How Smart is My Process Water?
The water supplied to your Central Sterile Processing equipment is one of the most important inputs to your medical device reprocessing activities. Like any other process with inputs, “garbage in equals garbage out,” which means that if the inputs to your process do not meet specifications, then it will inevitably affect the outcomes and result in what is commonly known as Surgical Site Infections (SSI’s). This ultimately affects the overall quality of patient care your facility can provide. The key to any successful process outcome is the ability to monitor, adjust and control those inputs and activities that affect process outcomes. This is what having Smart water is all about.
Why is regularly monitoring your water quality necessary?
The Center for Medicare and Medicaid Services (CMS) recognized the negative impact that water quality was having on Hospital Acquired Infections (HAI’s) and SSI’s. In 2017 CMS issued Policy Memorandum S&C 17-300 establishing requirements for hospitals to have a water quality management program that consists of a Program Team, functional maps and diagrams of your facility’s water system, a method of routine risk assessment, a control diagram, and a way to monitor the system through testing or other methods to confirm that it is conforming to the various governing specifications. For 2022 the Joint Commission is issuing an Environment of Care Standard EC.02.05.22 that recognizes the requirements by CMS for water quality management by the facility. What does this mean for hospitals? It means during a facility audit you will be asked to produce documentation that you comply.
What does this mean for the Central Sterile Department?
Most hospital quality management programs recognize and point to the specifications and guidelines established through FGI (Facilities Guidelines Institute), ASHRAE (American Society of Heating, Refrigeration, and Air-conditioning Engineers), and CMS which are either similar or point directly to those established by the Association for the Advancement of Medical Instrumentation (AAMI) which fall under the umbrella of ANSI/ISO (American National Standards Institute/International Organization for Standardization). This organization consists of representatives that are the stakeholders in the use and re-use of medical instruments. There are representatives from hospitals, manufacturers, and service providers that are directly involved in the creation of standards with the goal to improve the outcomes of surgery that involve reusable instruments. What does this mean for the Central Sterile Department? It means a reduction in rejected instrument sets and fewer Surgical Site Infections. AAMI TIR34 is the document that most hospital quality programs cite as their water quality standard for their sterile processing operations. This document requires periodic (daily, weekly, monthly, quarterly, yearly) monitoring of various aspects of water chemistry, as well as the health and performance of the water purification equipment. The AAMI working group responsible for this guideline is finishing its work to transition this to a standard, ST108. In its current draft form, it expands the parameters that need to be monitored and may now include steam quality. Most Central Sterile Departments would find it challenging to prove they are complying with the current guideline subject to this new scrutiny by CMS and the Joint Commission because their monitoring program is limited, and in some cases their water purification and delivery systems do not conform to current best practices. While the technology exists to automate this data acquisition process and make it much more actionable, in general it has not been tailored to water quality requirements in the Central Sterile Department.
Many hospitals are unaware of the importance of monitoring and documentation processes, and how they contribute to the optimal operation of their system, the production of high-quality water, and reductions in SSIs and instrument set rejection rates.
We don’t talk about our water that much at our facility.
You are not alone! Most facilities have limited water quality and equipment monitoring and are not doing it in a meaningful way. The suppliers of the water purification equipment typically offer basic preventive maintenance and consumables replacement on some periodic interval based on what your facility has decided to purchase. Regular disinfecting of the Central Sterile critical water system, as well as the plumbing to the point of use, should be occurring regularly, while at many facilities it may only be occurring in the dialysis clinic and not the Central Sterile Department.
Another aspect of water as an input to your process that is often neglected by your water equipment purification suppliers is the water you are using at your process sinks and equipment that is not going through a demineralization process (RO or DI). AAMI refers to this as utility water. The water that is being fed to you by the hospital, in most cases municipal water, may meet AAMI utility water specifications, but often does not. This is true of many places in the United States. The challenge for Central Sterile departments is they often depend upon facility supplied hot and cold utility water and steam feedwater. These often don’t meet the unique and specific needs of the Central Sterile Department. Instruments that are subject to poor water quality prior to the steps that involve purified water will corrode, stain, and spot instruments, experience wet packs, elevated bioburden levels, and biofilms, and potentially contribute to rejected sets and SSI’s. Poor water quality also impacts the performance, maintenance, and uptime of sterile reprocessing equipment.
What about steam?
Another aspect of water quality that is being expanded in the draft ST108 standard is the requirement for steam condensate testing. Steam quality and specifications are included as part of AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, the governing standard for Central Sterile Processing use of steam sterilizers. Continuously Monitored pH of Department Utility Water; The pH of the utility water that is being used at the sinks, in the washers, and ultrasonic exceeds the guidelines at this facility and is not acceptable for use in Sterile Processing operations. Treating the incoming utility water is advisable in this case.
Steam quality is important for some of the same reasons that water quality is important. Poor steam
quality can lead to instrument spots, corrosion, wet packs, bioburdens, and biofilms. House steam from your facility’s plant will not necessarily meet the requirements for wetness, superheating, and compressible gasses. Steam piping in your facility can contribute to the problem as well as the initial quality of the boiler water and how it is treated. Any water management plan should include steam quality monitoring. There are dozens of pieces of data a facility could/should be monitoring regarding their water and purification equipment that impact outcomes, but that capability isn’t readily available from most water purification equipment suppliers.
In summary, there is a lack of a comprehensive approach to all aspects of treating, purifying, monitoring, and managing the Central Sterile water quality which is creating a serious problem in the industry today.
What should we do to improve our process?
Facilities should review the requirements from CMS and then determine how they apply to their Central Sterile Department. Work with your building facilities group to determine what and how to monitor and control your water quality. Most people don’t realize it, but the chemical makeup of water from your municipality can change seasonally since many cities will often change or introduce additional water sources depending on the season and usage. Your monitoring system should be capable of identifying these changes, alerting you, and then being able to be adjusted to respond to the new inputs.
What makes water smart?
A water production and usage system that is monitored and controlled to a specification is adequate. A water production and usage system that is “Smart” leverages current data logging and controls technology to enable the equipment, or those managing the system, to be notified and then adjust as soon as a problem begins to manifest itself. Most water management plans are designed to avoid a problem or respond to a problem after it happens. A “Smart” system can respond as or even before the problem occurs. Like any other process, there are key indicators that change when the process is becoming unstable, is Out of Trend (“OOT”), or Out of Specification (“OOS”).
Current guidelines and proposed standards may not specify a monitoring frequency that is frequent enough for a department to catch a problem proactively. For example, if the source of the water seasonally changes, under current guidelines, it could be a month or longer before a testing or monitoring event would catch the problem. During this time, the department would be processing instruments with substandard water and causing rejected instrument sets and SSI’s.
How do I make my water smart?
The best approach to making your water Smart is to find a partner that is knowledgeable about Sterile Processing, Water Management, and modern controls technology as it pertains to water purification and monitoring. The partner should be able to speak intelligently about AAMI TIR34 and the proposed ST108. They should have experience working with water testing labs. Most hospitals don’t understand that many water testing laboratories are focused on meeting the EPA standard for potable and wastewater, and some are focused on meeting the AAMI guidelines for dialysis water. However, not many laboratories are knowledgeable in the unique needs of Sterile Processing water or have equipment that can provide the minimum reporting limits (“MRL”) sufficient to meet the requirements for AAMI utility and critical water in the Central Sterile Department. In some cases, this means the results may be meaningless or at best inaccurate.
A strong partner should also be able to engineer a system that complies with current and future requirements. Finally, they should be able to work with you on an ongoing basis on monitoring and reporting so that you can demonstrate you comply and prove to your management that there is a correlation between your water management program and a reduction in SSI’s and significant cost savings.