Your laboratory has a number of opportunities to investigate its current practices and improve upon efficiencies and overall operations.  When your laboratory embraces continual learning and finds opportunities to improve, patient care will benefit.  I will explore three improvement opportunities during my educational sessions at the 2015 CRI® Symposium for Clinical Laboratories next month.

Nonconforming Events: Unearthing Buried Treasure

A “nonconforming event” is the internationally accepted term for something that happened in the laboratory that shouldn’t have happened. These events, called NCEs, do not conform with regulatory or accreditation requirements or the laboratory’s approved policies, processes, or procedures. NCEs represent laboratory processes that are not working as intended and are highly likely to recur; a problem that goes unreported to those who can fix it, is a problem that remains buried. Recurring NCEs waste the laboratory’s limited operating funds on repeated investigation and resolution and can expose the laboratory and parent organization to unwanted risks.

An NCE management program includes the following key activities:

  • Managing an individual NCE from discovery through closure
  • NCE data assessment process for classifying NCE data, analysis, trending and reporting
  • Management review of NCE information
  • Continual improvement opportunities identified from NCE information

Your laboratory should analyze the wealth of information uncovered from trending NCEs and remove the root cause(s) through laboratory process improvements. Don’t bury problems – dig them up and reap the savings!

Flowcharts: How to Make Them and Reap the Benefits

Most laboratorians know that laboratory work flows from an order for a laboratory test through preanalytic, analytic, and postanalytic processes to derive the laboratory’s report of test results, interpretations, and related comments. Laboratories of all sizes, scopes, and specialties have the same sequence of workflow processes, whatever level of support  is provided by automated sample processing and testing, and electronic information systems. At any level of laboratory sophistication, process flow charts provide an easy means to accomplish all of the following activities critical to quality laboratory services and patient safety:

  • Visualize laboratory work processes
  • Simplify procedure writing
  • Develop effective staff training and competence assessment programs
  • Identify and implement effective corrective actions to nonconformances.

Electronic software is not needed to produce informative, useful flow charts. A key laboratory improvement is how to document laboratory work processes as simple one-page flow charts rather than the multi-page verbal descriptions commonly called “SOPs.” Simple flow chart display methods are readily available.  Examples of common basic laboratory flow charts will prove that laboratory work is more alike than different.

Effective Training: The Path to Competence

Whatever level of education, certification, and previous experience a new hire brings to the laboratory, management should not assume this background learning confers competence in this laboratory’s processes, procedures, instruments, and information systems. All new employees need training in their respective job processes and procedures, and all employees need training for new or changed processes and procedures. Effective training programs are essential for staff to achieve the expected level of competence and are built on understanding and documenting the laboratory’s preanalytic, analytic, and postanalytic workflow processes. As discussed, flow charting laboratory processes is the basis for developing useful process and procedure documents that in turn form the basis for an effective training event. Process-based training reflects how work happens in the day-to-day routine. For example, every automated laboratory test system has the following sequence of activities:

  • Verifying sample acceptability at arrival at the analyzer
  • Verifying that the analyzer is ready for testing – OR- Performing readiness procedures such as daily maintenance and QC
  • Verifying QC acceptability
  • Loading patient samples for testing
  • Verifying proper analyzer functioning – OR – troubleshooting as needed
  • Evaluating results and taking any necessary follow-up action such as repeat testing or communicating critical values
  • Verifying the results
  • Unloading and storing samples

Training that follows work process flow helps ensure all important information is covered, helps reduce trainer-to-trainer variation, and is more effective in preparing competent staff. The approach described meets CLIA requirements for competence assessment programs.


  1. CLSI. QMS11, ed.2. Nonconforming Event Management. Wayne, PA: Clinical and Laboratory Standards Institute, 2015.

  1. CLSI. QMS02, ed.6. Development and Management of Laboratory Documents. Wayne, PA: Clinical and Laboratory Standards Institute, 2013.

  1. CLSI. QMS03, ed.4. Training and Competence Assessment. Wayne, PA: Clinical and Laboratory Standards Institute, in press for late 2015.

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