Improving quality in a cytopathology laboratory ABSTRACT

Improvingquality in a cytopathology laboratory

ABSTRACT

Qualityassurance in a cytopathology laboratory is achieved by involving allthe parties that contributes to cytopathology procedures. Qualityassurance measures start with the laboratory directors to thecytopathotechnologists at work. High-quality results are achievedwhen all the parties work together by following the Standardoperation procedures failure to which quality is undermined.Laboratory directors in a cytopathology laboratory are responsiblefor risk analysis and management. Proper risk analysis techniqueshelp the lab manager to identify the weak points among thetechnologists. Proper management involves giving out good guidelinesor instructions on what should be done to solve the problems thathave been identified. There is the need to accredit and comply withthe international accepted policies and procedures and excellentdocumentation to help deal with malpractices. Cytopathologylaboratories should only employ laboratory technologists haveundergone through the recommended training and have licenses from theregulatory bodies. The staff members of cytopathology laboratoryshould follow the standard operating procedures. SOPs help in comingup with high-quality results.

Cytopathologyas a diagnostic technique examines cells of the body to determine thenature and cause of disease. Pap test was the first cytology test tobe developed and has been used for over half a century for screeningcervical cancer. Pap smear has been successful in almost all parts ofthe world. The practice of cytopathology started with a sample fromthe cervical region only, but now it has been expanded to includesamples from other body sites. Cytopathology techniques such as Papsmear have been of much importance in preventing cancer.Population-based screening is now practiced in most of the developedcountries (Davey et al., 2013). Therefore, it is important toimplement quality control programs regarding the cytopathologyprocedures and steps. Quality is crucial when carrying outcytopathology procedures. Cytopathologists are required to follow theStandard Operating Procedures set by the WHO or their laboratorymanagement. This paper evaluates and discusses ways of improvingquality in a cytopathology laboratory.

PART0NE

QualityControl

Qualitycontrol is the practice of ensuring that both accuracy and precisionare maintained when processing the cytopathology samples. Qualitycontrol samples and reagents should be of high integrity as well asmeet the necessities of proficiency testing. In a cytopathologylaboratory, quality control helps in identifying the mistakes withthe samples and calibration of machines (Eden,2015). Thepractice of quality control ensures all the laboratory tests are donein the right way hence producing accurate results. QC samples shouldlook similar to patient samples. Usually, it is necessary to repeatquality control testing to certify precision and accuracy of thepatient’s results (Eden,2015). Precisionis the level of concurrence amongst repetitive measurements of theidentical characteristic on an equivalent sample. On the other hand,accuracy is checked whether the end results are close to what isexpected at the end of the procedure.

ISO15189 and Medical Laboratories

ISO15189 gives in details how a medical laboratory is supposed to workor operate so as to produce quality results. ISO 15189 helps themedical laboratories to come up with the appropriate managementsystem and assessing their competence. In many countries, theaccreditation bodies use ISO15189 criteria to confirm and recognizethe laboratory’s competence. ISO 15189 stress that the laboratorytechnologist, reagents, equipment among other factors must becompetent (Jameset al., 2014). OnlyLaboratories that meet the ISO 15189 criteria should be accredited toISO 15189. A cytopathology laboratory should meet the followingcriteria before for it to be ISO certified:

Qualityassurance and control practices in a cytopathology lab include theuse of Intra-laboratory and extra-departmental consultations,correlation of histopathology and cytological specimens and review ofthe diagnostic reports. The following are the quality assurance andcontrol measures Laboratory Directors: The Director of Cytopathologylaboratory should be a well-qualified physician with a postgraduatedegree in pathology including training and experience incytopathology procedures.

Cytotechnologists:These are the staff members involved in the processing of thesamples. This position requires a suitably qualified person, mostprobably one who possesses the first degree in medical laboratorysciences and a master in histo-cytopathology (Herbert et al. 2014).However, the qualification criteria may differ from one country toanother.

Thelaboratory facility: The laboratory should meet the recommendedstandards. It must be well organized and ventilated. Biosafetycabinets and the fridges should be in good working condition.Chemicals should be kept away from direct sunlight or fire since thismay destroy them (Pouliakis et al., 2014). Fridges help to maintainthe recommended temperatures for some reagents. Only laboratory staffmembers should access the facility. Patients should wait for orreceive the results at the reception.

Safetyprecautions: The staff must be in protective gear when working.Infectious materials should be discarded safely. The laboratoryshould have fire extinguishers to put off the fire in case it arises.All laboratory technologists must be in lab coats and gloves whenworking (Panel, 2012). It is vital to post and test all the fireprecautions.

Equipment:The director of lab services must ensure all the equipment are ofhigh quality and are in proper conditions (Director-ihsm, 2016). Onlyqualified technicians should service the machine and ensure themalfunctions are fixed. Malfunctions affect the quality of results.All cytopathology laboratories should consider using the most modernequipment that produces high-quality results (Joste &ampGober-Wilcox, 2013).

SpecimenCollection: The person receiving the samples at the laboratory shouldensure that the samples meet the recommended standards. Thepathologists must collect the samples using the right procedures. Theright procedure for specimen rejection should be applied. Therejected sample should be accompanied by a rejection reportindicating why the samples were rejected. Only qualified medicalpractitioners should take samples from the patients (Sheaff &ampSingh, 2013).

Preparation,Fixation, and staining methods: The staff should ensure that thesamples have the patient’s detail. The request form should have therequesting doctor’s and patient’s information. The slides in thelaboratory should be assigned a number corresponding to the number ofthe patient’s request form or a unique identifier. All specimensthat do not meet the processing criteria should be rejected using theset standards for rejection. It is good to fix conventional cellsamples while they are wet. Most of the cytological samples areprocessed using through Papanicolaou procedures (Sheaff &amp Singh2013). The staining solutions and the reagents should be coveredimmediately after. Some of the solutions are flammable and therefore,immediate covering reduces risks (Shambayati, 2011). The laboratoryreagents should both the manufacturing and the date of preparationsand the expiry dates.

Slideevaluation and workload: Cytopathotechnologists should not over work.They should only handle the recommended number of slides per day.Samples from cases that require urgency should be given priority. Atechnologist should only work for eight hours in a day. Overworkingis highly discouraged since it can cause poor service delivery(Branca &amp Adhemar, 2015). The director of laboratory services isresponsible for evaluating the number of slides or workload perstaff. However, internationally set standards should be followed.

CytologicTerminology: Bethesda is the recommended system for interpreting mostof the cytology samples such as an ectocervical or endocervicalsample. On the other hand, Nongynecologic materials should beinterpreted using the appropriate medical terminologies (Pitman etal. 2014).

Laboratoryrecords, logs and files: Proper record keeping is very important inthe laboratory. The person receiving the samples at the laboratoryshould ensure that he/she has assigned them appropriate numbersdepending on the laboratory’s numbering systems. Laboratory recordsmust be kept for a long period for future reference. The samplesshould not be kept for a period less than five years. Samples thatneed further research or investigation should be kept safely for alonger period (Pantanowitz &amp Austin, 2014). The results shouldalso be recorded well in the laboratory’s record book before theresults are dispatched to the client or the doctor.

Riskanalysis and management

Analysis

Aftercytophathotechnologist has identified a risk in the laboratory, it isimportant to carry out the quality control process. It is the role ofthe management to identify the severity and the risk the underlyingproblem posed to the laboratory staff. Therefore, the management canapply tools and come up with procedures that can put a value on theidentified risk. In most cytopathology laboratories, the directorgives the steps that should be followed to report the accidents andincidences however small they are (Pantanowitz &amp Parwani, 2014).The recorded data is then recorded, and this enables the manager toevaluate the issue accordingly.

Riskmanagement

Thereis the need to accredit and comply with the international acceptedpolicies and procedures and excellent documentation to help deal withmalpractices (Stavros &amp Nasioutziki, 2016). Cervical cytologyclaims for cytology laboratories, pathologists, and cytotechnologisthave been rapidly increasing over the years. Currently, the severityof the claims is very high thus putting pathologists at par withobstetricians and anesthesiologists (Kocjan et al., 2013). It isimportant to check the details of a cytological specimen whenever apatient claims that his or her results were misleading. All cytologylaboratories in the United States are expected to be in fullcompliance with the States and the Federal laws to avoidmalpractices. It is importance to make sure the entire laboratoryfollows the documented workload policy. In the case of malpractices,the laboratory director should establish whether the specimenunderwent through the right procedure and if the results wererecorded well.TheClinical Laboratory Improvement Amendments of 1988(CLIA) raised thefollowing risk and quality, management concerns proper recordkeeping of all the cytologic specimens, proper slide handling, andretention, amended reports from retrospective review and workloadlimits.

PARTTWO

Equivalentknowledge and skills: Medical technologists in cytopathologylaboratory should have enough knowledge on all cytology proceduresand be in a position to follow them from the first step to the lastwithout any difficulties. The technologist must understand and carryout their duties with minimum supervision (Crothers et al., 2013).Knowledge must be professionally acquired through training at amedical school. The technologist must have enough knowledge of basicprinciples, concepts, and cytopathology in addition to laboratorymathematics and statistics and skills in carrying out all thespecialized tests (Crothers et al., 2013). Knowledge of mathematicsand statistics is vital in establishing quality controls, calculateand correlate test results and troubleshoot procedures and equipment.The cytopathotechnologists should also have enough knowledge ofrelated disciplines such as physiology, anatomy, epidemiology amongothers. The knowledge and understanding of the medicolegalrequirements, internationally recognized standards and requirementsof the accrediting agency is vital (Crothers et al., 2013).

Supervisorycontrols: Each cytopathologist should have supervisory controlskills. This skill enables a technologist to give instructions, givepriority to the urgent results, set appropriate deadlines and defineobjectives. However, the overall supervision is done by the directorof laboratory services in the cytopathology laboratory. A supervisorhas the following roles and duties in the laboratory assigns dutiesby giving instructions which cover the steps to be followed.Cytopathologists fresh from college should work under a supervisorwho gives the instructions and oversees the work done. The supervisormonitors the progress of all the laboratory procedures (Crothers etal., 2013). The supervisor in a cytopathology laboratory indicateswhat is to be done, quality of work expected, problems anticipated,deadlines, the priority of assignments and suggests ways of handlingand solving problems that may arise. The laboratory supervisor shouldclosely control the work by reviewing the progress and on completionthe accuracy of results, and adherence to instructions andestablished procedures. The director ensures that the results andcytopathology methods followed are technically accurate and inaccordance with established procedures. The supervisor should assistthe new technologist to learn all the test methods.

Healthadvocate: Cytopathologists should responsibly use their knowledgegained in medical school and their influence to improve thewell-being of patients and the entire population they serve (Yu,2011). They should demonstrate awareness of the risk factors thatcontribute to a disease, the main reasons for screening the communityagainst a particular disease condition and the role of otherhealthcare professionals in such processes (Smart et al., 2016). Thecytopathologist should demonstrate knowledge of all the factors thatcontribute to a disease within a given community, the importance ofscreening and the role of technologists in this process.Cytopathologists should also work towards promoting the health of allpeople. They should demonstrate safe practices when carrying out theprocedures on patients and when processing the specimens in thelaboratory (Mourtzikou et al., 2013). Scholars Cytopathologistsshould always be ready to advance their knowledge by leading wide,attending cytopathology workshops and seminars, and participate inassessment programs.

PARTTHREE

Theway to evaluate laboratory performance is by carrying out internalquality control on a routine basis. Positive and negative controlshelp to know whether the test was performed well without omitting anystep. Positive controls monitor the calibration of the system thusproviding the assurance that the right procedures are followed (Allenet al., 2013). Cytopathologists should run positive control besidesthe tests every day. Negative controls evaluate the specificity ofthe tests to identify false-positive staining results. They includenegative tissue controls. Cytopathologist should select the besttissue controls. At the end of the staining or processing, thepathologists compare the three slides, that is, the sample slide, thenegative control slide, and the positive control slide to knowwhether the cytopathologists carried out the staining procedure well(Denton et al., 2010). External quality control is also an importantpractice of ensuring that the laboratory is performing as per theinternational set standards. The laboratory manager should ensurethat sample slides are exchanged with slides from other laboratoriesto assess the quality of the testing procedure and the resultsobtained (Ázara et al., 2013).

PARTFOUR

Themain specific role to improve quality in the laboratory is makingsure that all the staff members strictly follow the standardoperation procedures (SOPS). The standard operating procedures coverthe following areas in the laboratory quality control, routines,performance management, and replication and growth. Routines in acytopathology laboratory, the SOPs helps the technologists to carryout their duties with much ease. SOPs should be well documented in aflow chart and placed on the walls or where, or the staff members canread see or reach them easily (Bibbo &amp Wilbur, 2014). SOPs makesthe laboratory procedures easy to follow either in the print out oron the computer.

Qualitycontrol SOPS in a cytopathology laboratory help to minimize errorsor variations that occur when the technologist are handling manysamples at a time. Each laboratory should have SOPs for quality(Maruta et al., 2012). SOPs help in the director of laboratoryservices and the senior technologist to discard results that fail tomeet quality and request for a repeat of the whole procedure.Performance management SOPs in a cytopathology laboratory helps tomake it easier to check the technologist’s performance appraisals(International Organization for Standardization, 2012). The directorof laboratory services should write each employee’s job descriptionand give them target level for each SOP in the job description. Thestaff’s SOPs should just have the procedures most crucial to thejob (Clary et al., 2013). Replication and Growth: SOPs helps toreplicate processes across the Laboratory if the health institutionhas more than one laboratory in different areas. This aid in makingsure that the end results are of high quality. Usually, it is easy tocompare the performance of the cytopathotechnologists who perform thesame SOP as part of their jobs.

Factorsinfluencing development and training of cytopathology staffs

Automationcytopathotechnologists in the United Kingdom are under pressure todeliver quality results by decreasing the turnaround time while atthe same time producing quality results. Technology changes from timeto time, and therefore the State is faced with a challenge of sendingcytotechnologists for training whenever the new machine that provesto be of high quality is invented (Oltvai, 2012). The governmentincurs much cost in this. In addition, the agedcytopathotechnologists who trained many years ago might not bewilling to learn the modern technologies or they are not in aposition to learn the new technology.

Trainingperiod it requires at least two years training acytopathotechnologist. Not many Medical officers or laboratorytechnologist are willing to undergo another two years of trainingafter attaining the first degree. Most of the doctors and medicallaboratory technologist fail to advance and opt to work as generalpractitioners. However, it is not possible to reduce the trainingperiod because many units and practical lessons have to be covered.The hospital attachments programs are also time consuming. Most ofthe technologists feel demoralized since they work for free duringthe internship period. Therefore, many students for health sciencecarries that are not time demanding.

Toimprove performance this is another factor that influences thetraining of cytopathology staff. Short courses help in updating thetechnologists the changes or new technologies in place. In addition,the short courses assist the staff members to refresh on the skillsthey acquired in college (Khurana, 2012). Cytopathology staffs whoattend seminars and short courses are likely to produce qualityresults since they keep on updating themselves.

Shortageof cytopathologists many countries across the world are faced withthe shortage of cytopathologists. There is the need to encourage moredoctors to major in this carrier since there is demand for morecytopathologists due to the increase in the number of cancer-relatedcases in most parts of the world. However, the cost and time requiredto train cytopathologist discourage most of the doctors fromenrolling from cytopathology career. The government should consideroffering partial or full scholarships to doctors willing to pursue acytopathology career.

Conclusion

Fromthe above discussion, one can conclude that it is vital for allcytopathology laboratories to ensure that they produce high-qualityresults. High-quality results are achievable strict adherence to thestandard operating procedures, employing qualified and competentstaff members, team-work and adopting the most modern testingtechnologies. The cytopathotechnologists should also undergospecialized training aimed at equipping them with all the testprocedures that take place in a cytopathology laboratory. Thedirector of the laboratory services should ensure that all the testsunderwent through the right procedure. Proper supervision ensuresthat the end results are of high quality. New technologies likeautomation reduce the time taken to produce results and improvequality.

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