Support for Automated CLIA Law Management within Clinical Testing Laboratory Environments

At first glance, the CLIA (Clinical Laboratory Improvement Amendments) regulations, like most governmental mandate documents, may provide a less-than-healthy dose of intimidation. However, it would seem safe to assume that most clinical laboratory directors are often aware that at least essentially, the CLIA regulations are actually quite simple. So what’s the problem with CLIA regulations? Why don’t all clinical laboratories comply? The answer lies in the concept of tedium.

Tedium over Time

Humans despise boredom. To illustrate this "assumption" I will share an experience I had one summer. I was young (about 20) and I was visiting a lake in northern Guatemala with my parents. We were riding about the lake one bright day in a boat and I observed various native Guatemalan Indian women as they washed their clothes in the lake. I pondered on the amount of time required for their task. Literally hours must be spent each week carrying, scrubbing, wringing, hanging, gathering and folding their clothing. I realize, of course, that perhaps they don’t become bored by this task but there are other women-women accustomed to automated processes (e.g. washing machines)---that would high-handedly asseverate that they would never return to "those days"! Why would they say this? Perhaps it is because they know the pleasure of time for the most essential goals vs. the tedium of those iterate processes that take away from those goals.

A Metaphor Unfolds

Imagine for a moment that washing machines and dryers are less expensive than ever and can be purchased by at least 75% of Guatemalan Indian women. Now, imagine that most of these women consider their most essential goals to be 1) to spend more time with family members and 2) to spend more time in school. The obvious conclusion would then be that it would be absolutely unthinkable for these women to continue the iterate process of washing clothing since they are 1) capable of purchasing the washing machine and 2) since time for washing clothes by hand does not fall in line with their essential goals. However, as the reader might have already guessed, many women will continue to washing their clothes in the river for no particular reasons save the inevitable favorite "reason" of simply becoming accustomed to a familiar processes of accomplishment.

Applications for the Clinical Laboratory

Laboratory professionals at times mirror the actions of the hypothetical Guatemalan women. For them quality control and documentation tasks associated with CLIA regulations have become as familiar as a well worn door knob. The fact is however that affordable technology exists for automating CLIA related documentation and quality control processes. This capacity for automation can save laboratories hundreds (perhaps thousands) of additional hours for the accomplishment of goals that are most important to laboratory professionals. The automation technology will also assist laboratory professionals in automating many processes associated with CLIA regulations.

How to Choose the Right Technology

There are a variety of software solutions available to clinical laboratory professionals. When searching for a solution that is right for a particular laboratory user requirements should be the first determiner for the solution and of course meeting specific CLIA regulations holds a close second.

To meet CLIA regulations, laboratory professionals should search for a software solution that provides the following controls:

Document Control

Since CLIA section 493.1200 requires that clinical laboratories maintain documented policies that dictate quality procedures, it is important to find a software solution that controls documentation. Recommended features include web-based capabilities since laboratory professionals can access the solution from virtually anywhere and at virtually any time electronic control since documents not longer need to be routed, approved or archived manually.

Training Control

CLIA section 493.1445 requires that the director of a clinical laboratory ensure that all employees responsible for testing are sufficiently trained to do so.

Look for a training solution that streamlines tasks, meeting schedules, escalations, exams, etc. Also, look for a solution that tracks training forms and documentation from start to finish. This feature comes in handy during internal or external audits. In addition, a training solution that is integrated with a document control system will provide great benefits with less maintenance.

Additional CLIA Clauses and Respective Solutions

Additional CLIA clauses and possible software solutions are listed as follows:

• CLIA Section 493.1251 – An Automated Change Control Solution
• CLIA Section 493.1282 – An Automated CAPA Control Solution
• CLIA Section 493.1233 – An Automated Customer Complaints Control Solution
• CLIA Section 493.1239 – An Automated Audit Control Solution

Integration

When looking for the right solution it is best to search for the solution that can be integrated with others. For instance, the solution that integrates document control, change control, CAPA, training, customer complaints management and audit control would be ideal solution for many clinical laboratories.

Conclusion

CLIA management and CLIA compliance tasks, once they are streamlined, can be as simple as washing clothes. Why not invest in the technology that can help streamline and automate those processes?

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to CLIA regulations and the software solutions that can help clinical testing laboratories manage them, please feel free to contact a MasterControl representative.