Checklist Phase 4

Does the laboratory have a standardized procedure for hiring new permanent and temporary staff, and having guests?

Does the procedure for hiring new permanent and temporary staff cover all the following elements:

• Regarding permanent and temporary staff:
  • Criteria to 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
  • 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).

Are educational needs consistently assessed in competency assessments and performance appraisals?

Does the laboratory have a Continuous Education Program?

Is the Continuous Education Program included as element in the Quality Year Plan?

Has a laboratory staff member appropriately been trained in performing failure-mode-effect-analyses?

Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing?

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.

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?

If problems arise in transportation of samples, is a nonconformity form always completed?

Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked?

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?

Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer?

Are specific laboratory staff members authorized to participate in clinical rounds?

Are meetings between laboratory staff and clinical staff held at least 4 times per year?

If action points arise from a meeting between clinical staff and laboratory staff, is feedback given in the following meeting?

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?

Is the audit report of the external mock audit with the action plan archived when all action points have been completed?

Does the laboratory have an SOP on Handling of Complaints?

Are complainers informed about the solution that was developed based on their complaint?

Is firefighting equipment in place?

Are evacuation routes indicated?

Are procedures in place on how to handle in different emergency situations?

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.

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?