The term document control refers to a group of information-management

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1 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 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: ) 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 Accepted for publication October 16, 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 ( paul@valenstein.org). 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 ( 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 stan- 942 Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al

2 dard IM.2.20 ( Information security and data integrity ), which appears in its Comprehensive Accreditation Manual for Hospitals 4 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, Table 1. Demographic Institution Demographics Institutions No. % Institution type Private, nonprofit State, county, or city hospital Governmental, federal University hospital Private, profit Private, independent laboratory Children s hospital Other Occupied beds, No Institution location City Suburban Rural Federal installation laboratory Governmental affiliation Nongovernmental Governmental, nonfederal Governmental, federal 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. Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al 943

3 Table 2. Laboratory Practices Related to Document Control Practice Institutions No. % Predominant method used to indicate that management has initially authorized new policies and procedures Laboratory director or director s appointee signs paper document Laboratory director or director s appointee signs paper signature page adjacent to a notation that lists each document Laboratory documents are maintained online, and an electronic method is used to indicate that the director or director s appointee has approved documents Other Predominant method used to indicate that management has reviewed policies and procedures Laboratory director or director s appointee signs paper document Laboratory director or director s appointee signs paper signature page adjacent to a notation that lists each document Laboratory documents are maintained online, and an electronic method is used to indicate that the director or director s appointee has reviewed documents Other Predominant method used to indicate that management has initially authorized forms and work aids Laboratory director or director s appointee signs paper document Laboratory director or director s appointee signs paper signature page adjacent to a notation that lists each document Laboratory documents are maintained online and an electronic method is used to indicate that director or director s appointee has approved documents Appendix to, or part of, document authorization process Not authorized, approved or documented Other Predominant method used to indicate that management has reviewed forms and work aids Laboratory director or director s appointee signs paper document Laboratory director or director s appointee signs paper signature page adjacent to a notation that lists each document Laboratory documents are maintained online, and an electronic method is used to indicate that director or director s appointee has reviewed documents Work aids are either not reviewed by management or the review is not documented Appendix to, or part of, document review process Other Predominant method used to store old policies and procedures that are no longer current Paper copy Electronic copy Other Predominant storage place for old policies and procedures Stored off-site Stored on-site 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 No Time since last change of laboratory director, mo Laboratory uses manufacturers printed inserts as laboratory procedures Yes No Laboratory uses a commercially available product or service for document control Yes No Best description of how document control responsibilities are divided within laboratory All documents are authorized and reviewed by laboratory medical director or administrative director Section-specific documents are authorized and reviewed by the section medical director or section manager/supervisor Other Individual primarily responsible for creating and distributing work aids Section manager/supervisor Lead or bench technologists Laboratory medical director or administrative director Section medical director Other Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al

4 Practice Table 2. Continued Institutions No. % Predominant method used to store old forms and work aids that were no longer current Paper Electronic Not saved Other Predominant storage place for old forms and work aids Stored off-site Stored on-site Predominant method used to indicate that new documents have been reviewed by staff Signatures/initials of review are maintained on paper document Message (paper or electronic) is issued that informs staff about the new procedure and instructs them to review, but no documentation is normally maintained Electronic process used to record that staff members have reviewed the document ( from staff members or other method) No documentation maintained Other Predominant method used to indicate that updated documents have been reviewed by staff Signatures/initials of review are maintained on paper document Message (paper or electronic) is issued that informs staff about the update and instructs them to review, but no documentation is normally maintained Electronic process used to record that staff members have reviewed the document ( from staff members or other method) No documentation maintained Other Documents available on an intranet or through a computer system (multiple responses allowed) Yes, most ( 50%) policies and procedures Yes, most ( 50%) forms Yes, most ( 50%) work aids None of the above Time since laboratory underwent an on-site inspection by representatives of the laboratory s main accrediting/certifying agency, mo Citation for failure to control documents during last external laboratory inspection Yes No 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 Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al 945

5 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 Table 3. Types of Documents Reviewed and Laboratory Sections Affected Document/Section Affected Demographic No. % Document Type Policy or procedure Form Work aid Laboratory Section Chemistry/Hematology/Coagulation Microbiology Transfusion service Test ordering/specimen processing Histology/cytology Call center or client services Other 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. 946 Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al

6 Table 4. Fulfillment of Control Requirements by Document Type Documents, No. (%) Control Requirement All Documents a (n 8814) Policy or Procedure (n 6978) Form (n 1193) Work Aid (n 632) Documents fulfilling all 6 requirements 3113 (35.3) 2804 (40.2) 204 (17.1) 101 (16.0) Documents fulfilling individual requirements Available all shifts/locations 8564 (97.2) 6824 (97.8) 1142 (95.7) 587 (92.9) Current/up-to-date 8382 (95.1) 6699 (96.0) 1110 (93.0) 562 (88.9) Authorized 7520 (85.3) 6434 (92.2) 743 (62.3) 333 (52.7) Management review 7344 (83.3) 6314 (90.5) 716 (60.0) 303 (47.9) Staff review 6810 (77.3) 5762 (82.6) 694 (58.2) 345 (54.6) Archived 4407 (50.0) 3713 (53.2) 489 (41.0) 201 (31.8) a Some documents were not classified by participants as to type. 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 Table 5. Fulfillment of Control Requirements by Laboratory Section Documents, No. (%) All Documents a (n 8814) Test Ordering/ Processing (n 1123) Chem/Heme/ Coag (n 2951) Microbiology (n 1266) Transfusion Service (n 1127) Histology/ Cytology (n 732) Call Center/ Client Service (n 151) Other Sections (n 1322) Documents fulfilling all 6 requirements 3113 (35.3) 364 (32.4) 1023 (34.7) 435 (34.4) 528 (46.9) 281 (38.4) 20 (13.2) 418 (31.6) Documents fulfilling individual requirements Available all shifts/locations 8564 (97.2) 1089 (97.0) 2898 (98.2) 1229 (97.1) 1108 (98.3) 695 (94.9) 148 (98.0) 1261 (95.4) Authorized 7520 (85.3) 934 (83.2) 2496 (84.6) 1111 (87.8) 1014 (90.0) 632 (86.3) 122 (80.8) 1094 (82.8) Current/up-to-date 8382 (95.1) 1064 (94.7) 2816 (95.4) 1182 (93.4) 1107 (98.2) 705 (96.3) 149 (98.7) 1226 (92.7) Management review 7344 (83.3) 947 (84.3) 2465 (83.5) 1001 (79.1) 986 (87.5) 622 (85.0) 124 (82.1) 1078 (81.5) Staff review 6810 (77.3) 864 (76.9) 2332 (79.0) 996 (78.7) 954 (84.6) 570 (77.9) 112 (74.2) 879 (66.5) Archived 447 (50.0) 507 (45.1) 1462 (49.5) 636 (50.2) 667 (59.2) 369 (50.4) 45 (29.8) 649 (49.1) Abbreviation: Chem/heme/coag, chemistry/hematology/coagulation. a Some documents were not assigned by participants to laboratory sections. Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al 947

7 Table 6. Document Control Performance Among 120 Institutions All Institutions Percentiles a 10th 25th 50th b 75th 90th Documents fulfilling individual document control requirements, % Available all shifts/locations Current Authorized Management review Staff review Archived Documents fulfilling all 6 requirements, % Documents fulfilling 5 requirements, excluding archived, % a Higher percentile is better relative to performance. b Median institution. 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 Table 7. Associations Between Practice Variables and Document Control Fulfillment Rates Document Control Practices Associated Variable No. of Institutions Median Fulfillment Rate, % Documents are current Resident training program Yes No Documents reviewed by management CAP inspection within the past 2 y Yes No Document reviewed by staff Teaching hospital Yes No Signatures/initials of review by each staff member for new documents are maintained on a paper document Yes No Abbreviation: CAP, College of American Pathologists. 948 Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al

8 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; Health Insurance Portability and Accountability Act of 1996, Pub L No , 120 Stat (1996). 3. College of American Pathologists (CAP). Laboratory General Checklist: Laboratory Accreditation Program. Northfield, IL; CAP publications GEN.20375, GEN.20376, GEN Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: JCAHO; Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing. Oakbrook Terrace, IL: JCAHO; Clinical Laboratory Standards Institute (CLSI). Application of a Quality Management System Model for Laboratory Services; Approved Guidelines. 3rd ed. Wayne, PA: CLSI; NCCLS document GP26-A3. 7. International Organization for Standardization (ISO). Medical Laboratories Particular Requirements for Quality and Competence. Geneva, Switzerland: ISO; ISO Standard 15189:2007, American Association of Blood Banks (AABB). Policies, processes and procedures. In: Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB; Standard American Association of Blood Banks (AABB). Document and records. In: Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB; Standards 6.0, 6.1, Laboratory requirements: standard procedure manual. Fed Regist. 2004; 42(3): To be codified at 42 CFR Laboratory requirements: standard retention requirements: test procedure. Fed Regist. 2004;42(3): To be codified at 42 CFR (2). 12. Howanitz PJ. Quality assurance measurements in departments of pathology and laboratory medicine. Arch Pathol Lab Med. 1990;114: 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: Arch Pathol Lab Med Vol 133, June 2009 Document Control Valenstein et al 949