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Document Control and Records Management Program Overview

Program Description

This module we will describe the requirements for quality system documentation and we will identify the regulatory requirements for document control and describe the elements for an effective document control process.

Learning Objectives

Upon completion of the workshop, the participant will be able to:

  • Define commonly used terms
  • Describe the regulatory/accreditation requirements for document control
  • Define and describe the differences between the terms policy, process and procedures
  • Provide a structure for a quality management document control system
  • Describe good recordkeeping practices
  • Describe the elements of an effective process for document control and records management

Level of Instruction

  • Basic

P.A.C.E. Statement

Blood Systems, Inc. is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program

In 1977, P.A.C.E.® was established by the American Society of Clinical Laboratory Science (ASCLS) to stimulate and serve as the quality assurance mechanism for continuing education programs offered to clinical laboratory professionals. ASCLS strongly supports continuing education opportunities to increase and enhance professional knowledge and ongoing proficiency. P.A.C.E.® ensures that the continuing education programs offered to clinical laboratory professionals maintain high standards of quality and professional acceptability.

CE Broker Statement

These courses are also approved for Florida continuing education credits for Laboratory Professionals and Nurses through Florida Blood Services Provider # 50-2063. Credits will be reported to CE Broker on a monthly basis. To obtain Florida credits, one must pass the quizzes with a score of 80% or higher. Individuals must choose between P.A.C.E. or Florida credits.

Contact hours

  • Completion of this program will provide 1 contact hour of P.A.C.E. continuing education credit.
  • Completion of this program will provide 1 contact hour of Supervision/Administration, Quality Control/Quality Assurance and Safety Florida CE Broker continuing education credit.

Speaker Credentials

Linda Stefaniak, B.S. (ASCP) SBB CQA(ASQ) CQM/OE has worked for Blood Systems for the past 4 years. Prior to her current position at Blood Systems Inc. she was Director of Quality Assurance at Miller-Keystone Blood Center for 15 years.

Technical Requirements and Assistance

To view the program material, you need a computer with a supported web browser and a dial-up or better internet connection. The supported operating systems and web browsers are:

Operating Systems

  • Windows 2000, XP, Vista, Windows 7
  • MacOS X 10.4 or later
  • Linux 2.6 with KDE or Gnome

Web Browsers

  • Internet Explorer 6 or later
  • Firefox 2 or later
  • Safari 3 or later
  • Opera 9 or later

Technical Support

Content Questions

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