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To maximize your ability to detect changes in cleaning performance, knowing that worker-to-worker variability is a key factor, it is recommended that one (1) room per every 20 discharges (5% of rooms) be monitored by collecting five (5) samples per room. This sample size provides the statistical power sufficient to detect a 10% change in cleaning performance. This approach is also recommended in the CDC Options for Evaluating Environmental Cleaning Toolkit.10 The Clean-Trace Online Software helps you track your progress by generating different report types that make it possible to carry out process improvements in a timely manner.
When determining which rooms to sample, it is recommended that the rooms chosen represent the cleaning efforts of all EVS staff members. This ensures adequate representation of the worker-to-worker variability within your institution. You can also apply this approach to terminally cleaned Operating Rooms.
3M Tier 2A Plan – Summary Routine Monitoring
3M Tier 2B Plan – Monitoring High-Risk Areas and Equipment All areas within the hospital are not created equal in regards to the amount and level of daily and terminal cleaning. Based on the potential for transmission of infection via environmental surfaces, a monitoring strategy should be created for different areas of the hospital. This is typically determined by a risk assessment. As with any risk assessment process, high risk areas should be monitored, results recorded and the data used to drive process improvements, thus ensuring high standards of infection prevention practice.
The Tier 2B plan has all the same elements as the Tier 2A plan with the addition of monitoring high risk areas and equipment. These high risks areas and surfaces should be monitored more frequently (every discharge or daily, as appropriate) as part of a risk-based approach to your monitoring program.
This will help you to identify adverse trends and developing problems in a timely fashion.
It is recommended that all contact isolation rooms, transplant patient rooms, ICUs and hemodialysis units are considered when deciding which high risk areas to include in your monitoring program. For example, if your facility has a high rate of Clostridium difficile infection, then all C. difficile isolation rooms would be the targeted highrisk area to include in Tier 2B of the 3M Recommended Monitoring Plan. Inclusion of mobile equipment, such as IV stands and mobile blood pressure units, in your monitoring program is also recommended.
3M Tier 2B Plan – Summary Routine Monitoring + High Risk Monitoring + Mobile Equipment = Total # Swabs/Day
An Objective Approach Implementation of an ATP hygiene monitoring system The successful implementation of an ATP hygiene monitoring program requires
consideration of the following topics:
1. Identification of test points and sample plans
2. Pass/Fail threshold recommendation
3. Determination of testing frequency
4. Collection of data
5. Establish metrics for each tier implemented
6. Establishment of corrective action procedures
7. Continuous improvement steps These topics are discussed in the remaining pages of this document.
1. Identification of test points and sample plans Selection of surfaces and areas to be monitored should focus on where poor environmental hygiene represents a high risk of cross-contamination. In addition, test points should be selected with the goal of providing realistic feedback on the hygienic status of the test area and be reflective of overall environmental cleanliness.
A sample plan for a particular area is comprised of a list of test points. Consideration of the level of risk needs to be taken into account when selecting test points i.e. high dependency and intensive care units where patients are more susceptible to risk of infection.
The list below provides some points to be considered when choosing testing points for inclusion in a sample plan.
• The test point provides representative feedback and data for current cleaning procedures.
• The test point should represent a surface at high risk of cross contamination to patients and hospital staff. These test points include those surfaces in close proximity to the patient, e.g. overbed table or bed rails.
• Test points should include those surfaces routinely used in the care of patients and subject to a high level of handling, e.g. buttons and handles on equipment and patient contact surfaces.
• Test points should be chosen from areas where there is likely to be a high level of organic build up resulting in high levels of contamination. Build up of high levels of organic residue is usually a consequence of a high level of contact or movement as well as “people” traffic in an area, e.g. buttons, door plates/handles, light switches.
• Test points should encompass surfaces that are difficult to clean, e.g. textured surfaces, irregular surfaces, surfaces difficult to reach.
• Test points located on equipment that is routinely cleaned immediately after use e.g. commodes.
Example test points and sample plans are included in Appendix 1 at the end of this document.
2. Pass/Fail Threshold Recommendation The recommended Pass/Fail values are derived from best practice standards. These levels are based on published clinical data and are also used in successful ATP monitoring programs.2,12,14
The recommended Pass and Fail ranges are as follows:
3. Determination of testing frequency In order to obtain valid feedback, sufficient data sets must be collected. This is especially important in the early implementation stages if a true understanding of current cleaning capability is to be achieved. Moreover, sufficient data is required to allow accurate trending of data on an ongoing basis and to provide key stakeholders with enough result based evidence to make any changes or decisions regarding existing cleaning practices.
The determination of the frequency of testing should take into consideration several 12 different factors which may include gathering enough data to make a statistically valid determination of cleaning performance, risk assessment and consideration of available resources. It is important that a valid frequency of testing be used that allows adaptation of continual improvement practices.
Tier 2A of the 3M Recommended Monitoring Plan focuses on terminally cleaned rooms. Because the number of terminally cleaned rooms is determined by the number of patient discharges, it is reasonable to base the frequency of testing on patient discharge rate.
The CDC Options for Evaluating Environmental Cleaning Toolkit recommends a testing frequency of 5% of rooms per evaluation cycle unless there is deterioration in practice.10 The 3M Tier 2A Plan recommends testing 1 room per every 20 discharges (5%).
Areas identified as high risk should be monitored after every terminal clean.
This will minimize the risk incurred by either a vulnerable patient population (e.g. transplant patients) or a room with higher probability of cross-contamination (e.g. contact isolation rooms). Increased frequency of monitoring is also recommended during situations where high endemic rates of multidrug resistant organisms (MDROs) are present as well as during outbreak situations.
4. Collection of Data When collecting monitoring data, it is suggested that results be carefully recorded as evidence of the process of implementation. It is recommended that the 3M™ Clean-Trace™ Online Software be used for this purpose.
Data is collected from the identified test points as listed in a sample plan for a specific area.
In order to accurately determine the level of cleaning efficacy being achieved, sufficient quantities of results need to be collected. It is recommended that the number of data points collected be sufficient so that a 10–20% change in cleaning performance can be detected.10 This measure of performance is described in the Options for Evaluating Environmental Cleaning Toolkit as a TDC score (%Pass ). This score is calculated as the # of objects cleaned / total # of objects evaluated x 100.10 Translated for use with the 3M™ Clean-Trace™ Hygiene Management System, cleaning efficacy is assessed by calculating the percent of surfaces cleaned that achieve a Pass threshold value of ≤ 250 RLU. The Clean-Trace Online Software will automatically calculate a %Pass (TDC score) value for a defined set of data.
A sample size that provides the statistical power to detect a 10% change in cleaning performance (%Pass) is 300 test points. To maximize the ability to detect changes in cleaning performance, it is recommended that results from 300 test points be obtained by sampling five (5) test points per room in sixty (60) terminally cleaned rooms. Data collection should be an ongoing process to provide feedback on the level of cleaning efficiacy.
Results should be collected over a sufficient time period to take into account any variation in the environment as a consequence of patient turnover or worker-to-worker variability. This will help in understanding changes that may impact cleaning procedures.
It should be noted that individual test points and areas may exhibit different ranges of RLU values reflective of varying levels of cleaning efficacy. For example, intensive care units may show noticeably lower RLU levels as a consequence of stricter cleaning protocols when compared to general patient areas. Similarly, individual test points may also show a wide range of RLU values. This type of variation results from multiple
• The nature of the surface being tested. For example, stainless steel surfaces are easier to clean than other surfaces and may routinely achieve lower RLU results than other surface types
• The age of the surface. Older surfaces may be more damaged, scratched or marked, presenting a greater surface area and opportunity for the build-up of organic contamination and formation of biofilm making the cleaning process more difficult
• Ease of access to the surface for cleaning
• Cleaning method employed
5. Establish metrics for each tier implemented Metrics are standards of measurements by which the efficiency of your cleaning process, efficacy of training programs as well as progress on a quality improvement plan can be quantitatively assessed. Metrics should reflect the objectives of your monitoring program and will evolve and change as, over time, you implement the various tiers of the 3M Recommended Monitoring Plan. Careful consideration should be given to your choice of metrics as they form the basis for continual improvement processes.
Metrics should be established for each tier of the program implemented. The Clean-Trace™ Online Software can be used to automatically record, track and trend the metrics established for each tier of the program implemented at your facility.
See below for suggestions for appropriate metrics.
In general, for all three Tiers, it is recommended that 80% of test points show RLU values ≤ 250 (80% Pass).10
3M Tier 2A Plan Metrics – Routine Monitoring of the Effectiveness of Terminal Cleaning Cleaning effectiveness – % Pass/Fail for each level of your monitoring plan (Hospital, Unit, Room) allows tracking and trending of cleaning effectiveness – % Pass/Fail for each test point allows identification of highest failing test points so you can focus your process improvement efforts 3M Tier 2B Plan Metrics – Monitoring High Risk Areas and Equipment Follow the recommended metrics for the 3M Tier 2A Plan and apply to high risk areas (e.g. Contact Isolation Rooms) Cleaning Effectiveness – Mobile Equipment – % Pass/Fail for each piece of mobile equipment allows for tracking and trending of cleaning effectiveness
6. Establishment of corrective action procedures A corrective action procedure is the process of intervention designed to address any any identified non-conformance. In the case of ATP monitoring, this is related to those actions taken in response to monitoring results (%Pass). The course of action will need to be determined at the unit level and will be related to the level of risk.