Using Lean Six Sigma to Decrease Delivery Time of Blood Products to the Operating Room.

Lean Six Sigma (LSS) is a process improvement strategy used in many industries. Its goal is to improve performance and quality by eliminating waste, optimizing flow, and reducing variability. This article describes LSS methods and their application in health care. We detail a successful quality improvement (QI) initiative in which we tested LSS tools to evaluate and enhance our institution's blood product delivery to the operating room (OR). Incorporating LSS-driven changes resulted in a revised workflow, which decreased personnel workload and significantly reduced delivery time. We hope this article will encourage other health care institutions to integrate LSS strategies into their workflows.

Development of a real-time quantitative PCR assay for detection of a stable genomic region of BK virus.

BACKGROUND: BK virus infections can have clinically significant consequences in immunocompromised individuals. Detection and monitoring of active BK virus infections in certain situations is recommended and therefore PCR assays for detection of BK virus have been developed. The performance of current BK PCR detection assays is limited by the existence of viral polymorphisms, unknown at the time of assay development, resulting in inconsistent detection of BK virus. The objective of this study was to identify a stable region of the BK viral genome for detection by PCR that would be minimally affected by polymorphisms as more sequence data for BK virus becomes available. RESULTS: Employing a combination of techniques, including amino acid and DNA sequence alignment and interspecies analysis, a conserved, stable PCR target region of the BK viral genomic region was identified within the VP2 gene. A real-time quantitative PCR assay was then developed that is specific for BK virus, has an analytical sensitivity of 15 copies/reaction (450 copies/ml) and is highly reproducible (CV ≤ 5.0%). CONCLUSION: Identifying stable PCR target regions when limited DNA sequence data is available may be possible by combining multiple analysis techniques to elucidate potential functional constraints on genomic regions. Applying this approach to the development of a real-time quantitative PCR assay for BK virus resulted in an accurate method with potential clinical applications and advantages over existing BK assays.

Streptococcus agalactiae sepsis after transfusion of a plateletpheresis concentrate: benefit of donor evaluation.

BACKGROUND: Bacterial contamination of platelet (PLT) components is an important cause of transfusion reactions. Recent efforts have focused on heightened surveillance to detect contamination before transfusion to limit recipient morbidity and mortality. Although identifying the cause of contamination is most often viewed in the context of recipient safety, this case illustrates the importance of a thorough evaluation on donor safety. CASE REPORT: A 68-year-old woman experienced a severe febrile reaction after a plateletpheresis transfusion. Blood cultures from the patient and from the plateletpheresis component were both positive for the presence of Streptococcus agalactiae. No abnormalities were identified on review of collection and processing records. The donor was asymptomatic and had a negative review of systems, a normal physical exam, normal laboratory values, and negative blood and urine cultures. One of three stool samples was positive for the presence of occult blood. Colonoscopy revealed a Dukes Stage B colonic adenocarcinoma. Fifteen months after surgical resection and adjuvant chemotherapy, the donor had no evidence of recurrent tumor. CONCLUSION: Identification of bacteria in blood components should trigger a comprehensive donor evaluation, particularly if donor bacteremia is suspected. Organisms that may be associated with an enteric source should prompt a thorough gastrointestinal evaluation. Because the primary reservoir of S. agalactiae in the human body is the gastrointestinal tract, and because no findings suggested an alternate portal of entry in our male donor, a gastrointestinal source was suspected. In this case, an evaluation for organism-specific pathology led to early identification of a potentially curable large bowel lesion.