Laboratory medicine in Ontario: its downsizing and the consequences on quality

Clinica Chimica Acta 290 (1999) 57–72www.elsevier.com/ locate /clinchim

Laboratory medicine in Ontario: its downsizing andthe consequences on quality

Harold Richardson

Laboratory Proficiency Testing Program, Ontario Medical Association, 501-250 Bloor Street East,Toronto, Ontario, Canada M4W 1E6

Abstract

Health care in Ontario consumes 35% of provincial government annual revenues. Fiscalconstraint mandates restructuring of health services to maintain a fully, publicly-funded uni-versally-accessible health system that is patient-focussed and health-outcome driven. Acute-carehospital restructuring under the authority of the Health Services Restructuring Commission andprimary health-care reform characterise present government initiatives. Laboratory medicineservices at about Can $1 billion annually account for about 5% of health expenditure. ALaboratory Services Restructuring Secretariat created by the Ministry of Health in 1995 hasplanned regionally-based integrated laboratory services systems bringing together public andprivate providers, designed a province-wide laboratory information system, developed a qualitymanagement program, reviewed the human resource needs for laboratory physicians, scientists andtechnologists, and recommended that the legislation be rewritten so as to be enabling — notcontrolling. Meanwhile both hospital and private laboratories have closed, leaving 296 in 1998compared to 394 in 1991. Laboratory physician numbers at 39 per million population falls farshort of the recommended target of 52 and many are within 10 years of retirement. Renewal oflaboratory physicians and scientists to meet the shortfall is not occurring. The numbers ofregistered laboratory technologists has fallen by 6.8% over 2 years. Consolidation and downsizingof laboratories with the formation of core laboratories has resulted in multi-discipline and crossdiscipline tasking of specialist technologists. Senior and middle level management technologistshave been declared redundant. As a consequence, quality control practices have been hard hit.Plans to address these deficiencies through regional integration and sharing of resources remain tobe implemented. 1999 Elsevier Science B.V. All rights reserved.

Keywords: Laboratory medicine restructuring; Health-care restructuring; Health-care expenditure;Laboratory Physicians; Medical biochemistry; Clinical Biochemists; Quality improvement

0009-8981/99/$ – see front matter 1999 Elsevier Science B.V. All rights reserved.PI I : S0009-8981( 99 )00177-1

58 H. Richardson / Clinica Chimica Acta 290 (1999) 57 –72

1. Introduction

The provisions of the Canada Health Act [1] govern health care throughoutCanada. The Act provides all Canadians with equal health-care coverage throughpublicly funded provincial government schemes that pay the total cost of allmedically necessary services. There is total portability across provincialboundaries. Equal access to the same quality of health care and to basic healthservices is guaranteed. Law prohibits private medical care for necessary insuredservices.

Under the Canadian constitution, responsibility for health care and educa-tion is primarily that of the provincial governments. Federal governmentjurisdiction extends to national policies as delineated in federal legislation.Each provincial health insurance plan must fulfil specified criteria andconditions each year before the province is eligible to receive full federalcash contributions under the Canada Health and Social Transfer system. Inrecent years, deficit budgets along with increasing national and provincialdebt have heralded an era of increasing fiscal constraint and changed thewhole dynamic of health care priorities and funding, not only in Ontario butthroughout Canada.

Canada is a federation of ten provinces along with two — soon to be three —2territories. Canada covers an area of 9 970 610 km . The population has

continued to grow, mainly through immigration, to its current level of 30.3million. Ontario covers 10.7% of the Canadian landmass and has a population of11.4 million, mainly in the major conurbations along the north shore of LakeOntario [2].

Regardless of the economic downturn in the early years of this decade, theOntario economy continues to perform well. The government is forecasting abalanced budget by the year 2000–1 [3]. Each year since 1995 the annual deficithas been smaller than that forecast, reflecting strong performance. Ontario(4.4%) out-performed the rest of Canada (3.7%) in real gross domestic productgrowth in 1997, outpacing all other major industrial nations. The personalincome per capita was Can $24 582.

Ontario health-care spending in 1998 increased by $500 million over 1997 to$18.4 billion and this represents 35% of the total government revenue of $52.5billion. Individuals do not contribute directly to the health-care budget.Employers pay a health tax amounting to 5% of government revenue. Mosthealth-care costs are met from general taxation and federal transfer payments.Even though total health-care expenditures have increased many health-caresectors are receiving considerably fewer dollars than in the past. This massiverestructuring of spending has mainly affected acute-care hospitals and supportservices, such as laboratories.

H. Richardson / Clinica Chimica Acta 290 (1999) 57 –72 59

2. Health care in Ontario

Since the practice of laboratory medicine is an essential component of thehealth-care system, it follows that the restructuring of laboratories and itsconsequences can be considered only in the context of what is happening to thehealth-care system as a whole. Some years ago, the Ontario governmentrecognised that the increasing cost of universal, publicly-funded health care wasunsustainable and began a process of needs analysis and cost-benefit assessment.In consequence, a Health Services Restructuring Commission was established inApril 1996 by authority of the Legislature as a stand-alone corporation, with a 4year mandate, operating at arms-length from the Government of Ontario [4]. TheCommission has the authority to restructure hospitals in Ontario. In addition, theCommission makes recommendations to the Ontario Minister of Health onrestructuring other elements of the health-services system. The Commission’srecommendations include advice concerning the funding needed both torestructure hospitals and to enhance other health-care services to meet the goalof developing an integrated health-services system.

The Commission has concluded that Ontario does not have a health-servicessystem in the ordinary sense of the word [5]. Rather, there is a collection ofdisparate parts with isolated management structures, separate budgets, and littleco-ordination. The vision for the future is of a publicly administered health-services system that provides universally available, comprehensive, accessibleand portable services that meet or exceed internationally-derived performancebenchmarks. The provincial system will be organised to foster diversity amongits elements and decision-making by the people affected. It will be constituted ofsectors that together provide the full spectrum of health services needed topromote health and provide health care for the population. Regions, the sectorsand their component institutions and organisations will be distinctive, butcommitted to common purposes. The contributions of each are to be integratedand to complement those of all others to meet the provincially set policies,goals, objectives, and priorities necessary for health.

The Commission has completed much of its review of Ontario hospitals. Ithas recommended hospital closures, amalgamations, and realignment of patient-care services for major conurbations and geographic regions throughout theprovince. Fiscal savings from acute-care hospital downsizing have been redi-rected to community-based health-care initiatives.

Some aspects of the laboratory sector restructuring and downsizing pre-datethe Commission, but the pace has increased since 1996 following the establish-ment of the Laboratory Services Restructuring Secretariat by the Ministry ofHealth (MOH). The Secretariat has a mandate to implement the recommenda-tions of the 1994 Report of the Laboratory Services Review [6]. The work of the


Secretariat regarding laboratory services parallels, in concert, that of theCommission.

3. Laboratory services

Traditionally, laboratory services in Ontario have been provided by threeseparate and distinct sectors — hospital-based, private and government. Hos-pital-based laboratories carry out examinations on inpatients and their samples,as well as serving the outpatients of each facility. The majority of hospitallaboratories operate according to what is known as the medical model. Therange of service is comprehensive, including many complex tests. The budgetfor these laboratories comes from the provincially funded hospital base. Qualityand added value in terms of clinical utility derives in large part from thelaboratory physicians, scientists, and technologists employed by or associatedwith these laboratories. Private laboratories owned or operated by commercialinterests provide about half of all testing in the province. Private laboratorieswere developed to bring laboratory testing to physicians in private practice andthus to patients who did not need to go to hospital. In large part they use anindustrial model approach where unit cost per test is of primary interest. Volumetesting has resulted in the development of large, highly automated centralisedtesting facilities linked to a large specimen collection network. Advancedlogistics and information systems support timely reporting of results to userphysicians. They are compensated for work performed on a ‘fee-for-service’basis, but subject to an absolute cap on total billings. In general, privatelaboratories do not have the intensity of professional staffing associated withhospital-based facilities. The final provider sector is the Laboratory ServicesBranch of the MOH itself. The one main laboratory of the Branch provides anextensive range of microbiology testing acting as a centre for epidemiologicalpurposes as well as providing reference services to both hospital and privatelaboratories. Ten regional laboratories with a limited scope that includes water,food and dairy product testing for microbial contamination support the mainlaboratory. This sector is funded directly by government and does not chargeuser fees.

Point-of-care or near-patient testing is increasingly used in many health-carefacilities because this type of testing is perceived to be less expensive than whenthe testing is performed in the laboratory and because of the timely productionof results. Such testing is not subject to the same regulatory control as islaboratory testing. In a recent survey of blood glucose meter use in Ontarioacute-care, health-care institutions, there were 2291 instruments in the 206reporting facilities. As the number of point-of-care instruments and the range oftarget analytes increase, the magnitude of near-patient testing will escalate.


Whatever the convenience of this approach, it will bring with it increased costsat a time of fiscal constraint. Studies on point-of-care testing have confirmed thatthis is more expensive than centralised testing [7–10]. True costing of suchtesting must include the expenses associated with the quality management of theprogramme and of test result documentation in the health record.

4. Laboratory licensing, inspection, and external quality assessment

Over 25 years ago, initiatives to improve the quality of Ontario laboratoryperformance resulted in legislation to this end. The Laboratory and SpecimenCollection Centre Licensing Act was passed into Statute in 1974 [11]. Under thisAct, all laboratories testing human samples in Ontario are required to be licensedannually by the MOH. The licence specifies the scope of service that thelaboratory may provide. Licensed laboratories are inspected periodically by theLaboratory Licensing and Inspection Service of the MOH. The LaboratoryProficiency Testing Program (LPTP), which is operated by the Ontario MedicalAssociation on behalf of the MOH, was established at the time the Act waspassed, and laboratories have been required to submit to a mandatory externalquality assessment by LPTP since 1974. The Act authorises LPTP to examineand evaluate the proficiency of the performance of tests by laboratories. TheProficiency Testing Agreement 1995 between the OMA and the MOH extendsthe authority to include both pre- and post-analytical components, as well as theanalytical phase of testing. LPTP offers on-site consultation to those licensedlaboratories when performance assessment indicates that the facility is ex-periencing difficulty in meeting the expected standard. Recommendationsresulting from the consultation must be adopted and implemented by thelaboratory. The MOH may revoke a laboratory licence when there is a persistentfailure to meet the standard and all available remediation efforts have failed.

5. Laboratory restructuring

In October 1992, the Minister of Health announced that a review of thelaboratory services system would be one of the goals and strategic priorities inachieving health-care reform. Over the subsequent 2 years, the MOH conductedthis Review with advice and support from an external advisory committee. Thecommittee membership reflected major interest groups and stakeholders. Aprincipal objective was to reduce or curtail the costs of laboratory services thatamounted to one billion dollars in 1990/91.

The review made five recommendations [6] to the Minister of Health inFebruary 1994:


• The establishment of a Quality Improvement Program for laboratory services.• The establishment of a centralised interactive database and electronic com-

munications links for laboratory service requesters and providers.• The establishment of a framework within which planning and development of

an integrated Laboratory Services Delivery System will occur.• To develop new legislation and regulations in support of the Laboratory

Services System that are enabling rather than controlling.• To establish a Human Resource Planning Committee to address the availabili-

ty of human resources necessary to provide quality laboratory services.

Subsequently, the Laboratory Services Restructuring Secretariat was createdwithin the MOH and charged with implementing these recommendations. Anexternal advisory council, broadly representing stakeholders, has assisted theSecretariat. Working groups have addressed each recommendation other thanthat dealing with revisions to the legislation. The framework for the proposedchanges is illustrated in Fig. 1. So far none of the revisions have beenimplemented, although planning to do so is well advanced. In the meanwhile,major piecemeal changes in laboratory medicine practice have occurred largelywithout regard to the government initiatives. As in other jurisdictions [12,13],

Fig. 1. The objective of Laboratory Services Reform.


there have been closures, downsizing, and the creation of strategic alliances inboth the hospital and private laboratory sectors. There are 21 fewer hospital-based laboratories now than there were in 1991. The funding cap placed onprivate laboratory fee-for-service billings has compromised the revenue genera-tion of these companies and the return on investment to their shareholders.Between 1991 and 1998 the number of private laboratories has fallen from 173to 77. As the government-imposed cutbacks in acute-care hospital funding havetaken hold, the administrations of these hospitals have identified the laboratorybudget as a source of revenue to underwrite patient care and other supportservices. Hospital administrators appear to regard the laboratory as a commoditythat can be sacrificed. Management contracts for hospital laboratories have beenissued to major private laboratory chains on the understanding that thesearrangements would save money for the hospitals. Exact numbers are difficult toobtain but approximately Can $150 million has been removed from hospitallaboratory budgets since 1992. The government froze the laboratory budgets inMarch of 1998 to ensure that there would be no further erosion prior to theadvent of the laboratory service reforms, but this appears to have been adirective ignored by hospital administrators. Retirement, attrition and redundan-cies have considerably reduced the numbers of laboratory physicians, scientists,and medical technologists in hospitals.

6. Laboratory physicians and scientists

Laboratory physicians are registered members of the College of Physiciansand Surgeons of Ontario (CPSO) practising anatomical pathology, neuropatholo-gy, general pathology, haematological pathology, medical microbiology ormedical biochemistry. All have completed the training requirements andspecialty certification examinations of the Royal College of Physicians andSurgeons of Canada (RCPSC) in one or more of those disciplines and most areFellows of the RCPSC. Approximately two-thirds of laboratory physicians aresalaried employees of hospitals with most of the remainder having time-limitedcontracts. Restructuring of the acute-care hospital base in Ontario will have amajor impact on the support for these employees and result in a continuingshortfall in the required number of laboratory physicians and scientists.Currently there is a concentration of anatomical pathologists and singlespeciality laboratory physicians in the five academic health science centres.Outside of these centres, general pathologists practising in all disciplines supplyclinical pathology services almost exclusively. In 1996, the supply of laboratoryphysicians was 39 per million of the Ontario population against the 52 permillion recommended by the RCPSC in 1988 [14]. Medical biochemists wereand remain in short supply at 1.8 per million in contrast to medical microbiolog-ists at 4.9, haematopathologists at 3.5, general pathologists at 12.5 and


anatomical pathologists at 16.6 per million population. Other than fiscalconstraint, two other factors will play an increasing importance in the under-supply of laboratory physicians; namely, the ageing of the present practitioners,and the lack of recruitment through the speciality training programmes.

The age distribution of physicians in all laboratory specialities is of greatconcern. According to the 1996 Canadian Association of Pathologists Databank,71% of the 19.5 full time equivalent medical biochemists in Ontario were within10 years of retirement and 22% were already above retirement age. In contrast,22% of 184.5 anatomical pathologists, 32% of 139 general pathologists, and21% of 55 medical microbiologists were over 56 years of age. Current federalimmigration policies, and the registration requirements of the CPSO, precludethe filling of anticipated vacancies in the laboratory physician establishment byphysician immigrants.

Any solution to the shortfall involving the training of new laboratoryphysicians will have a lag time of at least 5 years to allow for completion oftraining. This solution requires adequate recruitment into laboratory medicinetraining programmes and this is not happening. There is a long establishedpattern of poor recruitment of Canadian physicians into laboratory-basedspecialities. Also with government restriction on funded postgraduate educationpositions there has been an undermining of support for laboratory medicine.However, many currently funded positions are unfilled. In 1997 there were 79residents in Ontario laboratory medicine programmes against anticipated needfor 115 replacements within 5 years and another 60 in the following 5 years.These projections are to maintain current staffing levels and do not address theadditional numbers needed to meet the target of 52 laboratory physicians permillion population. Even allowing that advancing technology may ameliorate theabove target, it seems likely that there will be a considerable and increasingshortfall in laboratory physician supply over the coming decade.

Significant shortfalls in supply of laboratory scientists can also be anticipated.The situation in clinical chemistry is at a critical stage given the Ontariopopulation demographics and illness burden, as well as the government healthpromotion strategies. Five trainees were enrolled in Ontario 3-year clinicalchemistry programmes in 1997. Nine of 43 clinical chemists are over the age of55 years and three over 60 years. Setting aside those who may elect forretirement before the age of 65 years, 20% of all clinical chemists are expectedto retire in the next 10 years.

7. Issues relating to the quality of laboratory performance

The negative impact of downsizing and restructuring has hit Ontario lab-oratories. Observed performance in LPTP’s challenge surveys, as well as the


findings and recommendations of on-site consultations to participating lab-oratories, show clear concerns regarding management and the quality of servicebeing provided [15].

The findings and recommendations from the on-site consultations haveidentified common themes relating to both structure and process. In the hospitalsector, significant erosion of management and analytical knowledge continuesthrough layoff or early retirement of laboratory physicians, scientists, and seniormedical laboratory technologists. Managers without experience or insight intothe demands of laboratory services are finding themselves responsible for theoperations of the laboratory.

Erosion of the senior medical laboratory technologist base has the samepotential impact on the quality of laboratory services as does the shortfall inlaboratory physicians and scientists. Membership data of the College of MedicalLaboratory Technologists of Ontario (CMLTO) illustrates this erosion [16]. Lawrequires any person using the title of medical laboratory technologist to be amember of CMLTO and to hold a certificate of registration issued by theCMLTO. Annual renewal ensures that membership data are accurate. Over the 2years from 1995, CMLTO membership fell by 6.8% to 7684. Only 9% are under30 years of age, 32% are between 31 and 40 years of age with 35% in the 41–50year bracket but only 15% over the age of 50 years. Since the normal age ofretirement is 65 years, the data suggest a disproportionately low number in theoldest age group reflective of the early retirement or forced-redundancy of manysenior experienced technical managers. Other trends in membership demo-graphics are of concern. There has been a 7.1% reduction to 5804 in thosemembers employed full-time and an increase of 5.2% to 1919 in those withpart-time employment. Those employed in hospital laboratories have fallen from5900 to 5387, while those in the private laboratory sector have increased from1492 to 1563. As the private sector handles about half of the Ontario laboratorytesting workload and the ratio of hospital-based to private-laboratory-basedtechnologists is 3.5:1, it follows that the technologist:test ratio is also of theorder 3.5 times greater in the private laboratory compared to that in a hospitallaboratory. This productivity difference can be explained in part by comparingthe sample and test mix, the complexity of testing, the degree of automation, andthe differing health-care demands of community versus hospital patients.

Many technologists now face challenges never previously experienced in theirprofessional careers as restructuring and downsizing modify the discipline-basedlaboratory to a technique-oriented laboratory [17]. As elsewhere [18], thesechallenges include increased workload, supervision of less skilled employees,process and procedure changes, multi-tasking, new and unfamiliar analyticalsystems/ reagents, and revised quality control requirements. Multi-tasking andquality control seem to be the most challenging. Except in laboratoriesassociated with smaller hospitals, most Ontario technologists customarily elected


to practice in a single discipline shortly after completion of broad-based 2 to 3year training. Over the past 3 to 4 years most laboratories have created so-calledcore laboratories and have abandoned to a considerable extent the concept ofsingle specialty divisions. Now, after varying years of single discipline practice,these technologists have had to undergo re-training across disciplines. The effectis a general reduction in knowledge and skills compared to that which could beexpected in a single discipline practitioner. So far the greatest impact seems tohave been on trouble-shooting and quality control.

A demonstrated lack of understanding of the principles and practice ofeffective quality control (QC) has become evident in LPTP’s external qualityassessment of laboratory performance. This is most noticeable in chemistry, butis also seen in the other quantitative laboratory disciplines. Many Ontariolaboratories appear to lack an understanding of the QC rules that determine theacceptability of analytical results or ignore them in practice [19]. Machinegenerated QC graphs based on the manufacturer’s limits and mean values areaccepted, rather than using the internal QC results to create the in-house meanand limits. It is a frequent observation that the true in-house values lackcongruence with the displayed mean and limits. Low and high bias is ignored, asare outliers exceeding 62 standard deviations (S.D.) or even 63 S.D. Cali-brators used to establish an instrument reading are applied subsequently as QCmaterials on the same instrument. QC materials covering the critical analyticalvalue range are not used to validate linearity of instrument response. Observa-tions are missing from the QC graphs without comment or explanation.Corrective actions are not documented for out-of-control situations. LPTP hasadvised participants repeatedly of minimum QC requirements.

An average of 197 laboratories participated in 48 LPTP chemistry-relatedexternal quality assessment surveys over 2 years from 1996. A total of 324potentially clinically significant errors were detected. This classification isassigned, following correspondence with the involved laboratory, wheneverthere is the possibility for an adverse health outcome created by the error.Clerical errors accounted for 82 of 324 errors; calibration mistakes for 62; bias,inadequate response to internal QC, and inadequate in-house QC programme for48; analyzer defect and random error for 30 each; and inappropriate handling ofthe specimen for 27.

A 1996 questionnaire-based survey of Ontario chemistry laboratory QCpractices using cholesterol as a QC paradigm was randomly distributed to 115participating laboratories. The survey included LPTP review of submitted QCcharts. Quality control practices did not meet expectations. Although mostlaboratories use some form of the Westgard rules or modified multi-rules forerror detection there is a need for more efficient use of these rules. Onlyone-third used the 1 /R rule to detect random error. Fifteen per cent of QC3s 4s

charts were assessed as of poor quality. One-third of laboratories demonstrated


failure to use adequate cholesterol concentrations at appropriate clinical de-cision-making levels in their QC material. The study concluded that QCpractices in Ontario are disappointing.

Restructuring and downsizing of laboratories so far has lacked overall visionand adherence to a provincial plan. It has been largely fiscally driven withoutrelevance to health outcomes or quality of service. In contrast, the vision forOntario health care espoused by government is patient-focussed and healthoutcome driven. It is within this latter broad vision that the Laboratory ServicesRestructuring Secretariat is developing a model for the future Ontario laboratoryservice system.

8. The evolving model for Ontario laboratory medicine services in thenew millennium

8.1. The changing face of health care

Hospital closures and consolidation of services, as recommended by theHealth Services Restructuring Commission, are likely to have a major impact onhealth care in Ontario. Difficult as it is to forecast all of the resulting changes,there is little doubt that the system will be based on health-care needs, will havea focus on the patient, will be directed at health outcomes, and will be driven bydemands for cost effectiveness. Already we are seeing increasing emphasis oncommunity care with fewer and smaller acute-care hospitals. With newtechnologies these trends will likely continue to increase. Two developments, inparticular, will have a major impact: electronic health records that capture allhealth information on each individual, and integrated health-delivery systems.The latter construct, based on the vertical integration of primary, secondary, andtertiary across-discipline providers and facilities, will bring Ontario into linewith developments elsewhere in Canada. Only Ontario has yet to introduceregionalization of health care. Laboratories are not isolated from these newdirections and must be active players as regional consolidation and integrationprogresses.

8.2. The integrated laboratory services system

The role of any laboratory service is to produce timely, accurate, clinicallyuseful, and cost-effective information for the promotion of health and themanagement of ill-health. Laboratories play a vital role in health care.

The challenges facing laboratories are not only a new structure, newapproaches and new technologies, but the need to demonstrate, and increaseawareness of, the added value that the knowledge and experience of the staff


bring to cost-effective health care. The role of the laboratory, as a fullyintegrated health-care service, includes:

• pre-analytical, analytical, and post-analytical components of testing;• production of timely, accurate, and clinically useful information;• generation of public health information;• quality improvement;• utilization management.

Within this integrated model, the new realities would be:

• the laboratory not confined by walls;• new roles for the laboratory professionals in bringing the laboratory

perspective to the design, implementation and evaluation of patient-care mapsand guidelines;

• multi-disciplined staff;• Multi-tasked instrument systems;• increasing reliance on electronic communications and information systems.

Continued consolidation and restructuring of laboratory services but within anintegrated health-delivery system will logically create a ‘virtual’ laboratory [20](Fig. 2) incorporating:

• point-of-care /near-patient testing;• rapid-response laboratories to provide critical patient-care information

beyond the scope of point-of-care testing;• core or multi-discipline laboratories handling routine analyses and reporting

on most specimens;• specialty laboratories providing discipline or procedure-specific tests that

cannot be provided cost effectively within the core laboratory structure;• reference laboratories providing unique expertise or analytical capability.

Underlying the concept of the virtual laboratory are six principal characteris-tics:

• an effective information management system that is real-time fully interactivebetween the service providers and users of the information;

• analytically robust multi-tasked instruments capable of operating withminimal human intervention and supervision;

• an appropriate mix and number of staff to select, maintain, operate andcontrol the analytical systems;

• an adequate number of health professionals with the knowledge, skills andexperience to guide and manage the testing, interpret the test results, adviseand interact with other health-care providers;


Fig. 2. A ‘virtual’ laboratory and patient-focused care.

• an effective operational and financial management infrastructure;• integration of all providers within a region or other geographic area into a

single seamless system serving a rostered patient population.

Laboratories account for as much as 80% of the clinical data available inhospitals. This data could be used more effectively if it was readily accessibletogether with all other patient data [21]. The Ontario Laboratory InformationSystem (OLIS) has been designed to meet this goal as part of the provincial planfor laboratory restructuring. It is based on a 5 year implementation plan that iswell advanced. OLIS will be integrated with the electronic health record system.Essentially all laboratory tests and the result information arising in anylaboratory will be captured to an electronic database that is available to all dulyauthorised health-care providers. Access to nominal data will be limited topreserve patient confidentiality. Data exchange will conform to the specificationsof Health Level Seven (HL7) Standard for electronic data exchange in health


care environments. HL7 is an American National Standards Institute (ANSI)Accredited Standards Developing Organisation. HL7 sanctioned groups existoutside of the United States in Australia, Germany, Japan, the Netherlands, NewZealand and Canada. Test names and codes will use the Logical ObservationIdentifier Names and Codes (LOINC) system modified to meet Ontario-specificrequirements. Once fully implemented OLIS will obviate much of the un-necessary repeat testing that characterises present disparate laboratory services.

The added value that laboratory professionals bring to the system throughtheir knowledge and experience is an under-appreciated asset. All too clearlythis has been demonstrated through the recent round of layoffs as hospitaladministrators struggle to meet their bottom-line fiscal targets. Laboratoryprofessionals are well educated and adaptable, retain their concern for the patientand provide an essential medical service that will become even more indispens-able in the future [22]. Laboratory service is not a production line with itsproduct a number of laboratory test results. Rather it is an information servicethat must follow and serve the patient seamlessly from the hospital to the homeor other community health provider. The laboratory physicians and scientistswho consult within this system should be viewed as local, regional or provincialresources rather than as hospital employees. Strategies that have been rec-ommended for the resolution of the current human resource issues include:re-direction of laboratory physician /scientist funding from hospital budgets toprotected regional programmatic budgets; a single, province-wide planningpolicy; province-wide coordination by academic health science centers ofteaching programmes to achieve an appropriate number and mix of specialistsfor future service needs; formation of group practices that contract to service aregional base; and re-training in undersupplied laboratory specialties. Regionalgroups should include both clinical and anatomical subspecialties capable ofproviding consultation services to general pathologists in each region. It is alsorecognized that larger community hospitals require on-site anatomical pathologyservices commensurate with the size and scope of their surgical programmes.The fully autonomous solo practice in small community hospitals is difficult tojustify, as the provision of cross coverage, consultations and breadth of expertisecannot be assured. These hospitals must be serviced by a group of laboratorymedicine specialists working out of a central laboratory and who travel to thesmaller facility on an ‘as needed’ basis.

The ultimate aim of Ontario laboratory reform goes beyond the concept of thevirtual laboratory to a vision of a fully integrated regional laboratory servicessystem serving a rostered population of between 100 000 and 500 000 people.This concept expands on the virtual laboratory as a local reality and broadens itinto a seamless regional system in which all hospital-based laboratories, privatelaboratories, and public health laboratories work together in a patient-focussed,health outcome driven single system to provide cost-effective service. Within


this system the traditional boundaries between the different provider sectors willnot apply. Economies of scale, evolving technology for presentation, review andinterpretation of material, available resources and expertise, result turnaroundtime and clinical utility of the laboratory reports, supported by de-centralisationof fiscal management and decision making, will determine the workloaddistribution and compensation to the components of the integrated system.

The model of a regionally integrated laboratory service system has itsopponents. In large part the opposition to the system comes from the privatelaboratory sector as it seems to deny business opportunities, would require themto function according to a system-wide operational plan, and would compensateaccording to formula yet to be determined. Setting aside this opposition,implementation of the model may be delayed as existing legislation does notprovide for licensing or inspection of any laboratory unless it is at a specificgeographic location as a stand-alone entity. Given the Ontario governmentinterest in primary health-care reform and integrated health-delivery systems itseems likely that integrated laboratory service systems will be the way of thefuture. The challenges of implementation, maintaining an appropriate numberand mix of laboratory physicians, scientists and technologists, providingitinerant consulting services to remote sites, accrediting a regional laboratorysystem, and introducing the system-wide laboratory information system remainto be faced.

Acknowledgements

I thank Ruby Dubash for manuscript preparation and editorial assistance.

References

[1] Canada Health Act. 1984, c.6, s.1.[2] Statistics Canada, CANSIM, Matrices 6367–6379 [database online]. Ottawa, On: Statistics

Canada 1998. Available at: http / /www.statcan.ca /english /Pgdb/People /Population /de-mo02.htm. Accessed December 15, 1998.

[3] Ministry of Finance, Province of Ontario. 1997–1998 Annual Report. Toronto, ON: Queen’sPrinter for Ontario; 1998.

[4] Ontario Ministry of Health Web site. Hospitals – Frequently Asked Questions. Available at:http / /www.gov.on.ca /MOH/english /contact /hops /hospfaq dt.html. Accessed December 17,

]1998.

[5] Health Services Restructuring Commission Web site. A vision of Ontario’s health servicessystem. Available at: http / /www.hsrc-crss.org /hsrc /vision.htm. Accessed December 17,1998.

[6] Report to the Ministry of Health, Laboratory Services Review. Toronto, Ontario: Ministry ofHealth, Government of Ontario; 1994.


[7] Greendyke RM. Cost analysis. Bedside glucose testing. Am J Clin Pathol 1992;97:106–7.[8] Lee-Lewandrowski E, Laposata M, Eschenbach K, Camoosa C, Nathan DM, Godine JE,

Hurxthal K, Goff J, Lewandrowski K. Utilization and cost analysis of bedside capillaryglucose testing in a large teaching hospital: implication for managing point of care testing.Am J Med 1994;97:222–30.

[9] Winkelman JW, Wybenga DR, Tanasijevic MJ. The fiscal consequences of central vs.distributed testing of glucose. Clin Chem 1994;40:1628–30.

[10] Nosanchuk JS, Keefner R. Cost analysis of point-of-care laboratory testing in a communityhospital. Am J Clin Pathol 1995;103:240–3.

[11] Laboratory and Specimen Collection Centre Licensing Act. Statutes of Ontario. Toronto,Ontario 1974.

[12] Bogue RJ, Shortell SM, Sohn MW, Manhem LM, Bazzoli G, Chan C. Hospital reorganiza-tion after merger. Med Care 1995;33:676–86.

[13] Kricka LJ, Parsons D, Coolen RB. Health care in the United States and the practice oflaboratory medicine. Clin Chim Acta 1997;267(1):5–32.

[14] National Specialty Physician Review. The Royal College of Physicians and Surgeons ofCanada, Ottawa, Ontario 1988.

[15] 1997 LPTP Review. Ontario. Toronto, Ontario: Laboratory Proficiency Testing Program;1998.

[16] 1997 Annual Report, College of Medical Laboratory Technologists. Toronto, Ontario:College of Medical Laboratory Technologists of Ontario; 1998.

[17] Boyd JC, Felder RA, Savory J. Robotics and the changing face of the clinical laboratory.Clin Chem 1996;42:1901–10.

[18] Kricka LJ. Please do not be alarmed — we are experiencing a paradigm shift. Clin Lab News1995;21:26–36.

[19] Krishnan S, Webb S, Henderson AR, Cheung CM, Nazir DJ, Richardson H. An Overview ofQuality Control Practices in Ontario with Particular Reference to Cholesterol Analysis.Clinical Biochemistry 1999;32(2):93–9.

[20] 1995 LPTP Review. Toronto, Ontario: Ontario Laboratory Proficiency Testing Program;1996.

[21] Diller W. Defining the value of laboratory data. In vivo 1995;October:40–6.[22] Conn RB, Snyder JW. Changes in the American health care system: Crisis in the clinical

laboratory. Clin Chim Acta 1997;267:33–49.

Documents

Laboratory medicine in Ontario: its downsizing and the consequences on quality