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.
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.[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.
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[2]:
- 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
List of certification programs and organizations
American Association of Bioanalysts: The AAB Board of Registry (ABOR) offers five different certifications, including medical technologist (MT) and medical laboratory technician (MLT).
American Medical Technologists: The AMT offers several laboratory-related certifications, including medical technologist (MT) and medical laboratory technician (MLT).
American Society for Clinical Pathology: The ASCP offers four levels of certification, with numerous subcategories in all but the Diplomate Certification. The four main levels are Technician, Technologist, Specialist, and Diplomate.
National Accrediting Agency for Clinical Laboratory Sciences: The NAACLS offers seven different accreditation programs, including medical laboratory scientist (MLS) and histotechnologist (HTL).
National Commission of Certifying Agencies: The NCCT offers several certifications, including medical assistant (NCMA) and phlebotomy technician (NCPT).
National Healthcareer Association: The NHA offers several certifications, including clinical medical assistant (CCMA) and phlebotomy technician (CPT).
National Phlebotomy Association: The NPA offers a certification for phlebotomists.
List of educational programs
Higher-education
Continuing education
ASCLS Certification Maintenance Membership: The American Society for Clinical Laboratory Science (ASCLS) offers a Certification Maintenance Membership, which provides "12 hours of PACE-approved online continuing education to be completed at any time before the end of the subscription year."
ASCLS Clinical Lab Investigations: The American Society for Clinical Laboratory Science (ASCLS) offers Clinical Lab Investigations, "designed to take you beyond the laboratory test and investigate the causes for abnormal laboratory results." They provide PACE-approved continuing education credit.
List of staffing agencies
References
- ↑ "Title 42: Public Health, Part 493 — Laboratory Requirements". U.S. Government Publishing Office. 3 August 2015. http://www.ecfr.gov/cgi-bin/text-idx?SID=f1d85c34dbb66a6dd7f7821c3c4f99f6&mc=true&node=pt42.5.493&rgn=div5. Retrieved 05 August 2015.
- ↑ "Laboratory State License - Personnel & Facility License Info". Lighthouse Recruiting, LLC. http://www.laboratorystartupconsultants.com/#!laboratorystatelicense/c14ce. Retrieved 05 August 2015.
