Checklist Phase 1

Has the Risk Group for each laboratory room been determined?

Is an action plan present to implement improvements based on findings from the Facility & Safety assessment?

Have the action points in this action plan from the Facility & Safety Assessment been fulfilled on or before the deadline?

Does the laboratory have a procedure for processing and disposal of the different types of waste produced?

Are up-to-date guidelines present on safe disposal of waste?

Is potentially infectious waste safely and securely stored before incineration?

Are sharps securely and safely incinerated without the risk for needle accidents?

Is infectious glassware for re-use autoclaved correctly?

Is chemical waste processed correctly?

Is normal waste processed according to local/national regulations (if applicable)?

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”?

Does the Biosafety Manual contain preventive safety procedures?

Are the Biosafety Manual chapters signed by the author, reviewer and Laboratory Management?

Is the Biosafety Manual read and signed by all staff members?

Does the SOP on cleaning of the laboratory building include a section with specific guidelines for cleaning laboratory rooms?

Does the cleaning schedule show what should be cleaned by who and when?

Are there spill kits present in adequate numbers and are these kits complete

Are first aid providers present in the laboratory?

Is the implementation of the quality management system coordinated through a Quality Project Team?

Are Quality Project Team meetings held on a regular basis?

The presence of minutes serve as prove for this.

Does the laboratory make use of action plans with SMART formulated action points?

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?

Are minutes made of weekly staff meetings?

Are the minutes of weekly staff meetings stored in a well-organized way?

Is there a description of the tasks and responsibilities of the Biosafety Officer?

Do all the staff members know the function of the Biosafety Officer?

Is the Equipment Officer trained in calibration and technical maintenance of equipment (if necessary)?

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

Do all laboratory staff members know who the Stock Officer is?

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?

Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory?

Are the Organizational Chart(s) stored in a folder that is accessible to all the staff members of the laboratory?

Have all staff members participated in an introductory course in quality management for medical laboratories?

Has the Biosafety Officer received laboratory biosafety training?

Does the laboratory have an Authorization Matrix, showing for each position in the laboratory the authorizations, responsibilities and tasks?

Is the Authorization Matrix accessible to all staff members?

Are staff members able to find the Authorization Matrix?

Does the laboratory have a job description for each position in the laboratory?

Have Personal Job Descriptions been made for all the staff members?

Are Personal Job Descriptions stored in an orderly fashion in the Personnel Files folder?

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?

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

Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function?

Are Equipment SOPs written in accordance with the procedure described in the Master SOP?

Have staff members demonstrably read the SOPs that are relevant for them?

Is the stock register in accordance with the actual stock (i.e. is it up-to-date)?

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

Does the Request Form for Laboratory Testing provide clear guidance on how it should be filled-out?

Have SOPs been written for all the tests routinely performed at the laboratory?

Do all SOPs have the same structure and lay-out, complying with the guidelines of the Master SOP?

Does the Master SOP have different sections on how to write Analysis SOPs, Equipment SOPs and Procedure SOPs?