CAP Pro Course - Laboratory Management - Document Control (2025 & 2026)

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
• The laboratory manager is revising the document control system by removing unnecessary documents from the system in an effort to minimize storage. Whi...
• The laboratory supervisors are sorting documents to include in a newly developed document control system. Which of the following would be stored withi...
• Which of the following documents is not appropriate for inclusion in document control?
• On a mock inspection of Bone Doctors Laboratory performed by the laboratory administration, five sticky notes with additional procedural reminders wer...
• Anytime Clinic is upgrading all of the current charting systems to include the Electronic Health Record (EHR) and the Laboratory Information System (L...
• 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 new laboratory started testing patients on January 2. The staff reviewed the policies and procedures on January 15. The laboratory director reviewed...
• A new immunoassay analyzer was purchased and recently installed. All validation steps are completed, and the laboratory is ready to implement the new ...
• An inspector for the accreditation agency is reviewing a revised version of a procedure for loading specimens on an analyzer. The procedure was approv...
• The laboratory manager is designing a template for document control. He does not have an estimate of the number of documents, and the system must enco...
• Differentiate controlled and uncontrolled documents.
• Differential Controlled and Uncontrolled Documents
• The laboratory has an electronic document control system. One printed master copy of each document is retained in the laboratory manager's office, and...
• A new laboratory manager is in the process of organizing random documents located in a binder in the specimen processing area. Which of the following ...
• A laboratory is using an electronic document control system that accesses documents over a network. Which of the following backups is NOT acceptable?
• A medical laboratory technician recorded a critical value and the repeat value on a notepad for reference while in transit to notify the on-site physi...
• One of the testing personnel in the laboratory has created a flowchart to assist the staff in remembering the steps in a new procedure. When presentin...
• 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
• A coagulation laboratory adopted a new procedure for calculating anticoagulant adjustment for patients with elevated hematocrits. Upon review by the a...
• The local hospital in Smalltown, Nebraska, has satellite acute care locations in small cities within a 50-mile radius. Each of these sites has a labor...
• The laboratory director for Rapid Labs is traveling overseas. Which of the following tasks cannot be completed during the laboratory director's absenc...
• The chemistry instrument manufacturer notified ABC laboratory of changes to four of its procedures that are part of the laboratory's test menu. The ch...
• Several procedures within the hematology department have been revised. The laboratory manager is new and would like to establish a standardized protoc...
• Explain the requirements for maintenance and document archiving and retirement of documents.
• Retiring and Archiving Documents and Versions
• Retention Period for Archived Documents
• The laboratory is striving to digitize its documents and is adopting an electronic document control system for this purpose. During the transition, it...
• The laboratory of an acute care hospital is implementing a document control system. The laboratory is accredited by an outside agency that also has th...
• A retired immunoassay analyzer will not be retained by the institution. The operator’s manual was incorporated into the procedures utilized for ...
• Rapid Access Laboratory has been sold. The laboratory supervisors are organizing and purging currently stored files for long-term storage. All files h...
• References
• References

Additional Information