Blood Transfusion

Zika virus strains fall into two major genetic lineages—one African, the other Asian—based on recent genome sequencing analysis, according to Young-Min Lee of Utah State University, Logan, and his collaborators. “Studies are currently underway at Utah State University to examine the functional importance of the genetic variation on viral replication and pathogenesis,” he says. Meanwhile, the World Health Organization (WHO) designated another Zika isolate as a reference strain for use in diagnosis. Its sequence was determined by Sally Baylis of the Paul-Ehrlich-Institut in Langen, Germany, and her collaborators. Details appeared online in Genome Announcements, August 18 and September 1, 2016, respectively (doi:10.1128/genomeA.00917–16, and doi:10.1128/genomeA.00800–16).

The economics of healthcare today challenge clinical laboratories nationwide to provide quality service and patient results in spite of decreasing resources. Decreasing reimbursement for patient testing and dwindling staff resources require the laboratorian to “do more with less.” One must be aware of one’s professional environment and be creative to utilize the existing resources effectively and efficiently. In many cases, this will require a laboratory environment of constant and major change. This chapter addresses some of these issues and their financial implications. Automation, computerization, point-of- care testing (POCT), and robotics will allow a more integrated, systemwide approach to providing high-quality laboratory services in support of patient care. Laboratory networks and multi-hospital systems may achieve economies of scale. There has been a steady increase in regulatory control of the healthcare industry by both federal and state governments. This increase in regulation extends to all clinical laboratories supporting both inpatients and outpatients. Government compliance regulations as well as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules have resulted in unplanned expenses for clinical laboratories and hospitals to modify existing computer systems and even add personnel to help meet the regulations.

This chapter presents an overview of the major changes that impact the practice of medicine over the first decade of the 21st century. As healthcare costs have risen, there has been pressure to gain control through restructuring, mostly in the form of changes in Medicare and Medicaid regulations as well as the continued growth of managed care. The chapter outlines the major cost-containment and medicolegal issues faced by the healthcare team, including laboratorians. Changing the rules of payment and reimbursement has had vast effects on the clinical laboratory. A description of the recent advances in medicine and information technology is presented. These include computerized information systems, electronic medical record (EMR), meaningful use/value-based purchasing, and advances in diagnostic testing. Describing physician practice and utilization patterns developing in response to societal, reimbursement, and emerging technology, the chapter outlines the emergence of clinical guidelines. Clinical pathways and clinical practice guidelines are also developed by individual institutions, as evidenced by reviews of peer-reviewed publications. The chapter also summarizes the steps required to develop a clinical pathway. We live in a litigious society and the medical community has felt the impact. Increases in medical malpractice awards impact medical care. Changes in the practice of medicine impact medical student and resident training. Finally, the chapter identifies the changes in medical school and residency curricula intended to prepare physicians for medical practice in the 21st century.

This chapter enables understanding the three phases of the total testing process; factors affecting quality of test ordering, specimen collection, and patient satisfaction; basic statistical processes involved in monitoring analytical performance; factors affecting test turnaround time; the role of corrected and incomplete reports in quality management and understanding systems for document control. Developing an effective quality management program is challenging because the goal of the program (good outcomes) is often difficult to quantify and may involve processes that are not directly under the laboratory manager's control. Quality management of analytical phase of the testing process is the most standardized and regulated and has therefore received the most attention. Setting up a hot line through which clients can report potential problems or errors and make inquiries may help large laboratories consolidate customer support services. Quality management of the analytical phase involves reducing inaccuracy and imprecision (variability) of test methods as much as possible. The primary quality characteristic that is monitored during the analytical process is the deviation of an analytical measurement from expected. Errors can be classified as systematic (resulting in a shift) or random (resulting in increased imprecision). Inadequate laboratory test turnaround time is one of the most common complaints that comes to the laboratory manager. Clinical laboratories process and handle an enormous amount of information each day. These processes require an organized approach for controlling and organizing this information and making it readily accessible to busy laboratory staff and laboratory inspectors.

The economics of healthcare today challenge clinical laboratories nationwide to provide quality service and patient results in spite of decreasing resources. Decreasing reimbursement for patient testing and dwindling staff resources require the laboratorian to do more with less. One must be aware of one’s professional environment and be creative to utilize the existing resources effectively and efficiently. In many cases, this will require a laboratory environment of constant and major change. This chapter addresses some of these issues and their financial implications. The challenge in many facilities is to keep a positive financial bottom line. Maintaining the status quo is not an option today, since the changing environment requires changes in our laboratory operations in order to maintain financial stability. A review of current laboratory services may reveal some labor-saving opportunities. Automation, computerization, point-of-care testing (POCT), and robotics will allow a more integrated, system-wide approach to providing high-quality laboratory services in support of patient care. Laboratory networks and multihospital systems may achieve economics of scale. The economics of healthcare have changed, decreasing the flow of dollars into diagnostic laboratories. It is imperative today that every laboratorian have a basic understanding of laboratory and healthcare finances. This financial knowledge will help the laboratory team work toward those changes that create a more efficient and cost-effective operation.