Checklist
Have the staff adequately been instructed on the symptoms of infection with pathogens worked with in the laboratory? |
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Is there a written procedure on how to act in case of a suspected laboratory associated infection/laboratory accident whereby a staff-member has potentially become infected? |
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Is access to the laboratory facility controlled against unauthorized persons? |
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Can the access control system, protecting the laboratory from unauthorized access, be overridden in case of an emergency such as fire? |
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Is access to first aid secured at the laboratory? |
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In laboratories where the presence of first aid providers is necessary: have enough staff members been appointed as first aid provider such that continuous presence of at least one first aid provider is ensured? |
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Is the training of the first aid providers up-to-date? |
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Does the Biosafety Manual contain an explanation of the tasks and responsibilities of first aid providers? |
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Is the laboratory staff aware of who the first aid providers are? |
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Have the Personal Job Descrptions of the first aid providers been adapted to reflect the authorizations of their position as first aid provider? |
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Has the Risk Group for each laboratory room been determined? |
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Are primary sample collection facilities separated from the laboratory rooms? |
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Is the sample processing room separated from the room where PCR is performed? |
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Are laboratory rooms where incompatible procedures are being undertaken separated from each other? |
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Are rooms for cleaning of laboratory glassware and tools separated from the laboratory rooms? |
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Are the rooms designed and furnished in a logical way enabling a unidirectional workflow and preventing unnecessary movements of people through the rooms? |
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Is office space separated from laboratory rooms? |
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Is there a dedicated area for breaks/lunches? |
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Is the biosafety level III laboratory equipped with a negative pressure system? |
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Is the pressure of the biosafety level III regularly monitored and recorded? |
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Is the negative pressure system connected to a backup electricity supply to ensure that it keeps functioning during a power failure? |
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Is the negative pressure system included in the preventive maintenance program of the laboratory? |
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Is access into the BSL III laboratory controlled to prevent unauthorized access? |
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Has a Facilities & Safety Assessment been performed? |
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Is an action plan present to implement improvements based on findings from the Facility & Safety assessment? |
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Are the action points in this action plan from the Facility & Safety Assessment formulated according to the SMART method? |
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Have the action points in this action plan from the Facility & Safety Assessment been fulfilled on or before the deadline? |
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Have completed action points from the Facility & Safety Assessment been signed and dated for completion? |
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Is communication to outside the laboratory rooms possible without leaving the room? |
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Are emergency numbers available near telephones and clearly visible? |
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Is the use of mobile phones forbidden inside all laboratory rooms? |
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Is a primary sample collection facility available and physically separate from the laboratory activities? |
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Are patients in the waiting area and primary sample collection facility protected against rain and direct sunlight? |
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Does the patient sample collection facility allow for the protection of privacy of patients? |
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Are there enough chairs in the waiting area and primary sample collection facility so that every patient can sit? |
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Is the waiting area and primary sample collection facility accessible for physically handicapped patients? |
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Does the laboratory have a procedure for processing and disposal of the different types of waste produced? |
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Does the laboratory demonstrably adhere to procedures for processing and disposal of different types of waste produced? |
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Are up-to-date guidelines present on safe disposal of waste? |
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Does lab staff adhere to guidelines on safe disposal of waste? |
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Is potentially infectious waste safely and securely stored before incineration? |
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Is potentially infectious material properly incinerated? |
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Are sharps securely and safely incinerated without the risk for needle accidents? |
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Is the area around the fire pit/incinerator free from clutter? |
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Is infectious glassware for re-use autoclaved correctly? |
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Are separate, clearly distinguishable containers present for different types of chemical waste? |
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Is chemical waste processed correctly? |
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Are trashcans for (bio)hazardous waste clearly distinguishable to prevent confusion with the bins for normal waste? |
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Is normal waste processed according to local/national regulations (if applicable)? |
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Is continuing delivery of electricity guaranteed through a working generator and/or Uninterrupted Power Supply (UPS) system in case of a power failure? |
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Is all the essential/critical equipment locked onto the generator? |
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Are samples stored under appropriate conditions, protected from unauthorized access and demonstrably easily retrievable? |
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Are all reagents and supplies stored under the proper conditions, protected from unauthorized access and easily retrievable? |
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Is equipment stored under appropriate conditions protected from unauthorized use? |
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Is defective equipment demonstrably contaminated and stored outside the laboratory protected from use? |
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Are documents and records stored under appropriate conditions, protected from fire, insects, humidity and other harmful elements? |
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Are documents and records protected from unauthorized access? |
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Are documents and records stored in a logical manner so that they are demonstrably easily retrievable? |
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Is an up-to-date Biosafety Manual present in the laboratory? |
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Does the biological safety manual have a logical structure with table of contents, an introduction and a title page clearly stating the words “Biosafety Manual”? |
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Does the Biosafety Manual contain general safety rules for working in the laboratory with human material? |
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Does the Biosafety Manual contain preventive safety procedures? |
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Does the Biosafety Manual contain procedures for emergency situations? |
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Are the Biosafety Manual chapters signed by the author, reviewer and Laboratory Management? |
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Is the Biosafety Manual easily accessible for all staff members at a logical location? |
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Is the Biosafety Manual read and signed by all staff members? |
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Is an indicator placed in relevant rooms for monitoring the air flow and preventing that pathogens are blown towards the staff working in the laboratory. |
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Does the retention schedule for storing different types of materials include the storage durations for samples and slides? |
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Does the retention schedule for storing different types of materials include the following documents:
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Is an SOP present describing how to clean the laboratory building? |
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Does the SOP on cleaning of the laboratory building include a section with specific guidelines for cleaning laboratory rooms? |
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Is a cleaning schedule present? |
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Does the cleaning schedule show what should be cleaned by who and when? |
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Is the laboratory cleaned on a regular basis? |
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Are all hazardous materials in the laboratory registered? Take a sample by identifying some hazardous materials and looking them up in the register. |
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Is the Hazardous Material Register up to date? Take a sample by comparing the amount of several materials as noted in the register and in reality. |
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Are MSDS Sheets present for all hazardous materials in the laboratory? Take a sample and check. |
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Are there spill kits present in adequate numbers and are these kits complete |
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Is there an SOP that provides procedures for dealing with the different types of spills? |
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Have critical environmental/equipment parameters been identified? |
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Are all critical environmental/equipment parameters monitored adequately? |
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Are all Critical Parameter Log Sheets filled out completely and up-to-date? |
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Are all Critical Parameter Log Sheets placed at a logical location? |
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Are first aid providers present in the laboratory? |
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Are first aid kits present and placed at accessible locations? |
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Is the implementation of the quality management system coordinated through a Quality Project Team? |
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Does the laboratory have a Quality Focal Point to which staff can turn to for information about the quality management system? |
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Are Quality Project Team meetings held on a regular basis? The presence of minutes serve as prove for this. |
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Is the Quality Project Team functioning correctly? Look into the minutes to find indications of the quality of functioning of the team; look at the action points, if these are often not completed on/before their deadline this is a sign that the team has trouble implementing activities. In this case, try to find out via signs in the minutes and interviewing team members what the cause of the problem is. |
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Has a Quality Officer been appointed? |
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Is the position of Quality Officer visible, at the right place, in the Organizational Chart? |
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Does the laboratory have a job description of the position of Quality Officer? |
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Is the position of Quality Officer included in the Authorization Matrix? |
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Do the Quality Officer and Laboratory Manager have regular bilateral meetings to discuss proceedings? Ask the Quality Officer. |
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If a staff member was appointed as Quality Officer, has his former position been filled by a new/another staff member if necessary? |
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Does the laboratory have a clear Vision? |
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Is the Vision of the laboratory documented and stored? |
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Is the SOP on performing a management review up-to-date? Compare elements in most recent Management Review Report with required elements defined in the SOP. |
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Does the laboratory make use of action plans with SMART formulated action points? |
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Are action plans all stored together in one folder, with a logical structure (e.g. completed action plans in the back, open action plans in the front, sorted on date, etc.)? |
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Is the completion of action points and action plans checked on a monthly basis and, if necessary, followed-up? I.e. do you see action points that have not been completed while their deadline has passed? |
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Has the laboratory manager been trained in principles of change management? |
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Does the laboratory have a clear Mission? |
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Is the Mission of the laboratory documented and stored? |
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Are staff meetings held regularly (weekly)? |
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Are minutes made of weekly staff meetings? |
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Do the minutes of weekly staff meetings include a summary of discussions, SMART action points and the agenda for next week? |
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Are the minutes of weekly staff meetings stored in a well-organized way? |
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Does the laboratory have an up-to-date routine work schedule? |
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Is this Daily Routine Work Schedule placed at a visible location accessible to all staff? |
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Do all staff members know where to find the Daily Routine Work Schedule? Take a sample by asking this question to several staff members. |
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Does the laboratory have long-term goals? |
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Are the long-term goals of the laboratory covering all the core-activities? |
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Are the long-term goals of the laboratory aimed at improvement? |
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Are the long-term goals of the laboratory documented and stored? |
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Has a Biosafety Officer been appointed? |
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Is there a description of the tasks and responsibilities of the Biosafety Officer? |
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Do all the staff members know who the Biosafety Officer is? |
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Do all the staff members know the function of the Biosafety Officer? |
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Is the laboratory legally identifiable? |
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Is the laboratory and its status recognized by the appropriate authorities? |
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Does the laboratory have a Quality Policy? |
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Does the Quality Policy describe clearly the scope of the laboratory services? |
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Does the Quality Policy describe clearly the Long Term Goals and what the laboratory will do to achieve these goals? |
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Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system? |
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Does the Quality Policy contain a statement of the laboratory's commitment to provide good professional practice, quality examinations, in compliance with the quality management system adhering to ISO 15189? |
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Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these? |
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Are staff aware of existence of the Quality Policy? Take a sample by randomly asking staff members. |
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Are staff familiar with the contents of the Quality Policy? Take a sample by randomly asking staff members. |
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Have all staff members read the Quality Policy? Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy. |
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Has an Equipment Officer been appointed? |
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Is the Equipment Officer trained in calibration and technical maintenance of equipment (if necessary)? |
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Is the Equipment Officer protected against overburdening of work by allocating tasks of his/her former work to other staff members (if necessary)? |
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Are the Organizational Charts up-to-date? |
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Are the Organizational Charts signed and dated by the appropriate management? |
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Does the laboratory have measures to prevent interruption of services due to break down of old equipment? |
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Is purchasing of new equipment taken into account in making the laboratory budget for the next year? |
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Are maintenance costs (including repairs) taken into account in the laboratory budget? |
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Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officerâ€)? |
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Are all laboratory staff members aware of the existence of the position of Stock Officer? |
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Do all laboratory staff members know who the Stock Officer is? |
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Do all laboratory staff members know what the tasks are of the Stock Officer? |
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Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan? |
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If the laboratory is part of a bigger organization: does the laboratory have an Organizational Chart that clearly shows the position of the laboratory within the bigger organization? |
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Is the Organizational Chart that shows the position of the laboratory in the bigger organization signed and dated by the management of the bigger organization? |
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Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory? |
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Is the chart showing the organization of positions within the laboratory signed and dated by the Laboratory Manager? |
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Are the Organizational Chart(s) stored in a folder that is accessible to all the staff members of the laboratory? |
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Does the laboratory plan its activities through a Quality Year Plan? |
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Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)? |
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Has the Quality Year Plan been formulated with input from the Quality Officer? Take a sample by asking the Quality Officer and some members of the Quality Project Team. |
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Is the Quality Year Plan appropriately stored and easily retrievable? |
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Is the Quality Year Plan signed and dated by management? |
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Is the Quality Year Plan translated into an action plan? |
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Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval? |
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Is staff aware of the existence of the Quality Year Plan? Take a sample by asking some random staff member to explain what the Quality Year Plan is. |
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Are staff members aware of action points assigned to them? Take a sample by asking staff members about action points assigned to them. |
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Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory? |
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Is the quality manual part of the document control system? |
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Have all staff members read the quality manual? |
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Is the performance of the quality management system recorded in Quarterly Reports? |
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Is the functioning of the quality management system reviewed annually by laboratory management? |
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Are reports drafted of management reviews? |
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Do Management Review Reports include action points if applicable? |
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Are the result of the management review presented to all staff? See meeting minutes. |
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Are Management Review Reports securely and orderly stored? |
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Does the Quality Year Plan include action points from the management review? |
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Does the Quality Year Plan take into account the Quality Policy, Long Term Goals, Core Values, Mission and Vision of the laboratory? |
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Is an action plan drafted based on the action points yielding from the Quality Year Plan? |
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Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff? See minutes of that meeting. |
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Have all the policy cycle activities been documented in an SOP (i.e. drafting a quality year plan, monitoring of performance of the quality management system and drafting quarterly reports, and performing a management review)? |
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Has commitment to implement a quality management system been created among laboratory staff? Interview various staff members to find out if a meeting was held and if this was successful. |
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Has an SOP for Competency Assessment been developed? |
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Does this SOP contain one or more standardized form(s) that must be used to record the findings of the assessment? |
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Are competency assessments done annually for each staff member? |
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Is a report made of each competency assessment? |
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Are the points for improvement described in the report of a competency assessment, including with a description of the strategy on how to improve these points? |
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Are the reports of the competency assessments stored in the personnel files? |
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If training needs are identified during competency assessment, is the staff member send to the appropriate training? |
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Is the competency of the Laboratory Manager annually assessed? |
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Has the laboratory investigated if there are potential conflicts of interest among laboratory staff? |
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If potential conflicts of interest among laboratory staff were identified, were they appropriately solved and documented? |
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Is staff safeguarded from overburdening? |
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Have all staff members participated in an introductory course in quality management for medical laboratories? |
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Have certificates of the introductory course in quality management been stored in the Personnel Files folder? |
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Does the laboratory have an induction program for new staff? |
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Is the procedure of the induction program documented in an SOP? |
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Does the SOP for Induction of New Personnel include a checklist for verifying correct completion of the program? |
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Are completed checklists stored at a logical location (e.g. in the personnel file of the new staff member)? |
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Is a personnel replacement matrix present in the laboratory? |
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Is a backup staff member defined for each staff member in the laboratory? |
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Is the competency of the backup staff members checked for the tasks they need to take over from absent staff members? |
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Is the laboratory staff aware of the existence of the personnel replacement matrix and which purpose it serves? Take a sample by interviewing some staff members. |
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Does the laboratory have a standardized procedure for hiring new permanent and temporary staff, and having guests? |
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Is the procedure for hiring new permanent and temporary staff and having guests correctly documented? |
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Does the procedure for hiring new permanent and temporary staff cover all the following elements:
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Has the Biosafety Officer received laboratory biosafety training? |
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Is the certificate of the laboratory biosafety training of the Biosafety Officer stored in a folder called "Personnel Files"? |
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Are performance appraisals performed for all staff members at least once per two years?
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Are findings of performance appraisals discussed with staff members that were assessed to find the root cause and come to a good approach on eliminating this root cause and improving performance? |
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Are findings of performance appraisals recorded, including the identification of root causes behind poor performance and the approach chosen to eliminate these and improve performance? |
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Are all staff members appropriately trained for the tasks performed? |
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Are educational needs consistently assessed in competency assessments and performance appraisals? |
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Are training needs consistently fulfilled? |
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Does the laboratory have an Authorization Matrix, showing for each position in the laboratory the authorizations, responsibilities and tasks? |
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Is the Authorization Matrix signed and dated by the Laboratory Manager? |
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Is the Authorization Matrix accessible to all staff members? |
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Do staff members know what the Authorization Matrix is? |
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Are staff members able to find the Authorization Matrix? |
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Are staff members able to explain how the Authorization Matrix works? |
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Is a personnel file present of each staff member? |
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Are all the records described in ISO 15189:2012 article 5.1.9 (ISO 15189:2007 5.1.2) present in the personnel file of each staff member? |
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Are the personnel files structured in an orderly fashion? |
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Is the Personnel Files folder stored in a locked cabinet that is only accessible to the Laboratory Manager and the secretary? |
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Does the laboratory have a Continuous Education Program? |
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Is budget available for the Continuous Education Program? |
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Is the Continuous Education Program included as element in the Quality Year Plan? |
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Does the laboratory have a job description for each position in the laboratory? |
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Does the job description for each position in the laboratory give a complete and clear impression of the tasks, responsibilities and authorities of each position? |
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Is the ability of all technical staff members to correctly perform examinations observed by letting them analyze external quality assessment samples and evaluating the results? |
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Have Personal Job Descriptions been made for all the staff members? |
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Are all job descriptions (both Position Job Descriptions and Personal Job Descriptions) up to date? |
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Are Personal Job Descriptions stored in an orderly fashion in the Personnel Files folder? |
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Has a laboratory staff member appropriately been trained in performing failure-mode-effect-analyses? |
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Has the personnel file of the staff member participating in failure mode effect analysis training been updated after completing this training? |
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Have all staff members adequately been trained in the procedures they are performing? Ask several staff members this question for the procedure they are doing at that moment and cross-check with their Personnel File. |
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Is the folder Personnel Files up-to-date; i.e. have all certificates and diplomas been collected for all staff members and been stored in the personnel files? |
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Does the laboratory have a clear register of all the equipment present? |
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Does the equipment register contain the following details for each piece of equipment? (tick off)
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Is all critical equipment functional? |
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Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function? |
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Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment? |
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Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment? |
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Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members? |
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Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members? |
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Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management? |
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Are all technical and managerial staff members aware of the existence of the SOP and do they know when to use it? |
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Have all pieces of equipment that have a direct influence on the outcome of examinations been validated? |
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Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports? |
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Are SOPs present for all pieces of equipment? |
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Are Equipment SOPs written in accordance with the procedure described in the Master SOP? |
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Are Equipment SOPs stored at a logical location (near the equipment they have been written for), accessible to all staff members? |
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Have staff members demonstrably read the SOPs that are relevant for them? |
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Has all equipment in the laboratory been labeled? |
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Do the equipment labels include the following data:
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Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels? |
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Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing? |
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Is the procedure for determining and correcting the negative influence of defective equipment documented in an SOP? |
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Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective? Ask the interviewee to show an example. |
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Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment? |
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Do staff members who are responsible for a piece of equipment know their responsibilities? Take a sample by asking such a staff member. |
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Are staff members authorized for use of a piece of equipment properly instructed/trained? |
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Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment? |
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Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary? |
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Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment? |
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Are the Usage Log Sheets placed near the piece of equipment they have been developed for? |
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Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive? |
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Does the laboratory have an Equipment Archive that contains all the documents and records needed for each piece of equipment as listed in ISO 15189:2007 article 5.3.4 or ISO 15189:2012 article 5.3.1.7? |
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Does the laboratory have a documented procedure that describes the following:
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Are Bench Aids used for various pieces of equipment? |
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Are these Bench Aids in accordance with the SOPs for equipment? |
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Is the method of maintenance and calibration of equipment documented? |
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Is the budget needed for the maintenance and calibration of equipment calculated and documented? |
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Have funds been identified for annual maintenance and calibration of equipment? |
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Have funds been identified for training of a staff member for internal maintenance and calibration of equipment? |
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Is a preventive maintenance program in place for all pieces of equipment? |
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Does the laboratory demonstrably adhere to this program? Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule. |
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Is the procedure for ensuring equipment maintenance standardized in an SOP? |
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Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”? |
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Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of adequate functioning of equipment when it is returned into service after repair? |
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Are all items available in the laboratory stock recorded in a Stock Inventory Register? Take a sample by checking for two or three supplies in the stock if their Stock Cards are in the Stock Inventory Register and check if the Stock Cards are up-to-date. |
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Is the stock register in accordance with the actual stock (i.e. is it up-to-date)? |
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Do staff members know the correct procedure of taking items from the stock? Take a sample by asking random staff members. |
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Does the laboratory have an overview of all the items in stock? |
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Has the laboratory formulated key specification for each item in stock? |
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Does the laboratory perform a financial analysis on a regular basis to anticipate income versus expenditure for the coming year? |
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Does the laboratory have an Inventory Control Register that contains the following details:
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Is the Inventory Control Register kept up to date by counting the items in stock and comparing this with the number of items shown in the register? |
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Does the laboratory have an SOP for Selection and Evaluation of Suppliers? |
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Does the laboratory select suppliers in a standardized way and documents this procedure? |
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Does the laboratory develop contracts for reception of services in a standardized way? |
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Does the laboratory evaluate contracts for reception of services in a standardized way and documents this procedure? |
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If contracts are amended/changed, does the laboratory have records/minutes explaining the amendments/changes and why they were made? |
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Does the laboratory routinely perform acceptance tests on newly delivered products before they are taken into service? Ask for evidence. |
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Has the laboratory formulated the procedure for selecting referral laboratories? If the laboratory does not refer samples to other laboratories: is a statement included in the quality manual explaining that no samples are referred to other laboratories? |
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Has the laboratory formulated the procedure for monitoring referral laboratories on a regular basis? |
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Is a folder present containing documents with appointments between the referral laboratories and this laboratory and monitoring data? |
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Is a folder present containing records of samples referred to referral laboratories, including the result reports? |
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Does the laboratory have a documented procedure on selecting, ordering, acceptance testing and storing of new reagents and consumables? |
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Does the laboratory have a documented procedure on maintenance of the stock and inventory system? |
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Are all supplies stored under the right conditions in the laboratory? |
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Are records of supplies kept with the following details? [tick off]
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Are all supplies stored such that they cannot fall from shelves or suffer damage in other ways? |
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In regions where earthquakes are a real risk: are supplies stored in such a way that they cannot be damaged due to an earthquake? |
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Are all supplies stored according to the first-in-first-out (FIFO) system? |
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Are all storage areas complying with the safety requirements related to the supplies stored in them? |
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Do storage areas protect the supplies from external influences such as humidity, light, insects, etc.? |
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Are all storage areas lockable to prevent unauthorized access? |
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Are all storage areas labeled with hazard symbols related to the supplies stored in them? |
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Is a list with R- and S-sentences provided on each storage area where this is relevant? |
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Do staff members know what R- and S-sentences are and how to find them? Take a sample by asking some staff members. |
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Does the laboratory have a Request Form that includes at least the following details (tick off):
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Is the Request Form for Laboratory Testing clear? |
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Does the Request Form for Laboratory Testing provide clear guidance on how it should be filled-out? |
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Has the laboratory formulated clear and specific sample acceptation/rejection criteria for each type of sample used by the laboratory, leaving no room for interpretation? |
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Have the maximum allowed turnaround time been determined for each examination performed in the laboratory? |
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Is a table with the maximum allowed turnaround times for each examination included in the quality manual of the laboratory? |
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Is a table with the maximum allowed turnaround times for each examination included in the SOP on Reporting and Archiving of Results? |
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Does the SOP on Reporting and Archiving of Results include the procedure that the requester is immediately informed if the TAT of an examination is exceeded and this can compromise patient care? |
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Are staff members aware of the procedure for immediately informing the requester if an examination is exceeding the turnaround time when this can compromise patient care? |
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Is there an SOP that covers all the more simple procedures for which it is too laborious/inefficient to make separate SOPs but that are critical for proper functioning of the laboratory? |
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Has the laboratory identified and listed all the tests performed to determine which SOPs need to be written? |
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Does the laboratory have an SOP for Sample Collection to ensure correct collection of good quality samples for each test, protecting the safety of both the sample collector and patient as well as the privacy of the patient? |
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Does the SOP for Sample Collection include at least the following element? [tick-off]
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Is the turnaround time monitored on a continuous basis for each examinations? |
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Is the result of turnaround time assessment included in the Quarterly Reports? |
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Are corrective and preventive actions implemented in an attempt to decrease the percentage of samples exceeding the turnaround time to a minimum? |
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When sudden increases are seen in the percentage of samples exceeding turnaround time, is an analysis performed to identify the cause and implement corrective and preventive actions? |
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Is the efficacy of corrective and preventive actions to minimize/counteract increase of samples exceeding turnaround time determined in subsequent turnaround time assessments? |
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Is correct transportation of samples monitored on a continuous basis by the laboratory by checking of the transportation requirements in the SOP for Sample Collection are met? |
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If problems arise in transportation of samples, does the laboratory investigate these problems to find the cause? |
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If problems arise in transportation of samples, is a nonconformity form always completed? |
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Are corrective and preventive actions undertaken to solve problems in sample transportation? |
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Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked? |
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Have SOPs been written for all the tests routinely performed at the laboratory? |
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Have all SOPs been written according to the procedures described in the Master SOP? |
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Do all SOPs have the same structure and lay-out, complying with the guidelines of the Master SOP? |
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Does the laboratory have an SOP for Sample Reception and Processing? |
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Does the SOP for Sample Reception and Processing cover the following procedures:
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Has the laboratory authorized staff members for reviewing requests and deciding which examinations must be performed? |
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Has the SOP for Sample Reception and Processing been read by all relevant staff members? |
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Does the laboratory use a Sample Reception Register? |
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Does the Sample Reception Register leave room for including the following information:
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Has the laboratory standardized the procedure of validation of examination methods and equipment in an SOP? |
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Does the laboratory monitor correct performance of all its processes using quality indicators? |
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Is action undertaken upon detection of a sudden change in the value of a quality indictors to identify and solve the problem and prevent it from reoccurring? |
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Have limits of acceptability been set for each quality indicator? |
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Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer? |
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Does the SOP for Sample Reception and Processing have an appendix with a Sample Rejection Form? |
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Does the Sample Rejection Form include the following elements?
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Are copies of completed forms stored at the laboratory? |
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Has the laboratory validated all the examination methods performed in the laboratory? Find evidence by asking for the validation reports. |
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When the laboratory, through validation, identified the need to change an examination method, was this change made (including adaption of the SOP for that method)? |
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Has the laboratory made flowcharts of all the procedures routinely being performed in the laboratory? |
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Has the laboratory formulated quality controls to guard the quality of each process step in each procedure? |
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Are internal quality control results recorded in a register? |
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Are internal quality control protocols included in all relevant SOPs? |
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Does the laboratory have an SOP for Internal Quality Control that contains:
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Does the laboratory monitor internal quality control results and act on quality control failures? |
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Are internal quality control results continuously monitored? |
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Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends? |
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Is reporting of results halted when internal quality controls deviate/fail? |
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Has the laboratory developed a list of all SOPs needed to standardize the entire primary process? |
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Are all routinely performed procedures in the laboratory standardized in SOPs? Take a sample by asking for several SOPs indicated in the flow charts and check the document control log of the laboratory. |
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Are all SOPs complete and in line with the Master SOP, covering all required elements such as quality control, safety, tasks, authorizations and responsibilities, references, appendixes, etc.? |
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Does the laboratory have a fixed format for the Result Report? |
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Does the Result Report include at least the following elements: [tick off]
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Was the format of the Result Report discussed with regular clients of the laboratory during development? |
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Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information? |
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Is the laboratory archive lockable? |
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Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.? |
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Is access to the laboratory archive controlled? |
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Is a procedure in place that ensures verification of correct transcription of results on reports? |
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Is a procedure in place for authorizing Result Reports for release only if review of results has taken place and correct transcription of correct results and other important information to the report has been confirmed? |
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Is the computerized system properly protected by a firewall? |
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Is the computerized system scanned for viruses on a weekly basis by a proper, up to date virus scanner? |
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Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities? |
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Are the Personal Job Descriptions adapted of the staff members who are authorized to access or access and change laboratory information? |
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Does the laboratory have a procedure to ensure immediate notification of the requester in case results fall within critical intervals? |
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Does the laboratory record the occurrences in which results fall within critical intervals and requesters have to be notified directly (for verification purposes)? |
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Is a documented contingency plan present in the laboratory that should be followed in case of downtime of the computerized information system, to ensure access to laboratory information at all times? |
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Does the laboratory use a method for sending the Result Reports to the requesters with a minimum risk for losing reports? |
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Does the laboratory use a method for sending the Result Reports to the requester that ensures that reports are delivered as soon as possible? |
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Has the laboratory standardized the procedures for information management in an SOP? |
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Does the SOP on management of laboratory information include at least the following procedures:
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Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored securely, protected from unauthorized access? |
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Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored in a logical way enabling quick and easy retrieval of data? |
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Does the laboratory have an SOP for Recording, Reporting and Archiving of Results, describing at least the following procedures:
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Are the procedures in the SOP for Recording, Reporting and Archiving of Results routinely and correctly implemented in practice? |
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Are all staff members that are involved in any way in recording, reporting and archiving of results aware of the contents of the SOP for Recording, Reporting and Archiving of Results? |
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Is the laboratory able to trace back the staff members who signed documents based on the signature or initials? |
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Have all laboratory staff members signed a confidentiality agreement? |
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If the laboratory stores information digitally: are weekly backups being made? |
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Are backups of the computerized system stored behind lock and key in another building than the laboratory building where the computerized system is? |
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Does the laboratory have a Master SOP that explains how to write SOPs? |
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Does the Master SOP have different sections on how to write Analysis SOPs, Equipment SOPs and Procedure SOPs? |
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Does the laboratory have an overview of the time each type of record should be archived? |
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Does the laboratory have an overview of where each type of record should be archived? |
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Are SOPs available at logical locations, at least:
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Are inconsistencies and errors found in documents recorded in a Document Revision Form? |
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Do staff members know where to find the Document Revision Form? |
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Do staff members know what the Document Revision Form is for and do they know how to use it? |
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Is a Document Control Log available that shows all the quality documents of the laboratory with at least the following details:
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Is each quality document (SOP, quality manual chapter, Biosafety Manual chapter) supplied with a front page that contains the following information: [tick off]
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Does the laboratory have a document control system that ensures that all its quality documents are reviewed, and, when necessary, revised on an annual (or, after maturation of the quality management system, biannual) basis? |
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Are the Bench Aids used in the laboratory based on current versions of SOPs? |
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Have all quality documents currently in use been reviewed by at least one reviewer? |
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Are all the quality documents used in the laboratory authorized for release? |
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Are all the quality documents used in the laboratory the current versions? |
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Are copies of replaced quality documents in the quality documentation archive clearly marked as “replaced” with the date on which they were replaced? |
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Are all the references in quality documents to other documents, locations and equipment correct? |
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Does the laboratory have a dedicated archive in which it stores all its current and replaced quality documents for a period of five years? |
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Are all the procedures related to the document control system standardized in an SOP? |
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Is staff aware of what they have to do when they detect an error in a quality document? Take a sample by asking several staff members. |
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Are the Equipment SOPs complete, i.e. do they include the procedures that were developed in phase 2 such as calibration, preventive maintenance and corrective maintenance? |
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Does the laboratory have a database/register with regular customers? |
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Is a client satisfaction survey conducted on a two-yearly basis? |
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Is a report drafted of the client satisfaction survey that shows the main findings and points for improvement that were identified? |
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Is a SMART action plan drafted to implement points for improvement identified in client satisfaction surveys in practice? |
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Have specific staff members been authorized to communicate with clients so that proper communication and information provision to clients is ensured? |
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Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Result Reports? |
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Is the correctness of the biological reference intervals/diagnostic decision values and alert/critical interval values regularly verified for all the examinations performed by the laboratory? |
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If the methodology of an examination is changed, does the laboratory verify if the biological reference interval/diagnostic decision value and alert/critical interval value is still correct for that examination? |
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Does the laboratory have a standardized procedure for entering into a contract for service delivery? |
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Does the laboratory maintain minutes of meetings to discuss the contents of the contracts for service delivery? |
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Are specific laboratory staff members authorized to participate in clinical rounds? |
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Do laboratory staff members participate in clinical rounds at least 4 times per year? |
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Are meetings between laboratory staff and clinical staff held at least 4 times per year? |
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Are minutes made of meetings between laboratory staff and clinical staff? |
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If action points arise from a meeting between clinical staff and laboratory staff, is feedback given in the following meeting? |
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Does the laboratory have a service manual that includes the following: [tick-off]
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Has the Laboratory Service Manual been sent to all the clients of the laboratory? |
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When changes are made to the service manual, is the new version directly printed and sent to the clients of the laboratory, with the note that they have to destroy the previous version? |
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Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Service Manual? |
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If the biological reference interval/diagnostic decision value and/or alert/critical interval values turn out to be incorrect after changing the methodology of an examination, is this value directly adapted in both the Laboratory Service Manual and the Laboratory Result Report format and is the new version of the Laboratory Service Manual sent directly to the clients of the laboratory? |
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Has a Baseline Assessment of the laboratory been conducted to gain information on where some elements of a quality management system may be already in place and functioning, or where there are gaps that need to be addressed? |
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Does the laboratory participate in proficiency testing/inter-laboratory comparison schemes for all the examinations performed? |
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If participation in a proficiency testing scheme or organization of an inter-laboratory comparison for a certain test is not possible: does the laboratory have a rechecking/retesting system to compare results? |
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If results of proficiency testing/inter-laboratory comparisons are deviating/incorrect, does the laboratory act with performing an analysis to identify the causes of the problem and does it implement corrective actions, controls and, if possible, preventive actions? |
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Is an appropriate number of staff members appointed as Internal Auditors? With appropriate is meant that the number of staff members appointed as Internal Auditors is sufficient to achieve auditing of the complete quality management system and all the examinations every 12 months, without overburdening the Internal Auditors with too much work, creating an unacceptably high work pressure. |
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Is the Quality Officer appointed as Internal Auditor? |
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Have Internal Auditors been appropriately trained and certified? |
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Is a Position Job Description present for the position of Internal Auditor? |
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Have the Personal Job Descriptions of the staff members appointed as Internal Auditors been adapted to include the tasks and responsibilities for their position as Internal Auditor? |
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Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor? |
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Have staff adequately been informed about what internal auditing is, why it is done, and who the Internal Auditors are? |
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Has an external audit been performed to verify complete and correct implementation of the quality management system in compliance with ISO 15189 before the laboratory applies for accreditation? |
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Does the laboratory have an SOP for participation in a proficiency testing scheme and/or an inter-laboratory comparison scheme? |
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If the laboratory is the organizer of an inter-laboratory comparison scheme, does the SOP for External Quality Assessment include the procedure for organizing this? |
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If the laboratory rechecks/retests samples for a certain test (in case no PT or inter-laboratory comparison was possible), does the SOP for External Quality Assessment include the procedure for organizing this? |
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Are internal audits planned on a yearly basis and is this audit plan communicated to all the laboratory staff involved? |
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Are action plans made to solve/correct the nonconformities identified in the external mock audit with corrective actions and control steps and preventive actions when necessary and applicable? |
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Is timely implementation of the action plans following the external mock audit monitored? |
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Is the audit report of the external mock audit with the action plan archived when all action points have been completed? |
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Are internal audits carried out in such a way that the complete quality management system and all examinations are audited every 12 months? |
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Are observations made during internal audits reported and are nonconformities identified and scored according to severity? |
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Is the audit report submitted to laboratory management for translation into a SMART action plan to ensure correcting/solving of all the nonconformities noted? |
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Are action plans made to solve/correct the nonconformities identified in internal audits with corrective actions, control steps and preventive actions when necessary and applicable? |
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Is timely implementation of the action plans following internal audit monitored? |
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Are Internal Audit Reports with action plans archived when all action points have been completed? |
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Is the procedure for planning, conducting and processing internal audits standardized in an SOP? |
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Does the laboratory have an SOP for Nonconformity Management that ensures that nonconformities are always solved/corrected in a standardized way with corrective and preventive actions and, if necessary and applicable, control steps? |
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Does the laboratory have an SOP on Handling of Complaints? |
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Are complaints handled in a standardized way? |
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Are complainers informed about the solution that was developed based on their complaint? |
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Has the laboratory procedures in place on how to act in specific emergency situations? |
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Is firefighting equipment in place? |
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Is an evacuation plan in place? |
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Are evacuation routes indicated? |
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Are there organizational emergency arrangements in place including a division of roles and responsibilities for specific emergency situations? |
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Are procedures in place on how to handle in different emergency situations? |
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Have failure mode and effect analyses been performed on all the procedures routinely performed in the laboratory to identify potential sources of nonconformity? |
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Have preventive actions, control steps and corrective actions appropriately been implement to prevent and control nonconformities? Look into the reports of failure mode effect analyses and see if failure modes have reasonably been prevented and controlled by preventive actions, control steps and corrective actions in practice. With reasonable is meant that the implementation of preventive actions, control steps and corrective actions weighs up against the probability of failure modes in combination with the severity of the consequences. |
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Has the effectiveness of control steps and preventive/corrective actions implemented in the laboratory routine procedures following the Failure-Mode-Effect-Analysis been evaluated? |
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When control steps and preventive/corrective actions of the Failure-Mode-Effect-Analysis appeared to be ineffective, have they been replaced by more feasible ones? |
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Has the effectiveness and feasibility of the control steps and preventive/corrective actions that were optimized based on the first audit been evaluated in subsequent audits? |
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