Leading for Quality
To create the most value for your lab, quality has to be woven into the fabric of your organization. This starts with a quality leader and emanates outward to the entire organization, engaging and empowering all levels of staff.
This may sound straightforward, but it’s easier said than done. Let’s take a look at how you can take a lead role in managing quality for your lab.
Quality management begins with centralized oversight from a quality leader. Without this organization around quality, people may be unsure of who’s doing what and how to operate soundly. Things start to fall through the cracks. Risks multiply. Patient safety suffers. Decentralized quality programs are a recipe for disaster.
While some lab leaders may be technical experts, you cannot expect them to also be quality and accreditation experts. A quality leader should be focused solely on quality management. He or she should be expertly trained in quality and familiar with all applicable regulatory requirements and where to find answers when questions arise.
An organization’s quality leader should hold a senior management role. This demonstrates the lab’s commitment to quality and gives the quality department the authority to “hold the line” if necessary and drive quality initiatives throughout the organization. It is unreasonable to expect a person at a “coordinator” or “specialist” level to run your organization’s entire quality management system (QMS), ensure regulatory compliance, represent your organization to external agencies and function as an integral part of your lab’s management team without giving them the proper position on the organizational chart. Likewise, larger labs and networks should have centralized leadership and sufficient resources to accomplish quality goals. Avoid conflicts of interest by having the quality leader report directly to the highest position in the organization (i.e. CEO). Do not have the quality leader report to operations.
Additionally, it is important that this quality leader possess leadership qualities, such as effective communication skills. Just being an expert in the area of lab quality will not cultivate a culture of quality. Effectively communicating the purpose and benefits of proposed quality initiatives will gain buy-in and participation from all levels of staff. Another thing to keep in mind is while the quality department leads the laboratory in quality efforts and manages the QMS, the quality department does not do all quality functions for the laboratory alone. An effective QMS requires participation from all staff under the guidance of an effective quality leader.
Quality leaders should be senior managers who are expertly trained in regulatory requirements.
Building a quality policy manual and translating that into measurable objectives is foundational for developing organizational buy-in.
Creating a culture of transparency and trust is the best way to create a culture of quality where all team members feel empowered and costs are controlled.
Contributing Lab Leaders
Jennifer Dawson, MHA, LSSBB, CPHQ,
CLSI Expert Panel on Quality Management
Systems and General Practices;
AACC Management Sciences and Patient Safety
Division Executive Committee;
Malcolm Baldridge National Quality Award
Board of Examiners
Build your foundation with a quality policy
Once you have a quality leader in place, it’s time to establish a quality policy, which is effectively a mission statement for quality. Your quality policy should clearly summarize the quality goals of your lab, and all laboratory management should participate in its development to ensure buy-in. This cannot just be a piece of paper that hangs on the wall. Once established, management must “walk the walk” and lead by example. When management leads by example, a culture of quality becomes the new standard.
Transform your policy into a manual
Various documents will be built from your quality policy—including your quality manual. Think of your manual as a guide to all things quality. It should be process-oriented and written simply. Each staff member should be given a copy of the manual upon hire so they can clearly understand how they will contribute to providing quality lab services. From the quality manual comes more specific quality policies, processes, procedures, job aids and associated forms (as indicated in the document hierarchy).
Empower your whole team
A quality leader is just the start. For quality to truly permeate your culture, it needs to be embodied by your whole team. This is why empowering your entire staff is essential.
I recommend starting with a mandatory quality training session. This will help establish quality message credibility, show management’s commitment to quality, provide foundational quality training for staff and emphasize the level of quality that’s expected in the lab. A well-executed quality training session should leave your team feeling educated, inspired and empowered to provide quality care for patients.
Establish a culture of trust
A heavy emphasis should be placed on establishing trust. Trust is key when building a culture of quality. Staff members do not want to walk on eggshells, fearing they will be punished for making or reporting errors—and they shouldn’t!
One effective way to build trust is to establish a Just Culture, which balances a blame-free culture with accountability. Just Culture promotes openness and honesty, so your team will feel comfortable reporting potential problems, near misses and actual non-conforming events.
The "don'ts" and "do's" for a more patient-centric lab
Focus on systems, not individuals
By and large, lab professionals get into laboratory science because they enjoy contributing to patient care. It stands to reason that 99.9% of lab employees want to do the right thing. It’s important to avoid the tendency to automatically blame someone when something goes wrong. Chances are, mistakes were made honestly and don’t reflect negative intentions. This is where systems thinking comes in.
Systems thinking frees us from the tendency to blame people. Instead, it focuses on the defects in the system that allowed a particular event to occur. The only way to correct a flaw in a system is to redesign the system so the event cannot occur again.
Think outside the bounds of the lab
Pre-pre- and post–post-analytical activities occur outside the lab. Although you cannot fully control quality in these phases of the total testing process, you can have a positive influence by encouraging your staff to think outside the bounds of the lab.
Labs often have information that providers do not, such as information about specimen quality. Labs should initiate feedback loops. This allows your lab to move from being strictly lab-focused to being more patient-centric. This helps build lab-provider communication and relationships to improve quality throughout the entire continuum of care.
Form a quality committee
Fostering quality requires input and commitment from stakeholders across disciplines and levels. An excellent way to keep quality at the forefront is to form a quality committee. By engaging staff in quality activities, you’re truly spreading awareness and ownership of quality.
The cost of poor quality
A best practice quality program with a pervasive culture of quality can turn your lab from a cost center into a value generator. Conversely, poor quality comes with great cost—financial and beyond.
Poor quality can result from internal and external failures, which create costs inside and outside the lab. Each of these can be divided into hard costs (direct financial impact) and soft costs (indirect financial impact). Quantifying the cost of poor quality associated with non-conforming events in your lab can help you demonstrate the return on investment of your quality program.
In short time, soft costs associated with non-conformities can add up to a significant loss to your organization. This underscores the need for effective event management as a part of your lab’s quality program to eliminate root causes and ensure cost avoidance. With an effectively established quality culture, failures will be reported and resolved before they even start or shortly after occurring—and you’ll be amazed at how savings and benefits to your patients and customers follow. Demonstrating the quality and patient safety gains as well as financial benefits will reposition your lab quality program as a value creator instead of a necessary cost center.
We’re all in this together
To create a true culture of quality, everyone needs to be on board. It takes a team effort to embrace lofty quality goals from the start and, more importantly, follow through with them. If you invest in a solid quality leader, develop a clearly communicated program, empower employees of all levels and employ progressive quality tools, such as electronic non-conforming event management and CoPQ calculation—a sustainable culture of quality will soon follow.
For additional insights and tools, watch the video below to see Jenni's presentation on this topic, delivered at CLMA's Knowledge Lab 2017.
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