A Guide to Hospital Environmental Monitoring

What you need to know about critical storage regulations, liabilities, audits, instrument selection and cost controls

Introduction--Environmental Monitoring is a Hospital-Wide Concern
All too often, managers of various hospital departments tend to think that the regulations and liability issues requiring temperature and/or humidity monitoring are strictly a worry for departments other than theirs. In truth, there are few areas in a hospital where environmental monitoring is not an issue?for compliance, liabilities, and/or cost controls. It's not just a matter of laboratories using proper instrumentation for clinical testing. The critical storage conditions for blood, tissues and organs are tightly regulated, even when they are in transport. Wherever there are drugs or vaccines in refrigerators or freezers?from the pharmacy to surgery center to ICU to emergency room, patient floors, physician offices, etc.?there are strict requirements on how the temperatures in those storage areas are monitored. Similarly, sterilizer function must be checked wherever sterilization is of clinical concern and a potential liability if handled incorrectly. Many hospital supplies beyond drugs and vaccines are similarly temperature or humidity sensitive, and poorly monitored storage areas can result in unnecessary costs for replacing deteriorated inventory. In the U.S. for example, Joint Commission auditors may want to check that temperature monitoring is as much a concern to the hospital food service as to the pharmacy. Facility managers not only have to keep an eye on balancing HVAC systems for patient comfort but also need to heed the rapidly rising energy costs they incur for not doing so.

In short, this Guide to Hospital Environmental Monitoring is for any and every hospital manager concerned about compliance, liabilities, and cost controls. This Guide lays out what the range of temperature and humidity monitoring issues are throughout the hospital and provides tips on how to handle environmental monitoring most efficiently.

Regulatory Landscape
Globally, there are numerous regulatory bodies that require attention to hospital environmental monitoring, with varying statutes as to how it is to be done. A partial list in the U.S. includes: state and local health departments (various regulations, such as food handling ordinances); Center for Disease Control Guidelines; JCAHO (Joint Commission on the Accreditation of Healthcare Organizations) regulations and standards, CAMH, and Comprehensive Accreditation Manual for Laboratory, (CAMLAB); U.S. FDA (21 CFR Part 1271 re: cells and tissues, Parts 606/640 re: blood products, Part 600/610 re: biological products such as vaccines; Part 120 HACCP re: food safety, Part 110 re: Good Manufacturing Practices); and US Pharmacopeia (USP 2005 797/1050). See the charts prepared by the building controls technology expert, Siemens Building Technologies, Appendix A, which summarizes what these various U.S. regulations stipulate regarding critical storage monitoring.

What all of these regulations have in common is that they are geared to ensure that storage conditions do not have a negative impact on patient safety. Food, medicines, vaccines, blood, tissues, organs, etc. are all susceptible to deterioration if not stored at proper temperatures. While everyone would readily agree that allowing patient safety to be compromised is unacceptable, the purpose of the various regulations is to ensure that everyone has the same understanding as to what is required when safeguarding temperature (or humidity) sensitive medical supplies or food.

Generally speaking, regulations in the U.S. and worldwide, as well as good common sense, requires that you can answer the following questions:
Are you sure that the temperature measuring device (thermometer, chart recorder, data logger, etc.) is accurate?

Is adequate and timely attention being paid to critical storage temperatures? (Note: The baseline is at least twice daily monitoring and that there are reliable alarm systems in place.)

Do responsible parties know what to do if temperatures move out of range and there is suspected damage to the stored items?

Is the record keeping system adequate to document critical storage area temperatures? (Note: In some cases, these records need to be archived for at least ten years!)

This might sound straightforward enough, but to those in-the-know there are actually some wild interpretations of what the various regulations stipulate. For example, when Dickson Company was conducting research to develop the first temperature chart recorder for monitoring vaccine storage areas, we visited many doctors offices where nurses in charge of vaccine supplies, used a frozen coin in the ice cube tray as an indication that freezer temperatures remained adequately cold. The logic went that if the coins hadn't moved, then the ice cubes had remained frozen, and the vaccines had stayed cold. One can only guess that there hadn't been a recent audit of those medical offices by regulatory compliance inspectors!

Liability Concerns and Regulatory Compliance Audits
Imagine being in a court of law defending your department's due diligence when it comes to safeguarding temperature or humidity sensitive food or materials used in patient care (drugs, vaccines, blood, tissues, organs, etc.). In the relatively litigious U.S. where medical malpractice suits abound, the regulations outlined in Appendix A become the standard for both JCAHO audits and demonstration of due diligence in a court of law as well. In all liklihood you will not only need to provide documentation but will also need to demonstrate that the documentation is authentic and that processes were in place that did not allow for tampering with records., in all likelihood, but you will need to demonstrate that the documentation is authentic and that processes were in place that did not allow for tampering with records.

You can expect that many, if not all, staff members responsible for monitoring storage conditions will be cross-examined as to their knowledge of what happened in your department and if they knew the steps to take if storage temperatures were found to be out of permissible ranges.

It also will not be enough to merely state that instruments were in working order. The methods used to validate the accuracy of measuring and recording instruments will in all likelihood be called into question. (See below Calibration Requirements, Issue #1 and #3.)

When it comes to environmental monitoring, the main thing to know about audits is that ALL departments in the hospital where monitoring is required by regulations can and will be examined by auditors. The temperatures of food storage areas are just as important as those of pharmacy refrigerators. If there are clinics onsite that do not operate 7 days/week, but store medicines in refrigerators that must be continuously monitored, there needs to be mechanisms and/or instrumentation in place that can work in the off-hours. A common mistake that some top hospital executives make is to focus narrowly on laboratories and pharmacies when it comes to environmental monitoring. The real world requirements for environmental monitoring to ensure patient safety and regulatory compliance are hospital-wide.

Monitoring Instrument Options
There are basically four different instrument types available for monitoring temperatures: thermometers, chart recorders, data loggers, and new wireless technology.

Where regulations only require a twice-daily manual check of temperatures, use of a thermometer may suffice, as long as the accuracy of the thermometer is validated. There are significant drawbacks to this method, however, which one can visualize easily if you imagine being cross-examined in a court of law. Would an attorney barrage you with questions such as, "What proof do you have that the temperatures were taken at these times and not filled in after the fact?" "Were refrigerators ever unplugged by cleaning crews?", "How did your (clinic/ outpatient department/etc.) offices monitor storage conditions on the days when you were not open?", etc.

More importantly, when one considers how periodic emergencies in many hospital departments can upset routine schedules the inadequacies of manual monitoring become even more apparent. To the extent that this is a manual process, it is fraught with the possibilities for human error.

A variant on manual thermometer monitoring is to employ what is known as an alarm thermometer. In fact, many regulations outlined in Appendix A require that there be an alarm system of some kind. The better alarm thermometers one can find have remote probes for monitoring both refrigerators and freezers, tamper-resistant alarms, and also will indicate MIN/MAx temperatures as well as current readings. The downside of alarm thermometer instruments, and in heavily regulated hospital applications it is a highly significant one, is that there isn't an automatic paper trail as with chart recorders or automatic storage of data points as in data loggers or wireless data logger technology. Chart recorders, data loggers, and wireless monitoring technology are relatively liability-proof, when compared to manual logging and use of temperature indicators such as alarm thermometers, precisely because of the vast amount of tamper-proof data that they capture and can provide as evidence of environmental stability.

Chart recorders provide either a strip or circular paper record of temperature (or temperature and humidity) conditions. These paper records can be validated with dates and signatures, photocopied and filed for more than 10 years. Their main advantage is that they make data immediately accessible, even to non-technical users, and do not require any computers or computer skills. Chart recorders also can feature alarms, digital displays of MIN/MAx or current readings, remote probes, and relays for connecting to auto-dialers. Chart data can be viewed in fine granular detail (e.g. over a 24-hour monitoring period) or as relative trend data (e.g. over a 7-day monitoring period).

If maximum flexibility in how and when you analyze data is essential to your department's operations, a data logger is typically the recording instrument of choice. Data loggers are electronic instruments that enable you to store data sample points on the logger's hard drive for later download to a PC or laptop. Accompanying software makes it possible to view data in graphical or tabular form and export it to whatever data analysis applications are required for an application.

Like chart recorders, data loggers monitor a variety of temperature and/or humidity ranges. Their features include alarm options, start/stop buttons for cleaner compliance records, data display options ranging from large flat panels showing detailed graphs at a glance to simple MIN/ MAx or current condition digital readouts, with remote probes, and a variety of options on how data is downloaded, such as by using the same type of removable FLASH memory cards that are now commonplace with digital cameras.

A variant of data logger technology that is now in increasing use by hospitals, especially by facility engineering departments attempting to balance HVAC systems for maximum patient comfort and minimum energy costs, are the newer wireless data loggers. The advantage of these wireless systems is that they monitor and display in real-time on PCs and eliminate the time ordinarily needed for data downloading. In older hospitals, wireless data loggers are also a way to sidestep any wiring issues. Until recently wireless technology was not thought to be up to the demands of the hospital environment, but there are now wireless data loggers that automate data backup for more than a week and give ongoing feedback that their wireless network is intact, i.e. the kind of reliability features that are required when proof of system functioning is both a compliance issue and requirement for patient safety.

Finding the Right Monitoring Instruments for Your Department
There is no one-size-fits-all solution for environmental monitoring. Indeed there are hundreds of data loggers, chart recorders, thermometers and wireless monitoring instruments available in the marketplace, but only a small percentage of these are best match technologies for any particular hospital department.

First, consider that the regulatory requirements for monitoring temperature or temperature and humidity vary from one application to another, as suggested by Appendix A's summary vis-à-vis U.S. hospital regulations. Secondly, consider how the differences in staff patterns and staff responsibilities from one department to another make one or another "optional" feature (e.g. ability to transfer data with FLASH memory cards or the ability to show a continuous display of logger readings on one manager's PC monitor at all times) more relevant to successful environmental monitoring in that particular hospital department. Third, upfront costs of monitoring instruments need to be weighed against the ongoing costs for operating these instruments, especially in terms of labor time requirements and associated costs. Lastly, ease-of-use features need to be considered as ways to ensure that monitoring procedures are adhered to, and that use of the instruments is within reach of the skill set of department staff members. For example, warehouse managers who rely on signing chart graphs and filing them rather than using computers and electronic data storage would generally opt for chart recorders, instead of data loggers.
There is a step-by-step method recommended to find the right instrument for your application.

Step One: Zero in on the chart recorders, data loggers, wireless monitoring instruments or alarm thermometers that are designed to operate within the specific temperature or temperature and humidity range of your application.
For example some temperature data loggers monitor only from -4 to 158°F (-20 to 70°C), while other models with remote probes can monitor from -300 to +2000°F (-184 to 1093°C).

Step Two: Determine how often you need to collect data. If you are using a chart recorder, the sampling rate will determine the granularity of data capture and display and also the frequency with which your staff will need to change and file data collection charts from the recorder. With data loggers, sample rate is a user selectable feature that lets you determine how frequently the instruments take a reading. Some data loggers let you sample every second, while others start sampling at every 10 seconds in 10-second increments. A facilities engineer monitoring conditions in patient rooms that will affect patient comfort might only need a sample every 10 minutes, while some laboratory testing, on the other hand, might require continuous detailed sampling every second. Sample Storage is the number of samples that can be stored in a data logger's memory before it needs to be downloaded or begins to write over old data. Depending on how often data is downloaded and upon the sample rate selected, you may require a logger with a large sample storage capacity. For example, a single channel data logger that stores 32,512 sample points that is set to a sample rate of one minute will run for 22.5 days before the memory is full. If the same data logger is set to a sample rate of every 5 minutes, it will run for 112 days before the memory is full.

(Note: Pre-determining sample rates is not usually relevant in wireless data loggers, because this is simply a setting selection to operate the instrument, meaning that the same wireless data logger could sample once every 15 minutes or once every 30 seconds, or anything in between. Data storage is limited only by the size of the computer's hard drive and remaining disk space at your disposal, which usually means there is no real limitation, practically speaking.) Step Three: Ensure that the instrument is practical and workable in the exact hospital environment where it will be used. The unit within a crowded refrigerator used for drug and vaccine storage would usually need to be compact, and zeroing in on smaller instruments would narrow the choices down. Food service departments may need to use watertight loggers that can withstand hot and wet conditions while cooking. Physician offices that want to use one instrument to monitor drug and vaccine storage in both refrigerators and freezers would be well served by models with remote probes.

Step Four: Select the real-time data display that is needed for your application. Chart recorders and data logger models are available that have digital displays of current conditions or MIN/MAx readings since the last reset. Some data loggers provide full graph-at-a-glance capabilities that make them the equivalent of a paperless chart recorder. Wireless data loggers make all information immediately accessible at the desktops of the dedicated PC assigned to the wireless receiver.

Step Five: Ensure that the models you select have the alarm systems that regulations require and that enable monitoring to be as fail safe as your application requires. For most critical applications, wireless data loggers that not only provide audio and visual alarms but also send alerts via email and text messages provide the gold standard for alarm backups. There are many thermometers, chart recorders, and standard data loggers that have some level of alarms built into them that will suffice if wireless technology is impractical for some other reason.

Calibration Requirements
The most important aspect of monitoring instrument calibration that every hospital department manager must deal with is ensuring that the calibrations are done as needed. Dickson Company provides a free reminder service to hospital department managers to notify them of scheduled calibrations required for every instrument being used in their department see http://www.dicksondata.
com/calibration/calibration_club.php. This service helps to ensure that each hospital department is as liability-proof as possible and up to regulatory standards.

While most hospital department managers with critical storage applications recognize the need to calibrate environmental monitoring instruments to validate that they are accurate in operating ranges, some may be confused as to what this really entails from a liability, compliance and patient safety standpoint.

Issue 1: "Recalibration" can mean different things, and some "recalibrations" do not adequately demonstrate the accuracy of a hospital department's recorded data (instruments). At issue are recalibrations that pre-set an instrument to the desired accuracy without first determining whether the instrument was in or out of acceptable range prior to recalibrating. These types of recalibrations are not recommended for most hospital applications. Determining an instrument's accuracy before it is recalibrated is clearly an extra step and usually costs more than a simple re-calibration. However, such before data is the only thing that will help you determine and demonstrate that your instrument was operating in acceptable ranges at all times. This would be critical if your department's temperature (and/or humidity) monitoring procedures were ever called into question in a court of law or by regulators. Don't be confused by the existence of recalibration services that do not include determinations of before data. They are not designed for the type of liabilities and demands for regulatory compliance that are inherent in hospitals.

Issue 2: A second issue is the nature of the calibration service itself.
There are two trends that have combined to jeopardize the quality standards in many clinical settings, whether recognized or not. The first is the proliferation of small metrology labs that typically do not adhere to rigorous third party accreditations. The second is the growing popularity of onsite calibration services, which are inherently disadvantaged at matching the standards achieved by off-site calibration services using less mobile but more sophisticated testing apparatus.

To make an apples-to-apples comparison of metrology lab services one must know the "best measurement uncertainty" offered by that service that is defined internationally as the ISO 17025 standard. In the U.S. a nonprofit organization, the American Association for Laboratory Accreditation (A2LA) was established in 1978 as a public service for all in need of standardized and reliable testing in keeping with the ISO 17025 standard. Getting A2LA accreditation takes time and resources, and many metrology labs, especially the great number of small startup calibration businesses that have spawned in the U.S. in the last few decades and which now call on hospital purchasing departments offering lower cost services, have often not gone through the rigors of A2LA accreditation.

A2LA accreditation and comparable certifications to the ISO 17025 standard involve giving you what is called a "scope" that defines the best a particular metrology lab can do. The 'best measurement uncertainty' takes into account the entire system affecting the measurements? the quality of the equipment, the quality of test chambers, personnel training, etc. This quality rating?the 'best measurement uncertainty'?is a way in which the A2LA (ISO 17025) accreditation is quantified. The National Voluntary Laboratory Accreditation Program (NAVLAP) is a commonly recognized equivalent of A2LA in the U.S.
Worldwide, hospital department managers and purchasing departments sourcing calibration vendors can use 'best measurement uncertainty' documentation as a quick way to do a first cut between the vendors who will be assets for regulatory compliance and liability-proofing operations and those that are actually a detriment to full compliance.

In some cases, it is not only the quality of the metrology service being hired, but also, the nature of the instrument itself that needs to be considered. This is especially the case when full calibrations are needed of instruments using proprietary software. If proprietary software is involved, only manufacturers and others with access to the proprietary code can perform a full calibration. A full calibration is when a lab or manufacturer takes an instrument and checks it across the full temperature and humidity range. More limited calibrations only look at a single point on the range, or sometimes two-point range.
Hospital laboratory managers need to be especially cautious regarding hiring one-stop-shop calibration services that offer to not only recalibrate temperature, pressure, and humidity, but also all electronic devices used in a lab. This may sound good, especially if lower prices are offered, but if you truly consider the type of capital investments required to get the best instrumentation available to recalibrate for different properties, you begin to get an insight as to why there might be a wide variation in metrology lab testing results, especially for those without ISO 17025 accreditation. It also suggests why manufacturers of testing and monitoring instruments, if they do provide calibration services, sometimes have an advantage in that the same equipment and instrumentation investments they need to make for product development are also used for recalibrations.

Issue 3: Among some hospital administrators there is confusion regarding how to determine an appropriate calibration schedule. One only needs to imagine being cross-examined by an attorney as to how you knew that your last instrument calibration was still accurate to understand why this is important. There is a relatively straightforward empirical procedure to determine necessary instrument calibration schedules.

Step 1: First calibration checkup?6 months For most applications, the recommended first-time interval for calibration is six months. This first calibration should include before calibration data.

Step 2: Stretch calibration interval if before data is acceptable If the data logger's or chart recorder's before calibration data, documented that it remained operating acceptably close to the stated accuracy of the instrument, you can stretch the next calibration to a longer interval such as seven months. Remember to include before calibration data

Step 3: Revert to prior calibration schedule if before data is unacceptable
If before calibration data reveals that the chart recorder or data logger has stayed acceptably close to the stated accuracy of the instrument, then you can continue to stretch the six-month interval. Eventually you will find the time period that does have significant effect on the accuracy of your unit. When your reach that point, go back to the prior calibration interval. This calibration schedule should be adhered to for the life of your data logger or chart recorder when used in the same application.

Issue 4: Lastly, adequate consideration must be made of whether one-point calibrations will suffice or if 3-point or custom point calibrations are required. While all calibrations from reputable sources will be accurate, there are many options in calibration details to choose from such as 1-point calibrations, 3-point, Custom point, and combinations of these options. Many times the proper choice is already known because regulatory compliance inspectors indicate the level of detail they want to see in a calibration certificate for a particular application.

In a 1-point calibration, a single point is selected for verification in the mid-range of the data logger or chart recorder. For most models this means ambient temperature (about 75°F or 24°C). A 1-point calibration tells you that your instrument is highly accurate at that one point.

If your application requires accuracy in a small range at the midpoint
of your data logger or chart recorder's range a 1-point calibration will suffice. Hospital facility engineers that are simply using data loggers or chart recorders to monitor room temperatures for optimizing patient and staff comfort while at the same time minimizing energy costs might be well served with a 1-point calibration of their monitoring instruments. Similarly, 1-point calibrations would be typically used for data loggers or chart recorders used to monitor food temperatures during transport. If your application only requires accuracy at one point that is not in the mid-range a Custom Point Plus 1-point calibration may be required. For example, hospital laboratories may need such instrument calibrations when media with special storage requirements are used.

Three-point calibrations are used to validate high-medium-low points in the data logger or chart recorder, covering the full operating range of the instrument. High-medium-low points are verified repeatedly to validate the instrument's accuracy over its full operating range. 3-point calibrations are often the best choice for monitoring environments that cycle in temperatures. For example, data loggers and chart recorders that are used for drug or vaccine monitoring in refrigerators, freezers, or warm environments such as autoclaves and incubators often require 3-point calibrations.

The most demanding applications are typically handled with a custom point calibration added to a 3-point calibration. This custom point gives added assurance that the data logger or chart recorder is accurate at that point in addition to the 3-point calibration tuning the instrument over its full range. Monitoring storage conditions for blood or tissues stored in ultra-low freezers are an example of when 3-point calibrations plus added custom points are recommended.

Energy Costs
In recent years, the economic benefits of environmental monitoring are also being considered by more forward thinking hospital administrators as a way to contain the impact of rising energy costs worldwide.

For an example of how significant this issue is, consider the U.S. Environmental Protection Agency's current estimates that hospitals use twice as much energy as office buildings. Given the rising costs of energy, now and projected for the future, any and all steps to minimize energy costs are a bottom line concern for hospital administration. The days of energy costs accounting for only 2% +/- of operating expenses are a thing of the past.
This means that balancing HVAC systems is now important to both patient comfort and budgets. Wireless monitoring systems that allow hospital facility engineers to keep an eye on hospital wide conditions from one desktop can be an especially efficient solution when one considers the savings in labor time for downloading data that would otherwise be required, as suggested by the wireless monitoring returnon-investment graph in Figure 1.

As an alternative to wireless monitoring or as an addition, equipping facilities engineering staff with relatively low-cost handheld temperature indicators for spot checks can be useful in pinpointing problem areas. Whichever monitoring instruments are selected, the return on investment from closely monitoring HVAC function is relatively rapid, given the costs for air conditioning or heating that such monitoring can help defray.

Purchasing Tips
Hospital purchasing departments that prefer to deal with as few vendors as possible need to take into account that the requests for monitoring instruments from various departments will certainly vary. Finding a single source for monitoring instruments is very doable if you can determine that the vendor has the broad array of monitoring instruments that might be required for the wide range of hospital application requirements. It only is problematic if a vendor offers a limited number of choices; because this will mean one or more departments will find that the monitoring instruments they have to choose from are not best-fit technology.

A key hospital-wide source for monitoring instruments should also be involved in ongoing product development and addition to its product lines. Consider that many of the time-saving features on data loggers? wireless configurations, FLASH cards for downloading, USB-enabled, etc. didn't exist several years ago. In all likelihood similar innovations will replace the best-in-class monitoring instruments of today in the years to come. Vendors that invest in ongoing R&D to keep up with state-of-art technology are better poised to be partners for years to come with all hospital departments needing environmental monitoring instruments.

Another consideration is that sourcing the best instruments worldwide is now facilitated by the Internet. This means that you can now obtain high qualityinstrumentsfromthebestpossibleworldwidesources.Forexample, the Dickson Company maintains a web portal www.DicksonData.com that can be accessed by hospital purchasing departments and other managers at any hour on any day in every time zone.

Lastly, reputable vendors of monitoring instruments will also provide calibration services that are highly ranked by independent bodies and that meet the exacting standards for "best measurement uncertainty" certifications in the array of calibration options required to make each department's environmental monitoring activities liability-proof and up to regulatory standards.

Appendix A
The following guideline summaries are excerpted from "Monitoring Critical Storage Devices in a Health Care Facility", authored by Kim A. Barker, Principal Engineer, Siemens Building Technologies, Inc. For more information contact Kim Barker at [e-mail], 847.941.6525.
As a leading provider of energy and environmental solutions, building controls, fire safety and security systems solutions, Siemens Building Technologies, Inc., makes buildings comfortable, safe, secure and less costly to operate. With U.S. headquarters in Buffalo Grove, Ill., Siemens Building Technologies employs 7,200 people and provides a full range of services and solutions from more than 100 locations coast-to-coast. Worldwide, the company has 28,000 employees and operates from more than 500 locations in 51 countries. For more information on Siemens Building Technologies, visit: www.usa.siemens.com/buildingtechnologies

Appendix B?Recommended Dickson Monitoring Instruments for Hospital Applications is a quick reference guide on key instrument features that provide best-match technology for hospital applications.

This Guide to Hospital Environmental Monitoring was created by Dickson Company www.DicksonData.com, which offers the widest range of data loggers, chart recorders, alarm thermometers and wireless monitoring instruments available in the world for hospital regulatory compliance. Inquiries can be directed to
Nick Kovacic, [e-mail], 800-757-3747 or [phone] outside the US, FAX 1+630-543-0498 or by writing Dickson, 930 South Westwood Avenue, Addison, IL 60101, USA
www.DicksonData.com