Laboratory medicine training for rural family physicians

Clinical laboratory directors may be pathologists, other specialty physicians or doctoral level scientists with laboratory training, such as in clinical chemistry. In small, rural hospitals, a pathologist may serve as laboratory director, but not be present, except on occasions when he or she is needed, such as for a meeting. However, this may also be a role for a local family physician or other non-pathologist physician trained in laboratory medicine, particularly in rural communities without a pathologist.

While there are no laboratory medicine fellowships for family physicians, we obtained the requirements for training a non-pathologist physician to be a laboratory director from the Alabama Department of Public Health (ADPH).

We then created a training program and now have a family physician serving as lab director. A local hospital or clinic and community physicians may also benefit from having a trained local family-medicine physician serve as the laboratory director, and there may be a role for a fellowship in laboratory medicine for family physicians.

What is laboratory medicine?

Laboratory medicine is the area of medicine dealing with laboratory analysis of blood, urine, and other specimens to provide important information about a patient. This assists physicians in determining diagnoses and how to care for sick patients. Laboratory medicine is taught in medical school and most residency and fellowship programs, and it is an essential element of patient healthcare, as 60-70% of healthcare decisions depend on laboratory analyses.¹ Medical practice and patient care depend on accurate, timely and quality laboratory results.² Clinical laboratory directors validate accurate laboratory results and ensure quality, and they are also the liaison between the clinical laboratory and healthcare providers.²

Clinical laboratory directors

Clinical laboratory directors may be pathologists, other specialty physicians with training in laboratory medicine or non-physician doctoral-level scientists with training in specific laboratory areas, such as clinical chemistry.^{2, 3} Pathologists are residency trained in clinical and anatomical pathology. Over time, there has been a decrease in the number of pathologists, especially clinical pathologists, resulting in a decrease in the number who serve as laboratory medical directors.² In smaller hospitals, especially in rural areas, a pathologist may serve as the clinical laboratory director but not be present in the laboratory except on certain days by request (i.e. for frozen sections) and for staff and executive committee meetings. They are usually available by phone for questions or problems when needed.

The Clinical Laboratory Improvement Amendments (CLIA) state that the clinical laboratory director may be a licensed doctor of medicine, osteopathy or podiatry with one year of laboratory training during a hematology or hematology/oncology fellowship or two years of experience directing or supervising high complexity testing.^{2, 4} Clinical laboratory directors may also be non-physician doctoral-level scientists with post-doctoral fellowships in clinical chemistry,^{2, 3} clinical immunology,² clinical microbiology^{2, 5} or clinical genetics.^{2, 6}

The clinical laboratory director at the College of Community Health Sciences (CCHS) University Medical Center supervises high complexity testing, certifies urine drug screens as the medical review officer, oversees medical functions of the laboratory, certifies proficiency testing, and validates outside-ordered laboratory tests. The director also teaches laboratory medicine to medical students, residents and fellows, serving as a liaison between the laboratory and faculty members and staff physicians. The CCHS laboratory is a high complexity laboratory because of its hematology and microbiology service. The laboratory serves the medical school practices, University Medical Centers in Tuscaloosa and Northport, the University of Alabama Student Health Center and several outlying practices and private physicians.

The lab provides full-service laboratory medicine and clinical pathology, including phlebotomy, urinalysis, hematology, chemistry, microbiology, toxicology, and special chemistry. The lab does not provide anatomical pathology, cytology, bone marrow, or blood bank services. CLIA recommendations for training a non-pathologist to be the laboratory director are outlined below. Training involves 3-4 hours a day in the lab over two years, which could conceivably evolve into a laboratory medicine fellowship for physicians in rural areas where there are no locally available pathologists.

Fellowships for family medicine physicians

Fellowships are usually clinical training beyond residency. Family medicine fellowships at the College of Community Health Sciences (CCHS) at the University of Alabama date back to 1984 with the formation of the Family Medicine/Obstetrics Fellowship. CCHS also has fellowships in emergency medicine, hospital medicine, behavioral health, geriatrics, and sports medicine. The American Academy of Family Physicians (AAFP) website lists 17 different types of fellowships for family physicians.⁷ The only fellowships for family medicine approved by the Accreditation Council for Graduated Medical Education (ACGME) are sports medicine, geriatrics, addiction medicine, clinical informatics, and hospice and palliative care.⁸

Most laboratory medicine fellowships are designed for pathologists or doctoral-level scientists with training in specialized areas, such as clinical chemistry.^{2, 3} To the authors’ knowledge, there are no laboratory medicine fellowships for family physicians.

Clinical laboratory director training

To train a non-pathologist physician to be a CLIA laboratory director, CCHS sought direction from the CLIA laboratory unit director and the licensure and certification supervisor at the Alabama Department of Public Health (ADPH). CCHS also referred to the Electronic Code of Federal Regulations (e-CFR), current as of Nov. 1, 2018,⁴ which lists the requirements for a laboratory director at laboratories performing high complexity testing.

There are numerous key requirements, according to these sources. The laboratory director must be qualified to manage and direct laboratory personnel and oversee the performance of high complexity tests, as well as be eligible to be an operator of a laboratory within the requirements, such as possessing a current license as a laboratory director issued by the state in which the laboratory is located, if such licensing is required.

The laboratory director also must be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the state in which the laboratory is located, as well as be certified in anatomic or clinical pathology, or both, from the American Board of Pathology or the American Osteopathic Board of Pathology (or possess qualifications that are equivalent to those required for such certification).

Additionally, the lab director should have at least one year of laboratory training during an internal medicine residency or hematology/oncology fellowship. Alternatively, the lab director could have at least two years of experience directing or supervising high complexity testing,³ or hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board with approval from the Department of Health and Human Services (HHS).⁴

According to ADPH, the training experience must be clinical in nature, with the laboratory director-in-training personally examining and performing tests on laboratory specimens, in contrast to ordering, interpreting, and applying test results to the care of patients.⁴ This is evidenced by laboratory worksheets, training checklists, exams, and competency evaluations over the two-year period. He or she must demonstrate supervisory skills, such as signing policies and procedures, or reviewing quality assurance and quality control, with oversight from the current laboratory director, which must be documented. Test performance must be supervised by the general laboratory supervisor. The trainee must also have periodic oversight and review from a supervisor, including signed documentation.⁹

The director-in-training is expected to learn to perform the tests ordered in the UMC laboratory and demonstrate proficiency. For example, the microbiology education and proficiency test includes specimen collection, gram stain, media selection, inoculation and isolation techniques, and culture incubation.

There are also lectures for the director trainee in (1) preparation for the biennial laboratory recertification survey, (2) statement of deficiencies and plan of corrective action, (3) proficiency testing, (4) alcohol testing, and (5) review of procedure manuals. The responsibilities of the clinical laboratory director include consultations, verification and certification of results, interactions with patients/physicians/administration, quality assurance, education of residents and medical students, standards of performance, safety, monitoring and correlation of laboratory data and ethical concerns.¹⁰

The benefits of having a non-pathologist in-house physician serving as the laboratory director at CCHS are:

1. CLIA certified laboratory director
2. Senior level practicing physician
3. In-house practicing physician present every day
4. Physician with a breadth of knowledge of codes for ordering and billing
5. Liaison with administration, most of whom are not physicians
6. Liaison between laboratory and medical school, student health center and community physicians
7. Laboratory medicine physician teaching medical students, residents, and fellows
8. Physician to interpret laboratory results
9. Verification of outside-ordered laboratory results, especially life-threatening values
10.  Public relations for the laboratory
11.  An interface between clinical medicine and laboratory medicine
12.  Medical review officer certification of drug screen and blood alcohol results
13.  Cost savings to the physician foundation

In summary, this postgraduate training may be useful to other rural communities as a laboratory medicine fellowship for family physicians. There is a shortage of pathologists, and at the same time, the likelihood of having a pathologist full-time in a small, rural hospital laboratory is very small. It may be beneficial to both the hospital/clinic and the practitioners to have a local physician serve as the CLIA laboratory director of their high complexity laboratory.⁴

References

1. Molinaro RJ, Winkler AN, Kraft CS, Fantz CR, et al. Teaching laboratory medicine to medical students: implementation and evaluation. Arch Pathol Lab Med. 2012; 136(11):1423-1429. doi:10.5858/arpa.2011-0537-EP.
2. Straseski JA.Postdoctoral professional fellowships in laboratory medicine. EJIFCC. 2013; 24(1):21-29.
3. Clinical chemistry and laboratory medicine fellowship. University of Virginia. https://med.virginia.edu/pathology/educational-programs/pathology-fellowship-programs/clinical-chemistry-fellowship/. Accessed November 11, 2018.
4. Electronic Code of Federal Regulations (e-CFR). § 493.1443 Standard laboratory director qualifications.https://www.ecfr.gov/cgi-bin/text-idx?node=se42.5.493_11443&rgn=div8.  Accessed November 3, 2018.
5. Microbiology fellowship program. University of Washington. http://depts.washington.edu/labweb/Education/Fellowship/index.htm. Accessed November 18, 2018.
6. Molecular genetic pathology fellowship program.University of Washington. http://depts.washington.edu/labweb/Education/Fellowship/index.htm. Accessed November 11, 2018.
7. Fellowship directory. American Academy of Family Physicians. https://www. aafp.org/Directories/Fellowship/Search. Accessed on October 10, 2011.
8. Family medicine subspecialties. Accreditation Council for Graduate Medical Education. https://www.acgme.org/Specialties/Overview/pfcatid/8/Family-Medicine.
9. Alabama Department of Public Health. Patricia Watson, BS, MT (ASCP), Licensure and Certification Supervisor, CLIA Laboratory Unit Director.
10. Medical directors of laboratories, responsibilities and role. College of American Pathologists. https://www.capacp.org/medical_director_lab_responsibilities_role.php. Accessed November 11, 2018.