Is your waived lab compliant? Try these four tips
By Harry Grandinett
Does your clinical laboratory meet the terms of its waiver certificate? You might be surprised to learn that procedures you think are waived are actually not covered, placing your lab out of compliance-and your practice at risk.
By law, laboratories that are granted a certificate of waiver are permitted to perform only waived tests. These are typically procedures that the FDA or CDC considers so simple that there is little risk of error.
Recent inspections of physician labs, however, have shown that many physician facilities are performing tests that put them out of compliance. In surveys by the Centers for Medicare and Medicaid Services (CMS), formerly HCFA, more than half of the physician labs performed tests beyond the scope of their waiver certificate, failed to follow manufacturers' instructions for test kits and failed to use or document quality control measures.
Because of these problems, analysts worry that the government is going to continue to inspect physician labs. The fear is that if the surveys continue to find that these labs are operating out of compliance, the government may draft new rules tightening control of the waiver process.
To help keep the government from creating any further regulations for physician labs with waivers, the College's Medical Laboratory Evaluation (MLE) program staff urges internists to make sure their labs are fully compliant. The following four steps can help you ensure that your lab complies with federal regulations-and help keep stiffer new regulations from being enacted in the future:
Don't exceed your waiver. One of the keys to complying with the terms of your waiver certificate is to avoid performing moderate- or high-complexity tests. Even if you have the instrumentation and technology to do more complex tests, it is illegal to perform tests that are beyond your laboratory's designated level of complexity.
When CMS conducted pilot surveys of waived labs, it cited noncompliance with this regulation as the No. 1 deficiency. A big part of the problem is that many physician labs simply don't understand what tests their waiver allows them to perform. Many of the labs that were surveyed believed that some of the non-waived tests they performed were waived and continued to perform them even when they knew inspectors would visit.
A good example of the mistake made by many practices can be found in testing for human chorionic gonadatropin (hCG), the hormone released during pregnancy. While it is possible to use basic test kits to detect hCG levels in either urine or serum, waived labs are not allowed to test for the presence of hCG in serum because the procedure has not been waived.
Recent growth in the number of waived tests and the methods to conduct these tests has only contributed to physician confusion about waivers. The number and types of tests waived under the Clinical Laboratory Improvement Amendments (CLIA) has increased from eight tests in 1992 to more than 50 today. In addition, there are now more than 700 methods to perform those waived tests.
How can you be sure that you're complying with your waiver? First check that the CDC or FDA has waived the kit your practice is using to perform a test. You should also be certain that the procedure you are following-or the manner in which you are using the kit-is also waived.
Rather than rely solely on manufacturer statements that a kit or procedure is waived, your practice should also check the CLIA regulations list to be sure you are in compliance. For more information, see the CLIA Web site. You can find specific information about waived tests online.
Document lab procedures. When documenting your lab procedures, be sure to focus on areas like quality control, quality assurance, specimen testing, specimen reporting, proficiency testing and procedure manuals.
Keep in mind that documentation does not have to be a daunting task. The College's MLE program offers easy-to-use templates to help you and your office staff compile these important document files.
(For information about the ACP-ASIM MLE program, contact the College's Washington office at 800-338-2746. College members receive a discount on all MLE services.)
Create a procedure manual. While waived facilities are not required to keep a procedure manual, it is helpful to create a single resource book where employees can find technical assistance, procedure clarification, patient policies and specimen- handling procedures.
You can create the test procedure section of your manual by simply placing manufacturers' package insert instructions in a clear page protector and storing them in a three-ring binder.
Package inserts must correspond to the tests and testing procedures your laboratory uses. When you receive a new kit, discard old package inserts and replace them with the new information from the manufacturer. Place package insert information where your testing personnel can easily access it, such as on the workbench where they perform tests. Also make sure that laboratory staff read all package inserts. Otherwise, they can make a mistake and use reagents from one test kit with similar kits from the same manufacturer.
Keep a physician's review page in the procedure manual to document the medical director's oversight of the lab. The medical director should periodically review the procedure manual to make sure it is up to date. The medical director should also sign and date a page in the manual to verify that it is regularly reviewed.
Test the proficiency of your lab. Waiver certificates do not release you or your employees from ensuring the accuracy of your laboratory results. While you might be performing basic waived tests, mistakes can be made that affect patient care.
Flawed results used to diagnose an illness, for instance, can lead to inappropriate medical care with possibly catastrophic complications. A cholesterol test that erroneously indicates a normal reading for a patient with high cholesterol, for example, may preclude that patient from receiving treatment to prevent a heart attack.
There is no better way to ensure the accuracy of your laboratory than to participate in a proficiency testing program. A testing program can pinpoint your lab's strengths and weaknesses in areas such as equipment maintenance, compliance with manufacturers' requirements and use of controls. Perhaps even more importantly, it tells inspectors that your lab is working to meet standards of quality, reliability and reproducibility beyond the minimum standards required by law.
The College's MLE program provides a proficiency testing service that is recognized by CMS and accrediting bodies.
Harry Grandinett is the Supervisor of Marketing and Customer Service for the Medical Laboratory Evaluation program.
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