Clinical laboratories, like all other components of the healthcare delivery system, have many “rooms.” With all the uncertainty in healthcare today, the most important room may be: room for improvement. Every lab can enhance clinical outcomes and patient experiences while reducing organizational costs. Every lab can initiate goal setting, implement systemic changes, measure outcomes, and develop processes to sustain change.
Labs need to identify areas of focus and the impact of errors through the pre-analytical, analytical, and post-analytical phases of testing. Beyond identifying errors, they need strategies for maintaining improvements or, as more commonly referenced, sustainability. With errors comes waste, in time, resources, and supplies. Even the best of clinical laboratories make errors, but streamlined and consistent execution of procedures will reduce the number and frequency of errors. This article will take a look at how a lab effectively or ineffectively responds to errors: what to do and what not to do.
The phases of errors: pre-analytical and critical
Without doubt, the number-one source of errors in the clinical laboratory is the pre-analytical phase: mislabeled specimens. Not every error in this category is blatant or life-threatening, but all can be costly. The good news is that there are ways to avoid or significantly reduce errors that are enabled by modern technology, including positive patient ID barcoding and handheld printers to provide labels at the patient bedside. It is important to note that this is an effective strategy and standard for inpatient populations, but that it is less effective at reducing errors for outpatient services. Unique specimens may or may not have layers of process in place to prevent errors.
For example, a mislabeled blood bank specimen is a costly error and creates serious challenges in the delivery of quality care. If a patient is given the wrong blood type, it can create a life-threatening situation. Many labs continue to utilize “old school” cross-checks with records to validate patient blood type, and/or they may choose to redraw if there is any level of doubt. Patients who require transfusions are sometimes double-banded to isolate any opportunity for error.
Sophistication in the lab has created delta checks that allow technology to cross-reference a patient’s results. Most clinical labs conduct high-volume testing daily, and delta checks provide another level of validation through automated notifications to laboratorians to prompt a manual comparison of reports to a patient’s existing electronic health record.
The phases of errors: analytical and post-analytical
In the analytical phase of testing, optimized technology is key for reducing errors. Rarely, but occasionally, a machine may be “off” and deliver less than desirable results. Most clinical labs apply quality control checks on machines daily, if not more often. The analytical phase contributes the fewest lab errors.
As the testing process continues into the post-analytical phase, connectivity is key. The more automated the post-analytical phase can be between the lab and the provider, the better. If a mislabeled specimen reaches this phase, the physician may receive the wrong report, and the provider who needs it may never get it. Physician dissatisfaction may occur, and ultimately the patient experience is altered too.
Analytical meets critical in the post-analytical phase, when a critical value is resulted. This test result is so far out of range that an immediate contact with the ordering physician is required. Fortunately, the test menu that has potential to generate a critical value is short. Critical values may be more prevalent in the inpatient population, but can also be resulted through outpatient testing. Some examples of critical values include hemoglobin, blood glucose, and prothrombin time (PT), which require immediate medical attention. Outpatient testing largely results fewer critical values but also may uncover undetectable conditions.
Effective versus non-effective responses
It goes without saying that one error in the clinical lab is one too many. Performance excellence is driven by action to implement change to improve outcomes and drive desirable outcomes. Integration of dashboards that generate high-level visibility across the enterprise and offer trends and granular insights by facility, department, clinicians, and physicians is key to managing by exception.
An effective response to an error occurs when the lab recognizes the error, analyzes the entire situation including investigating any harm to patients, confirms that it is an isolated case (rather than systemic), and implements a process to insulate it and prevent a recurrence. Investigating the root cause of errors takes time. CLIA regulations require this course of action as well. Ineffective responses reflect an absence of the effective responses outlined above and result in increased risk for repeated errors as well as the potential for lost physician confidence, increased revenue loss, and accreditation concerns. The business of healthcare includes maintaining the integrity of the testing process from the point of testing to result delivery.
Error impact and prevention
In the clinical lab, errors include the cost of redrawing and retesting, wasted time, patient dissatisfaction, and compromised quality of care. Continuous performance improvement initiatives drive value for a hospital or health system, but to be effective they must be recognized as part of the culture, benchmarked, and measured for sustainability. Three key performance improvement opportunities exist in nearly every organization:
1. Measure performance improvement opportunities using key metrics and specific analytics to make the best day-to-day clinical or financial decisions.
2. Create performance improvement teams that are cross-functional and understand the process and workflow of sustaining quality improvements.
3. Implement a data-driven approach to performance improvement with a single-source solution that drives implementation of evidence-based best practices and enhances deployment of scarce resources.
Recognizing errors is a good first step. Then, a progressive and proactive clinical lab accepts the challenge of reducing them to a minimum.
Jeff Osborne serves as President and Chief Executive Officer of Accumen, a San Diego-based healthcare performance partner. Prior to joining Accumen, he was Chief Performance Officer at Accenture and Chief Operating Officer for Accenture’s Business Process Outsourcing business.
