Checklist Personnel

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:

  • Regarding permanent and temporary staff:
    • Criteria with which all applicants must comply
    • Procedure for defining specific criteria for the vacancy
    • Procedure of drafting and publishing the vacancy
    • Procedure of selecting suitable applicants based on application letters/CVs
    • Procedure of inviting applicants and organizing the application interview
    • Procedure of selecting applicants based on the application interview
    • Procedure of hiring suitable applicant, including:
      • Determining salary
      • Writing Personal Job Description
      • Adapting Authorization Matrix
      • Creating a personnel file
      • Ensuring that staff member is properly induced according to the SOP for Induction of New Personnel
      • Providing training to new staff (e.g. training into quality management to ensure that the staff member understands and works via the quality management system).
  • Regarding guests:
    • Procedure of identification and recording of guest details
    • Procedure of recording details of the visit
    • Procedure of allowing access of the staff member to the laboratory (including a health check to determine if the guest’s health allows for accessing the testing areas).

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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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