Patty Malone, quality assurance director, Community Blood Center/Community Tissue Services, Dayton, OH
Patty Malone, an ASQ member, is the quality assurance director for Community Blood Center/Community Tissue Services (CBC/CTS), which is headquartered in Dayton, OH. CBC/CTS supports the blood component needs for 25 hospitals in 15 counties in Ohio and Indiana. CBC/CTS operates nine locations across the United States, making it one of the five largest full service tissue banks and the largest nonprofit skin bank in the nation.
Malone works with staff at all levels to support CBC/CTS in its efforts to save and
enhance lives. Her areas of responsibility within quality assurance include internal auditing, inspections, compliance, regulatory affairs, process improvement, and education and training. She also serves as the management representative for CBC/CTS’ registration to ISO 9001:2000.
She received her bachelor’s degree from Wright State University in Dayton. She completed her medical technology internship at St. Elizabeth Medical Center in Dayton, and worked in their clinical laboratory for a short time before moving to microbiology at Mercy Medical Center in Springfield, OH. In 1990, Malone took a laboratory position at CBC/CTS, and moved to quality assurance in 1996. She has been the quality assurance director since December 1998. Malone is a member of the Quality Steering Committee for America’s Blood Centers and serves as the chair its human cell, tissue, cellular and tissue-based products regulatory review committee. She is an ASQ certified quality auditor and a medical technologist, certified by the American Society of Clinical Pathologists.
Malone’s entry into the quality field was a natural progression. “Clinical laboratory scientists are very detail oriented, analytical and organized,” she said. “This combination was a recipe for success in quality for the highly regulated environment of blood/tissue banking. There are so many regulatory and accrediting agencies governing and monitoring what we do. The quality assurance staff helps create a balance between the rules and the efficiency of processes, all the while assuring compliance.”
Malone enjoys quality at CBC/CTS because it touches so many aspects of healthcare. “There are many challenges facing our industry, one of which is accurately defining the quality indicators that will truly help to improve processes,” she said. “More often than not, data is recorded, tracked and reported, but not acted upon. Sometimes this is the result of selecting an indicator that you have no control over, such as donor age, weight or blood count. Indicators that can lead to continuous process improvement are not always easy to define.”
One quality initiative in progress at CBC/CTS is the improvement of current standard operating procedures. “We need to make them more user friendly,” Malone said. “Some of our current procedures are very lengthy, which makes it difficult to pinpoint information.” In addition, CBC/CTS will be implementing computer software that will automate its document creation, review, approval and implementation processes.
Malone’s advice to someone new in quality is quite basic: “Quality must be built from the bottom up—there is nothing worse than having quality applied from the top down. Staff must believe in quality, and the only way to achieve this is openness, communication, training and good, solid standard operating procedures”.
