Document control systems are required by clinical laboratory accreditation programs, such as the program offered through the College of American Pathologists.1 Despite this, document control often is an underappreciated and underutilized component of a comprehensive quality management system in the clinical laboratory setting. Therefore, it is important to understand the intent of proper document control systems, as well as the benefits such systems can provide.
Clinical laboratories are driven by well-defined policies and standardized procedures, but without a clear and accessible method for documenting its activities, a laboratory cannot be confident that it is consistently producing high quality results. With a well-designed document control system, the laboratory can ensure it utilizes only validated and verified practices that have been shown to produce high quality outcomes.2
When discussing document and record keeping in the lab, it is easy to overlook the important distinctions that exist between terms used to describe various documents. Most commonly, laboratory documents consist of policies, processes, procedures, job aids, forms, and memos:
Governing these documents requires a master list. A document master list provides a means for the laboratory to track information about each document, including its unique identification number, name, version number, effective dates, author(s), reviewers, due date for next periodic review, and locations of any printed copies.
Documents Versus Records
These terms often are used interchangeably, but they are, in fact, distinctly different. Documents communicate information about how to perform an activity; they tend to be considered living, in that they must be updated and maintained. Examples of documents include policies, standard operating procedures (SOPs), process maps, job aids, and blank forms.
Conversely, records are permanent, static evidence of results achieved or activities performed.4 Perhaps the most important difference is that records cannot be changed. Examples of records include completed forms, proficiency testing results, competency assessments, validations, and verifications.4 Although regulatory attention is typically focused on document control or document management systems, management of records is equally important. Fortunately, document control systems can be utilized to manage records and can provide many of the same benefits to record management as they do for document management. Furthermore, records control is a requirement of ISO 151895—an international standard that details requirements for quality and competence in the clinical lab.
Document Control Systems
Whether researching a new system, or augmenting an existing one, a document control system should provide:
One of the most prominent benefits of a document control system, aside from regulatory compliance, is preventing outdated and/or obsolete documents from being accessed. In this way, all staff members access and follow the most current version of documents, which include the standardized, validated, or verified process sequences and instructions. Also, this facilitates more organized document retention practices, including easy identification of use and disposal dates for documents, in accordance with regulatory requirements.
By definition, a document control system is a computer-based program used to facilitate management and manipulation of multiple documents. Although it is possible to effectively control documents without an electronic or computerized software solution, this tends to be a viable option only for smaller laboratories that lack budget resources and an expansive library of documents. A number of benefits are associated with an electronic solution, including:
Document Control Tips
Assigning one or two point people, or document controllers, is crucial to maintaining consistency within a document control system. It also may be helpful, depending on the size of the laboratory, to train one person from each laboratory section to serve as a document controller in the event that the primary document controller cannot address an urgent request in a timely manner. In addition, the following tips will help create a robust, adaptable control and management system for all documents and records:
Given the depth and scope of today’s clinical laboratory operations, ever-tightening budgets, and the intolerability of error, electronic document management systems are more crucial than ever. With potentially hundreds of policies and procedures guiding daily operations, labs cannot afford to be unsure of how every activity is performed or unable to demonstrate the outcomes of those activities. Although the knowledge that the lab is running smoothly and appropriately under the purview of current regulatory standards should ease the anxiety of laboratory managers and directors, it is the extension of this—enhanced patient safety—that elucidates the full value of proper document and record control.
Jennifer Dawson, MHA, DLM(ASCP)CMSLS, QIHC, is the director of quality for Sonic Reference Laboratory in Austin, Texas. She is responsible for building and maintaining a robust, best practice quality management system from the ground up for a newly established esoteric reference laboratory. Jennifer’s areas of interest include ISO 15189 deployment, real-time quality metrics, costs of poor quality, electronic management of non-conformities, and quality in the pre-analytical phase. She also is interested in collaboration with other laboratory administrators on research projects and publications and has recently been named to the CLMA Board of Directors.