Checklist Phase 1

Have the staff adequately been instructed on the symptoms of infection with Mycobacterium tuberculosis, the HIV virus and other 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 there an action plan to upgrade the facilities and safety to comply with the essential TB laboratory safety requirements of the WHO TB Laboratory Biosafety Manual?

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Has the Risk Group for each laboratory room been determined?

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Is there an action plan to upgrade the facilities and safety to get each laboratory room into compliance with the risk group defined for that room (based on the WHO TB Laboratory Biosafety Manual)?

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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 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 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 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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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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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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p>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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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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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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Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officer”)?

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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 of the Stock Officer are?

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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 total organization?

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Is the Organizational Chart that shows the position of the laboratory in the total organization signed and dated by the management of the total 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 Charts stored in a folder that is accessible to all the staff members of the laboratory?

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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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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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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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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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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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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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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)

  • Identity
  • Label
  • Serial number
  • Manufacturer name
  • Manufacturer’s contact person and contact details
  • Service provider name
  • Service provider’s contact person and contact details
  • Date of purchase
  • Date of putting into service
  • Location
  • Condition
  • Frequency of maintenance
  • Date of previous maintenance
  • Date of next scheduled maintenance
  • Remarks

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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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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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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 a Request Form that includes at least the following details (tick off):

  • Patient details (name, address, telephone number, birth date, gender, etc.)
  • Requester details
  • Type of primary sample
  • Examination(s) requested
  • Clinical information relevant to the laboratory (HIV status, CD4 count, etc)
  • Date, time and place of sample collection
  • Date and time of receipt of the sample at the laboratory

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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 identified and listed all the tests performed to determine which SOPs need to be written?

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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 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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