CLIA has specific requirements for personnel, depending on the complexity of testing performed. Laboratory testing is classified in three different categories: waived, moderate, and high. Laboratories performing only waived testing have no personnel requirements, according to CLIA.
Moderate complexity testing requires the laboratory to have a Laboratory Director and one or more of the following: Clinical Consultant; Technical Consultant; and Testing Personnel. The Laboratory Director (and there may only be one) is responsible for all the operations of the laboratory and must have at least a Bachelor Degree in Medical Technology, or a chemical, physical, or biological science, must have at least two years laboratory experience, and must have at least two years supervisory experience in a laboratory setting. The laboratory director may be a licensed physician, however not all licensed physicians qualify to be a laboratory director. In order for a physician to qualify as a laboratory director for a moderately complex lab, the physician must either be a pathologist, or must have 20 continuing medical education (CME) credit hours in laboratory practice prior to performing duties as a laboratory director.
The Clinical Consultant in a moderately complex laboratory may perform certain duties, as delegated by the laboratory director in a job description. In order to qualify as a Clinical Consultant, an individual must either be a licensed physician or must have a PhD in laboratory science, or another chemical, physical, biological science and must be certified by ABMM, ABCC, ABB, or ABMLI.
Technical Consultants in a moderately complex laboratory may also perform certain duties which are delegated by the laboratory director through a job description. To qualify as a Technical Consultant, an individual must have a minimum of a Bachelor Degree in a chemical, physical, or biological science and must have at least two years laboratory experience in the specialty or subspecialty for which they are responsible.
The minimum requirement for Testing Personnel in a moderately complex laboratory is an academic high school diploma, or equivalent. CLIA requires demonstration of all qualifications in a moderately complex lab through a copy of a diploma or transcript. It is important to note that laboratories holding a CLIA Certificate of Provider Performed Microscopy Procedures (PPMP) must comply with the personnel requirements of a moderately complex laboratory.
Laboratories performing highly complex laboratory testing, as defined by the Food and Drug Administration (FDA) must have one Laboratory Director and one or more of the following personnel: Clinical Consultant; Technical Supervisor; General Supervisor; and Testing Personnel. The Laboratory Director in a highly complex laboratory is responsible for the overall operations of the laboratory and must have a minimum of a PhD in laboratory science or another chemical, physical, or biochemical science and be certified by ABMM, ABCC, ABB, or ABMLI. A physician who is the laboratory director of a highly complex lab must either be a pathologist, or must have experience or training in directing highly complex laboratories.
A Clinical Consultant may perform certain duties delegated by the laboratory director through a job description and must be either a licensed physician, or must have a PhD in laboratory science or a chemical, physical, or biological science and certificationby ABMM, ABCC, ABB, or ABMLI.
Technical Supervisors may also perform certain delegated duties and must be either a pathologist or must have a minimum of a Bachelor degree in medical technology or a chemical, physical, or biological science and have at least four years experience in the specialty or subspecialty for which they are responsible.
The General Supervisor may perform certain duties, as delegated, and must have at least an Associate Degree in medical laboratory technology or a laboratory science and have a minimum of two years laboratory experience.
Testing Personnel in a highly complex laboratory must have a minimum of an Associate Degree in medical laboratory technology or a laboratory science. However, personnel who were performing laboratory testing prior to February 28, 1992 may fall under CLIA’s “grandfather clause” if they have been performing high complexity testing continuously since then. Once an individual who was “grandfathered” breaks employment (i.e. leaves the laboratory for two years to care for a family member), then they must meet the regular CLIA requirements to return to the clinical laboratory (i.e. a minimum of an Associate degree).
CLIA does have exceptions in the requirements for blood gas testing, histopathology, oral pathology, dermatopathology, and ophthalmic pathology. In addition, the subspecialty of Cytology contains personnel requirements specific to that field.
Personnel requirements in general can be confusing and difficult to understand. ProLab’s Consultants are familiar with the CLIA personnel requirements. Let our consultants help you with ensuring your personnel are qualified to perform their respective duties. We also offer assistance with the hiring process.
After ProLab Consulting, LLC has performed an initial assessment of the laboratory’s personnel records for compliance with CLIA regulations and provided our client with a “Report of Laboratory Assessment”, the laboratory director may recognize a need for assistance with personnel records.
ProLab Consulting, LLC offers a “Personnel Review” service to assist laboratories with establishing and maintaining applicable personnel records in accordance with CLIA regulations. This service includes:
- development / review of policies and procedures related to personnel;
- development / revision of job descriptions;
- assistance with continuing education;
- assistance with training and competency assessment (including establishment and / or revision of applicable documentation);
- review of laboratory director (and other personnel) qualifications;
- assistance with the hiring process.
Any documents developed may be delivered to the laboratory electronically or in the form of a hard copy (may be subject to an additional printing fee).
This service is offered through a one or two year contract.