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Quality Control01:05

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Safety Precautions and Operating Procedures in an (A)BSL-4 Laboratory: 2. General Practices
08:53

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Published on: October 3, 2016

Document control practices in 120 clinical laboratories.

Paul N Valenstein1, Ana K Stankovic, Rhona J Souers

  • 1Department of Pathology, St Joseph Mercy Hospital, Ann Arbor, MI 48106-0995, USA. paul@valenstein.org

Archives of Pathology & Laboratory Medicine
|June 5, 2009
PubMed
Summary
This summary is machine-generated.

Clinical laboratories struggle with document control, with only 35% meeting all requirements. This study highlights widespread issues in implementing document control practices, impacting regulatory compliance.

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Area of Science:

  • Clinical Laboratory Science
  • Quality Management Systems

Background:

  • Clinical laboratories face stringent document control requirements from regulatory bodies, accreditors, and standard-setting organizations.
  • Effective document control is crucial for maintaining compliance and operational integrity.

Purpose of the Study:

  • To assess the practical implementation of document control in clinical laboratories.
  • To investigate if specific document control strategies correlate with higher compliance rates.

Main Methods:

  • A structured audit was conducted on 8814 documents across 120 laboratories.
  • Conformance was evaluated against six key document control criteria: availability, authorization, currency, management review, staff review, and archiving.

Main Results:

  • Only 35% of audited documents met all six document control requirements.
  • Document availability was high (97%), but proper archiving compliance was only 50%.
  • Policies and procedures were better controlled than forms; some lab sections performed better than others.

Conclusions:

  • Most clinical laboratories are failing to meet regulatory and accreditation standards for document control.
  • The impact of these document control failures on laboratory result quality and patient outcomes remains undetermined.