Proceed with Caution: Heeding the Required Trade-Offs of Standardization

Proceed with Caution: Heeding the Required Trade-Offs of Standardization

Laboratory standardization clearly has its benefits, from the efficiencies it can bring to a healthcare system to its impact on costs and the quality of patient care. But most standardization initiatives also require trade-offs to avoid potential mistakes that could prevent success. Here's a look at what those trade-offs are, and some thoughts from industry leaders on how to handle them.

Adjusting to Regulatory Requirements

According to Myra Wilkerson, MD, FCAP, Chair of the Division of Laboratory Medicine with the Geisinger Health System, one of the biggest trade-offs associated with standardization has to do with the regulatory environment. “You have to have a plan for how you're going to bring that into your laboratory, and how you're going to help people understand it," Wilkerson says. Regulatory concerns will vary from state to state, and even from one locality to the next. Invest in the time and expertise required to understand the regulations that affect your organization—and what you can and cannot do as your project proceeds—and then make adjustments as required. If you don't, Wilkerson says, “your lab can be in real trouble."

Bending to the Needs of Leadership—and Employees

Some understandably assume that laboratory leaders are really the only ones who need to be involved in the standardization process, but according to Wilkerson, that's a big mistake. “When you inherit all these different hospital laboratories and independent community laboratories, how do you bring them together? How do you combine purchasing power? How do you standardize your instruments? How do you do policies and procedures? How do you share staff, maybe for better efficiencies? How do you decide what's needed locally versus centrally?" These are questions that can only be answered through close collaboration with C-Suite executives and through discussions with physicians and employees, Wilkerson says.

Article highlights:

  • Most laboratory standardization projects require trade-offs to avoid potential mistakes that could prevent success.
  • The key to navigating those trade-offs is strong leadership within the lab.
  • Federal, state, and local regulations, the needs of the organization's leaders and employees, and issues related to design and planning all create challenges that require trade-offs


Contributing Lab Leaders

Myra Wilkerson

Myra Wilkerson, MD, FCAP

Anatomic and Clinical Pathology, Cytopathology Chair, Division of Laboratory Medicine

Michelle Barthel

Michelle Barthel, MT(ASCP), MHA

System Director of Laboratory Services, Regional Health

Eyas Hattab

Eyas Hattab, MD, MBA

Chair of Pathology and Laboratory Medicine
A.J. Miller Endowed Chair in Pathology
University of Louisville



To avoid potential problems as your standardization project unfolds, appoint a “physician champion" to participate in the process, and communicate with leaders in the C-Suite so they're aware of the lab's needs and understand your goals. In addition, says Eyas Hattab, MD, MBA, Chair of Pathology and Laboratory Medicine and the A.J. Miller Endowed Chair in Pathology at the University of Louisville, be sure to bring your staff on board by “engaging them early and asking them what laboratory consolidation means to them."

Investing in Design, Planning, and Infrastructure

Some laboratory standardization projects fail due to inadequate investment in required infrastructure, while others languish as a result of poor preparation. It's important to be willing to sacrifice speed in return for the security that comes with careful planning, suggests Huron Healthcare consultant Donna Beasley, MT(ASCP)DLM. “Before you come out of that chute," Beasley says, describing the early days of the typical standardization initiative, “you have to have a very careful design and planning phase" that involves gathering data and building project teams. “Everybody needs to be on the same page before you hit the start button," she says.

Similarly, Wilkerson says, rather than rushing into the project before you know what your infrastructure needs will be, take the time to map out those needs in advance. “You have to agree with your local providers on what reasonable service standards will happen before and after—what's our current state, can we actually improve on our current state." And then, Wilkerson adds, you have to invest in putting the tools in place to support the standardization project from start to finish. “If you don't have that infrastructure and it fails, you lose all credibility."

In the end, Wilkerson and Beasley agree: The key to navigating the trade-offs that are required for most standardization initiatives to succeed is strong leadership within the lab—and collaboration with the stakeholders outside of it, as well.


Additional resources

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