After a brief absence, we are delighted to welcome you back to the Expert Access Live Online program.

Our June topic is From Data Management to Information Management : Implementing Point of Care Connectivity . The expert for this session, Christopher Fetters is well known to and highly regarded by many people in the POCT field. Chris is currently in France and despite the wonders of the country is online awaiting your questions, so please submit them now.

We would like to extend our most sincere thanks to the Bayer Corporation for making this program possible.

Where do you see the use of wireless applications in information management
washington, dc

Chris Fetters:Today, there are a few hospitals that are buying off the shelf wireless "dongles" to connect the larger, non-handheld analyzers to their wireless network. Then, they can use a cart to drive around their point of care instruments and have the results immediately downloaded to the data manager. An example of this implementation is blood gas instruments at Duke University and often, the vendors are facilitating this effort. However, wireless will be most useful in handheld, battery-powered instruments like glucose meters. Then, they can be easily transported to the patient's bedside and upon result, the data will go right to the data manager without waiting for today's "docking event" to happen. Unfortunately, since many hospitals don't have a wireless infrastructure in place, most of your hospitals are years away from being able to use these devices. Then, the vendors need to develop handheld devices with useful wireless technology at a price point that we are all willing to pay for. Push the vendors in this direction, but don't hold your breath. Medical devices typically lag 5-8 years behind other markets. We are about two years into home wireless networks and ubiquitous wireless technology in warehousing and point of sale. 3-5 years to go.....

Do you have an studies that show this standard has improved reimbursement, patient saftey or reduced errors?
Mishawaka, IN

Chris Fetters: Since I'm no longer attached to a hospital, I have not completed any published studies; all I can provide is anecdotal evidence. 1. Reimbursement- I have spent the last year speaking around the country on reimbursement. Over that time period, many POCC's have come up to me and told me that they are charging for POCT, especially glucose testing. LuAnn Hildebrand at Wellspan Health noted that she saw a 20-30% improvement in captured charges after they went from a manual billing method to a data management system. You can imagine that gaining compliance from the nurses is difficult when you want them to fill out a separate form for POCT charges. 2. Reduced errors- Reduced errors comes from three things: a. A full time Point of Care Coordinator who establishes good rappore with the nursing staff and cajoles, rewards and educates to improve compliance and reduce errors. b. Barcoded armbands (patients) and badges (operators) so that transcription errors can be reduced on instruments that accept a barcode. c. Data Management so that the data collected can be reviewed in a timely manner. When a POCC responds daily to incorrect patient id's and operators id's, compliance goes up. The nurses realize that someone is watching and someone cares about the accuracy of their data.

I notice that the three POC Testing Environments highlighted are Hospital, Out-of-Hospital and Alternate, Home Care and that in your listing of Top User Requirements, ease of use is listed only as a secondary requirement. Would you agree that as more people are moving toward in-home care for long-term and terminal illnesses, ease of use should become a primary requirement? It seems to me that ease of use would also help to minimize user error rates.
Gaithersburg, MD

Chris Fetters: The User Needs Survey completed for CIC was given to in-hospital providers. When we looked at the environments for POCT, we noted that it can be found not only in the clinical setting but in the home. The CIC standard was written primarily for the inpatient setting because it is currently the most "connected." However, as more devices appear on the market and more consumers have Internet access, the demand will increase for the consumer to send their results to a GP. Ease of use fell to a secondary requirement because most hospitals train until the operator "gets it." I think that ease of use should always be an overriding concern. Especially with the push of the vendors to make more instrumentation waived. It is scary to think that in-hospital providers and consumers alike could be doing testing on instruments classified as waived which if done incorrectly, could result in bad treatment decisions. Don't buy instruments for your hospital or your family that are difficult to use.

What percentage of companies comply with the connectivity standard? Do any of the vendors provide updates to current devices?
Santa Barbara, CA

Chris Fetters: There are a few LIS companies and a few data management software packages which claim to be CIC-compliant already. They have the luxury of building software patches without submission to the FDA (in most cases.) The device vendors are not in the same boat. The POCT1-A standard was approved by the NCCLS Board of Directors on Nov 13, 2001. Since most all the instruments you can buy were already on the market, no device (to my knowledge) is yet CIC/POCT1-A compliant. Maybe we'll see one or two at AACC this year in Orlando. More likely, the first devices will hit the market in the next year. If the Access Point vendors also build to the standard a hospital might be completely compliant to the standard by the end of 2003. We wrote the standard such that a vendor could do a firmware update to most devices and achieve compliance. I assume that unless the market demands it, most vendors will only provide POCT1-A complaince in new instruments. Only you can change that assumption. Pressure your vendors to update their current instruments to POCT1-A compliance.

Have you explored using the Internet or wireless communication methods to connect POCT to the LIS? What are the benefits and pitfalls?
Orchard Park, NY

Chris Fetters: I know that some of the LIS vendors actually test their instrument interfaces across the Internet. So it's possible. I know of no institution that is currently doing this. Benefits and pitfalls: The Internet provides a simple, ubiquitous medium to transfer data, even to far-reaching physician offices or remote data centers. However, there is a concern about the security of the data. We should be able to achieve complete security using standard encryption techniques, but the actual implementation of HIPAA over the next year will be interesting to watch.

Mr. Fetters, Thank you for your presentation; the visual effect were excellent. A great deal of effort has been expended to standardize connectivity, however, there continues to be significant problems with getting the correct patient data into the meter. Can you comment on any initiatives that are under discussion to decrease these errors, such as mandating barcoded patient identification bands.
Tallahassee , FL

Chris Fetters: There are three ways to improve the quality of patient id's. Two are prospective and one is retrospective. 1. BARCODE YOUR PATIENTS! I cannot emphasize this enough. If you think about how many times in a month you mis-dial the phone, you can imagine how hard it is to read a 9 digit number from a patient's armband and type it into the keypad of a POCT instrument. Give your nurses the tools for success they need. 2. Look for instruments with census lists. Systems like Pyxis (pharmacy dispensing devices) and Omnicell have had this for years. Continuously connected instruments will have a list of patients to choose from on whom the testing will be performed. If they are choosing, rather than typing lots of complicated numbers, you are improving their chance for success. VERY FEW POCT device have this ability and it will require continuous connection to keep an update patient list. 3. ADT interfaces. Installing an ADT interface with you data manager means that it can check the ID of a pt against the time of the test and the nursing unit of download. If these fields all agree, then, the id is assumed to be correct. It still may not be, but one floor of patients is better than a whole hospital of patients for potential misidentification. It will drastically increase your "false positives" on flagged results. But, it is worth it if we avoid the inherent liability of a bad pt id allowing a test to drop on the wrong patient's record.

Our health system is in the process of deciding software for a multianalyte interface (Surestep Pro, Flexx and i-STAT). Is it important to have an ADT interface? It will be an HL7, EDI interface, but one of the vendors does not use ADT, but rather a workstation based system. Please tell me the pros and cons of these setups.
Appleton, Wisconsin

Chris Fetters: From my last answer, you can tell that I am a proponent of ADT-capable systems. Some vendors do not equip their data managers with the option of an ADT interface. But, some of the vendors have designed very elegant workarounds to negate the need for ADT. I have seen this work quite well. And, many hospitals have looked at their options and decided against ADT for the problems it can uncover. If your patients are not consistently moved from floor to floor both physically and in the census system, then ADT will be nearly worthless to you. In this case, make sure you have barcoded armbands on your patients so that you can provide some sort of positive patient id. Give yourself and your nurses every opportunity to get accurate data into the information system all the time.

We are in the process of selecting an interface for multianalyte use (SureStep Pro, Flexx, i-STAT). Please give me info (pros and cons) of lease vs. capital (if any). We can purchase the workstation (with Windows 2000) on our own with one vendor which can save us MANY dollars. Another vendor is a bit more proprietary and will only let us purchase their hardware as a lease option (same as what we can purchase ourselves). Both include service agreements for their products/software. Do you have any opinions about this which may aid in our selection of vendors? Thanks.
Appleton, Wisconsin 

Chris Fetters: Having "walked-through" too many CER's (Capital Equipment Requests) to every Vice President in the hospital, I love bundling the price of a data management system into the strip or cartridge price. I don't see any real downside. You are distributing the cost of the system either to the nursing floor or to the patient of everyone who uses the system. However, if you crunch the numbers in your hospital and show the time-savings of not walking around with a laptop to each meter, the reduced liability of improved compliance and transparency of data (how closely do YOU look at month-old data) and the ability to fully bill for each test performed (even in a 8% fee for service market (miserable) you should be able to justify disposables and a data manager) buying the system outright should be a "no-brainer" for the administration of your hospital. Simply put, one or two persons CANNOT administrate even a handful of analytes across a health system without the aid of computerization. It can't be done well. Your hospital should sit down as a committee and with the input of the contracts and financial geniuses at your institution, see which system and which payment method will work best.

What are the advantages of POCT connectivity when it comes to satisfying JCAHO and CAP requirements?
Bradenton, Fla.

Chris Fetters: Most institutions will buy a data manager for this reason alone. Your ability to review Levey-Jennings charts, manage and track operators and their certification, and document corrective action should be top-of-list concerns as you buy a system. You want to be able to go through the CAP or JCAHO checklist and point to the feature of the software than enables you to generate a report which satisfies each requirement. If you can't do this the first time you look at the software, then the vendor hasn't done a good job of designing it. When the inspector walks in the door, you shouldn't be going for your file cabinet or sitting in front of a bunch of file folders, you should be logging into your computer. Most of the documentation requirements from JCAHO and CAP can be met with most of the systems currently on the market. I would especially look for systems which allow for electronic signature of daily QC and notation of corrective action. You shouldn't have to print, intial and data anything.

The future of patient information seems to be web based, how will this effect the recently approved connectivity guidelines?
Buffalo, NY

Chris Fetters: Shouldn't affect it all. One of the vendors has just released a web-based data manager. This is exciting because it will allow you to access your data manager from anywhere in the hospital which is probably where you spend most of your time... anywhere but your office (closet :-) And, you can dish out some of the responsibility to the other stakeholders in the POCT system like nurse managers and nurse educators. They can use pieces of the data manager for their specific piece of the pie and everything doesn't have to go throug the POCC office because that's the only place that the data manager is installed. All vendors should be working on a web-based data manager and if you're looking to purchase, look closely at companies that do. As far as compliance with the standard, the computer and the database that interface to the instruments and to the LIS should be unaffected by the presentation of the data on your computer screen. Compliance will not be any more difficult for vendors building a web-based data manager.

More and more testing is being made available on POCT. Do you think there will be an initiative to have all POCT equipment developed to allow for connectivity?
Indianapolis, IN

Chris Fetters: The initiative is yours alone. If you have any sort of Five Year POCT Connectivity Plan (you all do, don't you,) then you know that you can't afford to purchase instruments which don't allow for connectivity. I'm not necessarily talking about compliance with POCT1-A. I'm more concerned with the fact that the two vendors who have urine instruments on the market, don't have keypads or barcode readers on their instruments which allow for the entry of patient id and operator id. How can you connect this device and expect to get good data into the electronic medical record of your patient? We should all demand that every patient care device is fully "connectable." It must collect enough data to make a complete patient record and if it doesn't then, please don't expect me to buy it for my hospital. Period.

Your presentation address cost saving in reduced FTE time by having connectivity. Since the manufacturers are incurring the cost of complying with the connectivity guidelines I suspect this expense will somehow be passed on to the user. Is there a way to estimate if there is increased cost to the user, probably in increased "supply" costs.
Maywood, IL

Chris Fetters: I'm sure that there are costs to the vendor for complying with the standard, but I think that, in the long run, compliance with the standard will benefit the vendors as much as the user. Two reasons: 1. Right now, each vendor has to commission an R&D team to design the interface of the instrument. If they comply with the standard, then all they have to do is read the standard and follow the manual. They avoid reinventing the wheel on every instrument and reduce their overall development costs. 2. Compliance with the standard will result in increased instrument sales. How many hospitals won't buy instruments for every unit that needs it, because then the instruments would be out of control. If we can bring them back in control by connected them and simplifying their use, maintenance and tracking, then hospitals will buy more instruments. More instruments means good things to the vendors and the overall cost should go down.

I hope you found this presentation and question and answer session very informative. This Expert session and all previous sessions, are archived on our website and serve as a continuing source of education.

Don't forget about the Expert Access program as the summer approachs; mark your calendar for our July Expert session when Dr. Larry Bernstein shares with us an outstanding presentation on Metabolic Changes Associated with Stress. Is there an individual in the healthcare profession who is not subject to the effects of stress? Dr. Bernstein will be on-line July 2 between 1 and 2 pm Eastern to answer your questions. Don't miss this timely and important topic.

Again, thank you to the Bayer Corporation for making this educational program possible.

See you in July!