Quality assurance (QA) is the total process whereby the quality of laboratory reports can be guaranteed. The term quality control covers that part of QA, which primarily concerns the control of errors in the performance of tests and verification of test results. All materials, equipment and procedures must be adequately controlled. Culture media must be tested for sterility and performance. Each laboratory must have standard operating procedures (SOPs). Quality assurance (QA) of pre-analytical, analytical and post-analytical stages of microbiological procedures should be incorporated in SOPs. The laboratory must be well lit with dust-free air-conditioned environment. Environmental conditions should be monitored. Supervisory and technical personnel should be well qualified. The laboratory should participate in external and internal quality assurance schemes.
Quality results are the desired outputs of any microbiology laboratory. The results generated should be accurate (i.e. reflecting the true situation) and precise (i.e. reproducible). The microbiology lab should correctly identify the organisms and correctly identify the antimicrobial susceptibility profile of that organism. Quality management is the holistic process that ensures quality results and can be defined as the “coordinated activities that direct and control laboratory activities with regards to quality”.
According to ISO, quality is defined as the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. The principal objective of quality assurance is to provide reliable laboratory results in all health care activities and to ensure inter-laboratory comparability of results in clinical laboratories, epidemiological investigations, health surveys, environmental monitoring, medical research, and other public health activities. Thus, all the microbiology work needs to be performed with utmost care to maintain a good standard at every level starting from the patients at one end to the dispatch of the report to the next end. It denotes the system for continuously improving reliability, efficiency, and utilization of the result and service to the patients.
Two ways of Quality Assurance
Internal Quality Assurance:- It means day to day quality assurance system. This covers all routine, control and test procedures that a laboratory undertakes and involves the monitoring and documentation of all procedures to ensure quality results. Aspects of routine laboratory operations that should be monitored as part of IQA are:
The quality of reagents: proper storage, pH, reagent effectiveness, observed expiry dates.
The functioning of equipment: regular manufacturer recommended maintenance and proper calibration.
Precision and accuracy of the test method: use of appropriate controls to ensure accurate results.
The qualifications and performance of the staff performing the tests.
The accuracy of the results being disseminated: proper recording and interpretation of results into databases or reports
External Quality Assessment
It means outside agencies sending sets of certain samples for testing regularly. This is an objective assessment conducted by an external agency to evaluate the performance of a laboratory. Typically this involves comparing the test outcomes of the laboratory being assessed against the test outcomes of a second or reference laboratory.
Confirmative diagnosis and appropriate treatment of the patients.
To improve the quality of the health facility.
To isolate pathogens of public health importance
Factor Affecting the Quality of the Works
Many pre-analytical, analytical, and post-analytical factors affect bacteriological works.
Specimen selection – The right specimens for the specific disease are requested
Personnel- The trained staffs are necessary for a good microbiological lab
Laboratory organization- The well-organized lab can have a good output. The ventilation, lighting, working space, availability of equipment and reagents, etc. are necessary
Good quality reagents – Availability of quality reagents is also important
Recording and reporting – The trained staff record all the events in the laboratory
Quality Control (Qc) Commonly Used Tests-
The equipment needs cleaning using a moist cotton cloth preferably soaked in the disinfectant. Cleaning must be done thoroughly inside the chambers and outside the equipment. Thereafter dried using a dry cloth. The microscopic lines are cleaned every time after use. the cleaning of other parts of the microscope is done by soft tissue paper or soft flamed cloth. Then it should be covered by dust-resistant plastic specially made for that purpose. The microscopes should be kept covered while not in use. The silica gel packets should be kept inside the chambers for the microscope so as to absorb moisture.
Table 1: Quality Control (Qc) Commonly Used Tests
Table 2: Care of the Equipment
Analytical Laboratory QA/QC Program
The goal of the Analytical Laboratory QA/QC Program is to guarantee the generation of precise and accurate analytical data. Quality assurance involves the planned and systematic actions necessary to provide confidence in each analytical result. The QA/QC Program has two components: Quality Assurance (QA) - the system used to verify that the entire analytical process is operating within acceptable limits and Quality Control (QC) - the mechanisms established to measure non-conforming method performance.
Standard Operating Procedures (SOPs): Each laboratory method is clearly described in standard operating procedures. These methods are periodically reviewed for updates
Training: Tests are performed by trained staff members. Each staff member must meet performance criteria before performing a test
Reliable And Well-Maintained Equipment: Each instrument is operated by trained staff members. Maintenance logbooks are kept for each instrument. The instruments are calibrated according to manufacturer guidelines and in accordance to the relevant SOPs. Balances, pipettes and other measuring devices are calibrated frequently
Traceability: Analytical standards used are traceable to certified reference materials. Internal reference materials are checked as far as is technically and economically practicable
Annual Review Of Qc Results: The results of proficiency testing and QC results are annually evaluated for trends. A system of control charts is used to determine if the system is in a state of statistical control and examine the relative variability of repetitive data. Control charts are also used with reference materials and spiked samples to assess the accuracy of measurements
Blanks: A reagent blank is analyzed with every set of samples that are extracted or digested. This reagent blank includes any and all reagents that are used in the analytical process and is carried through the entire process, including extraction and filtering or digestion
Duplicates: At least ten percent of samples are analyzed in duplicate. The first, last and every tenth sample are run in duplicate. Duplicate values typically should fall within 8% of each other for all samples unless sample homogeneity is a problem. This information is included in the report
Standard Reference Materials: At least one standard reference material is analyzed with each set of samples. The values for the standard reference materials are included in the final report. Samples run with a standard reference material that falls outside the acceptable range are reanalyzed, including digestion or extraction if necessary
Spike Samples: Sample fortifications or spikes are used to verify accuracy of tests requiring extensive sample manipulation (such as acid digestion) or for non-standard sample types
Sample Exchange and Certification Programs: The Analytical Laboratory participates in a number of sample exchange and certification programs. The Laboratory participates in the North American Proficiency Testing Program for soils, water and plant material. The Laboratory participates in the Agriculture Laboratory Proficiency Program for plant tissue. The Laboratory is certified by the National Forage Testing Association for the analysis of moisture, crude protein, acid detergent fiber and neutral detergent fiber in feed
Benefits of a Quality Assurance Program
Delivering a quality product or generation of a reliable service
Helping the physician establish a proper and rapid diagnosis, thus generating confidence and better health care for the patient
Creation of a good reputation for the laboratory
Motivation factor for staff to work better
Mandatory requirement for accreditation
Prevention of legal suits and associated complications
Efficient utilization of resources
Cost-saving on account of wrong/over/under treatment
Assuring the safety of patients, staff, visitors, community, and environment
Plan and define aims of validation
Validation
Definition of Validation: It is that part of a quality assurance system that evaluates in advance the steps involved in operational procedures or product preparation to ensure quality, effectiveness, and reliability. The laboratory should record the results obtained and the procedure used for the validation.
Process of validation
Develop a protocol for the process of validation
Execute the process and collect data
Compare results against agreed requirements
Consider any other issues: e.g. health and safety
Accept or reject
Document
Implement
Review
Assessment of quality can be checked by Man-driven (Internal and External audit) and Material-driven (internal and external quality assessment).
Inter-laboratory testing and split sample testing are the types of external quality assessment schemes (EQAS).
Quality Assurance (QA) = (Quality Control) QC + (Internal quality assessment) IQA+ (external quality assessment) EQA
Quality control (QC) must be practical, achievable, and affordable
Quality assurance (QA) is important in the diagnosis, treatment, and surveillance of infectious diseases and policies regarding the selection and use of antimicrobial drugs
Trained technical staff and clinical microbiologists are important resource persons in providing the establishment of essential microbiology services
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