How is compliance documented in your laboratory? Chances are your laboratory amasses an evidence binder, a notebook full of examples of how the lab has complied with each requirement, writes Jennifer Dawson, MHA, DLM (ASCP) SLS, QIHC, in the September issue of CLN.
But there is an innate problem with this approach, Dawson, vice president of quality and regulatory affairs at Sonic Healthcare USA, emphasizes. Addressing CLN readers as a laboratory administrator and director of quality programs, Dawson explains why labs, in cherry-picking the best quality records, are not taking full advantage of the inspection process:
Letting go of an attachment to an evidence binder requires an important shift in thinking—to stop acting in a defensive manner and denying deficiencies presented at an inspection closeout meeting, she writes.
With these goals in mind, Dawson imparts the following advice about approaching regulatory inspections.
1. Allow systems to speak for themselves. This means letting the inspection process flow organically instead of supplying
hand-picked examples of your best work for each checklist item, which may not represent typical performance in that area on a day-to-day basis.
2. Use your time wisely. Rather than making a scrapbook of your compliance evidence, spend your time preparing for inspections by designing compliance audits and enhancing your quality program. Showing the auditors how things
really work in your lab saves time and demonstrates what the lab staff experience in their daily work.
3. Shift to a culture of quality. In order to effectively foster a culture of quality and organizational honesty, labs must balance accountability and systems thinking. Under such a model, managers embrace deficiencies and non-conformity reporting as opportunities to provide increasingly better services and approach each resulting quality improvement
initiative with enthusiasm and encouragement.
4. Climb the quality hierarchy. Historically, clinical laboratorians have been very good at controlling quality in the analytical phase. Moving up the hierarchy, quality assurance is aimed at fulfilling regulatory requirements. Next, in the quality management system (QMS) level of the hierarchy, the lab formalizes a systematic, process-oriented approach to and
framework for the quality programs to meet quality objectives.
Pick up the September issue of CLN and read more about achieving transparency in laboratory compliance.