Clia Compliance Streamlining Software : Science & Lab Software

By: Marci Lynn Crane

The public eye is on the medical industry as well as big business. Gone are the days of deregulated science, business and technology. Today and tomorrow are days for regulation.

Welcome to Big Brother land, right?

Actually, regulation isn't exactly what it is often perceived to be.

The Problem with Regulation
The problem with regulation isn't necessarily regulation itself. The problem with regulation is how it may be viewed by science, business and high-tech professionals. For example, consider the clinical testing industry. Any diagnostically focused clinical tester or testing agency is considered to be a laboratory entity, and any clinical testing laboratory must (at the very least) register with the CLIA organization and (at the very most) comply with strict standards of safety, data gathering, test verification, equipment calibration, quality control, customer complaints management, personnel certification, quality assessment and record retention.

These regulations and standards, though seemingly restrictive, are actually calls-to-action for laboratory professionals to find the technology that will streamline CLIA while they calmly return to the jobs they REALLY want to focus us.

Search for Technology that Streamlines CLIA Compliance
Technology that streamlines a laboratory's CLIA procedures doesn't have to be complex-just smart. For example, when considering CLIA streamlining technologies the only salient questions that professionals need to ask are will the solution do what a CLIA regulated lab needs and (if the answer is affirmative), where can it be purchased?

This article will provide the information that CLIA regulated laboratory professionals need to answer the first question and indirectly-the second.

Will the solution do what it is supposed to?
Clinical laboratories want to get a quick return on revenue invested in technology. Laboratories haven't always succeeded in this endeavor since so many technological solutions are faulty or overly complex. This of course might explain why many CLIA laboratories are still utilizing quality systems that are paper or hybrid based. Since paper and hybrid solutions are sorely tedious however, and result in more errors than a laboratory should even think about committing, technology has to be the answer, but the question still remains---what kind of technology? AND, will the solution do what it is supposed to?

The Solution will Correspond with the Regulation
A CLIA solution should simply respond to the regulations specified by the CLIA documentation. For example since CLIA requires that quality system processes be documented and complied with, and that all customer complaints solutions be documented and responded to when necessary, a software solution should provide both http://members.ezinearticles.com/submit.php"">document control and a solution for the handling of customer complaints. Since CLIA also requires that documentation be created for the determination of employee needs for training, a training solution that can be triggered by changed documentation, deviations, nonconformance, audit, or customer complaints data would also be valuable. A change control solution that can be triggered by deviations, nonconformance or audit data can also be valuable since CLIA requires a lab director to directly approve procedural changes. The change control solution should also be able to trigger the training solution. CLIA regulations also specify that CAPA processes should be documented and followed when appropriate. The CLIA technology should include a CAPA solution that streamlines CAPA investigations and triggers audits, change control orders, etc.

Conclusion
Overall, the CLIA solution should be flexible to change and should meet other user requirements specified by individual enterprises. The solution should also be able to manifest a history of continued development and improvement. If they can't, then laboratory professionals would do well to sign-off and continue their search elsewhere.

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