Install a system to prevent access of unauthorized persons to the laboratory
Develop sample acceptation/rejection criteria
Make an inventory of all supplies, their specifications and the suppliers
Make a fixed format for the Result Reports
Make an inventory of clients of your laboratory services
Appoint a Quality Officer
Write an SOP for Procurement and Reception of Equipment
Create a Document Retention List: determine the storage time and location for all types of documents used
Optimize communication channels within the laboratory building (appropriate to the size of the building) to facilitate easy transfer of information
Ensure that the laboratory is legally identifiable and is recognized as national or regional (if applicable: reference-) laboratory by the authorities
Make process flowcharts
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
Ensure that defective equipment is taken out of service, clearly labeled and disinfected, and that proper validation is performed once equipment is repaired
Label all equipment in accordance with the codes in the inventory list made in phase 1 under Equipment
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
Start reviewing and authorizing results (i.e. validation of results) before releasing the report
It is strongly advised that the laboratory manager is trained in change management
Make an Inventory Control Register
Document biological reference intervals/decision values of all examinations performed
Write an SOP for Sample Collection
Ensure uninterrupted supply of electricity
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
Establish a preventive maintenance program for equipment
Amend the Equipment SOPs developed in phase 1
Write a Laboratory Service Manual and start to follow the procedures formulated in this manual
Establish a system for immediate notification of the requester for samples marked as urgent and for results that fall within critical intervals
Determine which staff members are authorized and which are responsible for use of each piece of equipment
Develop an SOP for Sample Reception and Processing and start registering all samples received by the laboratory
Design a Document Revision Form
Start performing acceptance tests upon delivery of new supplies
Create Daily Routine Work Schedules
Install a visual indicator for directional airflow in the laboratory rooms
Monitor and investigate failure of internal controls and improve accordingly
Define in an SOP the maintenance schedule for all listed equipment
Perform staff competency assessments
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
Develop maintenance and Usage Log Sheets/logbooks for each piece of equipment
Make a document control log
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
Standardize the stock and ordering system in an SOP
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
Develop an appropriate, documented induction program for new personnel
Store supplies appropriately
Collect all equipment documents and records and store these in the Equipment Archive
If patient data are recorded in a paper system, ensure secure and proper storage
Add a front page to each quality document used in 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
Organize performance appraisals of staff members
Write an SOP explaining the system used for the identification and management of equipment
Roll out a document control system
Write an SOP for Recording, Reporting and Archiving of Results
Write an SOP for external quality assessment procedures
Create an archive dedicated to quality management documentation
Develop a Signature List of all staff members
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
Organize regular backup of computerized systems
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