TOPIC 2: Documentation Management Flashcards
-Used to describe any policy, procedure, manual, log, file, report, record, etc. kept by the laboratory.
-“If it was not written, or documented, it did not happen.”
Allow you to easily review and track your laboratory’s activities.
Provide an audit trail for laboratory inspectors and surveyors to see if the requirements have been met.
Be useful when a problem arises.
Documentation
-Provide written information about policies, processes, and procedures.
-Tell staff what activities to perform, and how and when to perform them.
Examples: Quality Manual, Policy, Standard Operating Procedure, Job Aids.
Characteristics:
Need to be updated or maintained.
Must be changed when policies, processes, or procedures change.
Establish formats for recording and reporting information by the use of standardized forms.
Documents
-Provide evidence that the activities were performed.
-Collected information produced by the laboratory in the process of performing and reporting a laboratory test.
-Examples: Forms, Charts, Patient Records, Patient Reports, Quality Control Information.
Characteristics:
Need to be easily retrieved or accessed.
Contain information that is permanent, and does not require updating.
Records
A documented statement of overall intentions and direction defined by those in the organization and endorsed by management. It tells “What to do.”
Policies
Steps involved in carrying out quality policies. It shows “How it happens.”
Processes:
Specific activities of a process. It explains “How to do it.” Often detailed in Standard Operating Procedures (SOPs).
Procedures
Simplified SOPs for point-of-use reference, supplementing full SOPs.
Job Aids
-An instructional document that provides explanations and step-by-step instructions on how to perform a task, test, or process.
-May include laboratory policies or be kept as a separate policy manual.
-Vital to laboratory processes.
Procedural Manual
Why are Documents Important?
-Documents are the communicators of the quality system.
-All policies, processes, and procedures must be written, so that everyone knows the proper procedures and can carry them out.
-Reflect the laboratory’s organization and its quality management.
-A well-managed laboratory will always have a strong set of documents to guide its work.
What Makes a Good Document?
-Written clearly and concisely, avoiding wordy, unnecessary explanations.
-Written in a user-friendly style, using a standard outline for familiar structure.
-Written explicitly and accurately, reflecting all implemented measures, responsibilities, and programs.
-Maintained to ensure that it is always up to date.
-The documents needed in the work process must be accessible to all staff.
-Persons managing samples should have the procedures for sample management directly available to them.
Accessibility
-Essential for optimal instrument performance.
-Equipment must be maintained for longer use.
-Includes a place to document instrument function checks, preventative maintenance, and any other required monitoring.
Equipment Maintenance
-The process of adjusting an instrument to ensure accurate measurements by comparing it to known standards.
-The manufacturer determines the number, type, and concentration of calibrators to be used.
Calibration
-Confirms that the calibration setting continues to allow test results to be accurate throughout the reportable range of the test system.
-Must be performed according to the manufacturer’s instructions at least once every six months or more often if required by your laboratory’s procedures.
Calibration Verification
Calibration verification is done when
-There is a new lot number of reagents.
-A complete change of reagents occurs.
-Instrument service affects critical parts.
-Used to troubleshoot unacceptable quality control or proficiency testing results.
