Lab Quality Management PDF

## Lab. Quality Management ### Clinical Laboratory Organizational Chart - Clinical Laboratory - Anatomical - Cytology - Histology - Cytogenetics - Clinical - Hematology - Coagulation - Chemistry - Blood bank - Serology (Immunolo...

## Lab. Quality Management ### Clinical Laboratory Organizational Chart - Clinical Laboratory - Anatomical - Cytology - Histology - Cytogenetics - Clinical - Hematology - Coagulation - Chemistry - Blood bank - Serology (Immunology) - Microbiology - Urinalysis - Phlebotomy ### The purpose of the laboratory - Detect disease or predisposition to disease - Confirm or reject a diagnosis - Establish prognosis - Guide patient management - Monitor efficacy of therapy - Education and research ## Leadership and Management - An organization is only as good as its people, and people are guided by leaders and managers - Leadership and Management are often used interchangeably but represent different qualities - Leadership provides the direction of where one (or an organization) is going - Management provides the ‘road’ to get there > ‘If you don’t know where you are going, any road will get you there’ ## SWOT Analysis - to evaluate the risks associated with new strategies - Internal: - Strengths - Weaknesses - External: - Opportunities - Threats ## Laboratory Design and Service Model Examples - Traditional Laboratory: - ‘Closed’ hospital laboratory has discrete sections in laboratory: hematology, chemistry, microbiology, and blood bank, generally separated into rooms or sections - 'Open' laboratory: - The discrete services are placed in one large room with portable walls that can be adjusted as needed based on volume. - Core laboratory: - A common type of consolidation has been hematology and chemistry laboratories (chematology). - Advantages include: - handling stat requests - improving off-shift workflow - Regional laboratory: - Specific low-volume or expensive laboratory services currently provided by more then one regional hospital laboratory, that are consolidated into one hospital laboratory - For example, consolidation of all virology or PCR testing into one hospital laboratory - Reference laboratory: - Traditional full service laboratory that handles all types of testing. - Point-of-care - Laboratory testing that is brought to the patient's bedside. - Test menu is generally limited to a few basic tests (e.g., glucose, pregnancy, activated clotting time, blood gases) - Stat laboratory: - Rapid response laboratory that is often located in or near an emergency department or surgical suite. - Provides critical laboratory tests such as hematocrite and blood gases - Limited service Laboratory: - provides limited menu of routine (like CBC. chemistry panel, prothrombin time) and/or specialty services (like fertility testing) on a stat or non-stat basis. - Includes downsized hospital labs that retain stats and some routine tests but send most work to an off-site core laboratory ## Why Medical Labs need Quality Management? - Medical Laboratories - Highly complex operations - Individuals doing complex tasks - Absolute need for Accuracy - Absolute need for Confidentiality - Absolute need for Time Effectiveness - Absolute need for Cost Effectiveness > If inaccurate results are provided, the consequences can be very significant, including: 1) Unnecessary treatment 2) Treatment complications 3) Failure to provide the proper treatment 4) Delay incorrect diagnosis 5) Additional and unnecessary diagnostic testing ## Develop Personal Safe Work Habits - Pipetting by mouth is strictly forbidden - Never eat, drink or smoke at the test site - Keep food out of the laboratory/testing site refrigerator ## How to do a Risk Assessment? 1. Determine hazards and evaluate risks 2. Use all relevant available data 3. Determine controls needed to minimise those risks 4. Document the assessment 5. Agree it with your supervisor 6. Use those control measures ## Policy for Handling Sharps - User responsible for disposal of sharps - Must dispose of sharps after each test - Must place sharps in sharps boxes - Do not drop sharps on the floor or in the office waste bin - Place sharps container near your workspace - Seal and remove when box is ¾ full - Incinerate all waste ## Different Cleaning Jobs Require Different Bleach Solutions* - General lab use - Hypochlorite Solutions | | Spills | General Disinfection | |----------|--------------|--------------------| | 10% | (1 part + 9 parts) | | | 1% | | (1 part + 99 parts) | > You should have 10% bleach readily available at your test site. > *WHO Laboratory Biosafety Manual ## First Aid - All laboratory workers should undergo simple first aid training - For ALL chemical splashes, wash with plenty of water for 10 minutes - Control bleeding with direct pressure, avoiding any foreign bodies such as glass - Report all accidents to your supervisor or departmental safety officer ## Overview ### Benefits - Careful management of inventory helps to prevent waste, which can occur if reagents and supplies are stored improperly, or if reagents become outdated before they can be used. Establishing a purchasing and inventory management programme will ensure that: - Supplies and reagents are always available when needed. - High-quality reagents are obtained at an appropriate cost - Reagents and supplies are not lost due to improper storage, or kept and used beyond expiration. ## Quantification ### Consumption-based quantification - Laboratories most frequently use the consumption-based method, drawing on their experience over time. This method is based on actual consumption, so there are a number of factors to consider. For example, to determine the actual usage, it is important to estimate how much wastage has occurred and how many expired or spoiled reagents and supplies have been discarded. An example of this type of n ### Morbidity-based quantification - In using the morbidity-based quantification method (shown below), the laboratory must take into account the actual number of episodes, illnesses and health problems that require laboratory testing. In other words, the laboratory needs to estimate an expected frequency of the disease in question-how many cases will occur per unit of population (per 1000, per 10 000, etc.)? Then, considering how many people the laboratory serves, it can estimate the total number of cases the community might reasonably expect to observe. Using standard guidelines for diagnosis and treatment, and considering how well health care providers adhere to these guidelines, can help to estimate how many laboratory tests will be performed. ## Introduction - Human Resources as a critical component of quality management in medical laboratories. - Importance in ensuring operational efficiency, staff competency, and service quality. ## Policy and Procedure Manuals - Definition: Standardized guidelines governing laboratory operations. - Importance: Consistency in performance, legal compliance, and minimizing errors. - Examples: Safety protocols, specimen handling manuals. ## Recruitment - Methods: Internal vs. external recruitment, job postings, agencies. - Best Practices: Attracting skilled candidates, structured interviews. - Challenges: Recruiting specialized lab personnel. ## Orientation - Purpose: Introducing new staff to lab policies, equipment, and procedures. - Components: Safety training, hands-on equipment training, admin orientation. - Importance: Smooth transition and minimizing initial errors. ## Evaluation of Performance - Methods: Appraisals, feedback sessions, competency assessments. - Criteria: Skills, adherence to protocols, teamwork, productivity. - Importance: Identifying improvement areas and recognizing excellence. ## Pre-Analytical - Decision - Order request - Sample collection - Transport and storage ## Post Analytical - Interpretation of data - Data management - Reporting - Treatment of patient ## Specimen collection..... - For example; - Sputum: 5-10 ml for mycobacterium examination. - Blood: - Serology: minimum 2 - 3 ml. - Culture: 10 – 20 ml (adult) & 1-5ml (infant). - CSF: 5 - 10 ml. ## Specimen collection..... - Labeling - Make sure that you are collecting/drawing the right person first. - Then label with: - Patient name - Unique identification number - Patient demographic information - Specimen collection date - Specimen collection location - Diagnostic test results ## Specimen collection..... - During Labeling: - Make sure that container label & the requisition match. - Label should be on the container not on the lid, since the lid can be mistakenly placed on a different container. - Ensure the labels on the containers are adherent under refrigerated conditions. ## 3.3 General Rejection Criteria - Unlabelled Specimens - Common specimen like blood, urine, swabs, sputum, stool, can be easily recollected. - less common specimens like CSF, fluids, tissues, etc. are more difficult to recollect. - Call the person who collected it for the identification of the specimen. - If he is unable to identify the specimen, the ordering physician will be notified. ## Specimen Transportation...... - This transportation is made by using different preservation methods - Physical - chemical. > chemical method of preservation is most common. ## Electrical Equipment Safety: Pre-Use Checks - One of the most essential steps before using any electrical equipment in the lab is ensuring that it has passed a Portable Appliance Testing (PAT) inspection. Equipment should display a current PAT test sticker to confirm that it has been tested for safety and is functioning properly. This minimizes the risk of electric shocks, short circuits, or equipment malfunctions, which could lead to accidents or damage. > Key Point: Always look for the PAT sticker before turning on any electrical device. ## Last Resort: Personal Protective Equipment (PPE) - While there are many safety measures in place to minimize exposure to hazardous materials, PPE is the last line of defense. Control measures like good ventilation, reducing exposure times, or using safer substances should be implemented first. When these are insufficient, you should rely on PPE like gloves, goggles, and lab coats. > Key Point: PPE is crucial, but it should not be your first method of protection. It's a fallback when other controls are not enough. ## Hygiene Practices: What Not to Do in the Lab - Maintaining hygiene in the lab is critical. Activities like applying cosmetics, eating, or drinking are strictly prohibited. These actions can introduce contaminants into the lab environment, potentially compromising experiments and increasing the risk of contamination. > Key Point: To maintain a clean and safe environment, avoid applying cosmetics or other personal grooming in the lab. ## Safe Handling of Gas Cylinders - When working with gas cylinders, safety is paramount. Always use a cylinder trolley when moving them. Gas cylinders are heavy and can cause severe injuries or leaks if mishandled. Furthermore, they should always be secured with chains when stationary to prevent tipping over. > Key Point: Never move gas cylinders without a trolley and always secure them to avoid accidents. ## Fire Safety: Containment and Evacuation - In case of a fire, it's vital to follow proper procedures. Keeping corridor and laboratory doors closed can help prevent the spread of fire. This simple action can limit the amount of oxygen fueling the fire and create barriers, giving everyone more time to evacuate safely. > Key Point: In the event of a fire, containment is key. Keep doors closed and evacuate immediately. ## Personal Protective Equipment (PPE) for Biological Hazards - When handling hazardous biological materials, it is crucial to wear the right PPE, which includes lab coats, gloves, and safety goggles. Each piece of equipment serves a different purpose, from protecting your skin to shielding your eyes from potential splashes or harmful agents. > Key Point: Always wear complete PPE when dealing with biohazards to minimize risk. ## Responding to Biohazard Spills - Spills happen, and when they do, it's important to act quickly. The first step is to contain the spill and then follow your lab's specific decontamination procedures. Always have the necessary disinfectants and spill kits ready in case of an emergency. > Key Point: Be familiar with your lab's biohazard spill protocols. Quick containment and disinfection are essential. ## Disposal of Biohazard Waste - Biohazard waste should always be disposed of in red bins marked for biohazards. Proper disposal ensures that infectious materials are not mishandled and are treated with the care required to prevent contamination. > Key Point: Ensure all biohazardous waste is disposed of in the designated red bins. ## Sharps Disposal - Sharps, such as needles and broken glass, must be discarded in labeled sharps containers. This prevents injuries and potential exposure to hazardous materials through accidental cuts or punctures. > Key Point: Never throw sharps in regular trash bins. Use specialized containers to protect yourself and others. ## Inspection and Certification of Biological Safety Cabinets - Biological Safety Cabinets (BSCs) must be inspected and certified annually to ensure they are functioning properly. This equipment is essential for safely handling hazardous biological materials by providing a contained environment. > Key Point: Regular certification of BSCs ensures they are working effectively to protect you from biological hazards. ## Understanding Biosafety Levels (BSL) - Biosafety levels define the containment precautions necessary for working with various pathogens. For example, BSL-3 is required for handling pathogens that can cause serious or potentially lethal diseases through inhalation, such as certain viruses and bacteria. > Key Point: Know the appropriate Biosafety Level for the organisms you are working with to follow the correct safety protocols. ## Decontaminating Biohazardous Waste - The standard method for decontaminating biohazardous waste is autoclaving, which uses high-pressure steam to sterilize materials. This is an essential step before disposing of biohazardous materials to ensure they do not pose a risk. > Key Point: Always autoclave biohazardous waste before disposal to neutralize any infectious agents. ## Handling Fires in a Biosafety Cabinet - If a fire occurs inside a Biosafety Cabinet, the first response is to close the sash, shut down the blower, and evacuate. Do not attempt to fight the fire yourself as it could lead to exposure to hazardous materials. > Key Point: In case of fire, focus on containment and evacuation rather than extinguishing the fire. ## Laboratory Hazards: A Multi-Faceted Threat - Common hazards in a microbiology lab include slippery floors, UV light exposure, and burns from autoclaved equipment. Be cautious and follow proper protocols for handling these risks. > Key Point: Stay aware of physical hazards in addition to biological and chemical risks. Proper safety procedures minimize accidents. ## Laboratory Quality Management - A critical component of a laboratory's quality management system is maintaining accurate records and specimen retention. This ensures that all processes are traceable and compliant with regulatory standards. > Key Point: Good record-keeping and specimen tracking are essential for lab quality control.