laboratory : 128 date : dd-mmm-yyyy page 1 feedback · date : dd-mmm-yyyy feedback page 1 for sweat...

Date : DD-MMM-YYYY

Feedback

for Sweat Testing

Distribution : 128

Laboratory :

Birmingham Quality is part of the University Hospitals Birmingham NHS Foundation Trust

and provides this UK NEQAS service from PO Box 3909, Birmingham B15 2UE, UK

To contact us, email [email protected] or phone us on +44 (0)121 414 7300

© The data in this UK NEQAS report is confidential.

For this Scheme, the Organiser is Finlay MacKenzie.

www.birminghamquality.org.uk Published at 12:49 on Friday 11 March 2016

Quality ManagerPathology LaboratoryBiochemistry DepartmentTownCountyPostcode

This Scheme is essentially web-based. We can alert you to information regarding the Scheme via email. The e-mail address (or addresses) we are currently using to contact your laboratory is shown below in red . If no e-mail address is displayed or the information shown is incorrect, please email us with an appropriate contact e-mail address as soon as possible, using the word 'feedback' in the title line.

Based on the date information you have provided, the transit time from specimen dispatch [ ] to receipt [ ] was day(s), and the subsequent time to analysis [ ] in your laboratory was day(s). (Missing values indicate dates not provided. "0 days" represents same day).

Any comments you made to us are shown below and have been acted upon where necessary

Any specific comments applicable only to laboratory are shown below

Any general comments applicable to all laboratories are shown below

Please see the commentary page. Feedback would be most welcome

Report authorised Friday 19 June 2015 by:

Finlay MacKenzie Director, UK NEQAS for Sweat Testing

Birmingham Quality is a UKAS accredited proficiency testing provider No. 7860. Please see http://www.ukas.com for full details of the accreditation status of our services

Birmingham Quality is proud to offer EQA services that adhere to the Code of Practice and have the badge of quality of UK NEQAS

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Distribution : 128 Date : DD-MMM-YYYY

Performance Summary Icons (click graph for details)

for Sweat Testing Laboratory :







B s

core

C score

Sweat Chloride

P-ABCPENR (DASH1)

0 5 10 15

-15

-10

-5

0

5

10

15

B s

core

C score

Sweat Conductivity

P-ABCPENR (DASH1)

0 5 10 15

-15

-10

-5

0

5

10

15

B s

core

C score

Sweat Sodium

P-ABCPENR (DASH1)

0 5 10 15

-15

-10

-5

0

5

10

15

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Date : DD-MMM-YYYY

Participation summary

for Sweat Testing

Distribution : 128

Laboratory :







All our time periods are 'rolling' to give you current information. You may wish to keep you own log of Calendar Year or Financial Year time points if you require 'year-end' statements for your own internal use. Any analytes with out of consensus performance will be highlighted in red and can be clicked for further details.

Sweat Conductivity Sweat Sodium

You have out of consensus performance for:

You have no performance data for:

You have in consensus performance for: Sweat Chloride

None

None

Analytical Performance over the last 6 months (rolling time window of 6 distributions)

This scheme cycle is notionally every four weeks. Analytically, we assess you over a six month time window (6 Distributions). For return rates, late and amended results we assess you over a twelve month period (12 distributions).

1 distribution accepted from the last 12

0 distributions from the last 12

Amendments

Satisfactory12 distributions out of a possible 12

Satisfactory

SatisfactoryLate Returns

Participation

Distributions Rating

Participation and Return Rates

You can judge, in association with your IQC and other QA measures, if your current performance is a blip or part of a trend.

In consensus for all specimens for:

Out of consensus for at least one specimen for:

You are not registered for:

Sweat Chloride Sweat Sodium

You have no specimen data for:

Sweat Conductivity

None

None

None

Analytical Performance for specimens from distribution 128 only

The new Participation Summary page is an exciting new feature which we hope you will like. It is currently in prototype mode but will ultimately expand into having the Interpretative analytes as well as the existing ‘numerical’ analytes listed and will contain turnaround graphs etc., too.

For the moment it would be helpful if you could check the accuracy of the data presented, particularly the return-rate elements.

Many thanks, Finlay

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Date : DD-MMM-YYYY

Distribution Summary

for Sweat Testing

Distribution : 128

Laboratory :







%biasBResult A score C scorePool CB scoreTargetSpecimen ASpecimen

IN

42

128A

41

128C

+2.9

41.0

128A

+2.9

232

41

+0.2+0.7

2.3

I

230

61

232

Conductivity interp

232

+3.0231

2.4

231232

40.8230

128C

128A

N

I

("units")

230

+1.0

69

230

231

-0.1

231+0.3128C

I

N

64

(mmol/L)

128C

(N, I or E)

57.6

128B N231

(mmol/L) 39.8Sweat Chloride

128B

128B

43

(N, I or E)N

-0.4Sweat Sodium

128A

128B

68.8

N

Chloride interp

58

41

40.2

50 -0.8

+2.1

60.4

39.9

N

128A

232

+2.7

128B2.1

53

Sweat Conductivity

230

128C I

49.9

41

If your laboratory is outside of the acceptable limits of performance for any its rolling time-window scores (A, B or C scores), this will be indicated by a red traffic light symbol. It is the responsibility of the laboratory to undertake an internal investigation to establish the underlying cause and put in place corrective and preventive action. Please do not wait to receive a formal notification of performance from the Scheme Organiser or the National Quality Assurance Advisory Panel (NQAAP) before logging the non-conformity and, where necessary, acting upon the data contained in your report. A green traffic light merely reflects that your laboratory is performing as well as the state-of-the-art allows; it does not necessarily mean that your assay / laboratory performance is good enough clinically.

Specimens for Distribution 129 will be dispatched on Monday 22 June 2015, results are due back in Birmingham by, notionally, 23:59 on Sunday 12 July 2015.

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Method Summary

for Sweat Testing

Distribution : 128

Laboratory :







arrow median

Units Method

A score

Your Method

A scoremedian

A scoreMethod Principle All labwith trend

"units"

62

Chloride interp

Sweat Sodium

Indirect ISE [I]

66

Sweat Chloride

Indirect ISE [I]

N, I or E

105

52mmol/L

Sweat Conductivity 64

43

106

Conductivity interp

N, I or E

53

mmol/L

Wescor Macroduct [W]

68

To correctly assign you to a method we require the following pieces of information for each analyte that you measure: [1] The Manufacturer and model number of the Analyser [2] The Manufacturer and kit product/catalogue number of the reagent used specifying 'method principle', if we breakdown data by method principle [3] The Manufacturer and kit product/catalogue number of the calibrator used [4] A confirmation that you are using the 'kit' according to the manufacturer's instructions including using their calibrator values with their calibrator (if you are not using the system according to the manufacturer's instructions you will be classed as an in-house user within that method principle)

For Sweat Testing, we also need to know which collection medium, filter-paper, gauze, Micro- or Nano-duct system you are using. Until now we have not used ‘named’ manufacturers because of the variable ‘pre-analytical’ stages but we will be endeavouring to collect more information on methodologies in future.

A s

core

Graphic Equalizer Plot of A scoresAll laboratories

P-BWATSCR2

SC

L

SC

LI

SC

N

SC

NI

SN

A

SC

NID

SC

LID

0

50

100

150

200

250

300

A s

core

Method Graphic Equalizer Plot of A scoresfor your methods

P-BWATSCM2

SC

L

SC

LI

SC

N

SC

NI

SN

A

SC

NID

SC

LID

0

50

100

150

200

250

300

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Date : DD-MMM-YYYY

Cumulative Summary

for Sweat Testing

Distribution : 128

Laboratory :







B s

core

C score

Sweat Chloride B score is +2.7 and C score is 2.4Your method is Indirect ISE [I] - Wescor

P-ABCPENR (ABCPENR)

0 5 10 15-15

-10

-5

0

5

10

15Your labYour methodYour method (n=37)

B s

core

C score

Sweat Conductivity B score is -0.8 and C score is 2.1Your method is Wescor Macroduct [W] - Wescor

P-ABCPENR (ABCPENR)

0 5 10 15-15

-10

-5

0

5

10


B s

core

C score

Sweat Sodium B score is -0.4 and C score is 2.3Your method is Indirect ISE [I] - Wescor

P-ABCPENR (ABCPENR)

0 5 10 15-15

-10

-5

0

5

10


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Date : DD-MMM-YYYY

Analyte : Sweat Chloride (mmol/L)

for Sweat Testing

Distribution : 128

Laboratory :







Aqueous 30 NaCl + 10 KCl + 10 other Na salts

232

Pool description / Treatments / Additions

128B Aqueous 20 NaCl + 20 KCl + 20 other Na saltsAqueous 20 NaCl + 20 KCl + 40 other Na salts

Pool

231

Spec.

128A

128C

230 2.4

The B limit is +/-

Your B score is

The A limit is10.0

53

10.0

Your A score is+2.7

The C limit is

200

Your C score is

All methods Indirect ISE [I] Wescor

Specimen : 128A

34 37 40 43 46Sweat Chloride (mmol/L)

0

10

20

30

40

50

no. o

f lab

orat

orie

s

39.82

Coulometry [L]

39.9

Filter paper

10

Meann

40.0

3.5

Wescor

Wescor

Vitros [V]

183.1

40.1

30.0

38

3.31.5

Titration [T]

1.2

Gauze88

Colorimetry [R]

1

4.91.9

112

39.9

40.2

39.81.4

169

3

Indirect ISE [I]39.8

SD

41.3

3.7

39.9

13

2.0

3.6

Undefined [U]

3.1

1.5

CV(%)

Wescor

1

37

1.24.8

1.3

39.0

All methods [ALTM]

Weighed-in value

(ALTM)

39.9

Accuracy Index

41

40.0

Your result

48+2.9

Your specimen:

39.9

Indirect ISE [I]

Standard Uncertainty

%bias

0.1

Target value

Specimen : 128B


0

10

20

30

40

50

60

no. o

f lab

orat

orie

s

38.32

Coulometry [L]

39.8

Filter paper

10

Meann

40.0

3.4

Wescor

Wescor

Vitros [V]

183.1

40.1

28.0

38

4.01.8

Titration [T]

1.2

Gauze88

Colorimetry [R]

1

4.21.6

112

39.8

40.2

39.91.4

169

3


SD

39.0

3.6

39.8

13

1.7

4.4

Undefined [U]

3.0

1.4

CV(%)

Wescor

1

37

1.24.1

1.6

39.0

All methods [ALTM]

Weighed-in value

(ALTM)

39.8

Accuracy Index

41

40.0

Your result

48+2.9

Your specimen:

Indirect ISE [I]

39.8


%bias

0.1

Target value

Specimen : 128C


0

10

20

30

40

50

no. o

f lab

orat

orie

s

40.32

Coulometry [L]

40.2

Filter paper

10

Meann

40.7

3.1

Wescor

Wescor

Vitros [V]

182.8

40.6

30.0

38

3.41.6

Titration [T]

1.1

Gauze88

Colorimetry [R]

1

4.51.7

112

40.0

40.5

40.11.3

169

3


SD

43.4

3.3

40.0

13

1.8

4.0

Undefined [U]

2.6

1.3

CV(%)

Wescor

1

37

1.14.4

1.4

40.0

All methods [ALTM]

Weighed-in value

(ALTM)

40.0

Accuracy Index

41

40.0

Your result

35+2.1

Your specimen:

Indirect ISE [I]

40.2


%bias

0.1

Target value

B s

core

Median and IQRs of B scores

P-BWABCBR

All R L I

-15

-10

-5

0

5

10

15

All

Met

hod

C s

core

Median and IQRs of C scores

P-BWABCCR

All R W L F W

I

W

0

5

10

15

All Met

hod

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Pool

(exclusion)

[Type]

Distribution 123

11-Jan-2015

result target %bias

Distribution 124

08-Feb-2015

result target %bias

Distribution 125

08-Mar-2015

result target %bias

Distribution 126

12-Apr-2015

result target %bias

Distribution 127

10-May-2015

result target %bias

Distribution 128

14-Jun-2015

result target %bias

Distribution

result target %bias

22 20.3 +8.6 23 20.4 +12.7218 35 31.7 +10.4224 41 39.7 +3.2225

40 39.7 +0.7 41 40.0 +2.6219 41 39.8 +2.9231 41 39.9 +2.9230 41 40.2 +2.1232

50 49.5 +1.1229 51 49.5 +3.1226

49 49.6 -1.1 51 49.8 +2.3220 61 59.2 +3.0221

61 59.3 +2.9227 60 59.3 +1.2223 59 59.3 -0.5222

70 69.3 +1.1228

MethodmeanA scoreB scoreC score

I+2.7

22+0.4

1.2

I+1.2

26+0.6

1.5

I+1.7

33+0.9

1.7

I+5.6

41+1.4

1.8

I+5.9

51+2.3

2.7

I+2.6

53+2.7

2.4

Date : DD-MMM-YYYY

Analyte : Sweat Chloride (mmol/L)

for Sweat Testing

Distribution : 128

Laboratory :







Spe

cim

en %

bias

Distribution

Specimen %biasfor each specimen in time-window

P-ABCBRS

123 124 125 126 127 128-15

-10

-5

0

5

10

15

B s

core

Distribution

B score by distributionYour current B score is +2.7

P-ABCBR

117 118 119 120 121 122 123 124 125 126 127 128-15

-10

-5

0

5

10

15

All

Met

hod

Spe

cim

en %

bias

Concentration (mmol/L)


P-BA1FS1P

0 10 20 30 40 50 60 70 80 90 100-15

-10

-5

0

5

10

15

C s

core

Distribution

C score by distributionYour current C score is 2.4

P-ABCCR

117 118 119 120 121 122 123 124 125 126 127 1280

5

10

15

All Met

hod

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Date : DD-MMM-YYYY

Sweat Chloride mmol/L

for Sweat Testing

Distribution : 128

Laboratory :







Spe

cim

en A

ccur

acy

Inde

x

Distribution

Specimen Accuracy Indexfor each specimen in time-window

P-ABCATS (ABC1)

123 124 125 126 127 1280

50

100

150

200

250

300

A s

core

Distribution

A score by distributionYour current A score is 53

P-ABCAT (ABC1)

117 118 119 120 121 122 123 124 125 126 127 1280

50

100

150

200

250

300

All M

etho

d

Spe

cim

en %

bias

Distribution


P-ABCBRS (ABC1)

123 124 125 126 127 128-15

-10

-5

0

5

10

15

B s

core

Distribution

B score by distributionYour current B score is +2.7

P-ABCBR (ABC1)

117 118 119 120 121 122 123 124 125 126 127 128-15

-10

-5

0

5

10

15

All

Met

hod

Diff

eren

ce (

mm

ol/L

)


Difference (result - target)for each specimen in time-window

P-BA1FS1A (ABC1)

0 10 20 30 40 50 60 70 80 90 100-12

-8

-4

0

4

8

12

C s

core

Distribution

C score by distributionYour current C score is 2.4

P-ABCCR (ABC1)

117 118 119 120 121 122 123 124 125 126 127 1280

5

10

15

All Met

hod

Spe

cim

en %

bias



P-BA1FS1P (ABC1)

0 10 20 30 40 50 60 70 80 90 100-15

-10

-5

0

5

10

15

B s

core

C score

Sweat Chloride B score is +2.7 and C score is 2.4Your method is Indirect ISE [I] - Wescor

P-ABCPENR (ABC1)

0 5 10 15-15

-10

-5

0

5

10


Spe

cim

en A

ccur

acy

Inde

x


Specimen Accuracy Indexfor each specimen in time-window

P-YSTMOD (ABC1)

0 10 20 30 40 50 60 70 80 90 1000

50

100

150

200

250

300 ALTMMLTM

CV

%


Sweat Chloride Between-laboratory agreementIndirect ISE [I]

P-PROFILE (ABC1)

0 10 20 30 40 50 60 70 80 90 1000

2

4

6

8

10

12

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Interpretations

You cannot tell by measuring conductivity what the Chloride concentration is in a sweat sample (and vice versa) This is obviously also true for any other matrix.

The 3 specimens in Distribution 128 all contained 40 mmol/L of Chloride, but they contained a different amount of other compounds, such that the conductivities were approximately 50, 60 and 70 ‘units’.

It is clear that the proportion of labs interpreting the specimens as N [Not Elevated] based on conductivity decreases as we go from specimen 128A through to specimen 128C as the concentration of these other compounds increase.

The question I have posed previously is, “How does your lab interpret results on a patient on which you have obtained contradictory interpretation ‘results’ between Chloride and Conductivity?”

It doesn’t help that despite the new guidelines stating that for a 5 month old child the recommended interpretation for Chloride should have been ‘Intermediate’ for all 3 specimens, a sizeable minority considered them to be N [Not Elevated]. For example, 32 UK laboratories considered 128A to be N [Not Elevated] despite the fact that they obtained numerical values greater than 30 mmol/L.

I am putting on record that I have informed laboratories about the new guidelines, but since they are only guidelines I cannot insist that laboratories follow their advice.

Chloride Interpretation

Conductivity Interpretation

Again, just for the record, I continue to describe the units for Conductivity as ‘Units’ rather than S/m or whatever and definitely not Chloride in mmol/L nor Chloride Equivalents in mmol/L.

As ever, feedback welcome. Finlay MacKenzie, June 2015

Date : DD-MMM-YYYY

for Sweat Testing

Distribution : 128

Laboratory :







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