Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Education, staffing, accreditation, and other considerations/Education and training

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4. Education, staffing, accreditation, and other considerations

Operation of a physician office laboratory (POL) requires more than a few documented procedures and some Clinical Laboratory Improvement Amendments (CLIA)-waived test kits. Even the CLIA-waived POL has to meet CLIA, HIPAA, and other regulations, while maintaining a respectable level of quality. As such, expertise in developing, running, and maintaining the lab is important, just like any other laboratory. But how should the POL be staffed, and what sort of education requirements should the staff have? This chapter briefly addresses those questions and also provides numerous other resources for both acquiring the necessary education towards medical laboratory science or technology and staffing your POL.


4.1 Education and training

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Subpart M of CLIA details requirements and responsibilities for laboratory personnel, consultants, supervisors, and directors.[1] The exception to this is a laboratory with a certificate of waiver, where personnel requirements and proficiency testing is not required. However, manufacturers' instructions must still be carefully followed, and only CLIA-waived tests may be performed by the personnel. As the American Association for Clinical Chemistry (AACC) notes in a 2021 advocacy letter, proper training of personnel conducting CLIA-waived tests is broadly found to be lacking, and when paired with high turnover of lab techs in waived testing site, this often leads to inconsistent quality throughout the enterprise.[2] Thus, despite most tests being waived, it's important for the POL to take operator training and competency seriously, engage in regular quality assessments, and participate in an accredited proficiency testing program to mitigate poor patient outcomes.[2]

For non-waived laboratories, the following resources provide paraphrasing of CLIA Subpart M. If your POL is going to engage in testing beyond CLIA-waived testing, reviewing what Subpart M means for your lab is important:

In some cases, state governments apply additional regulations and responsibilities to clinical laboratories and their personnel. According to consultancy Lighthouse Lab Services, the following states have staffing, education, and licensing requirements beyond that of CLIA[3]:

As always, it remains your lab's responsibility to ensure that not only the necessary federal regulations are being followed but also state regulations and any accreditation standards are being met. For the POL short on knowledgeable staff, this may be a daunting task, requiring outside help. The final section of this guide includes additional resources for the POL, including a representative list of consultants who advertise working in the POL space.

References