In the 1990s, blood centers and transfusion services within the United States began adopting the concepts of quality systems into their routine operations, primarily based on direction provided by a 1993 FDAQA guideline (64). After a series of revisions, the American Association of Blood Banks (AABB) published its 10 Quality System Essentials (QSEs) (65). These have been incorporated into the most recent edition of the AABB Standards for Blood Banks and Transfusion Services (66).
It became very obvious that the QSEs proposed for the blood bank were applicable to the entire laboratory operation. These essentials also incorporated many of the quality requirements developed by CLIA ’88, The Joint Commission (formerly JCAHO), and the College of American Pathologists (CAP).
Recognizing that standardization would be not only valuable, but also essential for high-quality laboratory operations as a whole, the Clinical and Laboratory Standards Institute (CLSI) (formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) developed a subcommittee to prepare a guideline encompassing a complete quality system for the clinical laboratory. This document was recently published as QMS01-A4 (GP26-A4), Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition (67).
Factors Influencing Future Laboratory Practice
The current atmosphere of uncertainty within the health care environment in the United States in the second decade of the 21st century is well recognized. Funding and support for health care are diminishing, and the economic future of health care is hostage to a number of identifiable trends and concerns (Table 11.12).
As consolidation among payers continues through mergers, acquisitions, and other arrangements, providers of care find themselves with fewer buyers of care with whom to negotiate. This requires the development of strategies through which provider leverage can be maintained. Consolidation on the provider side has been one response. Price reductions and exclusive arrangements have been others. Response to these changes also includes affiliation with community providers to increase bargaining strength and aggressive cost reduction to allow more competitive bidding. However, many institutions are now facing the acceptance of marked reductions in reimbursement rates or terminating contracts. As additional changes occur and negotiations continue on these issues, each institution much achieve a balance between the market share realized from each contract, the revenue per service unit, and the total revenue.
Marketplace trends include continued growth in managed care, particularly in the health maintenance organization sector; integration of payers, providers, suppliers, and buyers; mergers and alliances; integration between hospitals and physicians; continued pressure for provider consolidation to address excess bed capacity; continued shift from inpatient to outpatient procedures; and provider alliances based on complementing services (linkage of primary-care facility with the tertiary or quaternary expertise of another institution).
Strategies for survival will include (i) increased ability to capture market share, preferably related to covered lives rather than patient days; (ii) improved information systems to accurately identify costs (fixed, variable by service, procedure) and track the profitability of contracts; and (iii) recognition of the importance of these issues and implementation of proactive measures to structure the organization for survival in the coming years.
With the increase in health care contracts and overall health care reform, a number of potential issues will affect the laboratory of the future. Each institution is actively seeking new markets, with the overall objective being to increase the patient base served by that particular institution. As these contracts increase in number, the reimbursement approach becomes one of capitated payment; the provider takes on the risk previously assumed by the third-party payer. The provider receives a certain amount for each patient per year, the assumption being that the care can be delivered at less than the reimbursement capitated amount; thus, a profit is realized. As these changes occur, there continue to be mergers and the development of large care networks. However, as more large networks are developed, there are fewer contracts on which to bid. Each institution may be forced to consider contracts that pay less than the current costs of service. Obviously, these changes serve as a tremendous incentive to deliver care at continued reduced costs. Once contracts are lost to other bidders, it may be more difficult to recapture that lost market.
Managed care is changing from a cost containment environment to a value purchasing environment. Considerations include careful examination of what is being received for the money spent, increases in requests for outcome data, and case management options. As competitiveness in the managed-care arena increases, long-standing partnerships between institutions and health maintenance organizations will have no inherent merit in guaranteeing continued partnerships. More focused medical management, lower costs, and higher efficiency will determine the continuation or elimination of present agreements. The new environment will demand increased cohesiveness, cooperation, and creativity on the part of all employees within an institution.
An insurance, payment, and delivery system for health care, loosely described as “managed care,” is increasingly viewed as dysfunctional by consumers (i.e., patients), providers, and employers, the last of which constitute the primary source of funding for health insurance for the employed sector of the population. In the current environment of managed-care dominance within the United States, clinical laboratories continue to change their focus of operations and mission in response to the continually changing landscape. Traditional laboratories that are unwilling to change and adapt to this environment will probably not survive. A synopsis of changes since the early 1990s is provided in Table 11.13.
There appears to be a climate of blame in which the various players in the health care arena reproach each other and advance conflicting solutions. Although the “demise” or significant modification of the managed-care system is widely predicted, there is a distinct absence of any consensus about the parameters of politically or economically viable alternatives. Nonetheless, it appears that “something else” will emerge—a return of the “managed-competition” plan proposed in the early years of the Clinton presidency, a national health model resembling the Canadian system, implicit and explicit rationing of resources, or other combinations and approaches. The Affordable Care Act, which was passed during the first term of the Obama administration, contains provisions that radically alter all aspects of health care delivery and financing. However, implementation has only begun, and it is clear, that whatever the outcome of the Affordable Care Act, decreased financial resources available for health care will continue.
Capitated reimbursement has already been mentioned as one of the driving forces behind the necessity to deliver health care at continuing reduced rates. Each year, reimbursement rates decline; currently, leverage lies with the payer, not the provider. Competitive bidding has become an absolute necessity. Also, institutions continue to review their costs in much greater detail
