Managing CLIA Related Documentation: Conformance with 42 CFR 493
Compliance with Regulation 42 CFR 493, more popularly known as CLIA (Clinical Laboratory Improvement Amendments) entails many requirements. From text complexity, to waived tests and from microscopy procedures to registration certificates, there is a plenty to manage and a lot to consider when complying with CLIA.
“Looming” Regulations
However, some CLIA requirements tower (at least metaphorically) above their sister requirements and present especially significant challenges for clinical laboratory professionals. Many clinical laboratories would agree that some of these “looming” requirements would be those associated with CLIA regulated documentation.
CLIA Regulated Documentation
One aspect of CLIA document compliance is that of document protection. Documents must, according to CLIA—and associated regulations--be protected in a variety of ways:
Document Protection: Record Information
The protection of documents requires more than a document lock down and clinical laboratories have to stay on their toes to stay ahead of CLIA. For example, the CLIA regulations do not spell out the actions a clinical laboratory has to take towards final compliance but does spell out what final end-goals must be achieved regardless of methodology. To meet CLIA compliance requirements for instance, laboratories need to “maintain…the confidentiality of record information and provide[] safeguards against loss, destruction or unauthorized use.”1 They can however meet these standards with the methodologies that seem best for their own unique businesses.
One business may meet these requirements with a lock, a key and a filing cabinet while another lab utilizes the latest software solution complete with digital vaults, automated audit trails, duel passwords, encryption and post-approval protection.
Document Protection: Document Syntax
CLIA related documentation also states that “Written policies and procedures govern the use and removal of records from the clinic or center and the conditions for release of information.”2
These written requirements may not be directly related to document protection standards but any experienced clinical laboratory professional can verify that clear policies and procedures can increase a lab’s ability to “protect” company documentation (at least from auditors, etc.)
Possible Implementation
To ensure that policies and procedures are clearly written and coincide with their respective quality system processes, clinical laboratories can choose from a variety of options. Two of these options include the following:
- Observe new employees during training and during their initial weeks “on the job.” Are the majority of these new employees understanding and complying with documented policies and with documented procedures? If not, it may be time to rewrite policies and procedures that are only resulting in confusion.
- Invest in a professional consultant. Whether a company’s system is manually operated or fully automated, the right consultation company may still be able to identify process redundancies, quality issues or overly extensive cycles for product release times. After careful consideration, companies that feel they could benefit from consultation should search for a consultant who can provide a redefinition of transaction and document requirements as well as data entry requirements, etc.
Document Protection: Signatures of Consent
According to CLIA, some documentation cannot be released to a patient without his or her written consent. This of course ensures that issues arising after 3 or 4 years can be tracked and cleared up (when necessary). Effective document tracking does of course depend on an employee’s ability to find a record quickly. For searching and retrieving documents quickly document control software is recommended over a manual solution.
Document Protection: Record Retention
According to CLIA documentation, “The records are retained for at least 6 years from date of last entry, and longer if required
by State statute.”3
For large amounts of documentation kept for significant amounts of time (like 6 years for instance) a filing cabinet approach is not recommended. Laboratories should look for a reasonably priced solution (i.e. a solution that will result in a significant ROI over a reasonable amount of time) with a high level of security.
Conclusion
Document compliance is at the heart of CLIA regulations but there are other prevalent issues as well. Training, change control management, customer complaints management and CAPA (Corrective and Preventive Action) procedures are essential for CLIA compliance as well. For this reason, it is important that clinical laboratory professionals look not only for a document control solution but for document, training, change control, complaints and CAPA solutions that can be launched from a single web-based platform.
1-3 http://edocket.access.gpo.gov/cfr_2004/octqtr/pdf/42cfr493.1.pdf
About the Author: Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to CLIA compliance consultation and CLIA compliant automated software, please feel free to contact a MasterControl representative.
More articles by mcrane@mastercontrol.com
Print Article | Download PDF | 62 views | Apr 18 2008
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