Carilion Roanoke Memorial Hospital Under Scrutiny 

A recent state investigation uncovered significant risks to patient safety at Carilion Roanoke Memorial Hospital. The Virginia Department of Health report, released last week, highlighted serious deficiencies in the cleaning and sterilization of surgical tools. These issues occurred between March and September of last year. 

Immediate Jeopardy Finding 

The hospital was placed in a state of "immediate jeopardy." This severe designation indicates that patient health was in significant danger. Further, it meant that, without immediate correction, Carilion could have lost its funding from the Centers for Medicare and Medicaid Services. Thankfully, Carilion submitted a detailed action plan, and the state has now approved it. There is no financial penalty associated with the report. 

No Patient Harm – But Surgeries Impacted 

Nancy Agee, chief executive officer at Carilion Clinic, insists that no patients came into contact with unsanitary surgical instruments. The issue did, however, cause rescheduling or transfer of roughly nine surgeries in August due to instrument shortages. 

Immediate jeopardy findings are uncommon. According to a 2021 National Library of Medicine study, only around 2% of the 30,000 reported deficiencies in hospitals over a 10-year period resulted in this serious designation. 

The Investigation 

The state investigation began after an anonymous complaint. This complaint alleged that surgical instruments were often arriving in the operating room (OR) stained with residue. In one disturbing instance, bits of suture material and an alcohol pad remained stuck to the metal. 

Following this complaint, the health department conducted three unannounced site surveys starting in September. Hospital staff confirmed an increase in rejected instrument trays prior to operations. 

Employee Concerns Went Unheeded 

According to the report, concerns about potentially contaminated instrumentation began surfacing in the cardiac surgery department in March 2023. Reports became steadily more frequent over the following months, reaching a peak in July and August. 

Operating room staff have the authority to reject any instrument they believe may pose a contamination risk. Agee confirmed the number of rejections during this period was far above normal but stated that some level of staining is not unusual. “It’s not only common, it’s everyday,” Agee said. “And the good news is that the processes worked.” 

However, troublingly, the Virginia Department of Health investigation found that Carilion's quality control team had not acted swiftly enough in response to the growing concerns. 

Leadership and Communication Failures 

Jami Salzberg, supervisor of quality control for Carilion's surgical departments, was the first to receive formal notice of the problem. Typically, she waits to report issues until receiving three to five similar complaints in a week. However, as concerns mounted in June, she took the issue to senior hospital leadership. 

Agee acknowledges that communication breakdowns were a major contributing factor. She noted that multiple departments play a role in cleaning and sanitation. The leadership team attempted to address problems behind the scenes, but those efforts weren't communicated to front-line staff. 

“Leadership was involved from the very beginning. I think what we learned from this is that doing some things in the background was insufficient,” Agee said. “The idea was let’s not worry them, let’s get this work done for them. We should have communicated differently.” 

Seeking Solutions, Ensuring Safety 

To address the situation comprehensively, Carilion leaders brought in outside experts. These included water quality and sterilization specialists. They even consulted with Marc Edwards, a Virginia Tech expert known for his role in uncovering the Flint, Michigan, water crisis in 2015. 

No bacteria were detected in Carilion's water supply. However, elevated levels of certain metals were present. 

Initially, most rejected instruments were cited for discoloration or staining, said Dr. Anthony Baffoe-Bonnie, Carilion’s chief of infectious disease services. Yet, as reports increased, staff frequently described the residue as blood, tissue, or even bone fragments. The state report refers to this type of contamination as bioburden. 

“Those would be extremely rare but conflate the picture. Someone you know may say they saw bone or something, and now all the staining is [bioburden],” Baffoe-Bonnie said. “It gets very complex very quickly.” 

Understanding Instrument Blemishes 

Staining and imperfections on stainless steel surgical instruments can have many causes. Roanoke's hard water can leave mineral deposits. The water also contains trace amounts of metals. These may react with the instruments and leave reddish stains. Sometimes, a substance appearing like a bone fragment may actually be a bit of cement used in a medical procedure. 

Crucially, all instruments pass through the hospital's autoclave system. This means that even a blemished tool has undergone the sterilization process upon arriving in an OR tray. 

New Standards and Training 

In response to the VDH investigation, Baffoe-Bonnie and colleagues developed a glossary of commonly observed stains and blemishes. This glossary, along with training materials, provides a standardized identification system for surgical staff. Information guides now hang prominently in every operating room. 

“It gives everybody that level playing field,” Baffoe-Bonnie said. “And then it allows us to trend what is being seen, truly seen, properly identified. So now we can create action items around those things.” 

Agee acknowledges that precisely what caused the rise in issues remains unclear. She describes the situation as "multifactorial." 

Increased Scrutiny and a Photo-Driven System 

The hospital has implemented additional checks throughout the cleaning and sterilization process, Salzburg explained. This will aid leadership in their ongoing monitoring efforts. 

Notably, employees now use a "point of use" feature This involves taking a photo of the instruments at the end of each cleaning stage with their cellphones. 

The Sterilization Process: Step-by-Step 

Let's break down the complex process surgical instruments undergo to ensure patient safety: 

Initial Cleaning: After a procedure, OR staff immediately scrub down the instruments. They use a pre-cleaning gel designed to keep blood and tissue from drying and hardening. 

Decontamination: Instruments are loaded onto carts and the decontamination process begins. Carilion has added a photo-audit step here, requiring staff to document their work. 

Central Sterile Department: In this specialized department, tools are thoroughly disassembled and disinfected. This is done both manually and through mechanical processes. 

Soaking and Scrubbing: Staff use protective gear and work with temperature-controlled, deionized water. They soak and scrub each tool meticulously. 

Industrial Washing: Next, tools are loaded into a washer, with a cycle similar to a high-powered dishwasher. 

Damage Inspection: Each tool undergoes a close visual inspection for any damage or remaining residue Carilion has added another audit with photo documentation at this stage. 

Autoclave Sterilization: Staff load the inspected tools into trays and place them in the autoclave. This machine uses high-pressure steam for sterilization. Importantly, Carilion uses biological indicators in every autoclave cycle to validate the system's effectiveness. The Centers for Disease Control and Prevention (CDC) considers this the most reliable sterilization verification method. 

A Commitment to Patient Safety 

Even in light of the state report and expanded oversight, Carilion's leadership strongly emphasizes its safety culture. Dr. Suzanne Kraemer, chief quality officer and an internal medicine physician, offers reassurance. 

“The frontline staff did exactly what we need them to do in healthcare every single day. It’s about having an exceptionally strong safety culture that if something is recognized, it doesn’t look right, you speak up on behalf of the patient. And that’s exactly what happened,” Kraemer said. 

What's Next? 

It's too early to say whether the new measures will entirely eliminate instrument contamination issues. Carilion leadership recognizes that continual monitoring and staff training are essential. 

The state investigation highlights a universal truth in healthcare – complex systems and intricate processes can break down. It also underscores how crucial open communication and swift action are to protecting patients. 

The hospital, for its part, seems to have learned some hard lessons. It's clear they intend to make patient safety paramount. 

Beyond Carilion: A National Problem? 

While the situation at Carilion Roanoke Memorial Hospital was severe enough to trigger an "immediate jeopardy" finding, it may not be an isolated incident. Surgical instrument contamination and sterilization issues appear to be a growing challenge across the United States. 

FDA Data and Recalls 

The Food and Drug Administration (FDA) tracks adverse events and problems with medical devices. Over the past decade, reports related to surgical tool cleaning and sterilization have increased substantially. Device recalls in this category have become more frequent as well. 

The exact reasons for this upward trend aren't fully clear. However, some factors likely contribute to the situation. 

Factors Affecting Sterilization 

Complex Instruments: Modern surgical tools are often incredibly intricate, with tiny, hard-to-reach components. Effective cleaning and sterilization become more difficult as instruments grow more complex. 

Turnaround Pressure: Hospitals and surgical centers face immense pressure to keep operating rooms running efficiently. This can lead to staff feeling rushed, potentially increasing the chance of errors. 

Staffing Shortages: The healthcare industry, like many sectors, is grappling with significant staffing shortages. Understaffed sterile processing departments may struggle to maintain the highest standards with a heavy workload. 

Staff Education: Ensuring staff have the necessary training and resources is crucial but can be a challenge in high-pressure environments. 

Recent High-Profile Case 

In 2022, a major hospital chain temporarily shut down five surgical centers in the wake of problems with sterilization. The company also recalled and re-sterilized surgical instruments used at 133 of its locations across multiple states. 

These types of incidents bring the issue into sharp focus and often lead to increased scrutiny within hospitals nationwide. 

The Role of Outsourcing 

Many hospitals outsource portions of surgical instrument preparation to third-party companies specializing in sterile processing. This can have benefits in terms of efficiency and expertise. However, outsourcing also introduces another layer of complexity. It requires careful oversight to prevent communication breakdowns and quality control issues. 

Proactive Measures 

Both the CDC and the Association for the Advancement of Medical Instrumentation (AAMI) offer guidelines and best practices for instrument handling and sterilization. Hospitals should regularly review and update their processes in light of these recommendations. Additionally, proactive steps worth considering include: 

Investing in Technology: New technologies, such as enhanced tracking systems and better cleaning equipment, can help mitigate risks. 

Continuous Training: Regular, updated training for all sterile processing staff is a must. 

Clear Accountability: A strong quality control program should identify responsible parties and establish clear communication channels for reporting concerns. 

The Patient's Perspective 

Most patients entering surgery have understandable anxieties. They likely aren't thinking about whether their surgeon's tools are flawlessly sterile. However, trust in a hospital's systems is essential. News of incidents like the Carilion situation naturally raise concerns. It's vital that hospitals not only implement robust safeguards but also communicate their safety commitments transparently to the public. 

Protecting Patients: A Shared Responsibility 

The Carilion Roanoke Memorial Hospital investigation serves as a stark reminder of the critical importance of surgical instrument sterilization. Ensuring patient safety is a complex and ongoing challenge. Hospitals, regulators, medical device manufacturers, and healthcare workers all share a role in meeting the highest standards. 

The Role of Regulators 

State health departments and federal agencies like the FDA conduct inspections and monitor adverse event reports. They have the authority to issue warnings, citations, and even shut down facilities if serious violations occur. While oversight is crucial, some experts argue that regulatory agencies are often understaffed and struggle to keep pace with the rapidly evolving healthcare landscape. 

Medical Device Manufacturers' Obligations 

Manufacturers of surgical instruments bear significant responsibility. They must design tools that are both effective for their intended purpose and relatively easy to clean thoroughly. Clear, detailed instructions for cleaning and sterilization should accompany every medical device. Advancements in materials science may also play a role, potentially leading to instruments that are less prone to contamination. 

Hospitals: The Front Line of Defense 

Ultimately, it falls to hospitals to uphold rigorous sterilization practices. This requires several key elements: 

Sufficient Resources: Sterile processing departments must have adequate staffing, equipment, and training resources. 

A "Safety First" Culture: Hospital leadership should foster an environment where staff feel empowered to speak up about any concerns without fear of reprisal. 

Transparency and Accountability: If problems do arise, hospitals must be forthright with the public and take swift corrective action. 

The Patient's Role 

While individual patients have limited direct control over hospital practices, they can act as informed healthcare consumers. Key actions include: 

Research: When choosing a hospital for a procedure, inquire about their safety record and accreditation status. 

Ask Questions: Don't be afraid to ask your healthcare team about the hospital's sterilization procedures and infection prevention strategies. 

Report Concerns: If something seems amiss during your hospital stay, speak to a nurse or patient advocate. 

The Takeaway 

The vast majority of surgeries performed in the U.S. every year are safe and successful. Dedicated healthcare professionals work tirelessly to protect patients. However, incidents like the one at Carilion underscore that there is no room for complacency. Continuous improvement, vigilance, and a commitment to the highest standards are essential. 

A Call for Collaboration 

Addressing the challenges of surgical instrument cleaning and sterilization will require cooperation and innovation across multiple sectors. By working together, regulators, manufacturers, hospitals, and healthcare workers can help ensure that patients receive the safe, high-quality care they deserve.