Rilibak - German Guidelines for

Quality
An unofficial English translation of the RiliBÄK (Richtlinien der Bundesärztekammer). The
term ‘RiliBÄK’ is an abbreviation meaning literally the Guidelines ("Rili") of the German
Federal Medical Council (BÄK).

Posted October 2009

 Analytes in Plasma, Serum or Whole Blood

 Analytes in Urine
 Analytes in Cerebrospinal Fluid

These guidelines include specifications for Acceptable % Root Mean Standard Deviation (RMSD)
and Acceptable relative deviation for interlaboratory tests.

There are two types of target values listed for the interlaboratory test specifications. RMW means
that a Reference Method Value was used to set the guideline. SW means that a target value specific
for the test method (more like a peer group median) was used to set the guideline.

For more information on the meaning and use of these recommendations, read the accompanying
guest essay by Jim Pierson-Perry and Oswald Sonntag.

Analytes in Plasma, Serum, and Whole Blood

Validity range of columns 3 Type of

Acceptable
and 5 target
relative
Acceptable value
# Analyte deviation
% RMSD lower upper in
units in interlab
limit limit interlab
tests
tests
Activated partial
1 thromboplastin time 10.5% 20 120 s 18.0% SW
(aPTT)
Alanine 20 300 U/L RMW
2 aminotransferase 11.5% 21.0%
(ALT) 0.33 5.0 ukat/L
3 Albumin 12.5% 20 70 g/L 20.0% SW
4 Alkaline phoshatase 13.0% 20 600 U/L 21.0% SW
(AP)
0.33 10 ukat/L
alpha-
5 17.0% 5 250 U/L 24.0% SW
Fetoprotein(AFP)
Aspartate 20 400 U/L RMW
6 aminotransferase 11.5% 21.0%
(AST) 0.33 6.67 ukat/L
 >2 30 mg/dL
13.0%
>34 513 umol/L
7 Bilirubin (total) 22.0% SW
0.1 ?2 mg/dL
22.0%
1.7 ? 34 umol/L
8 Ca 19-9 14.0% 5 300 KU/L 27.0% SW
9 Calcium (total) 6.0% 1 6 mmol/L 10.0% RMW
7.5% >1 2.5 mmol/L 15.0%
10 Calcium (ionized) SW
14.5% 0.2 ?1 mmol/L 18.0%
11 Carbamazepin 12.0% 2 20 mg/L 20.0% SW
Carcinoembryonic
12 14.0% 1 200 ug/L 24.0% SW
antigen (CEA)
13 Chloride 4.5% 70 150 mmol/L 8.0% RMW
50 350 mg/dL
14 Cholesterin (total) 7.0% 13.0% RMW
1.3 9.1 mmol/L
>60 500 ug/L
16.0%
>166 1380 nmol/L
15 Cortisol 30.0% RMW
20 60 ug/L
18.5%
55 ? 166 nmol/L

Creatine kinase 50 1000 U/L

16 11/0% 20.0% RMW
(CK) 0.83 16.7+ ukat/L
C-reactive protein
17 13.5% 1 120 mg/L 20.0% RMW
(CRP)
18 Digitoxin 15.5% 5 80 ug/L 30.0% RMW
14.0% >1 5 ug/L
19 Digoxin 30.0% RMW
17.5% 0.5 ?1 ug/L
20 Erythrocytes 4.0% 1.5 7 1012/L 8.0% RMW
10 500 ng/L
21 Estradiol, 17-beta 22.0% 35.0% RMW
37 1835 pmol/L

Ethanol (clin. 9.0% >0.06 5 g/L 12.0%

22 SW
toxicological) 15.0% 0.2 ? 0.6 g/L 21.0%
23 Ferritin 13.5% 10 600 ug/L 25.0% SW
24 11.5% 20 300 U/L 21.0% RMW
 Gamma-Glutamyl-
0.33 5 ukat/L
Transferase (y-GT)
25 Glucose 11.0% 40 400 mg/dL 15.0% RMW
2.2 22 mmol/L
26 Hematocrit 5.0% 10 60 % 9.0% TV
0.1 0.6 L/L
27 Hemoglobin 4.0% 2 20 g/dL 6.0% RMW
1.2 12.4 mmol/L
Hemoglobin A1c
(HbA1c)
Hemoglobin beta
28 chain (Blood)-N-(1- 10.0% 30 140 mmol/molHb 18.0% RMV
deoxyfructos-1-yl)
haemoglobin beta
chain
29 Uric acid 7.0% 2 13 mg/dL 13.0% RMW
119 773 umol/L
30 Urea 10.5% 20 200 mg/dL 20.0% RMV
2.5 33 mmol/L
31 Human chorionic 14.0% >100 1500 IU/L 30.0% TV
gonadotropin (hCG)
17.0% 2 ? 100 g/L
32 Immunoglobulin A 12.0% 0.5 6 g/L 20.0% SW
33 Immunoglobulin G 10.0% 4 30 g/L 180.0% SW
Immunoglobulin
34 13.0% 0.4 5 g/L 26.0% SW
MA
35 Potassium 4.5% 2 8 mmol/L 8.0% RMW
36 Creatinine 11.5% 0.5 10 mg/dL 20.0% RMW
44 884 umol/L
37 Lactate 11.0% 9 90 mg/dL 18.0% SW
1 10 mmol/L
38 Lactate 9.0% 100 700 U/L 18.0% RMW
dehydrogenase
(LDH) 1.67 11.7 ukat/L
39 Leukocytes 6.5% 2 30 109/L 18.0% RMV
40 Lipase 12.0% 10 350 U/LM 25.0% SW
 0.17 5.83 ukat/L
41 Lithium 6.0% 0.3 3.5 mmol/L 12.0% RMW
42 Magnesium 7.5% 0.3 3.5 mmol/L 15.0% RMW
43 Sodium 3.0% 110 180 mmol/L 5.0% RMW
44 pCO2 6.5% 15 110 mmHg 12.0% SW
45 pH 0.4% 6.75 7.80 0.80% RMW
46 Pheonbarbital 10% 8 80 mg/L 20.0% SW
47 Phenytoin 11.0% 3 35 mg/L 20.0% SW

Phosphate 1 10 mg/dL
48 9.0% 16.0% RMW
(anorganic) 0.3 3.2 mmol/L
5.5% >125 350 mmHg 12.0%
49 pO2 7.0% >80 ? 125 mmHg 18.0% SW
11.0% 40 ? 80 mmHg 18.0%
>5.0 35 ug/L
17.0%
> 16 111 nmol/L
50 Progesterone 35.0% RMW
0.2 ? 5.0 ug/L
22.0%
0.6 ? 16 nmol/L
Prostate-specific
51 15.5% 0.2 50 ug/L 25.0% SW
antigen (PSA)
52 Protein (Total) 6.0% 0.2 50 ug/L 10.0% RMW
0.2 50 ug/L
53 Testosterone 20.5% 35.0% RMW
0.7 69 nmol/L
54 Theophylline 13.0% 3 40 mg/L 24.0% RMW
Thromboplastin
55 11.5% 10 120 % 23.0% SW
time
7.5% >300 700 109/L 13.0%
56 Thrombocytes 8.5% >150 ? 300 109/L 15.0% SW
13.5% 40 ? 150 109/L 18.0%
Thyrotropic
57 13.5% 0.1 40 mU/L 24.0% SW
hormone (TSH)
0.5 22 ug/L
58 Thyroxine, total 12.5% 24.0% RMW
6.4 283 nmol/L
 >20 85 ng/L
14.0%
Thyroxine, free >26 109 pmol/L
59 24.0% SW
(FT4) 2 ? 20 ng/L
15.5%
2.6 ? 26 pmol/L
60 Transferrin 9.5% 0.5 6 g/L 15.0% SW
60 400 mg/dL
61 Triglycerides 9.0% 16.0% RMW
0.68 4.6 mmol/L
>1.2 10 ug/L
15.0%
Triiodine thyronine, >1.8 15 nmol/L
62 24.0% SW
total (T3) 0.2 ? 1.2 ug/L
16.0%
0.3 ? 1.8 nmol/L

Triidione thyronine, 1 25 ng/L

63 14.5% 24.0% SW
free (T3) 1.5 39 pmol/L
64 Troponin I 20.0% 0.1 35 ug/L 33.0% SW
16.0% >1 8 ug/L
65 Troponin T 33.0% SW
21.0% 0.08 ?1 ug/L
66 Valproic acid 11.5% 20 150 mg/L 20.0% SW
13.0% >15 100 mg/L
67 Vancomycin 21.0% SW
15.% 4 ? 15 mg/L

Table B 1 b: Analytes in urine

Validity range of Acceptable

type of target
columns 3 and 5 relative
value
Acceptable deviation
# Analyte in
% RMSD lower upper in
units interlaboratory
limit limit interlaboratory
tests
tests
1 Albumin 15.0% 1 500 mg/L 26.0% SW
2 Calcium 8.5% 0.5 6 mmol/L 17.0% SW
100 4000 mg/L
3 Glucose 11.0% 22.0% RMW
0.6 22 mmol/L
4 Uric acid 13.5% 5 300 mg/L 23.0% RMW
 30 1784 umol/L
0.1 20 g/L
5 Urea 13.5% 21.0% RMW
1.7 333 mmol/L
6 Potassium 8.5% 2 140 mmol/L 15.0% RMW
0.01 3 g/L
7 Creatinin 12.0% 21.0% RMW
0.1 27 mmol/L
8 Sodium 6.5% 50 200 mmol/L 12.0% RMW

Phosphate 30 900 mg/L

9 11.5% 20.0% SW
(anorganic) 1 29 mmol/L
10 Protein (total) 11.5% 5 10000 mg/L 24.0% SW

Table B 1 c: Analytes in cerebrospinal fluid

Validity range of Acceptable

Type of target
columns 3 and 5 relative
value
Acceptable deviation
# Analyte in
% RMSD lower upper in
units interlaboratory
limit limit interlaboratory
tests
tests
1 Albumin 13.5% 20 1000 mg/L 23.0% SW
20 300 mg/dL
2 Glucose 9.5% 18.0% RMW
1.1 17 mmol/L
Immunoglobulin
3 15.5% 2 40 mg/L 27.0% SW
A
Immunoglobulin
4 12.0% 15 500 mg/L 20.0% SW
G
Immunoglobulin
5 15.5% 1 30 mg/L 33.0% SW
M
10 99 mg/dL
6 Lactate 11.5% 20.0% SW
1.1 11 mmol/L
7 Protein (total) 13.5% 10 2000 mg/L 23.0% SW
Rilibak: Quality Goals the
German way
Jim Pierson-Perry and Oswald Sonntag discuss the German RiliBÄK rules. These new
guidelines set new specifications for quality, both for performance of laboratories in EQA as
well as routine operations. New concepts like the %Root Mean Square Deviation are
introduced and explained.

October 2009

Jim Pierson-Perry
Senior Key Expert-Biochemistry
Siemens Healthcare Diagnostics

Oswald Sonntag
Senior Scientist
Ortho-Clinical Diagnostics

See an unofficial English translation of the RiliBÄK guidelines.

German law mandates a set of quality regulations, known as the RiliBÄK, which govern medical
devices in laboratory medicine. These regulations are further tied to the European IVD directive and
the ISO standards e. g. 15189. They are updated periodically to reflect changes in clinical need of
regulated analytes, as well as improvements in technological capability of the devices. The most
recent update was proposed in 2007. It is in partial effect now, with full implementation due by April
2010.

What are the RiliBÄK? Richtlinien der Bundesärztekammer

RiliBÄK are literally the Guidelines ("Rili") of the German Federal Medical Council (BÄK). Much
like CLIA limits in the US, they are meant to provide minimum requirements for the quality of
quantitative test results in medical laboratories. Unlike CLIA, these guidelines do not cover any
qualitative tests yet. An update with qualitative and also serological assays will follow within the
next year.

The RiliBÄK quality requirements are synchronized with the well-known ISO 15189 principles and
standards. But going beyond the ISO generalities, the RiliBÄK also set specific quality requirements
/ allowable errors / uncertainty recommendations. The 2007 guidelines mandate specifications for 67
analytes in serum and whole blood, as well as 10 analytes in urine, and 7 in cerebrospinal fluid.
While that list may seem small, the guideline also give a method for determining specifications for
any unlisted analytes, as well as the permission for laboratories to apply the specifications of listed
analytes to similar unlisted analytes .

A laboratory must do proficiency testing (PT), external quality control, or peer comparison testing
for any analytes that they test which is listed in the RiliBÄK tables. For those analytes not listed in
the RiliBÄK, laboratories are strongly encouraged to do PT, but is it not mandatory. For the analytes
where PT is mandatory, if the laboratory fails two successive PT events for the same analyte, a
report must be filed with the government. Germany's equivalent (BfARM) of the FDA is to receive
the notice and investigate the deficiencies. A fine up to 25,000 Euros is possible, although it is not
yet known how these failures and investigations will be handled.

The RiliBÄK guidelines are somewhat unusual in that they don't describe total allowable errors, as
we think of them in the US. Instead, in some cases the specifications are supposed to be written
directly onto the daily control charts. Here's the difference: In the US, CLIA sets an allowable error
limit for the result but labs still use 2s, 3s, etc. limits on their charts. In Germany, the laboratories are
encouraged to draw the error specifications directly on their control charts.

Another unique aspect of the RiliBÄK is that the guideline cover both internal assessment of quality
as well as external assessment. The internal assessment guideline are designed to assess a
laboratory's quality using only a manufacturer-supplied target value and the laboratory's routine QC
data. These assessments are done on a daily basis as well as retrospective over a period of time
(referred to as a Control Cycle). The external assessment guideline is for comparing laboratory
results with those of a peer group, proficiency testing group, or other external quality assessment.

How were the RiliBÄK recommendations developed?

The German Federal Medical Council conducted several surveys to determine the specifications. At
first a large number of laboratories was surveyed, then a smaller working group of 20 laboratories
was surveyed again. This workgroup was selected to contain representatives of all types of
laboratories, from small clinics to large reference labs. Preliminary quality targets were calculated
from data submitted by the laboratory working group. After trimming 10% of results from the
extremes, the remaining 90% range of values was used to formulate the final guideline

%RMSD = Root Mean Square Deviation

The 2007 RiliBÄK release introduced a new quality metric for internal assessments, Root Mean
Square Deviation, abbreviated as %RSMD, and expressed as a percentage relative to a target value.
Previous versions of the RiliBÄK used separate quality goals for bias and imprecision. These were
replaced by the %RMSD in a move toward a total analytical error type of metric, expressed in a way
similar to the ISO concepts of uncertainty. The %RMSD is computed from data acquired during a
Control Cycle (CC), which is a period of time that contains at least 15 observations, generally about
one month of data, but not more than 3 months.

where:

SDcc = standard deviation

Bias = difference of observed mean from Target Value (TV)
k = statistical “coverage factor” to account for uncertainty (1 for metric, 3 to calculate specification)
TV = Target Value for the control sample (from manufacturer)

Two approaches, Two time periods for internal assessments

The RiliBÄK provide a set of explicit goals for the listed analytes. The tables also provide a
concentration range for the tests - if your test value is within the specified range, then you can use
the specification given in column 3 of the table. Note that multiple ranges are provided in several
cases (e.g., total bilirubin, digoxin, ethanol, etc.) where performance goals at low analyte
concentrations are different than for the rest of the range. If your level is outside the concentration
range(s) listed in the table, however, then you must consider that the test is not on the list and use the
second approach.

The second approach directs you to develop internal assessment goals for tests not found on the list,
or for concentration ranges not found on the list. This requires use of the %RMSD (Root mean
standard deviation) equation above, with a coverage value of k=3, and a set of data from one Control
Cycle. Note: you still need an assigned target value from the manufacturer in order to calculate the
bias component and to express the result in percentage units. This calculated %RMSD result
becomes the Lab Observed Specification and is done separately for each level of control used in
your laboratory.

Once you have the %RMSD goal, either from the RiliBÄK tables or the calculated Lab Observed
Specification, you can begin internal assessment. There are two periods of time when this internal
assessment should be performed. First, there should be a daily assessment of control results versus
the Error Margin (the Target Value ± %RMSD goal). Your laboratory's daily control values should
not exceed the respective Error Margin. Secondly, there should be a retrospective check for Control
Cycle. For each level of control, calculate the mean, SD, bias, and %RMSD from the daily control
results over the entire Control Cycle. Your calculated values should not exceed the respective
%RMSD goals.

If an individual daily control result exceeds its Error Margin, the method is out-of-control and
results are not released until a cause is identified and corrected. You may need to run additional QC
or validation in order to resume the method. If the monthly retrospective result exceeds the goal, the
method is out-of-control. You must perform the same corrective actions as with the individual
control result failure, but you may also need to do more to revalidate the method. The consequences
of failing consecutive retrospective assessments are more severe, requiring significantly more effort
and documentation to revalidate the method, as well as potentially needing to notify the Federal
authority. The lab has to inform the federal authority as soon as they may fail two times (two
months) in a row.

External Assessment Goals.

The external assessment goals in the RiliBÄK were established through the survey process as well
as with the help of consultants and specialists. It is intended that the analytes and specifications in
the tables will be regularly reviewed and updated, although a formal process or specific time interval
has not been specified.

Laboratories must take part in Proficiency Testing or External Quality Assessment events, also
known as Ring Trials, at least every six months for the mandated analytes, as a certificate of passing
from the RiliBÄK is only good for six months. Depending on the analyte, however, testing may be
offered more frequently, up to eight times a year.

Another unique feature of the RiliBÄK is that the goals also indicate the grading system. Roughly
half of the mandated analytes are supposed to be graded against a reference method (designated in
the table as RMV), the others only against the peer group median (designated in the table as TV).
Part of this reflects the greater effort in Germany to establish reference methods for external QC.

So, are the RiliBÄK really good?

It's refreshing to see new thinking in the setting of quality requirements. The RiliBÄK bring several
new approaches and calculations to the field. True, not everyone will agree with or even consult
these guideline. Indeed, outside of Germany there is no mandate to use them. (In a future article, we
will discuss some of the RiliBÄK calculations in depth and compare them to existing guidelines).
However, these guidelines certainly provide food for thought and a new perspective. The concept
that the guidelines will be periodically adjusted and updated to reflect the state of the laboratory is
probably the best feature of the guidelines. For too long, the regulations and requirements in the US
have been set in stone. Allowing a set of guidelines to evolve should be a part of any and all future
quality specifications.

See an unofficial English translation of the RiliBÄK guidelines.

Rilibak: Quality Goals the

German way
Jim Pierson-Perry and Oswald Sonntag discuss the German RiliBÄK rules. These new
guidelines set new specifications for quality, both for performance of laboratories in EQA as
well as routine operations. New concepts like the %Root Mean Square Deviation are
introduced and explained.

October 2009

Jim Pierson-Perry
Senior Key Expert-Biochemistry
Siemens Healthcare Diagnostics

Oswald Sonntag
Senior Scientist
Ortho-Clinical Diagnostics

See an unofficial English translation of the RiliBÄK guidelines.

German law mandates a set of quality regulations, known as the RiliBÄK, which govern medical
devices in laboratory medicine. These regulations are further tied to the European IVD directive and
the ISO standards e. g. 15189. They are updated periodically to reflect changes in clinical need of
regulated analytes, as well as improvements in technological capability of the devices. The most
recent update was proposed in 2007. It is in partial effect now, with full implementation due by April
2010.

What are the RiliBÄK? Richtlinien der Bundesärztekammer

RiliBÄK are literally the Guidelines ("Rili") of the German Federal Medical Council (BÄK). Much
like CLIA limits in the US, they are meant to provide minimum requirements for the quality of
quantitative test results in medical laboratories. Unlike CLIA, these guidelines do not cover any
qualitative tests yet. An update with qualitative and also serological assays will follow within the
next year.

The RiliBÄK quality requirements are synchronized with the well-known ISO 15189 principles and
standards. But going beyond the ISO generalities, the RiliBÄK also set specific quality requirements
/ allowable errors / uncertainty recommendations. The 2007 guidelines mandate specifications for 67
analytes in serum and whole blood, as well as 10 analytes in urine, and 7 in cerebrospinal fluid.
While that list may seem small, the guideline also give a method for determining specifications for
any unlisted analytes, as well as the permission for laboratories to apply the specifications of listed
analytes to similar unlisted analytes .

A laboratory must do proficiency testing (PT), external quality control, or peer comparison testing
for any analytes that they test which is listed in the RiliBÄK tables. For those analytes not listed in
the RiliBÄK, laboratories are strongly encouraged to do PT, but is it not mandatory. For the analytes
where PT is mandatory, if the laboratory fails two successive PT events for the same analyte, a
report must be filed with the government. Germany's equivalent (BfARM) of the FDA is to receive
the notice and investigate the deficiencies. A fine up to 25,000 Euros is possible, although it is not
yet known how these failures and investigations will be handled.

The RiliBÄK guidelines are somewhat unusual in that they don't describe total allowable errors, as
we think of them in the US. Instead, in some cases the specifications are supposed to be written
directly onto the daily control charts. Here's the difference: In the US, CLIA sets an allowable error
limit for the result but labs still use 2s, 3s, etc. limits on their charts. In Germany, the laboratories are
encouraged to draw the error specifications directly on their control charts.

Another unique aspect of the RiliBÄK is that the guideline cover both internal assessment of quality
as well as external assessment. The internal assessment guideline are designed to assess a
laboratory's quality using only a manufacturer-supplied target value and the laboratory's routine QC
data. These assessments are done on a daily basis as well as retrospective over a period of time
(referred to as a Control Cycle). The external assessment guideline is for comparing laboratory
results with those of a peer group, proficiency testing group, or other external quality assessment.
How were the RiliBÄK recommendations developed?

The German Federal Medical Council conducted several surveys to determine the specifications. At
first a large number of laboratories was surveyed, then a smaller working group of 20 laboratories
was surveyed again. This workgroup was selected to contain representatives of all types of
laboratories, from small clinics to large reference labs. Preliminary quality targets were calculated
from data submitted by the laboratory working group. After trimming 10% of results from the
extremes, the remaining 90% range of values was used to formulate the final guideline

%RMSD = Root Mean Square Deviation

The 2007 RiliBÄK release introduced a new quality metric for internal assessments, Root Mean
Square Deviation, abbreviated as %RSMD, and expressed as a percentage relative to a target value.
Previous versions of the RiliBÄK used separate quality goals for bias and imprecision. These were
replaced by the %RMSD in a move toward a total analytical error type of metric, expressed in a way
similar to the ISO concepts of uncertainty. The %RMSD is computed from data acquired during a
Control Cycle (CC), which is a period of time that contains at least 15 observations, generally about
one month of data, but not more than 3 months.

where:

SDcc = standard deviation

Bias = difference of observed mean from Target Value (TV)
k = statistical “coverage factor” to account for uncertainty (1 for metric, 3 to calculate specification)
TV = Target Value for the control sample (from manufacturer)

Two approaches, Two time periods for internal assessments

The RiliBÄK provide a set of explicit goals for the listed analytes. The tables also provide a
concentration range for the tests - if your test value is within the specified range, then you can use
the specification given in column 3 of the table. Note that multiple ranges are provided in several
cases (e.g., total bilirubin, digoxin, ethanol, etc.) where performance goals at low analyte
concentrations are different than for the rest of the range. If your level is outside the concentration
range(s) listed in the table, however, then you must consider that the test is not on the list and use the
second approach.

The second approach directs you to develop internal assessment goals for tests not found on the list,
or for concentration ranges not found on the list. This requires use of the %RMSD (Root mean
standard deviation) equation above, with a coverage value of k=3, and a set of data from one Control
Cycle. Note: you still need an assigned target value from the manufacturer in order to calculate the
bias component and to express the result in percentage units. This calculated %RMSD result
becomes the Lab Observed Specification and is done separately for each level of control used in
your laboratory.

Once you have the %RMSD goal, either from the RiliBÄK tables or the calculated Lab Observed
Specification, you can begin internal assessment. There are two periods of time when this internal
assessment should be performed. First, there should be a daily assessment of control results versus
the Error Margin (the Target Value ± %RMSD goal). Your laboratory's daily control values should
not exceed the respective Error Margin. Secondly, there should be a retrospective check for Control
Cycle. For each level of control, calculate the mean, SD, bias, and %RMSD from the daily control
results over the entire Control Cycle. Your calculated values should not exceed the respective
%RMSD goals.

If an individual daily control result exceeds its Error Margin, the method is out-of-control and
results are not released until a cause is identified and corrected. You may need to run additional QC
or validation in order to resume the method. If the monthly retrospective result exceeds the goal, the
method is out-of-control. You must perform the same corrective actions as with the individual
control result failure, but you may also need to do more to revalidate the method. The consequences
of failing consecutive retrospective assessments are more severe, requiring significantly more effort
and documentation to revalidate the method, as well as potentially needing to notify the Federal
authority. The lab has to inform the federal authority as soon as they may fail two times (two
months) in a row.

External Assessment Goals.

The external assessment goals in the RiliBÄK were established through the survey process as well
as with the help of consultants and specialists. It is intended that the analytes and specifications in
the tables will be regularly reviewed and updated, although a formal process or specific time interval
has not been specified.

Laboratories must take part in Proficiency Testing or External Quality Assessment events, also
known as Ring Trials, at least every six months for the mandated analytes, as a certificate of passing
from the RiliBÄK is only good for six months. Depending on the analyte, however, testing may be
offered more frequently, up to eight times a year.

Another unique feature of the RiliBÄK is that the goals also indicate the grading system. Roughly
half of the mandated analytes are supposed to be graded against a reference method (designated in
the table as RMV), the others only against the peer group median (designated in the table as TV).
Part of this reflects the greater effort in Germany to establish reference methods for external QC.

So, are the RiliBÄK really good?

It's refreshing to see new thinking in the setting of quality requirements. The RiliBÄK bring several
new approaches and calculations to the field. True, not everyone will agree with or even consult
these guideline. Indeed, outside of Germany there is no mandate to use them. (In a future article, we
will discuss some of the RiliBÄK calculations in depth and compare them to existing guidelines).
However, these guidelines certainly provide food for thought and a new perspective. The concept
that the guidelines will be periodically adjusted and updated to reflect the state of the laboratory is
probably the best feature of the guidelines. For too long, the regulations and requirements in the US
have been set in stone. Allowing a set of guidelines to evolve should be a part of any and all future
quality specifications.

See an unofficial English translation of the RiliBÄK guidelines.

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