Introduction to Clinical Microbiology Laboratory Organization:
A clinical microbiology lab performs analytical tests on human body substances for disease diagnosis, prevention and aids patient management for promotion of good health. Organization means an orderly structure making arrangements for achievement of purpose. In microbiology lab, the purpose is clinical relevance i.e., promotion of patient’s health.
Key Elements in Laboratory Organization:
Organization and design
Previously labs were centralized. Then the concept of decentralization came up for performing alternate site testing. The organization and design depend on whether the site of testing is Physician Officer Lab or Point of care Lab (bed side).
It includes
- Needs and requirements
- Space
- Utilities
- Storage
Needs and requirements
Human resource: It depends on nature and extent of clinical services and financial availability. For a population of 250000 with 150000 specimen/ year, 3 consultants trained in microbiology, 1 principal grade scientist trained in microbiology, 1-2 technologists. Medical laboratory Scientific Officers (20) with university degree in science are required.
Furniture: Furniture are installed as per need of the laboratory. The lab design can be with fixed furniture or flexible furniture. Mostly, flexible furniture are desired. There should be dry bench for repair and constructing apparatus and wet benches with drawing board and running water. The benching could be perimeter and island benching, peninsular benching or peninsular and perimeter benching.
Future expansion: The lab should be designed such that if the lab wants to expand its testing and equipment ranges, it should be flexible enough for future expansion.
Space
Space is based on testing, microorganisms sought, staffs, equipment, air handling systems, waste treatment requirements.
Space design
- Space per individual is desired to be 2-meter squares
- The space for work, circulation and bench space should be there. The space for 2-3 workers is desired to be 6m X 3m
It includes:
Specified space (museum, equipment, instrument room, preparation room)
There should be space for specimen receiving, processing, microscopy, media preparation, glassware washing, AFB isolation, room for molecular testing, open benches for routine specimen workup.
In microbiology lab there has to be room for: Aerobic and anaerobic culture, Mycology, Parasitology, Virology, Mycobacteriology, Serology and Molecular biology.
Safety measures
Safety measures should include chemical safety, fire safety and chemical safety, fire extinguishers should be readily available, first aid cart should be centrally located, 2 outlets in case of fire. Electrical circuits should be grounded and there should be use of dedicated electrical circuits. If radio labelled elements are used then they should be licensed and well disposed.
Standard working protocols should be followed and safety precautions should be adopted. Personnel should be given training regarding handling of potentially lethal agents, containment equipment and functions. Strictly controlled access to the laboratory should be there and safety cabinets are desired as per level of risk organism being handled.
Cost effectiveness should also be considered.
Utilities
Necessary utilities like water supply (cold, hot, distilled), electricity should be available. Waste water should be treated prior to release into drainage.
Storage
Gas, chemicals specimens, materials, glass wares, equipment and tools should be well stored with lock system and strict access. For this, lockable cupboard and shelves should be used.
Day to day management
Tidying lab and equipment should be done on day-to-day basis
The supplies need to be checked and manager should look after all administrative works including purchases of supply, budgeting
Wastes should be properly disposed as they are bio hazardous to people and environment if not decontaminated and properly disposed.
Stock control and purchase
The chemicals, reagents and consumables and equipment required for the performance of tests should be on hand. Manager has to determine the costs for both the direct and indirect costs. For this, past usage and ledger has to be documented well. Stock should be rotation keeping in mind the expiry date of reagents.
Files and records
Document is a record of any information including lab policy, quality manual, procedures, specification, reports, job description etc. It may be a hard copy or electronic. Documentation attains detailed records for all aspects of lab activities for traceability and validation. Document structure includes style, format, and document number and distribution list. Lab should ensure only current version of relevant documents is available where operation is done. Most documents are in paper form. Use of computers betters the storage and retrieval of data. Records in general are maintained for 2 years.
Records in lab can be accession list that records all specimens received in lab, requisition form, Work card, Test report and Standard Operating Protocol (SOP). SOP is the most important document in a laboratory. It details the complete technique for performing tests. Each section of lab should have a copy of SOP and should be reviewed annually.
Communication
- There has to exist a good communication between director, manager and lab staffs regarding the tests and other aspects of the laboratory.
- Director is responsible for all aspects of lab operations including standards, expenditure and control of staffs. He should be able to communicate the lab data.
- A manager looks after the lab needs, purchases and there has to be communication between manager and organization in the purchase of inventories and in case of need of using a reference lab, the costs and needs need to be communicated.
- Communication is also important in external quality assessment when a blind sample is given for inter-lab comparison. Internal quality assessment can be performed by rechecking the self-lab produced sample to reference lab.
Maintenance
The routine monitoring and inspection should be performed on daily, weekly, monthly, yearly basis. Then the problem trouble shooting should be done. These preventive and corrective actions aids in the maintenance of quality in lab.
Use of computers
Computers are used for various clerical works in office and data storage in lab. Data and information produced by laboratory should be managed to ensure integrity, security and traceability. Information can be managed manually or electronically. Verification should be done to confirm accuracy of manual. Example: Calculation made electronically should be verified periodically and software should be monitored. If Information system is replaced or upgraded, there should be process to retrieve the old data.
Components of Laboratory organization includes:
Staffing
It depends on nature and extent of clinical services and financial availability. For a population of 250000 with 150000 specimen/ year, 3 consultants trained in microbiology, 1 principal grade scientist trained in microbiology, 1-2 technologists. Medical laboratory Scientific Officers (20) with university degree in science are required.
Director is responsible for all aspects of lab operations including standards, expenditure and control of staffs. He should be able to communicate the lab data.
A manager looks after the lab needs, purchases and there has to be communication between manager and organization in the purchase of inventories and in case of need of using a reference lab, the costs and needs need to be communicated
Management
Management role is charged with providing manual that defines the Quality Management System (QMS). Lab directors have principal responsibility for setting up the organization. They develop policies, play administrative and educational roles.
Quality managers assist in developing policies, planning and implementing MS. She/he has to be strategic, a problem solver and should communicate all aspects of QMS to lab director. Lab staffs should follow all quality policies in daily routine works.
Elements of service
Guidance to user
- Delivery of specimens- The specimens should be delivered to lab in proper condition of temperature (e.g., CSF at 37 degree) and transport media should be used in case of delay request forms
- Reception of specimens- Right specimen at right time by right technique should be collected.
- Safety in reception area- Since the specimen could contain potentially harmful agents, they should be handled with safety precautions and in containment facility if possible.
Work station of laboratory
Choice of test- In the analytical phase, choice of test has to be done so that the test is clinically relevant and there is no non-conformity cost needed to be wasted. Good choice of test aids in right treatment.
Reading of results
Wording of results: The report should be properly worded and should be short and simple with right technical terms.
Issue of reports
Computerization of reports- Computers are used data storage in lab to ensure integrity, security and traceability. Information can be managed manually or electronically.
Verification should be done to confirm accuracy of manual
- Laboratory manual- Standard Operating Protocol (SOP) is the most important document in a laboratory. It details the complete technique for performing tests. Each section of lab should have a copy of SOP and should be reviewed annually.
- Equipment- Laboratory should have necessary equipment to provide services that includes lab specific equipment, analytical equipment, software and information system. Lab should have process to identify qualified supplier from whom equipment are purchased. Result of calibration and verification should be documented.
- Training- Proper training to lab personnel should be given in handling of equipment and to be aware of safety protocols
- Safety precaution- Safety precautions should be adopted while handling hazardous material in lab.
- Quality assurance
- Quality control
External and internal quality Assessment
Retrospective and periodic assessment of quality can be conducted by independent external agency or laboratory staff. External quality assessment (EQA) assesses quality by external agency using material of known but undisclosed result. Scoring system can be used to stimulate lab improvement.
Internal quality assessment (IQA): All the processes are same as EQA but the material is prepared, distributed and results evaluated within the lab. IQA access variability of test, statistical analysis and confidence limit testing. Reconfirmation can be done in referral lab.
Audit: Man driven quality assurance is performed by first second and third party to ensure quality of results produced by lab
Duties of QC officer: It is the duty of QC officer to look after all the analytical phase critical points and ensure the result of good quality.
ISO 15189- Key Management and Technical Requirements:
Management requirements
- Organization and management responsibilities
- Quality management system
- Management review
- Service agreements
- Examination by referral lab
- Advisory services
- Identification and control of non-conformities
- Corrective action
- Preventive action
- Continual improvement
- Control of records
Technical requirements
- Personnel
- Lab equipment, reagents and consumables
- Pre examination process
- Examination process
- Post examination process
- Reporting result
- Information system