Clinical Laboratory Technology Advisory Committee
Laboratory Workforce Subcommittee 2022 ​

REPORT ON CHALLENGES TO CALIFORNIA LABORATORY WORKFORCE CAPACITY

Submitted to CLTAC Board: December 2, 2022; Approved by the CLTAC Board: March 3, 2023
Reformatted version submitted to CLTAC Board: June 2​​, 2023; Approved by the CLTAC Board: June 2​, 2023​​

Situation:

California is experiencing an acute shortage of clinical laboratory scientists and public health microbiologists, a situation that has been highlighted and exacerbated by the COVID-19 pandemic.

Background:

Nationwide, shortages of laboratory staff have impacted clinical and public health laboratories. In particular, the shortage of qualified clinical laboratory scientists (CLS) and public health microbiologists (PHM) to perform diagnostic testing has become a serious problem faced by many laboratories in California. Laboratorians play an important role in healthcare and the public health of over 39 million Californians, performing billions of tests annually (estimated). In a survey extended to clinical laboratories by the California Association of Medical Laboratory Technology in 2020 which was performed to support a subsequent budget proposal (CAMLT, 2021), the CLS vacancy rates in respondent laboratories was 11%, and this estimate was expected to increase to 19% within 6-months from the time of the survey due to impending retirements (Doty, 2022, unpublished). Public health laboratories have also experienced high personnel vacancy rates; based on a survey administered by the California Association of Public Health Laboratory Directors in 2022 (Dadone, 2022, unpublished). Approximately one-third of public health laboratories lack a full-time laboratory director, and 65% of public health labs that responded to the survey reported personnel vacancies. Shortages in testing personnel in both clinical and public health lab settings were exacerbated by the COVID-19 pandemic.

To address the lack of staffing to manage the surge in testing demand due to the COVID-19 pandemic, Governor Newsom's Executive Order N-39-20 (issued March 30, 2020) temporarily waived some State professional licensing and certification requirements for personnel performing SARS-CoV-2 testing for the duration of the public health emergency. However, laboratory workforce shortages had been problematic prior to the COVID-19 pandemic, indicating on-going challenges that could have serious implications to healthcare and public health.

In March 2022, the Clinical Laboratory Technology Advisory Committee (CLTAC) was charged by the California Department of Public Health’s Laboratory Field Services (LFS) with forming a Subcommittee to gather relevant data from the laboratory community on the workforce needs across laboratory license or certificate categories, availability and capacity of current CLS and PHM training programs, potential regulatory barriers impacting personnel training, licensing or certification, and other relevant feedback on factors that may contribute to the workforce shortages.

Specifically, the charge was presented as follows:

“In order to plan for the future workforce needs of California’s clinical and public health laboratories, pursuant to its authority under BPC 1228, LFS charges the CLTAC Clinical and Public Health Laboratory Workforce subcommittee to gather information and report its findings in a white paper to address the following:

• ​The need to increase the number of qualified testing personnel in California Labs
• What are the needs for each category of testing?
• Is there a greater need for a particular category?
• Which areas or specialties are in greatest demand? Which areas are expected to experience growth or expansion?
• What are the needs for training programs?
• Are there suggestions for increasing the number of training programs?
• ​Are there suggestions for increasing the number of trainees in labs?
• What are the implications of these problems for public health and safety?
• What are the implications of proposed solutions?
• How might LFS assist in meeting these needs?
  
• Other concerns the subcommittee may identify in the course of its research”

The Laboratory Workforce Subcommittee membership included clinical laboratory scientists and laboratory directors with expertise in various clinical laboratory specialties (microbiology, blood banking, genomics, hematology, chemistry, reproductive biology, etc.), as well as public health microbiologists and public health lab directors, and CLS and PHM educators.

Assessment:

The Subcommittee discussed known contributing factors to the clinical and public health laboratory workforce shortage and summarized the major challenges that they and their professional colleagues have experienced. Common contributing factors were identified, including significant gaps in the number of trainee positions offered by training programs due to financial or infrastructure constraints, lack of partner training laboratories (if applicable), shortage of qualified trainers, inability to meet the licensed personnel-to-trainee ratio (17 CCR § 1035), and various education and training requirements specific to State regulations that limit acceptance of students into training programs or prohibit out-of-state laboratorians from adopting California licensure.

The Subcommittee constructed and distributed a survey to collect data and responses specific to laboratory training capacity. The survey was distributed to 82 clinical and public health training program points of contact representing 80 LFS-approved programs (61 clinical lab programs and 19 public health lab programs) on June 29, 2022 and was closed August 9, 2022. 

The survey was comprised of questions designed to capture training program information, and a combination of discrete ranking and free-text open-ended questions [see Appendix 1. Survey Questions]

Data collected from the survey was analyzed for the following:

1. Training Capacity:
   1. Number of trainees that respondent training programs are approved by LFS to train.
   2. Number of trainees that respondent training programs have accepted for training from 2018 to 2022.
      
2. Factors impacting training capacity (ranked and open-ended questions)
3. Factors that would allow training programs to increase their capacity (ranked and open-ended questions)
4. Additional comments or context related to training capacity that training programs wanted to share
   

Forty-nine total responses were received: 40 clinical laboratory training programs and/or training labs and nine public health laboratories (PHL). Clinical laboratory training programs included collegiate level training programs offering pre-clinical didactics only, collegiate level training programs offering both didactics and in-lab experience via a partner clinical institution, and post-graduate hospital-based training programs offering a comprehensive training program. One limitation to the survey is that not every respondent answered every question. However, important training capacity challenges were identified for most of the respondents.

On average PHLs (n=9) were able to accept and train only 23% of qualified applicants and could nearly triple their training capacity if they had access to additional resources.

On average clinical training sites offering both didactic and clinical training (n=40) were able to accept and train only 37% of qualified applicants and some report that they could significantly increase their training capacity if they had the required resources.

Respondents were asked to “rank all applicable factors” [out of eleven] that contribute to internships or State-approved training spots remaining unfilled in their programs. As summarized below in Table 1 “Top 5 Factors Contributing to Unfilled Training Spots”, analysis of the data showed that among each respondent’s top 5 factors, the ones most frequently identified were that their workload/productivity were too high or too low, and that they had an insufficient number of instructors/trainers. That is, most labs are too busy and/or short staffed to be able to add (more) training to their employees’ tasks. This is consistent with the shortage that is being studied here.

Table 1.
​​​Top 5 Factors Contributing to Unfilled Training Spots 

The third most common factor among the top 5 lists was the lack of funds to support training. Further comments regarding funding availability tended to align with either of two main areas of discussion: low wages make recruitment and retention of educators and trainers difficult, which is again exacerbated by the shortage; and some facilities need physical expansion (more student labs, teaching staff, etc.) in order to increase their education/training capacity. There was also mention of the desire to increase trainee stipends for those programs that provide stipends. Threats to funding sources are always on the horizon and it is important to support and create strategies for sustainable funding.

In addition to information provided through the Subcommittee Workforce survey, data on approved training programs and licensed personnel and trainees was provided by LFS. According to these data, there are 69 CLS training programs and partner laboratories, and 19 approved PHM training program sites. Results from the survey suggest common issues and needs across training programs. Both types of training programs need additional qualified trainers and instructors, facility and laboratory space, laboratory equipment, supplies, and the funding to meet these needs.

For each training program, LFS approves the number of trainees that can be hosted during a training cycle. According to data provided by LFS, a total of 584 CLS trainee positions and 48 PHM trainee positions are available to fill annually.

In order to assess the possible current and future workforce of CLS in California, as of August 31, 2022, there were 17,449 active licensed CLS or CLS trainees (see Table 2, “Total Active Clinical Laboratory Scientists (CLS)”). LFS requires TRL applicants to submit documentation of academic coursework to qualify for trainee licensure. The MTA license prefix indicates that the person holding the license has completed training and passed the required examination to become a generalist CLS in California. Of the 17,449 CLS, 16,188 (93%) are Medical Technology Associates (MTA) and 1,261 (7%) are Trainees (TRL). The annual total breakdown illustrated in the table below is based on the license start date and included both new license and renewal applications.

Table 2.
Total Active Clinical Laboratory Scientist (CLS) by Start Date: New and Renewal Licenses

These data have some limitations, e.g., there may be duplication of records as some MTAs may still have their TRL licenses that are still active in the system; the TRL is removed only after it has expired. In addition, those with TRL licenses may not be actively training; and those with active CLS licenses may not be currently employed in a laboratory performing diagnostic testing. Regardless, the data suggest that training programs are not able to train enough CLS trainees to fill the need and this is a bottleneck to increasing the number of testing personnel. As of the time of this writing, there are currently 1,261 qualified, licensed CLS trainees with only 584 training spots available, many of which are not filled. There is a strong implication that there are hundreds of qualified, licensed CLS trainees who are waiting to be placed for clinical training.

There are a total of 19 training sites approved by LFS to provide training for PHMs. The CDPH hosts the “PHM Training consortium” that hosts 15 to 30 trainees for six months each year in the San Francisco Bay area; this is a collaboration between CDPH and local public health laboratories. Additional trainees are trained at host laboratories in Southern California or other local public health labs that do not participate in the consortium. During the COVID-19 pandemic in 2020, the CDPH training cohort size had to be reduced to adhere to social distancing practices and to be able to safely resume PHM training. The efforts to expand the training program and increase the number of trainees has historically been limited by laboratory space and seating for PHM trainees, availability of trainers, and/or the number of PHM vacancies that a host laboratory had need to fill.

Recommendations:

While the Charge of the Subcommittee focused on identifying key issues contributing to the clinical and public health laboratory testing personnel shortages (in particular, those related to training capacity), several recommendations were discussed that may help to build workforce capacity in the future:

1. Increase the number of training programs and / or laboratory training sites, or participating county laboratories, by supporting the following initiatives:
   1. Provide sustainable funding and opportunities to support the needs, resources, and expansion of training programs, including increasing the ability of programs to hire trainers or expand physical space and make facilities or other infrastructure improvements. Funding is the main factor impacting stipends and sustaining training in an already stretched workforce environment.
      1. ​Create or support legislative bills that will facilitate stable funding for workforce development efforts and activities, as well as contingency plans for emergencies and workforce shortages.
         
      2. Support and adopt strategies to leverage funding partnerships to help secure and strengthen funding sources for training programs, including increasing the number of trainers and training program managers. For those training programs that provide stipends, consider options to increase trainee stipends.
         
   2. Establish collaborations between CLS, PHM, and other clinical fields that may provide solutions to the needs of laboratory training programs. Collaborative efforts could include a pool of educators, Subject Matter Experts (SMEs) and PHM trainers.
      
   3. Facilitate partnerships between academic programs and biotechnology laboratories, blood banks, or other training locations. Partnerships with academic institutions may help with recruitment of SMEs and trainers and assist with set-up of new host labs and/or partner hospitals. This would help address the need for space and trainers.
      
   4. Facilitate training programs whereby trainees could obtain required generalist clinical laboratory training across institutions.
      1. ​Mix and match rotations. Review and update (as necessary) the requirement for program training locations (i.e., how much percentage of rotation would be scheduled in a single facility versus mix/match).
   5. Facilitate an increase in training programs in California by providing guidance on the Department’s application process and other templates (e.g., program manuals) that may assist new laboratories understand the requirements and application process to become an approved training program.
      
2. Development of remote or alternative training options. The PHM Training Consortium and the San Jose State University CLS program are examples of alternative training models.
1. Public health laboratories that participate in the PHM training consortium broadcast and record didactic lectures and make these available to other training laboratories; this collaboration allows many more trainees to attend didactic training from remote locations and standardizes the training material.
2. The San Jose State University CLS program has a robust remote learning program with a high board exam pass rate. It is one of the largest CLS training programs in California and would like to expand.
3. Update regulations to increase the number of trainees-to-licensed personnel/trainer ratio (reference 17 CCR § 1035 (d)). Currently, required the ratio of licensed personnel to trainee ratio is 2:1. This can be a limitation for smaller laboratories and may not be necessary depending on how the training is administered and supervised. By increasing the number of trainees that a laboratory can safely train, fewer trainees will be waiting for a laboratory spot to open.
4. Update or revise regulations related to training programs to allow more programs to train. This includes updating:
   
1. Requirements for host clinical training settings may also need to be updated to encourage more laboratories to participate in clinical training.​
   
2. Review current training requirements for to possibly shorten training in certain specialty areas. For instance, the amount of microbiology training required for a CLS generalist is less than that for a CLS with a limited license in microbiology.
   
3. An intermediate layer of training curriculum may be developed since the licensee will be trained at work and deemed competent prior to performing the job.
   
5. Develop accelerated pathways to clinical licensure (including new MLT to CLS pathway that is currently being developed by LFS).
1. Consider relevant, applicable education and experience obtained during baccalaureate and post-baccalaureate education to reduce training time.
2. Create expanded pathways for cross-licensing/certification; for instance, allowing PHM certification for those licensed from other clinical laboratory fields, such as MLT and CLS. LFS could work with CAPHLD to create these pathways, which may be similar to an accelerated training program.
   
3. Create accelerated pathways to licensing and certification for those that have out of state, military, or international experience, licensing, or certification in clinical or public health laboratories.
   
6. Update licenses and licensing requirements (training, education, prerequisites) to meet current workforce needs. This would include assessment and updates to the following:
1. Educational requirements to reflect the current training curriculums and college courses that would qualify meet trainee requirements. If updating the education requirements for trainees would require legislative action, LFS could continue to work with the Subcommittee on these specific efforts.
2. Determine licensing categories that need updates to training or education. An example includes establishment of a new Clinical Laboratory license for genetics which will combine the limited Molecular Biology and Cytogenetics licenses into one new clinical license category to align with updated training requirements (if the bill passes, active 01/2024).
   

Other ideas for increasing capacity of testing personnel workforce were discussed by the Subcommittee, including consideration of California adopting CLIA standards and eliminating the requirement for CA licensure or certification for testing personnel. Temporary suspension of CA licensure or certification requirements and defaulting to CLIA standards for testing personnel during the COVID pandemic under the Governor’s Executive Order was crucial to provide the level of diagnostic testing needed to respond to the pandemic. Anecdotally, utilizing personnel that did not hold CA licensure or certification under this exemption did not necessarily compromise quality of lab results because on-the-job training and competency assessment requirements are the same regardless of licensure or certification status. However, without a more comprehensive evaluation of the benefits and risks to patient and public safety, and the broader impacts of aligning personnel qualifications with CLIA, the Subcommittee does not have consensus recommendations regarding this pathway to increase testing personnel workforce. Such an evaluation by the Department may be able to inform future updates to CA laboratory personnel regulations and statutes.

​Implications:

Inadequate numbers of clinical and public health laboratory testing personnel negatively impact public health and safety. In a laboratory setting, the workload is time-sensitive and there is pressure to complete work regardless of the available staffing level. The lack of licensed staff to appropriately distribute the workload leads to burnout, which has been defined as “physical or emotional exhaustion usually due to prolonged stress or frustration” (Garcia, 2020; Golab, 2021; Smith, 2020; Wigert; 2018). Subsequently, the rate of laboratory errors increases when staffing levels are inadequate for the workload, and personal interactions with patients may become more stressful. Public health laboratories are confronting an inability to service the testing demand in California both for routine and surge testing, leading to inequitable access to lab services since PHLs often provide laboratory testing for under-served segments of the population. To manage the workload, clinical and public health laboratories may need to send-out laboratory testing to off-site labs, which could compromise patient care when quick turn-around time is essential. Finally, if the personnel shortage is extreme, clinical institutions may need to cut back on the number or severity of patients they can treat due to an inability to properly support the laboratory testing needs of their patients.

Public health laboratories that are impacted by testing personnel shortages are unable to perform essential public health laboratory testing to detect or investigate outbreaks, provide reference laboratory services to clinical submitters, or respond to public health threats from emerging pathogens or other biothreats. Lab staff shortages have led to an increase in wages in California clinical laboratories, but public health laboratories are unable to keep pace with wage levels in the clinical lab sector, which leads to difficulties retaining certified PHMs in public health laboratories (Association of Public Health Laboratories, 2022).

The implications of testing personnel shortages extend beyond the health of employees and provision of high-quality laboratory service to patients and the public; personnel shortages make it increasingly difficult to train new CLSs and PHMs because dedicated training time/instructors have been diverted to meet routine operational requirements. This cycle perpetuates the personnel shortage.

Most of the recommendations presented by the Subcommittee focus on closing the gaps identified by training programs to increase the number of trainees that can complete requisite training and become fully licensed or certified laboratorians that can perform diagnostic testing. It is imperative that an assessment of requirements for host training programs and training curriculums take place to determine where legislative updates can be made to facilitate increasing the number of programs and subsequently increase the number of CLS and PHM trainees able to complete training.

Funding support is needed to improve available training infrastructure and hire additional staff to provide an increased level of training. New workforce funding opportunities are presenting themselves in California; however, it may be difficult to take full advantage of new funding opportunities if there are regulatory or Department policy barriers preventing expansion of training. It is crucial to support and develop sustainable funding and strategies to maintain the functions of training programs and the continuous efforts to advance workforce development.

The proposed solutions, if implemented, could help alleviate the laboratory workforce shortage in California. Each solution would require its own process for implementation whether by legislative or other means. LFS can assist by providing guidance on which solutions might be feasible in the short or long term, and the most effective method for implementing the proposed changes. Working with educators, trainers, and SMEs will allow objective assessment of the training needs for the different license and certification categories, and where reasonable updates to training and qualification regulations should be evaluated for feasibility and impact.

Subcommittee Members:

• ​Zenda L. Berrada, Ph.D., PHM, PHLD(ABB), D(ABMM); CLTAC Chair (2022) ​
• Alka Chaubey, Ph.D., FACMG
• Megan Crumpler, Ph.D., PHM, HCLD(ABB)
• Anne Deucher, M.D., Ph.D.
• Kathleen Doty, M.A., MT(ASCP)SC
• Joselita Joaquin, M.P.A., CMS, M(ASCP)CM, PHM
• Rachel Rees, DrPH, PHM, CLS, PHLD(ABB); Subcommittee Co-Chair
• Salustiano Ribeiro, M.S., TS(ABB), ELS/ASL(ABOR)
• Mark L. Richardson, CGMBS, MB (ASCP)
• Jowin P. Rioveros, BB (ASCP)CM; Subcommittee Co-Chair
• Rodney M Roath, Ph.D., MBA, MT(ASCP)

Note: Draft version reviewed by CLTAC and final edits made 02/24/2023. Additional minor formatting edits made to ensure ADA compliance, clarity and ease of access on 04/18/2023.

References:

1. Association of Public Health Laboratories (2022). PHL Salary Comparison Dashboard. https://www.aphl.org/programs/QSA/ResearchStudies/Pages/PHL-Salary-Dashboard.aspx 
   
2. California Association of Public Health Laboratory Directors (CAPHLD), (2022, December 12). 2022 CAPHLD Workforce Survey. Patricia Dadone (unpublished).
3. California Association for Medical Laboratory Technology (CAMLT). (2021). Initiatives to Increase Clinical Laboratory Testing Personnel Internships Legislative Proposal. https://camlt.org/wp-content/uploads/2021/11/CLS-and-MLT-Internship-BUDGET-PROPOSAL.pdf [link no longer active]
4. California Association for Medical Laboratory Technology (CAMLT). (2020). CAMLT Workforce Survey. Kathleen Doty (unpublished).
5. Garcia, Edna, et al. (2020 March 9). “The American Society for Clinical Pathology's job satisfaction, well-being, and burnout survey of laboratory professionals.” American Journal of Clinical Pathology 153(4):470-486. doi: 10.1093/ajcp/aqaa008. https://pubmed.ncbi.nlm.nih.gov/32080719/
6. Golab, K. (2021 September 2; updated July 05, 2022). The Impact of Burnout on Clinical Lab Staff. Today’s Clinical Lab. https://www.clinicallab.com/trends/laboratory-training/the-impact-of-burnout-on-clinical-lab-staff-25911
7. Smith, Melinda, et al. (2020, October). “Burnout Prevention and Treatment.” HelpGuide.org. www.helpguide.org/articles/stress/burnout-prevention-and-recovery.htm.
8. Wigert, Ben, and Sangeeta Agrawal. (2018, July 12). “Employee Burnout, Part 1: The 5 Main Causes.” Gallup.com. www.gallup.com/workplace/237059/employee-burnout-part-main-causes.aspx.
   

Additional Resources:

1. California Association of Public Health Laboratory Directors (CAPHLD), Local Health Jurisdiction 2021 Salary Data. Katya Ledin (unpublished).
   
2. California Association of Public Health Laboratory Directors (CAPHLD), Website. (2022). https://www.caphld.org/labaspire
3. CDPH Lab Field Services web site. (2022). Clinical Laboratory Scientist Trainee License https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/CLS-Trainee.aspx
4. Garcia, E. et al. (2021, April). “The Clinical Laboratory Workforce: Understanding the Challenges to Meeting Current and Future Needs”. American Society of Clinical Pathology. https://ascpcdn.s3.amazonaws.com/static/ISTP/ASCP_UW_Clinical+Laboratory+Workforce_Report_2021.pdf
   
5. Michel, R. (2022, October 28). “Clinical Laboratory and Pathology Leaders in Canada Gather to Assess New Diagnostic Technologies and Respond to the Acute Shortage of Medical Technologists”. https://www.darkdaily.com/2022/10/28/clinical-laboratory-and-pathology-leaders-in-canada-gather-to-assess-new-diagnostic-technologies-and-respond-to-the-acute-shortage-of-medical-technologists/
6. Wilson, L. (April 2020). “MLO’s 2020 Annual Salary Survey of laboratory professionals”. Medical Laboratory Observer. (https://www.mlo-online.com/management/careers/article/21134640/mlos-2020-annual-salary-survey-of-laboratory-professionals#:~:text=In)
   

Appendix 1.

CLTAC Laboratory Workforce Subcommittee Training Program Survey 2022

Question 1​.

Question 2.

Question 3.

Question 4.

How many training internships is your program approved for by CDPH LFS (if these data are available) to train annually. If not applicable, please indicate "N/A".

Question 5.

How many trainees is your program able to accept and train annually with your current resources?

Question 6.

If your program is approved to train for more than one category of license or certificate, why are some categories actively training and others not? If not applicable, please indicate "N/A".

Question 7.

Question 8.

Question 9.

Question 10. (open-ended)

Question 11.​

Question 12.

Please provide additional information regarding response to question #11 that you would like to share.

Question 13.

Question 14.

Assuming that you have all of the required resources, how many trainees would your program accept to train annually?

Question 15.

Question 16.

Question 17.

If question #16 is applicable, is retention of trainees after the training period a problem at your institution? If yes, what are the primary reasons why (if known)?​

Question 18.

Please provide any other information you would like to share about your current training program, and additional ideas about increasing training capacity that you might like to share:​