When unusable blood samples from Emergency Department (ED) patients kept turning up at a hospital laboratory recently, the lab team engaged the ED to search together for an answer.

It all began when the lab noticed a major spike in the number of hemolyzed blood specimens coming from ED patients over the course of a month. Hemolysis — the breaking of the membrane of red blood cells resulting in leakage of hemoglobin into the surrounding fluid – typically renders blood specimens unusable. While a common problem in laboratory medicine,  especially in samples from EDs because of the fast-paced nature of their work, the growing number of these hemolyzed specimens was alarming. The lab was being forced to reject the samples and, as a result, patients were being subjected to the inconvenience and discomfort of a second blood draw. Patient dissatisfaction levels were mounting. And, perhaps most concerning was that the time-consuming redraws had the potential to delay treatment for those most in need of a rapid emergency response.

Although hemolyzed specimens can signify other conditions, such as hemolytic anemia, in most cases, they are due to pre-analytic issues related to the incorrect collection, handling and storage of samples. Suspecting the problem was most likely related to competency, the lab team, with the aid of COLA’S Quality Assessment (QA) criteria related to pre-analytic issues, began its investigation by partnering with the ED’s nurses and phlebotomists. The lab team observed nurses and phlebotomists as they performed blood draws. However, they could not link the hemolyzed blood specimens to any specific individuals. Having ruled out competency as the cause, the team took another step in their investigation.

After further investigation, the problem was eventually traced to a specific lot number of vacutainer needles that were being used by ER personnel. As the result of a manufacturing defect, the affected needles had small burrs inside their barrels. As blood flowed through the needle barrel, red blood cells were being punctured by the burrs, leading to hemolysis.

The lot number of needles that was affected by this abnormality was immediately removed from use in the hospital, and the manufacturer also recalled all other affected lots at other facilities. The rate of hemolyzed specimens at the hospital ED returned to expected rates shortly thereafter.

Laboratorians, nurses, physicians and other providers must work together to achieve the highest standards of patient care, including ensuring that all phases of testing are done right so that lab results are accurate and the patient experience is a positive one.   Using COLA’s Quality Assessment (QA) Plan, the multi-disciplinary team was able to continuously monitor laboratory performance and services to detect and identify potential problems and help the team work in collaboration to investigate to determine the root cause, implement corrective actions and monitor to ensure the problem does not reoccur.

As this example illustrates, working together as a team and having a solid QA plan are  essential to creating a culture of quality and patient safety for laboratory medicine in any healthcare system.  Following are some recommended steps for developing a QA plan which monitors all phases of lab testing:

  1. State the purpose of your plan, and list your goals

  2. Describe what you will review (i.e., the path of workflow and all of your quality systems), the standards that you expect, and how you will collect data to assess your laboratory’s activities

  3. Describe how you will implement the plan, and schedule and perform reviews

  4. Describe how you will respond to identified problems, methods for corrective action, and how follow-up reviews will be scheduled and performed

  5. Develop forms for documenting observed problems, collecting data, performing reviews, and documenting all QA activities

  6. Describe how you will share findings with your Laboratory Director, staff, and other appropriate parties

  7. Engage other healthcare professionals in the root cause analysis and ensure you close the loop on the outcome.

To learn more about COLA’s recommended QA Plan, you can access a copy of the complimentary COLA Lab Guide on Quality Assessment here.