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 Allen College U.S. - IA (Waterloo) Medical Laboratory Science Program "Students receive the Bachelor of Health Sciences degree with a MLS major and qualify for MLS certification upon completion of program requirements. This option is also possible for those who already have a baccalaureate degree and have completed all general education courses." 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." Armstrong State University U.S. - GA (Savannah) Medical Laboratory Science Program Armstrong offers the Bachelor of Science in Medical Laboratory Science in three tracks: Traditional, MLT to MLS Online, and MLS Online Fast Track (for South Carolina residents only) Baptist College of Health Sciences U.S. - TN (Memphis) Medical Laboratory Science Program "The MLS program at Baptist College is an accelerated full-time program designed to be completed in 16 months (four trimesters). Graduates earn a bachelor of health sciences (BHS) with a major in medical laboratory science." Bellarmine University U.S. - KY (Louisville) Medical Laboratory Science Program Offers three Bachelor of Health Science degree tracks in MLS: 4-Year Practitioner Track, 4-Year Pre-professional Track, and an Accelerated Second Degree Boise State University U.S. - ID (Boise) Pre-medical Laboratory Science Program "Pre-professional studies is designed for students who need to have undergraduate studies prior to applying to a professional school." 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." Centennial College Canada - ON (Scarborough) Medical Laboratory Technician Program "Credential: Certificate; Program Type: Post-secondary program; Program Length: 1 year/ 3 semesters" College of the North Atlantic Canada - NL (St. John's) Medical Laboratory Science Program "The curriculum for this program is designed to encompass three years of training. Graduates of the program at the Prince Philip Drive Campus will be eligible to sit the certification examination set by the Canadian Society for Medical Laboratory Science (CSMLS)." Dixie State University U.S. - UT (St. George) Medical Laboratory Science Program "Dixie State University offers BS and AAS degrees in MLS where graduates will be eligible to sit for the national Board of Certification (BOC) Exam through the American Society for Clinical Pathology (ASCP)." Emory Healthcare U.S. - GA (Atlanta) Medical Laboratory Science Program "The program is designed to prepare students (already holding a bachelor's degree) for the national Medical Laboratory Science certifying examination by the American Society for Clinical Pathology (ASCP). Students are awarded a certificate in Medical Laboratory Science from the EHC MLS upon successful completion of the program." 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." Houston Methodist U.S. - TX (Houston) Medical Laboratory Science Program "Houston Methodist Hospital Medical Laboratory Science Program is a 12-month professional course of study, which is fully accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Upon successful completion of this course of study, you will qualify for the examination and certification by the board of certification of the American Society of Clinical Pathology (ASCP)." 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." Illinois State University U.S. - IL (Normal) Medical Laboratory Science Program "The current [baccalaureate] program supports a four year integrated curriculum, providing students the opportunity to declare Medical laboratory science as a major in the freshman year." 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 Metropolitan State University of Denver U.S. - CO (Denver) Medical Laboratory Science Program "The Center offers a nationally accredited, one year curriculum that includes a variety of didactic, student laboratory, and clinical course work in all areas of laboratory medicine. Our graduates are eligible to sit for national certification examinations in medical laboratory science (MLS) offered by the American Society for Clinical Pathology (ASCP)." 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)." Northern College Canada - ON (South Porcupine) Medical Laboratory Technician Program "Credential Earned: Ontario College Certificate; Program Length: 3 Semesters" Northern Illinois University U.S. - IL (DeKalb) Medical Laboratory Science Program Offers traditional B.S. in MLS as well as a degree completion program Ohio State University U.S. - OH (Columbus) Medical Laboratory Science Program Bachelor's program; "Certified MLTs can apply to the MLT Articulation Track. Students who already hold a bachelor's degree in something other than medical technology and would like to become eligible for certification have three options." Oregon Tech U.S. - OR (Wilsonville) Medical Laboratory Science Program "Oregon Tech, in partnership with Oregon Health and Science University (OHSU), offers a course of study leading to a Bachelor of Science in Clinical Laboratory Science degree. Students who successfully complete the degree program are eligible to take the Medical Laboratory Scientist (MLS) national board certification examination offered by the American Society for Clinical Pathology (ASCP)." Pennsylvania College of Health Sciences U.S. - PN (Lancaster) Medical Laboratory Science Program Bachelor's program? Phoenix College U.S. - AZ (Phoenix) Medical Laboratory Science Program "In this program you can earn the following: Associate in Applied Science (AAS) in Medical Laboratory Science, Certificate of Completion (CCL) in Medical Laboratory Science" Providence Sacred Heart School of Medical Technology U.S. - WA (Spokane) Medical Laboratory Science Program Medical Laboratory Technician Program MLS: "4+1 or 3+1 options available; 12-month internship from July-June"; MLT: "Two-year program; Associate of Technical Science (ATS) degree awarded from Wenatchee Valley College" Quinnipiac University U.S. - CT (New Haven) Medical Laboratory Science Program "Quinnipiac's master of health science (MHS) program in medical laboratory sciences/biomedical sciences provides students with the cutting-edge skills they need to manage the more complex operations carried out today in hospitals and research facilities..." Red River College Canada - MB (Winnipeg) Medical Laboratory Science Program "Two-year diploma (22 consecutive months); This program also helps prepare students to write the Canadian Society of Medical Laboratory Sciences Certification (CSMLS) exam." Rush University U.S. - IL (Chicago) Medical Laboratory Science Program Offerings: B.S. and M.S. Rutgers U.S. - NJ (Newark) Medical Laboratory Science Program "Upon completion of the 45 credits of professional coursework in Medical Laboratory Science at the University, one of three credentials is conferred...": Joint Baccalaureate, Second Baccalaureate, or Rutgers-SHRP Certificate. "Graduates of the Program are eligible for certifying examinations in the Medical Laboratory Scientist category offered by the Board of Certification of the American Society for Clinical Pathology - MLS (ASCP)." Salisbury University U.S. - MD (Salisbury) Medical Laboratory Science Program "[The MLS baccalaureate degree] consists of two years of pre-requisite on-campus course work followed by three semesters of on-campus upper division professional courses and then one winter semester and one spring semester of off-site clinical internships in regional hospitals. Internships begin the first week of January the semester prior to graduation and last for approximately 20 weeks." 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. Edward's University U.S. - TX (Austin) Medical Laboratory Science Program "The Bachelor of Science in Medical Laboratory Science (MLS) employs exploratory project-based learning to prepare students for careers in medicine and research. The degree involves a minimum of six semesters of coursework at St. Edward’s University and one year of clinical training at an affiliated MLS program (currently Austin State Hospital)." 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." Tarleton State University U.S. - TX (Fort Worth) Medical Laboratory Science Program Offerings: Bachelor in Medical Laboratory Science (BS-MLS), Master of Science in Medical Laboratory Sciences (MS-MLS), Health Professions Technology (BAT-HPT), Public Health (BS in PH), Medical Laboratory Technician (AAS-MLT), Histotechnician (AAS-HT) Thomas Jefferson University U.S. - PA (Philadelphia) Medical Laboratory Science Program Bachelor's program? University of Alabama at Birmingham U.S. - AL (Birmingham) Medical Laboratory Science Program M.S. program: "All applications to the Clinical Laboratory Sciences program are done online through the UAB Graduate School." University of Arkansas for Medical Sciences U.S. - AR (Little Rock) Medical Laboratory Science Program "The professional program has full-time and part-time tracks. The full-time track requires 17 months to complete. The part-time track allows students a maximum of five (5) semesters to complete the program. The MLT-to-MLS advanced placement track is designed for employed medical laboratory technicians (MLTs) who desire to continue their education within the framework of their home environment. Upon completion of the full-time, part-time, or MLT-to-MLS track the Bachelor of Science degree in Medical Laboratory Sciences is awarded." University of Alberta Canada - AB (Edmonton) Medical Laboratory Science Program "...a four-year professional degree program. Students acquire general certification from the Canadian Society for Medical Laboratory Science (CSMLS) and a BSc in Medical Laboratory Science (MLS)." University of British Columbia Canada - BC (Vancouver) Medical Laboratory Science Program "The Bachelor of Medical Laboratory Science (BMLSc) is an undergraduate science degree in the Faculty of Medicine." University of Central Florida U.S. - FL (Orlando) Medical Laboratory Science Program "To earn a Bachelor of Science in Medical Laboratory Sciences, students must achieve a 2.5 GPA in the major courses. The degree is awarded upon completion of the university’s didactic and clinical program. Upon receiving a degree in medical laboratory sciences, graduates are eligible for national certification and State of Florida licensure." 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 Connecticut U.S. - CT (Storrs) Medical Laboratory Science Program Options: Undergraduate degree and post-baccalaureate certificate University of Deleware U.S. - DE (Newark) Medical Laboratory Science Program "The Department of Medical Laboratory Sciences offers majors in Medical Laboratory Science, in Medical Diagnostics, and in Medical Diagnostics with a Pre-Physician Assistant concentration, a minor in Medical Diagnostics, as well as Honors Degrees in Medical Laboratory Science and Medical Diagnostics and Honors courses." University of Kentucky U.S. - KY (Lexington) Medical Laboratory Science Program Track Options: Second B.S. Degree, Transfer Students, Online MLT to MLS University of Massachusetts - Dartmouth U.S. - MA (Dartmouth) Medical Laboratory Science Program "UMass Dartmouth offers a Bachelor of Science Degree in Medical Laboratory Science. All graduates meet requirements for national certification or state licensure. The Department of Medical Laboratory Science offers four options: Clinical Laboratory Science, Cytotechnology, Health Services and Biotechnology." 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 New Mexico U.S. - NM (Albuquerque) Medical Laboratory Science Program Offerings: B.S. and M.S. University of North Dakota U.S. - ND (Grand Forks) Medical Laboratory Science Program "In addition to traditional Bachelor of Science in Medical Laboratory Science degree offerings, UND's MLS program has a cohort program with the Mayo Clinic in Rochester, Minnesota and affiliation agreements with higher education institutions in Minnesota, North Dakota, South Dakota, Wisconsin, Arizona and Montana. The program has over 70 clinical affiliates in 12 states. Students are able to complete coursework at both a Bachelor's and Master's level online nationwide." 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 Utah U.S. - UT (Salt Lake City) Medical Laboratory Science Program Offerings: Medical Laboratory Sciences, BS; Cytotechnology, BS; Master of Science in Laboratory Medicine and Biomedical Science 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." Vanderbilt University U.S. - TN (Nashville) Medical Laboratory Science Program "Upon satisfactory completion of the training program, a certificate of completion is awarded to the student. The course of study during the clinical year may be credited towards a baccalaureate degree where an affiliation between the student's college or university and the Medical Center exists. Students completing the year of training are eligible for the national certification by examination through agencies such as the American Society of Clinical Pathologist Board of Certification (BOC)." Weber State University U.S. - UT (Ogden) Medical Laboratory Science Program Offerings: Bachelor of Science, Associate of Applied Science, Clinical Laboratory Assistant West Virginia University U.S. - WV (Morgantown) Medical Laboratory Science Program "The WVU Bachelor of Science in Medical Laboratory Science, is a four-year program..." with two areas of emphasis: clinical laboratory scientist and histotechnologist.

One-year hospital-based programs

One-year hospital-based programs School/Hospital Location Program Description Atlantic Health System U.S. - NJ (Various) Medical Laboratory Science Program "...our 12-month program incorporates didactic sessions and rotations of clinical practice in laboratories at Morristown Medical Center in Morristown, NJ, Overlook Medical Center in Summit, NJ, and Newton Medical Center in Newton, NJ." Austin State Hospital U.S. - TX (Austin) Medical Laboratory Science Program "Graduates are eligible to take the certifying examination given by the American Society of Clinical Pathologists (ASCP) Board of Certification. Issuance of a degree or certificate IS NOT contingent upon the student passing an external certification examination." Denver Health School of Medical Laboratory Science U.S. - CO (Denver) Medical Laboratory Science Program "...a 12-month hospital-based education program, offered by Denver Health, designed to provide theoretical knowledge and student and clinical laboratory experiences in all laboratory disciplines. The program begins the first week in January and finishes the first or second week in December." DMC University Laboratories U.S. - MI (Detroit) Medical Laboratory Science Program "The program accepts 10 students each year for 41 weeks of practical training. Both degree and non degree students are acceptable, providing admission criteria are met." Jefferson College of Health Sciences U.S. - VA (Roanoke) Medical Laboratory Science Program "12-month program of study accredited by the National Accrediting Agency for Clinical Laboratory Sciences, our certificate-awarding program is designed to prepare students to become medical laboratory scientists. Upon completion of the curriculum, students will be eligible to take the national certification exam." Myron E. Rubnitz, M.D. School of Medical Laboratory Science U.S. - IL (Hines) Medical Laboratory Science Program "Offers a 11-month clinical education program beginning the first week of August. Graduates are eligible to take the certifying examination offered by the ASCP Board of Certification or any other approved certifying agency" Nebraska Methodist Hospital U.S. - NE (Omaha) Medical Laboratory Science Program "...an intensive 11-month educational program providing experience in all major departments of a hospital clinical lab." Sanford USD Medical Center U.S. - SD (Sioux Falls) Medical Laboratory Science Program "The majority of students enrolled in the program are college seniors on affiliation from their respective colleges to complete the requirements for a medical laboratory science degree. Other students are those who have obtained a baccalaureate degree prior to entry. Graduates of this program are eligible to take national certifying examinations, including those of the American Society of Clinical Pathologists (ASCP) Board of Certification." School of Medical Laboratory Science at Pennsylvania Hospital U.S. - PA (Philadelphia) Medical Laboratory Science Program "Upon successful completion of the program, students receive a certificate from Pennsylvania Hospital, and are granted a baccalaureate degree from their affiliated college or university. Students are then eligible to take the certification exam offered by the American Society of Clinical Pathologists (ASCP) Board of Certification or other nationally recognized certification agencies." UnityPoint Health - Cedar Rapids U.S. - IA (Cedar Rapids) Medical Laboratory Science Program "The MLS Program grants 32 credits to students who attend affiliated academic institutions which can be utilized towards an overall baccalaureate degree at that institution. A certificate of completion is awarded to all students who successfully complete the Program (including those who already have their baccalaureate degree)." WCA Hospital U.S. - NY (Jamestown) Medical Laboratory Science Program "The WCA Hospital Medical Laboratory Science Program is an accredited, 45-week, program offering intensive study and clinical experience in medical laboratory science as the final year of a Bachelor's degree."

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.