At the end of March 2017, President Donald J. Trump signed an executive order to…
A major goal of keeping documents and records is to find information whenever you need it. Seems simple, right? But when you produce reams of information every day, it gets more difficult to keep track of it all. That’s why the management of documents and records – both use and maintenance – is one of the 12 quality system essentials.
WHAT DO YOU MEAN BY ‘DOCUMENTS’?
Documents communicate updated information, so they need to be edited when policies, processes or procedures change. They also establish formats for recording and reporting information produced when you perform those processes. Some examples of the documents you’ll maintain are the quality manual, standard operating procedures and job aids.
Documents provide written information about policies, processes and procedures for the organization. These three elements are the communicators of the quality system, so you need to understand how they relate to each other.
- Policies give broad and general direction, serving as the framework for the quality system. Policies tell us what to do and include statements of the organization’s mission, goals and purpose.
- Processes are the steps involved in carrying out policies, thus transforming inputs into outputs. Laboratory ‘inputs’ include test requests, samples and requests for information, while laboratory ‘outputs’ include data and reports of results. One process might be how to transform a test request (input) into a test result (output). The process explains how it happens and can be represented in a flow chart as a series of steps showing how events occur over time.
- Procedures explain how to do something, showing the step-by-step instructions that should be followed meticulously for each activity. The term Standard Operating Procedure (SOP) is often used to indicate these detailed instructions. SOPs may reference product inserts included with manufacturer’s instructions to help explain how to perform a test, but the SOP should further explain how to record results, outline the sequence of testing and define the safety practices to be followed specific to your organization. A job aid is a shortened version of an SOP and is designed to be used directly at the testing area (bench) as a reminder of the steps that need to be taken to complete a task. Job aids must include the same exact instructions as the corresponding, fully detailed SOP.
SO WHAT, THEN, ARE ‘RECORDS’?
Records are the collected information produced through performing and reporting a laboratory test. Records contain information that does not require updating, so it is permanent, and that needs to be easily retrieved or accessed. Some of the records you’ll maintain are completed forms, charts, sample logs, patient records, quality control information and patient reports.
Records are not to be revised or modified. They are used for many purposes, such as continuous monitoring through data collection, tracking samples for troubleshooting and error investigation and evaluating problems using equipment and maintenance records. Good records serve as an important and effective management tool.
Give special consideration to proper storage of records, as the main goal of keeping them is easily getting to the information whenever you need it. Whether you use a paper or electronic storage system, consider the following: permanence, accessibility, security, traceability and retention.
- In terms of permanence, your paper systems should have pages bound together in hard-cover books, include a log register and have all pages numbered in permanent ink. You need to have backup systems in place for your electronic systems in case the main system fails. That way you’ll avoid any loss of data.
- As far as accessibility is concerned, no matter what system you use, make sure all your records are easily and readily accessible whenever you need them.
- Security considerations for both paper and electronic systems must include maintaining patient confidentiality. Paper systems also need to address how records can be protected in the event of environmental hazards such as spills, fire or flood.
- Concerning traceability, you should be able to follow a specimen throughout the entire process in the laboratory. In the event questions or problems about any reported result arise, you should be able to view all reports and identify who collected the specimen, who ran the test and what the quality control results were for the test run.
- Retention should be determined based on government requirements and standards regulating the specific laboratory. Record retention times may come from the laboratory’s research affiliation, accreditations held and the time interval between assessments and audits.
MAINTENANCE OF INFORMATION IS A REFLECTION OF THE ORGANIZATION
In the laboratory, information is your product.
By managing a good document and record control program, you ensure availability and easy access to the most current version of your document whenever the need arises. Documents and records are essential for assuring accuracy and consistency in the laboratory, and documents are the reflection of the laboratory’s organization and its quality management.
A well-managed laboratory will always have a strong set of documents to guide its work.