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 Page  Q&A

 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 MASTERCONTROL MODULES AND

“LABORATORY GENERAL” CHECKLIST THEIR FEATURES

Does the laboratory have a document control system? MasterControl Documents™, automates paper-
based 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.

CAP Accreditation and Document Control Page  Q&A

Are all quality management procedures, forms, and
records maintained under document control?
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?
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
Is there documentation of retraining and reassessment With MasterControl Training’s exam feature, you’ll
for employees who initially fail to demonstrate
satisfactory performance on competency assessment? proficiency. Approved tests are linked to a course and
CAP Accreditation and 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.
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.
courses that require trainees to learn their tasks and
demonstrate competency. You can create, update, and
control trainee examinations better.
always be ready to show the proof of your employees’
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.
Page  Q&A
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, 210-
211, 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.

CAP Accreditation and Document Control Page  Q&A

MasterControl Inc.
6340 S. 3000 E. Suite 150
Salt Lake City, UT 84121

P. 800.825.9117
F. 801.942.7088
www.MasterControl.com