Academy of Diagnostics & Laboratory Medicine - Scientific Short

What tools can help clinical laboratories begin the process of standardization?

Joshua Hayden

This post is part of a collaboration between AACC Academy and SYCL, to highlight the excellent work being done by young laboratorians, and the knowledge and perspectives they bring to the laboratory community.

Financial pressures and the changing healthcare market continue to drive clinical laboratories towards standardization. A primary driver of the financial pressures are the reductions in the Clinical Laboratory Fee Schedule (CLFS) under the Protecting Access to Medicare Act of 2014 (PAMA). These reductions have spurred similar fee reductions by Medicaid and private insurance and hit laboratory budgets significantly. These cuts are forcing laboratories to seek out more and more opportunities to improve laboratory efficiency. This is all occurring at a time when health systems in the United States (US) continue to grow through mergers and acquisitions. This trend towards consolidation means that more and more individual laboratories are becoming part of a larger system that includes multiple laboratories. This confluence of events, financial pressures to be more efficient and consolidation of health systems, is driving laboratories down the path towards standardization, which can bring substantial and risks (1). How do separate sites within a single health system take the first step towards standardization and what tools are available to help?

The implementation of a shared, online document management system (DMS) is one of the first and most readily-achievable tools laboratories can implement in the process of standardization. The implementation of such a DMS reduces the upfront implementation cost, ensures consistent practice across the organization, reduces the training required for staff to go between sites, and allows all sites within the system to benefit from regulatory findings at any one site. Almost every clinical laboratory can benefit from an online DMS, with a large number of laboratories not meeting regulatory standards related to document control (2). The use of a single, shared DMS across the system is a more affordable option compared to separate DMSs at each site. In addition, the upfront work of implementing or switching to a new DMS is greatly minimized by doing it as a system- instead of each site uploading procedures for their site, you can upload system procedures that are shared across sites. These shared system procedures are essential for starting to standardize processes across the system. Every single laboratory needs a procedure for handling mislabeled samples. Writing a separate protocol for this at each site in a five site health system takes substantially more work than writing and maintaining a single, system-wide

procedure for dealing with this. Once written, this procedure ensures that all sites across the system are handling these situations in an identical manner. The use of these shared procedures are essential for ensuring that the expectations clinicians have of the laboratory are identical at every site throughout the system. Further, having these standardized procedures ensures that the laboratory staff are better prepared to go between sites. A bench technologist could accept a supervisor position at another site and walk into that new position already having a strong familiarity with the procedures and practices. This is invaluable as it facilitates cross-pollination across the system. When technologists work at multiple sites in the system it allows for more advancement opportunities, helps keep in-demand medical technologists in the system, and fosters a culture of being system employees rather than site-specific employees. A final advantage to maintaining system-wide protocols on your DMS is that any regulatory inspection at one site, be it external or internal, will help uncover any issues at all of the sites. If all sites are using the same procedures, then any issue with that procedure uncovered by one site helps improve the procedure for all sites. As an example, if all sites are using the same delegation of authority and one site’s inspection finds that this procedure does not adequately list the duties of supervisors then all of the other sites in the system are now aware of this and can correct this deficiency. If separate procedures are used, then the deficiencies of any one site are just that- one site’s deficiency. There is not the same opportunity for the system to improve through the course of each individual site’s inspections. Ultimately, this ability to learn from the experience of every site helps make the system as a whole a higher quality laboratory system. This ability is greatly helped by implementing a shared, online DMS.

Beyond the more tangible benefits of the DMS described above, the process of working together as a system to implement the DMS starts to create the culture needed for successful standardization. Successful laboratory standardization requires a culture of us and not me; a culture of “our laboratory system,” not “my individual laboratory site.” The process of agreeing on and uploading standardized system procedures into the DMS requires group discussion and input. While these meetings can at times be contentious depending on differences that might exist, the process of coming together and working towards system procedures is invaluable. It is during these discussions that individual sites begin to think

about how they as a system will handle things and it is during these discussions that folks begin to see the value and input of their fellow system employees. These discussions and the work of implementing the DMS are sometimes the most valuable asset in the standardization process.

The use of a shared, online DMS is a necessary but by no means sufficient step towards successful laboratory standardization. It is the merging of cultures and generating sufficient support for these standardization efforts that will be the greatest challenge. However, those issues of personnel and culture are not the sort of things that can be readily purchased and implemented. Fortunately, a DMS is and this can serve as a useful first step for any system looking to move forward with laboratory standardization.

REFERENCES

  1. Church DL, Naugler C. Benefits and risks of standardization, harmonization and conformity to opinion in clinical laboratories. Crit Rev Clin Lab Sci. 2019 Aug;56(5):287-306.
  2. Valenstein PN, Stankovic AK, Souers RJ, Schneider F, Wagar EA. Document control practices in 120 clinical laboratories. Arch Pathol Lab Med. 2009 Jun;133(6):942-9.

Academy of Diagnostics & Laboratory Medicine Designation

Fellows of the Academy use the designation of FADLM. This designation is equivalent to FACB and FAACC, the previous designations used by fellows of the National Academy of Clinical Biochemistry and AACC Academy. Those groups were rebranded as Academy of Diagnostics & Laboratory Medicine in 2023.