Patient Safety Program


COLA began its Patient Safety Program in 2008.  Each year, COLA focuses on an area of laboratory medicine that has high error rates and significant impact on patient safety. COLA develops education on best practices for the implementation of the selected area.

Topics covered have included the following:

  • The importance of proper patient identification
  • Identifying specimens across the path of workflow
  • Safe storage of blood for transfusion
  • Universal Precautions
  • Hand Hygiene

 COLA members can access the current and past Patient Safety Materials via the Education Center on COLAcentral.


The COLA Patient Safety Goal for 2021 is:


WAV 1: Are manufacturer’s instructions followed in the performance of each waived testing procedure and are all kits, reagents, and controls stored according to manufacturer requirements?

WAV 2: Is all Quality Control performed per manufacturer’s instructions, and are the results of QC recorded, reviewed, and found to be acceptable prior to patient result reporting?


Waived testing is not completely error proof. Errors occur especially when manufacturer’s instructions are not followed and when testing personnel are not appropriately trained. This can result in a significant impact on patient care. For example, waived test results can be used to adjust medications for diabetics or patients undergoing anticoagulant therapy. Erroneous test results for diseases such as HIV-1 can have unintended consequences. Test results used to monitor the spread of infection during a pandemic can have social and economic impacts if results are not accurate. To minimize the risk of erroneous results, it is important that the testing personnel are trained appropriately, the tests are performed correctly, and good laboratory practices are in place.

Proper storage of test kits is essential to preserve the stability of all reagents. Improper storage of the test kit and/or components can affect the results of the test. Follow the instructions in the package insert for the correct storage temperature for the test kits, and make sure the temperature is monitored and recorded daily. Corrective action must be performed and documented if temperature exceeds the manufacturer’s requirements.

Another important aspect of waived testing is quality control. The test system may contain both internal and external controls. When quality control gives expected results defined by the manufacturer, this ensures that the test has been performed appropriately. Testing personnel must be trained on the proper performance of quality control, interpretation of the results, and when patient results may be reported. QC must always be documented, along with any corrective action when QC does not give expected results.

There may be an occasion when the manufacturer will institute a change in a procedure. These changes will be reflected in the package insert. To help draw your attention to a change, the manufacturer may also place a separate insert/notice in the test kit. It is important to check for changes/revisions to the package insert when a new shipment of tests arrives. An easy way to check for these changes is to compare the revision date (e.g. REV 1/2021) of the package insert from the last shipment of the same test to the revision date of the package insert in the new shipment of tests. If the revision dates are different, something in that package insert has changed. Examine both package inserts side by side and locate the change(s). If the manufacturer has made a change to the procedure, the lab must revise their existing procedure to include the change. The Lab Director must sign and date the revised procedure and documented training for all testing personnel on the revised procedure must take place before patient testing begins again.

Proper training for all testing personnel on all these elements will ensure quality laboratory results for your patients.


COLA’s Previous Safety Goals

  • COLA Patient Safety Program 2008: Patient Identification
  • COLA Patient Safety Program 2009: Specimen Identification
  • COLA Patient Safety Program 2010: Specimen ID Across the Path of Workflow
  • COLA Patient Safety Program 2011: Reporting Panic Results
  • COLA Patient Safety Program 2012:  FDA voluntary reporting of device-related adverse events
  • COLA Patient Safety Program 2013: Patient Identification
  • COLA Patient Safety Program 2014: Safe storage of blood for transfusion
  • COLA Patient Safety Program 2015:  Universal Precautions
  • COLA Patient Safety Program 2016:  Hand Hygiene
  • COLA Patient Safety Program 2017:  Risk Management
  • COLA Patient Safety Program 2018:  Patient Identification
  • COLA Patient Safety Program 2019:  Specimen Integrity
  • COLA Patient Safety Program 2021: Waived Testing

Click Here to Download Previous Safety Goal Documents


Other Safety Resources

  • COLA Lab Guide 53 – Individual Quality Control Plans