Perspective On: An Academic Clinical Lab

Quality Assured: Troubleshooting, scheduling, communicating, and consulting are just part of lab manager Lisa Wright's many responsibilities

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Lisa Wright is in the business of improving people’s health. Through her several roles at the facilities of Indiana University School of Medicine, Wright, along with her colleagues, tests for genetic and metabolic disorders, supporting physicians, nurses, nurse practitioners, and genetic counselors in finding the right care for their patients.

“The results from our testing assist clinicians in determining diagnosis and prognosis and also assist with the treatment of many disorders,” says Wright, who is the quality control and regulatory specialist for the Division of Diagnostic Genomics, the laboratory manager at the Clinical Cytogenetics Laboratory, and the supervisor of the Cancer Cytogenetics Laboratory— all within the Department of Medical and Molecular Genetics at the School of Medicine.

The clinical laboratories in the Division of Diagnostic Genomics are the Clinical Cytogenetics, Clinical Molecular Genetics Diagnostic, and Pediatric Biochemical Genetics laboratories.

Together, the laboratories provide clinical services to the patients of Indianapolis and the surrounding area. In addition, the labs at Indiana University School of Medicine are also committed to educating students, residents, and fellows in the fields of cytogenetics, molecular genetics, and associated testing.

Fairbanks Hall Indiana UniversityLaboratory structure

The division’s three labs—Clinical Cytogenetics, Clinical Molecular Genetics Diagnostic, and Pediatric Biochemical Genetics—take up around 7,000 square feet on three floors in two buildings.

“Space is at a premium in an academic institution located in the middle of a large city,” Wright says. “We are looking to expand our laboratory to new space in the next few years, but we make what space we have available now work.”

The Clinical Cytogenetics Lab has 23 employees. These include 17 technologists, two administrative staff members, two postdoctoral fellows, one assistant director, and one director/ medical director. The lab runs approximately 7,500 tests each year.

Three technologists, one administrative staff member (shared with the Pediatric Biochemical Genetics Lab) two assistant directors, one director, and a medical director make up the staff of the Clinical Molecular Genetics Diagnostic Lab. This eight-person team processes around 1,400 tests annually.

With two technologists, one administrative staff member (shared with the Clinical Molecular Genetics Diagnostic Lab) and one director who also serves as medical director, the Pediatric Biochemical Genetics Lab has the least staff of the three labs yet manages to run about 1,100 tests each year.

The director of the Division of Diagnostic Genomics clinical labs, Gail H. Vance, MD, who is also the director of the Cytogenetics Laboratory, oversees all three labs. Wright reports directly to Vance. She also reports to the other directors regarding compliance and quality assurance as she represents all the laboratories at the IU Health, IU Agreement Laboratories Quality Assurance meetings.

“The cytogenetics staff supervisors—and their staff members in their absence—report to me,” Wright says. “The biochemical genetics lab staff report to me and the medical director of the lab.”

The lab staff are mainly educated and trained in biology, biochemistry, and chemistry, some with an emphasis in genetics. Wright herself has a Bachelor of Science degree in biology from Indiana University in Bloomington and a Master of Science in medical genetics from Indiana University-Purdue University Indianapolis.

Because it is an academic lab setting, Wright and her staff often utilize work-study students as lab assistants both in the lab and office areas. This gives the labs additional help when needed but also provides an opportunity for graduate students, medical residents and fellows, postdoctoral fellows, medical students, and genetic counseling students to gain valuable hands-on experience.

IU Department of Medical and Molecular GeneticsThe cytogenetics lab staff at the Indiana University School of Medicine's Department of Medical and Molecular Genetics in Indianapolis.  Photo credit: A. MorseDuties

Wright’s overarching roles include assisting with troubleshooting for all sections of the division labs in order to maintain and improve quality of services provided to their clients.

As manager of the Clinical Cytogenetics Laboratory, Wright is responsible for scheduling holiday and Saturday duties. She also works with laboratory supervisors from the various sections of the lab to schedule daily activities.

“I consult with the director or assistant director regarding unusual situations in the laboratories,” Wright says. “I also communicate with current and future clients regarding laboratory processes to ensure quality preparation, accuracy of results, and competitive turnaround time.”

As supervisor of the Cancer Cytogenetics Laboratory, Wright reviews the accuracy and quality of results of tasks completed before submission of the final report to the assistant director or laboratory director. She also assists in communicating the preliminary and final results to physicians and other appropriate personnel to assist in diagnosis, prognosis, or treatment of leukemia or cancer.

Being the quality control and regulatory specialist for the clinical laboratories in the division, Wright designs, implements, and maintains an effective and unified quality management system for all three sections of the laboratory.

“I oversee quality assurance meetings for each of the laboratories,” Wright says. “I also participate on the quality assurance committee of the IU School of Medicine Laboratories.”

As part of this process, she prepares reports and makes recommendations for areas of improvement, and revises policies and procedures related to quality assurance, regulatory compliance, and safety.

“I participate in oversight of daily operations of all sections of the Division of Diagnostic Genomics laboratories to maintain good laboratory practices that meet the guidelines of all appropriate regulatory agencies,” Wright says.

IU School of Medicine FISH roomA technologist completes analysis in the FISH room.  Photo credit: L. WrightInventory, maintenance, scheduling, and hiring

Ensuring that all materials in the lab—such as reagents, instruments, and disposables—are up to date is not an easy task, especially for three labs. At IU School of Medicine laboratories, each section of each lab is responsible for maintaining its own inventory. When a lab needs supplies, the staff informs the clinical administrative laboratory coordinator (CALC) responsible for ordering for all three labs.

“Inventory is tracked in an Access database created by the CALC,” Wright says. “The university uses a unified ordering process that is electronic for almost all items used in the laboratories. Expenditures and costs are also tracked by the CALC.”

The CALC is also responsible for setting up maintenance contracts and coordinating the maintenance schedule of instruments such as automated slide stainers, thermal cyclers or PCR machines, and gas chromatography-mass spectrometry machines.

Main Instruments“Another Access database is used to track this process,” Wright explains. “The university uses a maintenance vendor for most contracted preventive maintenance services to take advantage of bulk use of vendors.”

With so much going on, Wright and her staff find that to run effective laboratories they need to ensure that they have a scheduling system that is beneficial for the employees and for the labs.

“For example, the Clinical Cytogenetics Lab is open six days a week from 7:00 a.m. until 5:30 p.m.,” Wright says. “We also have staff members on call on all major holidays. I like to say that people don’t get sick on a schedule. To provide the best service, we have staff members who arrive early and others who arrive later, and we need to be able to communicate effectively to keep the flow of work moving.”

Scheduling also works smoothly if proper communication is in place within the lab.

“We also need to communicate effectively with our clientele to ensure that accurate results are given in a timely manner,” Wright says.

Communication, however, works only when staff members with appropriate backgrounds and training are in place. For this reason, the management team takes great care in picking a strong team.

When Wright or any of the lab managers notice a need to add or replace a staff member, they need to go through the university’s established process.

“Jobs are posted to the university website and applicants apply through the site,” Wright explains. “Batches of resumes and applications are sent for review and then interviews are scheduled.”

Once the lab managers find a good fit, they notify the university Human Resources department, which will review the recommendation and make an offer to the candidate.

“I think it is important to realize that working in an academic lab, we can’t always compete with commercial labs as far as salaries and some benefits,” Wright says of the hiring process. “There are some benefits that we have that are more difficult to find in commercial labs, including frequent opportunities for continuing education. We also have the benefit of a tuition discount from the university.”

Additionally, the supervising staff works hard to provide incentives to their employees. These include holding fun events during Medical Laboratory Professionals Week each spring, providing several breakfasts and lunches throughout the year, and holding an annual holiday party in December.

Leica Microsystems GSL automated slide scannerA technologist sets up a run on the Leica Microsystems GSL automated slide scanner.  Photo credit: L. Wright

 

 

Challenges

As academic facilities, the labs at the Division of Diagnostic Genomics are smaller than commercial labs performing similar tasks. For this reason, Wright and her colleagues find it challenging to stay competitive with commercial laboratories that can cut costs due to high-volume work. Also because of the labs’ size, the managers face some difficulty marketing their labs at IU and rely mostly on word of mouth from their clients who are satisfied with the quality of the work produced.

“One of our main sources of pride in the laboratory is that we produce reliable, quality results in a timely fashion,” Wright says. “We are very accessible to our clients and have had some clients indicate that they have been contacted by larger laboratories but are staying with our lab due to our quality results and accessibility.”

It’s these challenges, combined with a competent staff and knowledge of the central goal of the labs that keep Wright in the lab business.

“When I first started working in the lab, I thought it was going to be a temporary position and I would move on to other things,” she says. “I didn’t realize how much I would enjoy the work and the challenges that come along with the job. In the ensuing 26 years, I have found that I really enjoy my work and working [with] the other staff members in the labs as well as our clients.”

Additionally, Wright knows that what she and her staff do has significant beneficial impact in the community.

“I know we are providing a service to our clients that is vital to providing excellent care and treatment,” Wright adds. “We care about our patients and provide a valuable service, and that makes it easy to come to work every day.”

Sara Goudarzi is a freelance writer based in New York City. Her website is www.saragoudarzi.com.

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5 Keys to Effective Communication Magazine Issue Cover
5 Keys to Effective Communication

Published: December 1, 2012

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