Quest Diagnostics 2008 Annual Report Download - page 25

office laboratories, blood banks and clinics, and a sales force that sells our point-of-care tests to customers
globally. We also have a sales force that focuses on our clinical trials services to drug developers. We focus our
sales efforts on obtaining and retaining profitable accounts. We have an active customer management process to
evaluate the growth potential and profitability of all accounts.
Information Technology. Information systems are used extensively in virtually all aspects of our business,
including clinical laboratory testing, test reporting, billing, customer service, logistics and management of medical
data. We endeavor to establish systems that create value and efficiencies for our patients and customers. The
successful delivery of our services depends, in part, on the continued and uninterrupted performance of our
information technology systems.
We believe that our healthcare information technology systems help differentiate us favorably. Innovations in
our healthcare information technology have the potential to improve patient care, promote efficiency and reduce
expense. Both at the federal and state levels, there are public and private efforts to bring together healthcare
providers, information technology vendors and other stakeholders to facilitate the creation of standards for the
exchange and use of electronic healthcare data, including standard clinical code sets.
Some of our historic growth has come through acquisitions and we continue to use non-standardized billing,
laboratory or other core information systems. We have standardized some of our systems and are implementing
standard laboratory information and billing systems across our operations, including those from our most recent
acquisitions. We expect implementation will take several more years to complete, and will result in significantly
more centralized systems, improve operating efficiency, provide management with more timely and
comprehensive information and enhance control over our operational environment.
Quality Assurance. In our clinical testing business, our goal is to continually improve the processes for
collection, storage and transportation of patient specimens, as well as the precision and accuracy of analysis and
result reporting. Our quality assurance efforts focus on positive patient identification of specimens and reports,
proficiency testing, process audits, statistical process control and personnel training for all of our laboratories and
patient service centers. We also focus on the licensing, credentialing, training and competency of our professional
and technical staff. We are implementing an enhanced specimen tracking system, with global positioning system
capabilities, that will enable us to better track specimens. We continue to implement our Six Sigma and
standardization initiatives to help achieve our goal of becoming recognized as the undisputed quality leader in the
healthcare services industry. In addition, some of our laboratories have achieved International Organization for
Standardization, or ISO, certification. These certifications are international standards for quality management
systems.
As part of our comprehensive quality assurance program, we have internal proficiency testing, extensive
quality control and rigorous process audits for our clinical laboratory operations. For most clinical laboratory
tests, quality control samples are processed in parallel with the analysis of patient specimens. The results of tests
on these quality control samples are monitored to identify trends, biases or imprecision in our analytical
processes.
We participate in external proficiency testing and have accreditation for our clinical laboratory operations
from various regulatory agencies, such as CMS, the College of American Pathologists (“CAP”) and certain states.
All of our laboratories participate in various external quality surveillance programs. They include, but are not
limited to, proficiency testing programs administered by CAP, as well as some state agencies. CAP is an
independent, non-governmental organization of board-certified pathologists approved by CMS to inspect clinical
laboratories to determine compliance with the standards required by the Clinical Laboratory Improvement
Amendments of 1988 (“CLIA”). CAP offers an accreditation program to which laboratories may voluntarily
subscribe. All of our major regional and esoteric laboratories, including our recently-opened facility in India, and
most of our rapid response laboratories, are accredited by CAP. Accreditation includes on-site inspections and
participation in the CAP (or equivalent) proficiency testing program. Also, all of our cytotechnologists and
pathologists participate in an individual proficiency testing program.
Our diagnostic products businesses, Focus Diagnostics, Enterix and HemoCue, maintain extensive quality
assurance programs focused on compliance with applicable regulatory requirements in the United States, Europe
and Australia. They are regulated by the FDA and are required to be in compliance with the Quality Systems
Regulations, 21 CFR part 820. In addition, they maintain sites certified in accordance with, or audited by the
deemed authority for, ISO 13485: 2003 standards. We endeavor to design and manufacture our diagnostics
products in compliance with Quality Systems Regulations so that the finished products are safe and effective. In
addition, the diagnostics products businesses maintain procedures designed to ensure that products we purchase
conform to the manufacturer’s specifications.
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