Document control practices in 120 clinical laboratories.
Abstract: * 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.

(Arch Pathol Lab Med. 2009;133:942-949)
Article Type: Report
Subject: Medical laboratories (Management)
Documentation (Control)
Documentation (Management)
Data entry (Management)
Patients (Care and treatment)
Patients (Management)
Authors: Valenstein, Paul N.
Stankovic, Ana K.
Souers, Rhona J.
Schneider, Frank
Wagar, Elizabeth A.
Pub Date: 06/01/2009
Publication: Name: Archives of Pathology & Laboratory Medicine Publisher: College of American Pathologists Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 College of American Pathologists ISSN: 1543-2165
Issue: Date: June, 2009 Source Volume: 133 Source Issue: 6
Topic: Event Code: 200 Management dynamics Computer Subject: Company business management
Product: Product Code: 7397030 Biomedical Testing Labs NAICS Code: 54138 Testing Laboratories SIC Code: 8071 Medical laboratories; 8731 Commercial physical research
Accession Number: 230152024
Full Text: The term document control refers to a group of information-management practices related to documents. There is no uniformly accepted definition of what constitutes document control in the clinical laboratory industry. (1) In our experience, the term is applied to a variety of different document types and a variety of control practices.

Commonly, laboratory managers apply the term document control to laboratory policies and procedures, but the term is sometimes also applied to laboratory forms, work aids (''cheat sheets''), and to laboratory records that include patient or quality data. Document control practices generally include provisions to ensure that documents are available to staff who need them, are current, have been properly authorized by the laboratory director or by someone the director appoints, and are properly archived when taken out of service. If the term documents is defined as including records containing patient health information, document control also includes measures to ensure the integrity and security of documents. (2)

A variety of health care-accrediting organizations (such as the College of American Pathologists [CAP], the Joint Commission, and the American Association of Blood Banks) and consensus-based standard-setting organizations (such as Clinical and Laboratory Standards Institute and International Organization for Standardization [ISO]) have emphasized the importance of document control by incorporating control requirements into their laboratory accreditation programs and standards. The CAP addresses document control in its laboratory accreditation standard GEN.20375 ("Does the laboratory have a document control system?"). (3) The CAP identifies 5 specific elements that are required to demonstrate document control: (1) documents should be current, (2) there should be evidence that personnel have read documents relevant to their job activities, (3) documents should be properly authorized before being placed in service, (4) documents are to be reviewed by an authorized individual at least annually, and (5) discontinued documents are to be retained for a minimum of 2 years after the date of discontinuation (5 years for transfusion medicine).

In any given year, between 6% and 7% of clinical laboratories inspected by CAP are cited for failure to implement some aspect of a document control system--one of the highest citation rates in the entire Laboratory Accreditation Program. (1) Between 1% and 5% of laboratories are cited for failing to review their procedure manual annually (citation rates vary by laboratory section), and 1% to 2% of laboratory sections are cited for failing to make a complete procedure manual available at the workbench.

The Joint Commission addresses the importance of document control through its information management standard IM.2.20 ("Information security and data integrity"), which appears in its Comprehensive Accreditation Manual for Hospitals4 and in its Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing. (5) Among other requirements, this accreditation standard requires that information be available to individuals who need to use a document and that documents be authentic (ie, the author of the document and the information itself can be verified). As with many Joint Commission standards, IM.2.20 sets out general principles that hospitals must follow but does not provide detailed guidance. The Joint Commission relies on the judgment of inspectors and assessors to determine compliance with its standard.

The Clinical and Laboratory Standards Institute (CLSI) addresses document control in its standard HS1-A2 (A Quality Management System Model for Health Care). (6) The CLSI recommends that policies and procedures be established for the creation, review, and approval of new documents, changes to documents, control of documents, use of external documents, and storage and retention. The international standard ISO15189:2007 lists similar requirements, (7) as does the American Association of Blood Banks. (8,9) The Clinical Laboratory Improvement Amendments of 1988 (CLIA) specify that laboratory procedures be available to laboratory personnel, and that the initial and all subsequent versions of each procedure be authorized by the laboratory director. (10) CLIA also specifies that a copy of each procedure, the date of first use, and the date of discontinuance must be retained for at least 2 years after a procedure has been removed from service. (11)

Document control is an important component of quality management and promotes consistency through standardization. Yet, in spite of the emphasis on document management by accrediting and standard-setting organizations and US federal regulations, little information exists about document control practices actually used in clinical laboratories. The aim of this study was to address this information gap by examining specific document control practices in a large number of clinical laboratories. Compliance with 6 separate document control requirements was studied in relation to 4 types of documents. In addition, we performed a statistical analysis to determine whether any institutional characteristics or practices were associated with compliance rates for specific document control requirements.

MATERIALS AND METHODS

Study Design

The study was conducted according to the Q-Probes study format previously described, (12) which relies on a convenient sample of clinical laboratories that subscribe to the CAP Q-Probes benchmarking program. After refinement of a standardized data collection instrument, CAP Q-Probes subscribers were mailed a data collection tool in early 2008 with instructions to return data by March 7.

Participants were instructed to select 75 documents for review (see "Definitions" for definition of a document). The manner in which documents were selected for review was prescribed: Participants were to begin with an actual specimen that arrived in the laboratory and to trace its path through the laboratory until a report was issued and distributed. As the order or specimen was processed, participants were instructed to identify the nearest version of up to 10 documents that were applicable to the work being done to the order or specimen. For example, if a specimen was first received in a central processing area of a laboratory, participants were to locate the nearest procedures, policies, forms, or work aids that described computer order entry for the specimen or how the specimen should be processed and tested. If reagents or equipment were used to test a specimen, documents related to quality control testing of the reagents or equipment would be included. This process was repeated with additional specimens related to different sections of the laboratory until 75 documents had been identified. The same document was never to be examined twice.

As documents were located, participants recorded the type of document (see "Definitions") and the laboratory section in which the document was located and assessed compliance with 6 document control attributes (see "Definitions"). The 6 attributes were (1) management review in past year, (2) up-to-dateness, (3) evidence of staff review, (4) availability to all shifts/locations, (5) properly archived, and (6) authorized.

Participants were to evaluate documents that were used in central specimen processing, chemistry, hematology, coagulation, histology/cytology, microbiology, transfusion service (blood bank), other testing section, and a call center or a client services center. Participants were to exclude documents related to courier functions, laboratory information systems, billing, supply chain management, and human resources.

Participants were also queried about several institutional characteristics: number of occupied beds, teaching status, pathology resident training status, government affiliation, institution location, institution type, CAP inspection status, and inspection status by the Joint Commission. They were also queried about practices used to maintain document control.

Participant Characteristics and Practices

One hundred and twenty institutions participated in the study. Most (93.3%) were located in the United States, with the remaining located in Australia (2), Saudi Arabia (2), Kuwait (1), Lebanon (1), Qatar (1), and Spain (1). Of the participating institutions, 41.2% were in teaching hospitals and 25.0% had a pathology residency program. Within the past 2 years the CAP inspected 86.5% of the laboratories (n = 104). The median institution performed 900,000 tests annually (interquartile range 170,000-4,260,000 tests/y). Tables 1 and 2 show other characteristics of the participating institutions.

Definitions

To ensure uniformity of responses, definitions were adopted for documents, document types, and document control requirements.

Document.--Any policy, procedure, form, or work aid that governs processing and handling of specimens and orders, as well as testing, reporting, or any quality control activity performed by humans in the laboratory. Documents could exist on paper or on computer screens. Policies and procedures that were not primarily related to processing of specimens and orders, testing, reporting, or quality control activities were not considered documents. Similarly, laboratory records containing patient or quality control testing results were not considered documents for the purpose of this study.

Four types of document were recognized:

Form.--A form is a document that is used to record information related to laboratory activities. A form most commonly consisted of paper used to record some observation (eg, results of quality control testing or Gram stain interpretation) but could consist of a computer screen used to record information if the screen had been developed by laboratory management and not a computer system vendor. A form must contain some information itself, above and beyond the information that was to be recorded.

Policy.--A policy is a document that indicates an organization's intentions or commitments, for example, a written statement that critical laboratory results should be called to caregivers within 60 minutes.

Procedure.--A procedure is a document that provides detailed step-by-step instructions for an individual to follow to perform an activity correctly, such as ABO identification or quality control of microbiology media.

Work Aid.--A work aid is a summary of part of a procedure that is immediately available in close proximity to where the procedure is to be performed.

Document Control Requirements.--Six document control requirements were recognized:

Authorized.--A document was authorized if it had been approved by someone with the proper authority. For paper documents, this approval may have been evidenced by a signature or initials on the document itself or on a signature page next to a notation that individually identifies the document. For electronic documents, approval may have been evidenced by (1) a paper form with signatures or initials indicating the electronic document has been authorized, (2) a scanned version of a signed or initialed document authorization sheet, (3) electronic signature, or (4) use of a process that prevents unauthorized electronic documents from being made available to staff. In other words, use of an electronic signature was acceptable but not required. Authorized documents should normally be approved by either the laboratory director or an individual who has been given explicit, written authority to approve documents on behalf of the laboratory director. For the purposes of this study, however, a document that was approved by a medical director or supervisor of a laboratory section or division was accepted as authorized if it was generally understood that the section medical director or supervisor had been given the authority to approve documents on the laboratory director's behalf.

Available.--A document was considered available if it was reasonably accessible by all individuals who were likely to need access to the document. This included all applicable sections of the laboratory and all applicable shifts.

Archived.--Documents were considered archived if older versions of the document were retrievable from a file or from some other source if they were in force during the past 2 years (5 years in the case of transfusion medicine). If no older versions of the document existed (ie, the document had not been changed since its first creation) or the current version has been in force for more than 2 years (5 years in the case of transfusion medicine), no archived copy was required, and the current version was considered to have been properly archived.

Current/Up-to-Date.--A document was considered current if it was available to staff and had not been superseded by a more recently authorized version of the document (eg, the version available to staff was up-to-date). A document was considered current/up-to-date if a newer version was in development but had not yet been authorized and made available to staff.

Management Review.--A document had received management review if there was evidence of management approval within the previous 12 months (for example, a document that had been created in January 2006 would require evidence of management review after January 2007). Evidence of review could consist of a dated signature or the initials of the laboratory director or an individual authorized by the laboratory director to review documents on the director's behalf. The signature/initials could be located on the document itself or on a review page adjacent to a notation that specifically identified the document. Scanned versions of signatures were considered acceptable, as was an electronic process that established that management has reviewed an electronic document during the past 12 months. Documents did not require management review if they were first placed in service less than 12 months before the study took place.

Staff Review.--A document had staff review if the laboratory had evidence that all staff affected by the document had reviewed it within 45 days of the time it first was placed in service or most recently updated (whichever came later). Evidence of staff review could consist of staff signatures or initials with dates or some sort of electronic, time-stamped record that signified that a staff member has reviewed the document. Evidence of review was required only for staff who were likely to require the document in their regular work. Laboratory reviewers were asked to apply reasonable judgment to determine whether changes were of sufficient magnitude to require documented staff review. Clarifications of ambiguous wording or correction of minor errors were provided as examples that did not normally require documentation of staff review. A work aid was considered reviewed by staff if staff reviewed the procedure or procedures from which the work aid was drawn. If a document had been last updated (changed) more than 2 years previously, participants were to consider the document to have been reviewed by staff, even if no documentation of review has been retained.

Statistical Analysis

Before performing statistical analysis, any laboratory that examined fewer than 10 documents was eliminated from the data set. Staff at several participating institutions did not answer all of the questions on the questionnaire about demographic characteristics or institutional practices. These institutions were excluded only from tabulations and analyses that required the missing data elements. All statistical analyses were performed using SAS (Version 9.1, SAS Inc, Cary, North Carolina).

The percentage of documents that fulfilled all 6 document control requirements and the percentage of documents that fulfilled each document control requirement were calculated for each participant. These quality indicators were tested individually for associations with institutional demographic and practice variables in Tables 1 and 2 with the Kruskal-Wallis test and then entered into a forward-selection multiple linear regression model. P < .05 was considered statistically significant.

RESULTS

Quality Indicators

In total, participants from 120 institutions reviewed 8814 documents. The average number of documents reviewed per institution was 73. Most of the documents (6978, 79%) were policies or procedures. The remainder were forms or work aids. Documents in a wide variety of laboratory sections were examined (Table 3).

Slightly more than one-third (3113, 35%) of the documents fulfilled all 6 document control requirements defined in the study (Table 4). The percentage of documents that fulfilled each document control requirement was also determined. Document control requirements fulfilled most frequently were availability (access by all shifts and locations; 8564; 97% of documents) and up-to-date (no more recent version of the document existing; 8382; 95% of documents). Only 4407 (50%) of the documents fulfilled the archived requirement.

Policies and procedures were more likely to fulfill document control requirements than forms, and forms were more likely to fulfill requirements than work aids (Table 4). Different laboratory sections tended to fulfill document control requirements at different rates. Of 1127 documents found in the transfusion service, 528 (47%) met all 6 document control requirements, whereas only 20 of 151 documents (13.2%) met all 6 requirements in client services and call centers (Table 5).

Performance varied among the 120 study laboratories. The distribution of performance among laboratories is shown in Table 6. In the median facility, only one-quarter of documents fulfilled all 6 document control requirements, and only two-thirds of the documents fulfilled all requirements except the archiving requirement. In the bottom quartile of institutions, no documents met all 6 document control requirements.

Association of Performance With Laboratory Practices and Demographics

Laboratory demographic and practice variables were evaluated to explore associations with document control fulfillment rates. There were no demographic or practice variables significantly associated with the study's primary quality indicator--the percentage of documents that fulfilled all 6 document control requirements. However, significant associations (P < .05) were found with the individual document control requirements. Management review of documents was more common in facilities that had been inspected by the CAP within the past 2 years. Staff review of documents was more common in institutions that did not have teaching programs, and documents were more likely to be current/up to date in institutions without pathology residency programs. These associations are shown in Table 7. Interestingly, neither the provision of documents online nor the use of a commercially available product for document control was statistically associated with better performance.

COMMENT

This study examined the compliance of 120 institutions with 6 elements of document control: (1) current/up to date, (2) staff review, (3) authorization, (4) management review, (5) archiving, and (6) availability. Compliance was assessed by prospective audits of 75 documents at each institution; a total of 8814 documents were examined. Notably, only 35% of documents fulfilled all 6 document control requirements, and in 30 institutions, no reviewed document fulfilled all requirements. Of the 6 requirements, the area where compliance was lowest was archiving of discontinued procedures. Given that retention of procedures for 2 years after discontinuation is a CLIA regulatory requirement, (11) we had expected higher rates of conformance. Retention of discontinued policies is not unduly burdensome and may be useful when mounting a defense to legal challenges related to events that transpired when previous versions of policies were in force.

We also observed particularly low rates of document control compliance in relation to work aids. Given that work aids (cheat sheets) are often the most referenced documents in a laboratory, work aids that are out of date or not authorized or reviewed by management represent a breakdown in the control environment that may produce undesirable variation in practices and results.

On a more positive note, high rates of compliance were found for most document control practices, particularly as they pertained to policies and procedures and in highly regulated sections of the laboratory (such as transfusion medicine).

The results of this study do not point toward particular practices that are significantly associated with more faithful control of documents. Although we examined a large group of practices for an association with better document control (Tables 1 and 2), few correlations were found. Recent laboratory inspection by the CAP was associated with higher rates of management review. CAP inspectors routinely check for certain elements of document control, and anticipation of an external CAP inspection may have caused laboratory managers to review documents. The CAP requires inspected laboratories to correct their deficiencies as a condition of CAP accreditation, which may have also elevated compliance rates among recently inspected facilities. A variety of document-management software solutions are available commercially to assist organizations with document control. (13) We did not find the use of commercial solutions to be associated with better performance, but the small number of study institutions using such products (n = 5; 4.3%) limited the power of our investigation to detect an effect.

Laboratories associated with teaching programs and pathology residency programs had lower rates of compliance with control requirements. The study did not provide an explanation for this association. It is possible that the demands of keeping training programs accredited diverts management attention from document control or that residents assigned to self-inspect laboratories as part of training exercises do not understand the principles of good document management. Whatever the explanation, we find it disconcerting that future pathologists appear to be learning laboratory management in settings that have worse-than-average performance in document control.

Perhaps the most useful recommendation to arise from this study is the development of the audit tool itself, which specifically defines expectations and provides a structured method for laboratory staff to conduct periodic self-audits of compliance. Laboratory managers can conduct audits of their own institutions using the data collection methods and 6 requirements for good document control described in this article.

Several limitations of this study should be borne in mind, some of which are generic to the Q-Probes program and some unique to this investigation:

1. Data from study participants were self-reported and were not independently validated.

2. The 120 study participants were self-selected and may not be representative of the laboratory industry as a whole. Willingness to participate in this study might reflect increased concern about document control practice or an untoward finding on a recent external inspection.

3. We did not examine document integrity or security--2 attributes that some consider part of document control. In our experience, the potential for corruption of documents in clinical laboratories is relatively small, and most laboratory policies, procedures, forms, and work aids do not contain highly confidential or patient-specific information that must be kept secure.

4. Our method for accumulating documents to evaluate relied upon identification of documents located in proximity to specimen work flow. It is possible that this method may have caused some applicable documents located distant from specimens to be overlooked and underrepresented in our sample.

5. Finally, we remind readers that this study focused on compliance with recommended document control practices but not on the relationship of good document control to the quality of laboratory results or patient outcomes. The importance of document control has been emphasized by quality experts and quality organizations both within and outside of medicine, but we are unaware of data that suggest a connection between good document control and high-quality outcomes in health care. Even if a statistical association between document control and quality outcomes was found, a cause-and-effect relationship would be difficult to establish. Good document control could signal a general level of discipline or enthusiasm that improves outcomes of care even if document control itself was not causally related to patient outcomes.

References

(1.) Valenstein P, ed. Quality Management in Clinical Laboratories: Promoting Patient Safety Through Systematic Risk Reduction. Northfield, IL: College of American Pathologists; 2005.

(2.) Health Insurance Portability and Accountability Act of 1996, Pub L No. 104-191, 120 Stat 1884-1962 (1996).

(3.) College of American Pathologists (CAP). Laboratory Genera/ Check/ist: Laboratory Accreditation Program. Northfield, IL; 2008. CAP publications GEN.20375, GEN.20376, GEN.20377.

(4.) Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: JCAHO; 2008.

(5.) Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing. Oakbrook Terrace, IL: JCAHO; 2008.

(6.) Clinical Laboratory Standards Institute (CLSI). Application of a Quality Management System Model for Laboratory Services; Approved Guidelines. 3rd ed. Wayne, PA: CLSI; 2004. NCCLS document GP26-A3.

(7.) International Organization for Standardization (ISO). Medical Laboratories--Particular Requirements for Quality and Competence. Geneva, Switzerland: ISO; 2007. ISO Standard 15189:2007,4.3.

(8.) American Association of Blood Banks (AABB). Policies, processes and procedures. In: Standards for Blood Banks and Transfusion Services. 24th ed. Be thesda, MD: AABB; 2006. Standard 1.3.

(9.) American Association of Blood Banks (AABB). Document and records. In: Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB; 2006. Standards 6.0, 6.1, 6.2.

(10.) Laboratory requirements: standard--procedure manual. Fed Regist. 2004; 42(3):1035-1036. To be codified at 42 CFR [section] 493.1251.

(11.) Laboratory requirements: standard--retention requirements: test procedure. Fed Regist. 2004;42(3):1030-1031. To be codified at 42 CFR [section] 493.1105(2).

(12.) Howanitz PJ. Quality assurance measurements in departments of pathology and laboratory medicine. Arch Pathol Lab Med. 1990;114:1131-1135.

(13.) Garcia F, Harrison E, Wise C, Wolk DM. Is your document control out of control?: complying with document control regulations. Clin Leadersh Manag Rev. 2003;17:255-262.

Paul N. Valenstein, MD; Ana K. Stankovic, MD, PhD, MPH; Rhona J. Souers, MS; Frank Schneider, MD; Elizabeth A. Wagar, MD

Accepted for publication October 16, 2008.

From the Department of Pathology, St Joseph Mercy Hospital, Ann Arbor, Michigan (Dr Valenstein); Preanalytical Systems, Becton Dickinson Diagnostics, Franklin Lakes, New Jersey (Dr Stankovic); the Division of Biostatistics, College of American Pathologists, Northfield, Illinois (Ms Souers); the Department of Pathology, Duke University Medical Center, Durham, North Carolina (Dr Schneider); and the Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at the University of California, Los Angeles (Dr Wagar).

The authors have no relevant financial interest in the products or companies described in this article.

Reprints: Paul N. Valenstein, MD, Department of Pathology, St Joseph Mercy Hospital, 5301 E Huron River Dr, Ann Arbor, MI 48106-0995 (e-mail: paul@valenstein.org).
Table 1. Institution Demographics

                                    Institutions

           Demographic              No.      %

Institution type
  Private, nonprofit                 59    57.8
  State, county, or city hospital    13    12.8
  Governmental, federal              9      8.8
  University hospital                7      6.9
  Private, profit                    6      5.9
  Private, independent laboratory    4      3.9
  Children's hospital                2      2.0
  Other                              2      2.0

Occupied beds, No.
  0-150                              39    40.6
  151-300                            29    29.2
  301-450                            10    10.4
  451-600                            4      4.2
  >600                               15    15.6

Institution location
  City                               59    57.3
  Suburban                           20    19.4
  Rural                              20    19.4
  Federal installation laboratory    4      3.9

Governmental affiliation
  Nongovernmental                    78    76.5
  Governmental, nonfederal           15    14.7
  Governmental, federal              9      8.8

Table 2. Laboratory Practices Related to Document Control

Institutions

Practice                                                  No.      %

Predominant method used to indicate that management
has initially authorized new policies and procedures
  Laboratory director or director's appointee signs
    paper document                                        96     81.4
  Laboratory director or director's appointee signs
    paper signature page adjacent to a notation that
    lists each document                                    8      6.8
  Laboratory documents are maintained online, and an
    electronic method is used to indicate that the
    director or director's appointee has approved
    documents                                             13     11.0
  Other                                                    1      0.8
Predominant method used to indicate that management
    has reviewed policies and procedures
  Laboratory director or director's appointee signs
    paper document                                        85     72.0
  Laboratory director or director's appointee signs
    paper signature page adjacent to a notation that
    lists each document                                   17     14.4
  Laboratory documents are maintained online, and an
    electronic method is used to indicate that the
    director or director's appointee has reviewed
    documents                                             15     12.7
  Other                                                    1      0.8
Predominant method used to indicate that management
    has initially authorized forms and work aids
  Laboratory director or director's appointee signs
    paper document                                        77     66.4
  Laboratory director or director's appointee signs
    paper signature page adjacent to a notation that
    lists each document                                    6      5.2
  Laboratory documents are maintained online and an
  electronic method is used to indicate that director
    or director's appointee has approved documents         8      6.9
  Appendix to, or part of, document authorization
    process                                                8      6.9
  Not authorized, approved or documented                   8      6.9
  Other                                                    9      7.8
Predominant method used to indicate that management
    has reviewed forms and work aids
  Laboratory director or director's appointee signs
    paper document                                        55     47.0
  Laboratory director or director's appointee signs
    paper signature page adjacent to a notation that
    lists each document                                    9      7.7
  Laboratory documents are maintained online, and an
    electronic method is used to indicate that
    director or director's appointee has reviewed
    documents                                              5      4.3
  Work aids are either not reviewed by management or
    the review is not documented                          36     30.8
  Appendix to, or part of, document review process         5      4.3
  Other                                                    7      6.0
Predominant method used to store old policies and
    procedures that are no longer current
  Paper copy                                              93     78.8
  Electronic copy                                         24     20.3
  Other                                                    1      0.8
Predominant storage place for old policies and
    procedures
  Stored off-site                                          8      6.8
  Stored on-site                                          110    93.2
The laboratory had a written document that
    specifically identified individuals who were
    authorized to approve and review documents on
    behalf of the laboratory director
  Yes                                                     106    89.8
  No                                                      12     10.2
Time since last change of laboratory director, mo
  <6                                                       7      5.9
  7-24                                                    21     17.8
  >24                                                     90     76.3
Laboratory uses manufacturers' printed inserts as
    laboratory procedures
  Yes                                                     13     11.2
  No                                                      103    88.8
Laboratory uses a commercially available product or
    service for document control
  Yes                                                      5      4.3
  No                                                      112    95.7
Best description of how document control
    responsibilities are divided within laboratory
  All documents are authorized and reviewed by
    laboratory medical director or administrative
    director                                              53     46.1
  Section-specific documents are authorized and
    reviewed by the section medical director or
      section manager/supervisor                          56     48.7
  Other                                                    6      5.2
Individual primarily responsible for creating and
    distributing work aids
  Section manager/supervisor                              82     70.1
  Lead or bench technologists                             19     16.2
  Laboratory medical director or administrative
    director                                              11      9.4
  Section medical director                                 3      2.6
  Other                                                    2      1.7
Predominant method used to store old forms and work
    aids that were no longer current
  Paper                                                   75     63.6
  Electronic                                              22     18.6
  Not saved                                               19     16.1
  Other                                                    2      1.7
Predominant storage place for old forms and work aids
  Stored off-site                                         15     13.8
  Stored on-site                                          94     86.2
Predominant method used to indicate that new documents
    have been reviewed by staff
  Signatures/initials of review are maintained on
    paper document                                        98     83.0
  Message (paper or electronic) is issued that informs
    staff about the new procedure and instructs them
    to review, but no documentation is normally
    maintained                                             9      7.6
  Electronic process used to record that staff members
    have reviewed the document (e-mail from staff
    members or other method)                               8      6.8
  No documentation maintained                              2      1.7
  Other                                                    1      0.8
Predominant method used to indicate that updated
    documents have been reviewed by staff
  Signatures/initials of review are maintained on
    paper document                                        92     78.0
  Message (paper or electronic) is issued that informs
    staff about the update and instructs them to
    review, but no documentation is normally
    maintained                                            12     10.2
  Electronic process used to record that staff members
    have reviewed the document (e-mail from staff
    members or other method)                               9      7.6
  No documentation maintained                              2      1.7
  Other                                                    3      2.5
Documents available on an intranet or through a
    computer system (multiple responses allowed)
  Yes, most (>50%) policies and procedures                66     55.9
  Yes, most (>50%) forms                                  48     40.7
  Yes, most (>50%) work aids                              32     27.1
  None of the above                                       47     39.8
Time since laboratory underwent an on-site inspection
    by representatives of the laboratory's main
    accrediting/certifying agency, mo
  <3                                                      21     17.8
  3-6                                                     23     19.5
  7-12                                                    24     20.3
  13-24                                                   48     40.7
  >24                                                      2      1.7
Citation for failure to control documents during last
    external laboratory inspection
  Yes                                                     23     19.7
  No                                                      94     80.3

Table 3. Types of Documents Reviewed and Laboratory Sections Affected

                                       Document/Section
                                           Affected

Demographic                             No.      %

Document Type
  Policy or procedure                  6978    79.3
  Form                                 1193    13.6
  Work aid                              632     7.2

Laboratory Section
  Chemistry/Hematology/Coagulation     2951    34.0
  Microbiology                         1266    14.6
  Transfusion service                  1127    13.0
  Test ordering/specimen processing    1123    13.0
  Histology/cytology                    732     8.4
  Call center or client services        151     1.7
  Other                                1322    15.2

Table 4. Fulfillment of Control Requirements by Document Type

                                        Documents, No. (%)

                                        All          Policy or
                                   Documents (a)     Procedure
      Control Requirement            (n = 8814)      (n = 6978)

Documents fulfilling                 3113 (35.3)    2804 (40.2)
  all 6 requirements

Documents fulfilling individual
    requirements
  Available all shifts/locations     8564 (97.2)    6824 (97.8)
  Current/up-to-date                 8382 (95.1)    6699 (96.0)
  Authorized                         7520 (85.3)    6434 (92.2)
  Management review                  7344 (83.3)    6314 (90.5)
  Staff review                       6810 (77.3)    5762 (82.6)
  Archived                           4407 (50.0)    3713 (53.2)

                                       Documents, No. (%)

                                       Form        Work Aid
      Control Requirement           (n = 1193)     (n = 632)

Documents fulfilling                204 (17.1)    101 (16.0)
  all 6 requirements

Documents fulfilling individual
    requirements
  Available all shifts/locations   1142 (95.7)    587 (92.9)
  Current/up-to-date               1110 (93.0)    562 (88.9)
  Authorized                        743 (62.3)    333 (52.7)
  Management review                 716 (60.0)    303 (47.9)
  Staff review                      694 (58.2)    345 (54.6)
  Archived                          489 (41.0)    201 (31.8)

(a) Some documents were not classified by participants as to type.

Table 5. Fulfillment of Control Requirements by Laboratory Section

                                    Documents, No. (%)

                            All        Test Ordering/    Chem/Heme/
                       Documents (a)     Processing         Coag
                        (n = 8814)       (n = 1123)      (n = 2951)

Documents fulfilling
  all 6 requirements    3113 (35.3)       364 (32.4)    1023 (34.7)

Documents fulfilling individual requirements
  Available all
    shifts/locations    8564 (97.2)      1089 (97.0)    2898 (98.2)
  Authorized            7520 (85.3)       934 (83.2)    2496 (84.6)
  Current/up-to-date    8382 (95.1)      1064 (94.7)    2816 (95.4)
  Management review     7344 (83.3)       947 (84.3)    2465 (83.5)
  Staff review          6810 (77.3)       864 (76.9)    2332 (79.0)
  Archived               447 (50.0)       507 (45.1)    1462 (49.5)

                                   Documents, No. (%)

                                      Transfusion    Histology/
                       Microbiology     Service       Cytology
                        (n = 1266)     (n = 1127)     (n = 732)

Documents fulfilling
  all 6 requirements    435 (34.4)     528 (46.9)    281 (38.4)

Documents fulfilling individual requirements
  Available all
    shifts/locations   1229 (97.1)    1108 (98.3)    695 (94.9)
  Authorized           1111 (87.8)    1014 (90.0)    632 (86.3)
  Current/up-to-date   1182 (93.4)    1107 (98.2)    705 (96.3)
  Management review    1001 (79.1)     986 (87.5)    622 (85.0)
  Staff review          996 (78.7)     954 (84.6)    570 (77.9)
  Archived              636 (50.2)     667 (59.2)    369 (50.4)

                            Documents, No. (%)

                        Call Center/       Other
                       Client Service     Sections
                         (n = 151)       (n = 1322)

Documents fulfilling
  all 6 requirements       20 (13.2)     418 (31.6)

Documents fulfilling individual requirements
  Available all
    shifts/locations      148 (98.0)    1261 (95.4)
  Authorized              122 (80.8)    1094 (82.8)
  Current/up-to-date      149 (98.7)    1226 (92.7)
  Management review       124 (82.1)    1078 (81.5)
  Staff review            112 (74.2)     879 (66.5)
  Archived                 45 (29.8)     649 (49.1)

Abbreviation: Chem/heme/coag, chemistry/hematology/coagulation.

(a) Some documents were not assigned by participants to laboratory
sections.

Table 6. Document Control Performance Among 120 Institutions

                                   All Institutions Percentiles (a)

                                   10th    25th    50th (b)

Documents fulfilling individual
    document control
    requirements, %
  Available all shifts/locations   91.9    96.0       98.7
  Current                          86.0    93.3       98.7
  Authorized                       62.0    79.3       93.3
  Management review                62.7    74.7       86.7
  Staff review                     40.0    66.7       83.4
  Archived                          0.0     2.7       58.9
Documents fulfilling all 6
  requirements, %                   0.0     0.0       25.4
Documents fulfilling 5
  requirements, excluding
  archived, %                      21.4    45.3       66.7

                                   All Institutions
                                   Percentiles (a)

                                    75th     90th

Documents fulfilling individual
    document control
    requirements, %
  Available all shifts/locations   100.0    100.0
  Current                          100.0    100.0
  Authorized                        98.7    100.0
  Management review                 97.3    100.0
  Staff review                      97.3    100.0
  Archived                          90.7     99.4
Documents fulfilling all 6
  requirements, %                   63.3     84.4
Documents fulfilling 5
  requirements, excluding
  archived, %                       84.5     97.3

(a) Higher percentile is better relative to performance.

(b) Median institution.

Table 7. Associations Between Practice Variables and Document
Control Fulfillment Rates

  Document                                                   Median
   Control                                    No. of       Fulfillment
  Practices        Associated Variable      Institutions     Rate, %

Documents       Resident training program
  are current       Yes                          26           94.7
                    No                           78           100.0

Documents       CAP inspection within
  reviewed by     the past 2 y
  management        Yes                          90           87.0
                    No                           14           79.4

Document        Teaching hospital
  reviewed          Yes                          40           75.4
  by staff          No                           57           89.3

                Signatures/initials of
                  review by each staff
                  member for new
                  documents are
                  maintained on a
                  paper document
                    Yes                          98           88.0
                    No                           18           67.4

Abbreviation: CAP, College of American Pathologists.
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