Quality Management Assessment

Qualifying Continued Improvement.

How Complete and Effective is Your Quality Management System?

Why is this important?
All regulatory and accrediting organizations require a medical laboratory to have a quality program.

How up-to-date is your quality system?
Many laboratories are not aware of the differences that exist between quality control (QC), quality assurance (QA), and quality management system (QMS). Add in the requirement of laboratories to have a quality policy and quality plan, and many find it a challenge to keep it simple and meaningful.

Quality Management Assessment:

In response to client requests, Chi has developed a service that will provide an external assessment of your quality program, identify gaps in performance, and provide recommendations for bringing the current system into compliance.

The assessment consists of three activities:

  1. Data Collection: Chi will review the desired policies, procedures, and performance management documents prior to the onsite visit.
  2. Onsite QMS Audit: The audit will consist of an onsite visit by a Chi Senior Operations Consultant that will include a facility tour and interviews with key individuals responsible for the QMS program and the leaders responsible for its oversight to identify the level of leadership involvement and support of the QMS program.
  3. Gap Analysis and Recommendations for Improvement: The audit findings will consist of a documented gap analysis of the current quality program with prioritized recommendations. The analysis will identify any high-risk areas that could potentially impact patient safety and/or the ability of the laboratory to maintain CMS licensure and current accreditation status.
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