General Concepts and Administrative Issues


Key Points

  • Effective laboratory management requires leaders to provide direction and managers to get things done. Strategic planning, marketing, human resource management, financial management, and quality management are all key elements of a laboratory organization.

  • Most laboratory errors occur in the preanalytic and postanalytic stages. Six Sigma and Lean Six Sigma are quality management tools that can be used to reduce laboratory errors and increase productivity.

  • Laboratory services are provided in many different ways on a continuum from point-of-care tests producing immediate answers to highly complex laboratory tests that require sophisticated technology and skilled staff.

  • Clinical laboratories are highly regulated; many laboratory practices are the direct result of federal or state/local legislation. At the federal level, laboratory activities are regulated through the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88).

  • Biological, chemical, and natural disasters, as well as ergonomic and fire hazards, cannot be completely avoided but can be minimized through preplanning and the use of engineering controls, personal protective equipment, and work practice controls.

The laboratory plays a central role in health care. Anecdotal evidence suggests that laboratory results impact up to 70% of medical decisions. While quantitative studies supporting this claim are lacking ( ; ), the clinical laboratory remains a vital tool in the practice of diagnostic medicine. It is of considerable note that although the laboratory is a $100 billion business, annual laboratory costs account for less than 2% of total health care dollars spent, offering high clinical value at relatively low cost ( ; ; American Clinical Laboratory Association, 2018). While laboratory testing currently seems to be a relative bargain (0.9% annual growth rate from 2012–2017), an estimated 2.7% annual growth rate is anticipated through the year 2022 ( ). Laboratory test menus have become dynamic, expanding to accommodate the ever-increasing number of new diagnostic tests in response to available advanced technology. In the area of genetic testing, as of August 2017, there were about 75,000 tests available representing approximately 10,000 unique test types. That number is expected to grow about 28% annually through 2020, creating a $7.7 billion worldwide industry ( ). Implementing new test modalities and technology will increase expenditures and increase the pressure on laboratory leadership to control costs and guide appropriate test utilization ( ).

The purpose of the laboratory is to provide physicians, other health care professionals, and patients with the necessary information to (1) detect a disease or the predisposition to a disease; (2) confirm or reject a diagnosis; (3) establish prognosis; (4) guide patient management; and (5) monitor the efficacy of therapy. The laboratory also plays a leading role in education, research, information technology design and implementation, and quality improvement. To achieve quality goals and ensure a well-functioning laboratory requires skilled personnel who not only understand state-of-the-art technologies but also financial management, business, marketing tactics, and human resource practices. This chapter will discuss key administrative concepts and issues that serve as the basis of sound laboratory practice. Committed leadership with skills to guide staff is crucial to a well-managed laboratory that generates accurate and timely laboratory results. A more detailed discussion of these topics is available elsewhere ( ; ; ).

An organization is only as good as its people, supervised by skilled managers but guided by visionary leaders. While leaders can be managers, not all managers are effective leaders, yet all should aspire to gain such expertise. The terms leadership and management are often used interchangeably but represent different qualities ( Table 1.1 ). Leadership provides the direction of where a group (or an organization) is going, whereas management provides the “road” to get there. Lewis Carroll pointed out that, “If you don’t know where you are going, any road will get you there.” This simple concept reminds us that leadership must be visionary and set clear goals with strategic objectives and that leaders ensure that the right things are done. Management is more tactical in practice. Managers implement objectives, control budgets, organize staff, and ensure that things are done right. Good leaders use learned management skills, while great leaders employ both skills and their innate characteristics to effectively grow their organization ( ). Effective managers use a variety of talents to work with people to get things done. Achieving organizational goals requires an optimal mix of skilled, dedicated, and task-oriented leaders and managers working with committed staff.

TABLE 1.1
Leader Versus Manager Traits
Modified from Ali M, Brookson S, Bruce A, et al. Managing for excellence . London: DK Publishing; 2001, pp 86–149.
Leader Manager
Administrator Implementer
Organizer and developer Maintains control
Risk taker Thinks short term
Inspiration Asks how and when
Thinks long term Watches bottom line
Asks what and why Accepts status quo
Challenges status quo Is a good soldier
Does the right thing Does things right

Leadership skills manifest as patterns of behavior that engage others to complete tasks in a timely and productive manner. The Situational Leadership model ( ) describes four key styles: supporting, directing, delegating, and coaching. A supportive leader provides high support but low direction in accomplishing duties. A directive leader presents rules, orders, or other defined instructions, but limited support. The former approach offers flexibility and encourages creative problem solving. The latter approach offers concise and detailed instructions from the leader on how to complete a task by independently solving the problems and making all the decisions. A delegating leader provides low support and low direction, allowing competent (generally, more experienced) staff to assume accountability and responsibility to complete the goals. The coaching leader provides high support and high direction by guiding individuals to make real-time decisions with appropriate support and corrective actions as needed. Most leaders adopt a combination of styles as appropriate to different situations but periodically default to one of the four styles to achieve desired results ( ).

Good managers use a variety of human, financial, physical, and informational resources to meet an organization’s strategic goals in the most efficient and effective manner. Some basic managerial responsibilities are listed in Box 1.1 . Managers can be stratified as first-line managers (supervisors, team leaders, chief technologists), middle managers (operations managers, division heads), and top managers (laboratory directors, board of directors, and the various C-suite [top-level] executives). Each managerial level dictates the daily activities and skill sets required for that position. Top-level managers concentrate on strategizing and planning for the next 1 to 5 years, while first-line managers are more concerned about completing the day’s work. A top-level manager may or may not possess technical skills that a first-line manager uses every day. Middle managers may straddle both areas to some degree by engaging in a variety of activities that may be strategic as well as tactical.

BOX 1.1
Basic Management Responsibilities
CPT, Current Procedural Terminology; HIPAA, Health Insurance Portability and Accountability Act; ICD-10, International Classification of Diseases, 10th revision.

Operations Management

  • Quality assurance

  • Policies and procedures

  • Strategic planning

  • Benchmarking

  • Productivity assessment

  • Legislation/regulations/HIPAA compliance

  • Medicolegal concerns

  • Continuing education

  • Staff meetings

Human Resource Management

  • Job descriptions

  • Recruitment and staffing

  • Orientation

  • Competency assessment

  • Personnel records

  • Performance evaluation/appraisals

  • Discipline and dismissal

Financial Management

  • Departmental budgets

  • Billing

  • CPT coding

  • ICD-10 coding

  • Compliance regulations

  • Test cost analysis

  • Fee schedule maintenance

Marketing Management

  • Customer service

  • Outreach marketing

  • Advertising

  • Website development

  • Client education

Strategic Planning

Technology has moved the science of laboratory medicine from using numerous manual methods to applying highly automated ones. The introduction of table-top instrumentation, point-of-care technology, and direct-access testing has leveled the playing field of laboratory science to a point at which some testing can be done in the clinic, in the physician’s office, at a drugstore, and even in the home by nontraditional laboratorians. In addition, the evolution of telemedicine/telepathology has greatly expanded the laboratory’s footprint ( ). These changes have eliminated some of the market protections that laboratories once enjoyed and made testing a commodity. Labs have been forced to adopt more competitive business practices. To survive and even thrive in a competitive environment, a laboratory must constantly reevaluate its goals and services and adapt to market forces (e.g., fewer qualified laboratory personnel, reduced budgets, stricter regulatory mandates, lower reimbursements, new sophisticated technologies). Leaders must carefully make strategic decisions that can have an impact on the laboratory for years.

The process by which high-level decisions are made is called strategic planning , which can be defined as (1) deciding on the objectives of the organization and the need to modify existing objectives if appropriate; (2) allocating resources to attain these objectives; and (3) establishing policies that govern the acquisition, use, and disposition of these resources ( ). Strategic planning is usually based on long-term projections and a global view that can have an impact on all levels of a laboratory’s operations. It is different from tactical planning, which consists of the detailed day-to-day operations needed to meet the immediate needs of the laboratory and works toward meeting the long-term strategic goals that have been set. For example, a global strategy to develop an outreach business may prompt addressing issues such as bringing more send-out reference work in-house, implementing new technologies, acquiring state-of-the-art instrumentation and/or automation, enhancing information technology tools, and employing adequate and skilled staff to satisfy service expectations. Risk can be involved in initiating a specific strategy. A wrong decision may burden a laboratory with unnecessary costs, unused equipment, and/or overstaffing, making it that much harder to change course in response to future market forces or new organizational strategies. Yet, not taking a risk may result in the loss of opportunities to grow the business and/or improve services.

Successful strategic planning requires appropriate data collection by observing current and projected conditions in the following areas: Social, Technological, Economic, Environmental, and Political (or STEEP) ( ). Effective data collection is generally not the work of a single individual but rather involves a diverse and dedicated committee. Commitment is an essential factor that each member of the committee must embrace and agree to in the early stages of the strategic planning process. Members must acknowledge that they may have to agree to disagree, setting differences of opinion aside to remain supportive of the overarching goal. Further, committee participation can consume a significant amount of time that is nonproductive if not efficiently organized. A variety of techniques can be used to guide the strategic planning process; these include histograms/graphs/scattergrams, brainstorming, fishbone diagrams, storyboarding, Pareto analyses, Delphi analyses, and SWOT (strengths, weaknesses, opportunities, threats) analyses ( ). Internal environmental factors in a SWOT analysis are generally classified as strengths and weaknesses, while external environmental factors are opportunities and threats. This process is a particularly useful tool for guiding a marketing strategy ( Box 1.2 ) and can be used in developing such a program ( Table 1.2 ). Successful strategic planning requires preplanning, organization, well-defined goals, communication, and a firm belief in what is to be accomplished.

BOX 1.2
SWOT Analysis for a New Hospital Outreach Program
LIS, Laboratory information system; SWOT, strengths, weaknesses, opportunities, threats.

Strengths

  • 1.

    Use current technology/instrumentation

  • 2.

    Have excess technical capacity

  • 3.

    Increased test volume will decrease cost per test

  • 4.

    Strong leadership support

  • 5.

    Financial resources available

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