Create commitment to go for accreditation
Develop a Request Form for Laboratory Testing
Make an Equipment Register and check proper functioning of equipment
Prepare Stock Cards and set up the inventory management system
Appoint a Quality Officer
Develop sample acceptation/rejection criteria
Make an inventory of clients of your laboratory services
Install a system to prevent access of unauthorized persons to the laboratory
Create a Document Retention List: determine the storage time and location for all types of documents used
Write an SOP for Procurement and Reception of Equipment
Make an inventory of all supplies, their specifications and the suppliers
Make a fixed format for the Result Reports
Identify potential conflicts of interest for every staff member
Determine the turnaround time for each examination performed in the laboratory
Perform a financial analysis of resources needed to ensure a quality laboratory
Establish an archive ensuring protection of laboratory information but also enables quick retrieval of information
Formulate the Vision of the laboratory, the reason why the laboratory exists
Arrange that the Quality Officer and other staff members are trained as Internal Auditors
Assess if the number of staff is still sufficient to assure continuity of work without overburdening staff members
Make an SOP covering the various support activities that are carried out such as cleaning of the laboratory and organization of work discussions
Validate all pieces of equipment used for examination in the laboratory, including software systems
Update the method of performing a management review
Perform failure mode and effect analyses on all processes of the laboratory
Organize an external audit to identify the last improvements necessary for accreditation
Determine which biosafety level the facilities need to comply with
When the laboratory works with pathogens requiring a biosafety level (BSL) III facility: create a negative pressure laboratory
Make access to digital data of the laboratory restricted (both physically and virtually)
Optimize communication channels within the laboratory building (appropriate to the size of the building) to facilitate easy transfer of information
Write an SOP on validation of examinations and equipment
Identify and start monitoring critical parameters: quality indicators
Appoint a Biosafety Officer
Ensure that the laboratory is legally identifiable and is recognized as national or regional (if applicable: reference-) laboratory by the authorities
Make process flowcharts
Plan for purchasing new equipment and equipment maintenance in the annual budget planning
Formulate the goals for the coming year specifically with respect to the quality management system
Prepare Bench Aids for each piece of equipment including daily maintenance instructions
Decide on the method of maintenance and calibration for each piece of equipment
Develop a quality manual
Start monitoring the functioning of the quality management system and produce Quarterly Reports
Ensure that defective equipment is taken out of service, clearly labeled and disinfected, and that proper validation is performed once equipment is repaired
Develop a Quality Year Plan for the following year based on the conclusions from the management review
Write a Master SOP
Provide staff with basic orientation on principles of quality management and a quality management system
Write procedures for operating equipment
It is strongly advised that the laboratory manager is trained in change management
Write an SOP for Sample Collection
Document biological reference intervals/decision values of all examinations performed
Separate laboratory areas to prevent cross contamination and optimize the floor plan
Create folders for storing SOPs at the most convenient locations for staff to have access to the SOPs when needed
Label all equipment in accordance with the codes in the inventory list made in phase 1 under Equipment
Make an Inventory Control Register
Start reviewing and authorizing results (i.e. validation of results) before releasing the report
Create a personnel replacement matrix
Monitor adherence to the turnaround times as determined for each examination
Standardize the method of developing, reviewing and evaluating a contract for service delivery
Standardize the method for choosing suppliers and evaluating contracts for purchasing and delivery of goods and services
Formulate the Mission of the laboratory
Make an Internal Audit Plan for the coming 12 months
Create a procedure for hiring new staff, hiring temporary staff, and having guests
Monitor transportation of samples
When equipment appears to be defective, determine and correct the potential negative influence on previous testing results
Evaluate the effectiveness of preventive actions, control steps and corrective actions implemented based on the failure mode and effect analyses
Make an action plan following the report of the external audit and monitor its implementation
Provide the Biosafety Officer with a biosafety training so that he/she is capable to fully perform his/her job tasks
Perform a facility and safety assessment
Create a primary sample collection facility separate from the laboratory
If laboratory information is only stored digitally: create a contingency plan that ensures availability of laboratory information in case of computer failure
Ensure uninterrupted supply of electricity
Validate all examination procedures performed in the laboratory
In phase 1 the Organizational Chart of the laboratory was developed. Revise this to the situation created in phase 2
Formulate and start monitoring internal quality controls
Formulate the first Quality Year Plan
Establish a preventive maintenance program for equipment
Amend the Equipment SOPs developed in phase 1
Perform a management review at the end of the quality year
Standardize and document the policy cycle in SOPs
Appoint a Quality Project Team. The chair of this team is appointed as a Quality Focal Point
Make sure that enough staff members are trained in providing first aid or that access to first aid is ensured
Measure the satisfaction of clients of the laboratory
Develop an SOP on Handling Nonconformities and start recording and solving/correcting them in a standardized way
Make a list of all tests performed in the laboratory
Develop an SOP for Sample Reception and Processing and start registering all samples received by the laboratory
Create Daily Routine Work Schedules
Write a Laboratory Service Manual and start to follow the procedures formulated in this manual
Design a Document Revision Form
Determine which staff members are authorized and which are responsible for use of each piece of equipment
Start performing acceptance tests upon delivery of new supplies
Establish a system for immediate notification of the requester for samples marked as urgent and for results that fall within critical intervals
Formulate the long-term goals of the laboratory
Start to carry out all internal audits and write audit reports
Assess the education needs of every staff member
Make a procedure for selection and regular monitoring of the functioning of referral laboratories.
Write and implement an SOP for Waste Segregation and Disposal
Arrange and monitor adequate storage space and conditions for samples, documents, records, equipment, consumables, etc.
Write an SOP on Information Management
Appoint an Equipment Officer
Install a visual indicator for directional airflow in the laboratory rooms
Monitor and investigate failure of internal controls and improve accordingly
Translate the Quality Year Plan into a SMART action plan
Define in an SOP the maintenance schedule for all listed equipment
Perform staff competency assessments
Conduct a baseline assessment of the laboratory
Write an SOP on Handling of Complaints and start to follow-up complaints in a standardized way
Make SOPs for all tests performed by the laboratory
Describe the procedure for rejecting a sample, make a Sample Rejection Form and send this to the requester when a sample and/or sample Request Form proves to be unsuitable for examination
Make a document control log
Develop maintenance and Usage Log Sheets/logbooks for each piece of equipment
Standardize the stock and ordering system in an SOP
Discuss with the clients of the laboratory the best method to assure that Result Reports are always received by the requester and as timely as possible
Formulate the Quality Policy
Formulate an action plan based on the audit report and monitor its implementation
Establish a Continuous Education Programme
Write a Biosafety Manual and make sure that it is read and signed by all staff
Define the length of storage/archiving of different items in a retention list
Appoint a staff member who is responsible for monitoring stocks and ordering supplies and reagents
Make an inventory list of all hazardous materials and their location within the facility
Define which SOPs are necessary based on the process flowcharts made earlier in this phase
Train staff to recognize symptoms of laboratory associated infections and facilitate access to diagnostic and medical services for when such cases occur
Make and use action plans with SMART action points
Develop an appropriate, documented induction program for new personnel
Identify potential emergencies that could take place in and around the laboratory (and could affect the need for the laboratory services) and implement procedures, equipment and organizational arrangements to ensure an adequate reaction to emergencies
Add a front page to each quality document used in the laboratory
Collect all equipment documents and records and store these in the Equipment Archive
Store supplies appropriately
If patient data are recorded in a paper system, ensure secure and proper storage
Write an SOP for Internal Audit
Ensure that all staff participate in quality assurance programs relevant to their positions
Arrange standardized regular cleaning of the laboratory
Monitor and record environmental parameters and equipment parameters
Develop SOPs for the entire primary process
Participate in a proficiency testing scheme for each examination performed by the laboratory
Start organizing regular (weekly) staff meetings
Organize performance appraisals of staff members
Roll out a document control system
Write an SOP explaining the system used for the identification and management of equipment
Write an SOP for Recording, Reporting and Archiving of Results
Send the Quality Officer to a training on Failure-Mode-Effect-Analysis
Make Organizational Charts
Purchase spill kits and write and implement an SOP on Dealing with Spills
Assign a staff member to which clients can turn for professional advice
Write an SOP for external quality assessment procedures
Make an Authorization Matrix
Create an archive dedicated to quality management documentation
Develop a Signature List of all staff members
Purchase first aid kits and train a selection of personnel members to become first aid providers
Participate in clinical rounds/schedule regular discussions with clinical staff to harmonize services provided and received
Make a job description for each position in the laboratory
Write an SOP for Document Control including the Document Retention List
Ensure that confidentiality of patient information is maintained by all personnel
Develop personnel files for all staff members
Make a Personal Job Description specific for each staff member
Organize regular backup of computerized systems
Ensure adequately qualified staff
Watch the LQSI tutorial
Create commitment to go for accreditation