| Document control practices in 120 clinical laboratories. | |
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MedLine Citation:
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PMID: 19492888 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. OBJECTIVE: To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. DESIGN: Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. RESULTS: Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. CONCLUSIONS: Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes. |
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Authors:
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Paul N Valenstein; Ana K Stankovic; Rhona J Souers; Frank Schneider; Elizabeth A Wagar |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Archives of pathology & laboratory medicine Volume: 133 ISSN: 1543-2165 ISO Abbreviation: Arch. Pathol. Lab. Med. Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2009-06-04 Completed Date: 2009-06-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7607091 Medline TA: Arch Pathol Lab Med Country: United States |
Other Details:
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Languages: eng Pagination: 942-9 Citation Subset: AIM; IM |
Affiliation:
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Department of Pathology, St Joseph Mercy Hospital, Ann Arbor, MI 48106-0995, USA. paul@valenstein.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Humans Laboratories, Hospital / standards* Laboratory Techniques and Procedures / standards* Records as Topic* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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