Using ATP in Healthcare Settings

Adenosine triphosphate (ATP) is an enzyme that is present in all living cells, and an ATP monitoring system can detect the amount of organic matter that remains after cleaning an environmental surface, a medical device or a surgical instrument. Hospitals are using ATP-based sanitation monitoring systems to detect and measure ATP on surfaces as a method of ensuring the effectiveness of their facilities sanitation efforts. The amount of ATP detected, and where this ATP was detected, indicates areas and items in the healthcare setting that may need to be recleaned, and the possible need for improvement in a healthcare facilitys cleaning protocols. We asked members of industry -- 3M, Charm Sciences, Ecolab Inc., Neogen and Ruhof -- to share best practices for ATP as used in a program to fight healthcare-acquired infections (HAIs).

What should healthcare professionals know about the importance of cleaning validation in the healthcare setting?

3M: In the CDC guidelines for multipledrug-resistant organisms, it is recommended that hospitals "monitor cleaning performance to ensure consistent cleaning and disinfection of surfaces in close proximity to the patient..." To gauge the effectiveness of a cleaning program, most healthcare facilities rely on visual inspection as a cleaning monitoring method. Although easy to implement, visual inspection has been shown to be inadequate for ensuring proper cleaning has been performed.

Charm Sciences: Proper procedures and policies need to be in place to monitor daily cleaning effectiveness using methods beyond visual assessment. With increased risk of hospital acquired infections, healthcare professionals need real-time results in order to make good decisions regarding proper cleaning and disinfection of rooms before the next patient admission. Monitoring patient rooms, as well as other departments, is a proactive approach with measurable results, helping reduce HAIs and ultimately saving money due to better cleaning.

Ecolab: With the increasing evidence that the environment plays a key role in the transmission of pathogens to patients, there is now an emphasis on objectively measuring cleaning outcomes as a means to reduce the bioburden in patient care areas. Weve seen the most success in organizations whose environmental services and infection prevention departments work together to monitor, evaluate and improve the cleanliness of the environment. To properly address environmental hygiene, there are several key components that must be in place to deliver improved cleaning outcomes. These include such critical process inputs as consistent delivery of the correct disinfectant concentration including compensation for the absorption of disinfectant by cleaning textiles; training and implementation of infection control best practices to prevent cross-contamination between rooms; standardized processes to ensure that high-touch surfaces are consistently disinfected; and an objective process to measure program effectiveness. To improve cleaning outcomes, healthcare facilities must consider a comprehensive, programmatic approach that incorporates dispensing accuracy, standardized processes, outcomes measurement and ongoing training.

Neogen: Healthcare professionals should recognize the critical role that unerringly thorough cleaning has on the overall patient experience. This relates to everything from HCAHPS scores, to community reputation, to the transmission of infectious agents or environmental HAIs. Because of its critical nature, cleaning should be regularly validated, verified and monitored. The role of cleaning in a healthcare setting has moved beyond simple aesthetics to being an integral part of a robust infection control program.

Ruhof: Reducing the number of healthcare-acquired infections (HAIs) is a major concern for all medical facilities. One way of doing this is being able to validate cleaning. Currently there are only two ways to do that. The first is to visually inspect the item after cleaning, which is very inaccurate; the human eye is unable to see micro-contamination which can cause HAIs. The second is to take a culture and send it to a lab for testing. This could take anywhere from two days to a week, during which time if there is any contamination it will remain present until the results come back. A new method to validate cleaning is measuring the amount of ATP on a surface. If ATP is present ,then there is micro-contamination on that surface. Ruhofs ATP Complete® monitoring device allows you to accurately measure the amount of micro-contamination on any surface in just 15 seconds. If there is micro-contamination present, the surface can be re-cleaned immediately and retested to make sure it has been removed. This will significantly help in lowering the risk of HAIs.

How does an ATP-based product/system best fit into a program of healthcare environmental hygiene/instrument reprocessing?

3M: Using the 3M Clean-Trace Hygiene Management System as an environmental hygiene monitoring tool, one can improve the consistency and quality of their facility cleaning practices and protocols. By using the data collected one is able to gauge the effectiveness of their current or modified cleaning practices as well as monitor them. The data results can be used to demonstrate and train personnel on the importance and effectiveness of proper cleaning practices and adherence to protocols.

Charm Sciences: Charm Pocketswab Plus ATP swabs provide a true measure of 'hygiene' and 'cleanliness' by detecting both microorganisms and bio-burden residues present on surfaces in 5 seconds. Conventional microbiological methods detect only microorganisms and can take up to 48 hours for results. If ATP residue is left on a surface, it can provide a nutritious medium for microbial growth and act as a barrier to the direct action of both cleaners and disinfectants. Cleaning agents, when used properly with appropriate contact time, remove ATP. The Pocktswab Plus ATP test demonstrates due diligence and adherence to quality standards in cleaning and sanitizing, thereby providing documentable evidence of corrective actions taken. Improved hygiene and cleaning standards along with daily monitoring will help reduce micro-organisms in the hospitals and provide a safer, cleaner environment. When using the Pocketswab Plus for monitoring cleaning effectiveness in the central sterile processing areas, the swabs can be used as a tool to optimize the cleaning procedures to verify washers/sonicators are properly removing bioburden from instruments.

Ecolab: The measurement of ATP by a bioluminescence reaction has been successfully used in the food industry as an alternative method of monitoring environmental contamination for many years. Within the healthcare industry, the use of ATP as an educational and training tool may have some merit because there is some relationship between RLU readings and environmental cleanliness. However, the use of ATP as a hygiene audit tool is not recommended because the relationship between RLU and environmental cleanliness it is not directly equivalent to microbial monitoring, as both living and recently killed organisms "spill" ATP on surfaces at various rates. Consequently, there is no known correlation between ATP level and numbers of microorganisms, and therefore potential pathogens, present on a surface. Additionally, ATP is not produced in certain microbes, most notably viruses, and ATP-based systems will not detect the presence of these organisms on a surface. A study conducted by Ecolab, presented at APIC 2009, demonstrated that used, but laundered, microfiber cloths may give a false positive reading for ATP as evidenced high RLU readings with no viable bacteria present. Finally, because there are significant differences in the sensitivity and reproducibility of results of ATP systems offered by different manufacturers, its application within the healthcare environment should be approached with caution and awareness of the limitations of the system.

Neogen: An ATP cleaning verification and tracking system provides environmental services managers a tool to gauge their teams cleaning effectiveness on an ongoing basis. It provides immediate and trend data for making important decisions on the status of cleaning activities on any particular day, while providing an objective metric for future improvement and best practice objectives. This tool allows the managers to move beyond the janitorial aspects of their jobs to being a part of the HAI solution. Working in conjunction with infection preventionists, they can help develop programs that serve a bigger purpose and become true partners in a comprehensive patient-care effort.

Ruhof: The ATP Complete® System is an invaluable tool for all departments in the hospital that are responsible for cleaning. It can be used by environmental services to test high-risk areas in the hospital to make sure they are being cleaned properly and often enough. Sterile processing can use it to test surgical instruments after cleaning to validate that the automatic washer is performing up to standard. It can be used to test the inside walls of the washers, counter tops, trays, etc. Endoscopy can use it to test the cleanliness of scopes surfaces and inside channels, scope cabinets, carts, etc. Surgery can use it to test operating tables, operating room carts, equipment, and any item that is used during surgical procedures. Infection control managers work hard at preventing cross contamination what better way to provide them with information than using the ATP Complete® to test the levels of contamination on areas that they feel are the greatest risk to patients and staff. A test program can be created to spot-check the cleanliness of surfaces or integrate regular testing as a way of monitoring the cleaning of items on an on-going basis.

If you manufacture a product for instrument applications, describe how it works.

3M: 3M Health Care is investigating the expansion and use of the 3M Clean-Trace ATP Surface Test for additional applications including use on surgical instruments.

Charm Sciences: The Charm novaLUM and Pocketswab Plus can be used to monitor the cleaning of hand-washed surgical instruments/endoscopes or instruments coming out of the washing system/sonicator before the sterilization process.

Neogen: Neogens AccuPoint HC utilizes a luminometer to measure the light produced by the reaction of ATP with the chemicals luciferin and luciferase. The luminometer detects the amount of light that is being produced from the chemiluminescent reaction occurring in the sampling devices. When an ATP sampler is used, ATP is collected on the sampling tip. When the device is activated by pushing the plunger through the cartridge, the ATP on the sampling tip mixes with luciferin and luciferase contained in the sampler. The system also features a liquid buffering agent to counteract the effects of sanitizers. Since the amount of luciferin and luciferase are fixed, the amount of light produced by the reaction is directly proportional to the amount of ATP collected. The dirtier the surface, the more ATP that is collected, and the more light that is produced. The luminometer reads the light and reports the reading in relative light units (RLUs). Most often, thresholds are established for pass, marginal and fail levels.

Ruhof: AAMI and AORN recommend weekly performance verification of washer disinfectors. Currently the only way to test the washers is to insert a protein test to see if it is dissolved during cleaning. Using the ATP Complete® you can actually swab the surface of instruments when they come out of the washer to see if there is any microbial contamination on the surface. This will not only give you a much more accurate and reliable confirmation if your washer is performing up to specs, but will also provide documented proof that your instruments are clean. ATP Complete® can also be used to spot check the cleanliness of any scope the outside surface with the use of the Test® Swab, and even the inner channel of the scope using the revolutionary Test® InstruSponge an exciting first for scope reprocessing services. The results are instant and if scopes or instruments do show microbial contamination they can be sent back to be re-cleaned and then retested.

If you manufacture a product for environmental hygiene applications, describe how it works.

3M: The 3M Clean-Trace Hygiene Management System uses adenosine triphosphate (ATP) bioluminescence technology that enables the user to assess the cleanliness of a surface and validate the efficacy of cleaning protocols. The test can be performed in less than 30 seconds. ATP is measured using a luciferin-luciferase bioluminescence assay that uses ATP to generate a light signal measured in Relative Light Units (RLU). The RLUs are quantified using the hand-held 3M Clean-Trace NGi Luminometer. The relationship between the amount of ATP and the amount of light produced is linear; the more organic residue that is present on a surface the more light is produced. ATP test results can be tracked and trended using the powerful and flexible 3M Clean-Trace Online Software. A sample plan is created that includes all test points with their associated Pass/Caution/Fail levels expressed in RLUs. The sample plans are then downloaded to the hand-held Clean-Trace Luminometer and used to direct the actual testing. Using the web based interface the data is captured, uploaded to a secure server, and automatically analyzed producing seven different types of reports. At a scheduled frequency reports are automatically generated and emailed in pdf format to identified stakeholders.

Charm Sciences: The Pocketswab Plus test is a user friendly swab device with a patented thread design to ensure proper activation from operator to operator. Swab the surface and twist down to activate the device. Once activated, the Pocketswab Plus is inserted in to the Charm novaLUM instrument where a numeric result is displayed in 5 seconds. The higher the numeric results (RLU=relative light unit), the dirtier the surface. A pass/fail interpretation is provided on the display of the novaLUM in real-time allowing healthcare professionals to perform re-cleaning should a failing result occur. When a surface has been cleaned properly the Pocketswab Plus will read 0 RLU and "pass" will be displayed.

Ecolab: DAZO® is a fluorescent marking gel that can be applied to high-touch surfaces to evaluate patient room cleaning. DAZO leaves a consistent circular mark which is invisible in natural light but fluoresces under a black light. To objectively evaluate cleaning, high touch objects such as bed rails, call buttons, light switches, toilet seats, and other objects are marked with DAZO before the room is cleaned. After cleaning, the high touch areas are inspected with a black light to determine if the marks were cleaned. If the mark is removed, the surface has been wiped with a wet cloth. If the mark is still intact, the surface has not been wiped.

Ruhof: Microbial contamination can be present in any location spreading infections to patients, visitors and facility staff. In the typical examination room patients can pick up contamination from exam room tables, or even from instruments used during examinations. Another location that can harbor contamination is the public and staff restrooms within healthcare facilities. The ATP Complete® can be used to test the level of contamination on sinks, faucets, soap dispensers, towel dispensers, and doors to check. The same can be said for any clinical waiting area chairs, tables, door surfaces can all carry contamination. How do you know that the cleaning protocols for these high-trafficked areas are effective? The ATP Complete® System now provides a 15 second test that will verify if the surfaces are clean.

What differentiates your product in the marketplace?

3M: The 3M Clean-Trace Integrated Solution reaches beyond just the 3M Clean-Trace ATP Surface Test and 3M Clean-Trace NGi Luminomenter; it also provides the customer the 3M Clean-TraceOnline Software that can be used for data tracking and trending. This software can generate graphs and reports for monitoring and verifying cleaning practices and can be used for educational and training purposes.

Charm Sciences: The Charm Sciences novaLUM uses a sensitive ATP photomultiplier detector which complements microbiological methods. The novaLUM results provide an early warning indicator to measure environmental surface cleanliness and evaluate the effectiveness of cleaning regimens. The novaLUM photomultiplier detector provides cutting edge sensitivity by detecting the lowest level of ATP residue on a surface thus driving a better level of clean. The Pocketswab Plus contains a lysing agent to help break open cells from both bacterial and non-bacterial sources, releasing ATP for better detection of surface contamination. The Pocketswab Plus is pre-moistened with a bio-film breaking detergent which is considered GRAS (Generally Recognized as Safe). The room-temperature stable swabs eliminate the need for refrigeration and have a 12-month shelf-life. These technological advancements reduce shipping waste associated with ice packs/Styrofoam coolers, helping customers meet their green initiatives. The Pocketswab Plus swabs are the only recyclable ATP test available. Charm Sciences offers swab site customization on the novaLUM, streamlining implementation upon delivery. On-site training is included to properly educate staff.

Ecolab: The EnCompassTM Environmental Hygiene Program combines highly accurate dispensing, clinically tested microfiber cloths and tools, standardized procedures and effective training programs to help facilities improve cleaning outcomes. The EnCompass program uses DAZO® Fluorescent Marking Gel to objectively measure process outcomes, collect data and help drive continuous cleaning improvement. This method allows immediate feedback on cleaning results and provides opportunities for data driven, ongoing training for environmental services staff. Used together, the tools and cleaning chemistries of the EnCompass program and the DAZO marking gel help ensure that the surfaces where DAZO marks are removed were properly cleaned. After implementing the comprehensive EnCompass program at a 650-bed urban hospital and a 350-bed non-urban hospital, a study evaluating cleaning effectiveness found a higher correlation between the removed DAZO marks and 0 CFU culture than before the implementation of the program, showing that the comprehensive program coupled with DAZO monitoring delivered decreased bioburden.1

Neogen: Neogens AccuPoint Healthcare (HC) ATP cleaning verification and tracking system is the only system designed for the unique needs of healthcare facilities. Other manufacturers have simply brought the same ATP systems they market to the food production industry to the healthcare market. Also, only our AccuPoint HC system utilizes a robust flat sponge-tip sampler instead of the typical Q-tip-type swab. Our sampler provides a much more consistent sample, which translates to a more consistent result. This is extremely important for valid long-term comparisons of surfaces throughout the facility. Neogens Data Manager HC software is an easy-to-use management tool that provides the facility with data focusing on whats happening with areas, rooms, test sites, employees and equipment to really see whats happening with cleaning in the facility. It has a number of performance reports that can be utilized to understand best practices and establish performance objectives.

Ruhof: The performance of five leading commercially available ATP hygiene monitoring systems were compared in the largest independent study of its kind. Linearity, sensitivity, repeatability, precision and accuracy are the major requirements of an effective ATP system. The findings indicate that some of the systems show large variations and background interference which significantly affects their ability to meet the performance criteria. The most accurate and most sensitive system on the market to detect ATP was revealed to be Ruhof ATP Complete®. Flexible and rigid scopes with hard to access internal channels pose a unique challenge for monitoring cleanliness. For this reason Ruhof created the Test® InstruSponge, an absorbent swab on a flexible wand, which feeds into the internal channels of a scope, allowing you for the first time to get an accurate indication of remaining bioburden. The Test® InstruSponge, used in conjunction with the ATP Complete®, is the only product available that can provide an accurate numerical reading of the level of contaminants present inside the channels of your scopes and cannulated instruments after cleaning.

What should healthcare professionals look for when evaluating an ATP-based product/system?

3M: When evaluating an ATP-based system, one should look first at data reliability parameters such as sensitivity and repeatability. When an ATP hygiene monitoring system has poor sensitivity or repeatability, there is a substantial risk that the result provided does not truly represent the hygienic status of the surface tested and could provide unreliable data. A system that is sensitive to low-level contamination of a surface allows you to more accurately rely on the test results. A test that will detect low level of contaminants will help ensure that you can take the appropriate action. The ability of a system to repeat results gives you peace of mind that the result is reliable and the actions taken are appropriate.

Charm Sciences: 1. Sensitivity: The ATP photomultiplier detectors and test kits should detect gram positive and gram negative bacteria at the lowest level possible. 2. Test kit shelf life: room temperature stable for 12 months. 3. Technical expertise and support with onsite education/training of staff.

Ecolab: The use of ATP as a hygiene audit tool in healthcare is not recommended due to the variability and potential for interference that the healthcare environment provides. Clearly, there is an appeal to generating quantitative data to compare clean and dirty areas rather than traditional subjective visual examination. However, outcomes using ATP as a marker cannot be directly correlated to microbial contamination and the potential for infection. An ATP RLU standard has not been set to define clean versus contaminated surfaces in the healthcare setting. A standard of 500 RLUs has been proposed, but in a study by Griffith, et al., 89 percent failed to meet the proposed standard of <500 RLUs while only 27percent of the same surfaces failed the accepted aerobic colony count cleanliness standard of <2.5 cfu/cm2.2

Neogen: The good news is that most of these systems are marketed by strong companies that have been in the business for many years. Its a proven technology, but new to the healthcare field. That said, it is incumbent on any facility considering the adoption of this technology to make sure that the system and the company behind it can support its application. Its important to work with a company that can help the facility establish an environmental monitoring program that they can stick with, and that provides value. As with many technology purchases, its what happens after the purchase that determines the technologys true value to the purchaser.

Ruhof: There are five things to take into consideration when looking into an ATP testing device. They are: linearity, sensitivity, repeatability, accuracy and precision. Linearity is the predictability and reliability of the results. This is very important when measuring very small amounts of microbial contamination. Sensitivity is the limit of detection, or the smallest amount detectable. Reliability is the variation between measurements by the same operator using the same test sample. The higher the variation means the results are less consistent and more unreliable. Accuracy is the Recovery and detection of all available ATP to reflect the true value of the sample and Precision is consistent and reliable results closest to the true value. Better accuracy and precision means more consistent and reliable results. Most systems give a good linear response to ATP, however there is a difference in the sensitivity, repeatability, precision and accuracy between systems.

Can you summarize the business case for the purchase of an ATP-based product/system?

3M: It is estimated that HAIs cost healthcare facilities 6.7 billion dollars each year.* Today every aspect of healthcare is scrutinized in an effort to reduce the risk of healthcare associated infections. According to a report by the U.S Agency for Healthcare Quality and Research the number of HAIs is on the rise. The 3M Clean-Trace Hygiene Management System provides real time, accurate and reliable results allowing users to assess and measure surface cleanliness, validate efficacy of cleaning procedures and immediately address "hot spots." A clean environment is an important factor in reducing the risk of cross contamination which can contribute to HAIs.

*Graves N. Economics and preventing hospital-acquired infection. Emerg Infect Dis. April 2004. Available from: http://www.cdc.gov/ncidod/EID/vol10no4/02-0754.htm

Charm Sciences: Proper cleaning, disinfection and monitoring of the hospital environment is an integral part to the hospital's success at reducing costs associated with HAIs and improving patient care. The Pocketswab Plus implementation should follow a tiered approach focusing on:

1. High-risk patient rooms (C. diff/MRSA): Must swab all high-touch areas post discharge until passing results on Pocketswab Plus are achieved.

2. Areas of hospital with repeated infection: Swab high touch areas daily until passing results are achieved.

3. Randomize swab monitoring of patient rooms on high touch areas to validate proper cleaning procedures are being followed.

4. Teaching tool: Proper concentration of the chemicals and contact time must be followed and monitored.

5. novaLUM results are downloaded to Excel for documentation purposes with trending/tracking capabilities.

Ecolab: Regulatory and standard setting organizations are increasingly looking for evidence that healthcare facilities have programs in place to monitor, analyze and improve the cleanliness of the environment. It is important for healthcare facilities to understand the limitations of ATP in healthcare settings. While widely used in other industries, ATP testing can have false positive results in certain contexts in healthcare environments, which must be addressed if facilities are considering ATP as an option for cleaning validation. Of particular concern is the fact that ATP is not produced in certain microbes, most notably viruses. Therefore, ATP-based systems will not detect the presence of these organisms on a surface. Since these organisms are of concern within the healthcare setting, users need to be aware of this significant limitation of ATP-based technology. Additionally, bleach based disinfectants quench the ATP reaction, giving falsely low RLU readings. Finally, other limitations of ATP that should be addressed include the fact that the results of ATP testing vary between commercially available systems, an ATP RLU standard has not been set to define clean vs. contaminated surfaces in the healthcare setting, and surface contaminants may artificially increase or decrease RLU readings.

Neogen: Everyone now knows the consequences of HAIs. No one can know if a surface is truly clean after sanitation has taken place just by looking at it. With the advent of ATP cleaning verification and tracking systems, there now exists an effective tool to measure the effectiveness of sanitation processes. A proactive monitoring program can improve the health of the facility, and its patients, by finding out whats working and what needs to change in a sanitation process. But in the real world, we all know the budget constraints and the need for an economic case for many important decisions. While improved patient satisfaction scores and a better perception from the community will likely translate to more revenue from additional patients choosing our facility, the CMS and other reimbursement bodies have also provided a business case for adopting ATP cleaning verification and tracking systems due to the threat of non-reimbursement for HAIs. It is estimated that a single reimbursement denial can cost $16,000. So if adoption of the system saves us just one of those, it has paid for itself and more.

Ruhof: Maintaining a high standard of cleanliness and lowering the risk of HAIs is an essential in all healthcare facilities. Verifying your cleaning protocols will have a significant effect on both of these. More and more, medical facilities are now being required to submit reports that include the number of HAIs to state regulatory boards. The ATP Complete® can help in lowering the risk of contamination while providing evidence of commitment to meet regulatory requirements. The ATP Complete® System is very affordable when compared to costly lawsuits and more importantly the pain and suffering of patients and family that can be caused by cross contamination.

References:

1. McCracken E, Martin K, Homan L. Evaluation of a Programmatic Approach to Improving Patient Room Cleaning Outcomes. Poster presented at the 2010 APIC annual meeting.

2. Griffith CJ, Cooper RA, Gilmore J, Davies C, Lewis M; An evaluation of hospital cleaning regimens and standards. J Hosp Infect. 2000; 45:19-28.