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