barnsley/rotherham integrated laboratories department ......qpulse reference sop-cb-d-1;...

Barnsley/Rotherham Integrated Laboratories Department: Blood Sciences

Filename : Blood Sciences Uncertainty of Results QMS No : SOP-BS-30

Version : 12 of 57

Author : N.Cuthbert/E.Lees Approved by : S.Dean

Active Date : 04/06/2019 Review due : 04/06/2020

Title: Blood Sciences Uncertainty of Results

No.of copies : 2

Location of copies : 1. QPulse

2. Website

3.

Table of contents 1.Introduction 2 2.Uncertainty of laboratory results 2

2.1 Qualitative tests ...................................................................................................... 2 2.2 Quantitative tests .................................................................................................... 2

3.Measurement Uncertainty for Biochemistry Assays 4 4.Measurement Uncertainty for Haematology Assays 24 5.Performance Requirements for the Measurement of Uncertainty 40 6.Appendix 1: Biochemistry IQC 42 7.Appendix 2: Haematology IQC 42 8.Appendix 3: Biochemistry Compatability of Performance 44 9.Summary of revisions 57



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1. Introduction

The laboratory strives to maintain a high standard of performance. Good laboratory practice and effective quality control procedures are invaluable at maintaining this position. However it should be understood that there is an inherent degree of uncertainty in any laboratory investigation. The level of uncertainty is a combination of three factors; pre-analytical influences, analytical variation and biological variation. This ‘uncertainty’ means that if a series of samples are taken from one individual, for any particular laboratory test, then the results will not be exactly the same. Although some of the uncertainty can be controlled by the laboratory it is important for users to recognise the effect of pre-analytical and biological variation when they interpret laboratory tests and to understand the changes in values that must occur before they can be regarded as significant. The following information regarding laboratory uncertanity of results is available to users on the Pathology Website.

2. Uncertainty of laboratory results

All assays carry an inevitable degree of uncertainty. The Uncertainty Policy in Pathology (QU-COM-D-32) identifies the risks/uncertainties with all the steps in the pre-examination, examination and post examination phase and the control measures that are used to ensure that variation and possibilities for error are minimised. These factors are well recognised but some occur by random error alone. A random error is associated with the fact that when a measurement is repeated it will generally provide a measured value that is different from the previous value. It is random in that the next measured value cannot be predicted exactly from previous such values. Within the laboratory we monitor analytical imprecision by a variety of methods: 2.1 Qualitative tests Some laboratory results require ‘intrepretative’ assessments i.e. Positive or Negative or subjective analysis e.g.. microcytic ++. There is an inevitable degree of observer bias in these assessments. However, internal quality schemes are designed to minimise this variability but observer bias will always be a factor. Not only should users bear in mind these uncertainties when interpreting any laboratory value, but they should also be cautious when attempting comparisons between different laboratories. Specific information for qualitative tests can be found in the individual test SOPs. 2.2 Quantitative tests Analytical variation can be divided into random error (precision) and systematic error (bias). For the monitoring of a patients’ condition both most be controlled and maintained at an acceptable level. This level may vary from analyte to analyte due to the nature of the assay but can be controlled by the laboratory. The Blood Sciences Quality Control Procedure (SOP-BS-076) outlines how it utilizes both Internal QC and External QA schemes within procedures to monitor performance. Regular review of External QA samples offers reassurance that accuracy and consistency are being maintained through peer group analysis.

-2SD



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Day to day assurance is provided by repeated analysis of internal quality control material. This analysis occurs at timed intervals. The time period will between analysers or specific tests due to manufacturers guidelines or the experience; backed up by statistical data; of the laboratory staff. This data is reviewed regularly for trends and required action. Using a basic interpretation of method mean and Standard Deviation cut off at + and – 2 intervals (see figure 1, below), we are able to access bias and uncertainty for parameters run on these analysers. Additional Westgard statistical rules may also be applied to aid the laboratory to spot biases and trends. Figure 1; Typical normal distribution around a mean with cut off points at + and – 2 standard deviations All staff members are trained in Quality Control procedures to recognise a deterioration in performance of an assay (for more information please see Qpulse reference HR-TR-CB-TUT-043; Quality Control Tutorial) and have procedures to follow in case more guidance is required (e.g. Qpulse reference SOP-CB-D-1; Biochemistry Quality Control Review and Interpretation). Senior staff review this data regulaly for trends in performance. As a laboratory generally employs a measurement procedure for long periods of time, the uncertainty of measurement information most relevant to interpreting its test results against fixed reference values is the imprecision of the test results across as many routine operating conditions as possible (for example; multiple calibrator and reagent batches, multiple operators, equipment maintenance, summer/winter etc). With the caveat that quality control materials may not totally reflect the analytical behaviour of patient specimens, this imprecision is most easily derived from long-term internal quality control (QC) data, calculated as standard deviation (SD) or coefficient of variation (CV%). For the purpose of recording estimates of uncertainty of measurement the imprecision should be documented as the 95% confidence interval (± 1.96 SD; or ± 1.96 CV%).

+2sd -2sd



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3. Measurement Uncertainty for Biochemistry Assays

The following table lists numeric Biochemisty assays perfomed by the Barnsley Blood Sciences Laboratory. The range refers to the quoted normal range unless otherwise stated. The table lists the QC with the target closest to these ranges and its CV (mean value of the QC is quoted). The effect that 1.96% of the CV would have on these ranges is listed. Please see Appendix 1 for the QC lot information and date range used for calculating the CV. Please note these values are for serum samples unless stated otherwise.



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Reference Range

Biochemistry Assay Sex Age Category Range Assay CV (%)

Lower Range

Upper Range

Mean QC value used

AFP Upper Limit

10.00 6.50 8.73 11.27 12.50

IQC Value 246.00 5.44 219.77 272.23 246.00

ALBUMIN

Lower Limit

35.00 1.90 33.70 36.30 26.00

Upper Limit

50.00 1.81 48.23 51.77 43.80

ALKALINE PHOSPHATASE

1 month

Lower Limit

70.00 4.00 64.51 75.49 88.00

Upper Limit

380.00 3.23 355.94 404.06 253.00

16 years

Lower Limit

60.00 4.00 55.30 64.70 88.00

Upper Limit

425.00 3.23 398.09 451.91 253.00

> 16 years

Lower Limit

30.00 6.60 26.12 33.88 21.90

Upper Limit

130.00 4.00 119.81 140.19 88.00

Alcohol QC value 62.30 3.60 57.90 66.70 62.30

QC value 128.00 3.70 118.72 137.28 128.00

ALT Upper Limit

40.00 4.70 36.32 43.68 35.90

QC value 246.00 1.53 238.62 253.38 246.00

AMMONIA

Lower Limit

17.00 1.68 16.44 17.56 71.80

Upper Limit

48.00 1.68 46.42 49.58 71.80

AMYLASE

Lower Limit

20.00 2.70 18.94 21.06 49.60

Upper Limit

100.00 1.88 96.32 103.68 133.00

AMYLASE (urine) Upper Limit

750.00 1.20 732.36 767.64 149.00



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Anti –CCP (Anti-Cyclic Citrullinated Peptide)

QC value 24.30 5.78 21.55 27.05 24.30

Upper Limit

5.00 6.54 4.36 5.64 3.60

AST Upper Limit

40.00 2.77 37.83 42.17 41.30

QC value 218.00 1.24 212.70 223.30 218.00

B12

Lower Limit

211.00 9.80 170.47 251.53 149.00

Upper Limit

911.00 5.90 805.65 1016.35 963.00

BHCG (Pregnancy) Upper Limit

25.00 5.50 22.31 27.70 22.80

BHCG (Tumour) Upper Limit

5.00 6.30 4.38 5.62 20.80

BILIRUBIN (TOTAL) Upper Limit

21.00 3.68 19.49 22.51 19.50

BILIRUBIN (CONJUGATED)

<1 month Upper Limit

10.00 4.65 9.09 10.91 9.80

>1 month Upper Limit

7.00 4.65 6.36 7.64 9.80

BNP

Heart failure probable

100.00 5.10 90.00 110.00 43.20

Heart failure very probable

500.00 3.50 465.70 534.30 452.00

CA125 Upper Limit

35.00 5.00 31.57 38.43 22.70

QC value 231.00 4.33 211.40 250.60 231.00

CA199 Upper Limit

35.00 7.70 29.72 40.28 64.60

QC value 552.00 4.47 503.64 600.36 4.47

CALCIUM (Adjusted Serum)

Lower Limit

2.10 2.61 1.99 2.21 2.19

Upper Limit

2.60 2.61 2.47 2.73 2.19



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CALCIUM (Urine 24 hour)

Lower Limit

2.50 2.77 2.36 2.64 1.78

Upper Limit

7.50 2.02 7.20 7.80 2.71

CALCIUM (Ionized)

Lower Limit

1.77 1.77 1.77 0.84

Upper Limit

1.77 1.77 1.77 0.84

CARBAMAZEPINE (Theraputic Range)

Lower Limit

4.00 7.20 3.44 4.56 5.30

Upper Limit

25.00 7.30 21.42 28.58 13.60

CARBOXY HAEMAGLOBIN

Upper Limit

1.50 0.00 1.50 1.50 30.70

Cholestrol QC value 5.00 2.96 4.71 5.29 5.00

QC value 7.66 2.00 7.36 7.96 7.66

CEA Upper Limit

5.00 6.90 4.31 5.69 4.1

QC value 54.1 48.69 52.26 59.51 54.1

CHLORIDE (Serum)

Lower Limit

98.00 0.93 96.21 99.79 104.90

Upper Limit

108.00 0.93 106.03 109.97 104.90

CHLORIDE (Whole Blood)

Lower Limit

95.00 1.12 92.91 97.09 134.40

Upper Limit

108.00 1.12 105.63 110.37 134.40

CHLORIDE (Urine 24 Hour)

Lower Limit

170.00 1.10 166.33 173.67 169.00

Upper Limit

250.00 1.10 244.61 255.39 169.00

CREATINE KINASE

Neonates Upper limit

900.00 0.80 885.89 914.11 498.00

Infants

Lower Limit

100.00 1.62 96.82 103.18 66.00

Upper Limit

480.00 1.22 468.52 491.48 230.00

M

Adult Lower Limit

40.00 1.62 38.73 41.27 66.00

Upper Limit

320.00 1.22 312.35 327.65 230.00



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F Adult

Lower Limit

25.00 1.62 24.21 25.79 66.00

Upper Limit

200.00 1.22 195.22 204.78 230.00

CREATININE (Serum)

M

Lower Limit

66.00 3.50 61.47 70.53 48.00

Upper Limit

118.00 2.71 111.73 124.27 119.00

F

Lower Limit

51.00 3.50 47.50 54.50 48.00

Upper Limit

96.00 2.71 90.90 101.10 119.00

CREATINE (24 hour urine)

Lower Limit

9.00 2.51 8.56 9.44 6.80

Upper Limit

17.00 2.74 16.09 17.91 15.30

CRP Upper Limit

10.00 11.50 7.75 12.25 3.50

QC value 46.10 1.82 44.46 47.74 46.10

CSF GLUCOSE

Lower Limit

2.50 2.00 2.40 2.60 3.10

Upper Limit

5.00 2.16 4.79 5.21 7.10

CSF LACTATE

Lower Limit

0.90 5.41 0.80 1.00 1.79

Upper Limit

1.80 5.41 1.61 1.99 1.79

CSF PROTEIN

<1year

Lower Limit

0.10 8.40 0.08 0.12 0.15

Upper Limit

1.20 3.50 1.12 1.28 0.68

> 1 year

Lower Limit

0.10 8.40 0.08 0.12 0.15

Upper Limit

0.40 8.40 0.33 0.47 0.15

CORTISOL (Morning)

Lower Limit

140.00 6.10 123.26 156.74 196.00

Upper Limit

500.00 5.70 444.14 555.86 686.00

DIGOXIN (Theraputic)

Lower Limit

0.50 8.10 0.42 0.58 0.73



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Upper Limit

2.00 4.20 1.84 2.16 2.50

FERRITIN

Lower Limit

22.00 7.30 18.85 25.15 14.60

Upper Limit

322.00 318.00 -

1684.96 2328.96 5.20

FOLATE

Lower Limit

3.40 7.80 2.88 3.92 3.76

Upper Limit

15.80 7.10 13.60 18.00 11.40

FREE T3

<3 days

Lower Limit

2.30 5.30 2.06 2.54 2.80

Upper Limit

8.10 2.90 7.64 8.56 13.60

<1 month

Lower Limit

3.50 5.30 3.14 3.86 2.80

Upper Limit

6.50 5.30 5.82 7.18 2.80

<2 month

Lower Limit

2.50 5.30 2.24 2.76 2.80

Upper Limit

7.80 5.30 6.99 8.61 2.80

< 1 year

Lower Limit

2.70 5.30 2.42 2.98 2.80

Upper Limit

7.30 5.30 6.54 8.06 2.80

< 5 year

Lower Limit

3.10 5.30 2.78 3.42 2.80

Upper Limit

6.90 5.30 6.18 7.62 2.80

<10 year

Lower Limit

2.30 5.30 2.06 2.54 2.80

Upper Limit

6.80 5.30 6.09 7.51 2.80

< 14 year

Lower Limit

3.50 5.30 3.14 3.86 2.80

Upper Limit

6.70 5.30 6.00 7.40 2.80

< 18 year Lower Limit

3.60 5.30 3.23 3.97 2.80



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Upper Limit

6.70 5.30 6.00 7.40 2.80

> 18 year

Lower Limit

3.50 5.30 3.14 3.86 2.80

Upper Limit

6.50 5.30 5.82 7.18 2.80

FREE T4

<3 days

Lower Limit

10.80 6.80 9.36 12.24 9.20

Upper Limit

26.80 5.30 24.02 29.58 30.50

<1 month

Lower Limit

10.90 6.80 9.45 12.35 9.20

Upper Limit

25.50 5.30 22.85 28.15 30.50

<2 month

Lower Limit

11.00 6.80 9.53 12.47 9.20

Upper Limit

24.30 5.30 21.78 26.82 30.50

< 1 year

Lower Limit

11.40 6.80 9.88 12.92 9.20

Upper Limit

20.90 5.30 18.73 23.07 30.50

< 5 year

Lower Limit

11.40 6.80 9.88 12.92 9.20

Upper Limit

19.00 6.80 16.47 21.53 9.20

<10 year

Lower Limit

11.00 6.80 9.53 12.47 9.20

Upper Limit

18.00 6.80 15.60 20.40 9.20

< 14 year

Lower Limit

10.80 6.80 9.36 12.24 9.20

Upper Limit

18.70 6.80 16.21 21.19 9.20

< 18 year

Lower Limit

10.70 6.80 9.27 12.13 9.20

Upper Limit

18.70 6.80 16.21 21.19 9.20

> 18 year

Lower Limit

10.00 6.80 8.67 11.33 9.20

Upper Limit

18.70 6.80 16.21 21.19 9.20



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FSH (Follicular) F

Lower Limit

3.00 6.10 2.64 3.36 8.20

Upper Limit

20.00 5.60 17.80 22.20 29.80

FSH (Peak) F

Lower Limit

9.00 6.10 7.92 10.08 8.20

Upper Limit

26.00 5.60 23.15 28.85 29.80

FSH (Luteal) F

Lower Limit

1.00 6.10 0.88 1.12 8.20

Upper Limit

12.00 6.10 10.57 13.43 8.20

FSH (Post Menopausal)

F

Lower Limit

18.00 5.60 16.02 19.98 29.80

Upper Limit

153.00 5.20 137.41 168.59 83.00

FSH M

Lower Limit

1.00 6.10 0.88 1.12 8.20

Upper Limit

12.00 6.10 10.57 13.43 8.20

FASTING GLUCOSE (Serum)

Indicative of Diabetes Mellitus

7.00 2.16 6.70 7.30 7.10

QC value 19.40 1.75 18.73 20.07 19.40

Gamma GT M 50.00 4.80 45.30 54.70 32.50

F 33.00 4.80 29.90 36.10 32.50

QC value 207.00 1.42 201.24 212.76 207.00

Gentamicin Upper limit

10.00 5.90 8.84 11.16 5.50

HbA1c Increased risk of Diabetes

36 1.50 34.94 37.06 39.00

HDL QC limit 2.49 2.06 2.39 2.59 2.49

QC limit 1.23 2.56 1.17 1.29 1.23

IGA

< 13 days

Lower Limit

0.01 3.42 0.01 0.01 1.12

Upper Limit

0.08 3.42 0.07 0.09 1.12

13 - 28 days Lower Limit

0.02 3.42 0.02 0.02 1.12



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Upper Limit

0.15 3.42 0.14 0.16 1.12

28 days – 2 months

Lower Limit

0.05 3.42 0.05 0.05 1.12

Upper Limit

0.40 3.42 0.37 0.43 1.12

2 months – 5 months

Lower Limit

0.10 3.42 0.09 0.11 1.12

Upper Limit

0.50 3.42 0.47 0.53 1.12


Lower Limit

0.15 3.42 0.14 0.16 1.12

Upper Limit

0.70 3.42 0.65 0.75 1.12


Lower Limit

0.20 3.42 0.19 0.21 1.12

Upper Limit

0.70 3.42 0.65 0.75 1.12

11 months – 1 year

Lower Limit

0.30 3.42 0.28 0.32 1.12

Upper Limit

1.20 3.42 1.12 1.28 1.12

1 year – 2 years

Lower Limit

0.30 3.42 0.28 0.32 1.12

Upper Limit

1.30 3.42 1.21 1.39 1.12

2 years – 5 years

Lower Limit

0.20 3.42 0.19 0.21 1.12

Upper Limit

2.00 3.42 1.87 2.13 1.12

5 years – 8 years

Lower Limit

0.50 3.42 0.47 0.53 1.12

Upper Limit

2.40 2.89 2.26 2.54 2.57

8 years- 11 years

Lower Limit

0.70 3.42 0.65 0.75 1.12

Upper Limit

2.50 2.89 2.36 2.64 2.57

11 years – 44 years

Lower Limit

0.80 3.42 0.75 0.85 1.12

Upper Limit

2.80 2.89 2.64 2.96 2.57



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> 44 years

Lower Limit

0.80 3.42 0.75 0.85 1.12

Upper Limit

4.00 2.26 3.82 4.18 3.14

IGG

< 13 days

Lower Limit

5.00 2.69 4.74 5.26 6.94

Upper Limit

17.00 2.53 16.16 17.84 13.40

13 - 28 days

Lower Limit

3.90 2.69 3.69 4.11 6.94

Upper Limit

13.00 2.53 12.36 13.64 13.40


Lower Limit

2.10 2.69 1.99 2.21 6.94

Upper Limit

7.70 2.69 7.29 8.11 6.94


Lower Limit

2.40 2.69 2.27 2.53 6.94

Upper Limit

8.80 2.69 8.34 9.26 6.94


Lower Limit

3.00 2.69 2.84 3.16 6.94

Upper Limit

9.00 2.69 8.53 9.47 6.94


Lower Limit

3.00 2.69 2.84 3.16 6.94

Upper Limit

10.90 2.53 10.36 11.44 13.40


Lower Limit

3.10 2.69 2.94 3.26 6.94

Upper Limit

13.80 2.53 13.12 14.48 13.40

1 year – 2 years

Lower Limit

3.70 2.69 3.50 3.90 6.94

Upper Limit

15.80 2.53 15.02 16.58 13.40

2 years – 5 years

Lower Limit

4.90 2.69 4.64 5.16 6.94

Upper Limit

16.10 2.53 15.30 16.90 13.40


Lower Limit

5.40 2.69 5.12 5.68 6.94



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Upper Limit

16.10 2.53 15.30 16.90 13.40

> 14 years

Lower Limit

6.00 2.69 5.68 6.32 6.94

Upper Limit

16.00 2.53 15.21 16.79 13.40

IGM

< 13 days

Lower Limit

0.05 4.63 0.05 0.05 0.46

Upper Limit

2.00 4.72 1.81 2.19 1.40

13 - 28 days

Lower Limit

0.08 4.63 0.07 0.09 0.46

Upper Limit

0.40 4.63 0.36 0.44 0.46


Lower Limit

0.17 4.63 0.15 0.19 0.46

Upper Limit

0.70 4.63 0.64 0.76 0.46


Lower Limit

0.20 4.63 0.18 0.22 0.46

Upper Limit

1.00 3.00 0.94 1.06 1.14


Lower Limit

0.40 4.63 0.36 0.44 0.46

Upper Limit

1.60 4.72 1.45 1.75 1.40


Lower Limit

0.60 4.63 0.55 0.65 0.46

Upper Limit

2.10 4.72 1.91 2.29 1.40


Lower Limit

0.50 4.63 0.45 0.55 0.46

Upper Limit

2.20 4.72 2.00 2.40 1.40

2 year – 5 years

Lower Limit

0.50 4.63 0.45 0.55 0.46

Upper Limit

2.00 3.00 1.88 2.12 1.14


Lower Limit

0.50 4.63 0.45 0.55 0.46

Upper Limit

1.80 4.72 1.63 1.97 1.40



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Lower Limit

0.50 4.63 0.45 0.55 0.46

Upper Limit

1.90 4.72 1.72 2.08 1.40

> 44 years

Lower Limit

0.50 4.63 0.45 0.55 0.46

Upper Limit

2.00 4.72 1.81 2.19 1.40

IRON

M

Lower Limit

12.00 2.28 11.46 12.54 14.40

Upper Limit

31.00 2.36 29.57 32.43 25.60

F

Lower Limit

9.00 2.28 8.60 9.40 14.40

Upper Limit

30.00 2.36 28.61 31.39 25.60

LACTATE

Lower Limit

0.67 5.41 0.60 0.74 1.79

Upper Limit

2.47 5.41 2.21 2.73 1.79

LACTATE DEHYDROGENASE

Lower Limit

208.00 3.10 195.36 220.64 119.00

Upper Limit

378.00 2.23 361.48 394.52 238.00

LH (Follicular levels)

F

Lower Limit

2.00 5.20 1.80 2.20 2.60

Upper Limit

15.00 4.60 13.65 16.35 28.30

LH (Peak levels) F

Lower Limit

22.00 4.60 20.02 23.98 28.30

Upper Limit

105.00 4.40 95.94 114.06 61.00

LH (Luteal) F

Lower Limit

0.60 5.20

0.54 0.66 2.60

Upper Limit

19.00 4.60 17.29 20.71 28.30

LH (Post Menopausall)

F

Lower Limit

16.00 4.60 14.56 17.44 28.30

Upper Limit

64.00 4.40 58.48 69.52 61.00



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LH M

Lower Limit

2.00 5.20 1.80 2.20 2.60

Upper Limit

12.00 4.60 10.92 13.08 28.30

LITHIUM (Theraputic Range)

Lower Limit

0.40 5.57 0.36 0.44 0.59

Upper Limit

1.00 3.99 0.92 1.08 1.22

MAGNESIUM Blood)

Lower Limit

0.70 3.20 0.66 0.74 0.56

Upper Limit

1.00 2.05 0.96 1.04 1.00

METHAEMAGLOBIN

Lower Limit

0.40 0.55 0.40 0.40 9.00

Upper Limit

1.50 0.55 1.48 1.52 9.00

Micro Albumin M Upper Limit

2.50 9.70 2.02 2.98 7.90

F Upper Limit

3.50 9.70 2.83 4.17 7.90

OESTRADIOL (Follicular levels)

F

Lower Limit

72.00 9.50 58.59 85.41 160.00

Upper Limit

529.00 4.20 485.45 572.55 967.00

OESTRADIOL (Mid Cycle)

F

Lower Limit

235.00 9.50 191.24 278.76 160.00

Upper Limit

1309.00 4.20 1201.24 1416.76 967.00

OESTRADIOL (Luteal)

F

Lower Limit

205.00 9.50 166.83 243.17 160.00

Upper Limit

786.00 4.20 721.30 850.70 967.00

OESTRADIOL (Post Menapausal)

Lower Limit

118.00 9.50 96.03 139.97 160.00

OESTRADIOL M

< 2 months Upper Limit

177.00 9.50 144.04 209.96 160.00

2 months – 14 years

Upper Limit

44.00 9.50 35.81 52.19 160.00

> 14 years Upper Limit

146.00 9.50 118.81 173.19 160.00

OSMOLALITY (SERUM)

Lower Limit

275.00 0.60 271.77 278.23 306.00



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Upper Limit

295.00 0.60 291.53 298.47 306.00

OSMOLALITY (URINE)

Lower Limit

50.00 0.56 49.45 50.55 427.00

Upper Limit

1200.00 0.33 1192.24 1207.76 813.00

Paracetamol 4 Hour level

200.00 2.07 191.89 208.11 73.00

QC value 165.00 1.60 159.83 170.17 165.00

PARATHYROID HORMONE

Lower Limit

1.95 11.60 1.51 2.39 3.30

Upper Limit

8.49 11.60 6.56 10.42 3.30

pCO2

Lower Limit

4.50 4.28 4.12 4.88 1.96

Upper Limit

6.10 4.28 5.59 6.61 1.96

pH

Lower Limit

7.35 0.13 7.33 7.37 7.57

Upper Limit

7.45 0.13 7.43 7.47 7.57

PHENOBARBITONE (Theraputic Range)

Lower Limit

10.00 5.60 8.90 11.10 8.90

Upper Limit

40.00 5.10 36.00 44.00 33.00

PHENYTOIN (Theraputic Range)

Lower Limit

5.00 6.85 4.33 5.67 7.30

Upper Limit

20.00 7.84 16.93 23.07 18.40

pO2

Lower Limit

12.00 4.85 10.86 13.14 15.33

Upper Limit

15.00 4.85 13.57 16.43 15.33

POTASSIUM (Serum)

Lower Limit

3.50 0.65 3.46 3.54 4.02

Upper Limit

5.30 0.65 5.23 5.37 4.02

POTASSIUM (Whole blood)

Lower Limit

3.50 1.09 3.43 3.57 7.64

Upper Limit

5.10 1.09 4.99 5.21 7.64

POTASSIUM (Urine) Lower Limit

40.00 0.85 39.33 40.67 30.10



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Upper Limit

120.00 1.06 117.51 122.49 74.40

PHOSPHATE (Serum)

< 1 month

Lower Limit

1.40 2.83 1.32 1.48 1.26

Upper Limit

3.10 1.83 2.99 3.21 2.18

1 month - 1 year

Lower Limit

1.00 2.83 0.94 1.06 1.26

Upper Limit

2.60 1.83 2.51 2.69 2.18

1 year- 16 years

Lower Limit

1.20 2.83 1.13 1.27 1.26

Upper Limit

2.30 1.83 2.22 2.38 2.18

> 16 years

Lower Limit

0.80 5.40 0.72 0.88 0.75

Upper Limit

1.50 2.83 1.42 1.58 1.26

PHOSPHATE (Urine)

Lower Limit

15.00 5.90 13.27 16.73 10.00

Upper Limit

50.00 4.28 45.81 54.19 16.30

PROGESTERONE (Follicular levels)

F

Lower Limit

24.70 4.50 22.52 26.88 28.00

Upper Limit

85.90 6.50 74.96 96.84 86.00

PROGESTERONE (Luteal)

F

Lower Limit

24.70 4.50 22.52 26.88 28.00

Upper Limit

85.90 6.50 74.96 96.84 86.00

PROGESTERONE (Mid Luteal)

F

Lower Limit

30.80 4.50 28.08 33.52 28.00

Upper Limit

36.80 4.50 33.55 40.05 28.00

PROGESTERONE (Post Menopausal)

F

Lower Limit

0.60 11.20 0.47 0.73 2.30

Upper Limit

1.60 11.20 1.25 1.95 2.30

M Upper Limit

373.00 6.50 325.48 420.52 86.00

PROLACTIN QC value 1011.00 3.87 934.31 1087.69 1011.00



Version : 12 of 57



F Upper Limit

646.00 4.20 592.82 699.18 625.00

PROTEIN (Serum)

Lower Limit

60.00 1.87 57.80 62.20 75.30

Upper Limit

80.00 1.82 77.15 82.85 90.00

PROTEIN (24 Hour Urine)

Upper Limit

0.15 8.40 0.13 0.17 0.15

PROTEIN (URINE) Upper Limit

0.10 8.40 0.08 0.12 0.15

PSA M

<60 years Upper Limit

3.00 4.90 2.71 3.29 1.40

60-70 years Upper Limit

4.00 4.90 3.62 4.38 1.40

>60 years Upper Limit

5.00 4.90 4.52 5.48 1.40

QC value 26.92 5.35 24.10 29.74 26.92

RF Upper Limit

13.00 8.50 10.83 15.17 10.90

QC value 60.60 1.60 58.70 62.50 60.60

SALICYLATE

Theraputic upper limit

250.00 4.84 226.28 273.72 138.00

Severe toxicity

500.00 1.84 481.97 518.03 458.00

SODIUM (Serum)

Lower Limit

133.00 0.65 131.31 134.69 142.50

Upper Limit

146.00 0.65 144.14 147.86 142.50

SODIUM (Whole Blood)

Lower Limit

133.00 0.83 130.84 135.16 151.94

Upper Limit

146.00 0.83 143.62 148.38 151.94

SODIUM (Urine 24 hour)

Lower Limit

100.00 0.72 98.59 101.41 75.40

Upper Limit

250.00 0.68 246.67 253.33 165.80

SHBG M <50 years

Lower Limit

14.60 5.10 13.14 16.06 8.80

Upper Limit

94.60 5.10 85.14 104.06 38.00



Version : 12 of 57



> 50 years

Lower Limit

21.60 5.10 19.44 23.76 8.80

Upper Limit

113.10 5.10 101.79 124.41 38.00

F

Pre menopausal

Lower Limit

10.80 5.10 9.72 11.88 8.80

Upper Limit

180.00 5.10 162.01 197.99 38.00

Post menopausal

Lower Limit

23.20 5.10 20.88 25.52 8.80

Upper Limit

159.10 5.10 143.20 175.00 38.00

TESTOSTERONE

M

<50 years

Lower Limit

5.70 6.00 5.03 6.37 1.40

Upper Limit

26.10 6.00 23.03 29.17 269.50

> 50 years

Lower Limit

3.00 6.00 2.65 3.35 1.40

Upper Limit

27.40 6.00 24.18 30.62 26.50

F

Pre menopausal

Lower Limit

0.40 6.00 0.35 0.45 1.40

Upper Limit

2.10 6.00 1.85 2.35 1.40

Post menopausal

Lower Limit

0.20 6.00 0.18 0.22 1.40

Upper Limit

1.70 6.00 1.50 1.90 1.40

THEOPHYLLINE (Theraputic Range)

Lower Limit

12.00 3.64 11.14 12.86 13.90

Upper Limit

20.00 5.02 18.03 21.97 29.60

TROPONIN I (high sensitivity

No Detectable cardiac damage

3.0 2.4 34.43 3.6 9.8

Detectable cardiac damage

120 5.2 107.5 132.5 79.3

TRANSFERRIN

Lower Limit

2.00 2.30 1.91 2.09 1.30

Upper Limit

3.20 2.28 3.06 3.34 2.81



Version : 12 of 57



Triglyceride Lower Limit

0.45 2.29 0.43 0.47 1.63

Upper Limit

1.88 2.29 1.80 1.96 1.63

TSH

< 3 days

Lower Limit

0.13 4.00 0.12 0.14 0.14

Upper Limit

9.23 3.50 8.60 9.86 2.32

< 1 month

Lower Limit

0.16 4.00 0.15 0.17 0.14

Upper Limit

8.48 3.50 7.90 9.06 2.32

<2 month

Lower Limit

0.19 4.00 0.18 0.20 0.14

Upper Limit

7.78 3.50 7.25 8.31 2.00

< 1 year

Lower Limit

0.30 4.00 0.28 0.32 2.32

Upper Limit

5.88 3.50 5.48 6.28 2.32

< 5 year

Lower Limit

0.42 4.00 0.39 0.45 0.14

Upper Limit

4.79 3.50 4.46 5.12 2.32

<10 year

Lower Limit

0.48 4.00 0.44 0.52 0.14

Upper Limit

4.67 3.50 4.35 4.99 2.32

< 14 year

Lower Limit

0.53 4.00 0.49 0.57 0.14

Upper Limit

4.58 3.50 4.27 4.89 2.32

< 18 year

Lower Limit

0.56 4.00 0.52 0.60 0.14

Upper Limit

4.53 3.50 4.22 4.84 2.32

> 18 year

Lower Limit

0.38 4.00 0.35 0.41 0.14

Upper Limit

5.50 3.50 5.12 5.88 2.32



Version : 12 of 57



UREA

< 1 month

Lower Limit

0.80 3.10 0.75 0.85 3.49

Upper Limit

5.50 3.10 5.17 5.83 3.49

< 1 year

Lower Limit

1.00 3.10 0.94 1.06 3.49

Upper Limit

5.10 3.10 4.79 5.41 3.49

< 16 year

Lower Limit

2.50 3.10 2.35 2.65 3.49

Upper Limit

6.50 3.10 6.11 6.89 3.49

> 16 years

Lower Limit

2.50 3.10 2.35 2.65 3.49

Upper Limit

7.80 3.10 7.33 8.27 3.49

Urine Urea IQC Value 158.00 2.89 149.05 166.95 158.00

URIC ACID

M

Lower Limit

200.00 1.83 192.83 207.17 152.00

Upper Limit

430.00 1.40 418.20 441.80 245.00

F

Lower Limit

140.00 1.83 134.98 145.02 152.00

Upper Limit

360.00 1.40 350.12 369.88 245.00

Urine Urate IQC Value 0.60 3.07 0.56 0.64 0.60

VALPROATE (Theraputic Range)

Lower Limit

50.00 3.67 46.40 53.60 41.80

Upper Limit

100.00 3.92 92.32 107.68 83.00

TOTAL VIT D

Deficiency 25.00 9.70 20.25 29.75 75.00

Mild deficiency

50.00 9.70 40.49 59.51 75.00

Toxic 150.00 6.60 130.60 169.40 110.00



Version : 12 of 57





Version : 12 of 57



4. Measurement Uncertainty for Haematology Assays

The following table lists numeric Haematology assays perfomed by the Barnsley Blood Sciences Laboratory. The range refers to the quoted normal range unless otherwise stated. The table lists the QC with the target closest to these ranges and its CV. The effect that 1.96% of the CV would have on these ranges is the listed. Please see Appendix 2 for the QC lot information and date range used for calculating the CV.

Assay Reference Range Uncertainty

Sex Age Category Range QC Value Used

Assay CV (%) applied

to range

Lower Range

Upper Range

FBC (whole blood)

Platelets 0 - 3 days lower 125 76.05 4.58 65.51 86.59

upper 450 453.39 2.74 378.09 528.69

3 - 7 days lower 150 213.83 3.02 180.95 235.75

upper 450 453.39 2.74 378.09 528.69

7 - 30 days lower 150 213.83 3.02 180.95 235.75

upper 475 453.39 2.74 378.09 528.69

1 - 2 months lower 180 213.83 3.02 180.95 235.75

upper 550 453.39 2.74 378.09 528.69

1 - 3 months lower 210 213.83 3.02 180.95 235.75

upper 650 453.39 2.74 378.09 528.69

3 -6 months lower 210 213.83 3.02 180.95 235.75

upper 600 453.39 2.74 378.09 528.69

6 months - 1 year lower 190 213.83 3.02 180.95 235.75

upper 530 453.39 2.74 378.09 528.69

1 - 3 years lower 190 213.83 3.02 180.95 235.75

upper 500 453.39 2.74 378.09 528.69

3 - 6 years lower 190 213.83 3.02 180.95 235.75

upper 490 453.39 2.74 378.09 528.69

6 -8 years lower 190 213.83 3.02 180.95 235.75

upper 440 453.39 2.74 378.09 528.69

8 - 10 years lower 185 213.83 3.02 180.95 235.75

upper 245 213.83 3.02 180.95 235.75

Platelets

10 - 12 years lower 180 213.83 3.02 180.95 235.75

upper 405 453.39 2.74 378.09 528.69



Version : 12 of 57






to range

Lower Range

Upper Range

12 - 14 years lower 180 213.83 3.02 180.95 235.75

upper 400 453.39 2.74 378.09 528.69

14 - 19 years lower 170 213.83 3.02 180.95 235.75

upper 400 453.39 2.74 378.09 528.69

19 years and above lower 150 213.83 3.02 180.95 235.75

upper 400 453.39 2.74 378.09 528.69

Red Blood Cells 0 -3 days lower 3.85 4.32 1.46 4.05 4.59

upper 6.5 5.2 1.64 4.87 5.53

3 - 7 days lower 3.85 4.32 1.46 4.05 4.59

upper 6.4 5.2 1.64 4.87 5.53

7-14 days lower 3.53 4.32 1.46 4.05 4.59

upper 6.2 5.2 1.64 4.87 5.53

14 - 30 days lower 3.1 2.31 1.53 2.16 2.46

upper 5.2 5.2 1.64 4.87 5.53

30 - 60 days lower 2.9 2.31 1.53 2.16 2.46

upper 4.6 4.32 1.46 4.05 4.59

60 - 90 days lower 3.1 2.31 1.53 2.16 2.46

upper 4.65 4.32 1.46 4.05 4.59

90 - 120 days lower 3.2 2.31 1.53 2.16 2.46

upper 5 5.2 1.64 4.87 5.53

120 days- 6 months lower 3.4 4.32 1.46 4.05 4.59

upper 5.1 5.2 1.64 4.87 5.53

6 months - 1 year lower 3.7 4.32 1.46 4.05 4.59

upper 5.1 5.2 1.64 4.87 5.53

1 - 2 years lower 3.8 4.32 1.46 4.05 4.59

F 12 - 15 years lower 4.04 4.32 1.46 4.05 4.59

Red Blood Cells upper 5.1 5.2 1.64 4.87 5.53

M 15 - 18 years lower 4.42 4.32 1.46 4.05 4.59

upper 5.6 5.2 1.64 4.87 5.53

F 15 - 18 years lower 4.0 4.32 1.46 4.05 4.59

upper 5.1 5.2 1.64 4.87 5.53

M over 21 years lower 4.33 4.32 1.46 4.05 4.59



Version : 12 of 57






to range

Lower Range

Upper Range

upper 5.6 5.2 1.64 4.87 5.53

F over 21 years lower 3.85 4.32 1.46 4.05 4.59

upper 4.9 5.2 1.64 4.87 5.53

Haemoglobin 0 -3 days lower 145 156.92 1.34 149.99 163.85

upper 230 156.92 1.34 149.99 163.85

3 - 7 days lower 140 156.92 1.34 149.99 163.85

upper 222 156.92 1.34 149.99 163.85

7-14 days lower 130 110.53 1.44 103.9 117.16

upper 195 156.92 1.34 149.99 163.85

14 - 30 days lower 115 110.53 1.44 103.9 117.16

upper 167 156.92 1.34 149.99 163.85

30 - 60 days lower 94 110.53 1.44 103.9 117.16

upper 132 110.53 1.44 103.9 117.16

60 - 90 days lower 98 110.53 1.44 103.9 117.16

upper 132 110.53 1.44 103.9 117.16

90 - 120 days lower 102 110.53 1.44 103.9 117.16

upper 137 156.92 1.34 149.99 163.85

120 days- 6 months lower 103 110.53 1.44 103.9 117.16

upper 137 156.92 1.34 149.99 163.85


upper 137 156.92 1.34 149.99 163.85

1 - 2 years lower 107 110.53 1.44 103.9 117.16

upper 134 110.53 1.44 103.9 117.16

2 - 3 years lower 110 110.53 1.44 103.9 117.16

upper 135 110.53 1.44 103.9 117.16

3 - 5 years lower 110 110.53 1.44 103.9 117.16

upper 136 156.92 1.34 149.99 163.85

Haemoglobin 5 - 6 years lower 111 110.53 1.44 103.9 117.16

upper 138 156.92 1.34 149.99 163.85

6 - 7 years lower 113 110.53 1.44 103.9 117.16

upper 142 156.92 1.34 149.99 163.85

7 - 8 years lower 115 110.53 1.44 103.9 117.16

upper 142 156.92 1.34 149.99 163.85

8 - 10 years lower 117 110.53 1.44 103.9 117.16



Version : 12 of 57






to range

Lower Range

Upper Range

upper 145 156.92 1.34 149.99 163.85

10 - 11 years lower 118 110.53 1.44 103.9 117.16

upper 145 156.92 1.34 149.99 163.85

11 - 12 years lower 120 110.53 1.44 103.9 117.16

upper 147 156.92 1.34 149.99 163.85

M 12 - 14 years lower 124 110.53 1.44 103.9 117.16

upper 156 156.92 1.34 149.99 163.85

F 12 - 14 years lower 119 110.53 1.44 103.9 117.16

upper 146 156.92 1.34 149.99 163.85

M 14 - 16 years lower 131 110.53 1.44 103.9 117.16

upper 163 156.92 1.34 149.99 163.85

F 14 - 16 years lower 117 110.53 1.44 103.9 117.16

upper 156 156.92 1.34 149.99 163.85

M 16 - 18 years lower 129 110.53 1.44 103.9 117.16

upper 165 156.92 1.34 149.99 163.85

F 16 - 18 years lower 117 110.53 1.44 103.9 117.16

upper 157 156.92 1.34 149.99 163.85

M Over 21 years lower 132 110.53 1.44 103.9 117.16

upper 169 156.92 1.34 149.99 163.85

F Over 21 years lower 119 110.53 1.44 103.9 117.16

upper 149 156.92 1.34 149.99 163.85

Haematocrit 0 -7 days lower 0.44 0.441 1.96 0.411 0.471

upper 0.70 0.441 1.96 0.411 0.471

7-14 days lower 0.41 0.441 1.96 0.411 0.471

upper 0.65 0.441 1.96 0.411 0.471

14 - 30 days lower 0.34 0.321 1.78 0.291 0.351

upper 0.55 0.441 1.96 0.411 0.471

Haematocrit 30 - 60 days lower 0.29 0.321 1.78 0.291 0.351

upper 0.47 0.441 1.96 0.411 0.471

60 - 90 days lower 0.29 0.321 1.78 0.291 0.351

upper 0.41 0.441 1.96 0.411 0.471

90 days - 6 months lower

0.30 0.321 1.78 0.291 0.351

upper 0.41 0.441 1.96 0.411 0.471



Version : 12 of 57






to range

Lower Range

Upper Range

6 months - 2 years lower

0.31 0.321 1.78 0.291 0.351

upper 0.41 0.441 1.96 0.411 0.471

2 - 3 years lower 0.32 0.321 1.78 0.291 0.351

upper 0.41 0.441 1.96 0.411 0.471

3 - 5 years lower 0.33 0.321 1.78 0.291 0.351

upper 0.41 0.441 1.96 0.411 0.471

5 - 7 years lower 0.33 0.321 1.78 0.291 0.351

upper 0.42 0.441 1.96 0.411 0.471

7 - 8 years lower 0.34 0.321 1.78 0.291 0.351

upper 0.44 0.441 1.96 0.411 0.471

8 - 12 years lower 0.35 0.321 1.78 0.291 0.351

upper 0.44 0.441 1.96 0.411 0.471

M 12 - 14 years lower 0.35 0.321 1.78 0.291 0.351

upper 0.47 0.441 1.96 0.411 0.471

F 12 - 14 years lower 0.35 0.321 1.78 0.291 0.351

upper 0.45 0.441 1.96 0.411 0.471

M 14 - 16 years lower 0.37 0.321 1.78 0.291 0.351

upper 0.49 0.441 1.96 0.411 0.471

F 14 - 16 years lower 0.35 0.321 1.78 0.291 0.351

upper 0.45 0.441 1.96 0.411 0.471

M Over 16 years lower 0.39 0.441 1.96 0.411 0.471

upper 0.49 0.441 1.96 0.411 0.471

F Over 16 years lower 0.35 0.321 1.78 0.291 0.351

upper 0.46 0.441 1.96 0.411 0.471

MCV 0 -3 days lower 100 86.40 1.19 80.94 91.86

upper 127 86.40 1.19 80.94 91.86

7 - 14 days lower 94 86.40 1.19 80.94 91.86

upper 126 86.40 1.19 80.94 91.86

14 - 30 days lower 90 86.40 1.19 80.94 91.86

upper 116 86.40 1.19 80.94 91.86

30 - 60 days lower 82 86.40 1.19 80.94 91.86

MCV upper 99 86.40 1.19 80.94 91.86

60 - 90 days lower 75 76 1.24 71.02 80.98



Version : 12 of 57






to range

Lower Range

Upper Range

upper 95 86.40 1.19 80.94 91.86

90 days - 6 months lower 70 69.7 1.25 66.56 74.41

upper 88 86.40 1.19 80.94 91.86


upper 84 86.4 1.19 80.94 91.86

1 year - 2 years lower 73 76 1.24 71.02 80.98

upper 84 86.4 1.19 80.94 91.86

2 years - 3 years lower 73 76 1.24 71.02 80.98

upper 85 86.4 1.19 80.94 91.86


upper 86 86.4 1.19 80.94 91.86


upper 89 86.4 1.19 80.94 91.86


upper 90 86.4 1.19 80.94 91.86


upper 90 86.4 1.19 80.94 91.86


upper 93 86.4 1.19 80.94 91.86


upper 95 86.4 1.19 80.94 91.86

Over 16 years lower 82 86.4 1.19 80.94 91.86

upper 100 86.4 1.19 80.94 91.86

MCH

0 -7 days

lower 31 30.15 1.43 27.93 32.37

upper 39 30.15 1.43 27.93 32.37

7 -14 days lower 30.5 30.15 1.43 27.93 32.37

upper 37.5 30.15 1.43 27.93 32.37

14 -30 days lower 28.5 30.15 1.43 27.93 32.37

upper 35.5 30.15 1.43 27.93 32.37

30 -60 days lower 26 25.62 1.70 23.58 27.66

upper 33 30.15 1.43 27.93 32.37

60 -90 days lower 24.5 23.69 1.84 21.74 25.64

MCH upper 30 30.15 1.43 27.93 32.37

90 days - 6 months lower 24 23.69 1.84 21.74 25.64



Version : 12 of 57






to range

Lower Range

Upper Range

upper 29 30.15 1.43 27.93 32.37

6 months - 6 years lower 24.5 23.69 1.84 21.74 25.64

upper 30 30.15 1.43 27.93 32.37

6 years - 8 years lower 25.2 25.62 1.70 23.58 27.66

upper 31.7 30.15 1.43 27.93 32.37


upper 31.7 30.15 1.43 27.93 32.37

10 years - 12 years lower 26 25.62 1.70 23.58 27.66

upper 31.7 30.15 1.43 27.93 32.37


upper 32.3 30.15 1.43 27.93 32.37


upper 32.5 30.15 1.43 27.93 32.37

Over 16 years lower 27 25.62 1.70 23.58 27.66

upper 32.5 30.15 1.43 27.93 32.37

MCHC 0 -3 days lower 308 343.87 1.94 314.80 372.94

upper 365 355.53 2.00 326.10 384.96

3 -7 days lower 303 343.87 1.94 314.80 372.94

upper 368 355.53 2.00 326.10 384.96

7 -14 days

lower 298 343.87 1.94 314.80 372.94

upper 373 355.53 2.00 326.10 384.96

14 -30 days lower 303 343.87 1.94 314.80 372.94

upper 368 355.53 2.00 326.10 384.96

60 -90 days lower 300 343.87 1.94 314.80 372.94

upper 365 355.53 2.00 326.10 384.96

90 days - 1 year lower 308 343.87 1.94 314.80 372.94

upper 365 355.53 2.00 326.10 384.96

1 year - 2 years lower 315 343.87 1.94 314.80 372.94

upper 365 355.53 2.00 326.10 384.96

Over 2 years lower 316 343.87 1.94 314.80 372.94

upper 365 355.53 2.00 326.10 384.96

RDW lower 12.2 14.72 1.42 13.4 16.04

upper 15.4 14.72 1.42 13.4 16.04

White Blood Cells 0 -3 days lower 10 7.31 2.69 6.44 8.18



Version : 12 of 57






to range

Lower Range

Upper Range

upper 26 16.13 2.90 13.88 18.38

5 - 7 days lower 8.5 7.31 2.69 6.44 8.18

upper 24.5 16.13 2.90 13.88 18.38

7 - 30 days lower 6 7.31 2.69 6.44 8.18

upper 19.2 16.13 2.90 13.88 18.38

30 - 60 days lower 5.1 3.45 3.31 2.97 3.93

upper 17.3 16.13 2.90 13.88 18.38

60 - 90 days lower 5.5 3.45 3.31 2.97 3.93

upper 15.3 16.13 2.90 13.88 18.38

90 - 120 days lower 5.5 3.45 3.31 2.97 3.93

upper 16 16.13 2.90 13.88 18.38

120 days-6 months lower 5 3.45 3.31 2.97 3.93

upper 15 16.13 2.90 13.88 18.38


upper 15 16.13 2.90 13.88 18.38

1 year - 2 years lower 5.3 3.45 3.31 2.97 3.93

upper 14 16.13 2.90 13.88 18.38


upper 14 16.13 2.90 13.88 18.38


upper 13.3 16.13 2.90 13.88 18.38


upper 12 16.13 2.90 13.88 18.38


upper 11.8 7.31 2.69 6.44 8.18


upper 10.6 7.31 2.69 6.44 8.18


White Blood Cells upper 10.6 7.31 2.69 6.44 8.18


upper 10.6 7.31 2.69 6.44 8.18


upper 10.6 7.31 2.69 6.44 8.18

14 years - 18 years lower 4 3.45 3.31 2.97 3.93



Version : 12 of 57






to range

Lower Range

Upper Range

upper 10 7.31 2.69 6.44 8.18

Over 18 years lower 3.7 3.45 3.31 2.97 3.93

upper 10 7.31 2.69 6.44 8.18

Automated Neutrophils

0 -1 day lower

2.8 1.88 2.23 1.45 2.36

upper 15 11.02 1.18 8.86 13.37

1 -2 day lower 2.8 1.88 2.23 1.45 2.36

upper 15 11.02 1.18 8.86 13.37

2 -8 days lower 2.8 1.88 2.23 1.45 2.36

upper 12 11.02 1.18 8.86 13.37

8 - 14 days lower 1.8 1.88 2.23 1.45 2.36

upper 7.8 4.70 1.60 3.84 5.64

14 - 30 days lower 1.8 1.88 2.23 1.45 2.36

upper 6.8 4.70 1.60 3.84 5.64

30 - 60 days lower 1 1.88 2.23 1.45 2.36

upper 6 4.70 1.60 3.84 5.64

60 - 90 days

lower 0.8 1.88 2.23 1.45 2.36

upper 5.5 4.70 1.60 3.84 5.64


1 1.88 2.23 1.45 2.36

upper 5.5 4.70 1.60 3.84 5.64

6 months - I year lower 1.3 1.88 2.23 1.45 2.36

upper 7 4.70 1.60 3.84 5.64

1 year - 2 years lower 1.4 1.88 2.23 1.45 2.36

upper 7.5 4.70 1.60 3.84 5.64


upper 7.5 4.70 1.60 3.84 5.64


upper 7.7 4.70 1.60 3.84 5.64


upper 7.8 4.70 1.60 3.84 5.64

Automated Neutrophils 5 years - 6 years lower 1.7

1.88 2.23 1.45 2.36

upper 7.4 4.70 1.60 3.84 5.64



Version : 12 of 57






to range

Lower Range

Upper Range


upper 7.1 4.70 1.60 3.84 5.64


upper 7.2 4.70 1.60 3.84 5.64

9 years - 11 years

lower 1.7 1.88 2.23 1.45 2.36

upper 6.7 4.70 1.60 3.84 5.64

Over 11 years lower 1.7 1.88 2.23 1.45 2.36

upper 6.6 4.70 1.60 3.84 5.64

Automated 0 -1 day lower 2 2.82 3.31 1.83 4.01

Lymphocytes upper 8.8 2.82 3.31 1.83 4.01

1 -2 day lower 2 2.82 3.31 1.83 4.01

upper 7.7 2.82 3.31 1.83 4.01

2 - 3 days lower 2 2.82 3.31 1.83 4.01

upper 7.5 2.82 3.31 1.83 4.01

3 - 5 days lower 2 2.82 3.31 1.83 4.01

upper 7.3 2.82 3.31 1.83 4.01

5 - 14 days

lower 2.9 2.82 3.31 1.83 4.01

upper 9 2.82 3.31 1.83 4.01

14 - 30 days lower 2.9 2.82 3.31 1.83 4.01

upper 9.1 2.82 3.31 1.83 4.01

30 - 60 days lower 3.3 2.82 3.31 1.83 4.01

upper 10 2.82 3.31 1.83 4.01

60 - 90 days lower 3.3 2.82 3.31 1.83 4.01

upper 10.6 2.82 3.31 1.83 4.01

90 days - 1 year lower 3.2 2.82 3.31 1.83 4.01

upper 9.6 2.82 3.31 1.83 4.01

1 - 2 years lower 2.5 2.82 3.31 1.83 4.01

upper 7.5 2.82 3.31 1.83 4.01

2 - 3 years lower 2.5 2.82 3.31 1.83 4.01

upper 6.5 2.82 3.31 1.83 4.01

4 - 5 years lower 1.7 1.54 3.56 1.15 1.98

upper 4.5 2.82 3.31 1.83 4.01

5 - 6 years lower 1.6 1.54 3.56 1.15 1.98

Automated upper 4.5 2.82 3.31 1.83 4.01



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to range

Lower Range

Upper Range

Lymphocytes 6 - 7 years lower 1.8 1.54 3.56 1.15 1.98

upper 4.5 2.82 3.31 1.83 4.01

7 - 9 years lower 1.5 1.54 3.56 1.15 1.98

upper 4.2 2.82 3.31 1.83 4.01

9 - 12 years lower 1.4 1.54 3.56 1.15 1.98

upper 4.1 2.82 3.31 1.83 4.01

12 - 13 years lower 1.4 1.54 3.56 1.15 1.98

upper 3.7 2.82 3.31 1.83 4.01

13 - 15 years lower 1.3 1.54 3.56 1.15 1.98

upper 3.6 2.82 3.31 1.83 4.01

15 - 18 years lower 1.2 1.05 4.17 0.76 1.38

upper 3.5 2.82 3.31 1.83 4.01

Over 18 years lower 1 1.05 4.17 0.76 1.38

upper 3 2.82 3.31 1.83 4.01

Automated 0 -1 day lower 0.2 0.29 11.75 0.14 0.47

Monocytes upper 2.3 1.32 6.56 0.83 1.90

1 -2 day

lower 0.2 0.29 11.75 0.14 0.47

upper 1.8 1.32 6.56 0.83 1.90

1 -30 day lower 0.2 0.29 11.75 0.14 0.47

upper 1.5 1.32 6.56 0.83 1.90

30 days - 6 months lower 0.3 0.29 11.75 0.14 0.47

upper 1.2 1.32 6.56 0.83 1.90


upper 1.2 0.32 6.56 0.83 1.90

1 year - 3 years lower 0.2 0.29 11.75 0.14 0.47

upper 1 1.32 6.56 0.83 1.90


upper 1.2 1.32 6.56 0.83 1.90


upper 1 1.32 6.56 0.83 1.90

Over 16 years lower 0.2 0.29 11.75 0.14 0.47

upper 0.8 0.62 8.99 0.33 0.97

Automated 0 -3 days lower 0.05 0.06 16.32 0.03 0.11



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to range

Lower Range

Upper Range

Eosinophils upper 1.23 0.33 8.71 0.10 0.61

3 -14 days lower 0.05 0.06 16.32 0.03 0.11

upper 1 0.33 8.71 0.10 0.61

14 days -10 years lower 0.05 0.06 16.32 0.03 0.11

upper 0.88 0.33 8.71 0.10 0.61

10 years -11 years lower 0.05 0.06 16.32 0.03 0.11

upper 0.8 0.33 8.71 0.10 0.61


upper 0.7 0.33 8.71 0.10 0.61


upper 0.6 0.33 8.71 0.10 0.61

Over 16 years lower 0.05 0.06 16.32 0.03 0.11

upper 0.45 0.33 8.71 0.10 0.61

Automated 0 -14 days upper 0.2 0.19 35.06 -0.53 0.75

Basophils

14 -16 days 16 days -1 year

upper 0.17 0.19 35.06 -0.53 0.75

upper 0.16 0.19 35.06 -0.53 0.75

1 - 12 years Over 12 years

upper 0.12 0.19 35.06 -0.53 0.75

upper 0.12 0.19 35.06 -0.53 0.75

Manual 0 -1 day lower 2.8 3.28 10.09 2.9 3.7

Neutrophils** upper 15 3.28 10.09 2.9 3.7

1 -2 day lower 2.8 3.28 10.09 2.9 3.7

upper 15 3.28 10.09 2.9 3.7

2 -8 days lower 2.8 3.28 10.09 2.9 3.7

upper 12 3.28 10.09 2.9 3.7

8 - 14 days lower 1.8 3.28 10.09 2.9 3.7

upper 7.8 3.28 10.09 2.9 3.7

14 - 30 days lower 1.8 3.28 10.09 2.9 3.7

upper 6.8 3.28 10.09 2.9 3.7

30 - 60 days lower 1 3.28 10.09 2.9 3.7

upper 6 3.28 10.09 2.9 3.7

60 - 90 days lower 0.8 3.28 10.09 2.9 3.7

upper 5.5 3.28 10.09 2.9 3.7


1 3.28 10.09 2.9 3.7



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to range

Lower Range

Upper Range

Manual Neutrophil** upper

5.5 3.28 10.09 2.9 3.7

6 months - I year lower 1.3 3.28 10.09 2.9 3.7

upper 7 3.28 10.09 2.9 3.7

1 year - 2 years lower 1.4 3.28 10.09 2.9 3.7

upper 7.5 3.28 10.09 2.9 3.7


upper 7.5 3.28 10.09 2.9 3.7


upper 7.7 3.28 10.09 2.9 3.7


upper 7.8 3.28 10.09 2.9 3.7


upper 7.4 3.28 10.09 2.9 3.7


upper 7.1 3.28 10.09 2.9 3.7


upper 7.2 3.28 10.09 2.9 3.7


upper 6.7 3.28 10.09 2.9 3.7

Over 11 years lower 1.7 3.28 10.09 2.9 3.7

upper 6.6 3.28 10.09 2.9 3.7

Manual 0 -1 day lower 2 2.23 13.18 1.9 2.6

Lymphocytes** upper 8.8 2.23 13.18 1.9 2.6

1 -2 day lower 2 2.23 13.18 1.9 2.6

upper 7.7 2.23 13.18 1.9 2.6

2 - 3 days lower 2 2.23 13.18 1.9 2.6

upper 7.5 2.23 13.18 1.9 2.6

3 - 5 days lower 2 2.23 13.18 1.9 2.6

upper 7.3 2.23 13.18 1.9 2.6

5 - 14 days lower 2.9 2.23 13.18 1.9 2.6

upper 9 2.23 13.18 1.9 2.6

14 - 30 days lower 2.9 2.23 13.18 1.9 2.6

upper 9.1 2.23 13.18 1.9 2.6



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to range

Lower Range

Upper Range

Manual

Lymphocytes** 30 - 60 days lower 3.3 2.23 13.18 1.9 2.6

upper 10 2.23 13.18 1.9 2.6

60 - 90 days lower 3.3 2.23 13.18 1.9 2.6

upper 10.6 2.23 13.18 1.9 2.6

90 days - 1 year lower 3.2 2.23 13.18 1.9 2.6

upper 9.6 2.23 13.18 1.9 2.6

1 - 2 years lower 2.5 2.23 13.18 1.9 2.6

upper 7.5 2.23 13.18 1.9 2.6

2 - 3 years lower 2.5 2.23 13.18 1.9 2.6

upper 6.5 2.23 13.18 1.9 2.6

4 - 5 years lower 1.7 2.23 13.18 1.9 2.6

upper 4.5 2.23 13.18 1.9 2.6

5 - 6 years lower 1.6 2.23 13.18 1.9 2.6

upper 4.5 2.23 13.18 1.9 2.6

6 - 7 years lower 1.8 2.23 13.18 1.9 2.6

upper 4.5 2.23 13.18 1.9 2.6

7 - 9 years lower 1.5 2.23 13.18 1.9 2.6

upper 4.2 2.23 13.18 1.9 2.6

9 - 12 years lower 1.4 2.23 13.18 1.9 2.6

upper 4.1 2.23 13.18 1.9 2.6

12 - 13 years lower 1.4 2.23 13.18 1.9 2.6

upper 3.7 2.23 13.18 1.9 2.6

13 - 15 years lower 1.3 2.23 13.18 1.9 2.6

upper 3.6 2.23 13.18 1.9 2.6

15 - 18 years lower 1.2 2.23 13.18 1.9 2.6

upper 3.5 2.23 13.18 1.9 2.6

Over 18 years lower 1 2.23 13.18 1.9 2.6

upper 3 2.23 13.18 1.9 2.6

Manual 0 -1 day lower 0.2 0.34 48.58 0.12 0.7

Monocytes** upper 2.3 0.34 48.58 0.12 0.7

1 -2 day lower 0.2 0.34 48.58 0.12 0.7

upper 1.8 0.34 48.58 0.12 0.7

1 -30 day lower 0.2 0.34 48.58 0.12 0.7



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to range

Lower Range

Upper Range

upper 1.5 0.34 48.58 0.12 0.7

30 days - 6 months lower 0.3 0.34 48.58 0.12 0.7

Manual upper 1.2 0.34 48.58 0.12 0.7

Monocytes** 6 months - 1 year lower 0.2 0.34 48.58 0.12 0.7

upper 1.2 0.34 48.58 0.12 0.7

1 year - 3 years lower 0.2 0.34 48.58 0.12 0.7

upper 1 0.34 48.58 0.12 0.7


upper 1.2 0.34 48.58 0.12 0.7


upper 1 0.34 48.58 0.12 0.7

Over 16 years lower 0.2 0.34 48.58 0.12 0.7

upper 0.8 0.34 48.58 0.12 0.7

Manual 0 -3 days lower 0.05 0.08 65.19 0.00 0.18

Eosinophils** upper 1.23 0.08 65.19 0.00 0.18

3 -14 days

lower 0.05 0.08 65.19 0.00 0.18

upper 1 0.08 65.19 0.00 0.18

14 days -10 years lower 0.05 0.08 65.19 0.00 0.18

upper 0.88 0.08 65.19 0.00 0.18


upper 0.8 0.08 65.19 0.00 0.18


upper 0.7 0.08 65.19 0.00 0.18


upper 0.6 0.08 65.19 0.00 0.18

Over 16 years lower 0.05 0.08 65.19 0.00 0.18

upper 0.45 0.08 65.19 0.00 0.18

Manual 0 -14 days 14 -16 days

upper 0.2 0.07 89.86 0.00 0.18

Basophils** upper 0.17 0.07 89.86 0.00 0.18

16 days -1 year 1 - 12 years

upper 0.16 0.07 89.86 0.00 0.18

upper 0.12 0.07 89.86 0.00 0.18

Over 12 years upper 0.12 0.07 89.86 0.00 0.18

Metamyelocytes***

upper 0

upper 0



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to range

Lower Range

Upper Range

Myelocytes***

upper 0

upper 0

Promyelocytes***

upper 0

upper 0

Blasts***

upper 0

upper 0

Manual parasitaemia for p.falicparum***

upper 0

upper 0

Coagulation (plasma)

Prothrombin Time 0 -1 days lower 14.4 15.67 1.75 13.91 14.89

upper 16.4 15.67 1.75 15.84 16.96

1 - 3 days lower 13.5 15.67 1.75 13.04 13.96

upper 16.4 15.67 1.75 15.84 16.96

3 days - 1 year lower 11.5 15.67 1.75 11.11 11.89

upper 15.3 15.67 1.75 14.78 15.82

Over 1 year lower 12.4 15.67 1.75 10.91 11.69

upper 17.3 15.67 1.75 15.55 16.65

APTT 0 -1 days lower 34.9 32.98 2.71 33.05 36.75

upper 47.4 32.98 2.71 44.88 49.92

1 - 3 days lower 31.2 32.98 2.71 29.54 32.86

upper 44 32.98 2.71 41.66 46.34

3 days - 1 year lower 29.1 32.98 2.71 27.55 30.65

upper 35.5 32.98 2.71 33.61 37.39

Over 1 year lower 22 32.98 2.71 20.83 23.17

upper 34 32.98 2.71 32.19 35.81

APTT using actin FS

Over 1 year

Lower 21.8 34.5 2.19 20.9 22.7

upper 31.9 34.5 2.19 30.5 33.3

Fibrinogen 0 -1 days lower 1.92 1.39 5.50 1.71 2.13

upper 3.74 2.65 7.15 3.22 4.26

1 - 3 days lower 2.83 2.65 7.15 2.43 3.23

upper 4.01 2.65 7.15 3.45 4.57

3 days - 1 year lower 0.82 1.39 5.50 0.73 0.91

upper 3.83 2.65 7.15 3.29 4.37

Over 1 year lower 1.9 1.39 5.50 1.70 2.10



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to range

Lower Range

Upper Range

upper 4.1 2.65 7.15 3.53 4.67

D Dimer^ 0 -1 days lower 0.41 0.3 0.41 0.41

upper 2.47 2.32 5.35 2.21 2.73

1 - 3 days lower 0.58 0.3 0.58 0.58

upper 2.74 2.32 5.35 2.45 3.03

3 days - 1 year lower 0.11 0.3 0.11 0.11

upper 0.42 0.3 0.42 0.42

Over 1 year lower 0.05 0.3 0.05 0.05

upper 0.5 0.3 0.50 0.50

Other

ESR

0-70 years

lower 1 40.0 4.07 30.01 49.99

upper 15 40.0 4.07 30.01 49.99

>70 years

lower 1 40.0 4.07 30.01 49.99

upper 30 40.0 4.07 30.01 49.99

** For manual differential results the CV is calculated from the results of a minimum of 9 BMS staff reading a blood film that has a quantity of the cell type within the reference range. *** These cells would not be expected to be found in a blood film from a patient with full blood count results within normal limits. EQA films are used for the purpose of measuring uncertainty when counting cell types, including parasites, not seen in a ‘normal’ blood film. Details can be found in QU-EV-HAE-REC-D-68. ^The DDimer normal IQC is a quantitative result as the assay is reported as <0.5µg/ml.

5. Performance Requirements for the Measurement of Uncertainty

Once the level of uncertainty has been calculated for each assay the laboratory compares the calculated imprecision values to quoted target values to assess the assays suitability. The quoted targets can be obtained from several sources including:

Westgard biological variation data – this data is calculated from the summary reports from available studies to give a desirable assay imprecision score (for more information please see https://www.westgard.com/guest17.htm);

Quoted imprecision values from manufacturers instructions for use (these are used where Westgard information is not available).

The laboratory use the Westgard desirable assay imprecision score as the primary target of choice (ref. BRILS Cross site Biochemistry Meeting; October 10th 2018).

https://www.westgard.com/guest17.htm



Version : 12 of 57



Comparison of the performance of each assay will be included in appendix 3 and reviewed during analyser ongoing verification, performed on an annual basis for all the analysers that the assay is performed on (please see Maintenance of ongoing validation/verification status; TEMP-D-84 for more information). All assays that fall outside of the desired criteria will be investigated. It should be noted however that assay imprecision does vary through out the assay range, with poorer performance recognised as each assay reaches their limits of detection. Many required parameters (e.g. rule in rule out) may occur at these limits and therefore a clinical perspective has to be applied to the assay and comparison of the target to the more stable portion of the assay linearity may be more applicable to assess suitability. The quoted Westgard and or IFU values are ‘desirable’ therefore any assay that is performing above the target, but within an acceptable limit, may also be designated as acceptable. In addition the laboratory is often confined to practical constraints during assay selection i.e. the laboratory may be restricted to the assays supplied by their manufacturer of choice, with not all assays performing to the same levels of performance. Also as a guide based on experience the Biochemistry laboratory at Barnsley uses the following imprecision levels to assess acceptable assay performance at the most stable fraction of assay linearity;

Immunoassay (including EMIT spectrophotometry assays) - CVs of 10% or less Ion selective electrodes - CVs of 1.5% or less Routine Biochemistry spectrophotometry assays - CVs of 4% or less HPLC - CVs of 4% or less



Version : 12 of 57



6. Appendix 1: Biochemistry IQC

CV was calculated using the data available for the lot of QC in use during the month of July 2018.

IQC Used Lot Date Range Analyser

Randox Liquid Chemistry 1 246UL 01/07/2018-31/07/2018 CAD 1,2 and 3 (CAD3 for Lithium)

Randox Liquid Chemistry 2 1220UN 01/07/2018-31/07/2018 CAD 1,2 and 3

(CAD3 for Lithium)

Randox Liquid Chemistry 3 990UE 01/07/2018-31/07/2018 CAD 1,2 and 3

(CAD3 for Lithium and Rf)

Randox Urine 2 908UC 01/07/2018-31/07/2018 CAD 2,3 and

Osmometer

Randox Urine 3 909UC 01/07/2018-31/07/2018 CAD 2,3 and

Osmometer

Randox Human Assay 2 1200UN 01/07/2018-31/07/2018 Osmometer

Randox Immunoassay 1 1619 01/07/2018-31/07/2018 Centaur 1-3



Randox PTH 22 01/07/2018-31/07/2018 Centaur 1

Siemens aCCP 627581 01/07/2018-31/07/2018 Centaur 3

Siemens BNP QC 1 3816491 01/07/2018-31/07/2018 Centaur 3

Siemens BNP QC 2 3816492 01/07/2018-31/07/2018 Centaur 3

Quantametrix Microalbumin 1 25631 01/07/2018-31/07/2018 CAD 2 and 3

Randox Card Control 1 4243 01/07/2018-31/07/2018 Centaur 1 and 2

CVP 1 1801 June - August 2017 GEM 4000

CVP 2 2801 June - August 2017 GEM 4000

MAS Diabetes QC DBCL19061 01/07/2018-31/07/2018 HA8180 A, B and C

For CEA

Randox Immunoassay 1 1810 01/06/19-30/06/19 Centaur 2

Randox Immunoassay 3 1815 01/06/19-30/06/19 Centaur 2

For hs TNI

WEQAS TC Low 01/06/19-30/06/19 Centaur 1 and 2

Randox Card Control 1 4243 01/06/19-30/06/19 Centaur 1 and 2

Where the assay is used on more than one platform the mean of the selected systems is used

7. Appendix 2: Haematology IQC

IQC Used Lot Date Range Analyser

Abnormal low 1065 28/7/2018-23/9/2018 Advia2120i

Normal 2065 28/7/2018-23/9/2018 Advia2120i



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Abnormal high 3065 28/7/2018-23/9/2018 Advia2120i

Normal/Abnormal (DD) 252299 Oct 2017-present Stago

Normal/Abnormal (other coag) 251920 Oct 2017-present Stago

Sed Check 0201709 02/03/2018-28/06/2018 ESR

Where the assay is used on more than one platform the mean of the selected systems is used.

Assay Established CV Acceptable CV

PT normal 1.75 3.30

PT abnormal 3.45 3.70

APTT normal 2.71 3.25

APTT abnormal 2.70 3.05

FIB normal 5.50 9.83

FIB abnormal 7.15 8.87

DDimer abnormal 5.35 13.13



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8. Appendix 3: Biochemistry Compatability of Performance

Biochemistry Assay Assay CV (%)

Mean QC value used

Lab Target

Variation from Target

Performance Assessment Target source

AFP 6.50 12.50 6.1 -0.40

Minimal variation at low end of the assay- acceptable performance Westgard

5.44 246.00 6.1 0.66 Acceptable performance Westgard

ALBUMIN

1.90 26.00 1.60 -0.30

Minimal variation from desirable target -acceptable performance Westgard

1.81 43.80 1.60 -0.21


ALKALINE PHOSPHATASE

4.00 88.00 3.23 -0.77



4.00 88.00 3.23 -0.77



6.60 21.90 3.23 -3.37

Variation at low end of the assay- acceptable performance at other ranges Westgard

4.00 88.00 3.23 -0.77


Alcohol 3.60 62.30 2 -1.60

Minimal variation from desirable target -acceptable performance IFU

3.70 128.00

2 -1.70 Minimal variation from desirable target -acceptable performance IFU

ALT 4.70 35.90 9.70 5.00 Acceptable performance Westgard


AMMONIA 1.68 71.80

4 2.32 Acceptable performance compared to lab target Lab

1.68 71.80 4 2.32 Acceptable performance Lab

AMYLASE 2.70 49.60 4.40 1.70 Acceptable performance Westgard


AMYLASE (urine) 1.20 149.00 47.00 45.80 Acceptable performance Westgard

Anti –CCP (Anti-Cyclic Citrullinated Peptide)

5.78 24.30 6.14 0.36 Acceptable performance IFU

6.54 3.60

6.14 -0.40 Minimal variation from desirable target -acceptable performance IFU

AST 2.77 41.30 6.15 3.38 Acceptable performance Westgard


B12


5.90 963.00

3.9 -2.00

Unachievable target with Siemens method, experience shows this is a good CV for the method and is within the lab target of 10% - acceptable performance IFU

BHCG (Pregnancy) 5.50 22.80 4.7 -0.80 IFU



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BHCG (Tumour) 6.30 20.80 7 0.70 Acceptable performance IFU

BILIRUBIN (TOTAL) 3.68 19.50 10.90 7.22 Acceptable performance Westgard

BILIRUBIN (CONJUGATED)



BNP

5.10 43.20 3.5 -1.60


3.50 452.00 2.8 -0.70


CA125 5.00 22.70 12.40 7.40 Acceptable performance Westgard


CA199 7.70 64.60 7.98 0.28 Acceptable performance Westgard


CALCIUM (Adjusted Serum)

2.61 2.19 2.10 -0.51


2.61 2.19 2.10 -0.51


CALCIUM (Urine 24 hour)



CARBAMAZEPINE (Theraputic Range)

7.20 5.30 6.9 -0.30


7.30 13.60 5.4 -1.90


CARBOXY HAEMAGLOBIN

0.00 30.70 4 4.00

Within lab ISE target of 1.5% -acceptable performance Lab

Cholestrol 2.96 5.00 2.98 0.02 Acceptable performance Westgard


CEA 5.80 4.10 6.40 0.60 Acceptable performance Westgard


CHLORIDE (Serum)

0.93 104.90 0.60 -0.33


0.93 104.90 0.60 -0.33


CHLORIDE (Whole Blood)

1.12 134.40 0.7 -0.42


1.12 134.40 0.7 -0.42


CHLORIDE (Urine 24 Hour)

1.10 169.00 1.5 0.40


1.10 169.00 1.5 0.40


CREATINE KINASE






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CREATININE (Serum)

3.50 48.00 2.98 -0.52



3.50 48.00 2.98 -0.52



CREATINE (24 hour urine)

2.51 6.80 12 9.49 Acceptable performance Westgard


CRP 11.50 3.50 21.1 9.60 Acceptable performance Westgard


CSF GLUCOSE 2.00 3.10 2.8 0.80 Acceptable performance Westgard


CSF LACTATE 5.41 1.79 13.6 8.19 Acceptable performance Westgard


CSF PROTEIN





CORTISOL (Morning)



DIGOXIN (Theraputic)


4.20 2.50 3.6 -0.60


FERRITIN

7.30 14.60 7.1 -0.20


7.30 5.20 7.1 -0.20


FOLATE 7.80 3.76 12 4.20 Acceptable performance Westgard


FREE T3

5.30 2.80 4 -1.30



5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30




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5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


5.30 2.80 4 -1.30


FREE T4

6.80 9.20 2.9 -3.90


5.30 30.50 2.9

-2.40

Unachievable target with Siemens method, experience shows this is a good CV for the method and is within the lab target of 10% - acceptable performance Westgard

6.80 9.20 2.9 -3.90


5.30 30.50 2.9

-2.40


6.80 9.20 2.9 -3.90


5.30 30.50 2.9

-2.40


6.80 9.20 2.9 -3.90


5.30 30.50 2.9

-2.40


6.80 9.20 2.9 -3.90




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6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


6.80 9.20 2.9 -3.90


FSH (Follicular)

6.10 8.20 5.5 -0.60


5.60 29.80 5.5 -0.10


FSH (Peak)

6.10 8.20 5.5 -0.60


5.60 29.80 5.5 -0.10


FSH (Luteal)

6.10 8.20 5.5 -0.60


6.10 8.20 5.5 -0.60


FSH (Post Menopausal)

5.60 29.80 5.5 -0.10



FSH

6.10 8.20 5.5 -0.60


6.10 8.20 5.5 -0.60


FASTING GLUCOSE (Serum)



Gamma GT 4.80 32.50 6.7 1.90 Acceptable performance Westgard



Gentamicin 5.90 5.50 7.8 1.90 Acceptable performance IFU

HbA1c 1.50 39.00 0.9 -0.60


HDL 2.06 2.49 3.65 1.59 Acceptable performance Westgard




Version : 12 of 57



IGA

3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


3.42 1.12 2.7 -0.72


2.89 2.57 2.7 -0.19


3.42 1.12 2.7 -0.72


2.89 2.57 2.7 -0.19


3.42 1.12 2.7 -0.72


2.89 2.57 2.7 -0.19




Version : 12 of 57



3.42 1.12 2.7 -0.72



IGG

2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


2.69 6.94 2.3 -0.39


2.53 13.40 2.3 -0.23


IGM 4.63 0.46 3 -1.63




Version : 12 of 57



4.72 1.40 3 -1.72


4.63 0.46 3 -1.63


4.63 0.46 3 -1.63


4.63 0.46 3 -1.63


4.63 0.46 3 -1.63


4.63 0.46 3 -1.63



4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


4.63 0.46 3 -1.63



4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


4.63 0.46 3 -1.63


4.72 1.40 3 -1.72


IRON





LACTATE 5.41 1.79 13.6 8.19 Acceptable performance Westgard



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LACTATE DEHYDROGENASE



LH (Follicular levels) 5.20 2.60 11.5 6.30 Acceptable performance Westgard


LH (Peak levels) 4.60 28.30 11.5 6.90 Acceptable performance Westgard


LH (Luteal)

5.20

2.60 11.5 6.30 Acceptable performance Westgard

11.5 11.50 Acceptable performance Westgard

11.5 11.50 Acceptable performance Westgard


LH (Post Menopausall)



LH



LITHIUM (Theraputic Range)

5.57 0.59 4.1 -1.47



MAGNESIUM Blood)

3.20 0.56 1.8 -1.40


2.05 1.00 1.8 -0.25


METHAEMAGLOBIN 0.55 9.00 1.43 0.88 Acceptable performance Westgard


Micro Albumin 9.70 7.90 18 8.30 Acceptable performance Westgard


OESTRADIOL (Follicular levels)



OESTRADIOL (Mid Cycle)



OESTRADIOL (Luteal) 9.50 160.00 11.25 1.75 Acceptable performance Westgard




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OESTRADIOL (Post Menapausal)


OESTRADIOL




OSMOLALITY (SERUM)



OSMOLALITY (URINE) 0.56 427.00 14.2 13.64 Acceptable performance Westgard


Paracetamol 2.07 73.00 1.7 -0.37



PARATHYROID HORMONE



pCO2

4.28 1.96 2.4 -1.88


4.28 1.96 2.4 -1.88


pH



PHENOBARBITONE (Theraputic Range)



PHENYTOIN (Theraputic Range)


7.84 18.40 6.1 -1.74


pO2 4.85 15.33 12 7.15 Acceptable performance IFU

4.85 15.33 12 7.15 Acceptable performance IFU

POTASSIUM (Serum)



POTASSIUM (Whole blood)



POTASSIUM (Urine) 0.85 30.10 12.20 11.35 Acceptable performance Westgard


PHOSPHATE (Serum)









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5.40 0.75 4.08 -1.32



PHOSPHATE (Urine)



PROGESTERONE (Follicular levels)

4.50 28.00 3.7 -0.80


6.50 86.00 4.8 -1.70


PROGESTERONE (Luteal)


6.50 86.00 4.8 -1.70


PROGESTERONE (Mid Luteal)

4.50 28.00

4.8 0.30 Acceptable performance IFU


PROGESTERONE (Post Menopausal)



6.50 86.00 4.8 -1.70


PROLACTIN 3.87 1011.00 4.4 0.53 Acceptable performance IFU


PROTEIN (Serum)

1.87 75.30 1.38 -0.49


1.82 90.00 1.38 -0.44


PROTEIN (24 Hour Urine)


PROTEIN (URINE) 8.40 0.15 17.80 9.40 Acceptable performance Westgard

PSA





RF 8.50 10.90 4.30 -4.20



SALICYLATE

4.84 138.00 4.4 -0.44

Minimal variation at low end of the assay- acceptable performance IFU

1.84 458.00 1.5 -0.34


SODIUM (Serum)

0.65 142.50 0.30 -0.35


0.65 142.50 0.30 -0.35




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SODIUM (Whole Blood)

0.83 151.94 1.50 0.67

Within lab ISE target of 1.5% -acceptable performance Westgard

0.83 151.94 1.50 0.67

Within lab ISE target of 1.5% -acceptable performance Westgard

SODIUM (Urine 24 hour)



SHBG









TESTOSTERONE

6.00 1.40 4.63 -1.37


6.00 269.50 4.63 -1.37


6.00 1.40 4.63 -1.37


6.00 26.50 4.63 -1.37


6.00 1.40 4.63 -1.37


6.00 1.40 4.63 -1.37


6.00 1.40 4.63 -1.37


6.00 1.40 4.63 -1.37


THEOPHYLLINE (Theraputic Range)



TROPONIN I 7.10 36.80 7.03 -0.07


4.13 4110.00 7.03 2.90 Westgard

TRANSFERRIN

2.30 1.30 1.50 -0.80


2.28 2.81 1.50 -0.78


Triglyceride 2.29 1.63 9.95 7.66 Acceptable performance Westgard


TSH 4.00 0.14 9.70 5.70 Acceptable performance Westgard




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UREA









Urine Urea 2.89 158.00 8.70 5.81 Acceptable performance Westgard

URIC ACID





Urine Urate 3.07 0.60 8.40 5.33 Acceptable performance Westgard

VALPROATE (Theraputic Range)


3.92 83.00 3 -0.92


TOTAL VIT D


9.70 75.00 8.2 -1.50


6.60 110.00 4.8 -1.80




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9. Summary of revisions

Version Summary of change

1 Not applicable – first issue.

2 1. Changed to include full range of Chemistry assays 2. Changed to reflect measurement of uncertainty

3 Further information on the calculation of results Addition of manual ESR

4 Addition of serum osmolality range and QC details

5 Addition of uncertainty for manual differential. Inclusion of IQC review information.

6 Updated for 2017 data

7 Updated aCCP date and statement in the introduction that information available on Pathology Website

8 Added PTH data

9 Updated for 2018 data

10 Levels added to cover range of the Biochemistry assays as suggestd in UKAS finding. Assays include; AFP, alcohol, ALT, aCCP, AST, Ca125, Ca199, Cholesterol, CEA, CRP, Glucose, GGT, HDL, paracetamol, prolaction, PSA, Rf and TNI Section 5. Performance Requirements for the Measurement of Uncertainty with data in Appendix 3 added

11 Data for Actin FS APTT assay included

12 New CEA lite reagent and hs TNI

barnsley/rotherham integrated laboratories department ......qpulse reference sop-cb-d-1;...

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