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CAP Announces Major Changes to Accreditation Program

The CAP today announced significant changes to the way its Laboratory
Accreditation Program (LAP) inspects and monitors the performance of
participating laboratories, including new techniques, tools and training
requirements for its inspectors and technology to closely monitor ongoing
compliance.

"The CAP believes these initiatives will enhance the consistency and
effectiveness of our inspection process, strengthen monitoring of laboratory
quality between inspections and reaffirm public confidence in the
accreditation process," said R. Bruce Williams, MD, FCAP, who chairs the
College's Commission on Laboratory Accreditation.

"The unfortunate incidents at Maryland General Hospital that came to light
in 2004 prompted the College to re-evaluate its accreditation process," he
said. "We believe the changes we announce today, and those made earlier,
will go far toward preventing another case like Maryland General from
occurring.

"The CAP is absolutely committed to ensuring quality through stringent
standards for our accredited laboratories. We're also demanding more of
ourselves. Being the best means striving continuously to be better, which
has been the foundation of this program for the past 45 years."

The comprehensive LAP changes announced today come in several areas:

New inspection techniques and tools

The College will train its inspection teams to uniformly employ best
practices, such as specimen tracking that requires more interaction with
laboratory personnel and direct observation of testing to ensure written
policies and procedures reflect actual laboratory practice. Teams also will
have in hand new checklist questions, instituted in October, to better gauge
laboratory compliance with CAP patient safety goals; and a new checklist to
assess the effectiveness and responsibilities of laboratory directors.

Knowledge Management for Sustained compliance

The College will invest more than $9 million over two years for new and
improved information systems and processes to strengthen the quality of the
LAP. Collectively, these investments will provide a basis for sustained
compliance by more continuously monitoring laboratory performance throughout
the entire accreditation cycle (before, during and after onsite
inspections). The CAP also will conduct validation surveys, beginning in
2006, for a percentage of its accredited laboratories to detect problems
between routine inspections and assess the effectiveness of the many changes
to its accreditation process.

Mandatory inspector training

To promote a consistent understanding of program standards and ensure
uniform application of techniques to achieve consistent, effective
inspections, mandatory training will be required for all inspection team
leaders assigned after July 2006. Mandatory training also is planned for
team members.

The initiatives announced today build upon previously announced changes to
the LAP program. Those earlier measures include a decision to begin
conducting all inspections, routine or otherwise, on an unannounced basis
beginning in spring 2006. As part of this change, the laboratory will not
know the date of its accreditation inspection, nor will it be told in
advance the name of its inspection team leader or team members.

Soon after the events at MGH, the College instituted new requirements to
encourage reporting of laboratory quality issues and protect personnel who
make such reports. In October 2004, all CAP accredited laboratories were
required to post a sign that provides a toll-free number for laboratory
staff to call if quality issues are not adequately addressed within their
institutions. The College also will make retaliation against an employee for
reporting quality concerns grounds for revocation of accreditation.

In another initiative already underway, the CAP continues to abide by a
structured communication protocol with the Centers for Medicare and Medicaid
Services and other accreditation stakeholders that facilitates the
identification and resolution of issues of non-compliance that may affect
quality of patient testing.

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