Laboratory quality is a continual process of education and improvement. Ensuring that effective Quality Control is being performed and that all laboratory professionals are trained and competent are only starting points to this journey towards quality. Laboratories should be engaged in continual learning, training, testing and analysis of current processes.

Just as those in the laboratories are constantly working to ensure the highest quality results are being obtained, a community of laboratory partners are working to ensure the tools and procedures being used by those on the bench are aiding in that goal of quality. Healthcare professionals collect and handle specimens with care to reduce likelihood of pre-analytical errors. Manufacturers design and create new equipment and testing systems that are increasingly accurate and efficient. Accrediting organizations (AO) create standards for their accredited labs based on existing and emerging quality practices. And at the foundation of the industry, regulators (Centers for Medicare and Medicaid Services) set regulations and asses the performance of the AO’s in promoting quality within the laboratories they serve.

What are validation surveys?

Every year, CMS, or its state agent, performs validation surveys on approximately 5 percent of an AO’s total inspected labs to assess compliance with CLIA requirements and performance of the AO. These surveys must be performed within 90 days of (or even simultaneously to) the AO’s survey or inspection.  The AO and the state reports are submitted to CMS central office where they are compared for disparities.

Disparities are discrepancies, or missed condition-level citations, by the AO.   According to CLIA regulations, CMS will conduct a review of the AO “whenever validation inspection results indicate a rate of disparity of 20 percent or more between the findings of the organization of state and those of CMS or a CMS agent for one year for accreditation organizations.”

Common issues to cause disparities are:

  • Lab Director Responsibilities – The Lab Director is responsible for the overall operation of the laboratory, and has many specific responsibilities denoted in CLIA. Most serious or systemic issues can be traced to failure of the Lab Director to oversee the core issue, such as PT, QC, QA, or personnel.  When an AO does not recognize that a Lab Director has failed to meet one of these responsibilities, a disparity may result.
  • Personnel qualifications – The CLIA regulations outline the qualifications of each required position in detail. Each person holding a position in the laboratory must not only be qualified, but must have acceptable documentation on file to demonstrate their qualifications.  This is a common cause of disparity.
  • PT Issues –Each AO must monitor the PT performance of their accredited laboratories. Failure of an AO to detect and document PT failures, corrective action for PT failures, or failure to enroll in PT for regulated anayltes has been among the top causes of disparities.
  • Analytics Systems –The “condition” level citation for Analytic Systems is often a compilation of technical failures related to QC, test performance, reagent storage, or documentation. The AO must be specific enough to match each issue that is mentioned in this category in order to avoid a disparity in Analytic Systems.

How to learn from validation surveys

It is important, as an accrediting organization to take these validation surveys as a learning opportunity and a mechanism for ensuring continual improvement and quality.

Validation surveys can be used to:

  • Tailor training and feedback to surveyors – The AOs can use disparities to identify training needs for all surveyors or for individual surveyors. These should be viewed as opportunities to learn, rather than for blame.
  • Identify common patterns and areas for improvement – By reviewing the annual validation disparity report, an AO may conclude that additional, or more specific standards, are necessary to communicate the requirements to the labs and to document the noncompliance. The annual validation disparity report should be used by AOs as they review their standards on a regular basis.
  • Create uniformity in reporting structures and procedures – An often overlooked learning opportunity from validation disparities is the openness that CMS provides to each AO to discuss the disparate issues. Each AO is assigned a CMS liaison from the central office.  Consistency and uniformity in documenting noncompliances is a goal for all regulatory partners, and one way that AOs can take steps toward this goal is to keep communication open with CMS and to take advantage of the opportunity to discuss and resolve questions related to disparities.

At all levels of the industry, we must be committed to continually assessing and improving our systems, processes, training and even mindsets to ensure the patients that we serve have the best possible care. The system will only be successful when all aspects come together with the primary focus of quality.