Quality System Software for Laboratories

By: Marci Lynn Crane

A clinical quality system under the Clinical Laboratory Improvement Amendments (CLIA) relies heavily on the influence of laboratory directors. In fact, laboratory directors are ultimately and personally responsible for many aspects of a clinical laboratory's quality system. This article offers tips for clinical laboratory directors and their respective quality systems:

Tip #1: Continued CLIA Education
A clinical director has primary and at times absolute responsibility for quality systems associated with moderately complex, highly complex or moderately and highly complex laboratory environments. He or she also has primary responsibility for gaining and maintaining continued compliance with CLIA regulations which often acts as a mold for clinical laboratory quality systems. To ensure that a clinical laboratory quality system remains compliant with the "CLIA mold" laboratory directors should remain thoroughly educated regarding CLIA regulations. Related courses are available for both types of directors and should be taken from time to time for educative purposes.

Refer to the Centers for Medicare & Medicaid Services' website for more information.

Tip #2: Take Employee Training Seriously
Under the http://mastercontrol.com/regulations/clia.html"">CLIA regulations, documentation (i.e. policies and procedures) outlining written monitoring methods for determining employee competency and events or situations which may require further training and education is the responsibility of a clinical laboratory director. Training, though often complex, (especially in an environment with continuous needs for continued education) should be thoroughly documented and reviewed for information that could prevent inappropriate handling of laboratory testing. Although, careful and continuous training may mean more money upfront, in the long run, additional training pays off.

Web-based training solutions are also valuable tools as they electronically streamline the training process, make training reports and escalations easy to automate. A web-based training solution may potentially be integrated with other quality related solutions such as document control, deviations identification, change control and CAPA software options.

Tip #3: Take Customer Complaints Management Seriously
For a clinical laboratory quality system, customer complaints can provide a foundation for powerful change. In fact, CLIA regulations mandate that all customer complaints received by a clinical laboratory must be systematically recorded and effectively addressed when necessary. For clinical laboratory directors integrated software solutions can help to streamline and effectively automated the customer complaints process. For instance, a certain type of customer complaint iterated repeatedly may result in a CAPA investigation, which in turn becomes a change control order which in turn results in a series of training tasks. Laboratory directors should look for document control, customer complaints management, CAPA, change control and training solutions that can be easily implemented and integrated for best quality system results. Such a system can save laboratory directors and employees hundreds (if not thousands) of annual hours.

Tip #4: Delegate Applicable Responsibilities
Under CLIA regulations, clinical laboratory directors must accept responsibility for a variety of directive tasks associated with the management of a clinical laboratory quality system. However, some responsibilities may be delegated from time to time and should be delegated to ease the directive load. Some of the tasks that may be delegated to a clinical consultant should be written prior to delegation and are listed as follows:

&bullPerformance of tests, AND
&bullInterpretation of test results

Delegation may also result in tasks assigned to a technical supervisor (over high complexity duties) or a technical consultant (over moderate complexity duties) consultant. Some of these tasks are listed as follows:

&bullSelection of Methodology for Testing
&bullLaboratory Enrollment in a PT (proficiency testing) program that is approved by the CMS, AND
&bullOther duties associated with PT assignments, samples or results

Tip #5: Consider a Coordinated Quality System
Many laboratory directors consider their quality systems to be coordinated but there are often extensive gaps during the transfer of information from one quality procedure to another (i.e. from customer complaints to a CAPA investigation) and laboratory documentation when controlled manually (i.e. paper-based) often results in lost, delayed, incomplete or difficult-to-find laboratory documentation slowing the entire quality system. Laboratory directors should consider automating document control and quality related processes for increased coordination and connection between quality processes, as well as decreased delays for product-to-market and testing operations.

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