American Association for Clinical Chemistry
Better health through laboratory medicine
August 2007 Clinical Laboratory News: Critcal Result Reporting

August 2007: Volume 33, Number 8

Critical Result Reporting
Can IT and Improved Communication Systems Help Labs Meet Patient Safety Standards?
By Julie McDowell

The Joint Commission’s 2008 National Patient Safety Goals—which debuted in June—will once again require laboratories to manage, document, and assess the timeliness of critical test result and value reporting to physicians and other licensed caregivers. In addition to being necessary for Joint Commission accreditation, critical result reporting procedures are also required under federal law, as part of the Centers for Medicare & Medicaid Services’ (CMS) CLIA, and voluntary quality monitoring and improvement programs like the College of American Pathologists (CAP) Q-Tracks and Q-Probes systems. However, many clinical laboratories struggle to establish and maintain a quality reporting system that delivers the correct results to the appropriate clinician in a timeframe that ensures patient safety, while not overburdening both the clinicians and laboratory staff. To help tackle these challenges, laboratory leaders and regulatory officials are emphasizing the importance of correct interpretation of the regulations, the role of IT tools in improving communication between the laboratory and caregivers, as well as how to streamline critical result and value reporting systems to maximize efficiency.

Beyond The Joint Commission, CLIA, and CAP critical test and critical result and value mandates, labs need to have an optimal system in place to withstand the increased scrutiny that patient safety concerns are placing on healthcare facilities. “Critical values reporting really needs to be on the short list of things that all labs closely monitor, along with turnaround times, customer satisfaction, and proficiency testing,” said Anand Dighe, MD, PhD, Director of the Core Laboratory at Boston’s Massachusetts General Hospital (MGH), at an AACC audioconference, “Improving the Reporting of Critical Test Values” presented on June 5. “Critical value reporting is a central monitor for the laboratory, because it really has medical, legal, and operational aspects,” he explained. While lawsuits involving laboratories are rare, when they do occur, they are often a result of poor communication, failure to adhere to state policies, or inadequate documentation. Dighe cited one recent lawsuit where a hospital settled out of court following a patient’s death from diabetic ketoacidosis. In that case, the hospital’s critical value policy stated that clinicians would be urgently contacted for all glucose levels greater than 250 mg/dL. The patient’s glucose measured 302 mg/dL, but was not communicated by the laboratory because it had stopped calling physicians about glucose values between 250 and 500 mg/dL due to increased workload.

“There is an increased awareness that poor communication is at the heart of medical errors and lawsuits, which is why The Joint Commission and CAP are emphasizing the role of communication in critical value reporting,” said Dighe. “It’s not enough just to have a policy established, however. Labs really need to monitor their system and strive for improvement.”

Ensuring Result Delivery and Receipt

Under Goal 2 of The Joint Commission’s 2007 and 2008 National Patient Safety Goals, laboratories must measure and assess both the timeliness of delivery and receipt of critical tests and critical results and values by the licensed caregiver (See Box, below). Many laboratorians, however, believe that this goal is vague in its distinction between critical tests and critical results and values. “Many people don’t really understand the distinction between critical test results and values,” explained Dighe. “They sound like almost the same thing, but they are distinct.”

Getting Critical
Joint Commission 2008 National
Patient Safety Goals for Laboratories

Since 2005, The Joint Commission has released annual National Patient Safety Goals. Intended to help healthcare institutions meet the Commissions’ standards for accreditation, the goals seek to reduce the risk of adverse outcomes for patients. Goal 2 and its components deal specifically with requirements for critical test result and value reporting.

Goal 2 Improve the effectiveness of communication among caregivers.
2A 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 information record and “read-back” the complete order or test result.
2B Standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used throughout the organization.
2C Measure and assess, and if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical tests and critical results and values.

When identifying critical results and values, the clinical laboratory community has generally adhered to the definition crafted by the former Journal of American Medical Association editor George Lundberg, MD, in the 1970s. He defined a critical value as a result indicating that the patient is in imminent danger unless appropriate therapy is promptly initiated. But this definition conflicts with the critical test recommendation from The Joint Commission, which states that if a test is ordered stat, it is critical.

“Some Joint Commission inspectors have taken the position that any test ordered stat is critical,” said Paul Valenstein, MD, President of Joint Venture Hospital Laboratories in Allen Park, Mich., and Chair of CAP’s Quality Management Committee, which oversees Q-Probes and Q-Tracks. “This is not the traditional industry definition of a critical result as developed by Lundberg, which restricted critical results or ‘panic’ values to results that indicated an imminently life-threatening condition that caregivers could do something about. A test that has been ordered stat, but which produced a perfectly normal result is something one wants to perform quickly, but represents a different type of challenge that should not be confused with a critical result as traditionally defined in our industry.”

The Joint Commission acknowledges recent confusion over this issue, according to Megan Sawchuk, MT (ASCP), the accrediting organization’s Associate Director of Standards Interpretation and Interim Field Director of the Laboratory Program’s Accreditation and Certification Operations. The Joint Commission defines critical results and values along the lines of the traditional “panic” value, meaning that if action is not taken immediately for an abnormal result, the patient may be subject to harm, she explained. The results may be obtained from any lab test, including routine tests, and should be reported as soon as it is apparent the result is critical. “In comparison, critical tests are those tests that the organization determines the results need to be reported in a timely fashion, regardless of whether the result is normal or abnormal,” explained Sawchuk.

An example of critical tests might be cardiac risk assessments done in the emergency room, because these would need to be done in a timely manner to ensure optimal care and outcomes for the patients. “For simplicity, we have generally referred to stat tests as good examples of critical tests,” explained Sawchuk. “The intent is that laboratories could readily comply with the goal by defining stat tests as critical tests because they are usually already collecting turn-around-time data.” It is important to remember that these goals and terms apply to other diagnostic services in the hospital as well, so it is appropriate for laboratory leaders to apply the term “critical test” as they see fit for their individual setting, she added.

Sawchuk also said that there is some misinterpretation among laboratory and clinical staff about the need to report critical tests verbally. “In actuality, there is no Joint Commission requirement to verbally report all critical tests or critical results,” she explained. The key for critical tests is that the results must be made available to the healthcare provider within the timeframes established by the organization. In contrast, critical results and values must be acknowledged by the receiver to ensure prompt action. A phone call is the most common reporting mechanism in today’s environment, although in the future, other emerging communication technologies may become more commonplace. “In any event, some labs have interpreted the goal as requiring that all criticals be reported in the same way,” said Sawchuck. “In turn, this has led to the impression that all critical tests—or stats, if included in the organization’s definition—must be verbally reported, but this simply is not true.”

The responsibility for determining what constitutes critical tests and critical results and values rests on each hospital and laboratory, and these determinations should be based on the needs of each facility and its patient population, emphasized Peter B. Angood, MD, Vice President and Chief Patient Safety Officer of The Joint Commission. “We are not trying to clarify the differences between a stat test or when is one test more important than others,” he said. “Our role is to prompt institutions to address what they would consider are critical tests and how the results should be reported consistently and in a standardized process.”

What’s Critical?

In order to build an efficient reporting system that is compliant, while not overburdening the laboratory or clinical staff, a facility’s critical test list and value ranges need to be periodically reviewed to ensure that appropriate values and tests are being called, according to MGH’s Dighe. “Labs need to routinely look at not only what tests are listed as critical, but also what ranges are considered critical values,” he said.

One good method for analyzing and benchmarking critical test result and value reporting is through CAP’s Q-Probes program, a “snap-shot in time” comparison of reporting data among other laboratories. Research in 180 clinical laboratories between 2001 and 2004 found that improvement was associated with both the Q-Probes system, as well as the Q-Tracks system that monitors reporting over time (Archives of Pathology and Laboratory Medicine 2007;131:44–49). “We found that the longer a lab participated in this program, the better it did over time in terms of fully calling critical values,” said study co-author Elizabeth Wagar, MD, Professor and Vice Chair, Laboratory Medical Director at the University of California Los Angeles. “I think that it’s an awareness factor that is most important, and developing a system, whether it be with CAP or something else, that allows a lab to look on a continuous basis at their performance is one of the keys to making sure that that they are doing a good job in reporting critical values.”

In some instances, these comparisons can prompt critical result and value revisions. In Dighe’s laboratory, for example, Q-Probe analysis of critical serum glucose levels compared MGH’s median low value of 60 mg/dL to the nationwide median low value of 40 mg/dL. The laboratory changed the median low level to 45 mg/dL, and then for the next 12 months, the staff analyzed the glucose test results and critical value limits, and published their findings last year (American Journal of Clinical Pathology 2006; 125: 758–64). “When we compared our old critical value range of 60 and our new range of 45, there are a huge number of results. There were 2,136 formerly critical results that we were calling for each year, which means over 2,000 fewer phone calls the staff is making every year,” he said.

When analyzing critical values, labs should pay particular attention to tests that are prompting the highest volume of calls and high rates of false positive results, Dighe recommended. At MGH’s core laboratory, this test was potassium, which accounted for 8,000 calls a year and 21% of critical values, with outpatients accounting for many of the calls. In some cases, when potassium was drawn on these patients in the clinic, the result would be high, but when the patient came back for a redraw at a phlebotomy station, it would be normal. After examining numerous incidences of these false high potassiums, Dighe and his staff made the connection that many of these patients also had an HbA1c drawn at the same time, which at the time, was required to be kept on ice. The lab suspected that the potassium sample was effectively being iced due to its proximity to the HbA1c sample and it is known that icing collected blood may raise plasma potassium levels. “We investigated whether we could eliminate the iced requirement on the HbA1cs,” said Dighe. “Once we did that, we immediately saw a 21 percent to 34 percent drop in the number of high potassiums drawn on our outpatients.”

Getting in Touch with the Physician

Another one of the patient safety goals that labs struggle with is 2A, which requires labs not only to deliver critical results timely to licensed caregivers, but also to document caregiver read-back of the test result, if it is verbally communicated. But tracking down the appropriate caregiver in a timely manner via telephone can be difficult. A 2002 survey showed that 30–40% of the time, the receiver was not a responsible licensed caregiver as defined by The Joint Commission or CAP (Arch Pathol Lab Med 2002; 126: 663–9). But it still remains the lab’s responsibility to ensure and document that the critical result is ultimately received by that responsible, licensed caregiver. In addition, The Joint Commission requires that the organization demonstrate that there will be no significant delays if the results are not communicated directly to the appropriate caregiver.

Problems with processes to get the result to the caregiver—and documenting the delivery and receipt of the result—become apparent in laboratories during many Joint Commission inspections, according to Sawchuk. “The most common cause of noncompliance is related to not having a process to collect, aggregate, and analyze the data for timeliness, typically outside the laboratory’s reporting process,” she explained, adding that the problems often lie in the interval between when the lab delivers the result to a nurse and when the nurse reports it to the physician. “It’s the nurse-to-physician reporting time that the organization is not collecting,” she said. “More often than not, the laboratory has an established process, and is following the process in a timely manner. Where we see noncompliance most often is outside the laboratory.”

To confront these communication problems, many labs—including the core lab at MGH—have examined the possibility of automated critical value alerting systems that rely on the laboratory information system (LIS), e-mail, and pagers to deliver results.

But these systems carry significant risks, especially if the LIS is down or the paging device malfunctions. In addition, locating the appropriate physician can be a hassle. “These alerting systems are relatively easy to set up, but the problem is who are you going to contact with the critical results? Finding this out can be a challenge,” said Dighe, adding that it can be difficult to document receipt and acknowledgment by the responding clinicians, especially if they are not available for paging. To address these risks and other communication issues, MGH launched a Responsible/Responding Clinician Project earlier this year. Software and systems were implemented to ensure that all inpatients always have an attending, responsible, and responding physician to receive critical values. MGH officials plan on expanding this program to outpatients in the future. “With many people collaborating on a single patient’s care, it is imperative to know the role of each clinician as well as who is ultimately responsible for the care of the patient,” said Dighe. “In order to provide excellent patient care, the clinician responsible for a patient’s care at any moment in time must always be known.”

But lab managers should stop and think before rushing into IT solutions to overcome communication obstacles, warned CAP’s Valenstein. “Critical results are like hot potatoes—laboratorians are anxious to pass these results on, but we sometimes overlook the burden we place on caregivers when we drop a critical result in their lap out of the blue, often for a patient they are cross covering and don’t know intimately,” he explained. “If every result the lab considered critical was truly life threatening, clinicians would be more interested in receiving notification from the lab. But many so-called critical results aren’t critical at all, and we risk overwhelming the information processing capacity of clinicians when we interrupt their regular work with too many pages and e-mails and phone calls.”

Before rushing into new communication solutions, Valenstein believes that laboratorians should spend more time thinking about the type of results that are imminently life threatening and that can be corrected by prompt intervention. “We owe it to our customers to be more discriminating,” he added. “Laboratories are rushing to install notification systems so they won’t be cited for failing to report critical results in a timely manner. However, I feel much more comfortable when I see that laboratory management is spending an equal amount of effort thinking about which values should be considered critical in the first place.”