Chapter 1 the clinical laboratory

Editor's Notes

• #4: …Strategic planning, marketing, human resource management and quality management are all key elements of a laboratory organization.  
• #5: . Safety strategies include engineering controls (e.g., safety features built into the overall design of a product), personal protective equipment and work practice controls (like hand washing).
• #10: illustrates why leadership must set clear goals and strategic objectives. Effective management uses certain skills to work with and through other people to get things done. It requires an optimal mix of dedicated people and task-oriented leaders to achieve these goals.
• #13: Leadership is a pattern of behaviors used to engage others to complete tasks in a timely and productive manner.
• #18: To survive and even thrive in a competitive environment, a laboratory must constantly re-evaluate its goals and services and adapt to market forces (e.g., fewer qualified laboratory personnel, reduced budgets, stricter regulatory mandates, lower reimbursements, and new sophisticated technologies). This requires a leader to make strategic decisions.
• #19: For example, a global strategy to develop an outreach business may prompt other questions like: ‘Should we perform more reference work in-house? Do we need additional instrumentation and/or laboratory automation? Are our information technology tools adequate? Is staffing adequate to satisfy service expectations?’ So, there is a risk associated with determining a strategy. A wrong decision may burden a laboratory with unnecessary costs, systems or equipment, making it that much harder to change course in response to future market forces or new o
• #20: ………….Another way to evaluate the risks associated with new strategies is the Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis. Generally, environmental factors internal to the laboratory are classified as strengths and weaknesses and external environmental factors are opportunities and threats. This process is a particularly useful tool when developing a marketing strategy ( Table 1-3 ) and should be used to help develop a marketing program ( Table 1-4 ).
• #21: Generally, environmental factors internal to the laboratory are classified as strengths and weaknesses and external environmental factors are opportunities and threats
• #27: Thus, it is clear there are opportunities to improve the quality of laboratory services.
• #29: TQM thinking strives to continually look for ways to reduce errors by empowering employees to assist in solving problems and getting them to understand their integral role within a greater system (‘’).
• #32: ….A defect is anything that does not meet customer requirements; for example, a laboratory result error, delay in reporting or a quality control problem. So, if a laboratory analyzes 1000 reports and finds 10 that are reported late, it has a 1% defect rate; this is equivalent to 10 000 DPMO. Six Sigma refers to the goal of reducing defects to near zero. The sigma or standard deviation expresses how much variability exists in products or services. By reducing variability one also reduces defects. Thus, one sigma represents 691463 defects per million opportunities (DPMO) or a yield (i.e., percentage of products without defects) of only 30.854% whereas the goal of Six Sigma is to reach 3.4 DPMO, or 99.9997% yield ( Brue, 2002 ). Most organizations operate at or near four sigma (6210 DPMO). To put this in perspective, per CLIA'88 guidelines, most proficiency testing (PT) requires an 80% accuracy rate. This translates to 200 000 defects per million tests or 2.4 sigma. The reported PT accuracy rate for CLIA participating laboratories was 97% or 3.4 sigma ( Garber, 2004 ). Six Sigma practices can be applied to patient care and safety ( Berte, 2004 ). Examples, based on College of American Pathologists (CAP) Q-Probes and Q-Tracks programs, show the relationship of applying Six Sigma to some common performance quality indicators. In these studies, the median variance (50th percentile) for test order accuracy was 2.3% or 23 000 DPMO; patient wristband error was 3.13% or 31 000 DPMO; blood culture contamination was 2.83% or 28300 DPMO; and pathology discrepancy rate was 5.1% or 51 000 DPMO ( Berte, 2004 ). By lowering defects, quality of care is improved and cost savings are realized by eliminating waste (e.g., supplies and materials for reruns), unnecessary steps, and/or staff time ( Sunyog, 2004 ). By some estimates, the cost of doing business is reduced by 25-40% in moving from three sigma to six sigma performance. An example of the Six Sigma process is provided in Table 1-6 .
• #34: So, if a laboratory analyzes 1000 reports and finds 10 that are reported late, it has a 1% defect rate; this is equivalent to 10 000 DPMO. Six Sigma refers to the goal of reducing defects to near zero.
• #39: review the authority level, experience, education, and job responsibilities of a position and compare them to any related changes in technology, required skills, or other environmental factors. This is to ensure that the position is still necessary and the duties are essential and current. Another question to consider is whether an unfilled position would negatively impact on the department or the hospital. For example, an unfilled phlebotomist position may delay morning blood collection and result availability.
• #42: esoteric tests are either rarely performed, of medium to high complexity, costly, or a combination of all three. , RNA (nucleic acids) micro RNAs, and complex proteomic or metabolomic pattern array based tests. Molecular diagnostics
• #50: Laboratories are obligated to identify hazards, implement safety strategies, and continually audit existing practices to determine whether new ones are needed Good safety practices benefit the laboratory as well as employees. Injuries affect staff morale and threaten the emotional and physical health of the party involved. Injuries are also expensive in terms of lost workdays and wages, damaged equipment, and medical treatment. An injured person may be absent for an indefinite period of time and often cannot work at peak efficiency upon return. While inexperience may be a cause for some accidents, others may be a result of ignoring known risks, haste, carelessness, fatigue, or mental preoccupation (failure to focus attention or concentrate on what is at hand).
• #64: evolve from environmental factors and when individuals push themselves too hard beyond their limits or when productivity limits are set too high.