CAP Pro Course - Laboratory Management - Document Control

Continuing Education Credits

• P.A.C.E.® Contact Hours: 1 hour(s)
• Florida Board of Clinical Laboratory Science CE Credit Hours -
  Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)

Objectives

• Define document control to include specific documents for inclusion in a document control system.
• Describe specific stages of the document development and retention.
• Differentiate controlled and uncontrolled documents.
• Explain required steps and best practices for revision and implementation of documents that are under document control.
• Explain the requirements for maintenance and document archiving and retirement of documents.

Course Outline

• Define document control to include specific documents for inclusion in a document control system.
• Purpose and Structure of a Document Control System
• Types of Documents Under Document Control
• Job Aids
• A new employee has posted a job aid with basic steps for properly performing a required flush on an instrument. Which of the following is a true state...
• A new laboratory manager is reviewing the document control system for familiarity. Following this review, the laboratory manager performed a purge of ...
• The laboratory manager is providing justification for adopting a document management system. She is preparing a presentation for the board of director...
• In preparation for a regulatory team visit, the lead technologist removed all retired versions of printed job aids that were posted in the laboratory....
• Describe specific stages of the document development and retention.
• Document Control Cycle
• Formatting and Classification of Laboratory Generated Documents
• Master Control Document
• Backups of Electronic Document Control Systems
• A site surveyor for the accreditation agency is reviewing a revised version of a procedure for loading specimens on an analyzer. The procedure was app...
• The laboratory manager is designing a template for document control. He does not have an estimate of number of documents and the system must encompass...
• An assistant supervisor is assigned the responsibility of maintenance of the Master Control Document. He is reviewing the procedure for this process. ...
• During a recent hurricane, Surf-Side Hospital was without power for two days. A new traveling technologist was on site overnight during the outage. Sh...
• A new administrator is adapting Clinical and Laboratory Standards Institute (CLSI) versions of procedures for a new immunoassay analyzer. He knows tha...
• A new document is provided for documentation of point-of-care (POC) quality control. All printed copies of the previous version were discarded. The ne...
• Differentiate controlled and uncontrolled documents.
• Differential Controlled and Uncontrolled Documents
• A memorandum regarding a meeting to occur at 3 pm is forwarded to all laboratory staff. The purpose of the meeting is to review the incorporation of a...
• A communication log is maintained in the chemistry department to assist with communication between shifts and minor adjustments for temporary issues, ...
• A technologist is using the sole printed copy of a controlled document to train a new technologist for chemistry reagent preparation. The reagent is s...
• Explain required steps and best practices for revision and implementation of documents that are under document control.
• Substantial Revisions vs. Minor Revisions
• Approval of New Documents and Revisions
• Periodic Review of Laboratory Technical Policies and Procedures
• Employee Review of New and Updated Documents
• Publishing
• Laboratory testing personnel of a satellite site performed a mandatory review of the policy and procedure manuals and job aids. The following items we...
• A new policy and procedure are being implemented for specimen processing. Printed copies of the approved procedures arrived from the print room on Wed...
• The laboratory director approved all policies and procedures on January 15, 2017. The director was leaving in three days for a two month medical leave...
• A new employee is reviewing general laboratory policies as a part of orientation. This laboratory follows regulatory requirements for employee review ...
• At the laboratory 2:00 PM staff meeting, the lead technologist presented a revised procedure for staff review. The technologists present at the meetin...
• The laboratory director will be out of the office for four weeks and will not be available for consultation. The assistant medical director for the la...
• The chemistry laboratory has a manual test procedure that requires the addition of 5 mL of reagent to 0.1 mL of patient plasma. The test kit manufactu...
• Explain the requirements for maintenance and document archiving and retirement of documents.
• Retiring and Archiving Documents and Versions
• Retention Period for Archived Documents
• A procedure for processing specimens for send-out to the local reference laboratory is incorporated into the specimen receiving department. The proced...
• The laboratory manager is organizing documents for inclusion in a new document control system. She finds multiple copies of procedures, notes, and job...
• A new trainee is instructed to review the procedure manual for the coagulation department. Further instruction was not provided. She removed the binde...
• References
• References

Additional Information