White Paper: Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

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2Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

“Compliance” is a key process for life science, high-tech companies and for public business. Life science companies specifically must answer to the FDA’s compliance regulations as well as to other regulatory bodies’ standards and regulations specific to their geographical region. For instance, clinical testing laboratories that wish to perform testing within the United States must comply with the Clinical Laboratory Improvement Act (CLIA) requirements which help improve the accuracy, safety, and efficacy of testing processes within clinical laboratory environments.

How Expensive is Compliance?Complying with CLIA and/or GCP regulations costs clinical laboratories a “pretty penny” and every cent is allegedly worth the trouble. However, it isn’t uncommon for the expenditures appropriated in the name of compliance to be unnecessarily extravagant.

Listed below are six common problems that clinical testing laboratories should avoid (for their pocketbook’s sake) when seeking compliance with CLIA regulations.

Mistake #1: Spending Too Much on Documentation Management CostsCLIA Section 493.1200 specifies that documentation of quality procedures/policies must be actualized and that systemic laboratory compliance processes must reflect a laboratory’s documentation.

Most clinical testing laboratories manage documentation well enough but often spend far more time than is necessary to do so. For example, a lab worker may, according to policy, be required to document five phases of a specified test and give the information to his or her supervisor. The supervisor however will likely be out of the office for much of the work day and his or her absence will inevitably create a delay in the routing of essential documentation. The problem with this touch-and-go method of document management/routing is that it is common for documentation to be left incomplete, to become lost or to become unnecessarily delayed. The utilization of hybrid electronic systems that consist of an e-mail client and a word processing application also commonly result in incomplete, lost or delayed documentation. In addition, the manual archival and retrieval of documents into filing cabinets or desktop computers cost laboratories wasted man hours and--worst of all--manual routing practices often result in lost or out-of-date documentation that can lead to serious errors in clinical laboratory practice.

The SolutionTo control documentation with more cost effective means, clinical testing laboratories need only invest in an automated web-based document control solution. Looking for solutions that provide the following features and benefits is recommended for CLIA-regulated laboratories:

Tracking• - When a web-based document control solution tracks documents from start to finish its easy to collaborate with co-workers and associates without becoming confused regarding the most recent versions of a document. Tracking features can also provide a readable audit trail which makes saving time and money a reality.

InfoCard• - When a web-based document control solution provides associated meta-data with every document version and every organizer (i.e. folder) it’s easy to locate and retrieve documents and files (based on the meta-data) from virtually any location. This feature makes finding documents simple which saves time and money for clinical laboratories.

Automatic Routing• - The automatic routing of any type of document assures users that the appropriate notices or reminders will reach those users who have been pre-assigned to certain routing pathways.

Escalations• - Automated escalation notices are especially valuable since it saves companies valuable time that employees might have originally spent manually tracking the status of important tasks that need to be but have not been completed.

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3Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

Approval• - Electronic approval saves managers and other professionals with “sign-off” or approval responsibilities the time (and money) that would have been spent searching for paperwork, manually routing the document to QA or searching for those employees who have not completed their assigned tasks during documentation processes.

A web-based document control system can save laboratories large amounts of valuable company funds.

Mistake #2: Spending Too Much on Training CostsUnder CLIA Section 493.1445, every director of a clinical testing laboratory must make sure that procedures/policies are documented to monitor employees’ performance. The policies and procedures must also determine methods for identifying needs for continued employee training and/or education.

Most clinical testing laboratories train their employees well enough to “get by” but many clinical laboratories would like to provide more/better training; employees would also appreciate additional training on processes in which they play an active part. Keeping up with a good training curriculum however can be difficult. For example, imagine that a laboratory has 70 employees and each employee must receive initial training, subsequent training every 6 months and additional training for performing new clinical tests. For training managers, scheduling training times, keeping track of chaging documentation (e.g., SOPs, work instructions, quality manuals, etc.) as well as those who do or don’t attend training and keeping track of those who pass related examinations is a gargantuan task that often costs more than laboratories would prefer.

SolutionTo avoid the training “money pit,” clinical laboratories need to invest in an automated, web-based training solution. A web-based training solution with the following features and benefits:

Centralized Repository• - A central and protected location for all training materials secures training related information and makes training materials easy to find.

Connected to the Document Management System• - The training software solution should be connected to the document control/management system. This is valuable when documents such as SOPs, work instructions or quality manuals are changed/updated and employees need to be automatically apprised of those changes as well as taught and tested in regard to those changes.

Automated Routing• - Since dozens (if not hundreds) of people are generally involved in any given training process, automated routing that is tracked (in case subsequent escalations are required) will save training supervisors a myriad of additional time for more important matters.

Automated Delivery • - Automatic delivery of training tasks and training schedules ensures that upper management and training personnel can quickly “spread the word” regarding upcoming trainings and be assured that each employee’s training record will be tracked to ensure accountability.

Grading of Exams• - A solution that can implement the technology that will automatically administer and grade exams online is very valuable for those clinical laboratories that don’t want to spend valuable time on grading that may be an ongoing task for many training personnel.

Audit Trail and Proof of Competency• - An audit trail of passed or failed exams/assignments is extremely valuable not only for audit preparation but for everyday business process management.

Connections• - One of the most valuable features a web-based training solution can have is configurable connections with other quality related web-based solutions. For example, web-based solutions that control CAPAs or change control procedures should be capable of triggering training tasks.

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4Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

A web-based training solution that automates scheduling and training tasks, maintains an electronic audit trail, administers/grades exams, and receives automatic triggers from information derived from deviations, nonconformance, CAPA or change control solutions can save a clinical laboratory thousands (if not hundreds of thousands) of dollars.

Mistake #3: Spending Too Much on Customer Complaints ManagementCustomer complaints can often reveal the path to real laboratory improvement. One of the CLIA regulatory clauses (CLIA Section 493.1233) for example, is designed to make customer complaints easier to find, sort through and act on. However, it isn’t uncommon to find that customer complaints management within clinical testing laboratories is often more expensive and less effective than it could be. For example, customer complaints may be gathered from telephones, over the Internet, via mail or by other means. Once the complaints are manually recorded or copied (this step takes too much time when performed manually or even electronically transferred from one system to another) they can then be manually entered into a computer system. Even if the computer system does work efficiently, it will not automate the trigger of CAPA investigations or change control orders---processes which can easily be handled by the right web-based customer complaints handling solution. SolutionTo streamline customer complaints management, employees that work in a CLIA-regulated clinical testing environment need a web-based customer complaints handling solution that can be configured with additional quality related solutions:

A Centralized System• - A customer complaints solution needs to provide a system where all customer complaints can be effectively stored and easily retrieved via simple search functions.

Meta-Data • - Each customer complaints form should be tied electronically to respective meta-data that will make the customer complaints forms easy to locate and retrieve.

Controlled Records and Reporting• - To meet CLIA regulations and to quickly respond to legal concerns a web-based customer complaints handling solution, with automated record keeping and reporting features, is exactly the solution that many clinical laboratories need to save valuable revenue.

Connected• - The customer complaints handling solution that can be connected to additional quality solutions (i.e. CAPA, audit, change control) and to additional computerized systems are especially valuable to clinical laboratories regulated by CLIA.

A web-based customer complaints handling system can save CLIA-regulated clinical laboratories additional revenue and help generate additional revenue by quickly triggering CAPA investigations and positive change within laboratory environments.

Mistake #4: Spending Too Much on Audit ExpendituresEffective audit processes, as valuable as they may be, don’t always result in reasonable expenditures. Audits are often performed at tediously slow speeds because clinical lab audit trials are often disjointed, and employees end up searching for missing documentation or forms to complete the trail that could have been tracked and reported electronically.

SolutionFor clinical laboratory professionals, less costly audits can be obtained with a web-based audit control solution that streamlines audit trails and triggers appropriate actions. CLIA-regulated clinical laboratories and those laboratories regulated by the FDA’s GCP standards should look for the following features and benefits in an audit solution:

Tracking• - Every step and every form or document related to audit procedures should be tracked and archived in one location by a web-based audit control solution. This feature saves employees time and plenty of headaches while making it easier to generate revenue on more predictable timetables.

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5Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

Automated Scheduling• - Audit schedules can be easy to set aside or disregard. A valuable audit control solution should include automated scheduling features that allow internal and external audit schedules and tasks to be planned in advance and automatically routed to the appropriate personnel.

Automated Tasks, Follow-Ups and Escalations• - Clinical laboratories can increase employee accountability with a web-based audit control solution that automates tasks, follow-ups and escalations. More responsible actions from employees generally equates to more effective use of company capital.

Online Charting• - A web-based audit control solution that provides analytics and reporting features that include online charting are monetarily valuable as they help to more effectively streamline necessary audit requirements with subsequent quality action.

Audit Management• - a solution that manages and automates audit scheduling, routing, planning and data is valuable for any company especially those companies with large auditing teams.

Mistake #5: Spending Too Much on Change Control CostsCLIA Section 493.1251 mandates another regulation for laboratory directors. The director of a clinical laboratory for instance must date and sign/approve changes that may be underway. This regulation ensures that changes are 1) being viewed by the laboratory director and 2) moved from an inert stage to a stage of action. For change control procedures, speed is of the utmost importance since a change that goes untouched is a change that will result in more expenditure and less productivity.

SolutionFor clinical testing laboratories that want to adhere to CLIA regulations and simultaneously spend less, investing in a web-based change control solution helps companies save time and save the high costs associated with the remedial procedures for faulty products. CLIA regulated clinical laboratories should search for the web-based change control solution that contains the following features and benefits:

Web-based• - When a change control solution is web-based anyone from virtually anywhere (even 3rd parties) can participate in a laboratory’s change control process when approved by system administrators to do so.

Best Practice Forms• - When it comes to change control procedures, priority levels must be considered. With electronic change control best practice forms, form fields contain appurtenant change control information and fields for assessing priority levels. These priority levels, once assigned, can be used to determine how quickly resolutions should be accomplished and whether or not training tasks should be triggered.

Connected• - A change control solution that can trigger appropriate training tasks automatically will be especially valuable to the CLIA regulated clinical laboratory.

Mistake #6: Spending Too Much on CAPA Management CostsA CAPA investigation can be the result of customer complaints, 483 forms, audits, etc. CLIA Section 493.1282 requires that clinical testing professionals create and implement the documentation that will manage an effective CAPA process. Many clinical testing facilities do create documented rules for CAPA procedures but often spend heaps of revenue trying to maintain processes that should reflect company documentation. For example, clinical testing employees commonly spend time manually collecting information from data gathering processes (customer complaints, deviations, audits, etc.), routing documentation from one person and one department to another and waiting for CAPA forms to be approved when changes should already be initiated when appropriate. A CAPA process that doesn’t function quickly costs a clinical laboratory large amounts of revenue by failing to speed products to delivery or by failing to make products more efficient.

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6Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory Should Avoid

SolutionOnce again, the solution for less costly CAPA management is to invest in electronic management. If customer complaints, audits and 483 forms were managed electronically, the information contained in their respective forms could be automatically configured (depending on preferred rules) to trigger a web-based CAPA investigation solution. Like other web-based solutions a CAPA solution should provide automation, connection, analytics and reporting features. About MasterControl Inc.MasterControl, a global provider of GxP, document control and compliance software solutions since 1993, proffers a wide range of products designed especially for life science and high-tech companies.

To access additional white papers or information regarding electronic solutions for regulatory and quality related processes, please contact a MasterControl representative by email or by phone (800) 825-9117. Related Videos

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