Laboratory Management PDF

Laboratory Management By: Jan Ethan V. Lovendino, RMT, MPSH A. BASIC MANAGEMENT CONCEPTS 1. Management/Leadership Styles a. Authoritarian - manager makes all decisions without input from others; least acceptance and commitment from staff a. democrat...

Laboratory Management By: Jan Ethan V. Lovendino, RMT, MPSH A. BASIC MANAGEMENT CONCEPTS 1. Management/Leadership Styles a. Authoritarian - manager makes all decisions without input from others; least acceptance and commitment from staff a. democratic – manager makes decision after polling staff; better quality and acceptance. a. Consensus – manager tries to get at least partial agreement from all staff; good acceptance and commitment a. Laissez-faire – manager leaves decision to staff; abdicates responsibility A. BASIC MANAGEMENT CONCEPTS 2. Management/Leadership Theories a. Maslow’s Hierarchy of needs - psychology theory proposed by Abraham Maslow in which all individuals focus on the fundamental needs and once fulfilled will progress to higher needs. NEED DEFINITION WORKPLACE CONTERPART Physiological Survival needs (food, water, air, rest) Income Safety Physical and psychological security Insurance, safe work environment, job security Social Sense of belonging, acceptance Social relationship with affection coworkers Esteem Respect, independence, Job title, privileges, respect of appreciation, recognition colleagues Self-actualization Realization of full potential Challenging work, autonomy, professional growth A. BASIC MANAGEMENT CONCEPTS 2. Management/Leadership Theories b. Frederick Herzberg’s Motivator-Hygiene Theory - employees base their satisfaction or dissatisfaction with work, on hygiene factors (company policies, wages, job security) and motivator factors (status, advancement opportunity, recognition, personal achievement) c. Douglas McGregor’s Theory X and Y Theory X is that humans have an inherent dislike of work and will avoid it if they can – therefore they need to be “controlled” Theory Y is that the expenditure of physical and mental effort in work is as natural as in play or rest – therefore, it the job is satisfying, the employee will be self-motivated. A. BASIC MANAGEMENT CONCEPTS 2. Management/Leadership Theories d. Tannerbaum -Schmidt Theory - a manager uses a broad range of leadership styles based on the prevailing circumstances in the current environment. e. Blake-Mouton Theory – describes five types of management situations: 1. Impoverished management – low concern for people and production 2. Authority-compliance – low concern for people, but high concern on production 3. Middle-of-the-road management – medium concern for people and production 4. Country club management – high concern for people, but low concern for production 5. Team management – high concern for people and production A. BASIC MANAGEMENT CONCEPTS 2. Management/Leadership Theories f. Hershey-Blanchard Theory - based on situational models; there is no single “best” style of leadership, but is more dependent on the task, knowledge, and group dynamics for each situation. f. Fiedler Theory – based on two factors of situational contingency; leadership style and situation control; a given situation may require a task-oriented or a relationship-oriented leader A. BASIC MANAGEMENT CONCEPTS 3. Skills of Managers a. Organizational skills – ability to conceptualize and apply management process, systematize workflow, make decisions, and communicate with coworkers. b. People skills – understanding basic theories of human needs and work motivation. c. Financial skills – effective use of and accounting for the monetary assets of the company d. Technical skills – synthesis of the first three skills and the management of physical resources into the operational parameters. A. BASIC MANAGEMENT CONCEPTS 4. Foundation of Management Processes a. Mission – organization’s purposes a. Goals – organization’s broad, long-term ambitions a. Objectives – directives that describe how a goal will be achieved; should be SMART (Specific, Measurable, Achievable, Realistic, Time bounded) A. BASIC MANAGEMENT CONCEPTS 5. Functions of a Manager a. Planning – establishing goals and objectives, formulating policies to carry out objectives; involves SWOT analysis: Strengths, Weaknesses, Opportunities, and Threats TYPES OF PLANS 1. Short range or tactical plan – covers a 1-5year period and focuses on tasks that can be completed in this time frame 2. Operational plan – may be for 1 year or one budget period and concerns operations 3. Strategic plan – maps out the course of an organization for approximately 20 years; evaluated and modified yearly A. BASIC MANAGEMENT CONCEPTS 5. Functions of a Manager b. Organizing – coordinating resources to achieve plans, defining working relationships, including line of authority and workflow. c. Directing – communicating, motivating, delegating, and coaching; creating a climate that meets the needs of individuals and the organization. Major techniques for directives 1. Autocratic – detailed instructions given of exactly how and what is to be done 2. Consultative – input is sought from employees to help solve a problem or tackle a project d. Controlling – defining standards of performance, developing a reporting system, and taking corrective action when necessary. B. QUALITY MANAGEMENT 1. APPROACHES TO QUALITY MANAGEMENT a. Management by Objective (MBO) targets organizational and employee performance by aligning goals and objectives throughout the organization, including timelines and feedback in the process a. Total Quality Management (TQM) focuses on teams, processes, statistics and delivery of services that meet or exceed customer expectations. It strives to continually look for ways to reduce errors (defect prevention by empowering employees and getting them to understand their integral role within the system (universal responsibility) B. QUALITY MANAGEMENT 1. APPROACHES TO QUALITY MANAGEMENT c. Continuous Quality Improvement (CQI) is an element of TQM that strives to continually improve practices and not just meet established quality standards. It is a team effort approach to identify potential problems and correct them. c. Six Sigma – based on statistics and quantitative measurements; applied in the clinical laboratory to reduce the frequency of test errors or the number of DPMO (Defect per million opportunities). The process consists of 5 steps: DMAIC (Define, Measure, Analyze, Improve, Control) B. QUALITY MANAGEMENT 1. APPROACHES TO QUALITY MANAGEMENT e. Lean – is designed to reduce waste (nonvalued activities) and improve customer satisfaction. It is often used in clinical laboratories to improve a process such as turnaround time. e. ISO 15189 – quality management system developed specifically for clinical laboratories; mandatory in some countries. e. PDCA strategy or cycle (Plan, Do, Check, Act) – most widely used approach to quality improvement in the healthcare) B. QUALITY MANAGEMENT 1. APPROACHES TO QUALITY MANAGEMENT h. Benchmarking – process whereby the best process in one organization is modified to fit similar processes in another organization. h. Use of Pareto chars, cause-and-effect diagrams and flow charts B. QUALITY MANAGEMENT 2. REGULATORY ELEMENTS a. Accreditation: the approval of an institution, part of an institution, or program, demonstrating that it meets all formal standards as defined by the accrediting body a. Certification: official acknowledgement of the passing of a qualifying examination a. Licensure: the process by which a competent public authority grants permission to an organization of an individual to engage in a specific professional practice, occupation, or activity. B. QUALITY MANAGEMENT 3. QUALITY SYSTEM ESSENTIALS Based on ISO standards; each covers pretesting, testing and post testing operations. a. Organization b. Personnel c. Documents and records d. Facilities and safety e. Equipment f. Purchasing and inventory g. Information management h. Occurrence management i. Assessments – internal and external j. Process improvement k. Customer service l. Process control B. QUALITY MANAGEMENT 4. EMPLOYEE PERFORMANCE APPRAISAL a. Error of central tendency. Everyone is rated toward middle of scale b. Contrast error. An individual is rated lower than justified because of comparison with another exceptional individual. c. Error of leniency. Everyone is rated high d. Halo effect. Good performance in one are influences evaluation in another areas e. Reverse halo effect. Poor performance in one area influences evaluation in other areas f. Recency phenomenon. Judgments are made based on recent events or unusual incidents. C. LABORATORY STATISTICS 1. Measurements of Center a. Mean – average or arithmetic mean a. Median – middle point of a data set after the values have been rank-ordered a. Mode – most frequently occurring value in a data set. D. QUALITY ASSURANCE 1. Phases a. Pre-analytical – include test requisition, patient preparation, patient identification, specimen collection, labeling, specimen transport, handling and processing a. Analytical – include reagents, preventive maintenance of equipment, calibration, analysis of samples, and quality control - Standard/Calibrator - substance of known purity and concentration used to calibrate an assay method and to determine the concentration of the unknown analyte. - Control – solution containing various analytes with known target values, analyzed with patient samples to monitor analytical performance D. QUALITY ASSURANCE 1. Phases c. Post-analytical – include verification of calculations and reference ranges, flagging and notification of panic/critical values, delta checks, reporting of results - Critical values – results that indicate a potentially life- threatening situation; typically includes glucose, Na, K, total CO2, Ca, Mg, phosphorus, bilirubin, ABG; requires “a read-pack policy” - Delta check – an algorithm in which a current laboratory result is compared with results obtained on a previous specimen from the same patient D. QUALITY ASSURANCE 2. Quality control a. Accuracy – closeness of the result to the true or actual value b. Precision – ability to produce a series of results that agree closely with each other; commonly expressed in terms of coefficient of variation; also called reproducibility c. Internal/Intralaboratory QC - Involves the analysis of at least 2 levels of control every 24h for at least 20days - Important for the daily monitoring of accuracy and precision of analytical methods d. External/Inter-laboratory QC= Proficiency testing - Involves testing samples of unknown concentration of analytes sent periodically by regulatory agencies to participating laboratories - Poor performance is indicated by an SDI of >2.0 D. QUALITY ASSURANCE 3. Analytical Variation a. Types of Error in Laboratory testing 1. Random Error - Present in all measurements due to chance or an unpredictable cause - Mislabeling, pipetting error, improper mixing of sample and reagent, temp fluctuation 2. Systematic Error - Influences observations, consistently in one direction - Deterioration of reagents, unstable reagent blanks, calibration error, changes in the standard concentration, contaminated control solutions, instrument malfunction. D. QUALITY ASSURANCE 3. Analytical Variation b. Patterns in QC charts that indicate errors 1. Shift – formed by control values that distribute themselves on one side or either side of the mean for 6 consecutive days; usually indicates calibration error 1. Trend – formed by control values that continue to increase or decrease over a period of 6 consecutive days passing through the mean; usually indicates deterioration of reagents 1. Outliers – highly deviating control values caused by random or systematic errors D. QUALITY ASSURANCE 3. Analytical Variation c. Interpretation of Quality Control Results 1. Shewhart Levey-Jennings Chart – most commonly used histogram in QC; allows the laboratory to apply multiple rules and detect errors even without the aid of a computer D. QUALITY ASSURANCE 2. Westgard Control Rules Rule Description Type of Decision error 12s One control value exceeds the x̄ + 2SD; warning; considered a warning rule accept the run 13s One control value exceeds the x̄ + 3SD Random R4s Distance between two levels of control within a run exceeds 4SD 22s Two consecutive control values exceed Reject either the x̄ + 2SD in the same the run direction 41s Four consecutive control values exceed systematic either x̄ + 1SD 10x Ten consecutive control values are on the same side of the mean D. QUALITY ASSURANCE 3. Analytical Variation c. Interpretation of Quality Control Results 3. CUSUM – algebraic sum of the difference between each QC results and the mean 3. Tonks-Youden plot – graphical technique for analyzing interlaboratory data (monthly means); identifies within-laboratory and between-laboratory variability D. QUALITY ASSURANCE 3. Analytical Variation d. Steps taken when a control is outside acceptable range 1. Hold patient results until problem is resolved 2. Rerun control (1 time only) 3. If control is still out, run a new vial of control or another lot number 4. If control is still out, look for and correct any problems, then run control 5. If control is still out, recalibrate, then run control 6. If control is still out, get assistance from supervisor or service representative 7. Once resolved, document corrective action 8. Evaluate all patient results in rejected run and since last run with acceptable QC. Repeat tests and issue corrected reports, as needed. e. Retention of QC records E. INFORMATION SYSTEM Laboratory System of hardware, software, connections, and information system communication protocols to handle all informational needs of lab, from intake of requests to delivery of results Hospital information Information system to handle all informational needs of system hospitals, both clinical and administrative Interface Hardware and software that allow for electronic communication between 2 computer systems, even if they use different programming languages Unidirectional Interface that transmits electronic information in 2 interface directions, e.g., a point-of-care analyzer downloads test results to LIS. Bidirectional Interface that transmits electronic information in 2 interface directions, e.g., the LIS downloads orders from the HIS & uploads results to the HIS F. LABORATORY OPERATING COSTS Budget – a template for forecasting revenue and expenses for an organization; preparation involves four processes; development of goals, forecasting of revenue using budget assumptions, forecasting of expenses, and ongoing monitoring of both revenue and expenses DEFINITION EXAMPLES Capital expense Money used for physical assets Acquiring or upgrading facilities or and is often depreciated over a equipment 5-plus year period Operational Money used for day-to-day Employee wages, taxes, and the expense operations general costs of doing business Fixed costs Expenses that don’t fluctuate Instrument leases, maintenance when volume of work changes contracts, computer services, over short term equipment costs, facilities upkeep, management salaries, custodial salaries, employee benefits, lease payments, rent, taxes F. LABORATORY OPERATING COSTS DEFINITION EXAMPLES Variable costs Expenses that fluctuate directly Labor costs, supplies, reagents, with change in work load disposables Direct costs Costs associated with Supplies, reagents, controls, performance of a test standards, disposables, equipment costs, equipment maintenance contracts, technical and supervisory labor Indirect costs Overhead Administration, plant maintenance, security, utilities, building depreciation, rent, taxes, insurance, housekeeping, purchasing, billing, regulatory expenses, LIS expenses Unit cost/ cost Total of direct and indirect per test expenses of producing a test results G. LABORATORY SAFETY 1. Biohazards a. Four levels of biosafety 1. Biosafety level 1 – agents that have no known potential of infecting healthy people 1. Biosafety level 2 – microorganisms associated with human diseases that are rarely serious and for which preventive or therapeutic interventions are often availble 1. Biosafety level 3 – materials that may contain viruses not normally encountered in a clinical laboratory and mycobacteria 1. Biosafety level 4 – dangerous and exotic agents that pose a high risk of aerosol-transmitted laboratory infections and life-threatening disease for which effective treatments are limited. G. LABORATORY SAFETY 1. Biohazards b. Biohazard label of chain of infection Hand washing Biohazardous waste disposal Decontamination Specimen bagging SOURCE N SIO HO MIS ST NS TRA Standard precautions Hand washing Immunization Personal protective Healthy lifestyle equipment Exposure control plan Aerosol prevention Postexposure prophylaxis Sterile/ disposable equipment Pest control G. LABORATORY SAFETY 1. Biohazards c. Hand washing – most important means of preventing the spread of infection - If hands are visibly soiled, wash hands with soap and water for 1-2mins - If hands are not visibly soiled, wash hands for at least 30secs or use alcohol-based hand cleansers. d. Personal protective equipment – gloves, gown, face shield or goggles, and mask or respirator - Don in correct sequence (gown, mask, goggles, gloves) - Remove in correct sequence (gloves, goggles, gown and mask) G. LABORATORY SAFETY 1. Biohazards e. Decontaminating of Body Fluid Spills - 5.25% NaOCl or 10% chlorine bleach - 1:10 dilution → 1 part household bleach + 9 parts water - Inactivates HBV for _______ and HIV for __________ f. Biological Safety Cabinet Class Description Use I Open front. Air passes through hepa Minimal personnel protection. filter before being exhausted Doesn’t protect work surface II Also called laminal flow; air passes Most commonly used in micro through 2 hepa filters labs. Provides protection for both worker and work III Completely enclosed with glove For extremely hazardous ports. Equipped with negative organisms. pressure G. LABORATORY SAFETY 2. Chemical Hazard - MSDS (Material Safety Data Sheets) - TLV (Threshold Limit Value) – allowable exposure value during an 8hour shift - The United Nations (UN) established nine classes of hazardous materials a. Class 1 – explosives b. Class 2 – compressed gas c. Class 3 – flammable liquids d. Class 4 – flammable solids e. Class 5 – oxidizer materials f. Class 6 – toxic materials g. Class 7 radioactive materials h. Class 8 – corrosive materials i. Class 9 – miscellaneous materials not otherwise classified G. LABORATORY SAFETY 2. Chemical Hazard - Standard hazards identification system by the NFPA Color codes and hazard types: BLUE = toxic/ health RED = flammability/ fire hazard YELLOW = instability/ reactivity? WHITE = specific Degree of hazard: 0 = no hazard 1 = slight 2 = moderate 3 = serious 4 = extreme G. LABORATORY SAFETY 3. Radiation Hazard - Nonionizing forms of radiation emitted by equipment Type Wavelength Example Ultraviolet 700 nm Heat lamps, lasers Microwaves 3um – 3mm Microwave energy beam used to accelerate tissue staining Low frequency >1cm Radiofrequency coil in ICP-MS G. LABORATORY SAFETY 4. Color Coding Scheme for Health Care Wastes Type of waste Color of container/bag Non-infectious dry waste Black Non-infectious wet waste Green Infectious and pathological wastes Yellow with black band Chemical wastes Yellow Radioactive wastes Orange Sharps pressurized containers red G. LABORATORY SAFETY 5. Fire Hazard Class Combustible materials Extinguishers A Ordinary combustibles Ordinary combustibles, water, dry powder, halon B Flammable liquids and Carbon dioxide, dry powder, gases halon C Electrical equipment Carbon dioxide, dry powder, halon D Combustible metals Special agents G. LABORATORY SAFETY 5. Fire Hazard - Actions to take in the event of fire: Rescue Alarm Contain Extinguish - Correct use of fire extinguishers: Pull Aim Squeeze Sweep