Billion-Dollar Baby

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By David More, BA, MPA, MLT

Each year, Ontario taxpayers buy nearly a billion dollars worth of medical diagnostic laboratory testing, split almost equally between for-profit labs and not-for-profit hospital labs.1 These laboratories, which process and analyse bodily fluids, cells and tissues from patients, will soon be able to demonstrate that they meet cutting-edge international quality standards. As of January 1, 2003, all provincially licensed labs must prepare to meet the mandatory new standards of the Quality Management Program — Laboratory Services (QMP-LS) and its associated accreditation process, Ontario Laboratory Accreditation (OLA). Existing quality standards in the province are being consolidated and updated to include new international standards as well as other widely accepted guidelines and various relevant statutory requirements.

Health care in Canada falls under provincial constitutional jurisdiction, so each province has a different regulatory regime for medical labs. Historically, Ontario has charged two bodies with ensuring quality. The Laboratory Licensing Branch is an arm of the Ministry of Health and Long-Term Care and inspects each lab every 18 months or so. It issues operating licences on an annual basis to those that pass muster. The Laboratory Proficiency Testing Program (LPTP) has been operated by the Ontario Medical Association (OMA) as an external testing agency for the ministry since 1974. Under the LPTP, serum or other samples are regularly sent to each licensed laboratory in the various disciplines (chemistry, hematology, microbiology, virology, cytology, transfusion services, surgical pathology, genetics) to assess their proficiency in analysing the known sample. Labs that do not perform well on these tests are reported to the ministry and often must pass more intensive on-site inspections to keep their licences. Labs which consistently fail to pass one or other of the inspecting agency standards may have their operating licences revoked, in part or in full.

Surprisingly, until recently there have been no broadly recognized international standards for medical diagnostic laboratories although such quality system standards are well established for manufacturers, as well as for the labs on which they depend for materials analysis. This trend focused primarily on easing trade barriers that were raised by national requirements to re-test goods or materials being imported, and which prevented specialized domestic laboratories from offering analytical services for export.2 Apart from a growing trade in testing for genes and their mutations, there is little cross-border business in diagnostic lab work, which may explain the lag in standards development for medical labs. Material testing labs can achieve accreditation through the Standards Council of Canada (SCC) and its Program for the Accreditation of Laboratories — Canada (PALCAN)3 under ISO 17025. This standard is only partially relevant to medical diagnostic laboratories and since November 2002, ISO has an approved additional standard developed specifically for diagnostic labs (ISO 15189). QMP-LS has incorporated both of these standards into its comprehensive accreditation requirements as well as relevant Canadian and Ontario law and other generally accepted guides for laboratory quality programs such as those published by the National Committee for Clinical Laboratory Standards (NCCLS).

The Ontario Ministry of Health and Long-Term Care initiated the new program in 2000, as a result of a comprehensive review of laboratory services in the mid-90s. The first recommendation (of five) was the creation of such a quality management program for diagnostic laboratories. Adding urgency to the seven-year-old report are recent studies documenting widespread medical errors.4,5,6 One such study reported that medical mistakes account for nearly 100,000 deaths each year in the United States. Another, that in 1997 each error cost hospitals $4,700. Additional drivers include ongoing political pressure to improve accountability and transparency to taxpayers.

QMP-LS is operated by the OMA and at the time of publication had completed pilot project assessments in selected laboratories across the province to determine program feasibility and effectiveness. An impact analysis will be done as a result of these pilots and the program, revamped as necessary, will roll out in its entirety this summer. The initial cycle of on-site assessment and accreditation of all laboratories under the new standards is expected to take two years. The previous inspection and licensing schemes are currently running in parallel, although the ministry has assured laboratories that they will not be expected to deal with two separate inspections within a short period of time. LPTP will continue to operate as a mandatory external testing agency, but under the new name of External Quality Assessment (EQA).

Requirements of the QMP-LS Quality Management System (QMS) program include 614 explicit criteria, 66 of which are not mandatory. These are split among 11 categories. Criteria include the appointment of a quality manager, implementation of a document control system, and production and use of a quality manual. Categories defined include organization, physical facilities, safety, point-of-care testing (POCT), pre-analytical, analytical, post-analytical, and laboratory information system (LIS). The QMS must be reviewed periodically by management and any deficits, as well as system repair and improvement activities, must be documented.

The on-site peer assessment process will occur every five years after the initial visit, but at the mid-point of the accreditation cycle a written self-assessment must be performed by each facility and submitted for evaluation. QMP-LS estimates that the on-site assessments will consume one to four working days for two to eight volunteer assessors, depending on the type of laboratory. Laboratories will receive written reports within 30 days of the visit and have 60 days from report receipt to correct identified deficiencies. A key assessment concept is that facility processes and procedures must be comprehensively documented and the documentation must reflect actual practice.

No additional funding has been provided to labs to prepare for the accreditation process, but the visits every fifth year are funded by the ministry through QMP-LS. Visits required for followup regarding deficiencies identified through OLA or the EQA process will be paid for by the recipient laboratory.

QMP-LS states that its vision is to be the leading international accreditation and quality assessment agency for diagnostic laboratories. It has set accreditation goals of establishing best practice and expected quality standards for the province’s labs in sync with international initiatives, to apply these standards uniformly, to provide recognition of excellence and to establish links with stakeholders.7

Admirably ambitious.

References
1) More, J. David, S.K. SenGupta and P.N. Manley. Promoting, Building and Sustaining a Regional Laboratory Network in a Changing Environment. Clinical Leadership and Management Review, September/October 2000, p.205.

2) Lab Business. Winter 2000/2001, p.22.

3) Standards Council of Canada. www.scc.ca

4) Kohn, L.T., J.M. Corrigan, M.S. Donaldson, editors. Committee on Quality of Health Care in America, Institute of Medicine. To Err is Human: Building a Safer Health System. Washington: National Academy Press, 1999. www.nap.edu/ books/0309068371/html/

5) Bates et al. 1997.

6) Callum, J.L., H.S. Kaplan, L.L. Merkley, et al. Reporting of near-miss events for transfusion medicine: improving transfusion safety. Transfusion 2001;41:1204-1211.

7) The Accreditation Process. www.qmpls.org