Nordic Hemolysis project 2014 - doc.noklus.no

This Nordic Hemolysis project was organized by EQAnord, the Nordic cooperation in External Quality Assurance.

No part of this report may be reproduced or transmitted without permission from Danish Institute for External Quality Assurance for Laboratories in Health Care (DEKS), External Quality Assurance in Laboratory Medicine in Sweden (Equalis), Icelandic Society for Clinical Biochemistry and Laboratory Medicine (ISLM), Labquality, Norwegian Clinical Chemistry EQA Program (NKK) and Norwegian Quality Improvement of Primary Health Care Laboratories

(Noklus).

Nordic Hemolysis project 2014 Effects of hemoglobin on some common serum analysis

2

No part of this report may be reproduced or transmitted without permission from DEKS, Equalis, ISLM, Labquality, NKK and Noklus.

3


SUMMARY The aim of this study has been to update information on the effect of hemolysis on analytical performance and how hemolyzed samples are handled in the laboratories.

143 laboratories participated; 32 from Denmark, 25 from Finland, 4 from Iceland, 53 from Norway and 29 from Sweden. The response rate was 97%.

Four samples with different degrees of hemolysis (0, 100, 200 and 400 mg Hb/dL) were distributed to the laboratories. The laboratories were asked to provide their H-index (Hb concentration) value and measure 15 different clinical chemistry components in duplicate: Alkaline phosphatase (ALP), bilirubin (total), calcium, creatine kinase (CK), chloride (Cl), cobalamin, folate, free thyroxine (FT4), gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, sodium, thyroid-stimulating hormone (TSH) and uric acid. Additionally they were asked to answer some questions concerning how hemolyzed samples were handled in the laboratory.

The results showed that the largest instrument groups were quite similar influenced by hemolysis, and measured the degree of hemolysis (H-index) quite similarly and in accordance with hemoglobin added.

It is a surprise, however, how much the laboratories differ in actions taken upon the analytical results for most of the components (reject, reject with comment, report or report with comment). For Ca, Cl, FT4 and TSH the laboratories fairly agree on action taken.

The laboratories would to some extent report additional results after a call from the requesting physician. If the sample (Sample 2; 100 mg Hb/dL) was from a 2-year-old child admitted to the Oncologic Department, half of the laboratories would report all or some additional results despite hemolysis (n=105). If the sample (Sample 3; 200 mg Hb/dL) was from a 60-year-old man admitted to the emergency department with acute chest pain, about one third (35%) would report all or some additional results (n=117).

For 1-2% of the samples received in the laboratories some kind of action due to hemolysis were taken.

64% of the laboratories used automated detection of H-index (hemoglobin concentration) in all samples, whereas 16% detected hemolyzed samples by manual inspection, and 9% used manual inspection followed by measuring H-index if hemolysis was suspected. 1% investigated samples with unexpected analytical results for interference by hemolysis and 10% used other procedures.

88% of the participants had written procedures/guidelines on how to handle samples with hemolysis.

EQAnord will work further with the aim of publishing the data, and evaluate the possibility of further work on the harmonization of how samples should be handled in the Nordic countries.

4


Contents 1. General information ........................................................................................................... 5

2. Results ................................................................................................................................. 7

2.1. Degree of hemolysis measured by the participants .................................................... 7

2.2. Analytical results and action taken for hemolyzed samples ....................................... 9

2.2.1. ALP ...................................................................................................................... 10

2.2.2. Bilirubin (total) ................................................................................................... 12

2.2.3. Ca ........................................................................................................................ 14

2.2.4. CK ........................................................................................................................ 16

2.2.5. Chloride .............................................................................................................. 18

2.2.6. Cobalamin ........................................................................................................... 20

2.2.7. Folate .................................................................................................................. 22

2.2.8. FT4 ...................................................................................................................... 24

2.2.9. GGT ..................................................................................................................... 26

2.2.10. Glucose ........................................................................................................... 28

2.2.11. LDH .................................................................................................................. 30

2.2.12. Potassium ....................................................................................................... 32

2.2.13. Sodium ............................................................................................................ 34

2.2.14. TSH .................................................................................................................. 36

2.2.15. Uric acid .......................................................................................................... 38

2.3. Questions about hemolyzed samples in the laboratories ......................................... 40

2.3.1. How do you investigate and detect interference by hemolysis in the samples you receive for analysis? Presented by country and by instrument ................................ 40

2.3.2. Of 1000 clinical chemistry samples (tubes) received in the laboratory, in how many do you take some kind of action due to hemolysis? .............................................. 42

2.3.3. Do you (in your laboratory) have written procedures / guidelines for handling of hemolyzed samples?..................................................................................................... 43

2.3.4. Report any additional results if the physician calls? .......................................... 44

3. Conclusion and future ....................................................................................................... 46

4. Acknowledgement ............................................................................................................ 47

5. References ........................................................................................................................ 47

6. Attachment ....................................................................................................................... 48

5


1. General information Design of the survey The survey consisted of four hemolyzed samples and an electronic report form that included information on how to handle and analyse the samples in addition to a questionnaire (please see Attachment 2) divided into three parts:

Question 1 and 2 concerned information about the laboratory.

Question 3 - 5 concerned information about date of analysis, instrument / reagent and analytical results.

Question 6 – 9 concerned information about how hemolyzed samples are handled in the laboratory.

Participants and response rate 143 laboratories participated; 32 from Denmark, 25 from Finland, 4 from Iceland, 53 from Norway and 29 from Sweden. They had been invited to participate by their national EQA-organisation. The response rate was 97%.

Samples and components Four samples with different degrees of hemolysis (0, 100, 200 and 400 mg Hb/dL) were prepared by Noklus and distributed to the laboratories.

Blood was drawn from eight healthy donors with the same ABO and Rh (D) group. The blood was drawn at Fenwal blood bags containing no anticoagulans (Fenwal Laboratories, Deerfield IL, USA). After centrifugation, serum from all donors was mixed and divided into four pools. Hemolysate was added to three of the pools. The hemolysate added was prepared from Lithium-heparin blood (BD Vacutainer Lithium-Heparin [17 I.U/mL], BD, Plymouth, UK) from the same eight donors, stored for two hours at minus 80 degrees (Lippi, 2012). The sample with the highest degree of hemolysis, Sample 4, had 11 mL hemolysate added to 397 mL serum, i.e. a 3 % dilution. Sample 3 and Sample 2 had 5,7 and 2,8mL hemolysate added to 397 mL serum, respectively.

The blood was drawn Friday October 31st and hemolysate added Sunday November 2nd. The participants were asked to analyse the samples Thursday November 6th, and 93% did so. The laboratories were asked to analyse the samples in duplicate and report the mean value.

The following components were analysed: Alkaline phosphatase (ALP), bilirubin (total), calcium, creatine kinase (CK), chloride (Cl), cobalamin, folate, free thyroxine (FT4), gamma glutamyltransferase (GGT), glucose, lactate dehydrogenase (LDH), potassium, sodium, thyroid-stimulating hormone (TSH), uric acid and hemoblobin (Hb) (e.g. H-index). Interferographs The results for each measured component for the different instrument groups are presented as linegraphs (interferographs). The interferograph show percent difference between the mean result obtained by the participants for the different instrument groups for Sample 2, 3 and 4 vs baseline (Sample 1), i.e. % Bias. The baseline values (“M” in the table below the interferographs) are the mean results for each component with no hemolysate added (Sample 1) for the different instrument groups.

6


Desirable limits for bias are shown in the interferographs by horizontal red dotted lines. They were calculated for each component based on biological variation (Table 1) (Fraser, 1999):

Table 1. Desirable limits based on biological variation (Westgard, 2015)

Component CVI (within-subject variation)

CVG (between-subject variation)

Desirable bias (%)

±0,25 x √CVI2 + CVG

2

ALP 6,45 26,1 6,72

Bilirubin (total) 21,8 28,4 8,95

Calcium 2,1 2,5 0,82

CK 22,8 40,0 11,5

Cloride 1,2 1,5 0,5

Cobalamin* 7,2

Folate 24,0 73,0 19,2

FT4 5,7 12,1 3,3

GGT 13,4 42,15 11,06

Glucose 5,6 7,5 2,31

LDH 8,6 14,7 4,3

Potassium 4,6 5,6 1,81

Sodium 0,6 0,7 0,23

TSH 19,3 24,6 7,8

Uric Acid 8,6 17,5 4,87 *CVI and CVG values are obtained from a Norwegian user manual in medical biochemistry, 1/16 of the reference interval (Hagve, Brun, Garmo, Lindberg, & Åsberg, 2014).

Instruments The instruments used by the participants are listed in a table in Attachment 1.

7


2. Results

2.1. Degree of hemolysis measured by the participants Table 2 at page 7 show the mean Hb concentrations (mg/dL or +/-) measured by the participants for each instruments for the different samples. Hemoglobin was not measured by a reference metod. The participants were asked to report the concentration of Hb as mg/dL or “+++”. However, the concentration of Hb was reported in several different unit. All quantitative results were converted to mg/dL in Table 2. The qualitative results (-, +, ++, +++, ++++) are presented as reported.

8


Table 2. The mean Hb concentrations (mg/dL or +/-) measured by the participants for each instrument for the different samples. “Pr” indicates main instrument group (see Attachment

1)

Pr Instrument n Sample 1 0 mg/dL added

Sample 2 100 mg/dL Hb added



A Abbott Architect c8000 1 1 68 132 272

A Abbott Architect c8000 1 - ++ +++ +++

A Abbott Architect c16000 7 2 112 218 384

A Abbott Architect ci16200 2 1 112 216 449

A Abbott Architect ci8200 6 2 108 210 436

A Abbott Celldyn Sapphire 1 20 130 240 460

A Abbott Ruby 1 240

BA Beckman Coulter AU640 1 - ++ +++ ++++

BA Beckman Coulter AU680 3 - ++ +++ ++++

BU Beckman Coulter UniCel DxC 600

1 0 125 275 600


2 0 125 275 600

EYE Eye 1 - + ++ +++

H Hemocue 1 0 140 270 550

Ph Photometry (405 nm) 1 21 118 213 412

R Roche Cobas 6000 11 3 110 212 436

R Roche Cobas 8000 1 3 108 213 443

R Roche Cobas c501 27 3 110 212 436

R Roche Cobas c701 1 3 111 217 442

R Roche Cobas c702 8 2 94 192 384

R Roche Cobas c8000 2 1 107 211 428

RM Roche Modular P/D 7 4 140 273 560

RS Roche Sysmex XS 1000i 1 100 180 350

RS Roche Sysmex XT 2000i 1 0 200 200 400

SA Siemens Advia 1200 1 - + ++ +++

SA Siemens Advia 1800 3 2 166 318 650

SA Siemens Advia 1800 7 - + ++ +++

SA Siemens Advia 2120 1 0 100 200 400

SA Siemens Advia 2400 1 0 200 300 400

SA Siemens Advia 2400 2 - ++ +++ ++++

SD Siemens Dimension Vista 8 + ++++ ++++ ++++++

V Vitros 3600 1 0 100 182 355

V Vitros 5.1 FS 8 0 106 197 386

V Vitros 5600 1 0 116 217 418

Mean of all participants with quantitative results

96 2 114 218 441

9


Comments There were some variation in the Hb concentrations measured, especially in Sample 4. Roche Modular P/D, Beckman Coulter Unicel and Siemens Advia 1800 measured the Hb concentration in Sample 4 slightly higher than the other instruments did. However, the largest instrument groups measured the hemolysis concentration quite similarly and in accordance with hemoglobin added.

2.2. Analytical results and action taken for hemolyzed

samples On the following pages (p. 9-38) the results for each component are presented.

First, an interferograph showing % difference between the mean result obtained for each instrument group vs baseline. The baseline values (M), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV (standard deviation of % deviation (Bias)), are shown in the tables for each instrument group.

Then a summary of the participants replies concerning action taken for Sample 2 and 3 (question 8a and 9a, see attachment 2), are shown for all participants (figures) and distributed among the different method groups (tables).

Finally, some comments are given for some components regarding interesting findings.

10


2.2.1. ALP

ALP interferograph:

The table above show baseline values (M) (U/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

11


Action taken for ALP in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for ALP. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is most pronounced for Sample 3 with Hb concentration 200 mg/dL.

Of the 52 laboratories with Roche Cobas, 28 (54%) answered they would “reject / reject with comment” and 23 (44%) would “report / report with comment” the result for the sample with Hb concentration 200 mg Hb/dl (Sample 3). The variation in action taken is not due to different measured concentration of Hb. All laboratories, except two, measured Hb concentration above 200 mg/dL. Median reported Hb value for laboratories that would reject the result was 211 mg/dL, while median reported Hb value for laboratories that would report the result was 209 mg/dL. Manufacturers interference limit for Roche Cobas is H-index 200 mg/dL. As mentioned above, 28 of the 52 laboratories with Roche Cobas would “reject / reject with comment” the results for Sample 3. We found some variation between the countries: Of the 52 laboratories, 9 were from Denmark, 8 from Sweden, 8 from Finland, 26 from Norway and 1 from Iceland. 89% (8/9) of the Danish, 63% (5/8) of the Swedish and Finnish, 38% (10/26) of the Norwegian and none (0/1) of the Icelandic laboratories would “reject / reject the result with comment”.

Reject

Reject

with

comment

Report

Report

with

comment

No

answer

Total

(n)Reject

Reject

with

comment

Report

Report

with

comment

No

answer

Total

(n)

Abbott 22 1 23 1 2 19 1 23

Beckman AU 5 5 5 5

Beckman Access/Unicel 4 4 3 1 4

Kone 4 1 5 1 4 5

Perkin Elmer 1 1 1 1

Roche Cobas 2 49 1 52 5 23 12 11 1 52

Roche Integra 2 1 3 2 1 3

Roche Modular 8 8 2 6 8

Siemens Advia 1 13 3 17 1 3 11 1 1 17

Siemens Dimension 1 9 10 1 9 10

Vitros 3 3 4 3 2 15 4 4 1 4 2 15

Total 4 6 120 8 5 143 11 39 70 17 6 143

ALP (n)

Sample 2 (Hb 100 mg/dL) Sample 3 (Hb 200 mg/dL)

3 % 4 %

84 %

6 %3 %

ALP Sample 2 (Hb 100 mg/dL)

Reject the result

Reject the result with a

comment

Report the result

Report the result with a

comment

No answer

8 %

27 %

49 %

12 %

4 %

ALP Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

12


2.2.2. Bilirubin (total)

Bilirubin (total) interferograph:

The table above show baseline values (M) (µmol/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

13


Action taken for Bil (tot) in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for bilirubin (total). The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is most pronounced for Sample 3 with Hb concentration 200 mg/dL.

None of the Vitros participants answered they would “reject / reject with comment” the result for Sample 2 with hemoglobin concentration 100 mg/dL. According to the results in the interferograph at the previous page, this means they would all accept a 45,9% increase in analytical result compared with baseline value for this sample.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 22 1 23 3 18 1 1 23

Beckman AU 4 1 5 5 5

Beckman Access/Unicel 2 1 1 4 4 4

Kone 2 2 1 5 1 2 1 1 5


Roche Cobas 1 1 46 3 1 52 1 1 44 2 4 52


Roche Modular 8 8 8 8

Siemens Advia 1 15 1 17 1 15 1 17

Siemens Dimension 10 10 10 10

Vitros 9 3 3 15 3 5 2 2 3 15

Total 2 7 115 11 8 143 5 19 101 7 11 143

Bil (tot)(n)


1 % 5 %

80 %

8 %

6 %

Bil (tot) Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

3 %

13 %

71 %

5 %8 %

Bil (tot) Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

14


2.2.3. Ca

Ca Interferograph:

The table above show baseline values (M) (mmol/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

15


Action taken for Ca in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories fairly agree in how they would handle the analytical results for calcium. Almost all results would be reported.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 22 1 23 2 19 2 23

Beckman AU 5 5 5 5

Beckman Access/Unicel 4 4 4 4

Kone 1 4 5 1 4 5


Roche Cobas 1 50 1 52 48 4 52

Roche Integra 3 3 2 1 3


Siemens Advia 16 1 17 16 1 17


Vitros 12 3 15 2 10 3 15

Total 1 130 1 11 143 2 2 121 4 14 143

Ca (n)


1 %

91 %

1 %

7 %

Ca Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 % 1 %

85 %

3 %10 %

Ca Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

16


2.2.4. CK CK interferograph:


17


Action taken for CK in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ very much in how they would handle the analytical result for CK. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is most pronounced for Sample 3 with Hb concentration 200 mg/dL.

Of the 52 laboratories with Roche Cobas, 30 (58%) answered they would “reject / reject with comment” and 20 (38%) would “report / report with comment” the result for the sample with Hb concentration 200 mg Hb/dl (Sample 3). The variation in action taken is not due to different measured concentration of Hb. All laboratories, except two, measured Hb concentration above 200 mg/dL. Median reported Hb value for laboratories that would “reject” or “reject with comment” the result was 209 mg/dL, while median reported Hb value for laboratories that would “report / report with comment” the result was 212 mg/dL. Manufacturers interference limit for Roche Cobas is H-index 200 mg/dL.

As mentioned above, 30 of the 52 laboratories with Roche Cobas would “reject / reject with comment”, the results for Sample 3. We found some variation between the countries: Of the 52 laboratories, 9 were from Denmark, 8 from Sweden, 8 from Finland, 26 from Norway and 1 from Iceland. 89% (8/9) of the Danish, 100% (8/8) of the Swedish, 63% (5/8) of the Finnish, 35% (9/26) of the Norwegian and none (0/1) of the Icelandic laboratories would “reject / reject the result with comment”.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 1 21 1 23 4 17 1 1 23

Beckman AU 2 2 1 5 2 3 5

Beckman Access/Unicel 3 1 4 2 1 1 4

Kone 2 1 2 5 1 1 1 2 5


Roche Cobas 1 8 36 5 2 52 5 25 7 13 2 52

Roche Integra 1 2 3 1 1 1 3

Roche Modular 3 2 3 8 1 4 3 8

Siemens Advia 1 5 8 2 1 17 1 8 4 3 1 17


Vitros 1 11 3 15 4 3 5 3 15

Total 2 29 86 15 11 143 11 59 35 27 11 143

CK


1 %

20 %

60 %

11 %

8 %

CK Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

8 %

41 %

24 %

19 %

8 %

CK Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

18


2.2.5. Chloride Chloride interferograph:


19


Action taken for Chloride in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories fairly agree in how they would handle the analytical results for chloride. Almost all results would be reported.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 1 18 4 23 3 16 4 23

Beckman AU 3 2 5 3 2 5


Kone 5 5 5 5


Roche Cobas 1 41 10 52 39 13 52


Roche Modular 4 4 8 4 4 8



Vitros 9 6 15 1 8 1 5 15

Total 2 100 41 143 1 3 94 2 43 143

Cl


1 %

70 %

29 %

Cl Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 % 2 %

66 %1 %

30 %

Cl Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

20


2.2.6. Cobalamin

Cobalamin interferograph:

The table above show baseline values (M) (pmol/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

21


Action taken for Cobalamin in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for cobalamin. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is almost the same for the two samples with Hb concentrations 100 and 200 mg/dL.

Of the 23 laboratories with Abbott, approximately 50 % of the laboratories answered they would “reject with comment” (n=8 Sample 2, n=11 Sample 3) and approximately 50 % answered they would “report” the results (n=11 Sample 2, n=9 Sample 3). We have studied whether the different actions are due to instrument model or country, but we have not found any correlation.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 8 11 1 3 23 11 9 3 23

Beckman AU 2 2 1 5 2 2 1 5


Kone 5 5 5 5


Roche Cobas 1 38 13 52 1 36 15 52



Siemens Advia 2 10 5 17 3 9 5 17


Vitros 1 8 2 4 15 1 2 5 3 4 15

Total 1 13 91 3 35 143 2 19 80 4 38 143

Cobalamin


1 %

9 %

64 %

2 %

24 %

Cobalamin Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 %

13 %

56 %

3 %

27 %

Cobalamin Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

22


2.2.7. Folate

Folate interferograph:

The table above show baseline values (M) (nmol/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

Comments

This component is very sensitive to hemolysis on all instruments.

23


Action taken for Fol in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ very much in how they would handle the analytical result for folate. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is almost the same for the two samples with Hb concentrations 100 and 200 mg/dL.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 1 11 4 6 1 23 1 14 2 5 1 23



Kone 5 5 5 5


Roche Cobas 3 27 3 6 13 52 5 26 4 4 13 52

Roche Integra 1 1 1 3 1 1 1 3

Roche Modular 1 5 1 1 8 1 5 2 8

Siemens Advia 1 8 1 2 5 17 1 9 1 1 5 17

Siemens Dimension 8 1 1 10 8 1 1 10

Vitros 2 6 1 1 5 15 3 7 5 15

Total 8 71 11 17 36 143 11 75 10 12 35 143

Fol


5 %

50 %

8 %

12 %

25 %

Fol Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

8 %

52 %

7 %

8 %

25 %

Fol Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

24


2.2.8. FT4

FT4 interferograph:

The table above show baseline values (M) (pmol/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

25


Action taken for FT4 in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories fairly agree in how they would handle the analytical results for FT4. Almost all results would be reported.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 21 2 23 2 19 2 23



Kone 1 4 5 1 4 5


Roche Cobas 45 7 52 1 42 9 52





Vitros 11 1 3 15 1 9 2 3 15

Total 115 1 27 143 1 3 107 3 29 143

FT4


80 %

1 %19 %

FT4 Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 % 2 %

75 %

2 %

20 %

FT4 Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

26


2.2.9. GGT

GGT interferograph:


27


Action taken for GGT in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories fairly agree on reporting the analytical results for GGT in Sample 2 with Hb concentration 100 mg/dL. However, they differ in how they would handle the analytical result in Sample 3 with Hb concentration 200 mg/dL. The result for Sample 3 would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample.

Of the 52 laboratories with Roche Cobas, 25 (48%) answered they would “reject / reject with comment” and 24 (46%) would “report / report with comment” the result for the sample with Hb concentration 200 mg Hb/dL (Sample 3). The variation in action taken is not due to different measured concentration of Hb. All laboratories, except two, measured Hb concentration above 200 mg/dL. Median reported Hb value for laboratories that would reject the result was 209 mg/dL, while median reported Hb value for laboratories that would report the result was 210 mg/dL. Manufacturers interference limit for Roche Cobas is H-index 200 mg/dL.

As mentioned above, 25 of the 52 laboratories with Roche Cobas would “reject / reject with comment” the results for Sample 3. We found some variation between the countries: Of the 52 laboratories, 9 were from Denmark, 8 from Sweden, 8 from Finland, 26 from Norway and 1 from Iceland. 67% (6/9) of the Danish, 75% (6/8) of the Swedish, 50% (4/8) of the Finnish, 35% (9/26) of the Norwegian and none (0/1) of the Icelandic laboratories would “reject / reject the result with comment”.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 21 1 1 23 3 16 3 1 23


Beckman Access/Unicel 3 1 4 2 1 1 4

Kone 4 1 5 1 4 5


Roche Cobas 49 3 52 5 20 12 12 3 52





Vitros 12 3 15 1 10 1 3 15

Total 131 3 9 143 6 33 75 19 10 143

GGT


92 %

2 % 6 %

GGT Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

4 %

23 %

53 %

13 %

7 %

GGT Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

28


2.2.10. Glucose

Glucose interferograph:


29


Action taken for Glucose in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for glucose. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is most pronounced for Sample 3 with Hb concentration 200 mg/dL.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 22 1 23 3 19 1 23

Beckman AU 5 5 5 5


Kone 4 1 5 1 4 5


Roche Cobas 1 50 1 52 48 4 52

Roche Integra 3 3 3 3




Vitros 12 1 2 15 2 2 8 1 2 15

Total 1 135 3 4 143 2 11 119 2 9 143

Glu


1 %

94 %

2 % 3 %

Glu Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

2 %

8 %

83 %

1 %6 %

Glu Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

30


2.2.11. LDH

LDH interferograph:


Comments


31


Action taken for LDH in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for LDH. The result would either be rejected, rejected with comment, reported (only one laboratory) or reported with comment, depending on which laboratory that received the sample.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 2 14 1 5 1 23 2 19 1 1 23



Kone 5 5 5 5


Roche Cobas 4 37 7 4 52 5 39 4 4 52



Siemens Advia 1 14 2 17 1 14 2 17


Vitros 4 4 1 3 3 15 5 6 1 3 15

Total 12 91 2 23 15 143 14 101 0 13 15 143

LDH


8 %

64 %

1 %

16 %

11 %

LDH Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

10 %

71 %

0 % 9 %

10 %

LDH Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

32


2.2.12. Potassium

Potassium interferograph:


Comments


33


Action taken for Potassium in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for potassium. The result would either be corrected, rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. Of the 15 laboratories with Vitros, 7 (47 %) answered they would “reject / reject with comment” and 6 (40%) answered they would “report / report with comment” the result from Sample 2 with Hb concentration 100 mg/dL. Manufacturers interference limit for Vitros is 51 mg Hb/dL.

Correct Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Correct Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 1 2 12 4 3 1 23 2 13 1 6 1 23


Beckman Access/Uni 3 1 4 3 1 4

Kone 1 4 5 5 5


Roche Cobas 4 39 3 6 52 7 40 2 2 1 52


Roche Modular 2 1 3 1 1 8 1 1 3 3 8

Siemens Advia 1 11 5 17 1 14 2 17


Vitros 4 3 2 4 2 15 4 7 2 2 15

Total 3 14 86 10 26 4 143 1 16 101 3 17 5 143

Potassium


10 %

60 %

7 %

18 %

3 % 2 %

Potassium Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

Correct the result

11 %

71 %

2 % 12 %

3 % 1 %

Potassium Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

Correct the result

34


2.2.13. Sodium

Sodium interferograph:


35


Action taken for Sodium in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for sodium. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is a bit more pronounced for Sample 3 with Hb concentration 200 mg/dL compared to Sample 2 with Hb concentration 100 mg/dL.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 22 1 23 3 17 2 1 23

Beckman AU 5 5 5 5

Beckman Access/Unicel 4 4 4 4

Kone 3 2 5 1 4 5


Roche Cobas 3 49 52 3 45 4 52





Vitros 12 1 2 15 1 10 2 2 15

Total 3 130 5 5 143 1 8 120 5 9 143

Sodium


1 %

1 %

80 %

1 %

17 %

T

SH

Sa

2 %

91 %

4 % 3 %

Sodium Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 % 6 %

84 %

3 %

6 %

Sodium Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

36


2.2.14. TSH

TSH interferograph:

The table above show baseline values (M) (mlU/L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

37


Action taken for TSH in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories fairly agree in how they would handle the analytical results for TSH. Almost all results would be reported.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 22 1 23 2 20 1 23



Kone 1 4 5 1 4 5


Roche Cobas 47 5 52 44 8 52





Vitros 11 1 3 15 1 10 1 3 15

Total 121 1 21 143 1 2 114 2 24 143

TSH


84 %

1 % 15 %

TSH Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

1 % 1 %

80 %

1 % 17 %

TSH Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

38


2.2.15. Uric acid

Uric acid interferograph:

The table above show baseline values (M) (µmol /L), the Bias (% deviation from the baseline) for the different degree of hemolysis (0, 100, 200, 400 mg/dL) and CV calculated for each bias.

39


Action taken for Uric acid in samples with Hb 100 and 200 mg/dL (question 8a and 9a):

Comments

The results showed that the laboratories differ in how they would handle the analytical result for uric acid. The result would either be rejected, rejected with comment, reported or reported with comment, depending on which laboratory that received the sample. The variation is most pronounced for Sample 3 with Hb concentration 200 mg/dL.

Of the 15 laboratories with Vitros, 6 (40 %) answered they would “reject / reject with comment” and 7 (47%) answered they would “report / report with comment” the result from Sample 3 with Hb concentration 200 mg/dL. Manufacturers interference limit for Vitros is 50 mg Hb/dL.

Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal Reject

Reject

with

comment

Report

Report

with

comment

No

answerTotal

Abbott 1 19 3 23 8 13 2 23

Beckman AU 5 5 5 5


Kone 3 1 1 5 1 3 1 5


Roche Cobas 1 50 1 52 48 4 52



Siemens Advia 16 1 17 2 14 1 17


Vitros 12 1 2 15 4 2 6 1 2 15

Total 2 130 5 6 143 4 16 109 5 9 143

Uric Acid


1 %

91 %

4 % 4 %

Uric Acid Sample 2 (Hb 100 mg/dL)

Reject the result


comment

Report the result


comment

No answer

3 %

11 %

76 %

4 %6 %

Uric Acid Sample 3 (Hb 200 mg/dL)

Reject the result


comment

Report the result


comment

No answer

40


2.3. Questions about hemolyzed samples in the laboratories

On page 39-44 a summary of the participants replies to question 5, 6 and 7 are shown in figures and tables.

2.3.1. How do you investigate and detect interference by

hemolysis in the samples you receive for analysis?

Presented by country and by instrument

Total

Den Fin Ice Nor Swe Total (%)

Automated detection of hemoglobin

concentration (all samples)28 11 1 30 20 90 64

Manual inspection (all samples) 10 1 10 1 22 16

Manual inspection, followed by automated

detection of hemoglobin concentration if

hemolysis is suspected

1 1 8 3 13 9

Samples with unexpected analytical results are

investigated for interference by hemolysis1 1 1

We do not investigate interference by hemolysis

in the samples we receive0 0

Other procedures 3 4 5 2 14 10

Total 32 25 4 53 26 140 100

How interference by hemolysis is investigated and detected in the laboratory, by country (n)

Diagramtittel

Automated detection of hemoglobin concentration (all samples)

Manual inspection (all samples)

Manual inspection, followed by automated detection of hemoglobin concentration if hemolysis issuspectedSamples with unexpected analytical results are investigated for interference by hemolysis

Other procedures

88 %

3 %9 %

Denmark

44 %

40 %

16 %

Finland

25 %

25 %25 %

25 %

Iceland

57 %19 %

15 %

9 %

Norway

77 %

4 %

11 %

8 %

Sweden

41


*If the laboratory used several instruments for analysis of the different components, the instrument used for the majority of components in each laboratory was selected in this table, see Attachment 1.

Comments

64% of the laboratories use automated detection of hemoglobin concentration (all samples); 88% in Denmark, 77% in Sweden, 57% in Norway, 44% in Finland and 25% in Iceland.

The laboratories use to varying degrees the automatic detection of hemoglobin concentration, although the feature is available in the instrument.

Main instrument group*

A (

Ab

bo

tt)

BA

(B

eckm

an A

U)

BU

(B

eckm

an A

cces

s/U

ni)

K (

Ko

ne)

P (

Per

kin

Elm

er)

R (

Ro

che

Co

bas

)

RI (

Ro

che

Inte

gra)

RM

(R

och

e M

od

ula

r)

SA (

Siem

ens

Ad

via)

SD (

Siem

ens

Dim

ensi

on

)

V (

Vit

ros)

Tota

l (n

)

Automated detection of hemoglobin

concentration (all samples) 11 1 3 43 5 9 10 8 90

Manual inspection (all samples) 6 2 1 5 1 2 2 1 2 22

Manual inspection, followed by

automated detection of hemoglobin

concentration if hemolysis is

suspected 4 3 1 2 2 1 13

Samples with unexpected analytical

results are investigated for

interference by hemolysis 1 1

We do not investigate interference

by hemolysis in the samples we

receive

Other procedures 1 2 4 1 5 1 14

Total (n) 22 5 4 5 1 52 3 8 17 10 13 140

How interference by hemolysis is investigated and detected in the laboratory, by instrument (n)

42


2.3.2. Of 1000 clinical chemistry samples (tubes) received in the

laboratory, in how many do you take some kind of action

due to hemolysis?

Comments

The laboratories take some kind of action, due to hemolysis, in 10 – 20‰, i.e. 1-2%, of the samples received in the laboratories.

Den Fin Ice Nor Swe Total

Median ‰ (10 and 90 percentile) 10 (3-50) 10 (3-50) 10 20 (5-50) 20 (8-42) 13 (3-50)

n 29 16 2 37 17 101

‰ clinical chemistry samples received in the laboratories where some kind of action is taken due to

hemolysis (by country):

43


2.3.3. Do you (in your laboratory) have written procedures /

guidelines for handling of hemolyzed samples?

Comments

88% of the laboratories have written procedures; 100% in Denmark, 96% in Sweden, 88% in Finland, 81% in Norway and 25% in Iceland.

Den Fin Ice Nor Swe Total Total (%)

Yes 32 22 1 43 27 125 88

No 2 2 8 12 8

Other 1 1 2 1 5 4

Total 32 25 4 53 28 142 100

Number of laboratories that have/have not written procedures/guidelines for handling of

hemolysed samples, by country (n)

Yes No Other

88 %

8 % 4 %

Finland

81 %

15 %

4 %

Norway

96 %

4 %

Swe

100 %

Denmark

25 %

50 %

25 %

Iceland

44


2.3.4. Report any additional results if the physician calls?

The questions were as follows:

Question 8a: If Sample 2 was analysed in your laboratory, which action would you take for the following components. Question 8b: Please answer this question if you chose to reject some of the results in question 8a: Imagine that Sample 2 was from a 2-year-old child admitted to the Oncologic Department in your hospital. Thirty minutes after rejecting some of the results do you receive a call from the requesting physician who asks for the non-reported results, arguing that the sampling was extremely difficult and claims that it is not possible to get a new sample. Please specify below which ADDITIONAL results (if any) you would report. Question 9a: If Sample 3 was analysed in your laboratory, which action would you take for the following components. Question 9b: Please answer this question if you chose to reject some of the results in question 9a: Imagine that Sample 3 was from a 60-year-old man who was admitted to the emergency department with acute chest pain. Ten minutes after rejecting some of the results do you receive a call from the requesting physician who asks for the non-reported results, arguing that rapid results are very important for further treatment of the patient. Please specify below which ADDITIONAL results (if any) you would report.

45


Comments

The laboratories would to some extent report additional results after a call from the requesting physician. Regarding question 8b, 56 of 105 (53%) laboratories would report all or some additional results, and 49 of 105 (47%) would not* report any additional results. Regarding question 9b, 41 of 117 (35%) laboratories would report all or some additional result, and 76 of 117 (65%) laboratories would not* report any additional results. Please see above which components that would be additionally reported.

* Laboratories reported “None” or “None applicable, all the result have already been reported in accordance with our local practice / guideline”.

8b: 9b:

Reported Rejected

Additional results

reported (despite

rejection initially)

Reported Rejected

Additional results

reported (despite

rejection initially)

ALP 128 10 5 87 50 12

Bil (total) 126 9 2 108 24 4

Calcium 131 1 0 125 4 0

Cobalamin 94 14 2 84 21 2

CK 101 31 8 62 70 16

Cl 100 2 0 96 4 0

Folate 28 79 20 22 86 9

FT4 116 0 - 110 4 0

GGT 134 0 - 94 39 9

Glucose 138 1 0 121 13 4

LDH 25 103 26 13 115 11

Potassium 39 100 41 21 117 26

Sodium 135 3 0 125 9 0

TSH 122 0 - 116 3 0

Uric Acid 135 2 1 114 20 3

Number of results that would be reported/rejected initially (8a and 9a) and additionally results

reported after a call from the physician (8b and 9b):

Sample 2 (Hb100 mg/dL) (n) Sample 3 (Hb 200 mg/dL) (n)

8a: 9a:

46


3. Conclusion and future The results showed that the largest instrument groups were quite similar influenced by hemolysis, and measured the degree of hemolysis (H-index) quite similarly and in accordance with hemoglobin added. It is a surprise, however, how much the laboratories differ in actions taken upon the analytical results for most of the components (reject, reject with comment, report or report with comment). For Ca, Cl, FT4 and TSH the laboratories fairly agree on action taken.

The laboratories would to some extent report additional results after a call from the requesting physician. If the sample (Sample 2; 100 mg Hb/dL) was from a 2-year-old child admitted to the Oncologic Department half of the laboratories would report additional results despite hemolysis (n=105). If the sample (Sample 3; 200 mg Hb/dL) was from a 60-year-old man admitted to the emergency department with acute chest pain, about one third (35%) would report all or some additional results (n=117).

For 1-2% of the samples received in the laboratories some kind of action due to hemolysis were taken.

64% of the laboratories used automated detection of H-index (hemoglobin concentration) in all samples, whereas 16% detected hemolyzed samples by manual inspection, and 9% used manual inspection followed by measuring H-index if hemolysis was suspected. 1% investigated samples with unexpected analytical results for interference by hemolysis and 10% used other procedures.

88% of the participants had written procedures/guidelines on how to handle samples with hemolysis.

EQAnord will work further with the aim of publishing the data, and evaluate the possibility of further work on the harmonization of how samples should be handled in the Nordic countries.

47


4. Acknowledgement The project received funding from Nordic Federation of Clinical Chemistry (NFKK).

5. References Fraser, C. G. (1999). General strategies to set quality specifications for reliability

performance characteristics. Scand J Clin Lab Invest, 59(7), 487-490. Hagve, T. A., Brun, A., Garmo, G., Lindberg, M., & Åsberg, A. (2014). Brukerhåndbok i

medisinsk biokjemi. Retrieved 04.03.2015, from http://brukerhandboken.no/ Lippi, G. (2012). Interference studies: focus on blood cell lysates preparation and testing. Clin

Lab, 58(3-4), 351-355. Westgard, J. O. (2015). Westgard QC. Retrieved 20.04.2015, from

https://www.westgard.com/

48


6. Attachment

Attachment 1: Instruments Number of each instrument used for each analyte. The first column (Pr) indicates main instrument group (A-Abbott, BU-Beckman Unicel, BA-Beckman AU, EYE-eye, H-Hemocue, K-Konelab, O-Other - please specify, R-Roche cobas, RA-Roche ABL, RI-Roche Cobas Integra, RM-Roche Modular, RS-Roche Sysmex, SA-Siemens Advia, SC-Siemens Advia Centaur, SD-Siemens Dimension, SI-Siemens Immulite, SR-Siemens Rapidlab 1265, V-Vitros), the second is instrument and the next columns are components.

Number of instruments used by the participants grouped according to their instrument group

Pr Instrument ALP Bil Ca CK Cl Cob Fol FT4 Glu GT Hb LD Po So TSH UA

A Abbott Architect c8000 2 2 2 2 2 2 2 2 2 2 2 2

A Abbott Architect c16000 7 7 7 6 4 7 6 7 7 7 7 7

A Abbott Architect ci16200 3 3 3 4 3 3 3 3 3 3 3 3 3 3 3 3

A Abbott Architect ci8200 10 10

11

10

7 6 8 7 11 11

6 10

10

10

7 11

A Abbott Architect i2000SR 14 13 10 12

A Abbott Celldyn Sapphire 1

A Abbott Ruby 1

BA Beckman Coulter AU2700 1 1 1 1 1 1 1 1 1 1 1

BA Beckman Coulter AU640 1 1 1 1 1 1 1 1 1 1 1

BA Beckman Coulter AU680 3 3 3 3 2 3 3 3 3 3 3 3

BU Beckman Coulter Access 1 1 1

BU Beckman Coulter DxI 1 1 1 1

BU Beckman Coulter UniCel 1 1 1 1


1 1 1 1 1 2 1 1 1 2 2 2


3 3 3 2 1 2 2 2 1 2 2 2 2 2 2 2

EYE Eye 1

H Hemocue 1

K Konelab 20i 2 2 2 2 2 2 1

K Konelab 20XTi 1 1 1 1 1 1 1 1

K Konelab 30i/60i 2 1 1 2 3 2 2 2 2

O Other, please specify 1

P Perkin Elmer Autodelfia 1 1

R Roche Cobas 1

R Roche Cobas 6000 12 12

12

11

8 8 8 10 11 11

11

11

12

13

10 12

R Roche Cobas 8000 1

49




R Roche Cobas 8000 ISE 8 1 11

11

1

R Roche cobas b221 1

R Roche Cobas C111 1 1

R Roche Cobas c501 27 27

27

27

17 1 26 25

27

25

27

25

1 27

R Roche Cobas c502 1 1 2 3 1 1

R Roche Cobas c701 1 1 1 1 1

R Roche Cobas c702 9 10

9 9 1 10 8 8 10

1 1 10

R Roche Cobas c8000 1 1 1 1 1 1 1 1 1 2 1 1 1

R Roche Cobas e411 1 1 3 3

R Roche Cobas e601 22 21 25 1 1 1 25

R Roche Cobas e602 11 12 11 12

RA ABL 800 Flex 1

RA ABL 825 1 1

RA ABL 835 Flex 5

RA ABL90 Flex 1

Ra Radiometer ABL800 1

RACC

ROCHE Accu-chek performa 1

RI Roche Cobas Integra 400 1 1 1 1 1 1 1 1 1 1

RI Roche Cobas Integra 800 2 2 2 2 1 2 2 2 2 2 1

RM Roche Modular E 8 8 8 8

RM Roche Modular ISE 1800 1 1

RM Roche Modular P/D 8 8 8 8 4 8 8 8 7 7 7 8

RS Roche Sysmex xs 1000i 1

RS Sysmex XS1000i 1

RS Sysmex XT-2000 1

SA Siemens Advia 1200 1 1 1 1 1 1 1 1 1 1 1 1

SA Siemens Advia 1800 13 12

13

11

11 13 13

10

13

13

13

12

SA Siemens Advia 2120 1

SA Siemens Advia 2400 3 3 3 3 2 3 3 3 2 3 3 3

SC Bayer Advia Centaur 1 1 2 2

SC Siemens Advia Centaur 1 1

SC Siemens Advia Centaur XP 14 15 15 1 16

50




SD Siemens Dimension Vista 10 10

9 10

3 8 9 9 10 10

10

10

10

10

10 10

SI Siemens Immulite 2000 1

SI Siemens Immulite 2000XPi 1 1 1 1

SR Siemens RapidLab 1265 2

V Vitros 1

V Vitros 250 1 1 1 1 1 1 1 1 1 1

V Vitros 350 1 1 1 1 1 1 1 1 1 1 1

V Vitros 3600 1 1 1 1

V Vitros 5.1 FS 10 10

10

10

7 9 10

9 10

10

10

V Vitros 5600 2 1 1 1 1 1 2 2 1 1 2 2 2 2

V Vitros ECi 1 1

Attachment 2: questionnaire (on the next page)

Nordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis project

Dear Colleague Thank you for participating in this Nordic Hemolysis Study, organized by EQAnord, the Nordic cooperation in External Quality Assurance, including DEKS, EQUALIS, ISLM, Labquality, NKK and Noklus. You have received 4 samples which include different concentrations of hemoglobin. These samples should be stored at 4 degrees Celcius. Please centrifuge the samples for 10 minutes, preferably at 2000 – 2500G and analyze them THURSDAY NOVEMBER 6th, when the following components should be analyzed: ALP, Bil (total), Calcium, CK, Cl, Folate, FT4, GGT, Glucose, Cobalamin, LDH, Potassium, Sodium, TSH, Uric Acid and Hb concentration (e.g. Hindex). Please analyze the samples in duplicate and register the mean value in the result form. You can report results from 1 instrument, please choose your main clinical chemistry instrument. This questionnaire should be FILLED IN BY THE PERSON IN CHARGE OF THE ROUTINE CLINICAL CHEMISTRY ANALYSES. If you complete the questionnaire and provide your email address, you will receive a feedback report with the results from this survey and recommendations. Be aware that you can go back and update your answers until the survey is closed. However, you have to use the same computer every time. By pressing the "Done" button (at the end of the questionnaire), the survey is completed, and you can not enter it again. The survey will be closed November 14th. If you have any questions, do not hesitate to contact Gro Gidske (see email address below) Best regards, On behalf of the Project Group Gro Gidske Leader of Control material Production, Noklus [email protected]

2. The feedback report can be sent to this emailadress:

General information

1. Please enter Your Labquality number:

*55

66

55

66


3. Date of analysis (Preferably November 6th):

4. Please enter your instrument and reagent for each component below:

Date of analysis, instrument and reagent

MM DD YYYY

Date / /

Instrument (choose from the options below) Reagent (choose from the options below)

ALP (U/L) 6 6

Bilirubin(total) (µmol/L) 6 6

Calcium (mmol/L) 6 6

CK (U/L) 6 6

Cl (mmol/L) 6 6

Folate (nmol/L) 6 6

FT4 (pmol/L) 6 6

GGT (U/L) 6 6

Glucose (mmol/L) 6 6

Cobalamin (pmol/L) 6 6

LDH (U/L) 6 6

Potassium (mmol/L) 6 6

Sodium (mmol/L) 6 6

TSH (mlU/L) 6 6

Uric Acid (µmol/L) 6 6

Hemoglobin concentration (mg/dL or "+++")

6 6

If "Other", please specify:

55

66


Please analyze in duplikate and register the mean values for ALL components

Analytical results, Sample 1: ALP (U/L)

Bil (total) (µmol/L)

Calcium (mmol/L)

CK (U/L)

Cl (mmol/L)

Folate (nmol/L)

FT4 (pmol/L)

GGT (U/L)

Glucose (mmol/L)

Cobalamin (pmol/L)

LDH (U/L)

Potassium (mmol/L)

Sodium (mmol/L)

TSH (mlU/L)

Uric Acid (µmol/L)


Analytical results, Sample 2ALP (U/L)


Calcium (mmol/L)

CK (U/L)

Cl (mmol/L)

Folate (nmol/L)

FT4 (pmol/L)

GGT (U/L)

Glucose (mmol/L)

Cobalamin (pmol/L)

LDH (U/L)

Potassium (mmol/L)

Sodium (mmol/L)

TSH (mlU/L)

Uric Acid (µmol/L)


Nordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis projectAnalytical results, Sample 3:ALP (U/L)


Calcium (mmol/L)

CK (U/L)

Cl (mmol/L)

Folate (nmol/L)

FT4 (pmol/L)

GGT (U/L)

Glucose (mmol/L)

Cobalamin (pmol/L)

LDH (U/L)

Potassium (mmol/L)

Sodium (mmol/L)

TSH (mlU/L)

Uric Acid (µmol/L)


Analytical results, Sample 4: ALP (U/L)


Calcium (mmol/L)

CK (U/L)

Cl (mmol/L)

Folate (nmol/L)

FT4 (pmol/L)

GGT (U/L)

Glucose (mmol/L)

Cobalamin (pmol/L)

LDH (U/L)

Potassium (mmol/L)

Sodium (mmol/L)

TSH (mlU/L)

Uric Acid (µmol/L)



5. How do you investigate and detect interference by hemolysis in the samples you receive for analysis?

6. Of 1000 clinical chemistry samples (tubes) received in the laboratory, in how many do you take some kind of action due to hemolysis?

7. Do you (in your laboratory) have written procedures/guidelines for handling of hemolysed samples?

Questions about hemolysed samples in your laboratory

We do not investigate interference by hemolysis in the samples we receive

nmlkj

Manual inspection (all samples)

nmlkj

Automated detection of hemoglobin concentration (all samples)

nmlkj

Manual inspection, followed by automated detection of hemoglobin concentration if hemolysis is suspected

nmlkj

Samples with unexpected analytical results are investigated for interference by hemolysis

nmlkj

Other procedures

nmlkj

If "Other procedures", please specify:

55

66

Yes

nmlkj

No

nmlkj

Other

nmlkj

If "Other", please specify:

55

66


8a. If Sample 2 was analysed in your laboratory, which action would you take for the following components:

Clinical story

Report the resultReport the result with

a commentCorrect the result Reject the result

Reject the result with a comment

ALP nmlkj nmlkj nmlkj nmlkj nmlkj

Bil (total) nmlkj nmlkj nmlkj nmlkj nmlkj

Calcium nmlkj nmlkj nmlkj nmlkj nmlkj

CK nmlkj nmlkj nmlkj nmlkj nmlkj

Cl nmlkj nmlkj nmlkj nmlkj nmlkj

Folate nmlkj nmlkj nmlkj nmlkj nmlkj

FT4 nmlkj nmlkj nmlkj nmlkj nmlkj

GGT nmlkj nmlkj nmlkj nmlkj nmlkj

Glucose nmlkj nmlkj nmlkj nmlkj nmlkj

Cobalamin nmlkj nmlkj nmlkj nmlkj nmlkj

LDH nmlkj nmlkj nmlkj nmlkj nmlkj

Potassium nmlkj nmlkj nmlkj nmlkj nmlkj

Sodium nmlkj nmlkj nmlkj nmlkj nmlkj

TSH nmlkj nmlkj nmlkj nmlkj nmlkj

Uric Acid nmlkj nmlkj nmlkj nmlkj nmlkj

Other (please specify):

55

66

Nordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis projectNordic Hemolysis project8b. Please answer this question if you chose to reject some of the results in question 8a: Imagine that sample 2 was from a 2 year old child admitted to the Oncologic Department in your hospital. Thirty minutes after rejecting some of the results do you receive a call from the requesting physician who asks for the nonreported results, arguing that the sampling was extremely difficult and claims that it is not possible to get a new sample. Please specify below which ADDITIONAL results (if any) you would report (if you would add comments to any of the results, please specify this in the textbox (“Other”):

All

gfedc

None

gfedc

Non applicable, all the result have already been reported in accordance with our local practice/guideline

gfedc

ALP

gfedc

Bil (total)

gfedc

Calcium

gfedc

CK

gfedc

Cl

gfedc

Folate

gfedc

FT4

gfedc

GGT

gfedc

Glucose

gfedc

Cobalamin

gfedc

LDH

gfedc

Potassium

gfedc

Sodium

gfedc

TSH

gfedc

Uric Acid

gfedc


55

66


9a. If sample 3 was analysed in your laboratory, which action would you take for the following components:

Clinical story

Report the resultReport the result with

a commentCorrect the result Reject the result

Reject the result with a comment

ALP nmlkj nmlkj nmlkj nmlkj nmlkj

Bil (total) nmlkj nmlkj nmlkj nmlkj nmlkj

Calcium nmlkj nmlkj nmlkj nmlkj nmlkj

CK nmlkj nmlkj nmlkj nmlkj nmlkj

Cl nmlkj nmlkj nmlkj nmlkj nmlkj

Folate nmlkj nmlkj nmlkj nmlkj nmlkj

FT4 nmlkj nmlkj nmlkj nmlkj nmlkj

GGT nmlkj nmlkj nmlkj nmlkj nmlkj

Glucose nmlkj nmlkj nmlkj nmlkj nmlkj

Cobalamin nmlkj nmlkj nmlkj nmlkj nmlkj

LDH nmlkj nmlkj nmlkj nmlkj nmlkj

Potassium nmlkj nmlkj nmlkj nmlkj nmlkj

Sodium nmlkj nmlkj nmlkj nmlkj nmlkj

TSH nmlkj nmlkj nmlkj nmlkj nmlkj

Uric Acid nmlkj nmlkj nmlkj nmlkj nmlkj


55

66


9b. Please answer this question if you chose to reject some of the results in question 9a: Imagine that sample 3 was from a 60 year old man who was admitted to the emergency department with acute chest pain. Ten minutes after rejecting some of the results do you receive a call from the requesting physician who asks for the nonreported results, arguing that rapid results are very important for further treatment of the patient. Please specify below which ADDITIONAL results (if any) you would report (if you would add comments to any of the results, please specify this in the textbox (“Other”):

Clinical story

All

gfedc

None

gfedc

Non applicable, all the result have already been reported in accordance with our local practice/guideline

gfedc

ALP

gfedc

Bil (total)

gfedc

Calcium

gfedc

CK

gfedc

Cl

gfedc

Folate

gfedc

FT4

gfedc

GGT

gfedc

Glucose

gfedc

Cobalamin

gfedc

LDH

gfedc

Potassium

gfedc

Sodium

gfedc

TSH

gfedc

Uric Acid

gfedc


55

66

Nordic Hemolysis project 2014 - doc.noklus.no

Documents

Transcript of Nordic Hemolysis project 2014 - doc.noklus.no