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55 St. Clair Avenue WestSuite 806 Box 18Toronto, Ontario, Canada M4V 2Y7Toll-Free: 1-888-377-7746Telephone: 416-326-1550Fax: 416-326-1549Web: www.hprac.orgInterprofessional CollaborationScope of Practice Review:Medical Laboratory TechnologySummary & Selected Highlights from the LiteratureOctober 2008

BackgroundIn June 2007, the Minister of Health and Long-Term Care requested the Health ProfessionsRegulatory Advisory Council (HPRAC) to:Recommend mechanisms to facilitate and support interprofessional collaboration betweenhealth Colleges, beginning with the development of standards of practice and professionalpractice guidelines where regulated professions share the same or similar controlled acts,acknowledging that individual health Colleges independently govern their professions andestablish the competencies for their profession. 1In the course of preparing an interim report to the Minister, in conjunction with its review of thescope of practice of nurse practitioners, HPRAC and the Ministry determined that it was necessary toinclude scope of practice reviews of six professions – dietetics, midwifery, pharmacy, physiotherapy,medical laboratory technology and medical radiation technology. Advice on the first four of theseprofessions is complete and has been delivered to the Minister.These reviews are being undertaken in the context of a broader review requested by the Minister ofHealth and Long-Term Care to explore opportunities to advance interprofessional collaborationamong regulatory health Colleges. It includes a review of scopes of practice for a number of healthprofessions that are most directly involved in interprofessional care to ensure that there are nolegislative, regulatory, structural or process barriers to members of the professions working to themaximum of their scope of practice or to working in interprofessional settings or collaborative teams.In Ontario, the legislative framework that defines health professions’ scope of practice includes theRegulated Health Professions Act, 1991 (RHPA) and a series of profession-specific Acts. The RHPAcontains provisions with respect to the duties and powers of the Minister, the role of HPRAC, a list ofcontrolled acts and other statutory requirements. It also includes a procedural code governing theoperation of regulatory colleges.Each profession-specific Act includes a scope of practice statement. The scope of practice statementin the Medical Laboratory Technology Act, 1991 states that:The practice of medical laboratory technology is the performance oflaboratory investigations on the human body or on specimens taken from thehuman body and the evaluation of the technical sufficiency of theinvestigations and their results. 2The scope of practice statement found in each health profession act provides a generic frame ofreference (or parameters) for the practice of each regulated health profession. A regulated healthprofessional may perform his or her profession’s authorized acts only in the course of practisingwithin the profession’s scope of practice. However, this statutory scope of practice statement is onlyone element of a profession’s scope of practice. Each profession-specific Act also indicates anycontrolled acts the profession is authorized to perform, the title or titles restricted to members of theprofession and other provisions.1 Letter from the Minister of Health and Long-Term Care to HPRAC. June 2007.http://www.hprac.org/en/reports/resources/HPRACletterJune28_2007.pdf2 Medical Radiation Technology Act, 1991. http://www.elaws.gov.on.ca/html/statutes/english/elaws_statutes_91m28_e.htm2

Accordingly, as part of its review of professional scope of practice HPRAC 3 :• analyzes the scope of practice statement and the controlled acts authorized to the profession;• considers the implications of the harm clause contained in the RHPA (which prohibitseveryone except health professionals acting within their scope of practice from treating orgiving advice with respect to health where serious physical harm may result); 4• considers regulations developed under the profession-specific Act and other legislation thatmay affect the profession; and• reviews the standards of practice, guidelines, policies and by-laws developed by theregulatory college.Collectively, these elements determine the profession’s scope of practice and therefore have beenconsidered by HPRAC in its review of the scope of practice for medical laboratory technology.The profession of medical laboratory technology was invited to submit recommendations articulatingproposed changes required to their scope of practice to enhance interprofessional collaboration andassist members in working to the maximum of their scope of practice. The College of MedicalLaboratory Technologists of Ontario (CMLTO), in collaboration with the Ontario Society of MedicalTechnologists (OSMT) and the Canadian Society for Medical Laboratory Science (CSMLS),submitted its response to HPRAC’s Applicant Questionnaire respecting the scope of practice reviewfor medical radiation technology in June 2008. The submission is available on HPRAC’s website. 5In addition to requesting access to additional controlled acts, the College of Medical LaboratoryTechnologists of Ontario, the Ontario Society of Medical Technologists and the Canadian Society forMedical Laboratory Science have proposed amending the profession’s scope of practice statement asfollows:“the design, performance, evaluation, reporting, interpreting andclinical correlation of clinical laboratory testing in the management ofall aspects of these activities.” 6HPRAC has established 10 criteria that it considers in reviewing a profession’s scope of practice. 73 See criteria. Review of a Professional Scope of Practice under the Regulated Health Professions Act. Health ProfessionsRegulatory Advisory Council. May 2007. http://www.hprac.org/en/reports/resources/Scope_of_Practice_June_12_2007.pdf4 s.30 Effective June 4, 2009, or on an earlier day to be established by proclamation, this section will be amended by strikingout “physical” and substituting “bodily”. See Health System Improvements Act, 2007, S.O. 2007, c.10, Sched.M, ss.6 and 75(1).5 http://hprac.org/en/projects/Medical_Laboratory_Technology_Scope_of_Practice.asp6 CMLTO, OSMT and CSMLS. Submission to HPRAC Regarding: Medical Laboratory Technologists’ Scope of Practice.Submitted to HPRAC June 30, 2008. p.11.http://hprac.org/en/projects/resources/CollegeofMedicalRadiationTechnologistsofOntarioSubmission.pdf7 See Review of a Professional Scope of Practice under the Regulated Health Professions Act.http://www.hprac.org/en/reports/resources/Scope_of_Practice_June_12_2007.pdf3

Purpose, Approach & Format of the PaperThis paper summarizes some of the recent literature on Medical Laboratory Technology (MLT)practice as it relates to the changes being proposed. It is not intended to represent an exhaustivereview of the literature; rather, it focuses on identifying key documents that may help to informdiscussions about and considerations of the scope of practice review for Medical LaboratoryTechnology in Ontario.The literature reviewed in this paper should be examined in conjunction with documents highlightedin a previous literature review 8 completed by HPRAC in January 2008. That review looked atinterprofessional collaboration with respect to the legislative, regulatory, policy andstructural/organizational issues that can facilitate and support health regulatory colleges and theirmembers in advancing collaborative practice.The literature included in the medical laboratory technology review comes from diverse sources. Initialreference documents were included in the submission to HPRAC by The College of Medical LaboratoryTechnologists of Ontario (June 30, 2008). 9 Additional literature sources were identified through aliterature search focused on the following terms:• “scope of practice medical laboratory technology”• “scope of practice medical laboratory technologists”• “medical laboratory technology and scope of practice”• “enhanced scope of practice for medical laboratory technologists”• “medical laboratory technologists Ontario”• “medical laboratory technolog* and interprofessional”• “medical laboratory technolog* and collaboration”• “medical laboratory technolog* and advanced”• “laboratory and error” - “pre-analytical error” – “pre-analytical phase”.Regulatory-related articles using PubMed Search were also reviewed. In addition, supplementarysearches were undertaken to identify specific reports from government websites, health care associations,and health policy think tanks in an attempt to locate studies related to regulation and medical laboratorytechnology scope of practice as identified in some of the literature reviewed. Some of these searcheswere successful, others were not.The literature reviewed on the issue has been organized as follows:• Section 1 provides a high level analysis summarizing some of the key findings arising from theliterature.• Section 2 summarizes the documents reviewed organized under the following three themes:scope of practice; health system needs/improvement; and health outcomes/patient safety/ risk ofharm.8 See www.hprac.org for the full copy of the literature review: HPRAC. Interprofessional Regulatory Collaboration – Asummary of key reference documents and selected highlights from the literature. January 2008.9 CMLTO, OSMT and CSMLS. Submission to HPRAC Regarding: Medical Laboratory Technologists’ Scope of Practice.Submitted to HPRAC June 30, 2008.4

Section 1: Key Findings Arising From the LiteratureThere is a shortage of literature related specifically to issues concerning MLT scope of practice.Included in the literature, however, is research on a number of issues related to the field of laboratorytechnology that can help inform discussions about scope of practice. These issues include: growth andother trends in laboratory testing; appropriateness/inappropriateness of testing; laboratorymistakes/errors; and guidelines and performance measures for error reduction.Given the importance of laboratory tests in providing essential information to make medicaldecisions, there is a significant body of research examining how laboratory testing mistakes occur,whether they cause patient harm, where they are most likely to occur in the testing process and howthey can be prevented.Data from recent studies suggest that the highest incidence of laboratory-related errors occurs in thepre-analytical phase of laboratory testing. However, few studies have examined the frequency oferrors in laboratory test selection and interpretation.The literature includes a number of recent studies that have been undertaken to examine the steadyincrease in laboratory utilization and the perception of inappropriate use/overuse within this system.Much of this research has focused on the growing numbers of diagnostic tests being ordered byprimary care physicians. Several of these studies have reported on the success of interventions aimedat improving physicians’ testing practices including the incidence of ‘unnecessary’ testing. Many ofthese interventions focus on behavioural factors such as peer interaction and social influence.There is a growing body of literature supporting the importance of good laboratory practice andcompliance with accreditation standards. This literature looks at the adoption of strategies for errorprevention, tracking and reduction, process redesign, the use of extra-analytical specifications andimproved communication among caregivers.Overview: Medical Laboratory Technologists• The laboratory is an integrated and complex system involving a wide variety of interactionsamong different parts and players of the health system. 10• Medical laboratory technology is strongly influenced by the developments of new technologyand new scientific testing discoveries. 11• Evidence-based culture underpins the practice of laboratory medicine. However, to date,evidence-based medicine appears to have had limited impact on laboratory medicine. A moreevidence-based approach is needed to inform education and training of health professionals,support clinical decision making, and support decisions related to resource allocation. 1210De Capitani, C. Automation of Pre-Analytical Phase: a Performance Evaluation and Alternative Scenarios. Journal of theAssociation for Laboratory Automation. Vol (2) : 89– 93. 2002.11Health Canada. An Environmental Scan of the Human Resource Issues Affecting Medical Laboratory Technologists andMedical Radiation Technologists. Section C: Findings on Medical Laboratory Technologists. Ottawa: Health Canada. 2002.12Price, C. Application of the Principles of Evidence-Based Medicine to Laboratory Medicine. Clinica Chemica Acta. Vol333. 147-154. 2003; Price, C. Evidence-Based Laboratory Medicine: Supporting Decision Making. Clinical Chemistry. Vol46:8. 1041-1050. 2000.5

Scope of Practice• The changing role and duties of MLTs are being impacted by: the availability of real-timelaboratory results, more effective tests, enhanced clinical consulting roles, involvement intherapeutic decisions, efforts to prevent rather than cure disease, shift from anecdotal care toevidence-based medicine, and the assessment of outcomes for laboratory tests. 13• The use of laboratory technicians for routine or automated testing is a current trend that isexpected to continue. This also reinforces the trend of educating and training multi-skilledlaboratory technologists who can respond effectively to changes in their role. 14Health System Changes/Trends• In recent decades, dramatic changes have occurred in the organization, number and type oftests, and role of medical laboratories in healthcare. These changes impact on the role oflaboratory professionals to require greater analytical accuracy, and more stringent test selectionand interpretation of results. 15• Trends in the practice of patient identification and specimen collection include: 16- Automated systems that integrate bar-coding of patient identification wristbands with properspecimen collection procedure;- Computerized physician order entry;- Standardization of specimen collection procedures within each healthcare organization;- Certification of phlebotomists;- Continued migration from glass to plastic blood tubes; and- Increased use of blood collection devices that have self-sheathing needles or no needles at allfor patients with indwelling catheters or lines.Patient Safety/ Risk of Harm (Laboratory Error)• The quality of results provided by the laboratory is dependent on the control of pre-analyticalfactors such as specimen collection, specimen handling/processing, and specimen integrity. 17• Improved communication between physicians and Laboratory Medicine regarding the preanalyticalphase and the implementation of educational programs for defining criteria andprocedures is needed. Improving the education of health care professionals is seen as a criticalcontributor for ultimately improving patient care and outcomes. 1813 Plebani, M. Charting the Course of Medical Laboratories in a Changing Environment. Clinica Chemica Acta. Vol 319.87-100. 2002.14 Health Canada. An Environmental Scan of the Human Resource Issues Affecting Medical Laboratory Technologists andMedical Radiation Technologists. Section C: Findings on Medical Laboratory Technologists. Ottawa: Health Canada. 2002.15 See, for example Plebani, M. Charting the Course of Medical Laboratories in a Changing Environment. Clinica ChemicaActa. Vol 319. 87-100. 2002.16 Astion, Michael. Future Trends in Patient Identification & Specimen Collection: Automation and Standardization.Laboratory Errors and Patient Safety. Vol 1: 2. 2004.17 Ajeneye, Francis. Pre-Analytical Quality Assurance: A Biomedical Perspective. The Biomedical Scientist. February 2007.18Pansini, N. et al. Total Testing Process: Appropriateness in Laboratory Medicine. Clinica Chemica Acta. Vol 333. 141-145. 2003.6

• Most laboratory errors occur in the pre- or post analytical phases, whereas a minority (13–32%) occur in the analytical portion. Most pre-analytical errors result from system flaws andinsufficient audit of the operators involved in specimen collection and handling responsibilities.Literature available on this issue, however, describes a significant heterogeneity in study designsand quality with respect to medical errors, little available data, and a lack of a shared definition oflaboratory error. 19• Evidence suggests that quality programs developed around the analytical phase of the totaltesting process would only produce limited improvements, since the large majority of errorsencountered in clinical laboratories still prevail within “extra-analytical” areas of testing. 20• Lack of standardized procedures for sample collection, including patient preparation, specimenacquisition, handling and storage, account for up to 93% of the errors currently encounteredwithin the entire diagnostic process. Standardization of specimen collection procedures reduceserrors by simplifying, optimizing and reducing the number of collection procedures followed in ahealthcare organization. There is evidence of personnel cost savings and service qualityimprovement with pre-analytical phase automation. 21• Four institutional factors were significantly associated with higher overall laboratory errorrates:- Orders verbally communicated to the laboratory;- No policy requiring laboratory staff to compare a printout or display of ordered tests with thelaboratory requisitions to confirm that orders had been entered correctly;- Failure to monitor the accuracy of outpatient order entry on a regular basis; and- A higher percentage of occupied beds (i.e., a busier hospital). 22• Most health care organizations use some combination of centralized specimen collectionservices which are usually under the laboratory’s control, and decentralized services providedby nurses, physicians’ assistants and medical assistants. Institutions that favour a morecentralized approach report that laboratory based control of the specimen collection processreduces errors significantly. Among the negative impacts of decentralization, labs repeatedlyidentify five factors that can directly impact errors and adverse events: 23- Reduced error tracking and reporting;- Less feedback to collection staff;- Difficult draws being performed by collectors who get less practice;- Collectors with less awareness of the impact of inadequate samples on laboratory testing;- Variations in collection procedures based on equipment, location, and personnel.19 Bonini, P. et al. Errors in Laboratory Medicine. Clinical Chemistry. Vol 48: 5. 691-698. 2002.20 Lippi, G. et al. Recommendations for Detection and Management of Unsuitable Samples in Clinical Laboratories. ClinicalChemistry Laboratory Medicine. Vol 45:6. 728-736. 2007.21 Lippi, G. et al. Pre-analytical Variability: the Dark Side of the Moon in Laboratory Testing. Clinical ChemistryLaboratory Medicine. Vol 44:4. 358-365. March 2006.22 Valenstein, P. and Meier, F. Outpatient Order Accuracy. A College of American Pathologists Q-Probes Study ofRequisition Order Entry Accuracy in 660 Institutions. Archives of Pathology and Laboratory Medicine. Vol 123. 1145-1150. 1999.23 Laboratory Errors and Patient Safety Editorial Staff. Decentralized Specimen Collection and Patient Safety. LaboratoryErrors and Patient Safety. Vol 1: 2. 2004.7

• Performance measures that have been identified to respond to error reduction strategiesinclude: customer satisfaction, test turnaround times, patient identification, specimenacceptability, proficiency testing, critical value reporting, blood product wastage, and bloodculture contamination. 24• The American Society for Clinical Pathology (ASCP) supports personnel standards forlaboratory professionals with a focus on patient safety and quality laboratory testing. Thesestandards include practice requirements, certification requirements, and/or licensure. Thepersonnel standards include the following elements: appropriate academic and clinical trainingfor laboratory professionals; passage of a competency examination offered by an approvednational certification organization; appropriate continuing competency standards; and recognitionof ASCP’s professional terminology. 25Future Priorities: Challenges & Opportunities• Future challenges for sustaining changes in the role and contribution of MLTs: 26- Guarantee the quality of laboratory tests irrespective of where they are performed;- Improve the quality of services;- Improve clinical outcomes;- Perform joint clinical/ laboratory research projects;- Awareness of the importance of the knowledge and skills required for the new role oflaboratory professionals.• Future research efforts to address gaps and shortcomings should focus on: 27- Development of guidelines to support guideline-driven decision support systems to reduce thenumber of laboratory tests ordered by primary care practitioners.- A more rigorous methodology for error detection and classification and the adoption ofproper technologies for error reduction.- Strategies to decrease computer order entry errors based on regular monitoring of theaccuracy of order entry, substituting written and facsimile orders for verbal orders, andinstituting a policy whereby orders entered into computer systems are routinely recheckedagainst orders on requisitions.24 Howantis, P. Errors in Laboratory Medicine: Practical Lessons to Improve Patient Safety. Archives of Pathology andLaboratory Medicine. Vol 129. 2005.25 American Society for Clinical Pathology. Personnel Standards for Laboratory Professionals. 2004.26 Plebani, M. Charting the Course of Medical Laboratories in a Changing Environment. Clinica Chemica Acta. Vol 319.87-100. 2002.27 Price, C. Evidence-Based Laboratory Medicine: Supporting Decision Making. Clinical Chemistry. Vol 46:8. 1041-1050.2000; Bonini, P. et al. Errors in Laboratory Medicine. Clinical Chemistry. Vol 48: 5. 691-698. 2002.8

Section 2: Summary of the LiteratureScope of PracticeAuthors, Title andPublicationAmerican Society forClinical Pathology.Personnel Standards forLaboratory Professionals.2004.American Society forClinical Pathology.Scope of Practice IssuesAffecting Pathology andLaboratory Medicine.2005.Grant, Moira. Guidingthe Growth ofProfessionalism inMedical LaboratoryScience: Eight Optionsfor Positive Change.Canadian Journal ofMedical LaboratoryScience. Vol 69: 5.October 2007.Context/Type of DocumentPolicy statementPolicy statementDescribes eight directions for themedical laboratory scienceprofession for constructing,maintaining and negotiatingprofessional values andboundaries.Main Findings/RecommendationsThe American Society for Clinical Pathology(ASCP) supports personnel standards for laboratoryprofessionals with a focus on patient safety andquality laboratory testing. These standards includepractice requirements, certification requirements,and/or licensure.The personnel standards include the followingelements: appropriate academic and clinical trainingfor laboratory professionals; passage of acompetency examination offered by an approvednational certification organization; appropriatecontinuing competency standards; and recognition ofASCP’s professional terminology.In order to protect patient health and ensure highquality laboratory testing, the ASCP opposes effortsto allow pharmacists, nurses, and other nonlaboratoryhealth care practitioners to perform and/orinterpret laboratory test results. Under the guidanceof pathologists, laboratory practitioners performquality laboratory services. Only under apathologist’s supervision can the scope andcompetency of other members of the laboratory teambe evaluated.Granting non-laboratory practitioners the ability toboth perform and interpret laboratory test results ispotentially dangerous and will impact a patient’sright to have their health care provided by the mostqualified medical professional. Furthermore, lessqualified non-physician health care personnel(including nurses and pharmacists) with little or noexperience in the laboratory cannot assess, manageor gauge the performance of laboratory staff.Recommendations:• Supporting the study of the profession and itsrelationships with other health professions andinterest groups;• Redefining professionalism;• Accepting personal responsibility forprofessionalism;• Breaking down barriers and assumptions;• Acting on opportunities to promote theprofession;• Taking advantage of the openness to changethat is emerging in some health careorganizations;• Channelling energy effectively;• Keeping an eye on the big picture (positivehealth care outcomes and the role of thelaboratory) while remembering the potential forprofessional change at the level of theindividual.9

Grant, Moira. TheChallenges of Definingthe Medical LaboratoryProfession. CanadianJournal of MedicalLaboratory Science. Vol69. 2007.Ontario Association ofMedical Laboratories.Standards and Protocolsfor the Delivery ofLaboratory Services inLong Term CareFacilities. November2003.First in a series of three articlesthat discusses the place ofmedical laboratory science inCanadian health care. The articleexplores common theories aboutmedical laboratory scienceprofessions to set the stage forhistorical contexts andprofessional implicationsdiscussed in subsequent articles.In 2001, OAML memberlaboratories and long term carefacilities establishedindividualized, written serviceagreements stipulating the level ofservices that could be expectedand the payment mechanisms forthose services. (Most services areOHIP funded.)Factors affecting service are:• Impact of geography• Role definition/ mandate ofcommunity laboratories• Criticality of patients• “STAT Testing” (reportingresults within four hours)Theories of the profession can be classified as ‘traittheories’, which provides a static and descriptivepicture, and ‘power theories’, which offer a dynamicframework.Commonly cited professional traits:• Educational Practices• Signifiers of Expertise• Collegial Activities• Individual BehavioursPrinciples that inform the standards and protocols toaddress service provision to patients in long termcare facilities:• Patients in long term care facilities are entitledto a level of service consistent with thatprovided to other patients in their communities;• Each OAML member shall maintain alaboratory service that is administered inaccordance with the highest ethical andprofessional standards;• Each OAML member shall comply with allapplicable legislation and regulations pertainingto the practice of laboratory medicine andoperation of diagnostic laboratory facilities;• No OAML member shall enter into anyarrangement with practitioners from whom themember receives patients or specimens wherethe impact of such arrangements is the orderingof diagnostic procedures that are medicallyunnecessary;• Each OAML member shall establish and followsystems of quality control that ensure thequality of laboratory services meets or exceedsthe standards set by the Quality ManagementProgram- Laboratory Services.10

Health System Needs/ ImprovementAuthors, Title andPublication2005 Annual Report ofthe Office of the AuditorGeneral of Ontario: 3.08Health LaboratoryServices.Astion, Michael. FutureTrends in PatientIdentification &Specimen Collection:Automation andStandardization.Laboratory Errors andPatient Safety. Vol 1: 2.2004.Context/Type of DocumentThe objective of the audit was toassess whether the OntarioMinistry of Health and Long-Term Care:• had adequate processes inplace to ensure that privatesectorand hospitallaboratories and specimencollectioncentres werecomplying with applicablelegislation and establishedpolicies and procedures, thattest results wereappropriately reported, andthat private-sectorlaboratories were funded in acost-effective manner; and• had adequate policies andprocedures to ensure thatpublic-health laboratorieswere reporting well-watertest results on a timely basis.In 2003/04 , the Ministry spent$1.3 billion on laboratoryservices. Hospital laboratoryexpenditures accounted for $730million ($541 million was paid toprivate-sector laboratories, withthree companies receiving over90% of these payments; and $3.7million paid to the OMA tooperate a quality-managementprogram for laboratory serviceson the Ministry’s behalf).Examines how the practice ofpatient identification andspecimen collection will evolveover the next decade.Main Findings/RecommendationsRecommendations:• To help ensure that laboratories comply withthe Laboratory and Specimen CollectionCentre Licensing Act and can be relied uponto produce accurate test results, the Ministryshould enhance its oversight of the OMA’squality-management activities, includingobtaining sufficient information on the resultsof the OMA’s accreditation process, as wellas significant and lesser errors found inlaboratory test results and evidence thatcorrective action has been taken on a timelybasis; and until such time as it ceases itsregular inspections, conduct themconsistently.• To help ensure that laboratory tests conductedin physicians’ offices are properly performedand produce accurate results, the Ministryshould assess whether the quality-assuranceprocesses required for other medicallaboratories should apply to laboratoriesoperated by physicians.• To help ensure that private laboratory servicesare acquired in an economical manner, theMinistry should periodically determine theactual cost of providing these services andutilize this information when negotiatingpayments for laboratory services.• To help ensure that individuals are aware ofall potential contaminants in their well water,the Ministry should indicate that the waterwas not tested for other contaminants,including chemical contaminants, andtherefore may be unsafe to drink even whenthere is no significant evidence of bacterialcontamination; and indicate on the test resultsreport where individuals can obtaininformation on having their water tested forother contaminants.• To better assist Ontarians in the timelyidentification of well water that is unsafe todrink, the Ministry should re-examine itspolicy of rejecting and not testing watersamples due to missing postal codes and/ortelephone numbers.Trends include:• Automated systems that integrate bar-coding ofpatient identification wristbands with properspecimen collection procedure;• Computerized physician order entry;• Standardization of specimen collectionprocedures within each healthcare organization;• Certification of phlebotomists;• Continued migration from glass to plastic bloodtubes;• Increased use of blood collection devices thathave self-sheathing needles or no needles at all11

Baker, G. Ross et al. TheCanadian Adverse EventsStudy: the incidence ofadverse events amonghospital patients inCanada. CanadianMedical AssociationJournal. Vol 170: 11.1678-86. 2004.Bandali, Karim et al.Skill Integration in aSimulated andInterprofessionalEnvironment: AnInnovativeUndergraduate AppliedHealth Curriculum.Journal ofInterprofessional Care.Vol 22:2: 179-189.March, 2008.This study estimates the incidenceof Adverse Events (AEs) amongpatients in Canadian acute carehospitals.1 teaching, 1 large communityand 2 small community hospitalsin each of 5 provinces(British Columbia, Alberta,Ontario, Quebec and NovaScotia) were randomly selectedand reviewed a random sample ofcharts for non psychiatric, nonobstetric adult patients in eachhospital for the fiscal year 2000.Trained reviewers screened alleligible charts, and physiciansreviewed the positively screenedcharts to identify AEs anddetermine their preventability.A study proposing an innovativeapplied health undergraduatecurriculum model that usessimulation and interprofessionaleducation to facilitate students’integration of both technical and‘humanistic’ core skills. Themodel incorporates assessment ofstudent readiness for clinicaleducation and readiness forprofessional practice in acollaborative, team-based,patient-centred environment.Improving the education of healthcare professionals is a criticalcontributor to ultimatelyimproving patient care andoutcomes.for patients with indwelling catheters or lines.Standardization of specimen collection proceduresreduces errors by simplifying, optimizing andreducing the number of collection proceduresfollowed in a healthcare organization.Research into adverse events (AEs) has highlightedthe need to improve patient safety. AEs areunintended injuries or complications resulting indeath, disability or prolonged hospital stay that arisefrom health care management.At least 1 screening criterion was identified in 1527(40.8%) of 3745 charts. The physician reviewersidentified AEs in 255 of the charts. After adjustmentfor the sampling strategy, the AE rate was 7.5 per100 hospital admissions. Among the patients withAEs, events judged to be preventable occurred in36.9% and death in 20.8%. Physician reviewersestimated that 1521 additional hospital days wereassociated with AEs. Although men and womenexperienced equal rates of AEs, patients who hadAEs were significantly older than those who did not(mean age 64.9 v. 62.0 years).The overall incidence rate of AEs of 7.5% in thestudy suggested that, of the almost 2.5 million annualhospital admissions in Canada similar to the typestudied, about 185,000 are associated with an AEand close to 70,000 of these are potentiallypreventable.Limitations:Budget constraints limited the number of hospitals inthe study – generalizabiity of results is unknown; AErates were not studied in small or remote hospitals;only adult patients in acute care general hospitalswere included.In 2001, an estimated 24,000 preventable deathsassociated with medical error were cited by theCanadian Adverse Events Study. Most are due tosystem errors; however, the current model of healthcare education may be a contributing factor.A review of the current models in health scienceseducation reveals a scarcity of clinical placements,concerns over students’ preparedness for clinicaleducation and profession-specific delivery of healthcare education which fundamentally lackscollaboration and communication amongprofessions. These educational shortcomingsultimately impact the delivery and efficacy of healthcare. Construct validation of clinical readiness willcontinue through primary research at the MichenerInstitute for Applied Health Sciences. As the neweducational model is implemented, its impact will beassessed and documented using specific outcomesmeasurements. Appropriate modifications to themodel will be made to ensure improvement andfurther applicability to an undergraduate medicalcurriculum.12

De Capitani, C.Automation of Pre-Analytical Phase: aPerformance Evaluationand AlternativeScenarios. Journal of theAssociation forLaboratoryAutomation. Vol (2) :89– 93. 2002.Health Canada. AnEnvironmental Scan ofthe Human ResourceIssues Affecting MedicalLaboratory Technologistsand Medical RadiationTechnologists. SectionC: Findings on MedicalLaboratoryTechnologists. Ottawa:Health Canada. 2002.Hurst, Jerry. ArePhysicians’ OfficeLaboratory Results ofComparable Quality toThose Produced in OtherLaboratory Settings?Describes the automation of thepre-analytical phase in abiochemical laboratory thatperforms more than 3.6 milliontests per year. The paper presentshow an investment in thelaboratory can be evaluatedconsidering economic criteria,future performance and servicequality. Alternative scenarios interms of personnel, pre-analyticaldevices and management policiesare also considered.This report presents the combinedfindings of two different studies:an environmental scan performedin 1998 and an update completedin 2001.The environmental scan presentedthe Advisory Committee onHealth Human Resources(ACHHR) with information aswell as a number ofrecommendations to help itdetermine appropriate strategiesto address human resource issuesaffecting medical laboratorytechnologists and medicalradiation technologists.The 1998 study confirmed thatserious shortages could beanticipated in both groups oftechnologists and that a nationalstrategy was needed. The 2001study confirmed a worsening ofhuman resource shortages.In 1995, California adopted a billthat brought laboratory laws inline with the 1988 ClinicalLaboratory ImprovementAmendments’ standards forclinical laboratories and mandatedThis paper shows how an investment in thelaboratory can be evaluated from an economic pointof view and also considering future performance andservice quality.The laboratory is an integrated and complex system.In order to take into account complexity andintegration in the study, simulation has been used.The study highlights the personnel cost saving (morethan 40% of saving ) and the improvement in servicequality of pre-analytical phase automation, evenduring the period without the connection betweenLaboratory Information System-HospitalInformation System (LIS-HIS).As of 2001, most provinces were experiencingserious shortages in medical laboratory technology.Several concurrent and sometimes conflicting forcesinfluencing the medical laboratory workforceincluding:• Diminishing supply of technologists in responseto a decline in employment opportunities.• Anticipated retirement among the baby boomtechnologist workforce in the next 5 to 10 years• Growth in demand for laboratory testing todiagnose the health conditions commonlyassociated with aging (e. g. cancer, heartdisease).Projecting the labour market needs of the future isdifficult because of the difficulty in anticipatingtechnological advances in this field.Medical laboratory technology is strongly influencedby the developments of new technology and newscientific testing discoveries. The future health careor laboratory restructuring initiatives that will beundertaken in response to these developments areunknown. However, the trend of using techniciansfor routine or automated testing is a trend that isexpected to continue. Educating multi-skilledtechnologists who can respond effectively to changesin their roles is another emerging trend.Gathering complete data on the technologistworkforce and incomplete databases are majorlimitations. The differences across Canada in thelaboratory personnel used (e.g., aides, assistants) andthe corresponding variations in the trainingrequirements (e.g., on-the-job vs. certificate) makethe analysis difficult.Ontario reports that positions are starting to open upwith the risk of shortages as the workforce begins toretire in higher numbers. Ontario reports a greatershortage in the private laboratories as salaries arebetter in the public sector. Program officials arefinding it difficult to find sufficient funding for theirprograms, especially with the high cost ofinstruments.The unsatisfactory failure rate for POLs was nearly 3times (21.5% vs 8.1%) the rate for the non-POLs andabout 1.5 times (21.5% vs 14.0%) for POLs that usedlaboratory professionals as testing or supervisorypersonnel. The POL unsuccessful rate was more than4 times (4.4% vs 0.9%) the rate for non-POLs and13

Journal of the AmericanMedical Association.Vol 279: 6. 1998.Neilson, E. et al. TheImpact of PeerManagement on Test-Ordering Behaviour. TheAnnals of InternalMedicine. Vol 141. 196-204. 2004.Pansini, N. et al. TotalTesting Process:Appropriateness inLaboratory Medicine.Clinica Chemica Acta.Vol 333. 141-145. 2003.a study comparing results inphysicians’ office laboratories(POLs) with other settings.This article seeks to determinewhether persons conducting testsin POLs produce accurate andreliable test results comparable tothose produced by non-POLs. ASurvey of clinical laboratoriesusing proficiency testing data wasundertaken of all Californiaclinical laboratories participatingin the American Association ofBioanalysts proficiency testingprogram in 1996 (n=1110).Main Outcome Measures:“Unsatisfactory” (single testingevent failure) and “unsuccessful”(repeated testing event failure) onproficiency testing samples.This interrupted time-series studyuses peer management through aresource utilization committee(RUC) to favorably modify testorderingbehavior in a largeacademic medical center withinpatient care provider order entry(CPOE) system and database ofordered tests. The participantswere predominantly house staffphysicians at VanderbiltUniversity Hospital who usedCPOE systems.The RUC analyzed the orderinghabits of providers duringprevious years and made 2interventions by modifyingsoftware for the CPOE system.Measurements:• Pre- and post-interventionvolumes of tests;• Proportion of patients withabnormal targeted chemistrylevels after 48 hours;• Rates of repeated admission,transfer to intensive careunits, and mortality;• Adjusted coefficient ofvariation for test ordering;• Length of stay.The need to reduce costs inLaboratory Medicine is oftenrelated to the possibility ofreducing test requests withouttaking into account patients’outcomes. Therefore, the term‘‘appropriateness’’ in Laboratorymore than twice (4.4% vs 1.8%) the rate for thePOLs using laboratory professionals.Significant differences exist among POLs, POLsusing licensed clinical laboratory scientists (medicaltechnologists), and non-POLs. Testing personnel inmany POLs might lack the necessary education,training, and oversight common to larger facilities.There is a need to better understand the contributingfactors that result in the poorer results of POLsrelative to non-POLs. In the meantime, patientsshould be aware that preliminary findings suggestthat differences in quality of laboratory tests basedon testing site may exist. Laboratory directors at alltesting sites must ensure that they understandlaboratory practice sufficiently to minimize errorsand maximize accuracy and reliability. Directorsmust understand their obligation when they elect tooversee those assigned testing responsibility.Laboratory testing of hospitalized patients can beexpensive and sometimes excessive.Voluntary reduction of testing beyond 72 hours (firstintervention) decreased orders for metabolic panelcomponent tests by 24% and electrocardiograms by57% but not orders for portable chest radiographs.Prospective constraints on recurrent test orderingwith panel unbundling (second intervention)produced an additional decrease of 51% formetabolic panel component tests and 16% forportable chest radiographs. Incidence of patientswith abnormal targeted blood chemistry levels after48 hours decreased after the intervention. Postintervention-adjusted coefficients of variationdecreased for metabolic panel component tests andelectrocardiography. Rates of (adjusted) monthlyreadmission, transfers to intensive care units,hospital length of stay, and mortality wereunchanged.Peer management reduced provider variability byaddressing the imperfect ability of clinicians torescind testing in a timely manner. Hospitals withgrowing health care costs can improve their resourceutilization through peer management of testingbehaviors by using CPOE systems.Limitations: Other activities occurring during thetime period of the interventions might haveinfluenced some test-ordering behaviors, and weassessed effects on only a limited number ofcommonly ordered tests.The authors obtained an economic saving (119,580euro/year) in cardiac markers request (analyticalappropriateness = 60%, pre-analyticalappropriateness = 40%) and also an improvement inclinical appropriateness (diagnosis and therapy).The data confirm the need to improvecommunications between physicians and Laboratory14

Medicine as referred to thespecific steps (pre-analytical,analytical, post-analytical) andrelated to the clinical processcould allow the improvement ofclinical effectiveness andeconomic efficiency.Medicine with respect to the pre-analytical step andto implement educational programs for definingcriteria and procedures. Appropriateness in analyticaland post-analytical steps contributes to achieveeconomic saving (Core lab, POCT) andimprovement of the turn-around time (TAT).Plebani, M. Charting theCourse of MedicalLaboratories in aChanging Environment.Clinica Chemica Acta.Vol 319. 87-100. 2002.Poutanen, S. Superbugson the Rise: The Role ofthe Medical Laboratory.CMLTO Summit – April3, 2008.Price, C. Application ofthe Principles ofEvidence-BasedMedicine to LaboratoryMedicine. ClinicaChemica Acta. Vol 333.147-154. 2003.Experience has shown animprovement in analyticalappropriateness (reorganizationand re-engineering by Laboratoryautomation) and pre-analyticalappropriateness (critical revisionof the panel for cardiac markers)by evaluating the workload anderrors rate in the pre-analyticalphase.In recent decades, dramaticchanges have occurred in theorganization, number and type oftests, and role of medicallaboratories in healthcare. Therole of laboratory professionalshas undergone a radical change,which calls for greater analyticalaccuracy, and more stringent testselection, and interpretation ofresults.The ancillary role of clinicallaboratories in the past wasanalyzed in order to understandwhy the change has taken place,and to identify old and new areasin which laboratory information islargely used for improving upondecision making for treatment,and patient management.Presentation delivered at theCollege of Medical LaboratoryTechnologists of Ontario’sSummit in April 2008.The principles of evidence-basedmedicine and the search forrobust evidence on outcomes playa central role in the practice oflaboratory medicine.The availability of real-time laboratory results andmore effective tests, the enhanced clinical consultingrole, the involvement in therapeutic decisions, theefforts to prevent rather than cure disease, the shiftfrom anecdotal care to evidence-based medicine, andthe assessment of outcome for laboratory tests haveall contributed to the changing role and duties ofmedical laboratories.Crucial elements in sustaining the changes in the roleand contribution of medical laboratories to a highqualityhealthcare are the ability of laboratoryprofessionals to: guarantee the quality of laboratorytests irrespective of where they are performed;improve the quality of services; improve clinicaloutcomes; and perform joint clinical/ laboratoryresearch projects. A key factor in effecting thechange has been the awareness of the importance ofthe knowledge and skills required for the new role oflaboratory professionals.New classes of Antimicrobials have been discovered.Superbugs are rising because of 1) Antimicrobialselective pressure (inappropriate human use andanimal use), and 2) transmission in the communityand in hospitals (especially due to a lack of humanhygiene). Solutions include measures to controlselective pressure, control the transmission ofsuperbugs and develop new treatments.Laboratories can contribute to all three solutions. Inorder to effectively do so, laboratories needappropriate staffing, expertise, materials, qualitycontrols and collaborations.Good quality evidence lies at the foundation of allaspects of laboratory medicine. Good qualityevidence is also central to being able to demonstratethe value and role played by laboratory medicine inpatient care.15

Price, C. Evidence-BasedLaboratory Medicine:Supporting DecisionMaking. ClinicalChemistry. Vol 46:8.1041-1050. 2000.Smith, B. and McNeely,M. The Influence of anExpert System for TestOrdering andInterpretation onLaboratoryInvestigations. ClinicalChemistry. Vol 45:8.1999.An evidence-based cultureunderpins the practice oflaboratory medicine, in partbecause it is perceived as thescientific foundation of medicine.However, evidence-basedmedicine appears to have hadlimited impact in the sphere oflaboratory medicine. Furthermore,there are some data to suggest thatadherence to criteria for the use ofrobust evidence in scientificpapers on the use of diagnostictests is poor.Laboratory medicine alsoprovides some of the more overtexamples of practice lacking agood foundation of evidence—perhaps the best examples beingthe variations seen in testingstrategies between differenthospitals for the same clinicalpresentations. A considerablebody of literature exists that isdevoted to the inappropriate useof diagnostic tests. One of thegreatest challenges to laboratorymedicine is the suggestion thatdiagnostic tests are not perceivedto have a major impact on patientoutcomes.The Laboratory Advisory System(LAS) is an expert systeminterface that works interactivelywith clinicians to assist with testselection and result interpretationthroughout the laboratoryinvestigation of a patient.To study the influence of the LASon laboratory investigations, arepeated-measures experimentusing clinical vignettes wasconducted. To collect baselinedata on how laboratoryinvestigations are currentlyconducted, clinicians investigatedone-half of the vignettes using aconventional (non-computer)approach. To determine theinfluence of the LAS onclinicians’ behaviour, the otherhalf of the vignettes wereinvestigated using the LAS.One of the key deficiencies in the scientific literatureon diagnostic tests often is the absence of an explicitstatement of the clinical need (i.e., the clinical oroperational question that the use of the test is seekingto answer). Several reviews of the literature onspecific procedures have also demonstrated that theexperimental methodology used is flawed with, insome cases, significant bias being introduced.Despite these limitations it is recognized that a moreevidence-based approach will help in the educationand training of health professionals, in the creationof a research agenda, in the production of guidelines,in the support of clinical decision making, and inresource allocation. Furthermore, as knowledge andtechnologies continue to be developed, an evidencebasedstrategy will be critical to harnessing thesedevelopments.The LAS enhances the outcome of the investigationand improves laboratory utilization. Clinicians usingthe LAS (compared with conventional practice)ordered fewer laboratory tests during the diagnosticprocess (mean, 17.8 vs 32.7), completed thediagnostic workup with fewer samplecollections (mean, 5.8 vs 7.5), generated lowerlaboratory costs (mean, $194 vs $232), shortened thetime required to reach a diagnosis (mean, 1 day vs3.2 days), showed closer adherence to establishedclinical practice guidelines, and exhibited a moreuniform and diagnostically successful investigation.16

Solomon, D. et al.Techniques to ImprovePhysicians’ Use ofDiagnostic Tests: A NewConceptual Framework.Journal of the AmericanMedical Association. Vol280: 23. 1998.Stuart, P. et al. AnInterventional Programfor Diagnostic Testing inthe EmergencyDepartment. MedicalJournal of Australia. Vol177. 2002.A review of the publishedliterature on interventions aimedat improving physicians’ testingpractices and proposemethodological standards forthese studies and to reviewselected studies using thePRECEDE framework, abehavioural model that helpscategorize interventions based onwhich behavioural factors arebeing affected.MEDLINE, EMBASE, andHEALTHStar databases weresearched for the years 1966 toJanuary 1, 1998, for Englishlanguagearticles pertaining todiagnostic testing behaviour;bibliographies were scanned toidentify articles of potentialinterest; and researchers in healthservices, health behaviour, andbehaviour modification werecontacted for proprietary andother unpublished articles.A total of 102 articles wereidentified that described theresults of interventions aimed atchanging physicians’ testingpractices. The review included 49studies that compared diagnostictesting practices in interventionand control groups. Twoinvestigators independentlyreviewed each article in a blindedfashion using a standard datacollection form to obtain amethodologic score and toabstract the key elements of eachintervention.Evaluation of an interventiondeveloped to improve testorderingpractice. Theintervention comprised threeintegrated components:implementation of a protocol fortest ordering; education programfor medical staff; andaudit/feedback process.Main outcome measure was testutilisation (assessed as cost perpatient).Setting: Public hospitalemergency department with anannual census of 42 500.The study comprised a six-monthpre-intervention stage (November1998 to April 1999), which wascompared with a similar postinterventionperiod (November1999 to April 2000), and trendsOn a 38-point methodologic criteria scale, the mean±SD score was 13 ± 4.4. The desired behaviourchange was reported in the intervention group in 37(76%) of 49 studies. Twenty-four (86%) of 28interventions targeted at many behavioural factorswere successful, while 13 (62%) of 21 studies aimedat a single behavioural factor were successful.A majority of interventions to improve physicians’testing practices reported in the literature claimedsuccess, with interventions based on multiplebehavioural factors trending toward being moresuccessful. While methodological flaws hamperdrawing strong conclusions from this literature,application of a behavioural framework appears to beuseful in explaining interventions that are successfuland can facilitate interpretation of interventionresults.The intervention appears to have produced long termmodification of test ordering in the emergencydepartment of a public teaching hospital. There wasa 40% decrease in the ordering of investigations inthe emergency department, with test utilisationfalling from a mean of $39.32/patient to$23.72/patient. The decrease was similar for bothlaboratory and imaging tests and was sustained forthe duration of the 18-month follow-up.17

van Walraven, C. et al.Do We Know WhatInappropriate LaboratoryUtilization is? ASystematic Review ofLaboratory ClinicalAudits. Journal of theAmerican MedicalAssociation. Vol 280.550-558. 1998.van Wijk, M. et al.Assessment of DecisionSupport for Blood TestOrdering in PrimaryCare: A RandomizedTrial. The Annals ofInternal Medicine. Vol124. 274-281. 2001.Verstappen, W. Effect ofa Practice-Based Strategyon Test OrderingPerformanceof Primary CarePhysicians: ARandomized Trial.Journal of the AmericanMedical Association. Vol289: 18. 2003.were examined over an 18-monthpost-intervention period(May 1999 to October 2000).Assesses studies that measureinappropriate laboratory use inlight of methodological criteria.Systematic review of publishedstudies was undertaken andMEDLINE, HEALTHSTAR, andEMBASE databases weresearched from 1966 to September1997 using a broad and inclusivestrategy with no languagerestriction. In addition, thereferences of all retrieved studiesand 3 textbooks on diagnostictesting were hand-searched.Studies were categorized based onwhether the criteria were implicit(objective criteria forinappropriate utilization notprovided or very broad) orexplicit. Guidelines for evaluationwere applied to each study by asingle reviewer.Randomized trial in 44 generalpractices that aims to compare theeffect of two versions ofBloodLink, a computer-basedclinical decision support system,on blood test ordering amonggeneral practitioners.After stratification by solopractices and grouppractices, practices wererandomly assigned to useBloodLink- Restricted, whichinitially displays a reduced list oftests, or Blood-Link-Guideline,which is based on the guidelinesof the DutchCollege of General Practitioners.Average numbers of blood testsordered per order form perpractice were measured.A research study aimed atdetermining the effects of amultifaceted strategy to improvethe performance of primary carephysicians’ test ordering.A multicentre randomizedcontrolled trial with a balanced,incomplete block design andrandomization at group level wasundertaken. Thirteen groups ofLaboratory utilization has steadily increased withsome studies suggesting inappropriate utilization.Forty-four eligible studies were identified. Elevenstudies used implicit criteria for inappropriatelaboratory utilization and contained small numbersof patients or physicians. Most did not adequatelyassess the reliability of the implicit criteria. Thirtythreestudies used explicit criteria based on theappropriateness of test choice, frequency, andtiming, as well as the probability of a positive result.There were large variations in the estimates ofinappropriate laboratory use (4.5%-95%). Evidencesupporting the explicit criteria was frequently weakby the standards suggested for therapeuticmanoeuvres, but was nonetheless compelling basedon principles of physiology, pharmacology, andprobability.Many studies identify inappropriate laboratory usebased on implicit or explicit criteria that do not meetmethodological standards suggested for audits oftherapeutic manoeuvres. Researchers should developalternative evidentiary standards for measuringinappropriateness of laboratory test use.Different methods for changing blood test–orderingbehaviour in primary care have been proveneffective. However, randomized trials comparingthese methods are lacking.Results of the trial indicated that generalpractitioners who used BloodLink-Guidelinerequested 20% fewer tests on average than didpractitioners who used BloodLink-Restricted.Decision support based on guidelines is moreeffective in changing blood test–ordering behaviourthan is decision support based on initially displayinga limited number of tests. Guideline-driven decisionsupport systems can be effective in reducing thenumber of laboratory tests ordered by primary carepractitioners.Numbers of diagnostic tests ordered by primary carephysicians are growing and many of these tests seemto be unnecessary according to established,evidence-based guidelines. An innovative strategythat focused on clinical problems and associated testswas developed.In this study, a practice-based, multifaceted strategyusing guidelines, feedback, and social interactionresulted in modest improvements in test ordering byprimary care physicians.18

primary care physiciansunderwent the strategy for 3clinical problems (arm A;cardiovascular topics, upper andlower abdominal complaints),while 13 other groups underwentthe strategy for 3 other clinicalproblems (arm B; chronicobstructive pulmonary diseaseand asthma, general complaints,degenerative joint complaints).Each arm acted as a control forthe other. During the 6 months ofintervention, physicians discussed3 consecutive, personal feedbackreports in 3 small group meetings,related them to 3 evidence-basedclinical guidelines, and madeplans for change.For clinical problems allocated to arm A, the meantotal number of requested tests per 6 months perphysician was reduced from baseline to follow-up by12% among physicians in the arm A intervention,but was unchanged in the arm B control, with a meanreduction of 67 more tests per physician per 6months in arm A than in arm B. For clinicalproblems allocated to arm B, the mean total numberof requested tests per 6 months per physician wasreduced from baseline to follow-up by 8% amongphysicians in the arm B intervention, and by 3% inthe arm A control, with a mean reduction of 28 moretests per physician per 6 months in arm B than inarm A. Physicians in arm A had a significantreduction in mean total number of inappropriate testsordered for problems allocated to arm A, whereas thereduction in inappropriate test ordered physicians inarm B for problems allocated to arm B was notstatistically significant.Verstappen, W. et al.Improving Test Orderingin Primary Care: TheAdded Value of a SmallGroup QualityImprovement StrategyCompared With ClassicFeedback Only. TheAnnals of FamilyMedicine. Vol 2. 569-575. 2004.The main outcome measure: adecrease in the total numbers oftests ordered per clinical problem,and of some defined inappropriatetests, is considered a qualityimprovement according toexisting national, evidence-basedguidelines.The purpose of the paper is toevaluate the added value of smallpeer-group quality improvementmeetings compared with simplefeedback as a strategy to improvetest-ordering behaviour.The study enrolled 194 primarycare physicians from 27 localprimary care practice groups in 5health care regions (5 diagnosticcenters). The study was a clusterrandomized trial withrandomization at the localphysician group level. Weevaluated an innovative,multifaceted strategy, combiningwritten comparative feedback,group education on nationalguidelines, and social influenceby peers in quality improvementsessions in small groups. Thestrategy was aimed at 3 specificclinical topics: cardiovascularissues, upper abdominalcomplaints, and lower abdominalcomplaints.The mean number of tests perphysician per 6 months atbaseline and the physicians’region were used as independentvariables, and the mean numberThe new strategy was executed in 13 primary caregroups, whereas 14 groups received feedback only.For all 3 clinical topics, the decrease in mean totalnumber of tests ordered by physicians in theintervention arm was far more substantial (onaverage 51 fewer tests per physician per half-year)than the decrease in mean number of tests ordered byphysicians in the feedback arm. Five tests consideredto be inappropriate for the clinical problem of upperabdominal complaints decreased in the interventionarm, with physicians in the feedback arm ordering 13more tests per 6 months. Inter-doctor variation in testordering decreased more in the intervention arm.Compared with only disseminating comparativefeedback reports to primary care physicians, the newstrategy of involving peer interaction and socialinfluence improved the physicians’ test-orderingbehaviour. To be effective, feedback needs to beintegrated in an interactive, educational environment.19

of tests per physician per 6months was the dependentvariable.Verstappen, W. et al.Variation in TestOrdering Behaviour ofGPs: Professional orContext Related Factors?Family Practice. Vol 21:4. 2004.Wensing, M. et al.Implementing guidelinesand innovations ingeneral practice: whichinterventions areeffective? British Journalof General Practice. Vol48. 991-997. 1998.The aim of this study was todescribe GPs’ test orderingbehaviour, and to establishprofessional and context-relateddeterminants of GPs’ inclinationto order tests.A cross-sectional analysis wascarried out of 229 GPs in 40 localGP groups from five regions inThe Netherlands of the combinednumber of 19 laboratory and eightimaging tests ordered by GPs,collected from five regionaldiagnostic centres. In amultivariable multilevelregression analysis, these datawere linked with survey data onprofessional characteristics suchas knowledge about and attitudetowards test ordering, and withdata on context-related factorssuch as practice type orexperience with feedback on testordering data. The main outcomemeasure was the percentage pointdifferences associated withprofessional and context-relatedfactors.It is crucial that research findingsare implemented in generalpractice if high-quality care is tobe achieved. Multifacetedinterventions are usually assumedto be more effective than singleinterventions, but this hypothesishas yet to be tested for generalpractice care.This review evaluates theeffectiveness of interventions ininfluencing the implementation ofguidelines and adoption ofinnovations in general practice. Asystematic literature study wascarried out using MEDLINEsearches for the period fromJanuary 1980 untilJune 1994, and 21 medicaljournals were searched manually.Randomized controlled trials andcontrolled before and after studies(with pre- and post-interventionmeasurements in all groups) wereselected for the analysis. Clinicalarea, interventions used,The total median number of tests per GP per yearwas 998 with significant differences between theregions. The response to the survey was 97%. At theprofessional level, ‘individual involvement indeveloping guidelines’ (yes versus no), and at thecontext-related level ‘group practice’ (versus singlehandedand two-person practices) and ‘more than 1year of experience working with a problem-orientedlaboratory order form’ (yes versus no) wereassociated with 27, 18 and 41% lower numbers oftests ordered, respectively.In addition to professional determinants, contextrelatedfactors appeared to be strongly associatedwith the numbers of tests ordered. Further studies onGPs’ test ordering behaviour should include localand regional factors.Of 143 studies found, 61 were selected for theanalysis, covering 86 intervention groups that couldbe compared with a control group without theintervention. Information transfer alone was effectivein two out of 18 groups, whereas combinations ofinformation transfer and learning through socialinfluence or management support were effective infour out of eight and three out of seven groupsrespectively. Information linked to performance waseffective in 10 out of 15 groups, but the combinationof information transfer and information linked toperformance was effective in only three out of 20groups.Some, but not all, multifaceted interventions areeffective in inducing change in general practice.Social influence and management support canimprove the effectiveness of information transfer,but information linked to performance does notnecessarily do so. The variation in the effectivenessof interventions needs further analysis.20

methodological characteristicsand effects on clinical behaviourwere noted independently by tworesearchers using a standardizedscoring form.Patient Safety/Risk of HarmAuthors, Title andPublicationAjeneye, Francis. Pre-Analytical QualityAssurance: A BiomedicalPerspective. TheBiomedical Scientist.February 2007.American Society forClinical Pathology.Quality LaboratoryPractice and its Role inPatient Safety. 2006.Context/Type of DocumentPre-analytical errors aremisleading results caused byproblems that occur prior tosample analysis. Controlling preanalytical factors prior to testingis a critical factor in ensuringaccurate results and is essential topatient safety. The quality ofresults provided by the laboratoryis dependent on the control of preanalytical factors such asspecimen collection, specimenhandling, interfering substancesand patient-related factors. It hasbeen estimated that 32–75% oferrors occur in the pre-analyticalphase. Guidelines for collectingsamples and for evaluatingsubmitted specimens during theanalysis cycle are essentialbecause such factors could affectpatient care, and theiridentification and the use ofcontinuous audit promotes qualityimprovements across thelaboratory services.Policy statement.Main Findings/RecommendationsFactors of the pre analytical period that have animpact on quality of laboratory results include:• Specimen collection• Sample Processing• Specimen IntegrityWith regard to analytical quality, cliniciansdepend on the laboratory for the detectionand correction of errors; thus, the followingpoints should be addressed:• define laboratory errors and their causes, and setup a plan for a corrective strategy;• create a standard for laboratory error detection,and accurately define reporting and error risk;• measure error reduction and demonstrate, viaprocess analysis, a reduction in risk;• create a culture in which the existence of erroris acknowledged, as blame, shame andpunishment have no part in addressing theproblem;• cooperation between medical and nonmedicalstaff outside the laboratory is essential, as is aregular update of the sample collection andtransportation protocol for non-laboratorypersonnel.ASCP supports the development and maintenance ofhigh quality practice standards for laboratory testingto assure patient safety and reduce medical errorsassociated with laboratory medicine.Recommendations:• Patient safety initiatives be designed to reduceerrors in all clinical environments including thelaboratory.• Laboratory professionals recognize and identifyall potential problems and vulnerabilities inlaboratory settings,• The establishment of electronic health recordsfor all Americans.• Laboratories closely follow the JCAHO PatientSafety Goals as they apply to pathology andlaboratory medicine.• The laboratory/hospital accreditation process aswell as standard operating procedures beutilized to help maximize patient safety goals.• The establishment of patient safetyorganizations as outlined in the new patientsafety law, Patient Safety and Quality21

Improvement Act of 2005.• Continuing medical education for physiciansand allied healthcare professionals to promotepatient health and safety.• Certification and licensure of laboratorypersonnel as a means to ensure laboratorysafety.• Laboratory industry should hold meetingsbetween laboratory and non-laboratory healthprofessionals to discuss patient safety strategies.• The examination of appropriate pay forperformance measures as a means to improvepatient safety.• Collaboration within the laboratory communityto optimize the value of laboratory services.• States adopt direct billing requirements forpathology services.• The federal government take additional steps toprevent fee splitting and other similar practices.Bonini, P. et al. Errors inLaboratory Medicine.Clinical Chemistry. Vol48: 5. 691-698. 2002.Boone, J. How Can WeMake Laboratory TestingSafer? Clinical ChemistryLaboratory Medicine.Vol 45:6. 708-711. 2007.Reviews medical errors in thefields of laboratory medicine andblood transfusion.MEDLINE and literature searcheswere undertaken to identifyresults that were not biased byobsolete technology. In addition,data on the frequency and type ofpre-analytical errors in aparticular institution werecollected.Diagnostic errors occur inlaboratory medicine resultingfrom an error or delay indiagnosis, a failure to employindicated tests, and the use ofoutmoded tests. Since laboratorytests provide essential informationused by physicians to makemedical decisions, it is importantto determine how laboratorytesting mistakes occur, whetherthey cause patient harm, wherethey are most likely to occur inthe testing process and how toprevent them from occurring.The search revealed large heterogeneity in studydesigns and quality on this topic as well as relativelyfew available data and the lack of a shared definitionof “laboratory error”. Nonetheless, there wasconsiderable concordance on the distribution oferrors throughout the laboratory working process:most occurred in the pre- or post- analytical phases,whereas a minority (13–32%) occurred in theanalytical portion. The reported frequency of errorswas related to how they were identified: when acareful process analysis was performed, substantiallymore errors were discovered than when studies reliedon complaints or report of near accidents.The large heterogeneity of literature on laboratoryerrors together with the prevalence of evidence thatmost errors occur in the pre- analytical phase suggestthe implementation of a more rigorous methodologyfor error detection and classification and theadoption of proper technologies for error reduction.Users of and payers for laboratory services mustbecome partners in the laboratory’s efforts to reducelaboratory testing errors and enhance patient safety.They must be linked to a laboratory informationsystem that provides assistance in decisions on testordering, patient preparation, and test interpretation.Laboratory quality assessment efforts need to beexpanded to encompass the detection of nonanalyticalmistakes. Healthcare institutions need toadopt a culture of safety that is implemented at alllevels of the organization.22

College of AmericanPathologists. LaboratoryTest Ordering &Documentation. Undated.Howantis, P. Errors inLaboratory Medicine:Practical Lessons toImprove Patient Safety.Archives of Pathologyand LaboratoryMedicine. Vol 129. 2005.Joint Commission onAccreditation ofHealthcareOrganizations. 2005National Patient SafetyGoals: Laboratory. 2005.Guidelines for laboratory testingand documentation.Patient safety is influenced by thefrequency and seriousness oferrors that occur in the health caresystem. Error rates in laboratorypractices are collected routinelyfor a variety of performancemeasures in all clinical pathologylaboratories in the United States,but a list of critical performancemeasures has not yet beenrecommended. The mostextensive databases describingerror rates in pathology weredeveloped and are maintained bythe College of AmericanPathologists (CAP). Thesedatabases include the CAP’s Q-Probes and Q-Tracks programs,which provide information onerror rates from more than130 inter-laboratory studies.This study defines criticalperformance measures inlaboratory medicine, describeserror rates of these measures, andprovides suggestions to decreasethese errors. Includes a list ofrecommended performancemeasures, the frequency of errorswhen these performance measureswere studied, and suggestions toimprove patient safety byreducing these errors.The Joint Commission establishesNational Patient Safety Goals(NPSGs) each year to evaluate thesafety and the quality of careprovided at accredited health careorganizations. These goals havespecific requirements forprotecting patients.Provides guidelines for:• Test Ordering• Recording Results• Resolving Problems• Reporting Test Results• Supplemental or Confirmatory Reporting• Disease Reporting• Record Keeping• Confidentiality, HIPPA Regulations.Error rates for pre-analytic and post-analyticperformance measures were higher than for analyticmeasures. Eight performance measures wereidentified, including customer satisfaction, testturnaround times, patient identification, specimenacceptability, proficiency testing, critical valuereporting, blood product wastage, and blood culturecontamination. Error rate benchmarks for theseperformance measures were cited andrecommendations for improving patient safetypresented.Not only has each of the 8 performance measuresproven practical, useful, and important for patientcare, taken together, they also fulfill regulatoryrequirements. All laboratories should considerimplementing these performance measures andstandardizing their own scientific designs, dataanalysis, and error reduction strategies according tofindings from these published studies.Goals:Improve the accuracy of patient identification.• Use at least two patient identifiers (neither to bethe patient's location) whenever collectinglaboratory samples or administeringmedications or blood products, and use twoidentifiers to label sample collection containersin the presence of the patient. Processes areestablished to maintain samples' identitythroughout the pre-analytical, analytical andpost-analytical processes.• Immediately prior to the start of any invasiveprocedure, conduct a final verification processto confirm the correct patient, procedure, site,and availability of appropriate documents. Thisverification process uses active—not passive—23

Laboratory Errors andPatient Safety EditorialStaff. DecentralizedSpecimen Collection andPatient Safety.Laboratory Errors andPatient Safety. Vol 1: 2.2004.Most health care organizationsuse some combination ofcentralized specimen collectionservices which are usually underthe laboratory’s control, anddecentralized services providedby nurses, physicians’ assistantsand medical assistants.Institutions that favour a morecentralized approach report thatlaboratory based control of thespecimen collection processreduces errors significantly.communication techniques. The patient'sidentity is re-established if the practitionerleaves the patient's location prior to initiatingthe procedure. Marking the site is requiredunless the practitioner is in continuousattendance from the time of the decision to dothe procedure and patient consent to theinitiation of the procedure (for example, bonemarrow collection, or fine needle aspiration).Improve the effectiveness of communicationamong caregivers.• For verbal or telephone orders or for telephonicreporting of critical test results, verify thecomplete order or test result by having theperson receiving the order or test result"readback" the complete order or test result.• Standardize a list of abbreviations, acronymsand symbols that are not to be used throughoutthe organization.• Measure, assess and, if appropriate, take actionto improve the timeliness of reporting, and thetimeliness of receipt by the responsible licensedcaregiver, of critical test results and values.• All values defined as critical by the laboratoryare reported directly to a responsible licensedcaregiver within time frames established by thelaboratory (defined in cooperation with nursingand medical staff). When the patient'sresponsible licensed caregiver is not availablewithin the time frames, there is a mechanism toreport the critical information to an alternativeresponsible caregiver.Reduce the risk of health care-associatedinfections.• Comply with current Centers for DiseaseControl and Prevention (CDC) hand hygieneguidelines.Manage as sentinel events all identified cases ofunanticipated death or major permanent loss offunction associated with a health care-associatedinfection.Among the negative impacts of decentralization, labsrepeatedly identify five factors that can directlyimpact errors and adverse events:• Reduced error tracking and reporting;• Less feedback to collection staff;• Difficult draws being performed by collectorswho get less practice;• Collectors with less awareness of the impact ofinadequate samples on laboratory testing;• Variations in collection procedures based onequipment, location, and personnel.When designing interventions in a facility, it iscritical to begin with standards that have alreadybeen established as industry best practices, and thenconsider basic steps that are easiest to implement.If decentralization of phlebotomy is beingconsidered, training and education for nurses and24

Laposata, M. and Dighe,A. “Pre-pre” and “postpost”analytical Error:High-Incidence PatientSafety Hazards Involvingthe Laboratory. ClinicalChemistry LaboratoryMedicine. Vol 45:6. 712-719. 2007.Lippi, G. et al. PreanalyticalVariability: theDark Side of the Moon inLaboratory Testing.Clinical ChemistryLaboratory Medicine.Vol 44:4. 358-365.March 2006.Lippi, G. et al.Recommendations forDetection andManagement ofUnsuitable Samples inClinical Laboratories.Clinical ChemistryLaboratory Medicine.Vol 45:6. 728-736. 2007.Data from recent studies suggestthat the highest incidence oflaboratory-related errors occurs inthe pre- analytical phase oflaboratory testing. However, fewstudies have examined thefrequency of errors in laboratorytest selection and interpretation. Asurvey of physicians who use ourclinical laboratory demonstratedthat the largest number of testordering errors appear to involvephysicians simply ordering thewrong test. Diagnostic algorithmsproviding guidance for testselection in specific disorders arealso used as the basis for theestablishment of reflex protocolsin the laboratory.Remarkable advances ininstrument technology,automation and computer sciencehave greatly simplified manyaspects of previously tedioustasks in laboratory diagnostics,creating a greater volume ofroutine work, and significantlyimproving the quality of results oflaboratory testing. Following thedevelopment and successfulimplementation of high qualityanalytical standards, analyticalerrors are no longer the mainfactor influencing the reliabilityand clinical utilization oflaboratory diagnostics. Therefore,additional sources of variation inthe entire laboratory testingprocess should become the focusfor further and necessary qualityimprovements.A large body of evidence atteststhat quality programs developedaround the analytical phase of thetotal testing process would onlyproduce limited improvements,since the large majority of errorsencountered in clinicallaboratories still prevail withinextra-analytical areas of testing,other collection staff is critical.The provision of an expert-driven interpretation bylaboratory professionals resulted in improvementsboth in the time to and the accuracy of diagnosis. Asurvey of the physician staff has shown that in theabsence of such an interpretation, for patients beingassessed for a coagulation disorder, approximately75% of the cases would have involved some level oftest result misinterpretation.It is clear that laboratory medicine must be learned,like any other medical specialty, by reviewing andacting upon actual clinical cases in real time. It is notpossible to learn how to advise physicians about alaboratory test that should be performed or themeaning of a test result by watching a medicaltechnologist perform a test. Current pathologistsmust train future pathologists regarding the meaningof clinical laboratory test results and interact withclinicians in a consultative partnership. If publicpolicy in the US drives the government to rewardpathologists who provide the value-added service ofinterpreting clinical laboratory test results and whoimprove the ability of physicians to order the correcttests as a pay-for-performance improvementmeasure, this could greatly spur the development ofconsultative laboratory medicine services to reducemedical error.Lack of standardized procedures for samplecollection, including patient preparation, specimenacquisition, handling and storage, account for up to93% of the errors currently encountered within theentire diagnostic process.Complete elimination of laboratory testing errors isunrealistic, especially those relating to extraanalyticalphases that are harder to control,highlights the importance of good laboratory practiceand compliance with the new accreditationstandards, which encompass the adoption of suitablestrategies for error prevention, tracking andreduction, including process redesign, the use ofextra-analytical specifications and improvedcommunication among caregivers.Recommendations:1) Education of and acceptance of responsibilityby laboratory personnel to limit the burden oferrors in the pre-analytical phase;2) Implementation of objective and standardized;criteria for detection of unsuitable specimens A;3) Systematic procedure for detection andmonitoring of unsuitable specimens A;4) Management of unsuitable specimens:25

Plebani, M. and Carraro,P. Mistakes in a StatLaboratory: Types andFrequency. ClinicalChemistry. Vol 43:8.1348-1351. 1997.Signori, C. et al. Processand Risk Analysis toReduce Errors in ClinicalLaboratories. ClinicalChemistry andLaboratory Medicine.Vol 45:6. 742-748. 2007.especially in manually intensivepre-analytical processes. Mostpre-analytical errors result fromsystem flaws and insufficientaudit of the operators involved inspecimen collection and handlingresponsibilities, leading to anunacceptable number ofunsuitable specimens due tomisidentification, in vitrohemolysis, clotting, inappropriatevolume, wrong container orcontamination from infusiveroutes. Detection andmanagement of unsuitablesamples are necessary toovercome this variability. Thisdocument reviews the majorcauses of unsuitable specimens inclinical laboratories, providingconsensus recommendations fordetection and management.This paper evaluated thefrequency and types of mistakesfound in the “stat” section of theDepartment of LaboratoryMedicine of the University-Hospital of Padova by monitoringfour different departments(internal medicine, nephrology,surgery, and intensive care unit)for 3 months.Five Italian hospital laboratoriescooperated in a project in whichmethodologies for process andrisk analysis, usually applied infields other than health care(typically aeronautical andtransport industries), wereadapted and applied to laboratorymedicine. The collaboration of aboard of experts played a key rolein underlining the limits of theproposed techniques and adaptingthem to the laboratory situation. Adetailed process analysisperformed in each center was thestarting point, followed by riskanalysis to evaluate risks andfacilitate benchmarking amongthe participants.a) Documentation of interferenceb) Prompt notification of the problemencountered in the specimen tohealthcare staff in charge of thepatientc) Management of unsuitable specimensfor the presence of interferingsubstancesd) Management of unsuitable specimensdue to inappropriate sample volumee) Management of unsuitable specimensfor clottingf) Management of unsuitable specimensfor wrong or misidentificationApplication of Total Quality Management conceptsto laboratory testing requires that the total process,including pre-analytical and post-analytical phases,be managed so as to reduce or, ideally, eliminate alldefects within the process itself.Among a total of 40,490 analyses, we identified 189laboratory mistakes, a relative frequency of 0.47%.The distribution of mistakes was: pre-analytical68.2%, analytical 13.3%, and post-analytical 18.5%.Most of the laboratory mistakes (74%) did not affectpatients’ outcome. However, in 37 patients (19%),laboratory mistakes were associated with furtherinappropriate investigations, thus resulting in anunjustifiable increase in costs. Moreover, in 12patients (6.4%) laboratory mistakes were associatedwith inappropriate care or inappropriate modificationof therapy. The promotion of quality control andcontinuous improvement of the total testing process,including pre- and post-analytical phases, seems tobe a prerequisite for an effective laboratory service.Improving laboratory quality will require definitionof indicators to be monitored as measures of alaboratory trend. The continuous observation ofthese indicators can help to reduce errors and risk oferrors, thus enhancing the laboratory outcome. Inaddition, the standardization of risk evaluationtechniques and the definition of a set of indicatorscan eventually contribute to a benchmarking processin clinical laboratories.The study involves an attempt to adapt some of thetechniques of process and risk analysis, usuallyapplied in fields different from healthcare, to theorganization of clinical laboratories, with thefollowing aims:1. To set up an efficient and objective procedure toquantify the risk of errors;26

Silverstein, Marc. AnApproach to MedicalErrors and Patient Safetyin Laboratory Services.Prepared for the QualityInstitute Meeting‘Making the Laboratory aPartner in Patient Safety’,Atlanta, April 2003.Stahl, M. et al. Reasonsfor a Laboratory’sInability to ReportResults for RequestedAnalytical Tests. ClinicalChemistry. Vol 44: 10.1998.Studies have documentedinappropriate utilization oflaboratory tests and interventionsare effective in improving theutilization of laboratory tests.Laboratory practice uses manymethods to reduce errors, assurepatient safety, and improvequality including quality controlprocedures, quality assuranceprograms, certification ofeducation programs, licensing oflaboratory professionals,accreditation of laboratories, andfederal regulation of laboratorypractices.There is increasing understandingof the importance of the preanalyticalcircumstances onlaboratory quality, includingfailures to report requestedresults. In the past, why thelaboratory was unable to deliver aresult was not investigated.Accordingly, when looking intothe computer system fordiscrepancies between number oftests requested and number oftests reported, only the volume ofthe problem, not the reasons,could be seen.2. To use such a procedure for uniform detectionof errors in clinical laboratories and for thedefinition of a benchmark strategy;3. To measure the impact of errors/risk of errorson the clinical laboratory outcome.Although errors still occur through all phases of thetesting cycle, the proportion of errors in the analyticphase of testing is lower than the proportion of errorsin the pre-analytic and post-analytic phases oftesting. This suggests that collectively the methods toreduce errors in laboratory medicine practice havebeen effective and that further efforts to reduceerrors and assure patient safety will requirepartnerships with providers.The Quality Institute, by focusing on thedevelopment of better ways to measure theeffectiveness of laboratory service (qualityindicators) and by holding the laboratory serviceindustry publicly accountable (national report) forachieving these goals could lead to substantialimprovements in patient safety and in the quality oflaboratory services. The benefits of having acoalition that addresses major policy questions andoffers solutions to issues before legal or regulatoryaction is required, and which acts as a clearinghousefor information could protect patient safety whiledealing effectively with the important issue ofaccess, cost, and quality of laboratory services.The laboratory has focused on solving the majorproblems and has reduced the specimen- andtransport-related problems. However, there are stillproblems:• microcoagulation in tubes;• general practitioners do not always follow theinstructions and rules on mailing and stability ofthe components;• the four laboratories in the county exchangespecimens for rare tests - during this procedure,specimens or results can be lost;• the intensity of diagnostic work and treatmentof the patients in the hospital per time unit hasgrossly increased, hence a new problem is thatpatients frequently are not available at the timefor specimen sampling because of other medicalprocedures. In 1996, this problem accounted for13% of all request failures.The authors’ goal is to detect the failures and preventthem to reduce report failures to

Stankovic, A. andRomeo, P. The Role of InVitro DiagnosticCompanies in ReducingLaboratory Error.Clinical Chemistry andLaboratory Medicine.Vol 45: 6. 781-788. 2007.Valenstein, P. and Meier,F. Outpatient OrderAccuracy. A College ofAmerican Pathologists Q-Probes Study ofRequisition Order EntryAccuracy in 660Institutions. Archives ofPathology andLaboratory Medicine.Vol 123. 1145-1150.1999.Laboratory errors have asignificant impact on patientsafety. The manufacturers of invitro diagnostic (IVD) productsplay an important role in thereduction of laboratory errors byensuring the highest possiblesafety and efficacy of theirproducts. In order to achieve this,the IVD industry hasimplemented rigorous productdevelopment and manufacturingprocesses. Many IVD companiesapply Six Sigma principles inorder to minimize variabilitywithin the whole product lifecycle, starting with customerrequirements, through productdesign and manufacture, as wellas management of the potentialissues that occur after theproducts have been released foruse. This article provides a closerlook into this process using anevacuated blood collection tube asa model device.The objective of this study is toevaluate the frequency and causesof computer order entry errors inoutpatients.Methods used were a crosssectionalsurvey and prospectivesample of errors. Participantsanswered questions about theirtest order entry policies andpractices. They then examined asample of outpatient requisitionsand compared information on therequisition with informationentered into the laboratorycomputer system. Order entryerrors were divided into 4 types:tests ordered on the requisition,but not in the computer; testsperformed but not ordered on therequisition; physician namediscrepancies; and test priorityerrors. The main outcomemeasure was the overall orderentry error rate.By adhering and complying with regulations andguidelines that were set by legislators and standardsetting bodies, IVD companies are ensuring that theirproducts are (a) safe (i.e., do not put patients at riskof harm), and (b) effective (i.e., meet customerrequirements/ needs). Furthermore, by designingIVD products for robustness or insensitivity to noise,and by controlling the manufacturing process afterdesign transfer, long term, IVD companies play acritical role in reducing laboratory errors andimproving patient outcomes.Laboratory test order entry errors potentially delaydiagnosis, consume resources, and cause patientinconvenience.A total of 5514 (4.8%) of 114 934 outpatientrequisitions were associated with at least 1 orderentry error. The median participant reported 1 ormore order errors on 6.0% of requisitions; 10% ofinstitutions reported errors with at least 18% ofrequisitions. Of the 4 specific error types, physicianname discrepancies had the highest error rate, andtest priority errors the lowest error rate.Four institutional factors were significantlyassociated with higher overall error rates:• orders verbally communicated to the laboratory;• no policy requiring laboratory staff to comparea printout or display of ordered tests with thelaboratory requisitions to confirm that ordershad been entered correctly;• failure to monitor the accuracy of outpatientorder entry on a regular basis; and• a higher percentage of occupied beds (i.e., abusier hospital).Computer order entry errors are common, involving5% of outpatient requisitions. Laboratories may beable to decrease error rates by regularly monitoringthe accuracy of order entry, substituting written andfacsimile orders for verbal orders, and instituting apolicy in which orders entered into computersystems are routinely rechecked against orders onrequisitions.28

Van der Weijden, T. et al.“Understandinglaboratory testing indiagnostic uncertainty: aqualitative study ingeneral practice.” BritishJournal of GeneralPractice. Vol 52: 974-980. 2002.The aim of this study is to gaininsight into the generalpractitioner’s (GP’s) motives forordering laboratory tests forpatients presenting withunexplained complaints. Betterknowledge of the professional’smotives for ordering laboratorytests in the case of diagnosticuncertainty may lead tointerventions directed at reducingunnecessary testing.The GP’s perceptions ofdeterminants of test-orderingbehaviour in the situation ofdiagnostic uncertainty wereinvestigated. Semi-structuredinterviews based on surgeryobservations in twenty-onegeneral practices in rural andurban areas of The Netherlandstook place. The interviews werestructured by evaluating theconsultations and test-orderingperformance of that day.Dutch GPs vary considerably in their motives forordering tests. Several motives emerged from thedata, and examples of important themes include:personal routines, tolerance of diagnosticuncertainty, time pressure and tactical motives fortest ordering. Complying with the perceived needs ofthe patient for reassurance through testing is seen asan easy, cost- and time-effective strategy. A clearhierarchy in the determinants was not found.van Wijk, M. et al.Compliance of GeneralPractitioners with aGuideline-based DecisionSupport System forOrdering Blood Tests.Clinical Chemistry. Vol48: 1. 55-60. 2002.This study determined thecompliance of Dutch generalpractitioners with therecommendations for blood testordering as defined in theguidelines of the Dutch Collegeof General Practitioners.An audit of guideline complianceover a 12-month period (March1996 through February1997). In an observational study,a guideline based decision supportsystem for blood test ordering,BloodLink, was integrated withthe electronic patient records of31 general practitioners practicingin 23 practices (16 solo).BloodLink followed theguidelines of the Dutch Collegeof General Practitioners. Wedetermined compliance bycomparing the recommendationsfor test ordering with the test(s)actually ordered. Compliance wasexpressed as the percentage oforder forms that followed therecommendations for testordering.Of 12 668 orders generated, 9091 (71%) used thedecision-support software rather than the paper orderforms. Twelve indications accounted for >80% of the7346 order forms that selected a testing indication inBloodLink. The most frequently used indication fortest ordering was “vague complaints” (2209 orderforms; 30.1%). Of the 7346 order forms, 39% werecompliant. The most frequent type of noncompliancewas the addition of tests. Six of the 12 tests mostfrequently added to the order forms were supportedby revisions of guidelines that occurred within 3years after the intervention period.In general practice, noncompliance with guidelines ispredominantly caused by adding tests. The authorsconclude that noncompliance with a guideline seemsto be partly caused by practitioners applying newmedical insight before it is incorporated in a revisionof that guideline.29

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