New Technology and Policies Improve Clinic Safety

Patient safety in healthcare is a complex endeavor with simple solutions that must be followed fastidiously on a daily basis. A certain infamous healthcare event that occurred earlier this year in Nevada shows that a singular act can have exponential consequences.

In March 2008, the Southern Nevada Health District received a report from a patient who had contracted hepatitis C, which led the agency to ramp up its investigation into the root cause. Lab tests confirmed that the patient tested negative for hepatitis C just days before undergoing a procedure at the Desert Shadow Endoscopy Center in Las Vegas, which became the investigation’s focus.

The Las Vegas clinic had been flagged for unsafe practices as recently as January. During a state inspection that month, a staff member at the Desert Shadow center was seen reusing vials of the sedative propofol, when the vials for the agent were only meant to be used once. Logs provided further proof that the bottle of anesthesia was used on a number of patients. Staff members, however, have not been able to document the reuse of syringes because the clinic location was closed before the patient reported the hepatitis C transmission.

State investigators have since been able to link the hepatitis C case to Desert Shadow, but, despite the documented transgressions, still could not determine the likely source of the disease’s transmission into the patient by the time the investigation concluded in June. More than 13,000 patients were treated at the Desert Shadow clinic during the last two years. In addition, seven cases of hepatitis C were associated with unsafe injection practices were found at the Endoscopy Center of Southern Nevada, which prompted officials to notify more than 40,000 people of their potential exposure to bloodborne illnesses.

The transmission of hepatitis C at these clinics was entirely preventable and could have been avoided if clinic protocol was followed. The Las Vegas situation is an extreme case of patient safety gone wrong, but it sent a clear reminder that education and tenacity are key components in keeping patients safe from preventable healthcare foibles such as falls, patient sedation and mishandling of personal information.

Sedation Safety

Sedation is a fact of life in endoscopy clinics, especially during colonoscopies. New technology could help healthcare providers better monitor how patients are reacting to sedatives. In late March, medical device company Ethicon Endo-Surgery submitted a premarket approval application to the U.S. Food and Drug Administration for the Sedasys System, which is the first computer-assisted personalized sedation (CAPS) system. Physicians often administer propofol for routine colonoscopy and EGD procedures because the drug produces rapid onset and quick recovery for patients.

The Sedasys system was designed to administer minimal to moderate propofol sedation to patients undergoing a colonoscopy or diagnostic procedures to detect disorders of the upper gastrointestinal tract (EGD). The FDA application submitted by Ethicon, which is a subsidiary of Johnson & Johnson, included the result of an eight-site, 1,000-person study, which found that the Sedasys System reduced the risk of propofol “over sedation” in colonoscopy or EGD patients.

“During the trial, the system made it possible for gastroenterologists to maintain minimal to moderate sedation with propofol, and helped prevent patients from entering deep sedation, which is traditionally associated with propofol,” says Daniel Pambianco, MD, FACG, medical director of Charlottesville (Va.) Medical Research and the trial investigator. “The system offers a way to personalize the level of sedation appropriate for each patient because it combines propofol delivery with sophisticated monitoring to help us better control and predict the patient’s sedation level.”

The device continually monitors and records six patient parameters including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness, according to Ethicon. In addition, Sedasys automatically detects and responds to signs of over-sedation by stopping or reducing propofol delivery, increasing oxygen delivery and automatically instructing patients to take a deep breath. Currently, the device is only for investigation use.

“Patients understand that recovery from sedation takes time after colonoscopy, but with propofol, they recuperate quicker and are functional sooner,” Pambianco adds. “GIs have been performing procedures with current standard of care sedatives for years and maintaining a constant sedation level in patients can be daunting. The novelty of this system is that it has the potential to accurately tune into my patient’s sedation needs by following their vital signs and delivering propofol in a precise manner.”

Preventing Falls

Sedation makes patients woozy, which makes falls a real threat in endoscopy clinics. In 1999, the Veterans Health Administration (VHA) created the National Center for Patients Safety (NCPS) with a goal to reduce and prevent inadvertent harm to patients during their care. Today, there are patient safety managers at 153 VHA hospitals and patient safety officers at 21 VHA regional headquarters.

Furthermore, the VHA estimated that in 1994, the total cost of fall injuries in patients over 65 years old at VHA hospitals, was $20.2 billion and could reach $32.4 billion in 2020. Falls have many consequences, including hip fracture and brain injury, which can lead to more time and costs in the hospital.

Despite concerted efforts to combat patient falls, it is still a major issue within the VHA system. In 2003, patient falls accounted for nearly 47 percent of all safety reports and aggregated events in the NCPS database. Therefore, in 2004, the center released a “falls toolkit” to help healthcare providers prevent patient falls.

To combat patient falls, the VHA recommends that facilities should assemble a “Falls Team,” which should include people with administrative and direct care responsibilities. Each of these team members could use his or her expertise to add to the team. For instance, a physician can look into the patient’s medical history in order to assess fall risk, and a facility manager could identify the fall hazards within the facility.

The key responsibilities of the fall team, according to the VHA, include the following: develop/review fall prevention protocols, implement fall prevention strategies, act as a resource for interdisciplinary treatment teams, review falls on a case-by-case basis, and collect and analyze data to identify any trends or factors.

The NCPS breaks down the facility fall policy as follows: definition of fall, fall risk assessment for inpatients and outpatients, environmental rounds, staff responsibility, intervention strategies and post fall procedures and management.

A fall is defined as a sudden, uncontrolled, unintentional, downward displacement of the body to the ground or other object, excluding falls resulting from violent blows or other purposeful actions. The NCPS also recommends that the clinic itself be as fall-proof as possible. For instance, hallways and patient areas should be well lit and uncluttered, handrails should be secure and tables and chairs should be sturdy.

Visit www.va.gov/ncps/SafetyTopics/fallstoolkit/index.html to download a full PDF of the fall toolkit.

Protecting Patient Information

Vulnerable patient medical records may not have the tangible side-effects of a sedation session gone wrong or a nasty spill, but a burgeoning cyber world has made patients more vulnerable to leaked personal information. It’s more important than ever for patients to protect their records.

Earlier this year, news of a scandal broke at the UCLA Medical Center where a number of employees, including physicians, were caught snooping into the medical records of co-workers and celebrities, such as Farrah Fawcett and Britney Spears. The Los Angeles Times reported in May that as many as 68 hospital workers have been implicated in violating patient privacy.

“We believe that this sends a clear message to the healthcare community that the confidentiality of patient medical records must be protected,” Kathleen Billingsley, director for the California state health department’s Center for Healthcare Quality, told the Los Angeles Times.

Perhaps the best way to prepare a clinic to protect patient information is to understand patient protections provided by federal law. Patient privacy protection first came into play with the Health Insurance Portability and Accountability Act of 1996, which required safeguards to protect the security and confidentiality of health information. In addition, in 2003, the first-ever federal privacy standards to protect patients’ medical records took effect. The standards limit the ways health plans, pharmacies, hospitals and other healthcare entities can use patient medical information, whether it’s on paper, in a computer or communicated orally. The following are key provisions of the privacy standards, according to the U.S. Department of Health & Human Services:

Access to medical records: Patients should be able to see their medical records to identify errors or mistakes. Providers should provide access within 30 days of the request.

Notice of privacy practices: Providers must give a notice to patients on how they can use their medical records. Patients will generally be asked to sign, initial or acknowledge they’ve received the notice. Patients can also ask providers to limit disclosure of their information beyond the notice.

Limits on use of personal medical information: Patient information can’t be used for purposes not related to healthcare. In addition, patients have to sign a specific authorization before their information can be released to a life insurer, bank, marketing firm or another outside business.

Confidential communications: Patients can request healthcare providers take steps to ensure that communications are confidential. For example, a patient could ask a doctor to call his or her office rather than home, and the doctor’s office should comply with that request if it can be reasonably accommodated.

Complaints: Patients can make complaints directly to the provider, health plan or the HHS’ Office for Civil Rights, which investigates and enforces privacy regulation. Visit www.hhs.gov/ocr/hipaa or call (866) 627-7748 for more information about filing complaints.

Healthcare providers must also become savvy on how to protect electronic medical information as healthcare continues to gravitate toward computers. Therefore, it is also vital to be able to evaluate companies that offer electronic medical records. The EHR Safety Institute (www.ehrsafety.com), which formed in 2007 to address EHR risks and challenges, recommends the following steps:

Meet with the vendor’s executive who is primarily responsible for EHR safety. Review staffing levels, and how human-factors, engineering principles and practices are incorporated in the development, testing, documentation, and upgrading of the product and its interfaces with other software products.

Review how the vendor gathers information regarding system flaws from customers and how they communicate flaws and resolutions to customers.

Review the vendors’ lists of safety flaws (active and resolved) and note how long it takes them to resolve flaws.

Include an explicit service-level agreement regarding timely flaw resolution in your contract.

REPROCESSING AND PATIENT SAFETY Q&A with Daniel J. Vukelich president of the Association of Medical Device Reprocessors

Does the AMDR have an official statement on the safety of reprocessing, especially after the recent GAO update?

The Association of Medical Device Reprocessors (AMDR) applauds the findings of the U.S. Government Accountability Office (GAO) January 2008 report entitled “Reprocessed Single Use Medical Devices — FDA Oversight Has Increased, and Available Information Does Not Indicate that Use Presents an Elevated Health Risk.” The Food and Drug Administration (FDA), stringently regulates medical device reprocessing, as the GAO again confirms. Twice in eight years GAO has looked at the practice of reprocessing ”single use“ devices (SUDs) and found no evidence of increased risk to patients.

How is patient safety affected by reprocessed medical devices?

AMDR believes that patient safety has been improved through the use of reprocessed medical devices. The nation’s third-party reprocessors have safely reprocessed over 55 million devices all the while maintaining an excellent safety record. Unlike original equipment manufacturers which may test or inspect a sampling of the devices they produce, AMDR’s members test or inspect 100 percent of the devices they reprocess. In fact, the GAO report noted that FDA focus group participants stated that there were actually fewer performance problems associated with reprocessed devices than with original devices.

Do you anticipate any changes/improvements to reprocessing in the near future?

Less than one-tenth of one percent (65 out of 320,000) of all adverse events reported to FDA from 2003-2006 possibly involved a reprocessed device. This is an outstanding achievement. The FDA also found that the types of adverse events reported as associated with the use of reprocessed devices were the same types of events that were reported for new, non-reprocessed devices. GAO concluded that there is “no causative link between a reprocessed SUD and reported patient injury or death.” It is our hope that in the next few years more hospitals and institutions will recognize the value of reprocessing, bringing increased patient safety as well as institutional cost savings and waste reduction to more people.