Ask the Expert: Assessing Quality in Your Lab

This month I am forgoing questions and focusing on one issue. Quality Assessment.

All laboratories, whether Waived or Non-Waived, need a solid QA plan in place. For Non-Waived labs it is required, for Waived labs it is a good idea. A good QA plan focuses on things that happen before testing takes place (pre-analytical), things that happen during the testing (analytical) and things that happen after testing (post-analytical).

Should problems be identified or should opportunities for improvement present themselves, corrective action should be taken to insure and maintain a high level of patient care.

Since the QA program is designed to improve patient care, it should continuously identify and monitor potential problems which may deter the delivery of optimal services. The program should objectively assess the scope of the problems and determine priorities for investigating and resolving problems.

The laboratory staff is responsible for compiling data, investigating and documenting all quality assessment activities and reporting to the Lab Director.

All reports and studies will be considered confidential under HIPPA guidelines. The following documents, reports, data, etc. are the items that would be reviewed.

  • Lab request slips or data entry
  • Test results
  • QC results
  • All maintenance logs, calibration records and instrument print-outs
  • Problem and error logs
  • Incident reports
  • QA logs
  • Personnel records
  • Training and competency records

The above items are called Quality Indicators. Quality Indicators selected should:

  • Evaluate the total testing process from when the test order is received to specimen collection to analysis to reporting of the results.
  • Target areas which need problem solving
  • Be areas that are capable of being monitored

Quality Indicators are grouped into the following categories

    1. Personnel qualifications, training and performance evaluation
    2. Evaluation of physical environment for safety compliance
    3. Monitoring confidentiality of patient information
    4. Monitoring patient and specimen identification, labeling and integrity of the specimen
    5. Communication and complaint investigation
    6. Evaluation of Proficiency Testing
    7. Retention of records and print-outs
    1. Test tracking (requisitions)
    2. Specimen handling, collection and labeling
    3. Specimen referral process
    1. Monitor supply and storage of reagents, test equipment, instruments, and materials
    2. Verification of calibration, QC and maintenance records
    3. Review of reference ranges and limits
    4. Review of testing records
    1. Results reporting, verification of records and procedures for corrected reports
    2. Documentation of critical values and turnaround time evaluation


Tabulated data can indicate that no problem exists for a given indicator and there may not be a need for corrective action. If corrective action is indicated, provide a place on the report form to show the actions taken as well as follow up to show the actions were effective.

Here is an example of how to use the above information. I know just reading it can be like understanding the tax code, so an example is a better way to show it.

In January each year, you decide you will review the personnel records. (Under GENERAL)

You decide to make the items reviewed the following:

1. Does everyone performing testing have documentation of training for that testing?

2. Does everyone performing testing have documentation of competency for that testing?

3. Is their documentation of education meeting CLIA and state requirements?

4. Has everyone been assessed for competency at the required CLIA intervals?

5. Has everyone participated in Proficiency Testing that performs testing?

So this is your checklist. Once you have looked all records over and talked to all involved, you end up with a “Yes or No” beside each column. For all “No” answers, you must show a definition of what the problem is, what will be done to correct the problem, a date by which the problem will be corrected, and a follow up to make sure the problem is stays fixed.

Once completed, have all involved sign off on the review, including the Lab Director.

I hope this has been helpful and gives you some good ideas for assessing quality in your lab.