OUTCOME ORIENTED SURVEY PROCESS
CMS' objectives in developing an outcome oriented survey process
is to not only determine the laboratory's regulatory compliance
but to assist laboratories in improving patient care by emphasizing
those aspects that have a direct impact on the laboratory's
overall test performance. CMS promotes the use of an educational
survey process. The surveyor determines, based on observation of the
laboratory's (past and current) practices, interviews with the
laboratory's personnel and review of the laboratory's relevant
documented records, whether the laboratory is meeting the requirements
of the CLIA regulations to produce accurate, reliable and timely
(quality) test results. The surveyor meets the objectives by employing
an outcome-oriented/quality improvement type of survey process or
approach, the intent of which is to focus the surveyor on the overall
performance of the laboratory and the way it monitors itself, rather
than on a methodical evaluation of each standard level regulatory
requirement.
The quality assurance (QA) requirements of the laboratory regulations
(42 CFR Part 493, Subpart P) are the appropriate guide surveyors use
for organizing their review. The surveyors select a cross-section of
information (from all aspects of the laboratory operation) for review
to assess the laboratory's ability to produce quality results as
well as its ability to identify and correct problems. Emphasis is
placed on overall laboratory performance and the structures and
processes contributing to the reliability of the testing. The surveyor
reviews the selected cross-section of information to see if the
laboratory has established and implemented appropriate mechanisms for
monitoring and evaluating its practices and solving its problems. The
surveyors investigate further any test areas identified as a problem
but not addressed by the laboratory's QA program. If the
laboratory is failing to monitor (or effectively monitor) its own
systems, the surveyor can direct the laboratory to the requirements
and the relevant sections for its particular setting, thereby
accomplishing the educational aspect of the survey process.
Last Modified on Thursday, September 16, 2004
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