Q&A: CAP Accreditation and Document Control: What You Need to Know

Questions and Answers: *The following questions and answers were prepared by MasterControl Inc., a leading provider of quality management software solutions for companies in regulated environments. Q: What is CAP? A: It’s the College of American Pathologists, the principal organization of board-certified pathologists that promotes excellence in the practice of pathology and laboratory medicine. It’s the world’s largest association composed exclusively of pathologists. Q: How does CAP promote excellence? A: CAP is considered the leader in providing quality improvement programs to laboratories around the world. There are 6,000 laboratories worldwide that adhere to CAP standards of excellence through accreditation. Q: What is CAP accreditation? A: The CAP Laboratory Accreditation Program aims to improve the quality of clinical laboratory services through voluntary participation, professional peer review, education, and compliance with established performance standards. An accredited laboratory is inspected by a private, non-profit accrediting organization approved by the Centers for Medicare and Medicaid Services (CMS). Q: What are the benefits of CAP accreditation? A: CAP accreditation helps laboratories meet, if not exceed, federal requirements. They benefit from an efficient process that saves time, promotes standardization, and helps ensure quality patient care. CAP has CMS authority to accredit all Clinical Laboratory Improvement Amendment (CLIA) specialties and subspecialties and recognition by the Joint Accreditation of Health Care Organizations (JCAHO) as an equivalent program in JCAHO-accredited institutions. Q: What does it take to be accredited by CAP? A: The CAP Accreditation Standards set the requirements for laboratories on such things as leadership (director), physical facilities and safety, quality control and performance improvement, and inspection. The inspection program consists of on-site inspection by an external team and interim self-inspection. CAP provides checklists designed to implement the standards. Q: What is document control and why is it important in CAP accreditation? A: Document control refers to a system or process for controlling the creation, review, approval, distribution, version, and change control of documents, usually in connection with compliance to quality standards or regulations.

CAP Accreditation and Document Control

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CAP checklists are updated periodically. The 2004 and 2005 checklists for “Laboratory General,” for example, include this question: “Does the laboratory have a document control system?” In this context, CAP requires that: “The laboratory should have a document management or control system to assure that 1) all copies (paper and electronic) of policies and procedures are current; 2) personnel have read the policies/procedures relevant to their job activities; and 3) all policies/ procedures have been authorized by the laboratory director or designee before implementation; 4) policies and procedures are reviewed at least annually by the laboratory director or designee; 5) discontinued policies/procedures are kept in a separate file for a minimum of two years after the date of discontinuation (five years for transfusion medicine)….” The 2005 checklists for other types of laboratories, from anatomic pathology to urinalysis, contain a document control requirement for electronic manuals. In a question pertaining to availability of a complete procedure manual at the workbench or in the work area, this note follows: “Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies to be available for routine operation of the laboratory, so long as the electronic versions are readily available to all personnel. Such electronic versions must be subjected to proper document control (i.e., only authorized persons may make changes, changes are dated/signed [manual or electronic], and there is documentation of periodic review)….” Q: How can MasterControl help laboratories achieve or maintain CAP accreditation? A: MasterControl Inc. is a pioneer in developing software solutions designed for industries in regulated environments. Hundreds of companies worldwide rely on MasterControl to help them automate, document, track, and manage their quality processes. Similarly, thousands of laboratories worldwide that adhere to CAP standards can utilize the MasterControl™ quality suite for meeting CAP document control and other related requirements. MasterControl, which is configurable and easy to use, provides a secure and centralized repository for all documents and records for easy search and retrieval. Following are some of the requirements found in CAP’s “Laboratory General” checklist pertaining to quality management and the relevant MasterControl features. HIGHLIGHTS FROM THE CAP “LABORATORY GENERAL” CHECKLIST MASTERCONTROL MODULES AND THEIR FEATURES

Does the laboratory have a document control system? MasterControl Documents™, automates paperbased or hybrid document control processes to improve efficiency and ensure compliance. It offers advanced routing, approval, and escalation. The “Check-in” and “Check-out” feature ensures that only the current version of a document is being used. Automated revision control guarantees documents will not be overwritten.

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Are all quality management procedures, forms, and records maintained under document control?

MasterControl Documents™ can handle all types of documents, regardless of the software used to create them. It maintains a time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record, when the action occurred, and the changes made to the record. MasterControl Forms™ automates any forms-based process and offers best-practice features that prompt users with selected data. It makes the transition from manual or hybrid system to automated system easier because it allows users to create electronic forms identical to their existing paper forms. Forms created in Microsoft Word, Excel, or PowerPoint, can be converted to PDF as is. Companies can also design new forms to suit their needs.

Are graphical tools (charts and graphs) used to communicate quality findings? Has the laboratory documented education of its personnel in the FDA procedure for voluntary reporting of device-related serious adverse patient events?

MasterControl Documents™ provides customizable reporting and graphing capability to monitor quality trends and other processes. MasterControl Training™ will help you execute, document, track, and manage all your training requirements in a timely manner. Integrate it with MasterControl Documents™ to automatically task trainees when required SOPs or other documents change and a new training becomes necessary.

Is there documented certified training of all personnel MasterControl Training™ allows the creation in the packaging and shipping of infectious materials? and deployment of simple or extensive training courses that require trainees to learn their tasks and demonstrate competency. You can create, update, and control trainee examinations better. Is there documentation of retraining and reassessment With MasterControl Training’s exam feature, you’ll for employees who initially fail to demonstrate always be ready to show the proof of your employees’ satisfactory performance on competency assessment? proficiency. Approved tests are linked to a course and sent out as part of a training task. It automatically grades the exam and either passes the employee, or directs them to additional training. To get a picture of your training status, you can run a report, including how many failed and need to be retrained.

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About MasterControl Inc. MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210211, 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com, or call, 800-825-9117.

MasterControl’s integrated quality management system helps connect quality processes enterprise-wide. The solution provides automatic triggers to ensure tasks for handling quality-related incidents don’t fall through the cracks. MasterControl’s integrated architecture ensures that the completion of one system process automatically launches the next quality sub-system until the process loop is closed. Managers have analytical and reporting capabilities at their fingertips to track and manage each quality process through completion.

© 2006 MasterControl Inc. All rights reserved.

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MasterControl Inc. 60 S. 000 E. Suite 10 Salt Lake City, UT 811 P. 800.8.9117 F. 801.9.7088 www.MasterControl.com

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