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Are accrediting agencies failing to take a close look at the pre-analytical aspects of clinical laboratory testing? If so, is it sending a signal that training and continuing education for the phlebotomist is of secondary importance?

Throughout my career, I have participated in a variety of accreditation inspections. I am always shocked by the limited focus inspectors place on sample collection and handling. Typically, the inspections are heavily focused on the analytical phase of testing. In 30 years, I have rarely seen an inspector interview or observe a phlebotomist or specimen processor, much less go offsite to a patient service center. 

As a phlebotomy instructor and supervisor, I always share what students and staff may see out in the real world, and why they need to stand up and do the right thing. Recently, I was reminded why standing on that soapbox and preaching about ethics and quality is so important.

A former student, “Sue” called recently to say she appreciated the training she received and the stories about what she may encounter in the workplace. Sue was shocked when my predictions came true. Sue had just started a new job as a phlebotomist in a state that does not require phlebotomy certification. Sue was working with another phlebotomist at a patient service center and realized after the patient had left that only a serum separator tube (SST) had been drawn. The physician’s order called for a CBC to be collected along with the chemistry panel. Sue stated to her co-worker that she needed to call the patient back. The co-worker replied, "We don’t call the patient back, we can just pour some specimen from the SST into the EDTA."

My former student found herself in the exact situation I had described early on in her training. That of an employee being asked to do something, knowing it will negatively affect the quality of the sample collected. Does she speak up, call her supervisor, or go with the flow and not make waves? I have always challenged my students and co-workers to treat each patient sample as though it were from someone they loved. Sue spoke up. She explained that pouring the sample from the SST, which contains a clot activator, into an EDTA tube would jeopardize the quality of the sample, as micro-clots and platelet clumps may have formed. That doing so could delay or prevent the provider from correctly diagnosing the patient and initiating appropriate treatment in a timely manner. Eventually, the patient was recalled.

On another occasion Sue noted that a plain, red-top tube was not collected for a therapeutic drug level that requires serum from a non-gel separator tube. Again, Sue suggested the patient be called back. She was told "No, just let the SST clot upside down. It will be fine!"

When phlebotomists make these kinds of decisions in the field, we have to wonder the reason. Is it a matter of ethics (i.e., what you do when no one is looking)? Or is it due to a lack of proper training, with clinical laboratories contributing to the problem by not providing regular and comprehensive competency checks? My guess is, in most cases, it is the latter.

If it were an ethics issue, the unorthodox practices described would not be so widespread. When new phlebotomists are taught improper technique by senior staff members, it demonstrates a general lack of understanding of preanalytical errors and their causes. The importance of specimen quality and the "accuracy depends on me" mentality is missing. Laboratories must invest in staff members who are responsible for the quality of blood sample collection and handling. A Clinical Laboratory Scientist (CLS) can perform the assay and report the result, but if the blood in an SST was poured into an EDTA tube a few minutes after collection, is the CLS reporting an accurate result? Or, if the SST was allowed to clot upside down (as suggested), then spun and poured off, is the reported therapeutic drug level going to assist the provider in properly dosing and treating the patient? On both accounts, the answer is "no."

What happens at your facility? Are the proper preanalytical processes followed or improvised? Are serum samples allowed to fully clot and then centrifuged within the appropriate time frame? Are specimens spun, refrigerated, or frozen in accordance with test requirements? Are patient samples stored in such a way to maintain integrity until and during transport to the testing laboratory? Are remote patient service centers equipped with a centrifuge, refrigerator and freezer?

If inspectors asked more of phlebotomists and processors, laboratories would be forced to place more emphasis on education and training. When facilities invest in the ongoing education of their pre-analytical staff, the investment produces knowledgeable and skilled healthcare professionals who more readily recognize and fulfill the crucial role they play in delivering accurate results.

Stephanie Ponti, CPT1 is a Phlebotomy Supervisor at Dignity Health and Phlebotomy Instructor at Cuesta College in San Luis Obispo, California.