Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta
At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs
ATLANTA, Oct. 15, 2019—Clinical laboratory professionals have a chance to advise the federal Centers for Disease Control and Prevention (CDC) on how the federal government could revise the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). That’s according to one of the keynote speakers on Wednesday at The Dark Report’s 13th Annual Lab Quality Confab (LQC), which began here on Tuesday.
Reynolds M. Salerno, PhD, Director of the Division of Laboratory Systems (DLS) for the CDC in Atlanta, explained that the agency is collecting comments from the public and from its Clinical Laboratory Improvement Advisory Committee (CLIAC) on how to revise the CLIA regulations.
This is an opportunity for clinical laboratory directors, pathologists, and other lab professionals, to comment on the proposed revisions to CLIA before or during the upcoming CLIAC meeting on Nov. 6.
The agenda for the meeting is posted on the CDC’s website.
Public to be Heard on CLIA Regulations
“For the first time in its 26-year history, the council has called for three workgroups to address how to revise CLIA,” Salerno said. The workgroups will address these topics:
- CLIA personnel regulations;
- Non-traditional testing workflow; and
- Next-generation sequencing.
“It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno commented. Chartered in 1992, the advisory council meets twice a year, once in April and once in November.
CLIAC issued a summary report of its April 10-11 meeting. It also published an agenda for its upcoming meeting in Nov. 6.
In the coming weeks, Dark Daily will publish more information on how clinical laboratory professionals can comment on the important issue of CLIA revisions.
Digital slides from Salerno’s keynote address are posted on LQC’s presentations website.
Clinical Laboratory Testing is Increasing in Value, Keynote Speaker Says
As a service to clinical laboratories, Salerno outlined many of the services the CDC’s Division of Laboratory Systems provides for free to clinical labs, including information on such topics as:
- Quality and Safety Systems;
- Informatics and Data Science;
- Training and Workforce Development; and
- Preparedness.
Healthcare System Disruption Impacts Providers, Including Clinical Laboratories
Other keynote speakers addressed how disruption in the US healthcare systems affects provider organizations in significant ways. For clinical laboratories, such disruption has resulted in reduced payment and demands for quality improvement and shorter turnaround times.
For all these reasons, quality management systems may be every clinical laboratory’s best strategy to survive and thrive, the keynote speakers said.
The first keynoter was Robert L. Michel, Editor-in-Chief and Publisher of The Dark Report. Michel’s remarks focused on how price cuts from Medicare, Medicaid, private payers, and the drive for value-based payment, are requiring labs to do more with less. For this reason, quality management systems are necessary for all labs seeking to improve results, eliminate errors, and cut costs, he said.
“The people closest to the work know how to fix these problems,” he added. “That’s why labs know they must train their staff to identify problems and then report them up the chain so they can be fixed,” Michel commented. “Labs that are best at listening to their employees are getting very good at identifying problems by measuring results and monitoring and reporting on their own performance.”
Michel identified three principle factors that are disrupting healthcare:
- The shift from reactive care in which the health system cares for sick patients to proactive care in which the health system aims to keep patients healthy and out of the hospital and other costly sites of care.
- The transition away from fee-for-service payment that encourages providers to do more for patients, whether more care is needed or not, to value-based payment that aims to reward providers for keeping patients healthy.
- The consolidation among hospitals, health systems, physicians, and other providers. A trend that requires clinical laboratories to find new partners and new ways to improve lab services and reduce costs.
Informatics Performance Data Help Clinical Laboratories Respond to Change
“The attributes of new and successful labs are that they will have faster workflow and shorter cycle times for clinical lab tests and anatomic pathology specimen results,” Michel explained. “That means that labs will attack non-value-added processes by implementing continuous improvement strategies [such as Lean and Six Sigma] and by the sophisticated use of informatics.”
Making use of performance data enables clinical laboratory directors to make changes in response to disruptions that affect healthcare. “If you have good informatics, then seven or eight of every 10 decisions you make will be good decisions, and with the other two and three decisions, you’ll have time to pull back and adjust,” Michel commented.
The second keynote speaker, Jeremy Schubert, MBA, MPH, Division Vice President of Abbott, reiterated what Michel said about how the health system is moving away from fee-for-service payment. Instead of focusing on caring for sick patients exclusively, he said, health insurers are paying all healthcare providers to keep patients healthy.
“Healthcare today is about the whole life course of the individual,” Schubert explained. “Patients no longer want healthcare only when they’re sick. Instead, they want to be healthy. And health creation is not just about a person’s physical health. It’s about their mental health, their emotional health, and their social wellbeing.
“In fact,” he continued, “you can learn more about a person’s health from their Zip code than from their genetic code.”
That is essentially what TriCore Reference Laboratories (TriCore) has been doing in New Mexico, Schubert added. During his presentation, Michel mentioned TriCore as being one of four clinical laboratories participating in Project Santa Fe, a non-profit organization that promotes the movement from Clinical Lab 1.0 to Clinical Lab 2.0. (See “TriCore Forges Ahead to Help Payers Manage Population Health,” The Dark Report, May 20, 2019.)
“If you want to be a quality engine in healthcare you have to be operating at Lab 2.0. Who is best qualified to interpret information? It’s the lab,” Schubert said. Then he challenged labs to begin pursuing the goal of achieving Lab 3.0, saying “Lab 3.0 is being able to interface with the patient to address each patient’s problems.”
The 13th Annual Lab Quality Confab (LQC) in Atlanta continues through the 17th with post-event workshops in Six Sigma and mastering quality management systems. In attendance are 300 clinical laboratory administrators, managers, and quality team members who are learning a complete array of professional training methods.
To register to attend, click here or enter https://www.labqualityconfab.com/register into your browser, or call 707-829-9485, or e-mail lqcreg@amcnetwork.com.
—Joseph Burns
Related Information:
Clinical Laboratory Improvement Advisory Committee Agenda for meeting Nov. 6
Clinical Laboratory Improvement Advisory Committee Summary Report
TriCore Forges Ahead to Help Payers Manage Population Health
