Laboratory leadership needs to develop coherent succession planning to allow for the continuity of laboratory operations. Without proper planning, labs may have to cease functioning altogether.
By Jennifer MacCormack
Hiring and retaining laboratory testing and supervisory personnel is becoming more difficult in laboratories across the country, as a dwindling number of training programs are producing too few clinical laboratory professionals to replace those who are retiring[i]. The personnel shortage in clinical laboratory science has many laboratories already stretched thin; having someone leave can strain the remaining staff even further.
In a moderate complexity laboratory, testing personnel with a high school diploma can be trained to perform patient testing, quality control, and instrument maintenance. The other CLIA-required positions, however, such as the laboratory director and technical consultant, require higher education and several years of relevant laboratory experience. Turnover is an even more difficult challenge for a high-complexity laboratory, as the experience and education requirements for high-complexity testing and supervisory personnel are more stringent. When the people in these positions leave your laboratory, they can be more difficult to replace than the average person on the bench.
Several steps can be taken for successful succession planning to ensure continuity of operations even if people in key positions leave the laboratory, but they require some forethought and investment in laboratory personnel. Keep in mind that some states define more stringent qualifications for the laboratory director and other personnel; always check with your state CLIA office to ensure you are meeting state requirements as well as federal ones.
Replacing the Laboratory Director
If the laboratory director leaves, and no replacement is immediately available, the laboratory cannot continue patient testing. There is no “grace period” during which a laboratory can operate without a qualified director; if the director leaves, testing must cease and cannot resume until a new director is approved by either the Centers for Medicare and Medicaid Services (CMS) or your accreditation organization (AO). Until then, the laboratory must send out all specimens for analysis elsewhere.
For moderate-complexity laboratories, often the easiest solution is to find another physician in the practice who is willing to take over the directorship. If they have previous experience supervising non-waived laboratory testing, they may be able to qualify for the role. If they have never directed a laboratory before, they can complete an approved 20 CME Laboratory Director course, which qualifies a licensed physician to direct a moderate-complexity laboratory[ii]. The average cost for these courses is $600, and they are generally self-paced and can be completed online.
To be prepared for the future, a physician working in a practice with a moderate-complexity laboratory can complete a qualifying course before there is an immediate need. They will earn valuable CME credit by doing so, and become qualified to take over the laboratory quickly in an emergency. Waiting to develop succession planning until the laboratory is in a difficult spot without an active director will cost the lab additional time and money as testing will have to pause until a qualifying physician completes the course.
It’s also helpful to remember that not all moderate-complexity laboratories are directed by a physician. The minimum requirement for the laboratory director in a moderate-complexity laboratory is a bachelor’s degree in a laboratory-related science, plus two years of work experience and two years of supervisory experience. Experienced clinical laboratory scientists (medical technologists) often direct moderate-complexity laboratories. Existing senior testing personnel or a laboratory supervisor could qualify by this route and take over so that the laboratory can continue testing.
Requirements for a laboratory director in a high-complexity laboratory are much more stringent. For non-physicians, the minimum education required is a doctoral level degree in a laboratory science, and any person with a PhD wishing to direct a high-complexity laboratory must maintain a current, approved board certification[iii]. For physicians, a board certification in pathology or hematology/oncology is required. There is no approved course that can be taken; the only other means for a physician to qualify is to have two years of experience supervising high-complexity testing.
Qualifying via experience is difficult as it requires significant time investment. That said, if the outgoing director gives enough notice, a physician may shadow the outgoing director for the required time period (one year for a moderate-complexity laboratory, and two years for a high-complexity laboratory) to obtain experience directing and supervising appropriate-complexity laboratory testing. This experience must be clearly documented, so it is important that they actively participate in the day-to-day operations of the laboratory as much as possible. This includes reviewing and approving documentation by co-signing along with the current director: quality control data, proficiency testing scores, competency assessments, instrument calibration data, and so on. They will need to learn the federal and state regulatory requirements that apply to their laboratory, as they will become responsible for the laboratory’s compliance once they take over.
Replacing the Technical Consultant or Technical Supervisor
The technical consultant (TC) or technical supervisor (TS) provides technical oversight of the laboratory and is often responsible for maintaining the laboratory’s regulatory compliance. They review laboratory records, provide training, and often perform many of the more complex tasks involved with instrument maintenance and calibration. The minimum qualifications for a technical consultant are a bachelor’s degree in a laboratory science and two years of hands-on work experience performing non-waived testing. For a technical supervisor in a high complexity laboratory, the educational requirement is the same, but four years of hands-on experience is required. Experience must be in the specialties of testing that the person will be performing and supervising.
A laboratory is not required to immediately cease testing if a TC or TS resigns without a replacement; however, it is a CLIA and AO requirement that the position be filled by a qualified person. If a laboratory is operating without a TC or TS, this will be noted as a regulatory non-compliance at their biennial survey, and they will be required to fill that position.
If no one in the laboratory qualifies for the role, then hiring an external TC or TS on a contract or remote basis is an option. There are many places to look when trying to fill this position:
- Local hospital or regional reference laboratory
- Websites such as myconsultantcentral.com, which list professional consultants and consulting companies
- Laboratory professional organizations such as ASCLS or ASCP
- Laboratory management groups
Replacing the General Supervisor (High-Complexity Laboratories)
High-complexity laboratories must also have a general supervisor (GS) who is present to oversee daily testing and to supervise personnel. With an associate’s degree in laboratory science, the GS must have two years of hands-on experience; with a bachelor’s degree, only one year of experience is necessary. The resources listed above for finding a new TC or TS can also be helpful in locating a new GS; however, the GS is expected to be on site to provide daily supervision. A remote employee is not a good choice for this role.
Succession Planning for the Future
Medical assistants (MAs) and medical laboratory technicians (MLTs) who work in the laboratory are often seasoned professionals with several years of experience performing and supervising laboratory testing. However, in general, few of them have the relevant BS degree required to be a technical consultant or technical supervisor. Some among your staff may be interested in taking classes to earn the required degree. Many larger medical centers offer varying levels of tuition reimbursement for degree completion, and it may be worth considering whether this is possible for your laboratory.
An investment in employee continuing education is also likely to improve employee engagement, retention, and successful succession planning. If tuition reimbursement is impossible, offer to support them in other ways, such as flexibility in scheduling or allowing them to study at work when workload is light.
Succession Planning Ahead for the Unexpected
Become familiar with the appropriate procedures for notifying either CMS or the laboratory’s accreditation organization about any changes to personnel and to the laboratory director. Some questions to ask:
- Is there specific paperwork to complete?
- What credentials must be submitted?
- How should the documents be sent?
- How long will it take for the change to be approved?
Because testing must cease if the laboratory is without a director, a relationship with a reference laboratory is important to ensure that patient care is still possible while seeking a replacement. If the laboratory does not already have an agreement with a reference laboratory, and a plan for sending out any testing that cannot be performed, make that a priority. Having a plan in place means it can be implemented immediately in an emergency, and reduce the impact on patient care.
Whether there is a likelihood of losing any staff members in the short term, it is a good idea to review job descriptions and determine where cross-training may help to hold things together if any key personnel leave the laboratory. Review the personnel in every role and determine whether any one person’s departure would cause serious problems due to loss of institutional knowledge or specialized skills. It’s wise to avoid a situation where the person leaving is the only one who knows how to handle certain tasks. Personnel who resign or retire often train someone else on their responsibilities before they leave, but training under pressure and a tight timeline is stressful and will probably not be as effective.
Take the time now to assess your laboratory’s workload, staffing and job descriptions and determine how you can build in some redundancy through cross-training, continuing education or hiring new personnel.
Proactive succession planning is a sign of good leadership. It can prevent costly errors that can occur when remaining personnel are stretched too thin and trying to handle tasks that are new to them. It can also prevent the delay of testing and the loss of revenue when the laboratory must cease testing due to the departure of the laboratory director. Finally, staff will be more engaged and more likely to remain with the laboratory if leadership demonstrates to them that they are worth investing in.
ABOUT THE AUTHOR
Jennifer MacCormack is COLA’s technical writer, developing webinars, technical bulletins, and educational materials, as well as articles for external publication. Prior to joining COLA as a technical advisor, she had more than 15 years of experience as a medical laboratory scientist, working in hospital core laboratories and transfusion services in both the U.S and Canada. She also worked in development and manufacturing of blood typing antisera. Her work has been featured in several industry publications and science communication blogs.