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What are the three most important elements of safe process design? The first is accounting for human factors. It is important to recognize that processes which rely on perfect human performance are incapable of high reliability. The second is standardization with limited discretionary variability (See “Examples,” below). Furthermore, reasons for appropriate variation should be captured and fed into the process design. The third is organizational culture. It is essential to have a positive reporting culture that exposes misses and near misses, because no process or procedure is failure-proof. Successful reporting cultures also identify key vulnerabilities. How do attitudes about safety in the laboratory affect process design? All processes that rely on vigilance and hard work are incapable of performing at a high level of reliability. If leadership and/or the front line worker do not understand the limitations of human performance, then high levels of reliability will not be possible. Also, a positive reporting culture is essential. Punishment for human error will impede process improvement and make the organization less safe and less reliable. 14 CliniCal laboratory news July 2011 PATIENT SAFETY FOCUS TAkING AIM AT REDuCING LAB ERRORS Designing Processes for Patient Safety The Key is Finding the Vulnerabilities and Fixing Them richard gitomer, Md, Mba, is chief quality officer for emory university Hospital Midtown and is a general internist by training. He has led numerous improvement projects related to access, efficiency, and innovation in the ambulatory setting and care of patients with chronic conditions. dr. gitomer is a recognized leader in process improvement through his collaborations with the institute for Healthcare improvement and the association of american Medical Colleges. this inteRview was ConDuCteD By CoRinne Fantz, phD. Clinical laboratories routinely monitor key processes. Is it not enough to know what errors occur and why they occur? Measurement alone does not result in improvement, but it is essential for identifying areas that need improvement and for monitoring improvement. There is a saying, “You don’t fatten the chicken by weighing it.” (See Figure, above). What opportunities and challenges do new technology bring to old processes? New technologies increase the capability of systems. For example, autoverification in the lab is faster and more reproducible than manual verification of results. But technology comes with some inherent risks. For those technologies that still require human intervention, the interface between humans and the technology remains the most vulnerable point. These vulnerabilities include incorrect human operation, due either to human error or errors that result from interacting with the new technology. All systems will fail at some point. With older technology, we know those failure modes and have designed processes to limit their impact. We do not have the same understanding of new technologies. So, until lab examples of standardization with limited variability ® standardized procedures across all sites ® standardized phlebotomy trays ® one type of point- of-care glucometer in the health system ® automation that limits the care providers choice of tube types ® selection of a primary referral laboratory ® use of templates for interpretative reports Prothrombin Time 90% Turn around Time measurement is important to quality improvement, but by itself will not significantly improve quality. those vulnerabilities are fully understood, there will be safety and reliability shortfalls. Communication errors are a major contributor of preventable harm to patients. How can laboratory staff make change-of-shift hand-offs safer? Handoffs, like all processes, benefit from standardization, which increases the likelihood that key information will not be missed. Standardization also creates an opportunity to measure and improve the process. The standard process should include a template, or checklist (See “Checklist,” opposite), which highlights key information that should be exchanged. While every laboratory has a process for communicating critical values, could you elaborate on a few design elements that make one process safer than another? Communicating critical lab values is a process that is heavily reliant on humans with all their inherent vulnerabilities. In addition, creating a first-level communication process that includes all the eventualities and exceptions necessary to respond to every situation would result in a process so complex that the staff would be unable to execute it in a reliable fashion. Using a reliable approach to design as described by Roger Resar, performance levels in the high 90 percentages can be achieved with a series of simple processes (See “Designing a Process,” opposite). The first step is to create a standardized process that effectively communicates at least 80% of the critical lab values on the first attempt. For all the failures, there is a second process that ensures appropriate communication. This second process usually is more resource-intensive, but it is able to handle the complexities not addressed in the first process. The benefit of this strategy is more effective use of resources. The risk is that failure of the initial standard process to function at an 80% level of reliability or better can overwhelm the redundant process. By design, the redundant process is more resource-intensive but has limited capacity. As a physician consumer of laboratory services, could you provide an example of a laboratory process that directly impacts the safety of your patients? I am a general internist who sees ambulatory patients. Reliable communication of critical lab results directly impacts the safety of my patients. By definition, these patients are mostly healthy, so the incidence of critical lab values is very low. Being an infrequent event makes the likelihood that any process designed to remedy the notification barriers has a greater likelihood of failing. Therefore, in my case, because receiving prompt and accurate notification of critical lab results is a rare event, it has a higher failure rate than a process that occurs regularly. Positive patient identification is essential to ensuring patient safety. Do errors in patient identification always mean the process is bad? Process failure is expected for all processes. Since identifying patients is a process carried out by humans, it will fail at some measurable rate. Based on the specifications of the clinical team, these error rates could be well below the needs of the users
checklist for structured handoffs at shift change o Current staffing __________________________________ _______________________________________________ o problem cases still pending ________________________ _______________________________________________ o instrument/method issues _________________________ _______________________________________________ o inventory/supplies _______________________________ _______________________________________________ o Computer issues _________________________________ _______________________________________________ o other issues _____________________________________ _______________________________________________ structured communication will reduce the likelihood of missing key elements. of the information and therefore considered a good process. But if the error rate is such that it significantly impedes the care of the patient, the process does not meet specifications and must be improved. Would you provide examples of a few good questions to ask when assessing how well a process is working? The first question to ask is: does the process meet the needs of the customer of the process? If it is not meeting the specifications of the customer, then there are three possibilities to assess. First, if there is no standard process to do the task, then the standard process must be developed. The second possibility is that there is a standard process, but it is not being followed. designing a Process for handling critical values step 1 ® standardize critical value list throughout the system ® employ templates for communication and documentation step 2 If critical value communication is unsuccessful after the first attempt: ® pass calls from busy technologist to call center with access to many other data feeds that help overcome problems, such as a patient being registered to wrong the physician. ® use a clear escalation plan, such as licensed practitioner, ordering provider, on-call physician, chief-of-service. ® Call patient at home if an outpatient. By design, the redundant process is more resource-intensive but has limited capacity. In this case, it is important to understand why the process is not being followed and redesign the process if necessary. Monitors have to be put in place to detect the decline in performance and allow for the appropriate response. Last, if the standard process is being followed, and customer need is not met, then the standard process must be improved. How can laboratories design processes that integrate clinical teams and patients? Laboratories are frequently accused of optimizing their processes at the expense of the patient and the clinical team. Part of the problem is that we tend to measure and Disruptive Behavior How Labs Can Recognize and Overcome Its Negative Effects By MiChael astion, MD, phD In the laboratory, producing accurate and timely patient test results depends on teamwork, communication, and a collaborative work environment. However, laboratory staff who display intimidating and disruptive behaviors can quickly destabilize this cooperative environment and negatively impact patient safety. The Joint Commis- examples of disruptive behavior Disruptive Behavior Potential Effect on Patient Safety physical and verbal intimidation of a coworker, leading to decreased communication. refusal to communicate with coworkers regarding a problem testing situation in the lab, such as an intermittent problem with lab reagents or instruments. refusal to perform a laboratory task, such as processing a specimen or performing a laboratory test. refusal to make an outgoing phone call or answer an incoming phone call related to patient care. refusal to come to work despite being on-call. perpetrator makes a harmful lab error because victim, who suspects the error, refuses to speak up. problem goes unresolved, leading to erroneous results, delays, and patient harm. delay in testing that harms patient. Critical/urgent test results not communicated to care provider in timely fashion leading to patient harm. lab understaffing leads to delays in testing. verbal abuse negatively impacts patient safety. sion advises health care organizations to confront behavior problems in order to promote a culture of safety and efficient team performance (1). To overcome the negative effects of disruptive employee behaviors, labs first need to recognize inappropriate conduct. The Joint Commission developed assess each section independently rather than the entire care process that results in healing the patient. There may be times, however, when efficiency in the lab may need to be subordinate to the efficiency of the entire process of care. SuGGESTED READING Grimm E. Shift-to-Shift communication: what can labs learn from NASA and other highly reliable organizations? Clinical Laboratory News 2011 (January). Resar RK. Making non-catastrophic health care processes more reliable: learning to walk before running in creating highreliability organizations. Health Serv Res 2006; 41:1677–1689. a list of workplace behaviors considered both disruptive and threatening to patient safety (1), including verbal abuse, physical threats, and intimidation, all of which can compromise laboratories’ ability to operate efficiently and effectively. Passive, uncooperative behavior, such as refusing to perform assigned tasks and not communicat- CliniCal laboratory news July 2011 15
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