Poor safety ratings can plague a facility for a long time, and may be very hard to shake off.
The Leapfrog Group, an organization founded in 2000, is an NPO which reports on the safety conditions in more than 1,800 hospitals across 38 states. They grade facilities by letter, based on their records of patient safety, with A being the best. The grades take into account public records of such things as reported errors, injuries, accidents and, notably, infections picked up during treatment such as CRE and MRSA. Anything below a C rating begs questions of procedural failures within a facility, failures which could often be resolved by minor workflow changes that would have huge impacts.
While we are certain that the standard of care at most facilities is beyond reproach, the fact remains that in many others safety procedures are clearly not all they could be. Somewhere, procedural holes allowed patient infections which caused trails of regrettable (and often easily avoidable) issues. This not only affects the patients, it affects facility reputations. And that in turn affects stakeholder bottom lines.
When patients elect to take their healthcare elsewhere, facilities lose income. All other things being equal, most people with a choice will opt for treatment by whichever facility has the better safety record. If one historically averages all A’s and another straight C’s, I know where I’m going for my surgery. And it is important to recognize that those grades don’t ever go away. They remain on the public record, potentially swaying patient choices of facility for many years to come.
Whether deserved or not, once earned a bad reputation can be the deciding factor that determines business success or failure. This being so, the investment in an infection control and inventory management system such as provided by DeviceTrak is not just a logical choice. It is a business critical choice. Protect your patients. Protect your reputation. Protect your income.
When procedural problems start to affect revenue streams potentially for years to come, it is time to make some changes. It is time to call DeviceTrak.
Kaiser Permanente have reached out to 23 patients treated at their Largo, Md facility, after a physical defect was identified in an endoscope. The defect may have resulted in ineffective cleaning of the scope, which would in turn allow transmission of bacteria and disease from one patient to the others. This potentially includes HIV and Hepatitis, which can hide easily in damaged scope elements.
In a statement released this week, Kaiser Permanente said they were contacting the 23 patients from an abundance of caution. They enforce national guidelines for cleaning procedures. However, when the visual inspection of the affected scope showed damage, they could not guarantee the effectiveness or cleanliness of the scope and retroactively identified the patients this scope had come into contact with. The hospital is offering screening to all 23 patients to ensure appropriate care is provided. There is no indication at this time that any of the 23 are suffering ill effects relating to this situation.
Visual inspection is the primary step in each cleaning process. DeviceTrak not only enforces it, but documents it. Each person on the scope cleaning chain signs off that the scope they cleaned passed visual inspection. This provides a legally admissible chain-of-evidence which can protect staff members and teams, or identify weak links and opportunities for staff training.
The simple act of requiring sign-off at each stage encourages adherence to mandated workflows, and good practices. People tend to look closer if they are putting their name on something. No steps are skipped, and due diligence is enforced.
DeviceTrak. For peace of mind.
Easy access to endoscope manufacturer guidelines is an important step in preventing patient infection. IFU (instructions For Use) and SOP (Standard Operating Procedure) documentation provides the starting point for implementation of effective scope reprocessing workflows. They work best when used in conjunction with decision support software such as DeviceTrak, which ensure that those manufacturer guidelines (as well as all regulatory mandated cleaning standards) are met.
An announcement this month by the US Air Force Surgeon General on the Air Force military web site revealed that an operational review of gastrointestinal procedures administered at the Al Udeid Air Force Base between April 2008 and April 2016, used improper endoscope cleaning procedures that did not follow manufacturer cleaning guidelines. In that time frame, 135 patients were potentially exposed to bacterial infection and associated risks.
Although no harm appears to have been done, this was by luck rather than design. This situation lasted for several years and is a perfect example of a systemic failure which should, and could, have been avoided. At the very least this is an embarrassing statement for the Air Force to have to make. At the very worst, lives were at stake. Credit to them for identifying and resolving the issue before any identifiable harm was done. However, it could have been avoided just by following the endoscope manufacturer’s IFU and SOP.
With DeviceTrak, this regrettable situation, literally, could not have happened.
Procedure reviews such as the one conducted by the Air Force highlight opportunities for improvement. If your organization would benefit from such a review we encourage you to undertake it sooner rather than later. And if you need a proven system that will protect you, your patients and your organization… we’re ready to help.
The average cost of an endoscope ranges between $38,000 and $50,000. Few facilities buy extra scopes. These high value items are often purchased as required to facilitate specific programs. Maximizing the usage of each scope is vital: The cost of a scope is not recouped while it sits idle.
Endoscopes also have high value repair costs. Moreover, when they are out for repair the disruption to patients, the knock-on effect on treatment schedules, staff allocation and resource distribution can all cause noticeable downturns in the revenue cycle of a hospital.
Enter DeviceTrak. DeviceTrak is the only endoscope management system which effectively tracks your entire endoscope inventory in real-time at all stages of use. From cabinet, to procedure room, to cleaning, back to cabinet. Or any variation that your facility uses.
You will know where every endoscope is at any given time, who is using it and where it has been. Tracking scope movement also allows workflow studies that can identify bottlenecks, potentially resulting in process improvements that allow more patients to be treated, more billable treatments to be performed.
DeviceTrak also regulates the scope cleaning process to ensure compliance with all current legislation. Enforcing regulatory cleaning and compliance helps to effectively identify potential issues before they arise, allowing for the implementation of scope maintenance and repair programs. Taking scopes out of service for maintenance on predetermined schedules prevents the upheaval of unplanned equipment failure, reduces unexpected repair costs, and eliminates down time.
These are only two of the many advantages of DeviceTrak. Maximize your investment in Endoscope by using the only Endoscope Management System proven to work.
Want to know more? Then please call or send us an email using the Contact link above. We look forward to your questions.
The 2016 AORN Surgical Conference and Expo has just ended. Held this year at the Anaheim Convention Center, this premier industry event provided attendees with more than 65 educational sessions designed to generate ideas and provoke new thinking, along with access to an expansive exhibit hall filled with vendors, events and networking opportunities for the more than 4,00 registered attendees.
And of course, DeviceTrak was there.
As the premier surgical conference of the year, we felt we had to demonstrate the DeviceTrak technology to these industry leading visitors, showcasing the benefits of a true end-to-end scope cleaning system. We received a large amount of interest both from practitioners and administrators, all keen to find how to minimize cross-contamination and bacterial infection risks at their facilities.
Attendees were very excited about what DeviceTrak had to offer. Geraldine Bautista of the Riverside University Health System said ““We are opening a new GI lab. It is on two floors, so we need to have tracking for everything. Tracking inventory in one place is so important and at the same time, so is making people accountable, as you are not there to see if they are skipping any processes.”
Another attendee, Christina from the Glendale Adventist Medical Center, said that “…we just passed joint commission, but we have so many people doing things differently because of their different needs and suites. This would absolutely help make things easier for everyone, all in one place. This (DeviceTrak) is exactly what we need!”
Clearly, the people that work with scopes every day have a keen appreciation of the challenges the industry faces when it comes to scope reprocessing, and see DeviceTrak as an opportunity to address them. We agree.
Beleaguered scope manufacturers Olympus face scrutiny again for entirely different reasons, as news breaks that they have arranged settlements totalling around $646 Million in order to draw a line under some ongoing criminal and civil claims that some of their agents and representatives paid out bribes and offered kickbacks in order to boost product sales.
When announcing the settlement, Attorney Paul J. Fishman said that this figure included a figure of $22 million specifically related to similar charges and acts in South America.
The story covers a period between 2006 and 2011 – no mention is made of the period between 2011 and the present. According to Fishman, during the period in question Olympus operated without a compliance officer to monitor such illegal activity. “That’s pretty remarkable”, he said.
Cited in court records is evidence that after purchasing Olympus equipment for use in their facilities, some doctors and hospital officials were rewarded with cash payments, overseas vacations, event tickets, meals and even spa treatments.
These practices first came to light after Olympus hired their very first compliance officer, John Slowik. Ironically, this attempt to act honourably is what finally caught up with Olympus, because one of the first things Slowik did was to file a whistle blower suit back in 2010 in the New Jersey federal court. As whistle blower suits reward the blowers of the whistles with a percentage of funds recovered, Slowik stands to personally benefit to the tune of an estimated $51 million.
Olympus has posted a statement regarding this announcement on the company web site in which it says, “Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees. Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct which guides our business processes, decisions and behavior. The company has implemented and will continue to enhance its robust compliance program.”
The government and Olympus will together monitor a deferred execution program which outlines the steps Olympus is required to implement, which will increase oversight and protect any future whistle blowers from punitive action by the company. Olympus has signed a corporate integrity agreement which will see the federal government seeking further financial and punitive penalties should further instances of such behaviour arise.
January 15, 2016
The U.S. F.D.A has today cleared the Olympus TJF-Q180V duodenoscope for active use, with a requirement for certain changes to the design of the device which aim to reduce risk of bacterial infection.
This concludes a series of events beginning in March 2014, when the F.D.A gave Olympus notice that a premarket 510(k) notification was required for what is called the ‘closed’ elevator channel model of their scope, as it had never been cleared or approved. The ‘open’ channels of the preceding models were deemed safer, with the ‘closed’ version introducing significant concerns which impacted the safe use of the device. In brief, this design had a seal which offered potential leakage of patient fluids and tissue into the closed elevator channel, a weakness which has since been resolved with the introduction of a more effective seal.
Olympus has in turn voluntarily agreed to withdraw from service all original TJF-Q180V models and will replace them with updated versions of the scope. Olympus estimates this recall will be completed by August 2016. Healthcare facilities may continue to use the older model scopes in the interim, as long as they adhere to the newly updated scope cleaning regime which was worked out by the F.D.A and Olympus back in March of 2015 to address this specific issue.
William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health said, “We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices. The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.”