The Basics of CLIA Compliance: Automated System Requirements
Marci L. Crane
May 10, 2008
Some clinical laboratories get too caught up with CLIA (Clinical Laboratory Improvement Amendments) compliance and other laboratories neglect even the most general CLIA standards.
Both types of laboratories could benefit from standardized automation solutions.
Automated Administration
Let´s face it. Most CLIA regulations require the performance of iterate administrative tasks, and for most humans, iterate administrative tasks are a pain in the neck.
It´s no wonder that professionals working in a $30 billion per annum industry either do too much or get frustrated enough to do too little. The good news however is that administrative tasks today can generally be automated. In the case of CLIA administration for example, there are solutions that can literally take the grand majority of CLIA administrative tasks and manage them with ease. This of course leaves more time for clinical laboratory professionals to practice their profession.
What Clinical Lab Professionals Should Look For
Automated solutions should 1) be able to meet all CLIA related administrative requirements (to a reasonable degree) and 2) should be able to provide a healthy ROI.
This article recommends a system that will provide solutions for document control, change control, training, customer complaints management, CAPA (Corrective and Preventative Action) and a solution for managing audit information and documentation.
Clinical laboratories may have noticed already that each of these solutions is carefully selected to meet exact CLIA requirements.
Take for example the following:
CLIA Requirement for Document Control
CLIA section 493.1200 requires written policies, written procedures and the maintenance of these documents. The documents--according to CLIA requirements--should clearly detail the implementation and continued monitoring of laboratory quality systems (for testing processes) as well as generalized laboratory systems. With all that responsibility and all of that documentation it´s easy to understand why an automated document control system that can maintain, track and route hundreds and thousands of documents would certainly be an asset to reckon with.
CLIA Requirement for Change Control
Change control in the clinical laboratory environment is heavily dependent on documentation, the clear transfer of information and on those experts assigned to change control management, change control approvals, etc. A change control solution that would manage change control forms, maintain the organization of change control issues, automatically route change control assignments to prescribed managers, send out automated reminders of change control issues and allow the laboratory director to date, approve and sign procedural changes electronically (in accordance with 21 CFR Part 11) would make clinical laboratory change control processes far easier to maintain and analyze.
CLIA Requirement for Training
CLIA section 493.1445 requires laboratory directors to identify their employees´ needs for training and education. Many of the administrative tasks associated with training include the following:
A software solution that allows training managers to track which employees have been trained and which employees have passed training examinations is a solid benefit for any clinical laboratory.
CLIA Requirement for CAPA Procedures
CLIA section 493.1282 requires that procedures and policies written for CAPAs should be followed. For clinical laboratory professionals, following CAPA procedures "to the letter" can be relatively difficult since CAPA procedures can become extensive, taking long periods of time to complete and often involving significant amounts of documentation and the participation of various personnel members. A solution that would manage CAPA information and route the appropriate CAPA assignments to the appropriate personnel is extremely valuable within the clinical laboratory environment.
Conclusion
A CLIA compliance management system should also include solutions for customer complaints management and audit control. To find such a system, companies should contact colleagues with automated solutions to learn whether they find their systems valuable or not. Then, a search via a favorite search engine may also return valuable software suggestions.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to streamlined CLIA compliance with automated solutions, please feel free to contact a MasterControl representative.
Both types of laboratories could benefit from standardized automation solutions.
Automated Administration
Let´s face it. Most CLIA regulations require the performance of iterate administrative tasks, and for most humans, iterate administrative tasks are a pain in the neck.
It´s no wonder that professionals working in a $30 billion per annum industry either do too much or get frustrated enough to do too little. The good news however is that administrative tasks today can generally be automated. In the case of CLIA administration for example, there are solutions that can literally take the grand majority of CLIA administrative tasks and manage them with ease. This of course leaves more time for clinical laboratory professionals to practice their profession.
What Clinical Lab Professionals Should Look For
Automated solutions should 1) be able to meet all CLIA related administrative requirements (to a reasonable degree) and 2) should be able to provide a healthy ROI.
This article recommends a system that will provide solutions for document control, change control, training, customer complaints management, CAPA (Corrective and Preventative Action) and a solution for managing audit information and documentation.
Clinical laboratories may have noticed already that each of these solutions is carefully selected to meet exact CLIA requirements.
Take for example the following:
CLIA Requirement for Document Control
CLIA section 493.1200 requires written policies, written procedures and the maintenance of these documents. The documents--according to CLIA requirements--should clearly detail the implementation and continued monitoring of laboratory quality systems (for testing processes) as well as generalized laboratory systems. With all that responsibility and all of that documentation it´s easy to understand why an automated document control system that can maintain, track and route hundreds and thousands of documents would certainly be an asset to reckon with.
CLIA Requirement for Change Control
Change control in the clinical laboratory environment is heavily dependent on documentation, the clear transfer of information and on those experts assigned to change control management, change control approvals, etc. A change control solution that would manage change control forms, maintain the organization of change control issues, automatically route change control assignments to prescribed managers, send out automated reminders of change control issues and allow the laboratory director to date, approve and sign procedural changes electronically (in accordance with 21 CFR Part 11) would make clinical laboratory change control processes far easier to maintain and analyze.
CLIA Requirement for Training
CLIA section 493.1445 requires laboratory directors to identify their employees´ needs for training and education. Many of the administrative tasks associated with training include the following:
- Tracking who has been trained and who has not (often for multiple types of training)
- Ensuring that the training has been understood and comprehended
- Following up on remedial training and additional training that could be required
A software solution that allows training managers to track which employees have been trained and which employees have passed training examinations is a solid benefit for any clinical laboratory.
CLIA Requirement for CAPA Procedures
CLIA section 493.1282 requires that procedures and policies written for CAPAs should be followed. For clinical laboratory professionals, following CAPA procedures "to the letter" can be relatively difficult since CAPA procedures can become extensive, taking long periods of time to complete and often involving significant amounts of documentation and the participation of various personnel members. A solution that would manage CAPA information and route the appropriate CAPA assignments to the appropriate personnel is extremely valuable within the clinical laboratory environment.
Conclusion
A CLIA compliance management system should also include solutions for customer complaints management and audit control. To find such a system, companies should contact colleagues with automated solutions to learn whether they find their systems valuable or not. Then, a search via a favorite search engine may also return valuable software suggestions.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to streamlined CLIA compliance with automated solutions, please feel free to contact a MasterControl representative.
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