Laboratory Management MTLE March 2025 PDF

MAIA Professional Development Center MTLE March 2025 LABORATORY MANAGEMENT Management (administration) can be defined as: the organizing and controlling of the affairs of a business or a sector of a business or “wor...

MAIA Professional Development Center MTLE March 2025 LABORATORY MANAGEMENT Management (administration) can be defined as: the organizing and controlling of the affairs of a business or a sector of a business or “working with and through people to accomplish a common mission.” MANAGEMENT/LEADERSHIP THEORIES: One factor that impacts leadership success is management style. There are primarily five leadership theories: 1.TANNENBAUM AND SCHMIDT theory. Styles can be plotted on a continuum from authoritative to democratic. 2. MCGREGOR X AND Y theory. McGregor X theory relates to authoritative leader, whereas the Y theory relates to the democratic leader 3. BLAKE AND MOUTON theory. Describes five types of management situations: a. Impoverished management: Low concern for people and production b. Authority-compliance: Low concern for people, but high concern for production c. Middle-of-the-road management: Medium concern for people and production d. Country club management: High concern for people, but low concern for production e. Team management: High concern for people and production 4. FIELDER theory. This theory indicates that the style used by the leader may vary according to the situation with a very favorable or very unfavorable situation requiring a task-oriented leader and a moderately favorable or moderately unfavorable situation requiring a relationship-oriented leader. 5. HERSEY-BLANCHARD theory. Four leadership situations: a. Employee new to job. b. Employee has mastered some of the job, but needs supervision. c. Employee has mastered the job, but needs verification. d. Employee has mastered the job and is confident. SKILLS OF MANAGERS 1. Organizational skills. Conceptualize and apply management process, systematize work flow, make decisions, and communicate with coworkers. 2. People skills. Understands basic theories of human needs and work motivation. 3. Financial skills. Effective use of and accounting for the monetary assets of the company. 4. Technical skills. Involve the synthesis of the first three skills above and the management of physical resources (supplies, equipment, facilities) into the operational parameters (products and services). MANAGEMENT THEORIES 1. SCIENTIFIC MANAGEMENT. Attempts to apply a systematic or scientific approach to the study of organizations developed by Frederick Taylor, the father of scientific theory. Applies cause-and-effect analysis, breaking down each task into segments to improve efficiency. 2. BUREAUCRACY MANAGEMENT. Examines the organizational aspects of the company and its work flow to explain how institutions function and how to improve their structural process. Hierarchical chain of command is an example. Special attention is given to the bureaucratic characteristics as they relate to rules, regulations, impersonality, and division of labor. 3. BEHAVIORAL SCIENCE. Focuses on the performance and interaction of people within the organization by utilizing psychology and sociology, as well as management theories. 4. SYSTEMS ANALYSIS. An outgrowth of management science, which views the organization as a continuous process interacting within itself and with its environment. a. Involves Peter Drucker’s five basic management operations: Setting objectives Motivating and communicating Organizing Developing people, including managers Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 1  MAIA Professional Development Center MTLE March 2025 Establishing standards (measurement of performance) MANAGEMENT PROCESS The concept of management as a continuous process of interacting functions, each dependent on the success of the other. FOUR MAIN FUNCTIONS: Planning Organizing Directing Controlling PLANNING 1. Definition: Develop a pathway(s) to accomplish the organization's mission and goals using resources and time 2. In order to plan for the future, one must first determine where the organization stands. A SWOT analysis should be performed to determine both internal and external factors. a. Internal factors 1) S: Strengths of the organization 2) W: Weaknesses of the organization b. External factors (1) O: Opportunities available to the organization 2) T: Threats to the organization 3. Once the SWOT analysis is complete, the manager can plan a course of action for the organization to follow that will accomplish its goals and mission. 4. FORMULATING GOALS a. Written goals allow all employees to work toward a common result. b. Goals should be broad; objectives are written to achieve specific tasks. 5. WRITING OBJECTIVES a. Objectives are tasks to achieve goals. b. Objectives are focused on achieving one goal. c. Each objective deals with one task. d. Objectives are very specific. e. Objectives are written using action verbs. f. Objectives are evaluated against specific and specified numerical criteria. 6. TYPES OF PLANS a. SHORT RANGE or TACTICAL PLANS cover a 1- to 5-year period and focus on tasks that can be completed in this time frame. b. OPERATIONAL PLANNING may be for 1 year or one budget period and concerns operations. c. STRATEGIC PLANNING maps out the course of an organization for approximately 20 years. Strategic plans involve tactical and operational plans as well as forming alliances and partnerships with key players (sometimes even competitors). This plan is evaluated and modified yearly. ORGANIZING 1. TIME MANAGEMENT a. Laboratorians have their work dictated by the healthcare system—patient admissions, emergency patients, and outpatients. Managers have more flexibility to plan their work because it is dictated by administration (organization). b. Managers have more control over their workload and, therefore, they must identify, control, and eliminate or curtail specific situations that rob them of time. 1) These tasks may require most of a manager's resources. Identify important tasks and make sure these are accomplished first. 2) Develop skills necessary to facilitate use of manager's time. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 2  MAIA Professional Development Center MTLE March 2025 a) Managerial skills: Organized, able to delegate, knows when to say "no," can take control, effective planning, able to prioritize, conducts effective meetings, good listening skills, gives clear and concise instructions, understands teams b) Educated: Self-study through seminars, management journals, experience, or formal management course work c) Awareness of the work culture: Knows the organization and/or goals, able to see the "big" picture d) Controls interferences: Avoids lengthy unnecessary phone calls, "drop-in" visitors, reading junk mail, and too much socializing e) Decision-making capabilities: Controls perfectionism, able to make a decision, appropriately detail oriented f) Develops resources: Adequate money in budget, functional and upto-date equipment, adequate staff, and support from the administration g) Self-discipline: Avoids procrastination, inappropriate socializing, meets deadlines, behavior sets example for employees 2. STRUCTURE a. The manager develops a structure that allows plans to be carried out and objectives accomplished. b. THE ORGANIZATIONAL STRUCTURE IS BASED ON AUTHORITY, RESPONSIBILITY, AND ACCOUNTABILITY. 1) Authority a) Formal: Assigned by organization or administration b) Informal: Gained informally through competence or leadership qualities 2) Responsibility: Assigned by administration through delegation 3) Accountability occurs when the person responsible for completing a task is evaluated to determine if the task was completed. 3. REENGINEERING a. Definition: Reorganizing work processes in an organization b. Flow diagram the specific work processes to determine if more effective processes could be implemented. c. Examples of reengineering 1) Use of robotics to automate (particularly specimen processing) 2) Computerization 3) Pneumatic tube system to transport specimens d. BENCHMARKING IS A PROCESS WHEREBY THE BEST PROCESS IN ONE ORGANIZATION IS MODIFIED TO FIT SIMILAR PROCESSES IN ANOTHER ORGANIZATION. ‘ e. Examples of benchmarking 1) Cost per test 2) Number of tests performed per FTE (full-time equivalent/employees paid for 2080 hours per year) 3) Number of corrected reports 4. INVENTORY MANAGEMENT a. Objective of an efficient laboratory is to experience few shortages in testing reagents, supplies, and materials. b. Requisitions for contract and purchase orders to obtain necessary quantities of materials, etc., in suitable time frames c. Managers are responsible for purchasing laboratory instruments and service contracts to maintain instalments. d. Instrument selection includes technical evaluation and cost comparison of instruments from various instrument manufacturers. e. Many hospital laboratories contract with outside agencies to provide blood products for patients. f. Hospitals contract with outside companies to manage biohazardous waste and/or hazardous waste disposal. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 3  MAIA Professional Development Center MTLE March 2025 DIRECTING 1. Definition: Persuading employees to perform the tasks that help the organization accomplish its mission and goals 2. Techniques of directing a. Authoritative encompasses issuing orders and telling someone what to do. It does not allow employee to decide how best to accomplish task. b. Coaching allows the instilling of confidence and motivation into an employee about accomplishing a task. The employee has more "say-so" in how to accomplish a task. c. Empowerment allows an employee to determine what task and how to accomplish the task to help the manager solve a problem or to allow an organization to come closer to accomplishing their mission and goals. Employees are allowed to be creative and innovative to solve problems. Employees are allowed to take risks without fear of admonishment for failing. 3. Communicating a. Face-to-face spoken communication 1) Advantages: Immediate message conveyed b) Feedback immediate c) Can determine other factors: body language, tone of voice, eye contact, and implied meanings 2) Disadvantages a) Cannot save the communication b) Receiver interpretation of message may be different from that of speaker's intentions. c) Body language, tone of voice, eye contact may confuse recipient or sender. d) Cannot retract spoken words e) Gender, age groups, ethnicity, professional, emotional state, and other barriers exist for effective communication. b. Written communication 1) Advantages a) Can save communication encounter b) Deliver same message to many receivers c) Can add graphics to explain or clarify message d) Readers can review, interpret, and then respond to initial message. 2) Disadvantages a) Feedback delayed b) Can be impersonal c) Final d) Memos and e-mail are considered informal communication; letters are considered formal communication. c. Listening 1) Active listening components a) Privacy b) Eliminate (reduce) physical barriers c) Listen to words, but look at behavior, and interpret implied meaning 2) Restate what you think you have heard to ensure accuracy and capture any implied meanings. 3) Remain objective, but give signals (nod, keep eye contact, say "go on") to show speaker that you are listening. 4) Identify what the sender wants from the listener. 5) Summarize the plan for action and the time when action will be complete. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 4  MAIA Professional Development Center MTLE March 2025 MOTIVATING a. Definition: Influencing a person to act in a particular way and to generate initiative within that person b. Motivators include: Reward Salary Empowerment Recognition Praise Encouragement DELEGATING a. Definition: Assigning responsibility, authority, and accountability for a task to an employee b. Effective delegation occurs when the manager selects the right task for the right person, prepares an overview of exactly what must be done, allows time for the task to be completed, and then provides recognition for performing the task. COACHING a. Create an atmosphere of trust. b. Allow employees to take risks and not be reprimanded for failures. c. Make everyone feel that he or she is important. d. Work through emotions of players. e. Seek feedback by asking questions. a. AUTOCRATIC 1) Detailed instructions given of exactly how and what is to be done. 2) The manager's way is the best, and employees need not think of another way to complete the task. 3) This inhibits employees from thinking for themselves. They lose interest and initiative. Ambition, imagination, and involvement in daily job will be diminished or lost. b. CONSULTATIVE 1) Also called participative, democratic, permissive, or empowered management 2) Views employees as eager to do a good job and equipped with the skills to do so 3) Believes employees will become more motivated if left alone to do their job 4) Input is sought from employees to help solve a problem or tackle a project. 5) Employees are consulted about tackling a project. When in agreement, an employee is assigned to the project and needs to complete it within a specific time frame. The employee decides how the project is to be accomplished. c. CHANGE AND INFLUENCE 1) Organizations are constantly changing in leadership positions to capture more market share and to meet technological advancements. 2) The degree and complexity of changes vary among departments in organizations. 3) Change is best accepted by employees if presented in a nonthreatening way. Managers must promote change and keep morale high. 4) Explaining the reasons for change may lead to acceptance by many employees. 5) REASONS PEOPLE RESIST CHANGE a) Uncertainty: They do not want to be moved out of their comfort zone, because it will take effort on their part to analyze the change, learn new procedures, or perform additional tasks. b) Perception: Everyone has particular life experiences, values, and perceptions. Each individual has a different perception of the same event. c) Loss: Within the organization, there exist relationships among all workers that are built upon respect, trust, and expertise. Change can destroy all those relationships and make people lose status or perceived status among peers. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 5  MAIA Professional Development Center MTLE March 2025 d) Self-interests: Change disturbs the current state of affairs. Even though it may not be perfect, people have arranged their lives so their need satisfaction is stable. Change produces instability and uncertainty. e) Insecurity: Job security and being able to earn a wage that will allow an individual to pay the bills and maintain a decent standard of life is why people work. Change usually produces insecurity because people see their jobs threatened or taken away from them. LEADERSHIP 1. ESSENTIAL COMPONENT OF EVERY ORGANIZATION; DIFFERENT FROM MANAGEMENT 2. Purpose: Leadership produces change. a. Management involves planning and budgeting, organizing and staffing, controlling, and problem solving. b. LEADERSHIP INVOLVES ESTABLISHING DIRECTION, ALIGNING, MOTIVATING, AND INSPIRING PEOPLE. 3. Structure of leadership a. Purpose: To create leadership processes and help produce changes needed to cope with a changing environment b. Content: Can vary from very focused to very broad c. Assignment: Roles are assumed or assigned in a more fluid way in businesses that change often. 4. The origin of leadership a. Personal characteristics: High drive/energy level, good intelligence and thinking skills, good mental and emotional health, and integrity b. Career experiences 1) Promote leadership: Challenging assignments early in a career, visible leadership role models who are very good or very bad, assignments that broaden a person's experience 2) Inhibit leadership: A long series of narrow and tactical jobs, vertical career movement, rapid promotions, measurements and rewards based on short-term results only 5. The following steps can assist a leader in producing meaningful change in an organization. a. Establish direction: A vision of the future of the organization is established and strategies are developed and implemented to bring the organization closer to that vision. b. Align people: Communicate the vision and strategies to other people using words and deeds so that the vision and strategies are understood and accepted. c. Motivate and inspire: Energize people to implement the vision and strategy changes by satisfying basic needs (achievement, belonging, recognition, self-esteem, and a control of one's life) that may go unmet. MANAGEMENT BY OBJECTIVES (MBO) A program that embodies all of the concepts in the management process (planning, operating, directing, and controlling). First introduced by Peter Drucker in the 1960s. The core of MBO is communications. Success or failure depends on how well employees understand the company’s mission and objectives. Managers who allow employees to share in the decision-making process will have effective MBO programs. Managers must understand and be skilled at writing and monitoring objectives. MOTIVATION The driving forces that make people act as they do. This also can be defined as incentives, motives, purpose, drive, desires, and needs. Includes three major theories: 1. Maslow’s hierarchy of needs. Identified physiological and safety needs as basic physical needs that would motivate if not satisfied. Satisfaction of physical needs is required before higher level social need, such as esteem and love, will motivate 2. Herzberg’s two-factor theory. Herzberg (1959) defined two factors: a. The basic needs, hygiene factors, which correspond primarily with Maslow’s physical and social needs. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 6  MAIA Professional Development Center MTLE March 2025 b. Motivators correspond primarily with Maslow’s growth needs. 3. Vroom’s expectancy theory. Effort will bring reward. The effort expended will be related to the perceived value of the reward. People make a choice between alternative courses of actions according to how they perceive the resulting benefits. PROFESSIONALISM Professionalism is judged by the professional quality with which one practices the profession and includes areas such as altruism, honor, integrity, caring, compassion, respect, responsibility, accountability, scholarship, and leadership. PROFESSIONAL ETHICS is the study of standards of conduct and moral judgments which provide a basis for right and wrong conduct. The American Society for Clinical Laboratory Science (ASCLS) has developed and published the Code of Ethics for Clinical Laboratory Science comprised of duty to the patient, duty to colleagues, and duty to society. JOB DESCRIPTION 1. Purpose. The job description defines the functions and purpose of a specific position for an employee. 2. The job description should include: Name of organization Essential functions required for the position Job title Immediate supervisor (chain of command) Summary of duties for the position Working conditions/environment Required qualifications and experience RESUME 1. A resume is a tool for a candidate to demonstrate their strengths, education, and accomplishments when seeking employment. The resume should include the following: a. Candidates name (legal) g. Certifications b. Contact information (including e-mail) h. Professional society memberships c. Career objective i. Honors d. Educational qualifications j. Publications/research activities/special projects e. Clinical experience k. Volunteer work f. Military experience l. Statement regarding references 2. A COVER LETTER should accompany a resume to focus attention on the applicant. It is best to address the cover letter to a specific individual. EMPLOYEE INTERVIEW AND SELECTION 1. The purpose of the interview process if for the employer to confirm that the provided, written information gathered from the resume and/or job application is valid. Additionally, the interview provides the employer with insight into the candidate’s interpersonal communication skills. The interview also provides the candidate with the opportunity to discuss information in more detail and to ask questions pertinent to the specific position. 2. The selection process should be conducted after the interview and should include an evaluation of the candidate’s resume/application and information from the interview. The manager is seeking to select the candidate with the appropriate skills, certifications, and personality to fit the institution and the position. EMPLOYEE EVALUATION Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 7  MAIA Professional Development Center MTLE March 2025 1. The employee evaluation process is a method of recognizing job excellence and determining areas for development and training. The job evaluation is directly linked to the job description and should be formative and summative in nature and conducted often enough to provide feedback and direction for the employee. a. Criteria-based evaluations indicate specific performance expectations that are linked to the job description. b. Competency-based evaluations are used to validate competency of skills. CORRECTIVE ACTION 1. The purpose of corrective action is to provide the employee with specific goals to enhance their effectiveness and performance within the institution. 2. THE ACTION TAKEN TO IDENTIFY AND ELIMINATE THE CAUSE OF A NONCONFORMANCE 3. often the immediate response to an undesirable event and is a reactive approach to the problem. a. The first step is verbal counseling to make the employee aware of the situation and to open the lines of communication. b. The second step is to issue a verbal warning that specifically involves stating the problem, performance in question, and offering resources and assistance (process is documented). c. The third step is a formal written warning that states the problem, expected improvement in performance, and a timeline for re-evaluation of performance. This document is signed by the immediate supervisor and employee. Failure to meet the stated requirements typically results in dismissal of the employee. d. Most institutions have a policy that allows the employee to seek an appeal of the situation to a higher level. PREVENTIVE ACTION is defined as the action taken to reduce or eliminate the potential for a nonconformance to occur at all. COMMUNICATION AND INTERPERSONAL RELATIONSHIPS 1. Communication is an ongoing process of interpreting symbols, decoding speech and phrases, interpreting ideas and feelings, and encoding that information to formulate an appropriate response. Communication typically serves the following purposes: a. Exchange of knowledge b. Expression of feelings c. Expression of ideas and thoughts d. To attempt to influence another’s thoughts and actions e. To meet social expectations Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 8  MAIA Professional Development Center MTLE March 2025 2. Barriers to effective communication are: a. Nonverbal expressions–body language b. Cultural differences–unfamiliar phrases c. Paraverbal issues–tone and pitch of voice d. Environmental–temperature, neatness of appearance e. Overcommunication–too much information offered at one time f. Undercommunication–not enough information provided for understanding the issue g. time issues TEAM BUILDING is essential for optimal employee performance and effectiveness of the section, department, and institution. 1. Tuckman (1965) suggests the following phases of team development: a. Identifying the team members b. Team members selecting their roles c. Determining standards of behavior and expectations d. Working together towards a common goal QUALITY MANAGEMENT A. QUALITY PROGRAMS: ACTIVITIES OF THE MANAGEMENT FUNCTION THAT DETERMINE THE QUALITY POLICY 1. Components a. Statistical analysis is especially important in production control. It is used to analyze the quality of results. In the laboratory, statistical analysis includes internal and external quality control. b. Training and education: Employees are not considered the problem. Employees need adequate training and education to perform the best possible job. Inadequate training and education leave an employee unprepared to perform their best. c. Evaluation: Quality programs establish goals or targets. The progress toward accomplishing these goals is assessed. If satisfactory progress toward a goal is not achieved, then the process needs to be changed or modified to achieve satisfactory progress toward a goal. d. Feedback: This is a continuous process. Monitoring and evaluation takes place for several indicators. QUALITY MANAGEMENT>>> QUALITY SYSTEM>>> QUALITY ASSURANCE>>> QUALITY CONTROL QUALITY SYSTEM: ORGANIZATIONAL STRUCTURE, PROCEDURES, PROCESSES, AND RESOURCES NEEDED TO IMPLEMENT QUALITY MANAGEMENT QUALITY ASSURANCE A. INTRODUCTION 1. Quality assurance (QA) is a comprehensive set of policies, procedures, and practices that are followed to ensure that a laboratory’s results are reliable. QA evaluates the quality of the services provided. QA provides a way to prevent problems as well as deal with problems that occur. It differs from quality control (QC) in that QC is included as part of a QA program. QC ensures that a particular test method is working properly and that results of that test are reliable. 2. QA includes record keeping, maintenance and calibration of equipment, proficiency testing, quality control, and training of personnel. QA is a commitment to quality. Physician and patient relations are a part of this plan. 3. PLANNED, SYSTEMATIC ACTIVITIES IMPLEMENTED WITHIN THE QUALITY SYSTEM TO PROVIDE CONFIDENCE THAT REQUIREMENTS FOR QUALITY WILL BE FULFILLED Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 9  MAIA Professional Development Center MTLE March 2025 4. is a set of planned actions that ensure that systems and elements that influence the quality of the product or service are working as expected, individually and collectively 5. QA is a comprehensive program monitoring the entire testing process. ELEMENTS OF QUALITY ASSURANCE Records and SOPs Process improvement Personnel selection and training Process control Supplier qualification Label control Error management Internal auditing Validation, calibration, preventive maintenance, proficiency testing QUALITY ASSURANCE DEPARTMENT RESPONSIBILITIES 1. Compliance with cGMPs 4. Development, review, and approval of 2. Review and approval of all standard operating training programs procedures (SOPs) 5. Investigation of product recalls, errors, and 3. Specifications and validation protocols complaints 6. Coordination of internal quality auditing programs VALIDATION: establishing that a specific process consistently produces a product that meets predetermined specifications; process that establishes documented evidence providing a high degree of assurance that a specific process consistently produces a product that meets its preestablished quality and performance specification Internal quality audits evaluate the effectiveness of the quality system in the organization. AUDITS are systematic investigations to confirm the level of compliance with established SOPs. GOOD MANUFACTURING PRACTICES > performed in blood banks and transfusion services as part of QA and are legal requirements established by the FDA. These regulations itemize “what” needs to be done without necessarily specifying “how.” ELEMENTS OF GOOD MANUFACTURING PRACTICES Write SOPs Clean by following a housekeeping schedule Follow SOPs Validate equipment, personnel, and processes Record and document all work performed Perform preventive maintenance on facilities & equipment Qualify personnel by training and education Control for quality Design and build proper facilities and equipment Audit for compliance with all of the above DOCUMENT CONTROL: plan for the management of all documents in an organization that addresses the design, responsibility, storage, removal, and revision of all records, forms, and procedures. STANDARD OPERATING PROCEDURES: written procedures to help ensure the complete understanding of a process and to achieve consistency in performance from one individual to another ELEMENTS OF STANDARD OPERATING PROCEDURES Principle or purpose Quality control Interpretations and reporting Specimen requirements Procedure instructions References Supplies, reagents, and equipment RECORD KEEPING: Good documentation practices (GDP), whether manual or computerized, allow tracing of all products collected or transfused by an organization; A thorough record-keeping system recreates every step related to the production and distribution of a unit of blood and all its components. AUDIT TRAIL: record-keeping system that recreates every step in the manufacturing process. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 10  MAIA Professional Development Center MTLE March 2025 CHANGE CONTROL: system to plan and implement changes in procedures, equipment, policies, and methods to increase effectiveness and prevent problems; key in change control is the anticipation and prevention of problems. QUALITY CONTROL: Operational techniques and activities used to fulfill the requirements for quality > It is a process that ensures the reproducibility and accuracy of results by utilizing control specimens or by ensuring that a method remains valid over time. > It is a system for ensuring precision and accuracy in the laboratory by utilizing quality control reagents in each series of measurements. > Quality control (QC) monitors the test system’s components such as reagents and instrumentation. > QC is part of the QA system. a. A written QC program is required that specifies: Frequency of performing controls Type of controls Number of controls to be used Acceptable limits for control results Acceptable limits for control results b. QC plots of control results are used to detect: SHIFTS (a sudden upward or downward change of four or more consecutive values) TRENDS (the tendency of results to gradually increase or decrease over a period of time). c. Equipment maintenance is performed and documented. d. Temperatures of incubators, certain instruments, and the room are noted and documented. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 11  MAIA Professional Development Center MTLE March 2025 Imprecision Dispersion of results for repeated measurements of aliquots of the same QC material Standard Deviation measure of expected imprecision in a measurement procedure when it is performing correctly. 1 SD 68% of measured values 2 SD 95% of measured values 3 SD 99% of measured values Systematic Bias Difference between the observed mean (assay) and the expected value (target value) for a QC material Brought about by changes in calibration Accuracy the combination of systematic bias and imprecision that occurred for that specific measurement. Trueness refer to an average systematic bias that may be present in a given method. Control A solution (or human/bovine specimen) which is analyzed solely for quality control purposes (not calibration). Assayed Control The value of the analyte is predetermined. Most commercially available controls have predetermined values of various analytes. The target value must be verified before use. Un-Assayed The target value is not predetermined. Control This control must be fully validated; run at least 20 times in a single run and then run once a day for 20 consecutive days to establish a target value. Homemade Prepared by the laboratory staff Control Pure material in an aqueous-based solvent (dissolved and weighed correctly) or in serum or whole blood (for an analyte not present in humans, e.g. a drug). Calibrators a.k.a standards- has known concentrations of analyte being measured; use to standardized (adjust) the assay. Functions of QUALITY CONTROL 1. Serves as a reference for the proper operation of equipment, reagents, and individual techniques. (Machine stability, reagent quality, and error detection) 2. Confirms the testing's accuracy when compared to reference values. 3. Recognizes an increase in the frequency of both excessively high and excessively low minimally acceptable values (dispersion). 4. Detects any progressive drift of values away from the average value over a period of at least three days (trends). Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 12  MAIA Professional Development Center MTLE March 2025 5. Exhibits an abrupt shift or change in value from the established average value for three consecutive days (shift). Levey-Jennings/Shewhart plot Most common presentation for evaluating QC results. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 13  MAIA Professional Development Center MTLE March 2025 Corrective Action When a Quality Control Result Indicates a Measurement Problem A QC alert occurs when a QC result fails an evaluation rule, which indicates that an analytic problem may exist. There is a high probability that the assay is producing results unreliable for patient care Delta Check with a Previous Result for a Patient Comparing a patient’s current test result to a previous result for the same analyte Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 14  MAIA Professional Development Center MTLE March 2025 Most useful to detect mislabeled samples and samples altered by dilution with IV fluid during collection from a patient LABORATORY ACCREDITATION a. Certification is based on the level of test complexity. (1) WAIVED TESTING performed in these sites is often wellness testing, screening tests, or other critical testing that introduces a large population of persons into the health care setting. Types of direct, unprocessed specimens suitable for waived testing are listed below: Whole blood (fingerstick or anticoagulated blood collected via venipuncture) Glucose, cholesterol, prothrombin time, infectious mononucleosis, erythrocyte sedimentation rate, hemoglobin-copper sulfate method, spun hematocrit HIV antibody Urine (i) Dipstick urinalysis and pregnancy test (hCG) H. pylori Throat swab (i) Group A streptococcal antigen Gastric biopsy Nasopharyngeal swab (i) Influenza Oral fluid (i) HIV antibody Stool (i) Occult blood Saliva (i) Alcohol (2) PROVIDER-PERFORMED MICROSCOPY (PPM) includes: Wet mount, including preparations of vaginal, cervical or skin specimens Potassium hydroxide (KOH) preparation Vaginal smears Pinworm slides Nasal smear examinations for granulocytes Fern test Fecal leukocyte examinations Urine sediment Semen analysis (3) MODERATELY COMPLEX TESTING includes: Hematology Chemistry Serology Coagulation Therapeutic drug monitoring Blood gases Urine colony counts Urine colony counts Limited immunology Blood type and Rh factor Gram’s stain Throat culture screen only Manual differential (limited identification) Microscopic urinalysis (non-PPM) Rapid kits (4) HIGHLY COMPLEX TESTING includes: Microbiology Immunohematology Bacteriology Cytology Histopathology Mycology Manual hematology counts Manual differential Identification of abnormal cells Complete identification Nonautomated chemistry tests Personnel requirements must be met by laboratories performing moderately or highly complex testing. These positions can be held by the same person or by different persons who meet the qualifications. a. Moderately complex laboratories must have the following personnel: (1) Laboratory director (2) Technical consultant (3) Clinical consultant (4) Testing personnel a. Each person performing moderately complex testing must: o Follow laboratory procedures o Maintain records Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 15  MAIA Professional Development Center MTLE March 2025 o Adhere to policies o Identify problems o Document corrective actions b. Testing personnel must have documented training in all areas of testing performed. b. Highly complex laboratories are required to have the same personnel as a moderately complex laboratory, but must also have: (1) General supervisor (2) Technical supervisor PROFICIENCY TESTING (PT) is a means to demonstrate that the facility’s testing processes provide results comparable to those of other facilities with the same instruments and methods. Laboratories receive between three and five challenges for each analyte that requires PT. Challenges are received three times a year. The same personnel who routinely perform the test procedures must perform the PT. Laboratories are required to score 80% on all analytes to be considered in compliance. Blood bank specimens require a score of 100%. CONTINUOUS QUALITY IMPROVEMENT (CQI) 1. Synonyms and processes: a. TOTAL QUALITY IMPROVEMENT (TQI), TOTAL QUALITY MANAGEMENT (TQM), PERFORMANCE IMPROVEMENT (PI) b. Quality circle is defined as 8-12 employees from various departments who work together using CQI principles to improve a process. c. Top management must be committed to CQI for it to work. d. The data teams generate is vital and important to the process, but the success of CQI is dependent upon using this data to improve existing processes. e. LEAN THINKING focuses on REMOVING WASTE and increasing the value of the service. Only do things that add value and eliminate all other activity. Lean processing does not require a lot of mathematical analysis. SEVEN AREAS OF WASTE Overproduction preparing extra reports, taking extra tubes of blood during phlebotomy Correction (defects) incorrect results, repeat testing Inventory supplies ordered in bulk, transactions not processed Motion extra steps in data entry, unnecessary movement of personnel Overprocessing communications, reports, e-mails that contain more information than necessary Conveyance distance travelled, moving paper around Waiting delayed work due to lack of communication from another person or group The ideal team size is fewer than eight people. ONE FREQUENTLY USED LEAN ACTIVITY IS REFERRED TO AS PERFORMING A 5S: SORT eliminate all unnecessary items, keeping only what is important SET IN ORDER arrange things in order of frequency of use and quickest to locate. SHINE clean the work area. STANDARDIZE arrange work stations the same so all persons doing the same job can easily find items. SUSTAIN maintain and control the improvement f. SIX SIGMA focuses on reducing the variation in a process to remove error. Six Sigma uses a disciplined methodology that is data driven. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 16  MAIA Professional Development Center MTLE March 2025 SIX SIGMA METHODOLOGY: (DMAIC) DEFINE project goal or deliverable that is critical to quality begins with identifying a problem that may be tied to a customer complaint or a regulatory issue as the result of an internal audit or external assessment MEASURE baseline performance and related variables involves gathering data about process problems and failures. It is important to understand the current state of the process. ANALYZE data using statistics and graphs to identify and quantify root cause begins with understanding the cause and effect relationships in the process. The actions identified at the end of the Measure phase are tested, and the resulting data are collected and further analyzed using statistical tools. IMPROVE performance by developing and implementing a solution CONTROL factors related to the improvement, verify impact, validate benefits and monitor time ensures that the implemented changes are sustained. Creating an effective control plan verifies that the improved process is being followed and also helps determine whether additional actions are necessary to achieve the goal. 2. The cycle of quality improvement that was developed by Deming: a. P.D.C.A.: Plan -> Do -> Check -» Act b. Feedback is a crucial step in this cycle. Without feedback, there is no improvement. 3. Quality management may use Pareto charts, flowcharts, or cause-and-effect charts to describe processes. Procedures manual must be written to include all testing methods used in the laboratory. It must be available and followed by all testing personnel. a. THE MANUAL MUST INCLUDE: (1) The principle and methodology of each test (2) Criteria for specimen collection, processing, and rejection (pre-analytical steps) (3) Instructions for microscopic examination procedures (4) Test procedures (analytical) Step-by-step instructions Result interpretation (5) Preparation of materials Required solutions (e.g., reagents, controls, calibrators, stains, slides) and their location Step-by-step preparation of all materials needed Storage after preparation Labeling and dating instructions Safety precautions needed Solutions used in preparation (e.g., deionized water, diluent) (6) Calibration procedures Step-by-step instructions Verifications of calibration results Concentration and number of calibrators used Calibration schedule (7) Control procedures Materials used, name, lot number, level, frequency used reparation of materials Instructions for testing controls Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 17  MAIA Professional Development Center MTLE March 2025 Control limits Description of how and where control results are recorded Corrective actions taken when controls are not within limits (8) Actions taken when results deviate from expected values: (a) Recalibration (c) Repeats (b) Troubleshooting (d) Dilutions (9) Limitations (a) Interfering substances (b) Common sources of error (10) Result reporting (postanalytical) (a) REFERENCE RANGES o Range for different specimens (e.g., serum, plasma, urine) o Demographic variables (e.g., age, sex) (b) PANIC VALUES o Life-threatening results o Results needing special attention (critical results) (11) References (a) Manufacturer’s product literature (e.g., inserts, manuals) (b) Literature (e.g., textbooks, professional magazines) (12) Specimen retention (a) How long specimen is kept (b) Where specimen is stored (13) System for reporting patient results (postanalytical) (a) Unacceptable results (b) How results are reported to physician (c) Protocol for panic and critical values (14) Course of action for problems (15) Specimen referral (a) To whom or where specimen is referred (b) How the specimen is sent (c) How results are received b. THE MANUAL MUST BE APPROVED. TO OBTAIN APPROVAL, THE MANUAL MUST BE: (1) Signed by the laboratory director (2) Reviewed by all personnel using the procedure (3) Reviewed and updated by the supervisor or director c. THE MANUAL MUST BE REWRITTEN WHEN NEW PROCEDURES ARE IMPLEMENTED. d. THE MANUAL MUST BE RETAINED FOR FUTURE REFERENCE. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) REGULATIONS FOR OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS REQUIRE LABORATORIES TO ESTABLISH WORKPLACE SAFETY PRACTICES TO PREVENT ACCIDENTAL EXPOSURE TO ETIOLOGIC AGENTS IN BLOOD. 1. The regulations limit occupational exposure to blood and other potentially infectious materials that can transmit bloodborne pathogens and include but are not limited to: a. Hepatitis B virus (HBV) b. Human immunodeficiency virus (HIV) 2. The basis for all preventive measures is the practice of universal precautions. These are recommendations from the Centers for Disease Control and Prevention (CDC). a. Laboratory personnel must treat all human blood and other potentially infectious body fluids as if they were infected with HIV, HBV, and other bloodborne pathogens. b. This includes materials that are contaminated with blood. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 18  MAIA Professional Development Center MTLE March 2025 3. A written exposure control plan must be in place that describes the procedures established to minimize employee exposure to bloodborne pathogens. a. There must be identification of job classification, tasks, and procedures in which there is the potential of exposure. (1) A determination must be made of the job types in which exposure could occur. (2) All tasks must be included in the job description. b. An explanation of PERSONAL PROTECTIVE EQUIPMENT (PPE) AVAILABLE and in use must be included. (1) Appropriate protective equipment must be supplied to employees at no cost to them. (2) Equipment is considered appropriate only if it does not permit blood or other potentially infectious materials (PIMs) to pass through to an employee’s clothes, skin, mouth, or other mucous membranes. (3) Types of PPE are gloves, gowns, laboratory coats, face shields or masks, and eye protection. (4) All employers are responsible for providing, maintaining, laundering, disposing of, replacing, and assuring the proper use of all PPE. c. ENGINEERING CONTROLS MUST BE IN PLACE TO MINIMIZE EXPOSURE. (1) These are devices that isolate or remove the pathogen hazard from the workplace. (2) These devices must be made available to all employees. (3) EXAMPLES OF ENGINEERING CONTROLS INCLUDE: (a) Sharps containers and biosafety bags (b) Splash guards and self-sheathing needles (c) Biosafety cabinets and fume hoods (d) Mechanical pipetting devices (e) Handwashing facilities, eyewash stations, and showers d. WORK PRACTICES must be developed to reduce or eliminate employee exposure to blood or PIMs during the execution of their work tasks. (1) Employees must fully understand these procedures. (2) The procedures must be implemented, when appropriate. (3) Work practice procedures include, but are not limited to: (a) Handwashing (b) No recapping of contaminated needles (c) No food or drink allowed in the laboratory (d) No mouth pipetting (e) Warning labels affixed where needed, and biohazard symbols placed appropriately (f) A dress code that ensures safety e. HOUSEKEEPING PROCEDURES are necessary for maintaining a clean and sanitary work site, which is a responsibility of employers. (1) All equipment and work surfaces must be decontaminated. (2) Sharps containers must be puncture resistant. (3) Containers for biohazard materials must be constructed to contain all contents and prevent leakage during handling, storage, transport, and shipping. (4) Procedure for disposal of biohazard materials will be based on federal, state, and local regulations. (5) All housekeeping personnel will handle contaminated materials with the use of PPE. f. An HBV VACCINATION PROGRAM must be established. (1) HBV vaccine and vaccination series must be made available to all employees who are identified as being exposed to PIMs. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 19  MAIA Professional Development Center MTLE March 2025 (2) The vaccination series will be offered within 10 days of the employee being assigned to an area of possible exposure. (3) The vaccination series must be offered at no cost to the employee. (4) The program must be established using the protocol outlined in the Federal Register. (5) The program must include procedures for evaluation of the circumstances of an exposure incident to prevent further incidents. h. The communication of hazards to employees is required by OSHA regulations. (1) All employees must receive free biosafety training during working hours. (2) Training sessions must be presented in a way that can be clearly understood. (3) These sessions must be designed for the particular situation and institution involved. (4) Generic information and signing of a statement will not satisfy the requirements. (5) Instructors must be knowledgeable and must: (a) Demonstrate use and location of all safety devices (b) Document all training (c) Ensure that employees understand how to cope with hazards they may come in contact with during their employment FLAMMABLE/COMBUSTIBLE CHEMICAL o Are among the most hazardous materials in the clinical chemistry laboratory because of possible fire or explosion. o Classified according to flash point, which is the temperature at which sufficient vapor is given off to form an ignitable mixture with air. CORROSIVE CHEMICALS o Injurious to the skin or eyes by direct contact or to the tissue of the respiratory and gastrointestinal tracts if inhaled or ingested. o Typical examples include acids (acetic, sulfuric, nitric, and hydrochloric) and bases (ammonium hydroxide, potassium hydroxide, and sodium hydroxide). REACTIVE CHEMICALS o Are substances that, under certain conditions, can spontaneously explode or ignite or that evolve heat or flammable or explosive gases. CARCINOGENIC CHEMICALS o Are substances that have been determined to be cancer-causing agents. ELECTRICAL HAZARDS o Most individuals are aware of the potential hazards associated with the use of electrical appliances and equipment. o Direct hazards of electrical energy can result in death, shock, or burns. o Indirect hazards can result in fire or explosion. COMPRESSED GAS HAZARDS o Compressed gases, which serve a number of functions in the laboratory, present a unique combination of hazards in the clinical laboratory: danger of fire, explosion, asphyxiation, or mechanical injuries. CRYOGENIC MATERIALS HAZARDS Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 20  MAIA Professional Development Center MTLE March 2025 o There are, however, several hazards associated with the use of any cryogenic material: Fire or Explosion, Asphyxiation, Pressure Buildup, Embrittlement of Materials, And Tissue Damage Similar to That of Thermal Burns. MECHANICAL HAZARDS o laboratory personnel should be aware of the mechanical hazards of equipment such as centrifuges, autoclaves, and homogenizers. ERGONOMIC HAZARDS o These physical actions can, over time, contribute to repetitive strain disorders such as tenosynovitis, bursitis, and ganglion cysts. The primary contributing factors associated with repetitive strain disorders are position/posture, applied force, and frequency of repetition. CLASSES OF FIRE A Ordinary combustible solid materials such as paper, wood, plastic and fabric Pressurized water, Dry Chemical B Flammable liquids/gases and combustible petroleum products Dry chemical, Carbon dioxide C Energized electrical equipment Carbon dioxide, Halon, Dry chemical D combustible/reactive metals, such as magnesium, sodium, and potassium Metal X FINANCIAL MANAGEMENT A. BUDGET PROCESS usually begins in advance of the implementation date and is prepared in phases dependent upon the fiscal year which consists of four phases. 1. Development of goals. Laboratory’s goals must be in line with those of the organization and must be achievable and measurable. 2. Budget assumptions. The organization provides a forecast of available money based on past earnings, cash flow, and changes in state or federal laws affecting reimbursement. Budget assumptions are based on annual test volume and revenue generated 3. Forecast of expenses. Capital expenditure is an investment and, thus, the rate of return must be evaluated and used as a criterion for budgeting decisions 4. Monitoring. After operational budget is made and implemented, reports are reviewed monthly for variances B. EMPLOYEE SCHEDULING. One of the most challenging aspects of being a supervisor/manager, which has a huge impact on the departmental budget. 1. Factors that impact scheduling. a. Test menu b. Education and experience Level of staff c. Number of employees needed for test volume d. Number of emergency areas served e. Turnaround time expectations (TAT) f. Level of test complexity C. HEALTH CARE REIMBURSEMENT 1. DIAGNOSTIC RELATED GROUP (DRG) is a system to classify hospital cases into one of approximately 500 groups. The system was developed for Medicare as part of the prospective payment system. DRGs are assigned by a “grouper” program based on diagnoses, procedures, age, sex, and the presence of complications or comorbidities. DRGs have been used since 1983 to determine how much Medicare pays the hospital, since patients within each category are similar clinically and are expected to use the same level of hospital resources. 2. CURRENT PROCEDURAL TERMINOLOGY (CPT) is a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 21  MAIA Professional Development Center MTLE March 2025 describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians, and other health care providers, patients, and third parties. This system of terminology is the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. 3. Third-party payment is the practice of an insurer paying providers directly for services rendered to an insured, as opposed to an indemnity contract that pays the insured person for the services incurred. OPERATING COSTS a. OPERATING COSTS are what it costs to produce test results. This includes direct and indirect costs. b. DIRECT COSTS are directly associated with producing test results. These include supplies and labor. c. INDIRECT COSTS indirectly contribute to producing laboratory tests. These include electricity, water, paper towels, soap, bleach, computer software, and the labor that supports these services, as well as supervisory, managerial and administrative labor. d. FIXED COSTS remain the same from month to month no matter how many tests are produced. e. VARIABLE COSTS change with the amount of work performed. f. CAPITAL COSTS are related to purchasing equipment or instruments that have a life span of more than 1 year and cost more than a set dollar amount. This figure is determined by the organization and usually ranges from $1000 to $5000. LABORATORY INFORMATION SYSTEMS (LIS) A. Benefits of an LIS 1. Reduces time-consuming paper work 2. Stores patient data 3. Stores QC data 4. Provides immediate access to results 5. Reduces the chance of an assay being ran on the wrong patient when barcode is used 6. Managerial reports (tests per month, workload units, TATs) B. Minimum requirements for LIS 1. Access codes or passwords per user for access to system 2. Assign a unique accession number 3. Provide a unique file for each assay (sample type, volume required, ranges) 4. Record time collected, received, and unique identifier of who received it, and who released results 5. Print bar-code labels (ISBT for immunohematology/transfusion services) 6. Interface with instruments and other information systems approved information contained in a written or electronic format DOCUMENTS define the QMS for external inspectors and internal staff. Examples of documents include written policies, process flowcharts, procedures and instructions, forms, manufacturers’ package inserts, computer software and instrument operator manuals, and copies of regulations and accreditation requirements. RECORDS capture the results or outcomes of performing procedures and testing on written forms or electronic media, such as manual worksheets, instrument printouts, tags, or labels FORMS are specially designed documents—either paper or electronic—on which are recorded the results or outcomes of performing a given procedure COMMON CLASSIFICATIONS OF VARIOUS TYPES OF NONCONFORMANCES Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 22  MAIA Professional Development Center MTLE March 2025 ACCIDENT Nonconformance generally not attributable to a person’s mistake, such as a power outage or an aged instrument’s malfunction ADVERSE Complications that occurred to the donor during or after the donation process or to the REACTION recipient of transfused blood components COMPLAINT Expression of dissatisfaction from internal customers (physicians, employees) or external customers (donors, patients) DISCREPANCY Difference or inconsistency in the outcomes of a process, procedure, or test results ERROR Nonconformance attributable to a human or system problem, such as a problem from failure to follow established procedure or a part of a process that did not work as expected classified as incidents, deviations, complaints, and nonconformances RECALLS manufacturers’ removal of products from the market that may compromise the safety of the recipient. INSTRUMENT SELECTION PROCESS A. NEEDS ASSESSMENT Characteristics of the individual laboratory Sample dilution (manual vs. automatic) Test volume (Random access vs. batch testing) Ease of troubleshooting Throughput (TAT for STATs) Special electrical or plumbing requirements Connectivity (LIS) Waste management Test menu for present and future needs Amount of heat generated FDA approved Safety features Maintenance downtime (mean time between downtime) B. MINIMUM STANDARDS FOR QUALITY Linearity Sensitivity Specificity Accuracy Precision Stability of hardware/software (bar coding & ID) Stability and availability of reagents C. COST 1. Instrument itself 3. Contracts (service, labor, travel) 2. Reagents 4. Interface costs (LIS) PROBLEM SOLVING A. Define the problem D. Examine solution B. Create scenarios E. Reflect (on problem/solution) C. Implement solution DELIVERY OF EDUCATION UNIT A. A goal is a general statement which describes the instructor’s purpose for a particular instructional activity. B. Objectives are statements that describe the specific learning outcomes of an instructional activity and are written in greater detail than goals. 1. Cognitive. Intellectual learning outcome such as the recall of information, the comprehension of that information, and the processes of analysis, synthesis, and evaluation. 2. Affective. Emphasize values, attitudes, and interests. 3. Psychomotor. Require neuromuscular coordination such as performing a task. C. Learning activities allow the student to master the objectives and are comprised of lectures, laboratory session, demonstration, computer assisted instruction, internet resources, tutorials, and online courses. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 23  MAIA Professional Development Center MTLE March 2025 D. Evaluation determines the effectiveness of the learning activity and provides feedback regarding the learner’s attainment of the objectives for the course. Prepared by: Jacque Andrei Vergara Ramos, RMT, MLS (ASCPi), M (ASCPi) 24