Pathologists and medical laboratory managers should be alert to compliance changes
CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories.
Laboratory management consultants tell Dark Daily that, for the most part, well-run medical laboratories are having few problems when CLIA inspectors show up on site. Because these laboratories are diligent about compliance with legal requirements, the CLIA inspection seldom turns up a serious deficiency nor identifies a major compliance failure within the laboratory.
CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations
But that is not the case for hospital laboratories, pathology groups, and other types of medical laboratories where diligent compliance is lacking. “When administrators of a hospital laboratory call us to ask for help, we are often told that the CLIA inspectors are much less tolerant of sloppy compliance practices, compared to CLIA inspections in past years,” revealed one veteran laboratory management consultant.
“Over the past 24 months, our consultants have been in several hospital laboratories that were identified as having serious deficiencies by CLIA inspectors,” continued this individual. “Having now worked with a number of these laboratories that needed to quickly correct major deficiencies to prevent suspension or revocation of their CLIA license, it is our observation that CLIA inspectors are taking a tougher stance when they inspect a laboratory that might be described as ‘sloppy’ in its compliance practices and operations.”
More Hospital Labs Calling For Help to Correct Regulatory Deficiencies
Another prominent laboratory management consulting firm contacted by Dark Daily had similar observations about tougher CLIA inspections. “In the past year, the number of requests our company gets from hospitals or health systems about a laboratory that has serious CLIA issues has definitely increased,” stated the CEO of this firm.
“We don’t do consulting to correct regulatory deficiencies and fix these types of compliance issues,” added the CEO, “so we can’t tell you what specifically might be different about how CLIA inspectors now conduct inspections compared to past years. But when we get these calls, the hospital lab is often facing a license suspension or revocation if it doesn’t respond quickly. And since the number of calls like this has increased, we would assume that CLIA inspections in some states are much more rigorous than in the past.”
Anecdotal reports about tougher CLIA inspections for clinical laboratories that are guilty of ragged operations and sloppy compliance policies may be useful evidence of a different stance by laboratory regulators tasked with enforcing the CLIA statute. Pathologists who are on a laboratory license as medical director will want to pay particular interest to this development.
Access to Experts with Information about Changing Compliance Issues
For its part, Dark Daily is responding to these developments in laboratory licensure and inspections with up-to-the minute information to forewarn and prepare laboratory administrators and pathologists in useful ways. For example, earlier this week, during an audio conference conducted on October 19, attorney Jane Pine Wood of McDonald Hopkins addressed important issues for pathologists who serve as medical directors of laboratories. These new issues are associated with federal regulation and inspections of clinical and pathology laboratories.
This audio conference was titled “How to Stay Legal in 2011: New Legal Issues and Regulatory Changes Affecting Clinical Laboratories and Pathology Groups .” It is still possible to purchase an audio recording of this well-attended audio conference, via this link . For pathologists who are medical directors of laboratories, Wood discussed important developments in compliance. Among other things, she noted that, should a CLIA inspection result in severe deficiencies, the medical director of the laboratory would also face certain consequences, up to suspension or revocation of his or her license for as long as two years.
Another opportunity to get the latest news and advice associated with CLIA inspections of medical laboratories is the upcoming Lab Quality Confab and Process Improvement Institute. This will take place in San Antonio, Texas, on November 2-3, 2010. Multiple sessions by experts in laboratory compliance, inspections, and quality management will be conducted.
To squarely address the challenge of tougher CLIA inspections at Lab Quality Confab, a never-before offered presentation titled “Mayday Boss! CLIA Inspectors Are in Our Lab and They are NOT Happy!” program will take place. It will be conducted by Nora Hess, MBA, Operations Managing Consultant of Chi Solutions, Inc., of Ann Arbor, Michigan. It will be a revealing workshop and a “must attend” for any lab manager or medical director who recognizes that his or her clinical laboratory may face serious deficiencies were CLIA inspectors to take to a critical look at the operations and staff practices of their medical labs during a future inspection.
To attend Lab Quality Confab and participate in this session, Dark Daily readers can register. The full agenda with more than 40 topics and speakers is available at http://www.labqualityconfab.com.
Pathologists and clinical laboratory managers should note that the anecdotal evidence of tougher CLIA inspections points to stricter enforcement in medical laboratories where operations and compliance practices are inconsistent. By contrast, clinical labs and pathology groups that maintain consistent compliance to requirements are experiencing few surprises during their CLIA inspections.
Related Information:
More U.S. Medical Laboratories Ready to Step up to ISO 15189 Accreditation
•Full program information and speaker agenda for Lab Quality Confab:
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
I am completely in favor of more stringent inspections by CLIA as long as the people inspecting are qualified (Medical Technologists, Pathologists, etc). However, I feel there needs to be more scrutiny of POL waived and PPMP testing. I know the FDA says they only waive tests that should do very little harm if performed incorrectly or with contaminated or incorrectly stored test kits. However, as we in laboratory know, some of the testing approved since the inception of CLIA is far from harmless if performed incorrectly. Unfortunately, while they don’t intend to do anything wrong, the people running in-office testing have no understanding of why mixing lot numbers of reagents can be a problem. Or why not running QC in compliance with manufacturer’s recommendations is so bad — they can get a couple of extra patient tests if they don’t run QC. Or why tightly recapping the vial of test strips is necessary.
Certainly some tests are approved for the patient to run at home but if the patient tests incorrectly and harms themselves, it is not good but is not like the physician they trust for their care treating them from an incorrectly run in-office test.