Effective January 1, 2004, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO of Oakbrook Terrace, Ill) altered the horizon of healthcare accreditation with sweeping changes that literally paved a new path for patient safety. Shared Visions-New Pathways shifted the focus from triennial survey preparation to a culture of continuous improvement. Factor in both the announcement from the FDA (Rockville, Md) on new bar-code rules¹ and the recent release of JCAHO's 2005 National Patient Safety Goals, and it's clear that healthcare organizations across the country are facing a new era of accountability for improving patient safety.

The JCAHO based its revised decisions on the numerous safety issues affecting both patients and healthcare staff. For example, a report from the Institute of Medicine (IOM of Washington), "To Err Is Human: Building a Safer Health System," attributed as many as 98,000 hospital deaths each year to medical errors.² Many of the causes of death were preventable, such as communication breakdowns, diagnostic delays, and equipment failures.

The FDA's new rule, which was released on February 26, first requires a linear bar code on human drug products and biological products to help reduce the number of healthcare medication errors by verifying the right drug, the right dose, and the right patient. Next, the rule adds bar coding to blood and blood component container labels to help in further reducing errors.

Technology Automates Safety

No one in radiology can forget the case-a mere 2 years after the IOM report-of a 6-year-old boy undergoing treatment for a benign tumor at Westchester Medical Center (Valhalla, NY). A hospital employee allegedly entered the MRI room with a metal oxygen canister, which was pulled by magnetic force into the center of the machine, killing the boy.

In June, Kopp Development (Jensen Beach, Fla) launched Ferralert Prescreen and Ferralert Entry, both of which are new to the MRI safety market and are designed to supplement existing MRI screening procedures. Inspired in part by the death of the boy at Westchester Medical, Keith Kopp, president of Kopp Development, designed a system that works similar to a metal detector. "We all make mistakes and get absentminded," he explains. "Our goal is to supplement safety with an alarm that warns, 'You're posing a danger!' "

An avid sailor who realizes it's not wise to place ferrous material near a compass, Kopp developed a machine that targets only ferrous material. "We make a point of calling our machine a ferrous detector for metal that will be pulled into the magnet. It's not a standard metal detector: Ours detects only ferrous metal, is totally passive, and doesn't radiate a signal," Kopp says.

He wanted a machine that could keep everyone safe-from the patient and supporting family members during the day to third-shift and janitorial staff during the night. "The system allows people to wear street clothes since it won't detect items like brass buttons," he adds. "It detects only things that get pulled into the magnet."

Did you know? The US Senate recently approved a version of a patient safety bill that the American Society for Therapeutic Radiology and Oncology (ASTRO of Fairfax, Va) has championed throughout this session of the 108th Congress. The Patient Safety and Quality Improvement Act amends the Public Health Service Act and would establish a confidential, voluntary reporting system to allow physicians, hospitals, and other healthcare providers to disclose information on medical errors without fear of legal repercussions. Representatives from both the House and Senate are meeting to reconcile the differences between the two bills.

Ferralert Prescreen is a metal-detector frame that prevents ferrous material from entering the magnet room. It consists of the operator console and the portal. If a dangerous object is brought through the doorway frame, audible and visual alarms are activated both at the doorway's sensor and on the operator's console. This system can detect an object as small as a hairpin-a seemingly innocuous object that can travel up to 40 mph into a 1.5 Tesla (1.5T) magnet. Unlike other types of detectors, it emits no electromagnetic radiation to detect objects. It complements Ferralert Entry and the two are sold together as a system.

"The Prescreen is a supplement since we're finding that people forget," Kopp explains. "It's a separate unit with higher sensitivity than at the door. It can be located where people are filling out patient forms or questionnaires, or near there as a last stop. This is not only for patients, but also for anyone going into the room. Everyone is equally vulnerable."

The Ferralert Entry, which consists of the operator console and the sensor array, is installed in the doorway entering the magnet room. It works by analyzing all objects entering into the magnet room; audio and visual alarms are activated both at the doorway and by the operator if a dangerous object passes through the doorway. The sensitivity is adjustable depending on the environment. For example, the system can detect an object as small as an X-Acto knife blade but ignore a sheet of nonmagnetic stainless steel.

"The risks in MR safety are getting worse with time," he says. "The fields are going up, from 1.5T to 3T, and when that happens, the hairpin goes from 40 mph to 80 mph."

Kopp is working in conjunction with Emanuel Kanal, MD, FACR, director of MR services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center. Further, Kanal is a fellow at the American College of Radiology (ACR of Reston, Va) and serves as chair of its MR Safety Committee. "He is evaluating our system and is writing a paper that he will submit at RSNA this November," Kopp adds.

Get Involved! Miami Valley Hospital recently joined the Stand Up for Patient Safety campaign, a program launched in 2002 by the National Patient Safety Foundation (McLean, Va). The program provides educational tools, conferences on safety topics, forums for sharing best practices, and materials for internal and external communication to hospitals looking to participate in the national patient safety movement. For more information, visit www.npsf.org.

With so many reported stories of medical errors, a litigious medical malpractice community, and a national nursing shortage, what's not to like about a company that manufactures technology that links all systems related to patient safety? McKesson Information Solutions (Alpharetta, Ga) claims that its patient safety solutions help avoid as many as 26,000 medication errors each week. The company-an authority on the bar-code technology that ensures positive patient identification for blood transfusion, medication administration, and specimen collection-provides an umbrella of medication management safety options.

McKesson's bar-code technology is based on using a handheld scanning device that allows for medical staff member verification, a confirmation of the patient, and approval of the patient's medication at the point of administration. By using a single wireless tool, medical staff can view everything from the patient's medication history and vital signs to administration records and other care comments. Specifically, the bar-code scanner allows hospital staff to use the following:

• Bar-code scanning at the point of care;
• Robotic drug dispensing;
• Electronic medical records; and
• Pharmacy distribution via a patient's bar-coded bracelet.

The FDA estimates that bar-code technology will save $93 billion over the next 20 years by eliminating many of the typical healthcare expenses brought on by lengthy hospital stays, malpractice lawsuits, and higher insurance costs.

"The problem with healthcare is the handoff. Bar-coding technology minimizes those handoffs and breakdowns," explains Teresa McCaskey, RN, MBA, the director of product management in nursing for McKesson. When the FDA announced its bar-code ruling, McCaskey admits she was thrilled. "That was our biggest barrier," she says. "The only way this will change is if the government intervenes."

The company offers three tools specifically for the medical imaging community:

1. Horizon Medical Imaging offers PACS-related technology for all departments;
2. Horizon Radiology is designed for acute-care and radiology departments to automate a variety of functions, including management reporting, medical image management, transcription, digital dictation, and more; and
3. HorizonWP Physician Portal offers radiologists, among other things, immediate access to urgent patient test results.

One of the most critical areas of preventing errors is in proper medication administration. The Admin-Rx-a scanning device that nurses use to review patients' medication profiles and care histories-is touted as "the last line of defense at the bedside." Nurses can apply the portable unit anywhere in the hospital to determine whether the right patient is receiving the right drug and dosage at the right time. (Medication Management is one of JCAHO's 14 Priority Focus Areas. See "New Goals Make Patient Safety More than a Buzzword" in the box near the end of this article.)

"You can implement pieces along the way," McCaskey says. "Hospitals can still implement bar coding to provide value. The nice thing is that most people can get a return on investment in 6 months."

Recently, Regional West Hospital (Scottsbluff, Neb) avoided a major sentinel event within 20 minutes of implementing McKesson's newest version of Admin-Rx. "The nurse bar-coded a medication and found she had picked up the wrong medication to give to a patient," McCaskey explains. "So, we are helping nurses and patient safety."

Another option the company offers is the All-in-One Nursing Solution, which combines a network of tools for real-time delivery that combines Acudose-Rx for medication retrieval, Admin-Rx for accurate medication administration, and MedDirect for relaying medication needs to the pharmacy.

The Long Road With Radiation

The radiation treatment methods used today are different from those of 5 years ago. For example, the advent of intensity modulated radiation therapy (IMRT)-the method of delivering much higher doses of radiation to target areas than with conventional radiation therapy-requires more planning, setup, and quality control. With the higher doses of radiation, the key with IMRT is to deliver the prescribed dose to the identified target and pinpoint that exact spot without hitting healthy tissue surrounding the tumor.

"Our core technology is in low-temperature polymer sheets for patient fixation in radiation oncology," explains Martin Ratner, VP of marketing at Orfit Industries America (Garden City, NY). "Our concept uses a thermoplastic mask system designed in different configurations. Multi-point precut masks enable the radiation therapist to closely contour the mask to the patient's anatomy. The precision of the mask makes a world of difference."

Efficast is a thermoplastic mask material that molds perfectly around the patient's anatomy for patient immobilization in the head and neck regions. Pelvicast also is made of the thermoplastic material but is used for pelvic fixation.

"The Efficast 3-point mask tells the user that three independent parts of the mask must be contoured to the patient," Ratner says. "The major benefit of this approach is the ability to closely contour the mask to the patient's anatomy-which isn't possible with the U-frame approach that is commonplace in the United States. This [contouring] results in a patient fixation that provides much higher precision and reproducibility, which are both of great importance during patient treatment."

Efficast 3-point size is for head and neck treatments; 4-point size is for head, neck, and shoulder treatments; 5-point size is for head, neck, and shoulder for IMRT treatments; and 6-point size is for pelvic treatments.

Another product in radiation safety is the CyberKnife, manufactured by Accuray (Sunnyvale, Calif). Recently, Overlook Hospital, part of New Jersey's Atlantic Health System, purchased the CyberKnife for treating patients. The "knife" provides incision-free surgery without the need for stereotactic frame; it's the "cyber" that pinpoints the precise outline of the tumor by digital radiographic images and sends a superhigh targeted level of radiation.

Read More! Want more information about patient safety, specifically in MRI? Don't miss "The Missile Threat," a guest editorial from R. Kemp Massengill, MD.

Another option is the long-successful Gamma Knife produced by Elekta (Atlanta). "Our newest version of the Gamma Knife has added robotic positioning. The physician doesn't have to go back in the room and change the patient's helmet but can do it right from the control panel," says Michelle Lee, marketing manager at Elekta. Like the CyberKnife, the incision-free Gamma Knife offers enhanced patient safety benefits. It provides options for patients who were unsuccessfully treated by conventional surgery, chemotherapy, or traditional radiation therapy.

Elaine Koritsas is a contributing writer for Medical Imaging.

References

1. Food and Drug Administration. Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule. February 26, 2004. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm. Accessed September 1, 2004.



2. Institute of Medicine of the National Academies. To err is human: building a safer health system. November 1, 1999. Available at: http://www.iom.edu/report.asp?id=5575. Accessed September 1, 2004.

New Goals Make Patient Safety More Than a Buzzword The Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) National Patient Safety Goals (NPSGs) for 2005 and the 14 Priority Focus Areas (PFAs) share many similarities-but there's more than meets the eye. The NPSGs are specific goals that hospitals must comply with in order to be accredited, whereas the PFAs are less specific and place attention on areas of interest. "The PFAs are part of the survey process. Think of the 14 goals as areas of emphasis and headings for critical-care concepts in healthcare delivery," explains Charlene Hill, spokeswoman for JCAHO. "It's up to the hospital to identify policies, procedures, and processes to have systems in place. The standards guide the surveyor through the more than 200 standards with which hospitals must comply to become accredited. The surveyor will randomly pull charts and records to follow the patients through the care process. The 14 PFAs tell the surveyor that these are high-priority standards to [examine]." The standards are not prescriptive, because each hospital might have its own state laws. "Or they may have their own credible sources," Hill says. "There are a million ways to get to the end point. We're not a government agency; accreditation is voluntary. It's not like the federal government where we can impose fines. However, they risk losing accreditation." In fact, in July, members of Congress proposed developing new laws to make JCAHO's accreditation program accountable to the federal government for deemed status purpose, according to a JCAHO press release. The overall goal of JCAHO is to reduce administrative burdens and enhance safety for both patients and medical staff. As part of the Shared Visions-New Pathways changes, a focused, on-site survey addresses the PFAs to help surveyors to compile, organize, and automate specific information and systems necessary for safe, quality care. Another change is the addition of "tracer" methodology. Essentially, a surveyor assesses overall systems and patient care by selecting a handful of patient records. The following 14 PFAs will help narrow the field for surveyors to choose which patients to "trace" during the on-site survey: Assessment and care/services Communication Credentialed practitioners Equipment use Infection control Information management Medication management Organizational structure Orientation and training Patient safety Physical environment Quality improvement expertise and activity Rights and ethics Staffing Unlike the PFAs, which are more akin to headers, the seven NPSGs are very specific. JCAHO highlighted patient safety as a priority because of an emerging pattern of care that showed it's increasingly more likely for sentinel events to occur, Hill explains. "For example, Goal #1 is very prescriptive. In this case, we've taken the extra step of saying that room identification is not enough of a verification," she says. "With the NPSGs, we've taken some levels of care we've seen that contribute to medical errors and identified some holes [that facilities] need to plug up. We're saying, 'If you take these specific steps, it will prevent errors from happening.' It's helping to focus healthcare organizations on patient safety goals that will have a great impact. These goals are not expensive to implement, but once you build the process, you can significantly reduce errors from happening." Additionally, there are no longer scores but new accreditation decision categories, including Accredited; Provisional Accreditation; Conditional Accreditation; Preliminary Denial of Accreditation; Denial of Accreditation; and Preliminary Accreditation. Other changes that JCAHO has unveiled include the Periodic Performance Review, which offers accredited organizations three ways, ranging from written reports to oral interviews, to conduct a mid-cycle self-assessment as a way to stave off problem areas before survey. Seven Goals for Seven Days The newly revised NPSGs specifically for hospitals were recently released. Review the goals to see how your healthcare organization stacks up. Goal #1: Improve the accuracy of patient identification. Use at least two patient identifiers (neither to be the patient's physical location) whenever administering medications or blood products, taking blood samples and other specimens for clinical testing, or providing any other treatments or procedures. Goal #2: Improve the effectiveness of communication among caregivers. For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the order or test result read back the complete order or test result. Standardize a list of abbreviations, acronyms, and symbols that are not to be used throughout the organization. Measure, assess, and, if appropriate, take action to improve the timeliness of reporting-and the timeliness of receipt by the responsible licensed caregiver-of critical test results and values. Goal #3: Improve the safety of using medications. Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, sodium chloride >0.9%) from patient care units. Standardize and limit the number of drug concentrations available in the organization. Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs. Goal #4: Improve the safety of using infusion pumps. Ensure free-flow protection on all general-use and patient-controlled-analgesia intravenous infusion pumps used in the organization. Goal #5: Reduce the risk of healthcare-associated infections. Comply with current Centers for Disease Control and Prevention hand-hygiene guidelines. Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a healthcare-associated infection. Goal #6: Accurately and completely reconcile medications across the continuum of care. During 2005, for full implementation by January 2006, develop a process for obtaining and documenting a complete list of the patient's current medications upon the patient's entry to the organization-with the involvement of the patient. This process includes a comparison of the medications the organization provides to those on the list. A complete list of the patient's medications is communicated to the next provider of service when it refers or transfers a patient to another setting, service, practitioner, or level of care within or outside the organization. Goal #7: Reduce the risk of patient harm resulting from falls. Assess and periodically reassess each patient's risk for falling, including the potential risk associated with the patient's medication regimen, and takeaction to address any identified risks. -EK

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