Helping lab professionals GoMolecular.

Building Your Staff

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In this article:

  • How to work best with MTs
  • The changing role of lab directors
  • Creating a desirable culture
 
 


By Frederick L. Kiechle, M.D., Ph.D.

Staffing a new molecular lab poses many difficult challenges in recruiting, hiring and retention. Can you hire from within, or do you need to look outside for quality candidates? One way to decide is to look at the positions you need to fill, and start from there.  


Medical Technologists

A recent survey confirms what we have been seeing for a while — there is a shortage of medical technologists (MT). The 2011 Vacancy Survey of M.S. Clinical Laboratories, published by the American Society for Clinical Pathology,1 reports vacancy rates throughout the U.S. that vary from 11.6 percent for Blood Bank to 5.14 percent for Cytology.1  An aging workforce, declining access to medical technology training programs, low salaries,2 as well as recruitment and retention problems3 contribute to the overall shortage.

To be a successful, flexible molecular diagnostics lab, it is imperative to have an MT available five days a week to perform validation of new tests or evaluation of assay modifications or trouble shooting. This individual will determine the speed at which new assays are introduced. This rate should be at least one new test introduced per month, or 12 new assays a year. This goal is made more challenging by the declining number of MTs entering the field each year.1-3

In general, MTs work in two different kinds of environments: generalists or specialists.  A generalist is usually working in a smaller hospital lab and is cross-trained to perform chemistry, immunochemistry (including immunoassays for drugs), coagulation, urinalysis and hematology. They usually enjoy the fast-paced workflow.  

Specialists have chosen to develop expertise in a single subspecialty area in the lab like molecular diagnostics, flow cytometry, HLA, microbiology or toxicology confirmation using LC-MS/MS, HPLC and/or GC. The career goals of a specialist are different than those of a generalist. Never attempt to cross train a specialist. If they wanted that job description, they would seek employment where generalists are required.

MTs in molecular diagnostics are usually specialists. Molecular diagnostics meets the CLIA requirement for high complexity testing which defines the requirements for the lab director, technical supervisor, and testing personnel.4 The recent ASCP vacancy study did not include data for the ASCP certified technologist in molecular biology or MB (ASCP).1  Tables 1 and 2 are adapted from this study.1

Another potential source of employees in molecular diagnostics is the research-trained individual employed in a basic molecular research laboratory. These researchers will have skills and knowledge of molecular techniques and equipment, sometimes more varied than the MB (ASCP).  However, the researcher will need to learn concepts of quality control, proficiency testing, standard operating procedures and other common clinical laboratory methods.
    

Lab Directors
    
The medical director of a molecular diagnostics laboratory may be a pathologist or medical geneticist.4 The pathologist’s leadership in molecular tests that provide a “yes or no” result, like molecular detection of an infectious agent or genotype, is not controversial.  However, medical geneticists certified by the American College of Medical Genetics (ACMG) claim unique skills to provide molecular genetic risk screening.5 Table 3 illustrates six interpretative categories of sequence variation defined by ACMG.5
    
In October 2010, a group of stakeholders met to develop a national strategy to ensure that the performance, interpretation and regulation of genome-based clinical testing came directly under the purview of pathologists and their national organization.6 An action plan of seven “blue dot” projects were developed to provide proof of concept, education goals, and enhanced computer programs that would acquire clinically actionable results from a patient’s whole genome sequence.6 

If this vision becomes a reality, the debate about medical genetics or pathology interpretation leadership for sequence variation5 will shift to pathology. This direction makes sense since currently in the U.S., there are 1,000 medical geneticists, 3,000 genetic counselors, and 17,000 pathologists.

The complexity of these tasks will benefit from the use of “hyper-specialization” 7 to improve the quality, speed and cost required to achieve a sought-after selection. People with appropriate skill sets are recruited to complete segments of a computer program needed for this project will improve the rate of goal achievement. On a smaller scale, molecular laboratories would benefit from the use of hyper-specialized individuals for validation guidance of new assays.


Table 1   

Molecular Diagnostics in ASCP Surveyed Facilities

  Type of Facility   Percentage of Facilities
 Do not perform molecular diagnostics  47.23%
 One central molecular diagnostics department  24.72%
 Molecular diagnostics performed in specific lab departments  21.52%
 Did not know if molecular diagnostics is performed at  their facility  6.52%
 Adapted from reference 1.

 

 

Table 2 

Molecular Diagnostics is Performed in Various Laboratory Departments

  Lab Department   Percent Performing Molecular Diagnostics
 Cytogenetics  57.1%
 Microbiology  57.1%
 Cytology  22.2%
 6 Other Sections  Each less than 10%
 Adapted from reference 1.




Table 3  

Six Interpretative Categories of Sequence Variation

 Sequence Variation  Relationship to Disorder
 1. Previously reported  Recognized cause
 2. Unreported  Expected to cause disorder
 3. Unreported  May or may not be causative
 4. Unreported  Probably not causative
 5. Previously reported  Recognized neutral variant
 6. Unreported  Associated with clinical presentation
 Adapted from reference 5.






References

  1. Garcia E, Bennett A, DeFranco M, et al. American Society for Clinical Pathology’s 2011 Vacancy Survey of U.S. Clinical Laboratories. Lab Med 2011; 42-199-206.
    2.    Garcia E, Bennett A, DeFranco M, et al. American Society for Clinical Pathology 2010 Wage Survey of U.S. Clinical Laboratories. Lab Med 2011; 42:141-146.
    3.    Malone B. Trends in recruitment and retention. How can labs thrive despite the staffing shortage? Clin Lab News 2011; 37(#5):1, 3-5.
    4.    Rennert H, Leonard DGB. Molecular pathology laboratory management. In: Molecular Pathology in Clinical Practice. (Eds: Leonard DGB). Springer: New York, NY 2007: pp. 553-575.
    5.    Richards CS, Bale S, Bellissimo DB, et al. ACMG recommendations for standards for interpretation and reporting of sequence variations: Revision 2007. Genet Med 2008; 10:294-300.
    6.    Tonellato PJ, Crawford JM, Boguski MS, Saffitz JZ. A national agenda for the future of pathology in personalized medicine. Report of the proceedings of a meeting at the Banbury conference center on genome-era pathology, precision diagnostics and preemptive care: A stakeholder summit. Am J Clin Pathol 2011; 135:668-672.
    7.    Malone TW, Loubacker RJ, Johns T. The age of hper specialization. Harvard Business Review. 2011; 89 (#7/8): 56-65.