Questionnaire finalized
EFCC

EFCC Questionnaire

USE AND IMPLEMENTATION OF CARDIAC MARKERS IN ACUTE CORONARY SYNDROME AND HEART FAILURE

May 2009

Please leave empty the questions that do not apply to your laboratory, as well as those for which you have no data available. In the questions where a numeric answer is expected, please answer using only digits, no letters or other symbols. For example, do not answer 20% or 10-20 or <30 etc.


1. Your country

ALBANIACZECH REPUBLICHUNGARYMALTAROMANIAUKRAINE
AUSTRIADENMARKICELANDMACEDONIASERBIAUNITED KINGDOM
BELGIUMESTONIAIRELANDMONTENEGROSLOVAK REPUBLIC 
BOSNIA HERZEGOVINAFINLANDITALYNETHERLANDSSLOVENIA 
BULGARIAFRANCELATVIANORWAYSPAIN 
CROATIAGERMANYLITHUANIAPOLANDSWEDEN 
CYPRUSGREECELUXEMBURGPORTUGALSWITZERLAND

2. Name of your hospital


3. Address of your hospital


4. Your name


5. Your phone number


6. Your email


7. Type of hospital

University hospital
Central hospital
District hospital
Primary care hospital

8. Does your hospital provide 24-hour admission of patients?

Yes    No

9. Do you have a designated separate chest pain unit (for less than 24 hours stay)?

Yes    No

10. Do you have an emergency unit or medical assessment unit (for more than 12 hours stay)?

Yes    No

11. Do you have a coronary care unit?

Yes    No

12. Percentage of your chest pain / ACS patients managed in the emergency department, if available


13. Percentage of your chest pain / ACS patients managed in a dedicated chest pain unit, if available


14. Percentage of your chest pain / ACS patients managed in a medical assessment/separate acute medical ward, if available


15. Percentage of your chest pain / ACS patients managed in a general medical ward, if available


16. Number of patients with suspected acute coronary syndrome (suspected heart attack) admitted per year


17. Number of patients with final diagnosis of acute myocardial infarction (ICD codes I21-I22) per year


18. Laboratory service availability (number of hours per day, for example 8 or 24)


19. Which biochemical test do you offer for routine diagnosis in suspected acute coronary syndrome?

Myoglobin
Troponin I
Troponin T
CK-MB mass
CK-MB activity

20. Do you offer CK as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

21. Do you offer AST as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

22. Do you offer LDH as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

23. Do you offer LD1 as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

24. Do you offer HBD as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

25. Do you offer LD isoenzymes as part of the routine profile for routine diagnosis in suspected ACS?

Yes    No

26. What is your preferred marker for routine diagnosis in suspected ACS

Total CK
CK-MB mass
CK-MB activity
total CK / CK-MB ratio
Troponin I
Troponin T
Myoglobin
Other (please specify)

27. Do you usually combine your preferred marker with other cardiac markers at your hospital? If yes, select the secondary marker from the following list

We usually do not combine the preferred marker with other markers
CK
CK-MB mass
CK-MB activity
total CK / CK-MB ratio
Troponin I
Troponin T
Myoglobin
other (please specify)

28. Does your laboratory plan any changes regarding the biochemical markers of acute myocardial infarction in the near future? If yes, please describe.

Yes    No

29. Does your laboratory plan any changes regarding the decision limits of the biochemical markers in the near future? If yes, please describe.

Yes    No

30. Do you have a written protocol for acute coronary syndrome / use of cardiac markers?

Yes    No

31. If applicable, is the protocol different for emergency unit and chest pain unit?

Yes    No

32. Were these protocols written in collaboration with the clinicians?

Yes    No

33. Do you measure Troponin I? If no, go to question 64.

Yes    No

34. How many Troponin I tests do you analyse per year?


35. Troponin I test name

Access, Beckman Coulter
Advia Centaur, Siemens
AiO, Innotrac
Architect STAT, Abbott
AxSym, Abbott
Dimension R&L, Siemens
Elecsys, Roche
Hexagon Troponin, Human
Immulite 2000, Siemens
Immulite 2500, Siemens
Immulite, Siemens
IMx, Abbott
Liaison, DiaSorin
Pathfast, Mitsubishi
Stratus CS, Siemens
Tosoh AIA
Triage, Biosite
Vidas, bioMerieux
Vitros ECi
Other, please specify below

36. Do you measure Troponin I for diagnosis of myocardial infarction?

Yes    No

37. Do you measure Troponin I for risk stratification

Yes    No

38. Do you measure Troponin I for infarct size estimation

Yes    No

39. Do you measure Troponin I for other purposes or other clinical situations? Please specify

Yes    No

40. Do you measure Troponin I in Heparin plasma?

Yes    No

41. Do you measure Troponin I in EDTA plasma?

Yes    No

42. Do you measure Troponin I in serum?

Yes    No

43. How is the Troponin I test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

44. If in batches, how often are these run per day?

Once
Two times
Three times
More often

45. Turn-around time (in minutes) for routine Troponin I requests (sample taken from patient to the validated result):

measured    estimated

46. Turn-around time (in minutes) for routine Troponin I requests (sample received in the lab to the validated result):

measured    estimated

47. Turn-around time (in minutes) for emergency Troponin I requests (sample taken from patient to the validated result):

measured    estimated

48. Turn-around time (in minutes) for emergency Troponin I requests (sample received in the lab to the validated result):

measured    estimated

49. What is your decision limit for Troponin I. If you use two limits, put the lower one here?


50. If you use two decision limits for Troponin I (i.e. the upper reference limit for healthy and the decision limit for AMI), put the higher one here.


51. Was the decision limit for Troponin I derived from

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile limit of a reference distribution)
ROC curve
Other (please specify)

52. If a reference population upper limit was used, where was it obtained?

Volunteers with screening for cardiac risk factors
Volunteers with no screening for cardiac risk factors
Blood donors
Manufactures' supplied data
Published literature

53. The source of the value chosen for the Troponin I decision limit(s) for AMI was:

Assay package insert information
Validation according to IFCC / NACB Recommendation 1999
ESC / ACC consensus statement 2000
Universal definition of MI (2007)
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision / reference limits

54. Do you have any criteria regarding frequency of Troponin I testing and number of samples to be collected? If yes, please specify.

Yes    No

55. Do you have internal quality control for Troponin I?

Yes    No

56. Do you have external quality assessment for Troponin I?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

57. Does your laboratory or a clinical unit have Troponin I point-of-care (POC) testing in use in your hospital?

Yes    No

58. Do you use the same method (POC and routine laboratory)

Yes    No

59. What POC method do you use


60. Is the POC method calibrated to the routine laboratory method?

Yes    No

61. Is POC testing for Troponin I used under supervision of the laboratory?

Yes    No

62. Do you have internal quality control for Troponin I POC testing?

Yes    No

63. Do you have external quality assessment for Troponin I POC testing?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

64. Do you measure Troponin T? If no, go to question 95.

Yes    No

65. How many Troponin T tests do you analyse per year?


66. Troponin T test name

Cardiac-reader, Roche
Cardiac TnT, cobas h 232, Roche
Elecsys & cobas e411, Roche
Modular E & cobas e601, Roche
Troponin T sens., Rapid Test, Roche
Other, please specify below

67. Do you measure Troponin T for diagnosis of myocardial infarction?

Yes    No

68. Do you measure Troponin T for risk stratification

Yes    No

69. Do you measure Troponin T for infarct size estimation

Yes    No

70. Do you measure Troponin T for other purposes or other clinical situations? Please specify

Yes    No

71. Do you measure Troponin T in Heparin plasma?

Yes    No

72. Do you measure Troponin T in EDTA plasma?

Yes    No

73. Do you measure Troponin T in serum?

Yes    No

74. How is the Troponin T test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

75. If in batches, how often are these run per day?

Once
Two times
Three times
More often

76. Turn-around time (in minutes) for routine Troponin T requests (sample taken from patient to the validated result):

measured    estimated

77. Turn-around time (in minutes) for routine Troponin T requests (sample received in the lab to the validated result):

measured    estimated

78. Turn-around time (in minutes) for emergency Troponin T requests (sample taken from patient to the validated result):

measured    estimated

79. Turn-around time (in minutes) for emergency Troponin T requests (sample received in the lab to the validated result):

measured    estimated

80. What is your decision limit for Troponin T. If you use two limits, put the lower one here?


81. If you use two decision limits for Troponin T (i.e. the upper reference limit for healthy and the decision limit for AMI), put the higher one here.


82. Was the decision limit for Troponin T derived from

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile limit of a reference distribution)
ROC curve
Other (please specify)

83. If a reference population upper limit was used, where was it obtained?

Volunteers with screening for cardiac risk factors
Volunteers with no screening for cardiac risk factors
Blood donors
Manufactures' supplied data
Published literature

84. The source of the value chosen for the Troponin T decision limit(s) for AMI was:

Assay package insert information
Validation according to IFCC / NACB Recommendation 1999
ESC / ACC consensus statement 2000
Universal definition of MI (2007)
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision / reference limits

85. Do you have any criteria regarding frequency of Troponin T testing and number of samples to be collected? If yes, please specify.

Yes    No

86. Do you have internal quality control for Troponin T?

Yes    No

87. Do you have external quality assessment for Troponin T?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

88. Does your laboratory or a clinical unit have Troponin T point-of-care (POC) testing in use in your hospital?

Yes    No

89. Do you use the same method (POC and routine laboratory)

Yes    No

90. What POC method do you use


91. Is the POC method calibrated to the routine laboratory method?

Yes    No

92. Is POC testing for Troponin T used under supervision of the laboratory?

Yes    No

93. Do you have internal quality control for Troponin T POC testing?

Yes    No

94. Do you have external quality assessment for Troponin T POC testing?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

95. Do you measure CK-MB mass? If no, go to question 118.

Yes    No

96. How many CK-MB mass tests do you analyse per year?


97. CK-MB mass test name

Access, Beckman Coulter
ACS:180, Siemens
Advia Centaur, Siemens
AiO, Innotrac
Architect STAT, Abbott
AxSym, Abbott
Cardiac-reader, Roche
Cardiac TnT, cobas h 232, Roche
Dimension R&L, Siemens
Elecsys & cobas e411, Roche
Immulite 2000, Siemens
Immulite 2500, Siemens
Immulite, Siemens
Immuno 1, Siemens
IMx, Abbott
Liaison, DiaSorin
Magic Lite, Siemens
Modular E & cobas e601, Roche
Opus, Siemens
Pathfast, Mitsubishi
Stratus CS, Siemens
Tosoh AIA
Triage, Biosite
Vidas, bioMerieux
Vitros ECi, Ortho
Other, please specify below

98. Do you measure CK-MB mass for diagnosis of myocardial infarction?

Yes    No

99. Do you measure CK-MB mass for risk stratification

Yes    No

100. Do you measure CK-MB mass for infarct size estimation

Yes    No

101. Do you measure CK-MB mass for other purposes or other clinical situations? Please specify

Yes    No

102. Do you measure CK-MB mass in plasma?

Yes    No

103. Do you measure CK-MB mass in serum?

Yes    No

104. How is the CK-MB mass test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

105. If in batches, how often are these run per day?

Once
Two times
Three times
More often

106. Turn-around time (in minutes) for routine CK-MB mass requests (sample taken from patient to the validated result):

measured    estimated

107. Turn-around time (in minutes) for routine CK-MB mass requests (sample received in the lab to the validated result):

measured    estimated

108. Turn-around time (in minutes) for emergency CK-MB mass requests (sample taken from patient to the validated result):

measured    estimated

109. Turn-around time (in minutes) for emergency CK-MB mass requests (sample received in the lab to the validated result):

measured    estimated

110. What is your decision limit for CK-MB mass. If you use two limits, put the lower one here?


111. If you use two decision limits for CK-MB mass (i.e. the upper reference limit for healthy and the decision limit for AMI), put the higher one here.


112. Was the decision limit for CK-MB mass derived from

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile limit of a reference distribution)
ROC curve
Other (please specify)

113. If a reference population upper limit was used, where was it obtained?

Volunteers with screening for cardiac risk factors
Volunteers with no screening for cardiac risk factors
Blood donors
Manufactures' supplied data
Published literature

114. The source of the value chosen for the CK-MB mass decision limit(s) for AMI was:

Assay package insert information
Validation according to IFCC / NACB Recommendation 1999
ESC / ACC consensus statement 2000
Universal definition of MI (2007)
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision / reference limits

115. Do you have any criteria regarding frequency of CK-MB mass testing and number of samples to be collected? If yes, please specify.

Yes    No

116. Do you have internal quality control for CK-MB mass?

Yes    No

117. Do you have external quality assessment for CK-MB mass?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

118. Do you measure CK-MB activity? If no, go to question 143.

Yes    No

119. How many CK-MB activity tests do you analyse per year?


120. CK-MB activity test name

Electrophoresis
Immunoinhibition
Vitros 250-950, Ortho
Vitros DT60, Ortho
Other, please specify below

121. Do you measure CK-MB activity for diagnosis of myocardial infarction?

Yes    No

122. Do you measure CK-MB activity for monitoring of myocardial infarction?

Yes    No

123. Do you measure CK-MB activity for risk stratification

Yes    No

124. Do you measure CK-MB activity for infarct size estimation

Yes    No

125. Do you measure CK-MB activity for other purposes or other clinical situations? Please specify

Yes    No

126. Do you measure CK-MB activity in plasma?

Yes    No

127. Do you measure CK-MB activity in serum?

Yes    No

128. How is the CK-MB activity test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

129. If in batches, how often are these run per day?

Once
Two times
Three times
More often

130. Turn-around time (in minutes) for routine CK-MB activity requests (sample taken from patient to the validated result):

measured    estimated

131. Turn-around time (in minutes) for routine CK-MB activity requests (sample received in the lab to the validated result):

measured    estimated

132. Turn-around time (in minutes) for emergency CK-MB activity requests (sample taken from patient to the validated result):

measured    estimated

133. Turn-around time (in minutes) for emergency CK-MB activity requests (sample received in the lab to the validated result):

measured    estimated

134. What is your decision limit for CK-MB activity. If you use several limits, put the lowest one here?


135. If you use two or three decision limits for CK-MB activity (i.e. the upper reference limit for healthy and the decision limit for AMI), put the second here.


136. If you use three decision limits for CK-MB activity, put the third (highest) here.


137. Was the decision limit for CK-MB activity derived from

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile limit of a reference distribution)
ROC curve
Other (please specify)

138. If a reference population upper limit was used, where was it obtained?

Volunteers with screening for cardiac risk factors
Volunteers with no screening for cardiac risk factors
Blood donors
Manufactures' supplied data
Published literature

139. The source of the value chosen for the CK-MB activity decision limit(s) for AMI was:

Assay package insert information
Validation according to IFCC / NACB Recommendation 1999
ESC / ACC consensus statement 2000
Universal definition of MI (2007)
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision / reference limits

140. Do you have any criteria regarding frequency of CK-MB activity testing and number of samples to be collected? If yes, please specify.

Yes    No

141. Do you have internal quality control for CK-MB activity?

Yes    No

142. Do you have external quality assessment for CK-MB activity?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

143. Do you measure myoglobin? If no, go to question 166.

Yes    No

144. How many myoglobin tests do you analyse per year?


145. myoglobin test name

Access, Beckman Coulter
ACS:180, Siemens
Advia Centaur, Siemens
AiO, Innotrac
Architect STAT, Abbott
AxSym, Abbott
BN 2, Siemens
Cobas Integra, Roche
Elecsys & cobas e411, Roche
Immulite 2500, Siemens
Immulite, Siemens
IMx, Abbott
Konelab, Thermo Electron
Liaison, DiaSorin
Modular E & cobas e601, Roche
Pathfast, Mitsubishi
Stratus CS, Siemens
Tina-Quant, Roche
Triage, Biosite
Vidas, bioMerieux
Vitros 250-950, Ortho
Other, please specify below

146. Do you measure myoglobin for diagnosis of myocardial infarction?

Yes    No

147. Do you measure myoglobin for risk stratification

Yes    No

148. Do you measure myoglobin for infarct size estimation

Yes    No

149. Do you measure myoglobin for other purposes or other clinical situations? Please specify

Yes    No

150. Do you measure myoglobin in plasma?

Yes    No

151. Do you measure myoglobin in serum?

Yes    No

152. How is the myoglobin test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

153. If in batches, how often are these run per day?

Once
Two times
Three times
More often

154. Turn-around time (in minutes) for routine myoglobin requests (sample taken from patient to the validated result):

measured    estimated

155. Turn-around time (in minutes) for routine myoglobin requests (sample received in the lab to the validated result):

measured    estimated

156. Turn-around time (in minutes) for emergency myoglobin requests (sample taken from patient to the validated result):

measured    estimated

157. Turn-around time (in minutes) for emergency myoglobin requests (sample received in the lab to the validated result):

measured    estimated

158. What is your decision limit for myoglobin. If you use two limits, put the lower one here?


159. If you use two decision limits for myoglobin (i.e. the upper reference limit for healthy and the decision limit for AMI), put the higher one here.


160. Was the decision limit for myoglobin derived from

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile limit of a reference distribution)
ROC curve
Other (please specify)

161. If a reference population upper limit was used, where was it obtained?

Volunteers with screening for cardiac risk factors
Volunteers with no screening for cardiac risk factors
Blood donors
Manufactures' supplied data
Published literature

162. The source of the value chosen for the myoglobin decision limit(s) for AMI was:

Assay package insert information
Validation according to IFCC / NACB Recommendation 1999
ESC / ACC consensus statement 2000
Universal definition of MI (2007)
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision / reference limits

163. Do you have any criteria regarding frequency of myoglobin testing and number of samples to be collected? If yes, please specify.

Yes    No

164. Do you have internal quality control for myoglobin?

Yes    No

165. Do you have external quality assessment for myoglobin?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

166. Number of admitted patients with suspected heart failure per year


167. Number of hospitalized patients with final diagnosis of heart failure per year


168. Laboratory service availability for the diagnosis of heart failure (number of hours per day, for example 8 or 24)


169. Do you measure BNP? If no, go to question 190.

Yes    No

170. For which type of population do you offer these tests?

outpatients
emergency department
coronary unit
other, please specify

171. How many BNP tests do you analyse per year?


172. BNP test name

Abbott
Bayer
Biosite
Roche
Other, please specify below

173. Do you measure BNP in Heparin plasma?

Yes    No

174. Do you measure BNP in EDTA plasma?

Yes    No

175. Do you measure BNP in serum?

Yes    No

176. How is the BNP test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

177. If in batches, how often are these run per day?

Once
Two times
Three times
More often

178. Turn-around time (in minutes) for routine BNP requests (sample taken from patient to the validated result):

measured    estimated

179. Turn-around time (in minutes) for routine BNP requests (sample received in the lab to the validated result):

measured    estimated

180. Turn-around time (in minutes) for emergency BNP requests (sample taken from patient to the validated result):

measured    estimated

181. Turn-around time (in minutes) for emergency BNP requests (sample received in the lab to the validated result):

measured    estimated

182. What is your decision limit for BNP. If you use two limits, put the lower one here?


183. If you use two decision limits for BNP put the higher one here.


184. Was the decision limit for BNP derived from

Reference values: upper reference limit
Reference values: multiple of URL
Other (please specify)

185. Was the decision limit for BNP determined by...

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile of a reference distribution)
ROC curve
Other (please specify)

186. The source of the value chosen for the BNP decision limit(s) was:

Assay package insert information
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision/reference limits
Published literature

187. Do you have any criteria regarding frequency of BNP testing and number of samples to be collected? If yes, please specify.

Yes    No

188. Do you have internal quality control for BNP?

Yes    No

189. Do you have external quality assessment for BNP?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment

190. Do you measure NT-pro-BNP? If no, go to end.

Yes    No

191. For which type of population do you offer these tests?

outpatients
emergency department
coronary unit
other, please specify

192. How many NT-pro-BNP tests do you analyse per year?


193. NT-pro-BNP test name

Abbott
Bayer
Biosite
Roche
Other, please specify below

194. Do you measure NT-pro-BNP in Heparin plasma?

Yes    No

195. Do you measure NT-pro-BNP in EDTA plasma?

Yes    No

196. Do you measure NT-pro-BNP in serum?

Yes    No

197. How is the NT-pro-BNP test assayed in the central laboratory?

stat
routine
batch
usually in batches but can be done stat if required

198. If in batches, how often are these run per day?

Once
Two times
Three times
More often

199. Turn-around time (in minutes) for routine NT-pro-BNP requests (sample taken from patient to the validated result):

measured    estimated

200. Turn-around time (in minutes) for routine NT-pro-BNP requests (sample received in the lab to the validated result):

measured    estimated

201. Turn-around time (in minutes) for emergency NT-pro-BNP requests (sample taken from patient to the validated result):

measured    estimated

202. Turn-around time (in minutes) for emergency NT-pro-BNP requests (sample received in the lab to the validated result):

measured    estimated

203. What is your decision limit for NT-pro-BNP. If you use two limits, put the lower one here?


204. If you use two decision limits for NT-pro-BNP put the higher one here.


205. Was the decision limit for NT-pro-BNP derived from

Reference values: upper reference limit
Reference values: multiple of upper reference limit
Other (please specify)

206. Was the decision limit for NT-pro-BNP determined by...

Assay imprecision (concentration at 10% CV)
Reference interval (99th percentile of a reference distribution)
ROC curve
Other, please specify

207. The source of the value chosen for the NT-pro-BNP decision limit(s) was:

Assay package insert information
Peer-reviewed literature
Age and gender related reference limits
Locally derived decision/reference limits
Published literature

208. Do you have any criteria regarding frequency of NT-pro-BNP testing and number of samples to be collected? If yes, please specify.

Yes    No

209. Do you have internal quality control for NT-pro-BNP?

Yes    No

210. Do you have external quality assessment for NT-pro-BNP?

No external quality assessment
National quality assessment
European quality assessment
International quality assessment