Blog | Mobile Aspects

How One Tissue Manager Passed Their Joint Commission Survey

January 16, 2019Suneil Mandava Clinical Documentation Hospital Management Joint Commission Operating Rooms Patient Safety Regulatory Compliance The Business of Surgery Tissue Management

A customer recently relayed on to us their experience going through a Joint Commission accreditation survey. The tissue manager in the operating rooms of this particular hospital utilizes Mobile Aspects’ iRISecure system to track their tissue. She uses iRISecure to ensure the quality of documentation for patient safety and regulatory compliance. The Joint Commission (“TJC”) has specific Standards and Elements of Performance (“EP”) with regards to tissue management.

During the recent survey by The Joint Commission, the Surveyor asked for a detailed review of their tissue tracking records. They also utilized the Tracer Methodology to understand how the system worked and whether the records created by iRISecure helped the healthcare facility meet TJC Standards. After the review the Surveyor stated verbally to the team in charge of tissue management: “You are lucky to have such an excellent system.” The Surveyor specifically asked about records for recalled tissue. The clinical staff was able to instantly show the Surveyor detailed records of recalled and many other types of tissue.

The iRISecure system was designed and is frequently updated to help hospitals in meeting Joint Commission, FDA, DNV and other accreditation agency standards for high quality tissue management. The system uses Radio Frequency Identification (“RFID”) technology to eliminate data entry required by clinical team members. The system also interfaces with Epic, Cerner and other leading electronic medical record systems to ensure high quality data. The iRISecure solution helps a hospital document the entire lifecycle of tissue. At receipt, the system documents the integrity of packaging, temperature and other items required for accreditation. The system also ensures that all ambient, refrigerated and frozen tissue is tracked and documented in an electronic report that can be shown to accreditation surveyors from anywhere in the hospital.

Further, Mobile Aspects provides services to assist during a Joint Commission or other group survey. Team members from Mobile Aspects can be requested to be on-site to assist during a mock or actual survey. This provides deep technical know-how as questions are asked, and provides peace of mind to clinicians as they prepare for the survey.

Having Trouble Tracing Endoscopes To Patients? This Technology Can Help

January 10, 2019Sri Mandava Clinical Documentation Hospital Management Infection Control Joint Commission Managing Endoscopes Operating Rooms Patient Safety Regulatory Compliance

With The Joint Commission (TJC) spending an increasing amount of time in Sterile Processing Departments, Perioperative Departments and Endoscopy Suites during site surveys, the focus on maintaining high quality endoscope-related documentation has become a focus for many hospitals. TJC surveys, though only occurring once every 3 years, have become a huge a point of emphasis for hospitals because passing them successfully is linked straight to their bottom line. This is due to TJC’s status as an accreditation agency for the Centers for Medicare and Medicaid Services (CMS), and any hospital that fails to pass a TJC survey is at risk of losing its Medicare and Medicaid funding – which can contribute 40-60% of a hospital’s top line.

As you would expect, many hospitals have been putting increasing emphasis on areas where TJC is spending more time during surveys. One such area of focus is the storage and reprocessing standards of endoscopes within hospitals. As dozens of reports of endoscope-related infections entered the mainstream media over the past several years, it was inevitable that endoscope cleaning practices would come under increased scrutiny. As such, many hospitals visited by TJC in the last 24 months have reported that their surveyors spent more time on endoscope-related processes than any previous visit.

TJC is not only focused on making sure that hospitals have documented processes for patient safety, but that they also follow them in practice. One piece of documentation that TJC has been asking many hospitals for is a tracer log related to endoscope usage. TJC surveyors typically look to make sure that there is a near perfect record of which scopes were used on which patients. Many hospitals keep a decent log of scope-to-patient usage by utilizing patient stickers in physical log books or a system of spreadsheets. However, TJC surveyors aren’t looking for “decent”, they are looking for near-perfect, 90%+ accuracy when it comes to scope tracer logs. This becomes a serious challenge for busy endoscopy and perioperative departments charged with tracking dozens of scopes across multiple suites. When tracking scopes becomes a logistical challenge, using technology to solve the problem may be the best option.

One such technology solution is iRIScope from Mobile Aspects. iRIScope is the industry’s first smart-cabinet based endoscope tracking solution that uses RFID technology to provide a seamless experience for nurses and techs. In the same way that medication dispensing cabinets require users to login and select a patient to ensure the proper medication is administered to the right patient, iRIScope requires users to login and select a patient to ensure a record of all scope usages to the correct patients. The system offers a host of other benefits such as smart alerts for potential dirty scope issues and re-wash alerts, but for busy departments the electronic log of scope usages can be a true game-changer.

Is The Joint Commission Too Conflicted?

January 4, 2019Sri Mandava Hospital Management Joint Commission Patient Safety Regulatory Compliance Tissue Management

Continued pressure on The Joint Commission (TJC) is calling into question whether or not the non-profit organization best known for its hospital accreditation services is too conflicted to provide high quality accreditation surveys. The Centers for Medicare and Medicaid Services (CMS) is weighing a decision to allow accreditation organizations that also have consulting arms to continue to provide accreditation services on its behalf.

As part of the inquiry, CMS is requesting the TJC and the other major accreditation organizations with consulting arms to provide information on how they sell consulting services to hospitals and how the benefit financially from these transactions. As this article by Maria Castellucci at Modern Healthcare notes:

“The hospital accreditation industry has been under heightened scrutiny since last year when an investigation from the Wall Street Journal found that the Joint Commission, which accredits nearly 80% of U.S. hospitals, rarely pulls accreditation for providers even when violations of Medicare requirements are found. The paper found that just 1% of facilities not in compliance in 2014 lost accreditation.

The CMS has faced pressure to address the concerns that the Joint Commission and other accrediting agencies engage in conflicts of interest by acting as both an enforcer of Medicare rules for hospital participation while taking on hospitals as clients to improve their performance. In its annual report to Congress in October, the CMS announced it would publicly post quality-of-care deficiency findings from surveys at facilities accredited by such organizations. It would also provide a list of providers determined by the CMS to be out of compliance.

The Joint Commission’s not-for-profit consultancy arm, called Joint Commission Resources, offers a substantial income stream for the organization. In 2016, Joint Commission Resources reported more than $6 million in profit on revenue of $63.5 million, according to its Internal Revenue Service Form 990 on GuideStar.org. The Joint Commission’s accreditation division reported $10.6 million of profit on revenue of $164 million to the IRS in 2016.

Maureen Lyons, a spokeswoman for the Joint Commission, said the commission is currently reviewing the CMS’ request for information. She added that its consultancy division, Joint Commission Resources, is separate from its accreditation division.

“The Joint Commission recognizes the importance of assuring the integrity of the accreditation process, which we accomplish by prohibiting any sharing of information about consulting services for individual organizations with anyone involved in accreditation … The Joint Commission enterprise has long-standing firewall policies, practices and procedures in place that assure that this goal is achieved,” Lyons said.

In an interview last year with Modern Healthcare, Joint Commission CEO Dr. Mark Chassin defended its tactics, arguing it’s in the public’s interest for the Joint Commission to help organizations with deficiencies improve. “If we abandon them, nobody’s going to help them improve and then the likely event is the organization closes, and access gets to be a problem for a lot of communities,” he said.

The CMS already requires accreditors to disclose its policies and procedures to avoid conflicts of interest, but the agency said, “we are seeking ways to enhance this oversight and review process.”

Along with information about the consultancy services accreditors offer, the CMS would also like them to provide how their revenue and operations may be affected if the CMS were to prohibit consulting services. “We are specifically looking for cost impacts, detailed accounting, and potential business risks for accrediting organizations,” the CMS said.”

Read the entire article here: CMS probes Joint Commission and other accreditors on conflicts of interest

One possible result of this probe may be that hospital inspection reports will be made public in order to give additional information to consumers regarding their choice of healthcare providers. Is your hospital ready for your inspection reports to be made public? To prepare, hospitals have to make sure that they are following all of their detailed processes all of the time. Any breakdown in your processes would be made public via an inspection report, putting your hospital’s reputation and finances at risk. Consider automation tools that help track the processes that The Joint Commission and other accreditation agencies focus on during their inspections. Systems such as iRIScope and iRISecure have been developed to ensure that processes and protocols are being followed since your managers can’t watch over every step of the way.

How A Health System Saved Over $70 Million Through Physician-Led Supply Chain Committees

January 2, 2019Sri Mandava Cost Reduction Hospital Finance Hospital Management Operational Efficiency Supply Chain The Business of Surgery

Louisville, Kentucky-based Baptist Health has revealed that it has saved over $70 million dollars by taking a fresh approach to its supply chain. By focusing on clinically-led processes that include physicians in the decision-making, the health system has driven cost-savings that many can only dream of.

Using physician-led councils across its various service lines, the hospital has seen over $70 million dollar in supply chain savings over the last five years. As this article from Jack O’Brien at HealthLeaders continues:

“The Louisville, Kentucky–based system developed physician-led committees for the 11 service lines and 12 resource councils to assist in making supply chain decisions, such as vendor contracting and expense reduction. The service lines are overseen by the physician-led committees while the resource councils consist of director-level leaders who run various clinical departments within the organization.

The system has recorded significant supply chain savings in recent years through a clinically led effort to remodel its operations, garnering $36.5 million in savings since 2016 and $74 million since 2013.

Stratifying for savings

A majority of the savings have been related to risk stratifying product utilization and partnering with the right vendor for the right product, according to Cindy Gueltzow, executive director of supply chain services for Baptist Health, as well as standardizing use of the best product.

Gueltzow explained that risk stratifying involves a physician reviewing a product and determining which one the patient needs when presenting with an ailment. Similarly, standardization has involved Baptist clinicians agreeing to use the same product for the same use.

This could include antibiotic bone cement, where Gueltzow and her team work with physicians to identify whether the patient would need antibiotic bone cement as opposed to standardized bone cement. Baptist also made the decision to calculate how many doses per patient would be necessary for male patients as opposed to female patients, a project that saved the system $400,000.

“It’s clinically driven and frequently physician-led decision-making,” Gueltzow said. “When we can’t get the vendor to meet the price, we have physicians who are more than willing to sit down with me and the vendor to think through [what is needed]. It’s very powerful to have a supply chain executive sitting next to two or three physicians talking to a vendor about their pricing and their products.”

By fostering a trust that goes both ways, Gueltzow said the inclusion of physicians and clinicians in the process has been helpful for the supply chain operation due to subject matter experts participating in the process. Gueltzow added that this has driven efficiency in the organization, made it easier for clinicians to receive the supplies they need, and boosted negotiations with device manufacturers.

Generating supply chain savings

This approach to supply chain savings has paid off for Baptist in fiscal year 2017, when the system saved $12 million on supplies and in fiscal year 2018, when the organization saved $14.5 million. Baptist’s physician-led councils were integral in the standardization of its cardiac rhythm management devices, by narrowing down the system’s two main dual vendors for 90% of its market share, a move that saved the system $5 million last year.

In addition to the councils’ work, Baptist has also generated supply chain savings of $8 million over the past two and a half years from a partnership with Medline, $4 million from partnering with pharmacies, as well as savings derived from standardizing capital equipment, cardiac catheter lab scanners, MRIs, and ultrasounds.

Baptist also relies on financial goal setting as well, charging each resource council to identify areas for potential savings going into each fiscal year.

Gueltzow told HealthLeaders that the success of the savings initiatives has spread across Baptist Health.

“Saving money is contagious; people get very excited about saving money, and they find all kinds of projects,” Gueltzow said. “The way Baptist is positioned with supply chain, resource councils, and service lines is that we no longer have to be the only ones coming up with great ideas. We have plenty of people out there now who are looking for all kinds of great ways to improve quality, drive value, and save money.”

Download a copy of the case study here: Want to Save Money on Supply Chain? Use Physician-led Councils

Most hospitals are learning to live in the new value-based care environment in real-time and adjusting on the fly. Many hospitals and health systems are looking to achieve significant savings by eliminating waste in their supply chain. Making substantial improvements to supply chain spend requires powerful and accurate data about spending patterns. One place that hospitals may find immediate opportunities for reducing their costs is by better managing their implants and supplies, which make up the second biggest component of procedure costs after labor. If your organization lacks the proper tools to provide powerful data around your supply chain spend, consider systems such as iRISupply which can collect real-time data around supply and implant usage using RFID technology and provide actionable insights to help with vendor negotiations, on-hand inventory levels and owned-consigned item mix. Powerful data analytics included with the software will give specific recommendations on which items to reduce or eliminate, and which items should be owned vs. consigned, leading to millions of dollars in cost-savings opportunities. These cost-savings opportunities can help hospitals increase their margins and provide valuable dollars to the bottom line.

Tissue Documentation Lacking? This Technology Can Help

December 21, 2018Sri Mandava Clinical Documentation Hospital Management Joint Commission Operating Rooms Regulatory Compliance The Business of Surgery Tissue Management

In the past few years, we have heard the stories about surprise inspections from The Joint Commission (TJC) from many of our customers. The tissue managers and operating room administrators have all agreed on two points: 1) TJC, state Departments of Health and the FDA have all been focused on the tissue management and documentation processes at their hospitals more than they have seen in the past and 2) having a comprehensive tissue management system such as iRISecure has helped them get through the inspection with flying colors. In fact, one customer recently told us that their TJC auditor said they “were lucky to have a system like this” in place, and that the site survey went so much better than the last visit before our system was implemented. With the always-increasing focus on passing TJC inspections to stay in compliance with The Centers for Medicare and Medicaid Services (CMS), tissue and OR managers must make sure that their tissue-related documentation won’t hold them back from passing TJC surveys.

Many hospitals have implemented paper-based logs or simple spreadsheet/database-centric systems to track their tissue throughout the hospital. However, these very manual systems have one common flaw: they rely on the compliance of hospital staff to keep an accurate record of tissue transactions. While having some system in place is better than no system at all, these basic systems leave tissue managers with too much missing data that require staff to investigate for hours upon hours each week to fill in the blanks.

Hospitals that have a lot of tissue volume or that suffer from unmanageable amounts of missing tissue tracking data for TJC compliance may need a more comprehensive tissue tracking and documentation system. One such product is iRISecure from Mobile Aspects. iRISecure takes advantage of patented RFID-based workflows to minimize any data input requirements from staff and to make sure that compliance is a no-brainer. By having all data input occur at the point of tissue receipt, and associating product information to an RFID tag affixed to the tissue, iRISecure ensures that all tissue transactions are recorded and traced to the correct patients without any manual data entry from nurses or techs. When TJC comes and requests to see your tissue logs, they are brought up at the touch of a button and quickly satisfy the TJC auditors – as our customers have recently attested.

In addition, iRISecure is a full inventory management system that helps tissue managers run lean tissue operations using real-time data and analytics coming out of the system. iRISecure can recommend the ideal stocking levels for inventory based on actual usage data coming out of the system. The system can also simplify the expiration tracking process by delivering expiration warnings straight to your inbox. The savings from running a healthier tissue practice can pay for the system (and then some).

If your operating room administrator or tissue manager is worried about the quality of their tissue documentation, iRISecure is definitely worth a look. The best-of-breed technology separates itself from the pack by making TJC compliance for tissue documentation as simple as possible using RFID technology. Manual data entry and countless hours spent searching for missing data will be a thing of the past, and reporting and data analytics coming out of the software will help you continuously improve your tissue operations.

Olympus Pleads Guilty To Selling Misbranded Duodenoscopes

December 14, 2018Sri Mandava Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

Olympus’ recent legal battles took a serious turn this week when the Japanese company pleaded guilty to distributing endoscopes carrying known infection risks.

Olympus and one of its executives pleaded guilty in a New Jersey court to 4 counts – 3 counts for Olympus and 1 count for an executive – of wrongful distribution of medical devices. The company also agreed to $85 million in fines and penalties. As this article by John Commins of HealthLeaders Media explains:

“[Hisao] Yabe will be sentenced on March 27, 2019, and faces a maximum potential penalty of a year in prison and a $100,000 fine, which is twice the gain or loss from the offense.

According to DOJ, Olympus admitted that it failed to file with the FDA required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope involving 30 patients.

Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division – Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States, DOJ said.

Rachael Honig, U.S. Attorney for the District of New Jersey, said the infractions were “especially troubling” because Olympus and Yabe were told about the safety concerns by an independent expert.

“Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves,” Honig said.

The FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury.

Under the FDCA, devices for which required MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce.

Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit.

Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.

Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs.

An independent report—which Olympus obtained in the summer of 2012—found numerous problems with the Q180V, including that the scope’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty.

The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.”

Read the entire article here: Endoscope Maker, Exec Plead Guilty In Medical Device Scheme

As legal battles persist with the manufacturers of endoscopes and the health facilities that use them, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. Documentation of rigorously followed procedures will become a must have for the hospitals in case of any legal issues. Make sure that you are investigating automated documentation systems such as iRIScope, which can make the capture and reproduction of such documentation seamless, and reduce the amount of time sterile processing staff spend documenting their work. This documentation can be the difference between successfully defending hospital staff in court and severely damaging a hospital’s bottom-line and reputation along with it.

Olympus Denies Link Between Its Scopes And Superbugs

December 6, 2018Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

In response to a recent research report by the International Consortium of Investigative Journalists (ICIJ), Olympus has claimed that there is no link between its endoscopes and for a series of over 200 superbug infections around the world.

The constant legal battles that Olympus is facing have yet to find the Japanese company solely responsible for any of the deaths. As this article from the Kyodo News elaborates:

“There is no fact that the cause has been determined regarding the matter,” Olympus said in a statement released Tuesday.

Olympus said, “We are faced with civil lawsuits in connection with a duodenum endoscope. We will make our cases in court regarding what has been reported.”

The International Consortium of Investigative Journalists said there had been nearly 200 cases of “superbug” infections following the use the TJF-Q180V duodenum endoscopes in Europe and the United States between 2012 and 2015.

The ICIJ also revealed that an Olympus executive in Tokyo sent an email in 2013 to the company’s U.S. arm stating, “It is not need (needed) to communicate to all the users actively” about the possibility of infection due to the use of Olympus duodenum endoscopes.

“You should communicate with the user who has asked a question,” the email, which was presented as evidence in lawsuits, said.

Olympus did not mention the email communication in the statement.”

Read the entire article here: Olympus defends endoscope quality, says link with infections not confirmed

Regardless of the outcome of the ongoing legal cases with Olympus, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. Documentation of rigorously followed procedures will become a must have for the hospitals in case of any legal issues. Make sure that you are investigating automated documentation systems such as iRIScope, which can make the capture and reproduction of such documentation seamless, and reduce the amount of time sterile processing staff spend documenting their work. This documentation can be the difference between successfully defending hospital staff in court and severely damaging a hospital’s reputation and pocketbook by losing a lawsuit related to patient safety.

Research Reveals Number Of Superbug Infections Tied To Olympus Endoscopes

November 29, 2018Sri Mandava Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

A research report by the International Consortium of Investigative Journalists (ICIJ) has revealed that the number of superbug infections in patients following the use of an Olympus endoscope totaled over 190 between 2012 and 2015 in the United States and Europe.

The number of deaths linked to patients infected with superbugs and the role superbugs played in those deaths remains unknown. As this article from the Japan Times further explains:

“The ICIJ also revealed that an Olympus executive in Tokyo sent an email in 2013 to the company’s U.S. arm stating, “It is not need (needed) to communicate to all the users actively” about the possibility of infection due to the use of Olympus duodenum endoscopes.

“You should communicate with the user who has asked a question,” the email presented as evidence in lawsuits said.

U.S. website Kaiser Health News has reported that at least 35 people have died since 2013 after developing infections linked to Olympus duodenoscopes.

It is believed infections may have occurred due to difficulties in cleaning and sterilizing the equipment.

Around 50 lawsuits have been brought against the major optical equipment maker seeking compensation over the superbug infections.

In 2015, the U.S. Food and Drug Administration issued a warning to the company for failing to promptly report the bacterial infections even though it was aware of them in November 2012.

Olympus declined to comment because doing so “could influence” the legal proceedings.

The TJF-Q180V duodenoscopes that are believed to have caused the infections have been sold since 2010 in Europe and the United States, according to a report compiled by a U.S. lawmaker and lawsuit documents.

More than 190 people were infected in 17 medical institutions in the United States, the Netherlands, France and Germany, they said.

European authorities, suspecting that the infections could be the result of difficulties in cleaning the endoscopes, ordered Olympus to warn equipment users of that possibility.

After the safety warning was issued by Olympus in Europe in January 2013, the number of infections in the region was about 50, significantly lower than the around 140 seen in the United States.

Separate data analysis by the ICIJ conducted since spring of this year showed that more than 5.4 million cases of health problems linked to medical devices, including Olympus duodenoscopes and other manufacturers’ products such as pacemakers and intrauterine devices, were reported to the FDA over the past 10 years.”

Read the entire article here: Over 190 superbug infections reported in U.S. and Europe after using Olympus endoscopes, probe finds

As legal problems and patient safety issues mount for Olympus and other manufacturers of endoscopes, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. Documentation of rigorously followed procedures will become a must have for the hospitals in case of legal issues. Make sure that you are investigating automated documentation systems such as iRIScope, which can make the capture and reproduction of such documentation seamless, and reduce the amount of time sterile processing staff spend documenting their work. This documentation can be the difference between successfully defending hospital staff in court and severely damaging a hospital’s reputation and pocketbook by losing a lawsuit related to patient safety.

Scope Documentation Lacking? This Technology Can Help

November 20, 2018Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety Regulatory Compliance

Over the last several years, endoscope-related outbreaks from around the US and the world have led to increased oversight of the endoscope high-level disinfection (HLD) process at many hospitals. Many hospitals are now finding themselves in a struggle to oversee the HLD process at their facilities without introducing too much oversight and intervention into the process due to resource constraints.

The simple solution that many facilities have introduced is to increase surveillance or sampling of their employees to make sure they are following standard protocols while being observed. But what happens when no one is watching? Do you trust that all of your employees, when no one is looking over their shoulder, will reprocess scopes properly and never skip any steps? Most facilities still have staff go through their HLD routines based on memorization, but recent technology products have been introduced in recent years to ensure staff follow the same process each and every time – even when no one is watching.

One such product is iRIScope from Mobile Aspects. The way that iRIScope and other systems like it work is to walk staff through the HLD process for each scope in a workflow that matches the hospital’s existing standard operating procedures. By using a combination of RFID technology and touchscreen kiosks, staff are guided through the HLD process and are required to log all steps as completed before they can move on to the next step. If a step is missed, a reminder to complete that step is displayed and the missed step is logged in the system. This ensures that no scopes are skipping any of the key steps in the HLD process. It also allows managers to properly train their employees by highlighting the employees that are most prone to skipping steps. Using this data helps managers train up their staff efficiently based on analytics coming out of the system, rather than observations noticed while sampling.

Additionally, these systems increase the quality of the documentation surrounding the use of endoscopes in hospitals. In addition to a complete record of all steps completed for every scope during reprocessing, the system also ensures that there is a record of each scope used on each patient for safety and compliance purposes. Having a centralized repository of this information, rather than having to check separate systems like the EMR, AER or surgical instrument tracking software, can be a life-saver when The Joint Commission visits or in case of an infection control issue.

The infection risk with flexible endoscopes continues to be a major worry for hospitals. Facilities must ensure that staff are trained on general infection control principles and must adhere to reprocessing best practices. To ensure that your staff is following reprocessing best practices on every scope they disinfect, investigate the use of software systems such as iRIScope. These systems help hospitals and surgery centers ensure that each of their flexible endoscopes is reprocessed the proper way each time, and any breaches of protocol are logged and immediately addressed. Documentation is also greatly improved by having a permanent record of all steps of the endoscope lifecycle, from procedure, to reprocessing and back to clean storage.

Olympus Continues To Set Aside Reserves For Expected Scope-Related Lawsuits

November 14, 2018Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

As the United States Department of Justice continues to examine Olympus’ role in infections related to the use of its duodenoscopes, the company is setting aside millions of dollars in reserves to cover expected losses from related lawsuits. As the leader in duodenoscope and endoscope sales in the US, Olympus expects to bear a majority of the losses from the DOJ investigation.

Olympus’ role in the illnesses of hundreds of patients worldwide who underwent procedures with contaminated scopes continues to be the focus of the investigation. Though the DOJ had no comment on the current status of the investigation, this article by Jon Harris of The Morning Call further explains:

“…The company said in a notice Tuesday that it recorded a reserve of 9,653 million yen — or about $85.6 million in U.S. dollars — in the second quarter of its current fiscal year, which will end March 31. While the ultimate loss will be dependent on the probe’s final outcome, Olympus said it believes the reserve amount is “reasonable as expected losses according to the status of the investigation.”

“The company has cooperated fully with the Department of Justice,” said Mark Miller, a spokesman for Olympus Corp. of the Americas in Center Valley. “As the matter is still pending, it would be inappropriate for us to comment further.”

It’s been more than three years since Olympus received subpoenas, in March 2015 and August 2015, from the Justice Department, seeking information about the duodenoscopes the company manufactures in Japan and sells across the globe. Federal prosecutors also sought information about Olympus, which controls about 85 percent of the U.S. market for gastrointestinal scopes, from hospitals that experienced deadly outbreaks of antibiotic-resistant bacteria in patients following procedures that used the duodenoscopes.

The Justice Department did not immediately respond to a request seeking comment on the status of its investigation.

As many as 350 patients at 41 medical facilities in the United States and worldwide were infected or exposed to contaminated scopes from Jan. 1, 2010, to Oct. 31, 2015, according to a U.S. Food and Drug Administration document obtained by the House Committee on Oversight and Government Reform and made public in mid-April 2016. While that document did not list how many deaths were reported, many medical facilities, including Huntington Hospital in Pasadena, Calif., and UCLA’s Ronald Reagan Medical Center, have confirmed that several patients died during that time period after being infected with bacteria tied to medical scopes.

While Olympus is, by far, the largest seller of duodenoscopes, Fujifilm and Pentax also sell the devices in the United States.

In Olympus’ case, its TJF-Q180V duodenoscope came under scrutiny because the device’s closed-channel design made it difficult to clean, leaving the potential for bacteria to become trapped and then transmitted from patient to patient. In January 2016, Olympus announced it was recalling and redesigning the device, replacing its forceps elevator mechanism with a new design consistent with a submission cleared by the U.S. Food and Drug Administration. The FDA said the new design created a tighter seal, reducing the potential for leakage of patient fluids and tissue into the closed elevator channel.

Across the United States in 2016 and 2017, Miller said Olympus “inspected and/or repaired” more than 5,800 duodenoscopes and also performed more than 4,000 educational and training visits to more than 1,700 customer sites.

Duodenoscopes, a flexible, lighted tube threaded through the mouth, throat and stomach into the top of the small intestine, are used during endoscopic retrograde cholangiopancreatography (ERCP), most commonly performed to diagnose and treat conditions in the pancreas and bile ducts. The FDA says duodenoscopes are used in more than 500,000 ERCP procedures each year.

More recently, on March 9, the FDA issued warning letters to Olympus, Fujifilm and Pentax for failing to comply with a federal law that required them to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the duodenoscopes.

Miller said Olympus, which responded to the FDA on March 23, has undertaken significant efforts to enroll the studies, but there have been challenges with the enrollment.

“We are working diligently to address these enrollment challenges, resulting in a robust plan with the goal of completing this study,” he said. “We take this matter extremely seriously and are working diligently to provide the requested information.”

Read the entire article here: Olympus setting aside more than $85 million related to federal investigation into its scopes

Olympus, other scope manufacturers and hospitals can all expect lawsuits from scope-related infections to increase in coming years based on the DOJ’s findings. In trials like these, documentation of rigorously followed procedures will become a must have for the hospital’s defense. Automated documentation systems such as iRIScope can make the capture and reproduction of such documentation seamless, and reduce the amount of time sterile processing staff spend documenting their work. This documentation can be the difference between successfully defending hospital staff in court and severely damaging a hospital’s reputation and pocketbook by losing a lawsuit related to patient safety.

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