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

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

Higher-education programs School Location Program Description Arizona State University U.S. - AZ (Phoenix) Medical Laboratory Science Program "The BAS with a concentration in medical laboratory science provides opportunities for career growth, including the exam for Clinical Laboratory Scientists." British Columbia Institute of Technology Canada - BC (Burnaby) Medical Laboratory Science Program "Two-and-a-half year, full-time, Diploma program; Students are ready to write the national certification exam upon graduation." Carolinas College of Health Sciences U.S. - NC (Charlotte) Medical Laboratory Science Program "The Medical Laboratory Science program at Carolinas College is a 12-month program for applicants who have a bachelor's degree, preferably in a science." George Washington University U.S. - DC (Washington) Medical Laboratory Science Program "We offer one undergraduate MLS Program, a Bachelor of Science in Health Sciences (BSHS), five post-baccalaureate certificates, and seven graduate program, the Master of Science in Health Sciences (MSHS)" Heritage University U.S. - WA (Toppenish) Medical Laboratory Science Program "Prospective Medical Laboratory Science (MLS) students who already have an undergraduate degree can purse a Certificate in MLS. Students without an undergraduate degree can pursue Bachelor of Science in biology with a specialization in MLS or a Bachelor of Science in MLS." Hunter College U.S. - NY (New York) Medical Laboratory Science Program "We offer one undergraduate MLS Program, a Bachelor of Science in Health Sciences (BSHS), five post-baccalaureate certificates, and seven graduate program, the Master of Science in Health Sciences (MSHS)" Idaho State University U.S. - ID (Pocatello) Medical Laboratory Science Program "The B.S. in Medical Laboratory Science prepares students as medical laboratory scientists or medical technologists and for graduate level programs in medical laboratory science or related disciplines.""The Master of Science in Medical Laboratory Science degree is designed for either the practicing medical laboratory scientist (certified lab professional) or those students who wish to become certified and then go into leadership positions in administration, education or specialize in a certain area of athology/laboratory medicine." Mayo School of Health Sciences U.S. - MN (Rochester) and FL (Jacksonville) Medical Laboratory Science Program "Program length: 10.5 or 12 months (e-learning didactic curriculum)"; contains a component for Florida-appointed students Michener Institute Canada - ON (Toronto) Medical Laboratory Science Program "Michener’s Medical Laboratory Science Advanced Diploma program is a full-time program which consists of 25 months of education over a period of two and one-half year(6 semesters)." St. Clair College Canada - ON (Windsor) Medical Laboratory Science Program Medical Laboratory Technician Program MLS: "Three Year - Ontario College Advanced Diploma"; MLT: "One Year - Ontario College Certificate (delivered in less than 1 year)" St. Lawrence College Canada - ON (Kingston) Medical Laboratory Science Program "Program Duration: 3 Years; Graduates of the program wishing to work in Canada as a certified medical laboratory technologist must successfully complete the Canadian Society for Medical Laboratory Science (CSMLS) national certification exam." University of Cincinnati U.S. - OH (Cincinnati) Medical Laboratory Science Program "University of Cincinnati’s Bachelor of Science in Medical Laboratory Science distance learning program is designed for working Clinical Laboratory Technicians (CLTs) and Medical Laboratory Technicians (MLTs) who hold an associate degree from a NAACLS accredited CLT/MLT program or equivalent coursework and CLT/MLT certification." University of Minnesota U.S. - MN (Minneapolis) Medical Laboratory Science Program "The MLS program at the University of Minnesota is the oldest baccalaureate medical laboratory educational program in the United States..." University of Ontario Institute of Technology Canada - ON (Toronto) Medical Laboratory Science Program "Bachelor of Health Science (Honours); Upon completion you will be eligible to write the Canadian Society for Medical Laboratory Science national certification examination." University of the Sciences in Philadelphia U.S. - PA (Philadelphia) Medical Laboratory Science Program "University of the Sciences’ BS program in medical laboratory science is one of the few hospital based programs in the region directed by a certified medical laboratory scientist..." University of Vermont U.S. - VT (Burlington) Medical Laboratory Science Program "Bachelor of Science in Medical Laboratory Science degree program" University of Washington U.S. - WA (Seattle) Medical Laboratory Science Program "The Medical Laboratory Sciences (MLS) Program was founded in 1970 as an undergraduate major of the Institute of Health Sciences."

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.