LifeSouth has two Immunohematology Reference Labs (IRLs) based in Gainesville, FL and Atlanta, GA. Their Quality Control Labs (QCLs) provide analytical testing to ensure the safety, purity, and potency of their blood components and cord blood products. Their Cord Blood Bank (CBB) is one of seven public CBBs licensed by the FDA and produces the biological drug product CORDCYTE. The CBB collects umbilical cord blood at 11 of their partner hospitals. Transfusion Services are provided for select area hospitals.
Customer service
LifeSouth achieves its mission of excellence by adhering STARS, which stands for Safety, Teamwork, A Difference, Reputation, and Stewardship.
The IRLs contribute to the American Rare Donor Program (ARDP) and participate in AABB’s National Blood Exchange (NBE).
In addition to highly skilled and certified technologists and Specialists in Blood Banking (SBBs), they have a Quality Assurance (QA) department which conducts regular reviews and audits. Each lab has a designated QA representative.
LifeSouth has an in-house Technical Communications department which specializes in technical writing and instructional design, as well as a Laboratory Resource Management team in Gainesville dedicated to internal/external blood component logistics and customer service.
Their Medical Directors are board certified in Blood Banking and Transfusion Medicine. The medical team provides a 24/7/365 consultation MD Hotline Service.
Productivity
The lab’s certified technologists and specialists performed nearly 85,000 tests in 2018. Tests performed on blood components include hematocrits and platelet counts on a Sysmex XE-2100D, residual WBCs using BD’s FACSCantoII flow cytometers, HLA antibody detection using the Luminex 200 and 3D, and microbial detection testing using Verax Platelet PGD Test.
Tests performed for cord blood products include complete blood counts on their two XE-2100D hematology analyzers; CD34/CD45 enumeration and viability, nRBC, and total WBC viability by flow cytometry; colony forming units (CFUs) using STEMVision; sterility testing using bioMérieux’s BACT/ALERT; and hemoglobinopathy testing using capillary electrophoresis.
Their CBB adopted both an automated processing platform (Sepax – GE Healthcare) and an automated cryopreservation platform (BioSafe – Thermogenesis) which robotically moves the unit after a controlled rate of freezing. They use a closed processing kit by GE Healthcare and sterile docking devices to reduce bioburden risk.
LifeSouth has a unique in-house software development team. To better meet their customers’ needs, the IRLs final report includes donor compatibility percentages based on patient antibodies present, supplementary information to assist with the interpretation of results, transfusion recommendations, and applicable references to articles.
Education and training
Each lab has designated Area Safety Coordinators (ASCs) who monitor safety practices and conduct emergency drills. Together with the laboratory’s QA representative, nonconformities are monitored for trends and protocols for Corrective Action Preventive Action (CAPA). Lab staff participates in root cause analysis (RCA) and follow a systemic plan to avoid recurrence.
A dedicated Laboratory Training Coordinator manages distribution and completion of training and competency assignments.
LifeSouth has one of only two Florida donor center-based Medical Technology Training Programs for Blood Bank and Immunohematology (MTBB). Since its inception, 30 MTs have graduated. Up to four qualified students are hired as LifeSouth employees. Trainees receive full-time benefits and pay, including all books, training materials, license, and exam fees. In exchange, the new med techs make a two-year work commitment. Since its beginning, 90 percent of participants worked beyond their two-year commitment, and 57 percent are still employed.
Teamwork
LifeSouth’s laboratories overcome challenges with the help of management and their Medical Directors. Their QA department meets monthly with staff to monitor and discuss deviations, proficiency testing, validations, audits, procedure change requests, and staff training.
LifeSouth provides opportunities for staff to recognize the efforts of their coworkers and managers through a system of “STARS points.” Employees are awarded points on a quarterly basis. Staff members nominate others online, with an explanation of which of the company values a fellow employee exemplifies. Points are then redeemed for prizes.
Strategic outlook
In addition to being a Center of Excellence in the Southeast, the CBB objectives include doubling the size of their hospital network; isolating and expanding mesenchymal stem cells (MSC) that are capable of differentiating down adipogenic, osteogenic, and chondrogenic lineages; adding an additional Class 6 clean room for cord blood processing; and participating in clinical research projects.
Their Laboratory Resource Management team is in the process of implementing a Centralized Order Management (COM) model. Trained staff will be available 24/7 to receive and coordinate orders which allows for the customer to have a single point of contact.
LifeSouth continues to expand. An IRL was brought online in Atlanta and they plan to open another IRL in Jacksonville. They are also working with the National Blood Collaborative to open a donor testing lab in Atlanta, as well as becoming accredited to perform HLA home testing.
More than 70,000 LifeSouth blood donors have been genotyped since 2007 to identify compatible donors for patients requiring red blood cells with special antigen phenotypes for transfusion. As a result, they’re able to support the large sickle cell population and are building a dedicated lab space for molecular testing.
Lab inspections
LifeSouth is a member of and accredited by the AABB. The AABB inspection for Blood Bank and Transfusion Services in 2017 resulted in zero non-conformances for the laboratories, and the most recent FDA inspection reported no 483 observations. The CBB is one of the first cord blood banks to become accredited by the Foundation for Accreditation for Cellular Therapy (FACT). The CBB is also a member bank of the National Marrow Donor Program (NMDP). It has been inspected by the FDA, NMDP, HRSA, and FACT. The QCLs have been inspected by the AABB, FDA, and FACT under the CBB with no deficiencies.