User Guide for the 3M™ Clean-Trace™
rapid hygiene monitoring system.
Introduction
Good hygiene practice is essential in reducing the risk of cross contamination that can
lead to transfer of potentially pathogenic organisms within the hospital environment.
Visible assessment of surfaces will not always indicate the presence of low levels of
organic residues that can harbour and protect both pathogens and other environmental
organisms that may present a significant risk to both patients and carers.
The 3M Clean-Trace system provides a solution to ensure that surfaces can be quickly
measured and assessed to provide assurance that cleaning regimes have been
effective.
3M Clean-Trace Surface ATP devices detect adenosine triphosphate (ATP), which is
present in all animal, vegetable, bacteria, yeast and mould cells. The presence of ATP
indicates contamination still remains from any one of these sources post-cleaning.
Measuring the level of ATP provides a real time indication of surface cleanliness,
demonstrating the presence of organic contamination that can both harbour and
provide a nutrient base for pathogenic bacteria to proliferate. High levels of organic
residues can also provide a protective barrier against the action of cleaning detergents.
When ATP comes in contact with the combined luciferin/luciferase reagent contained
in one of the tests, a reaction takes place which emits light in direct proportion to the
amount of ATP present. Within seconds, the 3M luminometer measures the amount of
light generated, indicating the level of contamination The level of light is measured
and presented as a number or Relative Light Unit (RLU). The greater the level of
contamination and ATP the greater the amount of light produced and the greater the
RLU number generated on the instrument.
The 3M hygiene monitoring system is also provided with Biotrack Plus software.
Sample plans containing specific sample or test points are created on the software and
these downloaded to the 3M Luminometer. Samples are taken according to specific
sample test points and the results are then logged against the test point being tested.
Results are then downloaded to the Biotrack software from the 3M Clean-Trace NG
luminometer. Biotrack Plus trend analysis software can then be used to determine the
overall effectiveness of cleaning regimes, highlight areas of concern and help in the
overall design on improved cleaning initiatives.
What kind of RLU levels can I expect and how do I use them?
The results obtained after cleaning can be influenced by a number of factors.
• The cleaning method employed.
• The effectiveness of the application of the cleaning method used.
• The nature of the surface being tested.
• The age and condition of the surface being tested.
• Frequency of cleaning.
The levels achieved will be determined by the factors above and an understanding on
the maximum level of cleaning which is achievable.
Where deep cleaning regimes are employed, information on the attainable level of
cleaning for a particular surface can be collected. However, where deep cleaning is
not a routine practice, some judgment will need to be made on levels which can be
attained on a routine basis.
Background data should be collected following cleaning procedures and based on the
results achieved an area a ward can be graded according to overall results. Pass and
Fail levels for the 3M system can be set to reflect current cleaning efficiency. Once a
grade has been determined then a systematic approach to continual improvement can
be applied.
Utilising the Biotrack Plus trend analysis software will help in identifying areas where
improvements can be made. Improvements may include
• Change in cleaning chemical used.
• Change in the cleaning procedure itself.
• Re-cleaning where high results are obtained.
• Increased focus on cleaning in areas where high results are obtained
Over time, improvements and increased awareness will be reflected in lower RLU
levels, enabling Pass and Fail levels to be set lower, and overall improvement in the
grade.
Example Grade Structure.
Grade PASS CAUTION FAIL
A 500 501-999 1000
B 750 751-1499 1500
C 1000 1001-1999 2000
D 1500 1501-2999 3000
E 2000 2001-3999 4000
F 2500 2501-4999 5000
G 3000 3001-5999 6000
Setting the Grade.
Each ward or area tested should be assessed using background results to set the initial
grade and levels to work with. Then process will involve
1. Identifying the areas or test points to be sampled.
These should test points that will provide representative data on cleaning efficiency
and also be considered as areas of a high risk of cross contamination.
2. Collection of data before cleaning.
Data should be collected before cleaning to assess the background level of
contamination existing or that can develop in the selected areas. This would only be
carried out during the implementation stage, but will provide valuable information on
the levels of contamination that can develop over time.
3. Collection of Data after cleaning.
Collection of data post-cleaning to indicate the level of cleanliness achieved by the
cleaning regime.
4. Determining the grade and Pass and Fail levels that best represent the level
of cleaning being achieved.
Once collected the data can be reviewed to determine the most appropriate grade, and
hence Pass and Fail levels to set. Setting a grade is part of a systematic approach to
continual improvement. The overall goal is to attain the best grade possible for each
selected area.
The key to this is moving initially towards consistency in cleaning efficiency and
subsequently, results. Once consistency is achieved then a grade improvement can be
considered to lower the Pass and Fail levels which have been set.
For example.
Below is a table of results for 9 test areas in a ward.
Based on the Grades A to G the result will either be Pass (P), Caution © or Fail (F) as
indicated and determined by the Pass and Fail level criteria which have been
previously set for each Grade.
Test Point Result A B C D E F G
Bedside frame 2456 F F F C C P P
Bedside hand rail 2317 F F F C C P P
Bedside cabinet 6793 F F F F F F F
Bedside Trolley 345 P P P P P P P
Bed adjuster buttons 2390 F F F C C P P
Main Ward door Handle 3431 F F F F C C C
Sink Taps 2178 F F F C C P P
Drug cabinet 3421 F F F F C C C
Ward Phone 4532 F F F F F C C
We can review the results in terms of a Graph (see below)
100.0%
90.0%
80.0%
70.0%
60.0% FAIL
50.0% CAUTION
40.0% PASS
30.0%
20.0%
10.0%
0.0%
A B C D E F G
A B C D E F G
Pass 11.1% 11.1% 11.1% 11.1% 11.1% 55.6% 55.6%
Caution 0.0% 0.0% 0.0% 44.4% 66.7% 33.3% 33.3%
Fail 88.9% 88.9% 88.9% 44.4% 22.2% 11.1% 11.1%
A Fail Rate of approximately 20% should be used to determine the best grade to set
the Pass and Fail levels, and in this case the nearest would be Grade E at 22.2%
Grade PASS CAUTION FAIL
E 2000 2001-3999 4000
Once the grade has been set the Pass and Fail levels should be used to establish
corrective action in response to results. In this case any results that fall above the 4000
RLU level would be considered as a fail result and corrective action should be taken.
This would involve re-cleaning and re-testing. The cleaning method should also be
reviewed to ensure it is meeting requirements and correct protocols are being
followed.
Once corrective actions are in place, and awareness of weaknesses in the cleaning
process identified, results should again be reviewed. This will help to determine if
there has been an improvement in cleaning consistency.
For example see table below.
Test Point Result A B C D E F G
Bedside frame 1567 F F C C P P P
Bedside hand rail 1904 F F C C P P P
Bedside cabinet 3416 F F F F C C C
Bedside Trolley 214 P P P P P P P
Bed adjuster buttons 3005 F F F F C C P
Main Ward door Handle 2315 F F F C C P P
Sink Taps 1765 F F C C P P P
Drug cabinet 1983 F F C C P P P
Ward Phone 2998 F F F C C C P
100.0%
90.0%
80.0%
70.0%
60.0% FAIL
50.0% CAUTION
40.0% PASS
30.0%
20.0%
10.0%
0.0%
A B C D E F G
A B C D E F G
PASS 11.1% 11.1% 11.1% 11.1% 55.6% 66.7% 88.9%
CAUTION 0.0% 0.0% 44.4% 66.7% 44.4% 33.3% 11.1%
FAIL 88.9% 88.9% 44.4% 22.2% 0.0% 0.0% 0.0%
In the case above there has been an improvement in overall consistency for the area
tested. We can see that approximately 20% of failures now occur in Grade D whereas
no results are failing in Grade E. In this case the area should now be moved to Grade
D, and new Pass and Fail level criteria and associated corrective actions applied.
Grade PASS CAUTION FAIL
D 1500 1501-2999 3000
When assessing results for review of cleaning efficiency it is important to only
include the initial first time result and not results after re-cleaning in response to a
failed result.
The above process of systematic improvement ensures a steady approach is taken to
ensure maintaining and improving cleaning consistency is achieved. Although it is
possible to set stricter requirements and move to a more stringent grade it is important
to ensure that cleaning consistency is maintained and radical changes to cleaning that
will impact on this are kept under control.
Use of the 3M Clean-Trace test.
Sampling technique.
How to achieve the best results with the Clean-Trace surface hygiene
test
DO hold the device in the VERTICAL position on activation and
shake rapidly from SIDE TO SIDE for at least 5 seconds and
read immediately in the luminometer.
DO NOT activate while holding out of the vertical, do not shake up
and down, do not shake like a thermometer.
DO activate when you are about to measure the device.
DO NOT activate all devices then take them to another location for
testing or activate and leave on a surface to test one at a
time
DO activate and test swabs ONE AT A TIME when testing a
number of swabs.
DO NOT activate all devices and then test one at a time.
DO place the instrument in the vertical position when reading
a device.
DO NOT hold the instrument horizontally or lay down on the bench
to read a device
DO always remove the last device from the instrument
chamber at the end of testing.
DO NOT leave a device in the chamber at the end of testing
Biotrack Plus software
Rapid ATP hygiene testing has provided many companies with the opportunity to quickly
assess the hygienic status of production surfaces before the production process starts.
Compatible with Due Diligence and HACCP initiatives, real time testing provides direct
feedback than can be acted upon immediately. But this is only half the story, the data
collected can provide valuable insight into the performance of cleaning regimes when
reviewed using trend analysis software.
Biotrack Plus has been developed with this mind, for use with 3M Clean-Trace hygiene
monitoring systems .
Biotrack Plus allows the user to create sample plans reflecting their current sampling regimes.
Plans are downloaded to the NG instrument and hygiene results collected. Results are then
uploaded to the Biotrack software and stored in the results data base. Once collected data can
be filtered and viewed and then reports and graphs created quickly and easily. Any retest
results are also available for auditing.
Filters are set up according to the data required. This may be overall data, site-specific data,
specific sample plans or test points. Data for specific time periods can then be set. Any
parameters set can be saved and then revisited, so monthly or weekly reports can be easily
created.
Pass Caution
Sample Plan Graphs
These represent an overview of a
5.94%3.85% overall site or specific sample plan
performance in term of percentage
Pass , Caution or Fail results. These
can also be overall or against time.
90.21%
Sample Plan: Ward One
Site ID: NEAS
Number of times Plan used = 33
Pass Caution Fail
100%
80%
60%
40%
20%
0%
01/01/2008
06/01/2008
12/01/2008
17/01/2008
23/01/2008
29/01/2008
31/01/2008
03/01/2008
04/01/2008
08/01/2008
10/01/2008
13/01/2008
15/01/2008
19/01/2008
21/01/2008
25/01/2008
27/01/2008
Sample Plan: Ward One
Site ID: NEAS
Number of times Plan used = 33
As well as overall sample plan reports Biotrack Plus allows the generation of graphs
against specific test points again as overall percentage Pass, Caution or Fail, and also
as a trend graph over time as shown below. These can also be set up to include any
retest results taken in response to an initial Fail results
Pass Value F Value Results Key
7000
6000
5000
4000
3000
2000
1000
0
01/01/2008
03/01/2008
04/01/2008
06/01/2008
10/01/2008
12/01/2008
14/01/2008
16/01/2008
18/01/2008
20/01/2008
24/01/2008
26/01/2008
28/01/2008
30/01/2008
08/01/2008
22/01/2008
Test Point: Bed Side Frame
Sample Plan: Ward One
Site ID: NEAS
Number of times Test Point used = 32 : Total number of Retests = 3 : Total number of Tests = 35
Sample Plan and Test Point Overall result range graphs can also be generated to show
Max, Min and the average result. This helps demonstrate the consistency of cleaning
regimes.
4000
3500
3000
2500
2000
1500
1000
500
0
Bed Bed Side Bed Side Bed Side Bed Side Drug Main Ward Sink Taps Ward
Adjuster Cabinet Fram e Hand Rail Trolley Cabinet Door Phone
Buttons Handle
Site ID: NEAS
Total number of Test Point(s) used = 9 : Total number of Plan(s) used = 1
The above graphs represent only a small sample of the options available to the nd
user.
Result reports can also be produced where a hard copy of result is required as shown
below.
In addition, Ranking reports can be produced to show the frequency of Pass, Caution
or Fail results for sample plans or Test points. This helps to identify areas of concern.
Biotrack Plus also allows the generation of a ‘master sanitation schedule’ for each
sample plan created. This presents a hygiene map of a sample plan indicating the
status of each result over a month and if the test point sampling frequency has been
met.