BLOOD BANK 5
“Similarities and differences among the types of organizations”
Fromthe table, the organizations that regulate laboratory and blood bankactivities are Puget Sound Blood Center (PSBC), American Associationof s (AABB) Accreditation, The Center for BiologicsEvaluation and Research (CBER), Food and Drug Administration (FDA)and Washington State Medical Test Site License (CLIA). One of themajor similarities between the organizations is their commitment tothe compliance of standards that of them has established to guideblood collection, storage and use. In addition, these organizationsare compliant to medical standards by national authorities. However,the differences lie in their mandate that control’s their work andperformance expectations. While the Puget Sound Blood Center focuseson research, education and blood laboratory services to hospitals totake care of patients, the AABB controls the accreditation of bloodbanks in the country. On the other hand, FDA provides licensing ofblood banks and medical supplier, a similar role played by the CLIA.
“How each organization will monitor performance, achieve regulatory and accreditation compliance, and improve overall organizational performance.”
Tomonitor performance and regulatory compliance, the PSBC has indicateda set of licensure regulations for every service that they offer.This provides a reference for verification of compliance. To ensureaccreditation compliance and performance, the AABB works closely withthe FDA as a way of monitoring its compliance (AABB, n.d). On theother hand, the FDA monitors its performance through its establisheddivisions of research and assessment of its work. Moreover, the FDAis monitored by many government authorities due to its large scope ofwork and sensitivity of its mandate. The CLIA monitors itsperformance by carrying out surveys that evaluate their regulationfor medical laboratory services. Through the observance of thestandards and regulations, these organizations seek to improve theiroverall organizational performance.
“Ways each organization will communicate with leadership to ensure alignment of organizational goals and gain buy-in from staff to achieve compliance with the standards and requirements issued by regulatory and accreditation bodies.”
TheAABB publishes Transfusion, a research journal that provides its witha platform to communicate with its leadership, stakeholders and othermedical bodies. To ensure further communication for its long termgoals and compliance to standards, AABB publishes a technical manualevery three years in addition to several other blood transfusionmaterials that relate to the accreditation (AABB, n.d). The FDAcommunicates through regular reports as well as on demand reports onits operations and performance. The PSBC communicates to itsleadership and stakeholders on blood transfusion through byorganizing events and publishing news in its organizational platformsand websites (PSBC, n.d). The CLIA communicates performance andorganizational goals by releasing regulatory requirements forlicensure to organizations that seek accreditation (CLIA, nd).Through regular assessments and provision of regular reports, theorganization communicates its goals, standards and requirementsrequired for accreditation of blood transfusion services.
“How compliance with the regulations and development of risk- and quality-management systems for each type of organization contribute to the organization’s overall performance-management system.”
InBlood banking and related laboratory services, compliance withregulations signifies the performance of these organizations becausetheir main mandate is to regulate the standards of blood services.The overall performance of the management systems of the AABB andPSBC is based on their level of compliance with their organizationaland national regulations. In addition, properly developed risk andquality management system provides the basis for evaluating theiroverall organizational performance. Compliance with regulations isthe basis of evaluating the performance of the FDA by governmentagencies. This is because the organization is highly regulated by thegovernment in terms of its compliance with standards in licensingblood transfusion and laboratory organizations. Risk and qualitymanagement systems for CLIA allow the organization to evaluate theeffectiveness of its standards and adherence of standards inaccrediting organizations.
AABB,AmericanAssociation of s.RetrievedFrom, <http://www.AABB.org>June 7, 2014
CLIA,ClinicalLaboratory Improvement Amendments.RetrievedFrom,<http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html>June 7, 2014
FDA,Food and Drugs Authority.Retrieved From, <http://www.FDA.gov>June 7, 2014
PSBC,PugetSound Blood Center.RetrievedFrom, <http://www.PSBC.org/home/index.htm>June 7, 2014