Checklist Phase 3

Are all reagents and supplies stored under the proper conditions, protected from unauthorized access and easily retrievable?

Is defective equipment demonstrably contaminated and stored outside the laboratory protected from use?

Are documents and records protected from unauthorized access?

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.

Have Internal Auditors been appropriately trained and certified?

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?

Have staff adequately been informed about what internal auditing is, why it is done, and who the Internal Auditors are?

Is a backup staff member defined for each staff member in the laboratory?

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.

Are patients in the waiting area and primary sample collection facility protected against rain and direct sunlight?

Are there enough chairs in the waiting area and primary sample collection facility so that every patient can sit?

Does the retention schedule for storing different types of materials include the storage durations for samples and slides?

Have the maximum allowed turnaround time been determined for each examination performed in the laboratory?

Is a table with the maximum allowed turnaround times for each examination included in the SOP on Reporting and Archiving of Results?

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?

Is the quality manual part of the document control system?

Does the Quality Year Plan include action points from the management review?

Is an action plan drafted based on the action points yielding from the Quality Year Plan?

Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information?

Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.?

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?

Are Internal Audit Reports with action plans archived when all action points have been completed?

Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)?

Is the Quality Year Plan appropriately stored and easily retrievable?

Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?

Are the long-term goals of the laboratory covering all the core-activities?

Are the long-term goals of the laboratory documented and stored?

Is the Mission of the laboratory documented and stored?

Does the Quality Policy describe clearly the scope of the laboratory services?

Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?

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?

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Does the laboratory have a clear Vision?

Has the laboratory investigated if there are potential conflicts of interest among laboratory staff?

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?

Has the laboratory formulated the procedure for monitoring referral laboratories on a regular basis?

Is a folder present containing records of samples referred to referral laboratories, including the result reports?

Is the computerized system scanned for viruses on a weekly basis by a proper, up to date virus scanner?

Are the Personal Job Descriptions adapted of the staff members who are authorized to access or access and change laboratory information?

Is access to first aid secured at the laboratory?

Is the training of the first aid providers up-to-date?

Is the laboratory staff aware of who the first aid providers are?

Is a client satisfaction survey conducted on a two-yearly basis?

Is a SMART action plan drafted to implement points for improvement identified in client satisfaction surveys in practice?

Is the result of turnaround time assessment included in the Quarterly Reports?

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?

Does the laboratory perform a financial analysis on a regular basis to anticipate income versus expenditure for the coming year?

Are reports drafted of management reviews?

Are the result of the management review presented to all staff?

See meeting minutes.

Does the laboratory have measures to prevent interruption of services due to break down of old equipment?

Are maintenance costs (including repairs) taken into account in the laboratory budget?

Does the laboratory have an SOP for Selection and Evaluation of Suppliers?

Does the laboratory develop contracts for reception of services in a standardized way?

If contracts are amended/changed, does the laboratory have records/minutes explaining the amendments/changes and why they were made?

Does the laboratory maintain minutes of meetings to discuss the contents of the contracts for service delivery?

Are internal audits carried out in such a way that the complete quality management system and all examinations are audited every 12 months?

Is the audit report submitted to laboratory management for translation into a SMART action plan to ensure correcting/solving of all the nonconformities noted?

Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?

Are staff members aware of action points assigned to them?

Take a sample by asking staff members about action points assigned to them.

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)?

Is the pressure of the biosafety level III regularly monitored and recorded?

Is the negative pressure system included in the preventive maintenance program of the laboratory?

Is the procedure for planning, conducting and processing internal audits standardized in an SOP?

Does the SOP on management of laboratory information include at least the following procedures:

• Management and maintenance of the computerized laboratory information system, including procedures regarding:
  • Regular backup, regular virus scanning and the contingency plan protocols
  • Accessing laboratory information in the computerized system
  • Entering laboratory information
  • Changing laboratory information stored in the computerized system
  • Defining authorizations for accessing, accessing and entering laboratory information, and accessing, entering and changing laboratory information in the computerized system
• Protocol for ensuring confidentiality of patient data
• Management and maintenance of the laboratory archive, including procedures regarding:
  • Accessing information
  • Storing information
  • Changing information in the archive
  • Ensuring protection of records from external deteriorating factors such as humidity, fire, insects, sunlight, etc.
  • Defining authorizations for accessing, accessing and storing laboratory information, and accessing, storing and changing laboratory information in the archive