Four attributes are essential to achieving a culture of quality: Leadership emphasis, message credibility, peer involvement, and employee ownership.1 Many organizations establish quality objectives, but accomplishing those objectives requires commitment to a compelling mission and vision, company-wide values, expected behaviors, and complementary performance metrics and incentives. Only when an organization upholds these standards can it be said to exhibit a true culture of quality.2
Sonic Reference Laboratory (SRL) is a state-of-the-art esoteric reference laboratory specializing in immunology, chemistry, hematology, analytical chemistry, and molecular testing. The lab’s executive team built the lab from the ground up with a go-live date of December 1st, 2014. A primary goal was to establish a culture of quality and a comprehensive, best-practice Quality Management System (QMS), striving for best practice and ISO 15189 conformance. SRL’s executive management team sought to advance the culture of quality achieved in its first year of operation and reap the associated patient-safety, operational, and financial benefits, in the long-term.
Materials & Methods
Development of the QMS was initiated by creating a Quality Policy statement along with a comprehensive quality manual. In order to educate staff on the new QMS, an interactive, two-hour onboarding program was created and presented to all staff members, including management, before the laboratory opened. The same program continues to be an integral component of orienting new employees to the ongoing quality program, with a heavy focus on the lab’s role in patient care. It is important to engage staff and encourage active participation in program exercises by emphasizing concepts such as Cost of Poor Quality (CoPQ), Total Quality Management (TQM), the QMS structure, systems thinking, Just Culture, and maintaining a culture of quality.
During the onboarding presentation, key quality policies and programs are reviewed with staff with a focus on the value of reporting non-conforming events and near misses. SRL developed a Hippocratic Pledge for laboratorians (the idea for which came from a presentation by ARUP Laboratories),3 that is read aloud during new staff onboarding in an effort to both highlight the importance of their role in patient care and to foster empowerment. Responsibility acknowledgement forms also are signed to ensure employees are aware of their regulatory obligations and organizational expectations for quality before they commence employment. The quality onboarding program encourages thinking outside the bounds of the lab, allowing our concept of quality to include the Total Testing Process (TTP) and the development of feedback mechanisms for non-conformities that affect patient safety. Annual refresher quality training is completed by all staff.
In order to ensure effective management review of metrics and quality improvement (QI) initiatives occur within each department, quality committee meetings are held with key stakeholders on a quarterly basis to discuss quarterly quality reports (QQR). The QQRs demonstrate key metrics within each department such as test volumes, turnaround times, proficiency testing performance, rerun statistics, quality control trending, and competency assessment completion. Quarterly quality committees serve to review each lab section’s metrics, track progress on QI initiatives, and identify quality improvement initiatives for the next quarter. SRL also holds monthly director-level quality council meetings to review highlights from each lab section’s QQR and address any overarching quality topics or concerns. A technologist-level quality improvement crew meets monthly to ensure integration of the quality program and participation at all levels of the organization. Focus groups are conducted monthly to ensure less assertive staff members have a voice as well.
A key component of SRL’s quality program is the consistent practice of reporting non-conforming events and near misses in an electronic event management system. Employees are encouraged to freely utilize the system to report and track events, opportunities for improvement, and any potential concern affecting patient or employee safety and/or the financial health of the organization, no matter how minor. CoPQ is captured in this system for each non-conforming event, which helps elucidate the positive financial impact of the quality program. The laboratory is in the early stages of capturing this information, but is able to make conservative rough estimates of both internal and external CoPQ values. An example of this is the submission of a mislabeled specimen. In such an event, we consider the hard internal costs associated with the resulting rework, such as labor and supplies associated with relabeling, but we also provide conservative estimates for soft costs, such as potential harm to the patient, client attrition, and litigation. CoPQ is determined by reviewing a list of related considerations (including internal and external failure costs). The considerations factored into each estimate are documented in the software along with the total CoPQ estimate. Reported non-conforming events are tracked and trended on an ongoing basis.
The employment of real-time metric dashboards, Lean Six Sigma, an employee recognition program for quality, electronic document control, wireless temperature monitoring, quality control software, and an aggressive, peer-to-peer internal audit program are other important components of the quality program.
In order to establish non-conformity benchmarks, SRL surveyed 16 clinical labs of varying types. The participants included hospital and reference labs with an FTE range from 10 to thousands. The labs surveyed reported: number of employees, total test volume, total number of reported non-conformities, number of serious non-conformities, and number of minor non-conformities. Serious non-conformities were defined as those with the potential for high patient– and/or employee-safety risk, and/or high financial loss. All other non-conformities were defined as minor. We calculated the number of serious and minor events reported per number of employees and per total test volume in order to establish rates of event reporting for each of the 16 labs, as well as SRL.
Results & Discussion
To quantify the success of SRL’s culture of quality and benchmark against other clinical labs, the rates of serious non-conforming events both as a proportion of the number of employees and monthly test volumes were compared. While SRL had fewer serious non-conforming events per test volume (reported monthly) than the average of all labs surveyed, the number of minor non-conformities per test volume exceeded the average for all labs (see FIGURE 1). The higher number of minor non-conforming events suggests SRL is proactive in reporting events, yet experiences relatively few serious events compared to the labs surveyed. SRL also is proud of the increase in self-reporting (intradepartmental) and interdepartmental reporting, as opposed to external identification of non-conformities (see FIGURE 2).
The cumulative number of near-miss and no-potential-for-harm events between when the lab opened and June 30, 2016, also was evaluated in order to assess whether staff had embraced the reporting culture indicative of an organization with a culture of quality (see FIGURE 3). Of the 649 events reported, 96 (15%) were near misses and 232 (36%) were events where no potential for employee and/or patient harm existed (see TABLE 1). This equates to 51% of all non-conformities reported. The vast majority of the remaining 49% were events with low potential for employee and/or patient harm, with a small percentage being moderate and high potential for harm. While many organizations only document events that result in actual harm to a patient or employee, it is important to embrace a reporting culture that allows organizational learning from near misses that could have, but did not, cause patient or employee harm, as well as errors that did not cause harm, but negatively affected the lab, such as operational inefficiencies, rework, and other wasteful practices.
SRL staff was surveyed to assess perceptions of leadership commitment to a quality culture. 70% of staff members participated in the 2015 survey, while 86% of staff participated in the 2016 survey. In general industry, only 60% of employees believe their management supports the quality vision and values of their organizations, unequivocally.1 This figure rises to 81% for world class organizations.1 These benchmarks are derived from a study with 2291 participants. In 2015, SRL exceeded both benchmarks, achieving 93% of staff believing management supports and fosters a culture of quality. In 2016, staff was polled again and SRL achieved its 100% goal.
The estimated CoPQ for year 1 has been captured in the event management system, totaling $288,798—a number representing lab losses related to poor quality. As a conservative year 2 estimate for CoPQ savings, the first year CoPQ was multiplied by the lab’s 95% success rate for corrective and preventive actions. Assuming that successful root-cause elimination will result in the prevention of one identical event over the course of year 2, the estimated CoPQ savings (or cost avoidance) is $274,358 (see TABLE 2).
SRL’s success in building and sustaining a culture of quality is owed in large part to its emphasis on best practices, instead of aiming to meet minimum requirements. Dedication to a quality program conveys leadership’s emphasis on and vision for quality, creates staff buy in, provides message credibility, establishes expectations and incentives for employee involvement, and instills a sense of employee ownership, empowerment, and obligation for quality in the laboratory.
Obtaining more accurate and reliable CoPQ values will remain a focus, as doing so allows SRL to further quantitate the value of investing in a culture of quality and maintaining a best practice quality program.
“Quality is the result of a carefully constructed cultural environment.” -PHIL CROSBY
Jennifer Dawson, MHA, LSSBB, CPHQ, DLM(ASCP)SLS, QLC, QIHC, is the vice president of quality and regulatory affairs for Sonic Reference Laboratory (SRL) in Austin, Texas. Jennifer built SRL’s quality program from the ground up and is responsible for oversight of a strategic approach to a robust, best practice quality management and regulatory compliance. She serves on the CLMA Board of Directors, the ASCLS Patient Safety Committee, the CLSI Expert Panel on Quality Management and General Practices, and the National Malcolm Baldrige Quality Award Board of Examiners.
Philip Mlaker, MLS(ASCP), is the quality manager at SRL and is responsible for maintaining several aspects of the quality management system, including proficiency testing, event management, and document control. Philip is certified through the College of American Pathologists as a medical laboratory scientist.
Melissa Hiserote, MS, PMP, is the director of projects for SRL and was a member of the core team responsible for establishing the new laboratory, which opened its doors on December 1, 2014. She is responsible for managing the test development pipeline and ensuring effective communication of new test launches. Melissa serves on the board for the Austin Chapter of the Project Management Institute.
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