Transforming and Supporting Patient Care - Health Professions ...

110Chapter 5 – Scope of Practice of Medical Laboratory TechnologyLaboratory and Specimen Collection Centre Licensing the discretion toapprove the qualifications and experience of individuals as meeting therequirements for employment in a laboratory. Public health laboratories,Canadian Blood Services blood donor clinics, pharmacies performingimmunologic tests for pregnancy and physicians who perform laboratorytesting for their own patients are exempt from parts of the Act and itsregulations. 26Similarly, Ontario Regulation 683 made under the LSCCLA sets out theconditions for the issuance and renewal of a licence to establish, operateor maintain a specimen collection centre. For staff, the regulation specifiesthat anyone employed by the owner or operator of a specimen collectioncentre for the purpose of collecting specimens from the human body shallhave his or her competence in techniques for specimen collection andhandling, ability to care for and manage patients, and standard of personalcleanliness assessed by a legally qualified medical practitioner. 27 Specimensare collected in a number of sites that are not necessarily licensed asspecimen collection centres, including physicians’ offices, long-term carefacilities and at the bedside in hospital. In addition, a number of individualsmay collect blood and other human specimens, including physicians,nurses, respiratory therapists, MLTs and unregulated staff such as MLA/Ts.The LSCCLA also makes it a condition of a license for a laboratory to submitto a quality management program. 28 The Ontario Medical Association (OMA)has been designated as the agency to carry out this quality managementprogram. 29 The Quality Management Program - Laboratory Services(QMP-LS), operated by the OMA, designs and delivers external qualityassessment, accreditation and education services and related products tomeet its regulatory mandate, relevant international standards and clientand stakeholder requirements. It has been in operation since 2003. Manylaboratories outside Ontario also voluntarily seek accreditation by QMP-LS.All applicant laboratories are issued ISO certificates by the Standards Councilof Canada for complying with several international standards and guidelines. 30All Ontario laboratories submit to rigorous monitoring by QMP-LS. They arerequired to provide evidence of quality goals, sound practices, continualimprovement and client satisfaction, among other indicators. There areexplicit quality management criteria against which all laboratories areevaluated to ensure the highest quality, safest laboratory operation. Boththe accreditation and the external quality assessment are mandatory forall Ontario medical laboratories and are meant to complement thelaboratories’ own quality control and quality assurance measures.Continued accreditation is dependent on the laboratory demonstratingcompetence through the external quality assessment visits and surveysthat determine the extent to which laboratories conform to requirementsfor all examinations performed. In particular, the external quality26Ibid. ss. 11-13.27Ontario Regulation 683, made under the LSCCLA, 1990. s.3.28LSCCLA, 1990. s.9(14).29Ontario Regulation 682, made under the LSCCLA, 1990. s.14.30Quality Management Program – Laboratory Services. About Ontario Laboratory Accreditation.Available at: www.qmpls.org/ola/ola.HPRAC Critical Links January 2009