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