Definition of Quality Control and its Major Components QA, QC, and QI
Quality rotates around relatedness on what a particular result is expected to give and what the test should actually realize. It is a match between what is wanted and what is actually got (WHO 2006). International organization for standards defines quality as a totality of characteristics of a product that suits it to the purpose for which it is made. Quality resonates well with excellence, value or worth. It is the driving force in every process and product manufacturing (WHO 2006). The word quality has been trivialized with every discipline coming up with an explanation that suits their system (WHO 2006). There are a variety of phrases that are synonymous with the word quality and these come in the form of ‘Quality Control’, and ‘Quality Assurance’ (WHO 2006). Every discipline strives to reach a level of utmost perfection in attainment of quality. Opportunities do exist for improvement of quality in health care facilities (WHO 2006). This comes under the backdrop that many lives are lost annually owing to iatrogenic conditions.
Quality control (QC) is about steps that are taken in the laboratory to control errors that arise when tests are performed and when the errors are being verified (WHO 2006). All procedures that are undertaken in the department must be subjected to quality control. Quality control procedures must be practical, tenable and affordable (WHO 2006).
World health organization (2003) defines quality assurance (QA) as a process which guarantees quality of laboratory reports. It entails getting right results, at the right time, using the right specimen obtained from the right patient (WHO 2003). Correct reference data should is very primary in interpretation of results. It is imperative that a clinical microbiology laboratory does quality assurance regularly to ensure that products that are produced and services offered have guaranteed high quality (WHO 2003).
Quality Assurance (QA) involves continuous improvements to and monitoring of reliability, efficiency, and clinical utilization of the laboratory tests (WHO 2006). Quality assurance also helps physicians to establish proper diagnosis within a short time (WHO 2006). This boosts the confidence of the patient thereby guaranteeing him or her better health care (WHO 2006). When quality of products and services that are undertaken in a laboratory are properly assured, the reputation of that particular laboratory gets a major boost and wins the confidence of the patients. In the process, the staffs get motivated to work even harder (WHO 2003). The laboratories with unequalled quality assurance processes get accredited for their good practices (WHO 2003). Legal suits and complaints that jeopardize a laboratory’s reputation as well as eating it their resources are normally kept at bay when a laboratory engages in good practices (WHO 2003).
Continuous quality improvement (QI) has always been likened to a Deming cycle divided into four parts comprising Plan, Do, Check, and Act (WHO 2006). Quality is not a static process and therefore involves continuous planning, doing, checking and acting. Quality cycle has top keep on turning for quality to improve. Qualities of the final product as well as the processes that give rise to the product are normally looked (WHO 2006).
What quality covers in clinical microbiology laboratory setting
Quality of specimen to be analyzed has the greatest bearing on the outcome of microbiological reports (Arora 2004). Quality of specimen is impacted on by a battery of factors like the timing of collection, transportation of the specimen to the laboratory, duration of transportation, and the accompanying clinical information provided (Arora 2004). Quality therefore encompasses all undertakings in the laboratory from the time the specimen is received up to when the report is submitted (Arora 2004). Care has to be taken to ensure that materials, equipment, and procedures are adequately controlled to guarantee best performance (Arora 2004). In observing quality standards, resources are used and managed to ensure that inputs are transformed into output. In the clinical microbiology laboratory context there has to be constant consultation with the users, receipt of request for examination, the actual laboratory test, reporting on the result found from the test. Interpretation of the report may be done if need be (Arora 2004). Clinical microbiology laboratory can be segregated into three phases: pre analytical phase, analytical phase, and post analytical phase (Bartlett et al 1994).
Pre analytical phase is involved with ordering of test by clinician, the clerical staff then processes the test request, nursing personnel then collects the specimen, specimen are transported to the laboratory, and finally the specimen is initially processed in the laboratory followed with subsequent accessioning (Bartlett et al 1994). The analytical phase involves culture work up and examination. Microscopy can be done by the microbiologist. The microbiologist then interprets the results (Bartlett et al 1994). In the post-analytical phase, the written report is formulated, the microbiologist communicates by writing comments and conclusions. Clinicians then interpret the report as well as establishing the appropriate therapy (Bartlett et al 1994). Laboratory director has to make sure that regularly monitor the quality control records for materials and apparatus. The newly introduced processes should be thoroughly evaluated and vetted before implementing their use in routine control. Monitoring should be done before settling on a particular level of control (Elder et al 1997).
Activities Designed in the Laboratory to aAssure qQuality (Llist and Discuss)
It is important that every clinical laboratory comes up with a standard operating procedure (SOP) so as to able to improve and maintain the quality of laboratory service to patients (Elder et al 1997). By doing this, the laboratory will identify problems that come as a result of poor work performance (Elder et al 1997). According to Murray et al, 2003, SOPs instructs laboratory staff on how they should perform tests consistently so that they can meet the set standards. The SOPs guard against any possible short cut that a laboratory staff may engage in. it provides written standardised techniques that can be used in training of the laboratory technicians (Murray et al 2003).Additionaly, it aids in preparing a list and an inventory of the reagents, apparatus and chemicals that are required in order to succeed in completing a tests. Finally, it guarantees safe laboratory practices. Experienced laboratory officers should see to it that SOPs are properly written and implemented (Snell et al 1982). It should be followed strictly so that accurate results are achieved. They should have titles and identification numbers. Effective quality assurance is able to detect errors early enough to avoid the possibility of attaining negative results (Winn et al 2006). According to Winn et al, 2006, Sops ought to give a description of selection and the right use of microbiological investigations. In addition, a description of how to adequately fill request forms, collect and transport specimen is also explained in this stage.
Laboratory personnel and clinicians collaborate in their effort to push for good laboratory practices. Priorities should clinical needs when resources are scarce. In clinical microbiology quality assurance should be comprehensive. It begins when one decides to collect specimen and stops when the report is being interpreted. Any error that occurs in between can lead to getting of erroneous results hence a faulty report (Winn et al 2006). Quality assurance has got its own parameters. Quality assurance helps one to get accurate, reliable, and reproducible information. This information comes from the clinical microbiology laboratory. This is actualized by assessing quality of the specimen, test procedure performance measurement (Winn et al 2006). The reagents, culture media, apparatus and laboratory staff have to be assessed. Test results have to be reviewed as well as the documentation of validity of the test method. Quality assurance parameters include collection of specimen and their transportation, procedural manual, personnel, quality control records, the patients reports, referral specimen, EQA, Equipment performance, commercially prepared media, user prepared media, stains, reagents and sera, and commercial kits (Winn et al 2006). Specimen collection and transportation gives instruction on how to collect and transport specimen, it has guidelines on criteria for establishing acceptable specimen as well as what to look to know whether the specimens are bad (Elder et al 1997). Procedural manual defines test performance, limits of tolerance, acceptability of specimen, preparation of reagent, and calculations and reporting in quality assurance (Murray et al 2003). Procedural manual should be reviewed annually and be made available in the work station.
The personnel should be sufficient and qualified depending on the amount of work to be done (Small et al 1982). Technical education to the personnel should be a continuous process. The personnel performance standards should be written. Specimen taken to the clinical laboratory for analysis has to be accompanied by a request form spells out the name, age, gender, occupation, out patient or in patient number, ward, and or health centre of the patient (Arora 2004). It details type and source of specimen, as well as date and time of their collection. The request form spells out the kind of investigation that is supposed to be done, and details of the medical officer who has requested the investigation (Bartlett et al 1994). A clinical note should list the patient’s disease history, prognosis, and information regarding antimicrobial treatment that he or she ought to have been given (Roemer and Montoya-Aguilar 1998). Elder et al (1997) retorts that reports compiled about a test is impacted on by specimen quality among other factors. For good results, urine and sputum specimen should be taken when a patient has just woken up because this is the time when the organisms multiply over several hours (Murray et al 2003). Blood samples should be taken when the patients temperature start rising (Elder al 1997). Samples should be taken from patients before they start a regime of antimicrobial medication. One should counter check the specimen after they reach the laboratory to make sure they are the one you required. It should be indicated on the request form when the specimen requires immediate attention.
At the analytical stage, myriad procedures for studying different specimens should be integrated into clinical microbiology laboratory SOPs. Other processes that fall under analytical stages include, techniques used for staining, and quality control of stains, aseptic procedures and taking care when handling infectious materials; preparation and quality control of culture media and stock strain preservation; media inoculation; interpretation and reading of cultures; techniques used in identification of pathogenic microbes; safe working practices; culture and specimen disposal; glass and plastic ware cleaning; and sterilization procedures (Winn et al 2006). Antimicrobial sensitivity testing and quality control can also be conducted. It is important that stains and reagents be clearly labelled. It is also imperative that they are dated and stored at favourable conditions. All the equipment in the quality control laboratory should have a clear guideline on how they are cleaned and operated. Equipment has to be regularly maintained to remain in a good working condition. At the post-analytical stage, SOPs should encompass reporting and verification of microbiological results, interpretation of the report of the test, and taking decisive decision when the test results has far reaching effects on the health and safety of the patient and that of public health (Elder et al 1997).There should be standards terminology that are used in reporting; after preliminary reports, one should ensure that he/she writes full reports which are then checked to ensure they are clear and correct and that they are signed by departmental head. Delivery and distribution of reports ha to be efficient. Urgent reports are normally telephoned. Reports have to be treated with utmost confidentiality.
Lack of clarity of any issue on the report should be appropriately illuminated. Good rapport has to be developed between those requesting for tests and the clinical microbiology laboratory staff (Murray et al 2003). Microbiologist should be in a position to shed light on the type of antibiotic that can be administered for treatment purposes. The staff should also be evaluated annually. All quality control results should be recorded on prescribed forms. All out of control observations should be reported to the supervisor. Any corrective action done on the quality control form should be clearly noted. Moreover, quality control records should be reviewed monthly. Report should only be taken to authorize personnel (Snell et al 1982). Test requester should be notified in the shortest time about any important values. Normal ranges ought to be provided where appropriate. There should also be timely correction of errors on patients report. Records of the patients report should be retained for a period not less than two years. For referral specimens, only authorized referral laboratory should be used and on the patient’s report the name of the reference laboratory should be included. Appropriate external quality assessment scheme should be adopted. Internal proficiency testing program should be considered. Document function checks of equipment should be done to ascertain performance of equipment. Equipment is supposed to perform as per the directions given by the manufacturer without which maintenance and calibration should be done. Maintenance records should be kept as long as the equipment is still around.
For commercially prepared media which have been shipped, inspection should be done to check for cracked media or Petri dishes, under fill, cases of haemolysis, contamination, and excessive bubbling. In case there are no documents accompanying the shipment that gives direction on use of the media, the manufacturer should be informed in due time. In house quality control should also be done on the media (Murray et al 2003). In case of media that the user has to prepare, the amount, source, lot number, method of sterilization, date it is prepared, its pH and expiry date should be recorded. Colour of the culture media should be checked as well as its consistency, slant, its smoothness, haemolysis related cases and contamination. The culture media should be tested with quality control microbes whose characters are known. The commercial kits should be tested as per the directions given by the manufacturer. Containers that contain stains, reagents, and sera should be labelled depending on their contents, their concentrations, and requirements for storage, date they were manufactured, date of receipt, and the period they take before expiring. They should be stored as per the recommendations given by the manufacturer (Elder et al 1997). Before these compounds are used they should be tested with positive and negative controls. Materials and reagents that fail to perform should be discarded forth with.
The sole reason for conducting quality control is to attain reliable laboratory results. This can only be possible if tests are done purposefully and efficiently. The extent at which the number of tests performed decreases determine whether one have improved in utilizing the tests. Difficulty has always arisen when it comes to associating reduced testing and the clinical outcomes (Snell et al 1982).One should do anything to avoid the costly tests. Restriction policies have been proved to be of any help to the patients despite the traditional belief that was held that it helps in avoiding unnecessary testing. Restricting microbiology testing entails examining bacterial culture and parasites on patients who have been in a medical facility for at least 3 days (Bartlett et al 1994). Cerebrospinal fluid cultures can also be used for mycobacterium specimens. Urine cultures can be used with patients who do not show disease symptoms and are taking antibiotics.
Laboratory internal audit is normally done ascertain whether all activities that appertain to quality are done. They are done by the laboratory staff with the spirit of inspecting their system. However, it is should be done by staff who have a wealth of expertise, competent and fairly objective (Murray et al 2003).
Activities in clinical microbiology laboratory used by management to assure quality in delivery of laboratory services like document control, audits, complaint management- list and discuss.
Quality management in clinical microbiology laboratories has kept evolving with years (Leifert and Woodward 1998). Laboratory accreditation programme in the United States was initiated by the government where as the college of American pathologists established proficiency testing and laboratory accreditation (Leifert and Woodward 1998). The activities include building a working quality assurance program, quality probes, in house quality assurance audit, and yearly management review. Quality assurance program should be incorporated into routine management function of an organization (Leifert and Woodward 1998). Building a quality assurance program involve coming up with a comprehensive quality assurance strategy and a problem oriented strategy (Leifert and Woodward 1998). The comprehensive approach has a top to bottom approach where there is simultaneous implementation of quality assurance policies, processes and procedures (Leifert and Woodward 1998). The approach commences with review of specifications and standards. This is subsequently followed by evaluation of the health care support services. This is attained by management of information system to monitor and measure quality of service provided. Training effort should be intensified to enhance technical competencies. This also helps to improve knowledge and skills (Leifert and Woodward 1998).
In problem oriented approach a lot of focus in the practical aspects, small scale activities, and quality aspects to enhance improvement in quality (Leifert and Woodward, 1998). Rather than embarking on comprehensive assessment, people should invest their efforts on single problem that has larger impact. In developing a quality assurance program much attention should be put on fostering commitment to quality, doing a prior review of quality assurance activities, coming up with the purpose and vision for quality assurance efforts (Leifert and Woodward 1998). Level and scope of initial quality assurance activities should be determined. Responsibility should be assigned for quality assurance as well as allocation of resources. Written quality assurance plan ought to be developed and finally critical management systems and quality assurance skills should be strengthened (Leifert and Woodward 1998).
Quality assurance programs should evaluated through regular audits as well as quality control committee regular meetings. The quality control committee is chaired by the director of the laboratory (Leifert and Woodward 1998). Section heads constitute the composition of the committee. Quality assurance audits should be should be planned and done bearing in mind the pre-analytical, analytical, and post analytical stages of testing (Leifert and Woodward 1998).
Annual management review is pivotal in management system of clinical microbiology laboratory as it sets the following years’ objectives. They help in identifying staff training needs.
It is imperative that every clinical microbiology laboratory conduct continual quality assurance program. The laboratory staff including the technical staff, the clerks, and the support personnel should have a deeper understanding of concepts of quality so that their output only spells quality. Senior laboratory personnel should come up with standard operating procedures that can be used in the laboratory to guarantee quality. Handling of specimen and other activities that happen at the pre-analytical stages, analytical stages and post-analytical stages should ensure that good laboratory practices are engaged in.
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