Checklist Phase 3
Is access to first aid secured 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:
|
Activity | |
Does the laboratory have a clear Vision? |
Activity | |
Is the Vision of the laboratory documented and stored? |
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 | |
Does the Quality Year Plan include action points from the management review? |
Activity | |
Does the Quality Year Plan take into account the Quality Policy, Long Term Goals, Core Values, Mission and Vision of the laboratory? |
Activity | |
Is an action plan drafted based on the action points yielding from the Quality Year Plan? |
Activity | |
Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff? See minutes of that meeting. |
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 | |
Have 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 or 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:
|
Activity | |
Is a client satisfaction survey conducted on a two-yearly basis? |
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 with too much work, 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 |