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

Operation of a physician office laboratory (POL) requires expertise, just like any other laboratory. But how should they be staffed, and what sort of education requirements should the staff have? This chapter addresses those questions and also provides additional resources for staffing a POL.

This sixth chapter on the topic of staffing and education has five sections.

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6. Staffing and Education Requirements

General staffing and education

Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) details requirements and responsibilities for laboratory personnel, consultants, supervisors, and directors. 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.

For non-waived laboratories, the following resources provide paraphrasing of CLIA Subpart M:

• American Academy of Family Physicians - Personnel Requirements
• American Academy of Family Physicians - Physician Office Laboratory (POL) Director Duties
• Commission on Office Laboratory Accreditation (COLA) - Personnel for Non-waived Testing (PDF)
• Laboratory Start-Up Consultants - Laboratory State License and Personnel & Facility License Info

In some cases, state governments apply additional regulations and responsibilities to clinical laboratories and their personnel. According to consultancy Laboratory Start-Up Consultants, the following states have staffing, education, and licensing requirements beyond that of CLIA:

• California: Department of Public Health - Laboratory Field Services
• Connecticut: Department of Public Health - Regulation & Licensure
• Florida: Board of Clinical Laboratory Personnel - Licensing and Agency for Health Care Administration - Laboratory Licensure Unit
• Georgia: Georgia Department of Community Help - Healthcare Facility Regulation
• Hawaii: Department of Health - State Laboratories Division
• Louisiana: State Board of Medical Examiners - Clinical Laboratory Personnel
• Montana: Department of Labor and Industry - Montana Board of Clinical Laboratory Science Practitioners
• Nevada: Nevada Division of Public and Behavioral Health - Medical Laboratory Services
• New Jersey: Department of Health - Public Health and Environmental Laboratories
• New York: Department of Health - Clinical Laboratory Evaluation Program and Education Department - Clinical Laboratory Technology
• North Dakota: North Dakota Board of Clinical Laboratory Practice
• Rhode Island: Department of Health - Healthcare Licensing
• Tennessee: Department of Health - Medical Laboratory Board
• Washington: Department of Health - Laboratory Quality Assurance
• West Virginia: Department of Health and Human Resources - Office of Laboratory Services