What Can and Can’t Your Assistant or Phlebotomist Do In A Laboratory?

As consultants, we often get asked the question, “What can my lab assistant or phlebotomist do in my laboratory?” As laboratories continue to experience a shortage of qualified individuals, and feel the pinch from PAMA reimbursements cuts that went into effect Jan 1st, 2017, many laboratories are having to find increasingly clever ways to reduce spending while maintaining the same or higher quality of patient care.

This is where a laboratory assistant or phlebotomist comes in handy. While you still need a licensed individual to perform certain essential aspects of patient testing, many other duties can be handed over to your entry level team members.

Note: If you want your assistant or phlebotomist to take on some of the more traditional medical technician or technologist roles, make sure that you are defining in their job description what they can do, and specify what they cannot do, very clearly. Make sure that you include them in your personnel competency assessments – you will want to update your competency to ensure that they are correctly performing the “Can”, and not accidentally performing the “Cannot”.

DISCLAIMER: As with everything in your laboratory, your lab director must ultimately decide what tasks they will allow unlicensed individuals to perform, and sign off on that position’s job description. This article is an opinion piece and is not necessarily acceptable in all U.S. states or provinces. Consult with your lab director and your technical consultant or supervisor before implementing any of the suggestions contained in this article.

Common Lab Activity Can Your Assistant or Phlebotomist Do It Instead?

PRE-ANALYTICAL

Record temperatures for fridges and freezers Yes – They must let a supervisor know if a result is out of range.
Record eyewash, fire extinguisher, and shower safety checks Yes – They must let a supervisor know if a result is out of range.
Perform inventory checks and ordering Yes
Enter requisitions into an LIS or EHR system Yes
Label tubes; centrifuge and pour off samples Yes
Perform daily, weekly, and monthly maintenance of instruments and equipment Yes, with documented training
Load reagents onto instruments Yes
Maintain a record of opened reagents, label reagents, dispose of expired reagents Yes
Run calibrators and quality controls on instruments Yes, with documented training
Accept the results of calibrators and quality controls NO, these have a direct effect on the accuracy of patient results. Exception: Waived tests may be performed by anyone who meets CLIA requirements.
Perform troubleshooting on an instrument Yes, with documented training
Create corrective action logs Yes, as long as they are reviewed and finalized by a CLIA approved individual who can create a corrective action plan, implement it, and follow-up on it.

ANALYTICAL

Load patient samples on an instrument that is not running, or is currently running. Yes, as long as it does not interrupt the operation of the instrument.
Start an instrument that was not previously running to test patient samples. NO. This is initiating testing of a patient sample.
Perform an activity that alters the original matrix, such as mixing in another substance. NO. This is part of the testing process. Exception: Waived tests may be performed by any individual who meets CLIA requirements.
Perform any activity (other than waived) that directly generates a patient result. NO. This is patient testing.

POST-ANALYTICAL

Enter results into an LIS or EHR system Yes
Release results from an LIS or EHR system for the doctor or caregiver to make medical decisions. NO. This is considered as making a decision regarding the accuracy of patient results. Even if a licensed individual has already approved them, most LIS and EHR systems record who released the result, making it appear as though an unlicensed individual had the final decision regarding the validity of results. Exception 1: The LIS system has a supervisor or MRO review function that prevents the final release of samples. Exception 2: Waived tests may be reported by anyone who meets CLIA requirements.
Report critical (life-threatening) results NO. This should be done by a licensed individual, and received by a licensed healthcare provider, with a read-back which includes 2 patient identifiers and the result. Documentation must be kept on both sides. Notification should be done promptly.

Written by Danielle Ziolo
June 3, 2018

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