Federal and state laboratory regulators tighten down during inspections of nation’s medical laboratories

Across the United States, medical laboratory accreditation and CLIA compliance is quietly getting tougher. This is a trend which affects every clinical laboratory and anatomic pathology medical group that must comply with CLIA and meet the accreditation requirements of the Medicare program.

One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.

Federal and state clinical laboratory regulators are backing up tough talk about tighter enforcement of the requirements of the Clinical Laboratory Improvement Act (CLIA) requirements. Over the past 18 months, Dark Daily is aware that two nationally-prominent medical laboratory companies—following CLIA inspections of certain lab facilities—were required to cease certain types of clinical testing until serious deficiencies were corrected. These consequences demonstrate that it is not just hospital laboratories feeling the brunt of more rigorous CLIA inspections.

Judy Yost of Medicare Program to Speak at Lab Quality Confab

Tougher laboratory accreditation and CLIA compliance will be major topics at the Fifth Annual Lab Quality Confab. This conference, which emphasizes excellence in laboratory operations and workflow, takes place on November 15-16, 2011, in San Antonio, Texas. (Speakers and topics can be viewed at this link.)

Different sessions will look at this subject from different perspectives. As a keynote speaker, Judy Yost, MA, MT (ASCP), who is the Director, Division of Laboratory Services Centers for Medicare and Medicaid Services, in Baltimore, Maryland, will provide a high level view of the current state of laboratory accreditation and CLIA compliance.

Among the issues Yost will discuss, two are particularly noteworthy. One issue is how and why CLIA inspectors, as they determine deficiencies during an inspection of a medical laboratory, are increasingly identifying, by name, the lab managers who have responsibility or authority over the specific lab activities which have been identified as deficient. This development signals a goal of lab regulators to hold managers more accountable for fulfilling the requirements of various state and federal laws.

The other issue Yost will address will be significant for most readers of Dark Daily. She is going to discuss the various ways that laboratory accreditation and licensure intersect with quality management systems (QMS). These important insights will help clinical laboratory managers and pathologists understand how a QMS like ISO 15189 can play an essential role helping their laboratories better meet regulatory requirements while improving the quality of lab test results and contributing to increased patient safety.

A First for the Clinical Laboratory Industry

Lab Quality Confab will also feature a first for the clinical laboratory testing industry. There will be a special debate around this important question: “Should Labs Complement CMS and CLIA Requirements with a Quality Management System (QMS)?”

Luci Berte, President of Laboratories Made Better! PC, will moderate the Great Debate titled: “Should Labs Complement CMS and CLIA Requirements with a Quality Management System (QMS)?” at the Fifth Annual Lab Quality Confab, which takes place November 15-16, at the Hyatt Regency Hotel in San Antonio, Texas.

Luci Berte, President of Laboratories Made Better! PC, will moderate the Great Debate titled: “Should Labs Complement CMS and CLIA Requirements with a Quality Management System (QMS)?” at the Fifth Annual Lab Quality Confab, which takes place November 15-16, at the Hyatt Regency Hotel in San Antonio, Texas.

Moderating the debate is Luci Berte, President of Laboratories Made Better! P.C., in Broomfield, Colorado. Berte is globally recognized for her work in participating in the work teams that have developed the standards for ISO 15189 and CSLI’s GP26—A4.

Panelists include:

All these panelists are active at the national level in committees and advisory panels associated with federal and state laboratory accreditation and compliance. Two panelists manage clinical laboratories that have implemented a quality management system. Serrano’s laboratory is accredited to CAP 15189. Flaherty’s laboratory uses the QMS standards of CLSI GP26. This panel will be rich in information and insights and is a “can’t miss” session for lab managers and pathologists.

Validating Laboratory-Developed Tests (LDT)

Another hot topic in the clinical laboratory industry involves LDTs—Laboratory-Developed Tests. The explosion in the number of new LDTs has caught the attention of lab regulators. Lab managers can attend the session titled: “Do’s and Don’ts of Validating a Laboratory-Developed Test (LDT) to Meet Regulatory Requirements.” The speaker is Deirdre A. Astin, Health Policy Analyst at the New York State Department of Health in Albany, New York.

Of course, the full range of experts and innovative lab managers will be on hand at Lab Quality Confab to present case studies of Lean and process improvement projects, share clever successes in workflow redesign, and teach beginning, intermediate, and advance lessons in Lean and performance improvement methods. More than 40 speakers and sessions will take place over the two days.

Poster sessions will take place, and national awards and prizes totaling $3,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com. To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register.

More than 250 participants are expected from as many as 10 different countries, and registrations are running ahead of last year.

Lab Quality Confab not only continues to be the most important meeting about performance improvement methods as used by innovative medical laboratories, but the large size of this meeting provides strong evidence that quality management and process improvement is now an established part of laboratory medicine. Interested lab managers and pathologists are encouraged to register today to guarantee their place at the Fifth Annual Lab Quality Confab.

Related Information:

Four Easy Ways to Register:

  1. Register ONLINE
  2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
  3. Fax this complete registration form to 512-264-0969
  4. Mail the one page form with payment to:

 THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

 

CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs

Georgetown University Hospital Suspends Testing at One of Its Pathology Laboratories

General Accounting Office (GAO)—Clinical Lab Quality: CMS and Survey Organization Oversight Should Be Strengthened

Surviving a CLIA Inspection

 CMS Rolls Out New CLIA Policy Change: What Labs Can Expect

ISO 15189 Laboratory Accreditation