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Journalof Automatic Chemistry Vol. 11, No . 3 (May-June 1989), pp. 99-105

Guidelines (1988) for training in clinicallaboratory management

International Federation of Clinical Chemistry (IFCC) , Education Division

International Union of Pure and Applied Chemistry (IUPAC), ClinicalChemistry Division, Commission on Teaching of Clinical Chemistry

Prepared fo r publication for the Education Divisionby:N. de Cediel15-47 Calle 49, Bogota,ColombiaC. G. Fra se rNinewells Hospital an d Medical School,Dundee, UK

A. DeomHbpital Cantonal Universitaire, Geneva,SwitzerlandL. JosefssonUniversityof Copenhagen,Copenhagen,DenmarkH. G. J. WorthKings Mill Hospital, Sutton-in-Ashdd, UKO. ZinderRambam Medical Center, Haifa, Israel

Education Division members: O. Zinder (Israel), Chairman;H. G.J. Worth (UK), Secretary;N. de Cediel (Colombia);A.Deom (Switzerland); C. G. Fraser (UK); L. Josefsson(Denmark),representative of the International Union of Bio-chemistry.Membership of the Teaching Commission during the period(1985-88)in which these Guidelines were prepared: O. Zinder(Israel), Chairman; H. G.J. Worth (UK), Secretary; Titularmember, C. G. Fraser (UK); Associate members: M. A.Drodsdowsky (France);P. Garcia Webb (Austria); N. Montal-betti (Italy); C.J. Porter (Canada);B. Straus (Yugoslavia);V. N. Titov (USSR); R. Vihko (Finland); W. H. C. Walker(Canada);National Representatives:M. M. Abdel Kader(Egypt); J. Agneray(France); K. Bergstrom(Sweden);B.Christophersen(Norway); A. F. Delbruck (Denmark);H. A.Fritsche,Jr (USA); A. Gornall (Canada);A. G. Hadjivassiliou(Greece);T. Kanno (Japan); M. Uemeth Csoka (Hungary);P.Strom (Italy).

Trainees in laboratorymedicine must developskills in laboratorymanagement. Guidelines are detailed for laboratory staff intraining, directors responsiblefor staff developmentan d profes-sional bodies wishing to generate material appropriate to theirneeds. The syllabus delineates the knowledge base requiredandincludes laboratoryplanning an d organization, control of opera-tions, methodologyan d instrumentation,data management an dstatistics, financialmanagement,clinical use of tests, communica-tion, personnel management an d training an d research an ddevelopment.Methods for achievement of the skills requiredaresuggested. A bibliographyof IFCC publications and othermaterial is provided to assist in training in laboratorymanagement.

Th e exclusiveCopyrightfor all languagesan d countries is vestedin theInternational Federation of Clinical Chemistry.

1. Introduction

The scope of the disciplines that comprise laboratorymedicine ha s expanded significantly in the last threedecades. The range of quantities assayed and the varietyand complexity of analytical techniques used havesubstantially increased. The turnaround time from thesubmission of a specimen to the receipt of a result ha sdecreased and the performance characteristics of analyt-ical procedures have continuously improved.

Simultaneously with these changes, the clinical use ofresults ha s also altered. Most results from patients inhospitals ar e used for management rather than as aids to

diagnosis. Frequently, laboratory tests ar e performedprior to the actual clinical examination. In certaincountries, the monitoring of apparently healthy individu-al s makes use of laboratory test results in preventativemedicine. Hospital practices also have changed with

significant ramificationsfor

laboratoryservices; fo r ex -

ample, more severely ill patients ar e being treated inspecialist units such as intensive care, neonatal, coronarycare and oncology units. The changing spectrum ofdisease, fo r example the growing number of patients withacquired immunodeficiency syndrome, also imposes ne wdemands on laboratory services.

Hence laboratory medicine is not a static discipline andundoubtedly changes will continue to occur, probablyever more rapidly as time progresses. For this reason andbecause, with the current worldwide concern about thecosts of health care, modifications and improvements inlaboratory services will probably need to be introduced

without significant new expenditure on staff or equip-ment, it is beholden upon trainees in laboratory medicineto develop adequate skills in laboratorymanagement. Thisdocument is intended to serve as guidelines fo r training inthis important area. It is suggested that the guidelineswill be of value to laboratory staff learning managementskills, directors of laboratories responsible for trainingstaff in management and professionalbodies wishing togenerate guidelines appropriate to their national needs.

2. Scope

Although a considerable amount of knowledge aboutlaboratory management is gained by experience, it isvital, particularly for those likely to become directors of

990142-0453/89 $3.00 () 1989 Taylor & Francis Ltd.


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N. de Cediel et al. IFCC and IUPAC guidelines fo r training in clinical laboratory management

laboratories, to learn both theory and application in anordered and systematic manner. The qualificationsregarded as necessary prerequisites for appointment as alaboratory director differ from country to country but,irrespective of this, the syllabus detailed here is designedto fulfil the needs of both medical and science graduates.

Before commencing in-depth training in laboratorymanagement, an adequate basic training must have beengained; ideally, for clinical chemists, the material detailedin the previous recommendations of the Committee/Commission on a scheme for a 2-year postgraduatecourse in clinical chemistry should have been assimilated.It is particularly important th at t he science graduate isfamiliar with the clinical and interpretative aspects andthat medical graduates have sufficient understanding oflaboratory techniques before undergoing the trainingdetailed in these guidelines.

3.1.4. Strategies fo r organization of the laboratory;benefits and disadvantages of discretionary andprofiling approaches, problems associated withbiochemical screening, analytical equipment oper-ated by non-laboratory personnel outside thelaboratory (including local regulations, medical

requirements, equipment and range of analysesavailable, training of analysts and quality assur-

ance).

3.1.5. Organization ofworkflow, including the collectionand transportation of specimens; identification ofspecimens and samples using colour codes, uniquenumbers, ba r codes and other methods, distribu-tion of specimens throughout the laboratory, worksimplification techniques, referral of specimens toother laboratories.

3. Syllabus

The subject material to be included in the trainingprogramme is organized under the following headings:

3. 1 Laboratory planning and organization.

3.2 Control of operations.

3.3 Methodology and instrumentation.

3.4 Data management and statistics.

3.5 Financial management.

3.6 Clinical use of tests.

3.7 Communication.

3.8 Personnel management and training.

3.9 Research and development.

3.1. Laboratory planning an d organization

It is essential tha t the ind iv idua l responsible for labora-tory management be able to plan and organize laboratoryservices and, as a necessary prerequisite, training shouldencompass the following:

3.1.1. Structure of health services in the country of thetrainee, current national policy, priorities andresources.

3.1.2. Classification of laboratories (for example, pri-mary, intermediate and specialist), interactionsbetween types of laboratory, functions of thelaboratory in diagnosis, management, screening,education and research and development.

3.1.3. Definition of workload and influencing factors, forexample, local spectrum of diseases, expertise ofclinical staff, availability of laboratory staff andequipment, type of population served--paediatric,adult, aged, chronic sick, acutely diseased, etc.,assessment of workload using performance indica-

tors, for example, unit values, number of requestsand test per request ratio.

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3.1.6. Laboratory design; space requirements, optimumutilization of space, requirements for services suchas electricity, gas and water, design requirementsfo r handling radioisotopes, high-risk specimensand disposal of waste materials.

3.1.7. Organization of emergency services; advantagesand disadvantages of dedicated laboratories,equipment and methods, turnaround timesrequired for emergency tests, selection of theappropriate repertoire, strategies to monitor useand abuse of the emergency laboratory, setting of ahierarchy of priorities fo r test requests.

3.2. Control ofoperationsAll aspects of laboratory work should be monitored withthe aim of always achieving the highest possible quality ofperformance. This implies that a quality assurance pro-gramme must be established, including internal qualitycontrol, participation in external quality assessment anda series of monitoring schemes specifically designed forother aspects of laboratory work, including the materialsused, specimens submitted, staff morale and skills,reporting systems and turnaround times.

Training in laboratory management should thereforeinc lude the following:

3.2.1. Establishment of comprehensive internal qualitycontrol programmes, participation in qualityassessment schemes, the availability of suchschemes, analysis of the data generated in theassessment of imprecision, inaccuracy, linearityand other performance characteristics, the use ofsuch d at a in method and instrument selection.

3.2.2. Quality control of specimens submit ted and strate-gies to deal w it h inadequate specimens, qualitycontrol of materials and reagents, quality controlof instrumentation including balances, water


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N. de Cediel et al. IFCC and IUPAC guidelines for training in clinical laboratory management

baths, incubators, refrigerators, spectrometers,automated analysers, isotope counters, pipettes,diluters, dispensers, etc., quality control of datahandling and calculation facilities, monitoring ofthe performance of individual members of staff,quality control of reporting systems and tu rn-around times.

3.2.3. Preparation and use of laboratory proceduremanuals as both educational material and a meansof ensuring that all methodology is maintained at aconstant high standard.

3.2.4. Setting of desirable standards of analytical perfor-mance, strategies for the improvement of labora-tory performance with existing staff, methods,instruments and resources.

3.3. Methodology an d instrumentation

Correct selection and use of methodology and instrumen-tation are of vital importance if the laboratory is to play a

full role in the provision of optimal health care; adequatetraining therefore must be provided in the following:

3.3.1. Preparation of ideal specifications for methods,instrumentation and reagent kit sets in order tofacilitate selection, assessment and evaluation ofmethods, instruments and reagent ki t sets, intro-duction of new methods into regular use in thelaboratory.

3.3.2. Purchase of equipment, preparation of documen-tation required for funding and purchase, negotia-tion of warranty and service agreements.

3.3.3. Maintenance of equipment, preparation of equip-ment usage and maintenance logs.

3.4. Data management an d statistics

The optimal use of laboratory data is not alwaysachieved; a knowledge of appropriate techniques for datahandling and interpretation is essential for the laboratorymanager. Moreover, the ever increasing use of computersrequires knowlege of their applications and limitations. Aworking knowledge of statistical techniques and theircorrect application is also required.

Trainingtherefore should inc lude the

following:

3.4.1. Units, use of numerical data in management, thefundamentals of computers, mainframe, mini- andmicrocomputers, networks, applications of com-puters, on-line acquisition of data from instru-ments, preparation of work lists, patient databasesand reports, use of computers in quality controland assessment, expert systems, system design,availability of commercial and other laboratorycomputer systems, data storage, retrieval andconfidentiality.

3.4.2. Laboratory calculations, curve-fitting routines,data handling for radioimmunoassay and otherligand assays.

3.4.3. Statistics including common parametric and non-parametric techniques; mode, median and mean,range, standard deviation, variance, linear regres-sion, correlation, and probability, Demingsmethod, t-tests, F-test, Wilcoxon test, simpleanalysis of variance.

3.5. Financial management

In addition to gaining a basic understanding of budget-ting systems, especially those adopted locally, an aware-ness of the following must be gained:

3.5.1. Costing of laboratory tests, division of expenditureinto fixed (staff, instrumentation, etc.) and vari-able (consumables, reagents, etc.) costs, patientbilling and/or clinical (management) budgetting(if appropriate), virement, methods of obtainingadditional resources.

3.5.2. Costs of consumables, advantages and disadvan-tages of bulk purchase and standing orders, costs

of service contracts, amortization of equipmentcosts and advantages and disadvantages of hireagreements.

3.5.3. Budgetary planning for future activities, presenta-tion of budgets, projected expenditure on methoddevelopment, instrument purchase, expansionand/or reorganization of services.

3.6. Clinical use of testsIt is of vital importance that senior laboratory staff areable to advise the clinician not only on the selection of themost appropriate tests and the interpretation of results,bu t also on the nosological characteristics of the tests.Moreover, the ability to discuss the introduction of newtests and the phasing out of obsolete tests with cliniciansmust be gained, as must the knowledge to be able todevelop efficient and effective strategies for the use of thelaboratory. Training should therefore cover the followingtopics:

3.6.1. The theory of reference values, selection of refer-ence individuals, statistical approaches to genera-tion of reference values, the endogenous, exoge-nous, ethnic, genetic and laboratory factors thataffect reference values and strategies for objectivecomparison of observed values with referencevalues, biological variability and the uses ofbiological variation data.

3.6.2. The uses of knowledge of the nosological sensitiv-ity and specificity and predictive value of tests,receiver-operating characteristic curves and likeli-hood ratios, objective analysis.of clinical literatureon laboratory test use.

3.6.3. Strategies to modify the requesting behaviour ofclinicians (including rationing, education, budgetincentives and development of protocols for inves-

tigation), introduction of new tests and eliminationof obsolete tests.

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3.6.4. Education of medical studies, training of juniorclinical staff, establishment ofjoint clinical/labora-tory educational activities, preparation of labora-tory case reports.

3.7 Communication

Inter-personal communication is vital and trainingshould not

only encompass communication with clinicalstaff on an individual level concerning the matters dealtwith in Section 3.6 bu t also be on a broader basis, toinclude:

3.7.1. Communication between staff within the labora-tory.

3.7.2. Communication with laboratory users throughlaboratory bulletins, request forms, reports andlaboratory handbooks.

3.7.3. The advantages and limitations of the variousstyles of request forms, styles of single or cumula-tive reports and laboratory data filing systems.

3.7.4. Communication with administrative and labora-tory staff, preparation of reports and memoranda,committee structures and procedures, roles ofChairman, Secretary and other members, taking ofminutes and preparations of agenda.

3.8. Personnel management and training

The individual responsiblefor laboratory managementmust be adequately trained in dealing wih the mostimportant laboratory resource--the laboratory staff--and therefore

trainingshould

encompass the following:

3.8.1. Laboratory staff structures, staff selection pro-cedures, preparation of job descriptions, setting ofresponsibilities and chains of command, promo-tional procedures, disciplinary and grievanceprocedures, legal conditions of service, require-ments for licensure and certification.

3.8.2. Evaluation of individual members of taff, assign-ment of functions and responsibilities.

3.8.3. Training and education of staff according to theirlevel, assessment of capabilities, career needs andaspirations, development of in-house training pro-grammes and the evaluation of these, liaison withexternal educational institutions and professionalbodies.

3.8.4. Laboratory safety including fire precautions,handling of potentially hazardous specimens andchemicals, disposal of wastes, accident reporting,awareness of local and national requirements oflegislation.

3.9. Research an d development

Although most individuals wh o are in the final stages oftraining for a career in laboratory management will have

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performed some research and development work, it isessential that adequate skills be gained in the following:

3.9.1. The ability to develop improvements in methodsand techniques, to evaluate proposals for bothlaboratory-based and clinical research projectsand to evaluate published work critically.

3.9.2. Analysis and documentation of results obtainedthrough research and development, presentationof results in lectures, seminars and workshops, oraland poster presentations at conferences, con-gresses and meetings and the preparation ofscientific papers.

3.9.3. Preparation of requests for grant funding, develop-ment of proposals for joint research projects, role ofcommittees on ethnics of research.

3.9.4. Supervision of junior staff and students in theday-to-day performance of research and develop-

ment projects.

4. Achievement of skills

As stated earlier, a considerable amount of knowledge onlaboratory management will be accumulated throughexperience; however, it is advisable, if possible, fortrainees to attend local or national courses that deal withthe more general issues of management, for example,personnel and finance.

These courses often have participants from a number ofdisciplines which enhances their value.

Visits to other laboratories should be undertaken and aspectrum of types and sizes should be studied during thetraining period in order to assess both the common anddifferent management problems and view the differentapproaches to solving problems. Indeed, attainment ofthe skills required may necessitate the trainee beingformally employed in different laboratories or beingseconded for appropriate lengths of time to laboratories ofdifferent types.

Ideally, much of the training in laboratory managementshould be performed in a large tertiary care teachinghospital laboratory where a large repertoire of tests ar e

performedon a wide

varietyof

specimensfrom

patientswith a broad range of clinical conditions. This willfacilitate review and tutorial sessions with a number ofsenior members of staff with different qualifications,backgrounds, interests and experience. Moreover, in suchlaboratories, there is likely to be a cohort of individuals intraining which facilitates learning by , fo r example, thesetting up of discussion groups, interactive solution ofproblem-solving exercises and simple peer pressure. Inaddition, it is easier in these situations gradually to givethe trainee increasing responsibilities and managementfunctions.

It is considered unlikely that a full-time didactic course in

laboratory management will be a satisfactory educationalvehicle. A part-time course of, for example, one evening


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or da y pe r week over year would have advantages; thenumber of participants should be limited to ensureeducat ional effectiveness.

An important component of the advocated training inlaboratory management is the performance of relevantproject work. Circumscribed projects, for example, on theselection of a new instrument, preparation of a budget fo ra section of the laboratory, assessment of a new clinicaltest in collaboration with a clinician, would provideuseful exercises during training. A summary project, ofpotential benefit to the laboratory of the trainee, could bea study reviewing the management of the laboratory inwhich the trainee is employed.

It is most important for the head of the laboratory toensure the availability of adequate resources for trainingin laboratory management, to encourage the develop-ment of managerial skills and to involve the trainee (evenas an observer)in the real decision-making processes ofthe laboratory.

Laboratory medicine is continuously and rapidly evol-ving, and therefore the syllabus detailed in these guide-lines should not be regarded as inflexible, bu t should bemodified as changes in practice occur. Moreover, indifferent countries, there are diverse approaches tolaboratory management of laboratories and these guide-lines should be modified locally as deemed necessary;professional bodies ar e considered to be ideal groups toperform such changes.

5. Bibliography

There are no texts which satisfactorily cover al l of thematerial outlined in the syllabus. The list of books, papersand other sources given below is aimed (i) to facilitatecurriculum design, development and implementation bythose responsible for training individuals in managementand (ii) to aid individuals wh o are undertaking training inlaboratory management. The bibliography is divided intotw o sections: (i) recommendations and other publicationsemanating from the IFCC and (ii) other material judgedto be of value and relevance. The content is mainlyconcerned with clinical chemistry.

Much valuable information on many of the topicsdetailed in this syllabus can be found in the manyexcellent and

widelyused text books, such as Tietz, N.W.

(Ed.), Fundamentals of Clinical Chemistry,3r d edn (Saun-ders, Philadelphia, 1985); this and other similar textsshould be familiar to those embarking upon in-depthtraining in laboratory management and are therefore notincluded in the bibliography.

5.1. IFCC Publications

5. l. l Quality control

1. BUTTNER, J. , BORTH, R., BOUTwELL,J. H. , BROUGHTON,P. M. G. and BOWYERR. C., Approved recommendations(1978) on quality control in clinical chemistry. Part 1.General principles and terminology, Journal of ClinicalChemistry an d Clinical Biochemistry,18 (1980),69-77; ClinicaChimica Acta, 98 (1979), 129F-143F.

2. BUTTNER,J. , BORTH, R., BOUTWELL,J. H. , BROUGHTON,P. M. G. and BOWYER,R. C., Approved recommendations(1979) on quality control in clinical chemistry. Part 3.Galibration and control materials, Journal of ClinicalChemistryand Clinical Biochemistry, 18 (1980), 855-860;Clinica Chimica Acta, 10 9 (1981), 105F-114F.

3. BUTTNER,J. , BORTH, R., BOUTWELL,J. H. , BROUGHTON,P. M. G. and BOWYER,R. C., Approved recommendations(1983) on quality control in clinical chemistry. Part 4.Internal quality control, Journal of Clinical Chemistry an dClinical Biochemistry,21 (1983), 877-884.

4. BUTTNER,J. , BORTH, R., BOUTWELL,J. H. , BROUGHTON,P. M. G. and BOWYER,R. C. Approved recommendations(1983) on quality control in clinical chemistry. Part 5.External quality control, Journalof Clinical Chemistryan dClinical Biochemistry,21 (1983),885-892.

5. BUTTNER,J. , BORTH, R., BOUTWELL,J. H. , BROUGHTON,P. M. G. , and BOWYER,R. C. Approved recommendations(1979) on quality control in clinical chemistry. Part 6.Quality requirements from the point of view of health care,Journal of Clinical Chemistryan d Clinical Biochemistry,18(1980) 861-866; Clinica Chimica Acta, 109 (1981), l15F-124F.

6. FRASER, C. G. , GEARY, T. D. and WORTH, H. G.J. ,Guidelines (1986) for the preparation of laboratory pro-

cedure manuals, Journal ofClinical Chemistryan d ClinicalBiochemistry,26 (1988),415-419.

5.1.2. Methodolog an d instrumentation

7. BUTTNER,J. , BORTH, R., BOUTWELL,J. H. , BROUGHTON,P. M. G. and BOWYER,R. C., Approved recommendations(1978) on quality control in clinical chemistry. Part 2.Assessment of analytical methods for routine use, JournalofClinical Chemistryan d Clinical Biochemistry,18 (1980),78-88;Clinica Chimica Acta 98, (1979), 145F-162F.

8. LOOAN,J. E., Revised recommendations (1983)on evalua-tion of diagnostic kits. Part 1. Recommendations forspecifications on labelling of clinical laboratory materials,Journal of Clinical Chemistry an d Clinical Biochemistry,21(1983), 893-898; Clinica Chimica Acta, 137, (1984), 371F-379F; Clinical Chemistry Newsletter,5 (1985),81-86.

9. LOC,AN, J. E., revised recommendations (1983)on evalua-tion of diagnostic kits. Part 2. Guidelines for the evaluationof clinical chemistry kits. Journalof Clinical Chemistry an dClinical Biochemistry,21 (1983), 899-902; Clinica ChimicaActa, 137, (1984)381F-386F; Clinical Chemistry Newsletter 5(1985),87-90.

10 . I,OGAN, J. E., BAYSE, D. D. , KOEDAM,J. C., MATHER,A.and WLDNO, P., IFCC/WHO principles and recommen-dations on evaluation of diagnostic reagent sets used inhealth laboratories with limited resources. Part 3. Selectionand evaluation using reference materials. General consider-ations,

JournalofClinical Chemistry an d Clinical Biochemistry,

22 (1984),573-582.11 . OKUDA,K. , Provisional guidelines (1981)for listing specifi-

cations of clinical chemistry analysers, Journalof ClinicalChemistry an d Clinical Biochemistry,18 (1980), 947-951;Clinica Chimica Acta, .119 (1982), 351F-362F; ClinicalBiochemistry,13 (1980),244-248.

12. DONOI-IOF,G. A. , GEARY, T. D. and JENNINOS, R. D.Bibliography on evaluation of instrumenta t ion in clinical

chemistry. Journalof Clinical Chemistry an d Clinical Biochem-istry, 20 (1982),931-945; Clinica Chimica Acta, 127 (1983),425F-439F, Clinical Chemistry Newsletter,3 (1983), 3-13.

5.1.3 Units

13 . DYBKAER,R., Approved recommendations (1978).Quanti-ties and units in clinical chemistry. Journal of ClinicalChemistry an d Clinical Biochemistry, 17 (1979), 807-821;

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Clinics Chimica Acts,96 (1979), 155F-183F; Pure andAppliedChemistry,51, (1979), 2451-2479.

14 . DYBKAER,R., Approved recommendations (1978). List ofquantities in clinical chemistry. Journalof Clinical Chemistryan d Clinical Biochemistry,17 (1979),822-835; Clinics ChimicaActs, 96 (1979), 185F-204F; Pure and Applied Chemistry,51(1979), 2481-2509.

15 . LEHMANN,P., WORTH, H. and ZINDER, O. , Clinicalchemists convert to the mole, ChemistryInternational, 10(1988), 52-57.

5.1.4 Referencevalues

16. SOLBERG,H. E., Approved recommendations (1986)on thetheory of reference values. Part 1. The concept of referencevalues, Journalof Clinical Chemistry and Clinical Biochemistry,25 (1987), 337-342; Clinics Chimica Acts, 16 5 (1987),111-118; Annals ofBiologicalChemistry,45 (I987), 237-241.

17. PETTCLERC,C. and SOLBERO,H. E., Approved recommen-dations (1987) on the theory of reference values. Part 2.Selection of individuals for the production of referencevalues. Journalof Clinical Chemistry an d Clinical Biochemistry,25 (1987), 639-644; Clinics Chimica Acts, 170, (1987),S1-S12.

18.SOLBERG,

H.E.

andPETITCLERC,C., Approved

recommen-dations (1988) on the theory of reference values. Part 3.Preparation of individuals and collection of specimens forthe production of reference values. Journal of ClinicalChemistry an d Clinical Biochemistry,26 (1988),593-598.

19 . SOLBER, H. E., Approved recommendations (1987)on thetheory of reference values. Part 5. Statistical treatment ofcollected reference values. Determination of referencelimits. JournalofClinical Chemistry and Clinical Biochemistry,25(1987),645-656; Clinics Chimica Acts, 17 0 (1987),S13-$32.

20 . DYmAER,R. and SOLBERO,H. E., Approved recommenda-tions on the theory of reference values. Part 6. Presentationof observed values related to reference values. JournalofClinical Chemistry and Clinical Biochemistry,25 (1987), 657-662; Clinics Chimica Acts, 170, (1987)$33-$42.

5.1.5. Communication

21 . FRASER, C. G., DECEDIEL, N., PORTER, C. J. , SCHWARTZ,M. K., WORTH, H. G.J. and ZINDER, O. , Guidelines (1985)for clinical chemists for effective communication of clinicalchemistry laboratory data, Journalof Clinical Chemistry andClinical Biochemistry,23 (1985), 891-897.

5.1.6 Training

22. PORTER,C.J. and CtJRNOW, D. H. , A scheme for a two yearpostgraduate course in clinical chemistry. Journalof ClinicalChemistry an d Clinical Biochemistry,21 (1983), 185-191;Clinics Chimica Acts, 13 1 (1983), 351F-359F; Pure an dApplied Chemistry,55 (1983),557-564.

23 . WoRarI,H. G. J. , A basic education and training frame-work for medical laboratory technicians in clinical chem-istry, Journalof Clinical Chemistryan d Clinical Biochemistry,22(1984), 497-501; Clinics Chimica Acts, 14 1 (1984), 305F-311F; Clinical Chemistry Newsletter,5 (1985),97-101; Pure an dApplied Chemistry,56 (1984), 1505-1510.

24 . FRASER, C. G., ZINDER, O. , DECEDIEL, N., Porter, C. J. ,SCHWARTZ,M. K. and WORTH, H. G.J., Guidelines (1985)for teaching of clinical chemistry to medical students.Journal of Clinical Chemistry and Clinical Biochemistry,23(1985), 697-703; Clinical Chemistry Newsletter, 5 (1985),102-108.

25 . SCHWARTZ,M. K. , DECEDIEL, N., CURNOW,D. H. , FRASER,C. G., PORTER, C. J. , WORTH, H. G. J. and ZlNDER, O. ,Definition of the terms certification, licensure and accredi-tation in clinical chemistry, Journalof Clinical ChemistryandClinical Biochemistry,23 (1985), 899-901.

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26. PANNALL, P. R., DENNIS, P. M., FARRANCE, I. andGARCIA-WEBB,P., Guidelines for the training of medicalgraduates in clinical chemistry, Journalof Clinical Chemistryand Clinical Biochemistry,26 (1988),585-591.

5.1.7 Safety

27 . BONINI, P. A., Safety in clinical laboratories, IFCC News, 37(1984), 10-11.

5.2. Other sources

5.2.1 General planning and organization

28 . WHO, LaboratoryServices at Primary Health Care Level,Lab/79.1 (WHO, Geneva, 1979).

29 . WHO, Working Group on Assessment of Clinical Technol-ogies, (i) Identificationof Essential Clinical Chemical an dHaematological Tests in Intermediate Hospital Laboratories,Lab/86.2; (ii) Methods Recommendedfor Essential Clinical Chemicaland Haematological Testsfor Intermediate Hospital Laboratories,Lab/86.3 (WHO, Geneva, 1986).

30. BENSON,E. S. and RUBIN, M. (Eds), Logic and Economics ofClinical LaboratoryUse (Elsevier, New York, 1978).

31. NOE, D. A., Th e Logic of LaboratoryMedicine, (Urban andSchwartzenburg, Baltimore, 1985).

32 . LUNDBERG,G. D. (Ed.), Using the Clinical LaboratoryinMedical Decision-Making (ASCP, Chicago, 1983).

33. SPEICHER, C. E., and SMITH, J. W., Choosing EffectiveLaboratoryTests Saunders, Philadelphia, 1983).

34. FRASER, C. G. , Interpretation of Clinical Chemistry LaboratoryData (Blackwell,Oxford, 1983).

35. BERMES,E. W. (Ed.), Th e Clinical Laboratoryin the New Era:Quality, Cost and Diagnostic Demands (AACC, Washington,1985).

36. MARIUS, V. and ALBERTI, K. G. M. M. (Eds), ClinicalChemistry Nearer the Patient (Churchill Livingstone, Edin-burgh, 1985).

37. Canadian Schedule of Unit Values for Clinical LaboratoryProcedures (Statistics Canada, Ottawa, 1977).

38. SLOCKBOWER,J. M. and BLUMENFELD,T. A., (Eds),Collection and Handling of LaboratorySpecimens: a PracticalGuide, (Lippincott, Philadelphia, 1983).

39. BARNETT,R. N., MCIvER, D. D. and GORTON,W., Themedical usefulness of stat tests, American Journalof ClinicalPathology,69 (1978),520-524.

5.2.2 Control of operations40. WHITEHEAD,T. P., Quality Control in Clinical Chemistry,

(Wiley, Chichester, 1977).41. BRtCE, A. W., Basic QualityAssurancean d QualityControl in the

Clinical Laboratory,(Little, Brown and Co., Boston,1984).42 . FRASER,C.

G.,Desirable

performance standards for clinicalchemistry tests, Advances in Clinical Chemistry,23 (1983),299-339.

43. JEFFCOATE, S. L., Efficiencyand Effectivenessin the EndocrineLaboratory,(Academic Press, London, 1981).

5.2.3. Methodology and instrumentation

44. LLOYD, P. H. , A scheme for the evaluation of diagnostickits, Annals of Clinical Biochemistry,15 (1978), 136-145.

45. BROUGHTON,P. M. G. , GOWELOCK,A. H. , McCormack,J.j. and NEILL, D. W., A revised scheme for the evaluationof automatic instruments fo r use in clinical chemistry,Annals of Clinical Biochemistry,11 (1974),207-218.

46. WHITE, G. H. and FRASER, C. G. , The evaluation kit forclinical chemistry: a practical guide for the evaluation ofmethods, instrumentation and reagent kits, Journal ofAutomatic Chemistry,6 (1984), 122-144.


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