > 20 mmol/L ± 15% > 80 nmol/L
Sweat Conductivity ± 2 ≤ 20 mmol/L DPD (Free) ± 15 ≤ 80 nmol/L
± 10% > 20 mmol/L ± 15% > 80 nmol/L
SPECIAL LIPIDS Glucose ± 1.0 ≤ 10.0 mmol/L
Cholesterol ± 0.50 ≤ 10.00 mmol/L ± 10% > 10.0 mmol/L
hCG-quantitative ± 5 ≤ 50 IU/L
± 5% > 10.00 mmol/L TUMOUR MARKERS ± 10% > 50 IU/L
HDL Cholesterol ± 0.20 ≤ 2.00 mmol/L ACTH ± 2.0 ≤ 20 pmol/L
± 10% > 2.00 mmol/L hCG-qualitative neg. ≤ 20 IU/L
± 10% > 20 pmol/L pos. > 30 IU/L
Triglyceride ± 0.2 ≤ 2.0 mmol/L Alpha-fetoprotein ± 5 ≤ 25 kIU/L
± 10% > 2.0 mmol/L Hydroxyproline ± 10 ≤ 100 µmol/L
± 20% > 25 kIU/L ± 10% > 100 µmol/L
Apolipoprotein A1 ± 0.2 ≤ 2.0 g/L Calcitonin ± 2 ≤ 20 ng/L
± 10% > 2.0 g/L Magnesium (Serum) ± 0.12 mmol/L
± 10% > 20 ng/L
Apolipoprotein B ± 0.2 ≤ 2.0 g/L N-Telopeptides ± 80 ≤ 700 nmolBCE/L
CEA ± 2.0 ≤ 10.0 µg/L
± 10% > 2.0 g/L ± 20% > 10.0 µg/L ± 10% > 700 nmolBCE/L
CA125 ± 10 ≤ 50 kU/L
Osmolality ± 6 ≤ 300 mmol/kg
± 20% > 50 kU/L ± 2% > 300 mmol/kg
SPECIAL THERAPEUTIC DRUGS CA15-3 ± 3 ≤ 20 kU/L
Potassium ± 2 ≤ 20 mmol/L
Amiodarone ± 0.2 ≤ 2.0 µmol/L ± 15% > 20 kU/L ± 10% > 20 mmol/L
± 10% > 2.0 µmol/L Phosphate ± 2.5 mmol/L
CA19-9 ± 3 ≤ 20 kU/L
Amitriptyline ± 10 ≤ 100 µmol/L ± 15% > 20 kU/L
Sodium ± 2 ≤ 20 mmol/L
± 10% > 20 mmol/L
± 10% > 100 µmol/L hCG ± 3 ≤ 20 IU/L
± 15% > 20 IU/L
Total Protein ± 0.10 ≤ 1.00 g/L
Disopyramide ± 2.0 ≤ 20.0 µmol/L
± 10% > 1.00 g/L
± 10% > 20.0 µmol/L Beta-2-Microglobulin ± 0.2 ≤ 2.0 mg/L
Urate ± 0.3 mmol/L
Ethosuximide ± 3 ≤ 30 µmol/L ± 10% > 2.0 mg/L
Urea ± 20 ≤ 200 mmol/L
± 10% > 30 µmol/L NSE ± 2.0 ≤ 20 µg/L
± 10% > 200 mmol/L
Lignocaine ± 2.0 ≤ 20.0 µmol/L ± 10% > 20 µg/L
± 10% > 20.0 µmol/L Prolactin ± 20 ≤ 100 mU/L
Methotrexate ± 0.10 ≤ 1.00 µmol/L ± 20% > 100 mU/L URINE PREGNANCY TESTING
± 10% > 1.00 µmol/L Total PSA ± 1.5 ≤ 10.0 µg/L hCG neg. ≤ 20 IU/L
Nortriptyline ± 10 ≤ 100 nmol/L ± 15% > 10.0 µg/L pos. > 30 IU/L
± 10% > 100 nmol/L
Quinidine ± 2.0 ≤ 20.0 µmol/L
± 10% > 20.0umol/L VITAMINS
URINE CHEMISTRY
Tricyclic Antidepressants ± 10 ≤ 100 nmol/L Vitamin A ± 0.3 ≤ 3.0 µmol/L
Albumin ± 0.10 ≤ 1.0 g/L
± 10% > 100 nmol/L ± 10% > 3.0 µmol/L
± 10% > 1.0 g/L
Calcium ± 0.20 mmol/L
Vitamin E ± 5.0 ≤ 50.0 µmol/L
Chloride ± 2 ≤ 20 mmol/L ± 10% > 50 µmol/L
SWEAT ELECTROLYTES ± 10% > 20 mmol/L β Carotene ± 0.2 ≤ 20 µmol/L
Sodium ± 2 ≤ 20 mmol/L Creatinine ± 0.5 ≤ 5.0 mmol/L ± 10% > 20 µmol/L
± 10% > 20 mmol/L ± 10% > 5.0 mmol/L Total Carotenoids ± 0.4 ≤ 4.0 µmol/L
± 10% > 4.0 µmol/L

© RCPA-AACB Chemical Pathology Quality Assurance Programs Group – Appendix A – Page 29

 Appendix B
Allowable Limits of Performance
The estimation of quality in an external quality assurance program can be relative or
absolute. Relative quality is achieved by comparing a laboratories performance
against their peers. Examples include ranking precision and the reporting of a
median as the ‘target’ for accuracy. Absolute quality is a difficult concept. The setting
of an absolute level for accuracy, relies on having absolute calibration standards
and/or reference methodologies. However to set absolute quality levels for precision,
standards are even more difficult to define. The ISO Technical Committee 212 task
force classified a hierarchy of approaches in defining analytical quality specificationi
which are listed in Table 1.
considering an improvement by moving to a broad based clinical strategy such as
limits based on biological variability. These limits are freely available in the
literatureiii.
However before we make any changes in this program we should be considering
these questions: Should we be aiming to have a minimum (safety) standard i.e. a
standard that if laboratories are performing below it is unacceptable or an optimal
(ideal) standard i.e. a standard that some laboratories are achieving and all
laboratories should be aiming for?

The most appropriate quality standard is one that is based on clinical need. Clinical need based on biological variability would, in general, have some of our
Unfortunately studies that define analytical performance in terms of clinical outcome assays performing at a minimum standard e.g. calcium and sodium while other
are few. An example is the setting of desirable performance for HbA1c based on assays generally exceed optimal standards e.g. triglyceride and most enzymes. We
DCCT trial requirements. would not want to set goals that are not generally achievable, neither would we want
to set goals that are significantly below what most laboratories can achieve.
Broad clinical need can be defined in two ways; A clinicians survey may give an idea Nevertheless we will be reviewing our allowable limits over the next couple of years
if what would be required clinically, however the process of collecting that to more clearly reflect what is desirable for the profession and ultimately for the need
information needs to be rigorous and may still be biased by the clinicians historical of our patients.
experience of laboratory performance. Another broad based clinical approach is to
have analytical precision that can generally reveal the typical variability in patients Table 1. Heirarchical listing of procedures available for the determination of
results. These biological variability requirements can further be defined as minimal, analytical quality.
desirable and optimal standards of analytical performance in terms of the ability to
LEVEL APPROACH PROCEDURE
track patients changesii.
I Specific Clinical Need Clinical Outcome Studies
The profession defined method, or a set of analytical standards defined by an group II Broad Clinical Need Biological Variation
of experts in the profession, is the way that this programs ‘Allowable Limits of Clinician Survey
Performance’ have been defined. They have been defined over the last decade or III Profession Defined Expert Committee
more with the assistance of the advisory and target setting committees that the IV Proficiency Testing EQA survey
program relies on. State of the art
Proficiency Testing approaches are different. They are based on setting the V Other Existing practice
standard in terms of the results from proficiency testing e.g. setting a minimum Publications
standard on what most laboratories are able to achieve, or an optimal standard on
the state of the art as measured within the program.
i
Kaplan L.A., “Determination and application f desirable analytical performance goals: the
Finally when none of the above information is available, a quality standard may be ISO/TC 212 approach.” Scand J Clin Lab Invest 1999; 59: 479-482.
based on some other estimate of performance that has been recorded by a group or ii
Fraser C.G., “General Strategies to set quality specifications for reliability performance
even an individual laboratory in a publication. characteristics.” Scand J Clin Lab Invest 1999; 59: 487-490.
iii
Ricos C. et al “Current databases on biological variation: pros, cons and progress.” Scand J
Therefore, the QAP’s Allowable Limits of Performance are a good approach,
Clin Lab Invest. 1999; 59: 491-500.
especially as clinical outcome studies are so few and far between. We have been
© RCPA-AACB Chemical Pathology Quality Assurance Programs Group – Page 30