Checklist Phase 3

Is access to first aid ensured at the laboratory?

Activity

In laboratories where the presence of first aid providers is necessary: have enough staff members been appointed as first aid provider such that continuous presence of at least one first aid provider is ensured?

Activity

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

Activity

Does the Biosafety Manual contain an explanation of the tasks and responsibilities of first aid providers?

Activity

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

Activity

Have the Personal Job Descrptions of the first aid providers been adapted to reflect the authorizations of their position as first aid provider?

Activity

Is the biosafety level III laboratory equipped with a negative pressure system?

Activity

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

Activity

Is the negative pressure system connected to a backup electricity supply to ensure that it keeps functioning during a power failure?

Activity

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

Activity

Is access into the BSL III laboratory controlled to prevent unauthorized access?

Activity

Is a primary sample collection facility available and physically separate from the laboratory activities?

Activity

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

Activity

Does the patient sample collection facility allow for the protection of privacy of patients?

Activity

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

Activity

Is the waiting area and primary sample collection facility accessible for physically handicapped patients?

Activity

Are samples stored under appropriate conditions, protected from unauthorized access and demonstrably easily retrievable?

Activity

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

Activity

Is equipment stored under appropriate conditions protected from unauthorized use?

Activity

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

Activity

Are documents and records stored under appropriate conditions, protected from fire, insects, humidity and other harmful elements?

Activity

Are documents and records protected from unauthorized access?

Activity

Are documents and records stored in a logical manner so that they are demonstrably easily retrievable?

Activity

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

Activity

Does the retention schedule for storing different types of materials include the following documents:

  • Replaced SOPs
  • Completed worksheets
  • Completed log sheets
  • Completed Request Forms
  • Patient reports
  • Result registers
  • All contracts of the laboratory with external parties
  • Personnel data

Activity

In this phase the management cycle will be implemented. This is a cycle of continuous improvement where the management plans activities, monitors their execution, check if they were done correctly, and based on that, plans for implementing improvement activities for the next year. This facilitates efficient planning and management of the laboratory. However, planning without having a clear goal in mind is impossible. Before implementing the management cycle one has to develop a clear Vision, Mission, long-term goals, and long-term planning, which will result in a Quality Policy.

Activity

Does the laboratory have a clear Mission?

Activity

Is the Mission of the laboratory documented and stored?

Activity

Does the laboratory have long-term goals?

Activity

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

Activity

Are the long-term goals of the laboratory aimed at improvement?

Activity

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

Activity

Does the laboratory have a Quality Policy?

Activity

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

Activity

Does the Quality Policy describe clearly the Long Term Goals and what the laboratory will do to achieve these goals?

Activity

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

Activity

Does the Quality Policy contain a statement of the laboratory’s commitment to provide good professional practice, quality examinations, in compliance with the quality management system adhering to ISO 15189?

Activity

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?

Activity

Are staff aware of existence of the Quality Policy?

Take a sample by randomly asking staff members.

Activity

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Activity

Have all staff members read the Quality Policy?

Request proof such as the Read & Understand List and interview staff members about the contents of the quality policy).

Activity

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

Activity

Is purchasing of new equipment taken into account in making the laboratory budget for the next year?

Activity

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

Activity

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

Activity

Does the laboratory plan its activities through a Quality Year Plan?

Activity

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

Activity

Has the Quality Year Plan been formulated with input from the Quality Officer?

Take a sample by asking the Quality Officer and some members of the Quality Project Team.

Activity

Is the Quality Year Plan appropriately stored and easily retrievable?

Activity

Is the Quality Year Plan signed and dated by management?

Activity

Is the Quality Year Plan translated into an action plan?

Activity

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

Activity

Is staff aware of the existence of the Quality Year Plan?

Take a sample by asking some random staff member to explain what the Quality Year Plan is.

Activity

Are staff members aware of action points assigned to them?

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

Activity

Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory?

Activity

Is the quality manual part of the document control system?

Activity

Have all staff members read the quality manual?

Activity

Is the performance of the quality management system recorded in Quarterly Reports?

Activity

Is the functioning of the quality management system reviewed annually by laboratory management?

Activity

Are reports drafted of management reviews?

Activity

Do Management Review Reports include action points if applicable?

Activity

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

See meeting minutes.

Activity

Are Management Review Reports securely and orderly stored?

Activity

After the management review has been completed, is a new quality year plan drafted, (among others) based on the findings from the management review?

Activity

Have all the policy cycle activities been documented in an SOP (i.e. drafting a quality year plan, monitoring of performance of the quality management system and drafting quarterly reports, and performing a management review)?

Activity

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

Activity

If potential conflicts of interest among laboratory staff were identified, were they appropriately solved and documented?

Activity

Is a personnel replacement matrix present in the laboratory?

Activity

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

Activity

Is the competency of the backup staff members checked for the tasks they need to take over from absent staff members?

Activity

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.

Activity

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

Activity

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

Activity

Does the laboratory select suppliers in a standardized way and documents this procedure?

Activity

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

Activity

Does the laboratory evaluate contracts for reception of services in a standardized way and documents this procedure?

Activity

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

Activity

Has the laboratory formulated the procedure for selecting referral laboratories? If the laboratory does not refer samples to other laboratories: is a statement included in the quality manual explaining that no samples are referred to other laboratories?

Activity

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

Activity

Is a folder present containing documents with appointments between the referral laboratories and this laboratory and monitoring data?

Activity

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

Activity

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

Activity

Is a table with the maximum allowed turnaround times for each examination included in the quality manual of the laboratory?

Activity

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

Activity

Does the SOP on Reporting and Archiving of Results include the procedure that the requester is immediately informed if the TAT of an examination is exceeded and this can compromise patient care?

Activity

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?

Activity

Is the turnaround time monitored on a continuous basis for each examinations?

Activity

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

Activity

Are corrective and preventive actions implemented in an attempt to decrease the percentage of samples exceeding the turnaround time to a minimum?

Activity

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?

Activity

Is the efficacy of corrective and preventive actions to minimize/counteract increase of samples exceeding turnaround time determined in subsequent turnaround time assessments?

Activity

Has the laboratory standardized the procedure of validation of examination methods and equipment in an SOP?

Activity

Has the laboratory validated all the examination methods performed in the laboratory?

Find evidence by asking for the validation reports.

Activity

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)?

Activity

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

Activity

Is the laboratory archive lockable?

Activity

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

Activity

Is access to the laboratory archive controlled?

Activity

Is the computerized system properly protected by a firewall?

Activity

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

Activity

Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities?

Activity

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

Activity

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?

Activity

Has the laboratory standardized the procedures for information management in an SOP?

Activity

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

Activity

Is a client satisfaction survey conducted at least once per two years?

Activity

Is a report drafted of the client satisfaction survey that shows the main findings and points for improvement that were identified?

Activity

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

Activity

Does the laboratory have a standardized procedure for entering into a contract for service delivery?

Activity

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

Activity

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, creating an unacceptably high work pressure.

Activity

Is the Quality Officer appointed as Internal Auditor?

Activity

Have Internal Auditors been appropriately trained and certified?

Activity

Is a Position Job Description present for the position of Internal Auditor?

Activity

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?

Activity

Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor?

Activity

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

Activity

Are internal audits planned on a yearly basis and is this audit plan communicated to all the laboratory staff involved?

Activity

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

Activity

Are observations made during internal audits reported and are nonconformities identified and scored according to severity?

Activity

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

Activity

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?

Activity

Is timely implementation of the action plans following internal audit monitored?

Activity

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

Activity

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

Activity