Facing Increasing Pressure from an Evolving Regulatory Environment, Clinical Laboratories Need to be ‘Inspection Ready’ in 2019

Experts say medical laboratories must overcome staffing challenges and develop a culture of continual inspection readiness

Clinical laboratories and anatomic pathology groups will be entering 2019 facing not only financial upheaval from Medicare Part B fee cuts and narrowing payer networks, but also an increasingly rigorous and ever-evolving regulatory environment.

Although the Clinical Laboratory Improvement Amendments (CLIA) requirements have not undergone major changes since debuting in 1992, the medical laboratory industry has become more complex and technology-laden, resulting in old rules being applied to emerging technologies.

“People can get lulled into this sense that we know what standards are and we’re meeting them, but what has happened is the rules haven’t really changed—the industry has,” says Nora L. Hess, MBA, MT(ASCP), Senior Consultant for Accumen, a lab quality improvement company in San Diego, CA. “Technology is now jumping ahead so fast that keeping up with it and understanding how the rules are going to be applied is challenging.”

Hess and Anne T. Daley, MS, Quality Officer at ARUP Laboratories in Salt Lake City, UT, will co-present a 90-minute webinar on Dec. 13th titled, “Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification and What to Expect in the Future.”

The program will review the top deficiencies reported by the College of American Pathologists (CAP), the Joint Commission, A2LA, and COLA.

Why being ‘Inspection Ready’ Can Improve Performance and Increase Revenue

Striving to be “inspection ready” should be the goal of every clinical laboratory and pathology group. However, Daley notes labs typically operate with staffs that are stretched thin by retirements, illnesses, staff shortages, or ancillary demands on administrators’ time, caused by system-wide initiatives that range from electronic health record (EHR) rollouts to integration and consolidation of other labs.

“Most hospital laboratories are staffed at a level where they are working hard just to meet the daily patient care needs,” Daley says. “You add in all these additional projects and something has to give.”

In today’s challenging environment, Hess says laboratories that consistently perform well during the inspection process share several characteristics, including the following:

a culture of quality across the laboratory; and,

an emphasis on inspection readiness.

“They make inspection readiness a consistent focus across the entire laboratory,” Hess notes. “It becomes part of the calendar. It becomes part of what they talk about all the time. It is a part of their decision-making. It is hardwired into who they are and what they do … successful laboratories are making this part of their day-to-day activities, so it doesn’t get lost in the shuffle and it doesn’t get back-burnered.”

Hess and Daley note the types of deficiencies cited by accreditation agencies tend not to vary much from year to year. Testing personnel competency and proficiency testing are common themes, annually ranking high on top-10 lists of deficiencies found. However, laboratory directors increasingly are being singled out for issues related to qualifications and performance of responsibilities.

(To register for their Dec. 13th webinar or to order a DVD, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/make-your-lab-assessment-ready-in-2019-know-the-most-common-deficiencies-in-accreditation-and-certification/).

—Andrea Downing Peck

Related Information:

Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification

CLIA Inspection–What they Mean and How to Avoid Them

‘We Wanted to Be the Best we Could Possibly Be’: CAP ISO 15189-Accredited Labs on the Difference it Makes

Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”