Quality management practices continue to be expounded upon by accrediting organizations in revisions and additions to checklist requirements as a means to ensure quality in clinical practice. Accordingly, quality assurance (QA)— the practice of ensuring and displaying confidence that quality requirements are routinely being met and/or corrected if deviation exists—is a necessary component of any well designed and effective quality management program. With QA (and its partner, quality control [QC]) a basic tenet of good laboratory practice, emphasizing an overall quality management (QM) program helps both lab management and staff members to build confidence in performance protocols and test results and reports produced by the department.
Among the predominant methods for ensuring QA over laboratory processes is the use of an auditing tool to assess and correct any variations that may be discovered in a routine task or process. These auditing tools and checklists can help simplify the QA process while allowing for direct and immediate feedback to personnel. As a universal process in health care, phlebotomy is one of several tasks that can be substantially improved via the proper application of QA.
Using Audits to Compliment Quality Management Practices
At Bellin Hospital, a community health system located in Green Bay, Wisconsin, we maintain a quarterly laboratory quality management meeting involving laboratory technical supervisors. The purpose of these meetings is to cover several QM functions, including the following, to ensure sound operating procedures:
QA audits can be tailored to any technical department and easily utilized by a department supervisor or staff member who routinely performs the task under audit. The results of these audits are then compiled as needed and reported on at the next laboratory QM meeting. The audit results are assessed for trends or concerns and the QM team formulates and implements both action plans and processes to assess the effectiveness of the action plans. As necessary, the audit findings, respective action plan(s), and effectiveness results may be reported up the hierarchal chain of quality governing bodies.
Routine Auditing Reduces User-Generated Variation
Laboratories are known for creating and building out stepwise policies and procedures; however, lengthy documents may be skimmed by the end-user without close attention paid to the finer details. End-users then will likely become wholly reliant on training, educational background, personal characteristics, etc. This pattern can be problematic, as substantial variation exists between individual employees’ educational backgrounds, personal characteristics, skillsets, job responsibilities, degree of experience, and on-the-job training.
Thus, auditing should focus on a task, process, or procedure that contains opportunity for greater amounts of user-generated variation. Unlike allowable variation, which may be seen in the performance of an assay, user-generated variation exists because the end-user introduces variation into an otherwise stepwise function. The employee may introduce this variation unwittingly due to any of the conditions mentioned above. Further, if left unchecked, this variation may continue to propagate for years and spread to other employees or new hires, thereby becoming ingrained in routine practice.
Quality Audits Extend Beyond Competency Assessments
Competency assessments are required to help ensure laboratory personnel are able to apply their skills, knowledge, and experience to properly perform their duties. That said, competency assessments are usually performed annually (for seasoned staff) and six months after hire date for any staff members new to the organization. A year, or even six months, can allow for significant variation to set in, and as is often evident when reviewing other health system laboratory operations, competency assessments themselves have the potential to introduce variation in practice.
Furthermore, competency assessments tend to focus primarily on analytical and post-analytical laboratory testing processes with less engagement on pre-analytical factors. In addition, laboratory-based competency assessments are designed for and applied to laboratory testing personnel, whereas non-laboratory testing personnel may not be obligated to undergo the same or similar assessments (annual or otherwise) in the course of their job functions.
Among other benefits, quality audits serve to extend beyond the competency assessments to which laboratory testing personnel are subject. Audits are more broadly applicable to a variety of staff members and can be designed to focus on any portion of the total testing process more thoroughly (and certainly more often) than competency assessments. Audits also are well suited to be applied to non-testing processes. The following are a few examples of both testing and non-testing processes that may be audited:
Creating an Audit Tool
An audit tool can be easily created based on a standard procedure or training checklist. Most laboratory procedures follow a stepwise formula that can be translated into an audit tool that should include instructions on frequency of use, staff members to include, audit result findings, and immediate follow-up actions. Assessment of follow-up actions also may be performed as part of the greater QM review process. See the FIGURE for an example of an audit tool developed by our team at Bellin Health for use in the laboratory outpatient phlebotomy section.
Auditing of Outpatient Phlebotomy
As with most laboratory practitioners, a phlebotomist’s personal characteristics, educational foundation, skillset, and experience level can be highly variable. This also is a laboratory practice section that can be subject to higher rates of staff turnover. Furthermore, on-the-job training is subject to training practices at a facility wherein several employees may be responsible for training. Likewise, medical laboratory technicians (MLTs), medical laboratory scientists (MLS), and nurses may cross-cover to perform this job function, though perhaps with less frequency than designated phlebotomy staff. All of these characteristics are additive to the opportunity for procedure variation.
Auditing of the outpatient phlebotomy section is one example of an area that encompasses several policies and procedures, but simultaneously is at risk for high user-generated variation. Our laboratory QM team discussed the variation they had directly experienced within our health system with a patient undergoing an outpatient blood draw. That discussion prompted the development and deployment of the auditing checklist for our outpatient phlebotomy department.
During subsequent phlebotomy audits, the most substantial variation noted involved patient identification. Every phlebotomist identified the patient prior to the draw, but with varying differences. For example, a phlebotomist would check the patient’s armband, but then forget to have the patient verbally confirm their name or date of birth. Similarly, a phlebotomist might properly identify the patient prior to venipuncture, but not confirm the labeled specimens with the patient or patient’s armband to ensure against mislabeling. As is well known among laboratory professionals and practically all members of the health care team, proper patient identification is the first and perhaps easiest way to avoid downstream error. Proper patient and sample identification goes a long way in reassuring patients that their samples are being handled properly and safely.
In addition to the obvious benefits to the patient in standardizing the phlebotomy process, by performing live audits with immediate feedback to the phlebotomist, variations of procedure can be corrected in real-time. After initial training of new employees is complete, an auditing process can be a highly standardized means of monitoring and ensuring that the procedural steps they were trained to perform are not skipped, altered, or forgotten over time. Moreover, when new employees are trained by phlebotomists who, as a group, are following the same steps and procedures, the chances of future errors are greatly reduced.
Deployment of an auditing tool is a straightforward and relatively easy way to add assurances to your quality management program, build confidence in staff performance, and mitigate variation that may affect patients and/or employees. Routine auditing of laboratory practices is a QA task that extends beyond competency assessment and serves to complement both the fulfillment of requirements dictated in a laboratory QM program, as well as ensure consistency in areas where high variation may occur. An auditing tool or checklist can simplify this process while allowing for direct and immediate feedback to personnel.
Tyler Radke, MLS(ASCP), began his career as a laboratorian at Froedtert St. Joseph’s Hospital in Wauwatosa, Wisconsin, before becoming the technical lead of microbiology at Bellin Memorial Hospital in Green Bay. In 2017, he became the laboratory manager at Bellin Memorial Hospital and Bellin Health Oconto Hospital. Tyler is a member of the Laboratory Technical Advisory Group (LabTAG) for the Wisconsin Clinical Laboratories Network (WCLN) serving as the representative for Region 7. He received his BS in Medical Technology from the University of Wisconsin Oshkosh.
Leah Borchardt, MLS(ASCP), has worked for Bellin Health since 2010 and in 2020 became team facilitator for core laboratory operations. She serves on the advisory committee for both Northeast Wisconsin Technical College’s MLT program and University of Wisconsin Stevens Point’s MLS program. Leah received her associate’s degree as a medical laboratory technician (MLT) from Northeast Wisconsin Technical College, then continued with a bachelor’s of applied sciences from University of Wisconsin, Green Bay before being certified as a medical laboratory scientist.