In 1999, the Institute of Medicine (Washington) issued a report connecting medical errors to as many as 98,000 deaths of hospital patients each year. Last month, the Joint Commission on Accreditation of Health Organizations (JCAHO; Oakbrook Terrace, Illinois) added its contribution to that concern, zeroing in on the nursing shortage in the U.S. as a factor increasing the number of potential mistakes and adverse events. The growing shortage of nurses is putting patient lives in danger and requires immediate attention, according to an expert panel put together by the JCAHO to discuss its white paper, "Health Care at the Crossroads."

Using the paper as its starting point, the panel said the current crisis could result in increased patient complications and deaths, greater lengths of stay and other undesirable outcomes. JCAHO said more than 126,000 nursing positions are unfilled today, and that number is expected to skyrocket just as 78 million Baby Boomers begin placing greater demands on healthcare systems. It said this staffing problem is a major factor in emergency department overcrowding, cancellation of elective surgeries, discontinuation of clinical services and the limited ability of the health system to respond to any mass casualty incident.

"The need for solutions to this problem is particularly urgent," said Dennis O'Leary, MD, president of JCAHO. "We must, as a country, understand not simply what needs to be done but who specifically is responsible for getting each task done. Otherwise, we face a future in which patient safety and health care quality will be significantly compromised." He said JCAHO found that about 25% of all the medical error reports can be traced to inadequate staffing, and he said there is evidence that high nursing turnover is associated with increased patient mortality.

Based on the roundtable's discussions, JCAHO offered recommendations for encouraging entry to the nursing profession:

Transforming the workplace in a way that will give nurses greater independence and create a culture of professional satisfaction that will encourage retention. This includes setting staffing levels that take into account the complexities of patient needs and nurses' skills and competencies.

Bolstering nursing education to ensure that new graduates are better prepared to care for fragile patients. This means "re-invigoration of nursing schools by funding new faculty positions," providing incentives to nurses to seek advanced degrees and creating standardized post-graduate nursing residency programs.

Making new federal money available for these education opportunities and encouraging hospitals to invest in nursing services. These monies "should be conditioned on achievement of evidenced-based, nursing-sensitive goals, including patient outcomes."

One section of the report, "Improving Work Flow," offers particular opportunities for the medical technology field. That section notes "emerging clinical information systems and other technologies that can improve safety, reduce paperwork and provide nurses with more time to spend on care-giving." The report argues that organizations that have adopted these technologies — such as electronic medical records and automated drug-dispensing machines — have reported gains in nurse satisfaction, retention and productivity, and have reduced the risk of errors. The paper cited a report in a May 2001 issue of Modern Healthcare describing an unnamed hospital that provided nurses with an automated medication record accessible on a handheld device and said it was able to reduce medication errors by 79% and save about $300,000 a year.

While noting the importance of the role of information and other timesaving technology in the healthcare workplace, Carol Bickford, RN, PhD, a senior policy fellow in the department of nursing practice and policy at the American Nurses Association (Washington), said it would be helpful if companies focused more on ergonomics issues. "It was very devastating when the OSHA ergonomics standard was repealed," she told The BBI Newsletter. She said her concern is that job-related injuries in the hospital will now be overlooked since there is no added need for hospitals to pay attention to it.

Bickford said assistive devices are key to helping nurses do their jobs more easily and safely for both themselves and their patients. At one time, she noted, hospitals were more focused on ambulatory patients, but that a substantial amount of patients that hospitals are seeing fall into the critical-care setting, which means they require a greater amount of staff attention and generally cannot move about on their own. "We need to think about the transformation of the big, bulky hospital-based equipment with the miniaturization to support the patient in that environment and also the nurses and the caregiver," Bickford said.

It also was noted in the JCAHO report that healthcare has lagged behind other industries in the adoption of information technology. It said the benefit of adoption of such technology lies not only in its potential to reduce errors and increase productivity but also in the enticements it offers for the recruitment and retention of nursing staff.

Medical device/bar code mix doubted

Drugs and biologics might be suitable for bar code labeling, but medical devices may be too different for such a requirement to work. The recommendation not to include medical devices in a proposed FDA regulation on bar coding was sent to the agency recently by the Advanced Medical Technology Association (AdvaMed; Washington), with the association saying it is committed to voluntary use of an automatic identification system for devices that is industry-approved and when economically and technically feasible. The most important consideration is practicality in clinical use, the group said in a recent letter to the FDA citing its concerns over bar code labeling.

While AdvaMed supports a voluntary approach to product labeling, it points out that the FDA's reason for wanting coding — to improve patient safety and reduce medical errors — requires cooperation from the providers who use the devices. Using a product label not only requires the manufacturers to apply it, but also that providers commit to appropriately using it as well, AdvaMed says.

The association's statement came in response to an FDA meeting in late July to hear from the industry, public and healthcare providers on a proposal to require bar code labeling for drugs, biologics and devices. At the meeting, industry representatives cautiously approached the proposal while professionals working in healthcare encouraged the agency to implement a policy sooner rather than later.

Tess Cammack, associate vice president for technology and regulatory affairs for AdvaMed, told panel members adding bar codes to drug packages may be helpful, but requiring the medical device industry to comply with similar standards would do little to cut down on any errors associated with devices. She said the medical device industry is so extensive and diverse that it should be excluded from any rule that applies to biologics and drugs. Furthermore, she said many small companies don't have the resources to pay for improvements that would be required to implement such a policy.

John Combes, a senior medical adviser with the American Hospital Association (Chicago, Illinois), said labeling could be useful on devices at some point to help track product failures, infections associated with device use and adverse events possibly caused by products. However, he said many products such as bandages, tongue suppressors or crutches may never need labeling.

Some saw the issuances of codes in a more positive light. "There are bar codes all over America — in grocery stores, in retail stores — but we don't have bar codes in the one place they could be the most helpful," Kasey Thompson, a pharmacist and representative of the American Society of Health Systems Pharmacists (Bethesda, Maryland) told FDA officials. "If the rule is proposed this fall, it will be another year before anything could be implemented. How long are we going to let the manufacturers hold it up?" In his view, it's a simple matter. Adding a bar code to packages containing drugs, biologics — and possibly medical devices — could ensure that the right medicines are given to the right patients, at the right dose, at the right time.

While Mary Grealy, president of the Healthcare Leadership Council (Washington), said bar codes, including an NDC, could be implemented rather swiftly based on technology readily available, she said it would take longer for companies to include a system of lot numbers and expiration dates. In response, several speakers recommended a "phase-in" process, which could begin with labels including the NDC and, down the road, end with a complete label including the lot numbers and expiration dates.

Any final regulation, if proposed, will be published following a 60-day comment period that ends at the end of September.

CMS unveils long-awaited appeal process

The Centers for Medicare & Medicaid Services (CMS) late last month complied with a congressional mandate — but almost a year after it was required to. With at least one lawsuit over the issue threatening, CMS rolled out a process for Medicare beneficiaries to appeal local or national coverage determinations, with that procedure mandated by a provision of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000. The appeals proposal appeared in the Aug. 22 Federal Register, with public comments to be accepted through Oct. 21. A final rule will be published "as soon as practicable" following the comment period, according to a CMS statement.

The CMS announcement comes on the heels of a lawsuit filed against the U.S. Department of Health and Human Services (HHS) on Aug. 6 from three Medicare beneficiaries who claimed they could not appeal a Medicare coverage decision because the government had failed to establish any process for doing so.

The announcement of an appeals process is irrelevant to the lawsuit, said Gillian Wood, an attorney with Arnold & Porter (Washington), the law firm representing the plaintiffs. "They [CMS] are still not in compliance with the law. The proposal doesn't implement section 522 of the act as it was defined in the legislation," Wood told BBI. Thus the lawsuit will still moving forward, she added.

Under the CMS proposal, appeals of local coverage decisions would first be reviewed by an administrative law judge. Appeals from national coverage decisions and appeals from the administrative law judge's decisions would go to a HHS departmental appeals board, and the board's decisions could then be appealed at a federal court level.