Lab Management Flashcards
What is strategic planning?
Strategic planning is the process by which high levels decisions are made, and is 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.
How are strategic planning and tactical planning different?
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.
What is SWOT analysis?
One 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 for guiding a marketing strategy and can be used in developing such a program.
What are TQM and CQI?
Total quality management (TQM) and continuous quality improvement (CQI) have been standard approaches to quality leadership and management for over 30 years. TQM is a systems approach that focuses on teams, processes, statistics, and delivery of services/products that meet or exceed customer expectations. CQI is an element of TQM that strives to continually improve practices and not just meet established quality standards.
What are Six Sigma and Lean?
Six Sigma and Lean are often-used quality tools. Six Sigma is a process improvement program that is a hands-on process with the single mantra of “improvement”: improved performance, improved quality, improved bottom line, improved customer satisfaction, and improved employee satisfaction. Six Sigma is a structured process that is based on statistics and quantitative measurements. Through this process, the number of defects per million opportunities (DPMO) is measured. The Lean process, first implemented by Toyota, was ultimately designed to reduce waste (“nonvalued activities”). The intent of Lean is to reduce costs by identifying daily work activities that do not directly add to the delivery of laboratory services in the most efficient or cost-effective ways. A Lean laboratory utilizes fewer resources, reduces costs, enhances productivity, promotes staff morale, and improves the quality of patient care.
What is DPMO, as it relates to Six Sigma?
Six Sigma is a process improvement program that is a hands-on process with the single mantra of “improvement”. Six Sigma is a structured process that is based on statistics and quantitative measurements. Through this process, the number of defects per million opportunities (DPMO) is measured. A defect is anything that does not meet customer requirements, for example, a laboratory result error, a delay in reporting, or a quality control problem. So, if a laboratory sends out 1000 reports and finds that 10 are reported late, it has a 1% defect rate; this is equivalent to 10,000 DPMO. The goal of Six Sigma is to reduce the number of defects to near zero. The sigma (σ), or standard deviation, expresses how much variability exists in products or services. By reducing variability, one also reduces defects. Thus, one sigma represents 691,463 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 a 99.9997% yield. Most organizations operate at or near four sigma (6210 DPMO).
What is ISO?
It is a more focused and stringent approach to quality system management. In a cooperative effort, the International Organization for Standardization (ISO) established guidelines that reflect the highest level of quality. The ISO 15189:2007 has been adopted by CAP in an effort to improve patient care through quality laboratory practices. A laboratory that meets or exceeds these guidelines can be CAP-certified, indicating a high level of confidence in the quality of services provided by that laboratory. In a similar fashion, the CLSI has created 12 Quality System Essentials based on ISO standards.
What are the 12 Quality System Essentials created by CLSI?
The Clinical and Laboratory Standards Institute has created 12 Quality System Essentials based on ISO standards. Each of these 12 areas serves as a starting point in establishing a quality system that covers pretesting, testing, and posttesting operations. The 12 elements are: organization, personnel, documents and records, facilities and safety, equipment, purchasing and inventory, information management, occurrence management, assessments - internal/external, process improvement, customer service, process control.
What is a “workcell?”
In the functional design of a laboratory, a single testing platform is a single analyzer, a workcell is two or more linked instruments, and total laboratory automation is a workcell with preanalytic and postanalytic processing.
As of 2011, how many states require laboratory personnel licensure?
13: CA, GA, LA, NV, ND, RI, FL, HI, MT, NY, PR, TN, WV.
What is CLIA ‘88?
The Clinical Laboratory Improvement Act of 1988 (amended 1990, 1992) established that all laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards based on test complexity. Until this time, the federal government regulated only the few laboratories conducting interstate commerce or independent or hospital laboratories that wanted Medicare reimbursement. CLIA applies to all sites where testing is done, including physician’s offices and clinics.
CLIA ‘88 was amended in what year(s)?
1990 and 1992.
What is the Stark Law?
The physician self-referral ban established in 1989, which prevents physicians from referring Medicare patients to self-owned laboratories.
What is the “three-day rule” regulation initiated by CMS?
Established in 1990. Payment for any laboratory testing done 3 calendar days before admission as an inpatient is not reimbursed because testing is considered to be part of the hospital stay (Omnibus Reconciliation Act); directs HHS to develop an outpatient DRG system.
In what year was HIPAA was enacted?
- The Health Insurance Portability and Accountability Act directs how health care information is managed. This law protects patients from inappropriate dispersion (oral, written, or electronic) of personal information and is the basis for many of the privacy standards currently in place.
What are the OIG Compliance Guidelines for clinical laboratories?
Guidelines established by the Office of Inspector General in 1997 that help laboratories develop programs that promote high ethical and lawful conduct, especially regarding billing practices and fraud and abuse.
Minimum national laboratory quality standards are enforced by ___.
Minimum national laboratory quality standards are enforced by the federal government or by their designees that have received “deemed status,” reflecting standards equivalent to or stricter than those put forth by CLIA ’88.
What is the Laboratory Compliance Program?
The Laboratory Compliance Program was mandated by Congress in 1998 in response to concerns from CMS about fraud and abuse of payments. This program requires that laboratories that receive payment for services from any federal agency must have policies addressing the medical necessity for tests ordered, ensuring accurate billing for testing, and promoting a standard of conduct to be adopted by laboratory employees.
What are the 3 main CLIA test categories and what types of tests are not categorized or not currently regulated by CLIA?
Test categories (based on analyst/operator and complexity to run test): waived (e.g., blood glucose, urine pregnancy), moderate complexity, and high complexity. Not categorized (because they do not produce a result): quality control materials, calibrators, collection kits (for HIV, drugs of abuse, etc.). Not currently regulated (by CLIA): noninvasive testing (e.g. bilirubin), breath tests (e.g., alcohol, H. pylori), drugs of abuse testing in the workplace, continuous monitoring/infusion devices (e.g., glucose/insulin).
List laboratory-related govenmental agencies.
CDC, CMS, DOT, EPA, EEOC, FDA, HHS, NARA, NRC, NIDA, NIOSH, NIH, NIST, OIG, OSHA, and state department of health.
CDC, FDA, NIOSH, NIH, and OIG are part of/overseen by the US department of ___.
CDC, FDA, NIOSH, NIH, and OIG are part of/overseen by the US department of Health and Human Services.
What is CMS?
The Centers for Medicare and Medicaid Services, formerly known as HCFA oversees the largest health care program in the United States, processing more than 1 billion claims per year. Medicare provides coverage to approximately 40 million Americans over the age of 65, some people with disabilities, and patients with end-stage renal disease, with a budget of $309 billion (2004). Medicaid provides coverage to approximately 50 million low-income individuals through a state–federal partnership that costs $277 billion (2004). CMS sets quality standards and reimbursement rates that apply to the laboratory and are often used by other third-party payers.
NIST (National Institute of Standards and Technology) is a branch of the ___ Department.
NIST (National Institute of Standards and Technology) is a branch of the Commerce Department, and has contributed to the development of many health care products. In addition, it has developed standards for calibration, weights and measures, and the International System of Units.
OSHA is part of the US Department of ___.
OSHA is part of the US Department of Labor.