CAP Pro Course - Laboratory Management - Document Control

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Author: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB
Reviewer: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM

Continuing Education Credits

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

Level of Instruction: Intermediate
Intended Audience: This program is designed as an educational and training tool for MLS, MT, and MLT personnel, medical laboratory science students and interns, pathology residents, and practicing pathologists.
Author Information: Sheryl A. Whitlock, MA.Ed, MT(ASCP)BB is the owner of ARK Laboratory Consulting, LLC and a part time technical consultant for McKesson. Sheryl served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. Sheryl received her Master’s degree in Education from Arcadia University. She has more than 35 years of experience in laboratory science to include management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals as well as having contributed to numerous online and print articles in the field of laboratory medicine.
Reviewer Information: Alexandru Casapu, MBA, MLS(ASCP)CM, PBTCM, has over 20 years of experience as a medical laboratory scientist, section supervisor, and laboratory manager. He is the former Director of Clinical Laboratory Technology Program at Georgia Piedmont Technical College. He is currently a Program Director at MediaLab, Inc. Alex holds BS degrees in Biology and Medical Technology from Clark Atlanta University and an MBA from the University of Georgia.

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