Document Control Practices in 120 Clinical Laboratories

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					                                             CAP Laboratory Improvement Programs




Document Control Practices in 120 Clinical Laboratories
              Paul N. Valenstein, MD; Ana K. Stankovic, MD, PhD, MPH; Rhona J. Souers, MS; Frank Schneider, MD;
                                                    Elizabeth A. Wagar, MD

● Context.—A variety of document control practices are                      (50%) of documents fulfilled Clinical Laboratory Improve-
required of clinical laboratories by US regulation, labora-                 ment Amendment requirements for being properly ar-
tory accreditors, and standard-setting organizations.                       chived after updating or discontinuation. Policies and pro-
   Objective.—To determine how faithfully document con-                     cedures were more likely to fulfill document control re-
trol is being implemented in practice and whether partic-                   quirements than forms and work aids. Documents tended
ular approaches to document control result in better levels                 to be better controlled in some laboratory sections (eg,
of compliance.                                                              transfusion service) than in others (eg, microbiology and
   Design.—Contemporaneous, structured audit of 8814                        client services). We could not identify document control
documents used in 120 laboratories for conformance with                     practices significantly associated with higher compliance
6 generally accepted document control requirements:                         rates.
available, authorized, current, reviewed by management,                        Conclusions.—Most laboratories are not meeting regu-
reviewed by staff, and archived.                                            latory and accreditation requirements related to control of
   Results.—Of the 8814 documents, 3113 (35%) fulfilled                      documents. It is not clear whether control failures have
all 6 document control requirements. The requirement ful-                   any impact on the quality of laboratory results or patient
filled most frequently was availability of the document at                   outcomes.
all shifts and locations (8564 documents; 97%). Only 4407                      (Arch Pathol Lab Med. 2009;133:942–949)


T   he term document control refers to a group of informa-
     tion-management practices related to documents.
There is no uniformly accepted definition of what consti-
                                                                               A variety of health care–accrediting organizations (such
                                                                            as the College of American Pathologists [CAP], the Joint
                                                                            Commission, and the American Association of Blood
tutes document control in the clinical laboratory industry.1                Banks) and consensus-based standard-setting organiza-
In our experience, the term is applied to a variety of dif-                 tions (such as Clinical and Laboratory Standards Institute
ferent document types and a variety of control practices.                   and International Organization for Standardization [ISO])
   Commonly, laboratory managers apply the term docu-                       have emphasized the importance of document control by
ment control to laboratory policies and procedures, but the                 incorporating control requirements into their laboratory
term is sometimes also applied to laboratory forms, work                    accreditation programs and standards. The CAP address-
aids (‘‘cheat sheets’’), and to laboratory records that in-                 es document control in its laboratory accreditation stan-
clude patient or quality data. Document control practices                   dard GEN.20375 (‘‘Does the laboratory have a document
generally include provisions to ensure that documents are                   control system?’’).3 The CAP identifies 5 specific elements
available to staff who need them, are current, have been                    that are required to demonstrate document control: (1)
properly authorized by the laboratory director or by some-                  documents should be current, (2) there should be evidence
one the director appoints, and are properly archived when                   that personnel have read documents relevant to their job
taken out of service. If the term documents is defined as                    activities, (3) documents should be properly authorized
including records containing patient health information,                    before being placed in service, (4) documents are to be
document control also includes measures to ensure the                       reviewed by an authorized individual at least annually,
integrity and security of documents.2
                                                                            and (5) discontinued documents are to be retained for a
                                                                            minimum of 2 years after the date of discontinuation (5
   Accepted for publication October 16, 2008.                               years for transfusion medicine).
   From the Department of Pathology, St Joseph Mercy Hospital, Ann             In any given year, between 6% and 7% of clinical lab-
Arbor, Michigan (Dr Valenstein); Preanalytical Systems, Becton Dick-        oratories inspected by CAP are cited for failure to imple-
inson Diagnostics, Franklin Lakes, New Jersey (Dr Stankovic); the Di-       ment some aspect of a document control system—one of
vision of Biostatistics, College of American Pathologists, Northfield, Il-
linois (Ms Souers); the Department of Pathology, Duke University Med-       the highest citation rates in the entire Laboratory Accred-
ical Center, Durham, North Carolina (Dr Schneider); and the Depart-         itation Program.1 Between 1% and 5% of laboratories are
ment of Pathology and Laboratory Medicine, David Geffen School of           cited for failing to review their procedure manual annu-
Medicine at the University of California, Los Angeles (Dr Wagar).           ally (citation rates vary by laboratory section), and 1% to
   The authors have no relevant financial interest in the products or        2% of laboratory sections are cited for failing to make a
companies described in this article.
   Reprints: Paul N. Valenstein, MD, Department of Pathology, St Joseph     complete procedure manual available at the workbench.
Mercy Hospital, 5301 E Huron River Dr, Ann Arbor, MI 48106-0995                The Joint Commission addr
				
DOCUMENT INFO
Description: 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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