Making patient information accessible and usable at the point of care, whenever and wherever it is needed, is the foundation for improving efficiency and quality of healthcare delivery. Electronic record systems have continued to evolve to meet the industry's changing needs. While today's imaging and workflow applications are excellent for viewing and accessing information, healthcare institutions continue to push for more. The challenge on developers is to keep integrating greater intelligence within their systems along with improving ease of use to serve this technologically evolving industry. This presentation examines the nature of emergence and obsolescence of electronic patient record systems used for cardiopulmonary bypass procedures.
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Electronic patient records technologies
1. Electronic Patient Records: Technologies in Transition Mark G. Bearss Walden University #A00161239 [email_address] May 22, 2010
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3. This technology generated an electronic digital record of a patient’s vital parameters, laboratory data, drugs and fluids received, and events that occur during cardiac surgery. These digital records accommodate electronic searching and retrieval of data to analyze trends or generate statistics. This technology obsoleted manual searching of data entries from a paper chart to create a report. Because charting is being scrutinized closer, this also obsoletes lapses in charting or charting errors. The ability to do calculations learned in school. Friendly competition. The desire and the ability to see how well you perform compared to others. Real-time entry of data from multiple devices in the cardiac surgery room. Practice changes to provide better quality outcomes for the patient.
13. “ It was always my belief that if we didn’t create something that was more of a cardiac workstation that took in information from a lot of different places… then we would be stuck with a me-too product…” “ Also, it was built by perfusionists, for perfusionists.” Denise Steinbring, Director of Marketing Medtronic CardioVascular Systems What does the Viper System make possible that is compelling?
14. “ I don’t think it will obsolete anything physical; I think the obsolescence process might be more of a mindset.” Steve Turner, CEO
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17. “ Hopefully it sets the stage for perfusionists to become more savvy in evidence-based medicine, because this is an area where they don’t excel right now.” Denise Steinbring, Director of Marketing Medtronic CardioVascular Systems
21. Spectrum Viper ™ Technologies in Transition ? Flow up or down ? increase or decrease oxygen ? Add fluids or drugs ? Increase hematocrit
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Editor's Notes
It is common-place for patient records to be largely kept as hard copies in physical files, often seen in the receptionist area of doctor's offices. This is all about to change after the federal government mandated that all patient medical records will be electronic by 2014. Making patient information accessible and usable at the point of care, wherever and whenever it is needed, is the foundation for improving efficiency and quality in service delivery. Electronic record systems have continued to evolve to meet the industry's changing needs. While today's imaging and workflow applications are excellent for viewing and accessing information, healthcare institutions continue to push for more. The challenge on suppliers is to keep developing greater intelligence within their systems along with improving ease of use to serve this technologically evolving industry.
One of the systems that enetered the market in the early 1990’s was OnCourse. This was designed to be used by perfusion technologists for [CLICK] creating an electronic record of certain parameters that were captured onto a paper flow chart during cardiac surgery. The purpose was to capture key parameters that were deemed [CLICK] essential for continuous quality improvement initiatives. Maintaining a digital record was promoted to be [CLICK] more accurate and more efficient for collating and analyzing data and compiling reports. It was comprised of a desktop computer usually located in an office somewhere outside the operating room. Once a surgical case was completed, the perfusionists would take their paper record and transcribe the necessary values into the OnCourse program.
Marshall McLuhan (McLuhan, 1989) proposed the tetrad as a process of asking questions based on historical, social and technological knowledge of the subject for assessing, analysing and predicting the social effects of that technology on society. (Hempell, 1996). The four elements aim to create a comprehensive awareness of both the technology and its surroundings. This tetrad examines the characteristics of the On Course technology at the time it was being used. What does ON COURSE make possible? [CLICK]. What does ON COURSE obsolete? [CLICK] What does ON COURSE rekindle? [CLICK] And finally, what does ON COURSE set the stage for? [CLICK] Hempell, A. (1996). The resonating interval: Exploring the process of the tetrad. Retrieved March 22, 2010 from http://www.anthonyhempell.com/papers/tetrad/concept.html McLuhan, M., Powers, B. R. (1989). Transformations in World Life and Media in the 21st Century. Oxford, MA: Oxford University Press
This technology was emerging in the 1996-1997 timeframe when the Society of Thoracic Surgeons (STS) had implemented a national database for heart surgeons to log patient and procedural information. The purpose of the STS database was to analyze the long-term outcomes with cardiothoracic surgery. It continues to serve as the basis for federally funded national quality improvement randomized trials, as well as research in targeted areas of cardiac surgery. During this same timeframe, perfusionists began looking at systems to query their own unique data and generate reports. Companies began emerging dedicated software programs such as On Course from Avecor CardioVascular, PerView from Medtronic, Inc., and S.T.A.R. from 3M Health Care. The software was designed to enable generating reports to promote Continuous Quality Improvement programs within the perfusion departments. The software was also designed to facilitate collating the necessary perfusion data for the STS database as well as for generating the required reports to their licensing and credentialing organizations. In fact, On course was approved by the American Board of cardiovascular perfusion as an accepted medium for filing activity reports and CEU’s. .
Aside from the timely appearance of this technology, there were attributes to the OnCouse System that influenced its emergence, which are described in this interview with Joe Nylin. Joe is a former perfusionist and currently a sales representative for Medtronic, but he happened to sell the OnCourse system in the mid-1990’s. Here’s what he had to say about its emergence and adoption. [CLICK AUDIO]
Interestingly, OnCourse along with other computerized charting systems fell out of favor from customers and vendors and became obsolete in a relatively short period of time. Looking back at that period of time, there was not one overarching factor but rather a number of undermining conditions. In the mid-1990’s computers [CLICK] were not being widely used by perfusionists in the hospital environment. [CLICK] Many clinicians were not computer savvy. [CLICK] The protocols and methods conducted by perfusionists vary widely from hospital to hospital. This made it difficult for On Course to be designed as a one device that fits all. Customers expected the software be customizable to fit their specific needs. These reporting systems were stand-alone and separate from the OR. Even after a case was done and “charted”, the clinician had to go back to the office and transcribe their data into the computer. [CLICK] Since compensation was either salaried or on a per-case basis, there was no incentive for perfusionists to complete this extra activity. [CLICK] Management was supportive of CQI initiatives but performance was not being measured against patient outcomes indices. [CLICK] Instead, hospitals were more focused on how to reduce direct costs associated with cardiac surgery procedures.
During his interview, Joe shed some light on other factors that about why some users were resistance to an electronic record [CLICK] that was easy to retrieve information and become a platform for finding fault. From the vendor’s perspective, it was costly to support and then difficult to prove to anybody in sales and marketing there was a tie-in to new sales or greater sales with existing customers
Of the six forces that drive emerging technologies, which stands out as having an impact with the On Course system? While the adoption of the three dominant systems behave like red queens, these same three players became obsolete at about the time. Neither was a disruptive technology that promoted the obsolescence of another. They were all quite similar in their indications, features, functions and benefits. There is no indication of Increasing returns, whereby one technology wins favor in the market at the expense of the other two falling out of favor. There wasn’t any force relative to the technology that contributed to becoming obsolete but rather the propensity of the market was not ready for this level of innovation. This absolescence behavior could also be characterized as a red queen because the rejection of one caused a ripple-effect to abandon all three.
There was a ten-year hiatus after the obsolescence of OnCourse and the other systems before we see the emergence of the Viper System from Spectrum Medical. It is a stand-alone data acquisition device with a touch-screen user interface. The software is designed to work as a Compliance tool intended to compliment the customer’s existing patient care strategies. It has [CLICK] 5 input channels for it’s own dedicated sensors for monitoring blood flow, the hemoglobin and hematocrit level of the blood, and the level of oxygen being carried on hemoglobin in the red blood cells.
What makes Viper unique is its capability to receive data streams from other multiple devices in the operating room, regardless of the manufacturer, either by USB cable connections or wireless via Wi-Fi. This would include such things as the heart lung machine, point of care testing devices, the patient monitor, and so forth.
Aside from creating a repository of clinical data and generating a digital perfusion record, the hallmark of the system is its ability for creating user-defined compliance parameters, then alerting the user during the case when compliances indices are outside their specified range. Compliance in Real-Time is better than Compliance at the end of the month.
Using Marshall McLuhan’s tetrad, lets examine the impact of this technology from a technological, social and historical perspective. What does the Viper System make possible? From a technical standpoint, it integrates the collection of real-time digital information of patient parameters being monitored or measured by multiple devices in the operating room. During an interview with Steve Turner, the CEO of Spectrum, additional insights were made evident about what the Viper System offers that lends to it’s adoption as an emerging technology. [CLICK ON AUDIO]. Mr. Turner then goes on to say…[CLICK NEXT AUDIO]
I also conducted an interview with Denise Steinbring, who is the director of marketing for the business sector within Medtronic that made the decision to purchase a minority investment with Spectrum Medical and incorporate the Viper System within into the Cardiovascular Systems product portfolio. There are numerous characteristics that the Viper System makes possible for the user from a technology perspective. Denise lends her viewpoint from a business perspective when asked the question, “what does the Viper System make possible that is a compelling reason to adopt?” [CLICK ON AUDIO] She then goes on to say…[CLICK ON AUDIO]
When it comes to the question, what does the Viper System obsolete, there are two perspectives that came into view. There are the more tangible factors that will become obsolete, like entering data intermittently using hand-written entries onto a paper record, or typing entries into a computer noted above in the tetrad model. Steve Turner lends an additional perspective on what’s being obsolesced during his interview. [CLICK AUDIO]
The nature of cardiac surgery has become more difficult with patients being presented with multiple disease states and co-morbidities. The cardiac surgery suite now employs numerous sophisticated technologies that provide both diagnostic with interventional procedures. Practitioners have become attendants of devices and data scribes. What does the Viper system rekindle? It’s integration of multiple devices actually simplify the workload of the perfusionist, making their job reminiscent of the time before the growth of technology when the primary focus was monitoring and treating the patient.
And finally, what does the Viper System set the stage for? There are numerous technical attributes for next-generation applications, features and uses. Much like the systems used in commercial aviation that warn the cockpit crew of flight conditions, like wind shear and collision avoidance, the Viper system has the potential of providing pre-emptive alerts of conditions that would avert deviations toward non-compliance, instead of waiting until parameters are already outside prescribed limits.
When asked the question, what does the Viper System set the stage for in the future, Denise Steinbring lends another near-future perspective on how the Viper technology, along with influences from other professional and regulatory agencies, could and may impact the future practice of perfusion. [CLICK ON AUDIO]
The concept of incorporating mathematical models into a sentry system, that is connected between the equipment that performs specific functions has been on the minds of clinical practitioners even before the microprocessors entered the medical device industry. The early applications were typically specific to a particular support need or procedure. The device in this picture is an example of one designed to maintain perfusion of explanted or isolated organs, like the liver or kidney.
The models that integrate blood oxygen, blood flow, hemoglobin levels, blood pressure, drug actions, lung function, and patient metabolism also exist in the framework [CLICK] of patient simulators used for training on perfusion methods. These same models have the potential of being incorporated within the design of devices used for the conduct of cardiopulmonary bypass. Their level of sophistication could serve as being a simple advisor to the practitioner, which I have noted above as the “smart” system. With additional sensor and technologies and software design, the system could also include servo-mechanisms that regulate basic functions as blood flow, oxygen concentration and gas flow to automatically support the patient’s metabolic requirements and acid-base balance.
Servo-modulation is being incorporated into more sophisticated and multi-function medical devices, but on a scale where only one control is being regulated. The device depicted above shows the graphic user interface of a modern heart-lung machine. This device is used to control and manage blood flow, blood pressure, tissue oxygenation and myocardial preservation while a patient is undergoing cardiac surgery. [CLICK] Highlighted on that screen are two icons that are used to initiate and monitor a servo-control feature that links pump speed to the fluid pressure in the blood tubing coming from the heart to the machine. If that pressure becomes more negative, the software adjusts the pump speed to maintain the user-defined pressure. It’s analogous to the cruise-control setting in an automobile. The driver sets the desired speed. When driving on an incline, the cruise-control detects the drop in speed and increases the engine throttle to maintain the driver-defined speed.
Incorporating software to advise the user on making machine adjustments will first have to achieve customer acceptance before crossing that chasm between design and regulatory approval by the FDA. As previously noted, the protocols and methods conducted by perfusionists vary widely from hospital to hospital, making it difficult for systems to be designed as a one device that fits all. But for now, practitioners need to prepare themselves for a government mandate requiring electronic patient records to be in place in all hospitals by 2014. The compliance capability of the Viper system is emerging at a time when practitioners are themselves beginning to realize that adoption is eminent.