The title of the procedure - Hôpital général juif - Jewish ... Medicine/Quality Manual.pdfDepartment of Diagnostic Medicine File Name: Quality Manual Last Reviewed: November 23,

Department of Diagnostic Medicine

File Name: Quality Manual Last Reviewed: November 23, 2012

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Quality Manual A0.5

Author(s): Dr. S. Eintracht Lena DAlessandro Dr. E. MacNamara

Authorized by: Dr. E. MacNamara

Date authorized: October 6, 2006

Historical list of changes. November 15, 2007: Updated Hematology MDs (Lena DAlessandro) November 15, 2007: Updated Safety Officer and committee mandates (Lena DAlessandro) November 15, 2007: Updated Quality Officer mandate (Lena DAlessandro) November 19, 2007: Retention time for employee files (Lena DAlessandro) July 20, 2009: Mission statement revised (H. Siandris and Dr. Eintracht) March August 2009: Multiple syntax corrections, updating of staff and instruments. (H. Siandris and Dr. Eintracht) April 14, 2010: Updated Document Control (B. Halar) June 21, 2010: Updated Retention times (B. Halar)

Quality Manual

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Planning and designing services ................................................................................................. 5 The mission of the Jewish General Hospital is: ...................................................................... 5 The Department of Diagnostic Medicine mission statement .................................................. 5 Department of Diagnostic Medicine clinical, teaching and research mandates ..................... 6 Quality Policy Statement ........................................................................................................ 6 List of the General Techniques and Methodologies used within the Department of Diagnostic Medicine ............................................................................................................... 7 Repertoire ................................................................................................................................ 9 Restricted assays ..................................................................................................................... 9 Consultation Services Available ........................................................................................... 10 The laboratory's planning processes. .................................................................................... 11 Procedure for Review of Contracts ....................................................................................... 11 Selection of referral laboratories ........................................................................................... 11

The laboratory's services are integrated and coordinated to ensure continuity of service for clients and service providers. .................................................................................................... 13

The laboratory as an integral part of patient care ................................................................. 13 Methods of communication .................................................................................................. 14 Laboratory Specialists ........................................................................................................... 16 Clinical and laboratory advice .............................................................................................. 19 Documentation and management of complaints, errors and deviations from SOPs ............. 19 The patient's rights ................................................................................................................ 20

The laboratory's staff are qualified and competent. .................................................................. 23 Staffing Plan.......................................................................................................................... 23 Recruitment and Selection of New Personnel ...................................................................... 23 Working Hours...................................................................................................................... 23 Laboratorys organizational chart ......................................................................................... 27 Manual of job descriptions.................................................................................................... 28 Responsibilities of the Chief of Diagnostic Medicine .......................................................... 28 Training of residents ............................................................................................................. 32 Training of student technologists .......................................................................................... 32 Training of technical personnel ............................................................................................ 32 Continuing Education Programs ........................................................................................... 33 Competency .......................................................................................................................... 33 Laws relating to laboratory practice in Quebec .................................................................... 34

Laboratory Ethics ...................................................................................................................... 36 General Statement ................................................................................................................. 36 Ethical Aspects of Information Collection ........................................................................... 36 Ethical Aspects of Specimen Collection ............................................................................... 36 Ethical Aspects of Assay Performance ................................................................................. 37 Ethical aspects of reporting laboratory results ...................................................................... 37 Ethical Aspects of laboratory Records Storage and Retention ............................................. 37 Ethical aspects of access to laboratory records ..................................................................... 38

Documentation .......................................................................................................................... 39 Identification ......................................................................................................................... 39 Document Structure .............................................................................................................. 39



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Document Control ................................................................................................................. 40 The laboratory keeps up-to-date, complete, accurate and secure records. ............................ 41 Validation of methods ........................................................................................................... 41 Validation of Test Results ..................................................................................................... 41 Amendments to results .......................................................................................................... 42

Laboratory Information System ................................................................................................ 43 Hardware ............................................................................................................................... 43 Software ................................................................................................................................ 43 Access Control ...................................................................................................................... 43 System Security .................................................................................................................... 43 Software Test Procedure ....................................................................................................... 44 LIS Maintenance ................................................................................................................... 44 Authorization Levels ............................................................................................................. 44 Emergency Procedure ........................................................................................................... 45

Laboratory layout and environment .......................................................................................... 46 Location ................................................................................................................................ 46 Principle areas of the laboratory ........................................................................................... 46 General facilities and safety .................................................................................................. 47 Inspections ............................................................................................................................ 48 Cleaning and Housekeeping ................................................................................................. 49 Staff facilities ........................................................................................................................ 49

Health and Safety ...................................................................................................................... 50 Workplace safety .................................................................................................................. 50 Health and Safety Committee ............................................................................................... 50 Health and safety manual ...................................................................................................... 51 Environmental safety ............................................................................................................ 51 Laboratory storage facilities ................................................................................................. 51 General laboratory waste ...................................................................................................... 52 Radioactive waste ................................................................................................................. 52 Facilities for patients ............................................................................................................. 52 Laboratory access.................................................................................................................. 52 Calls, pages and communication within laboratory .............................................................. 53

Laboratory equipment ............................................................................................................... 54 Selection of equipment ......................................................................................................... 54 Suppliers ............................................................................................................................... 54 Receipt and Inspection .......................................................................................................... 55 Identification ......................................................................................................................... 55 Reporting and correcting faults ............................................................................................. 55 Malfunctioning Equipment ................................................................................................... 55 Maintenance .......................................................................................................................... 56 Logbooks............................................................................................................................... 56 Storage and Stock Control of Spare Parts ............................................................................. 56 Performance of and Responsibility for Maintenance............................................................ 56 Calibration............................................................................................................................. 57 Inventory control system....................................................................................................... 57



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Labeling of supplies, reagents and media ............................................................................. 58 Record keeping of supplies, reagents and media .................................................................. 58 Preparation of reagents and media ........................................................................................ 59 Management of Reagents and Consumable Goods .............................................................. 59 Receipt and Inspection .......................................................................................................... 60 Storage .................................................................................................................................. 60 Defective Reagents ............................................................................................................... 60 Verification ........................................................................................................................... 60 Glassware .............................................................................................................................. 61

The laboratory regularly evaluates and improves the quality of its processes and services to achieve the best possible results. .............................................................................................. 62 Retention times ......................................................................................................................... 64



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Planning and designing services

The mission of the Jewish General Hospital is: To provide general and specialized care of the highest quality in a safe, humane

and caring manner, with an emphasis on specialized and ultra-specialized care To develop and promote an environment for leadership and excellence in health

sciences education To encourage and support research in order to advance the knowledge of the

prevention, cause and treatment of illness and health To actively participate in and lead the development and evaluation of new

technologies in order to enhance patient care We also recognize that the talent and commitment of our staff contribute to our strength. We will continue to foster a work environment where each person is valued, respected and supported in professional endeavours and educational programs for personal and professional growth. Based on a philosophy of providing Care for All, the JGH respects the concerns of all religions, cultures and ethnic communities. Although the hospital is a non-sectarian institution, it maintains an environment that respects the culture and the spiritual and religious beliefs of the Jewish faith.

The Department of Diagnostic Medicine mission statement To provide medical laboratory services consistent with the needs of the health

care team and their patients in a professional and caring manner. To initiate and collaborate in research activities directed towards the improved

understanding of disease, its diagnosis and monitoring To ensure the optimal use of the laboratory service To encourage and develop all staff to attain their true potential and to develop a

milieu which promotes teamwork



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Department of Diagnostic Medicine clinical, teaching and research mandates

Quality Policy Statement It is the policy of Department of Diagnostic Medicine to provide the highest standard of quality concerning all aspects of the service it provides. SCOPE: The laboratory provides services for clinical, teaching and research activities. See below for details. The laboratorys services are integrated and coordinated to ensure continuity of service for the patients, doctors, nurses, allied health professionals and partners of the laboratory. Every member of the laboratory is responsible for effectively working and communicating results, problems, concerns, incidents and relevant information to their colleagues both inside and outside the laboratory. All personnel concerned with Laboratory's activities are familiar with the quality documentation. The quality policies and procedures are implemented at all times. The laboratory is committed to good professional practice, to the quality of its assays and complies with the quality management system. The laboratory is committed to performing its activities in accordance with the requirements of International Standard ISO 15189:2007. Clinical activities

The laboratory performs in-house over 500 tests. In addition, it offers the possibility to its physicians to correctly collect, prepare ship and store samples for analyses at other tertiary care laboratories.

The laboratory has an on-line, up to date Test Catalogue, of all the tests it performs. This is found on the JGH website and is available to everyone inside and outside the hospital. It is easy to use and provides information on collecting samples, reference intervals, turnaround times, etc.

There is 24 hours a day 7 days a week (including statutory holidays), a medical biochemist, medical microbiologist, and a hematologist on call to help with clinical

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interpretation of results and advice on the most appropriate laboratory investigations.

Teaching activities

Teaching of undergraduate students Teaching of postgraduate students Teaching of technologist Teaching of clerical staff Continuing education for all staff

Research activities

Participation in research projects is part of our normal academic function. This usually takes the form of collaboration, as a team member, with our hospital researchers. This is part of the service we provide to our organization to support its academic vision, mission, and values.

List of the General Techniques and Methodologies used within the Department of Diagnostic Medicine

Section Instruments and Methodologies

Core laboratory

Roche Cobas 8000 Roche Modular Pre-analytics Urisys 2400 Sysmex HST-N System PFA-100 Stago STA-R Evolution Sienco Platelet Aggregometer Gem Premier 4000 Blood Gas Analyzers Adeza Advanced Micro Osmometer 3320

Microbiology

Axsym Bactec MGIT 960 PCR Cobas Amplicor Bactec 9240 and 9120 (Blood cultures) Bactec 9050 (Myco/F lytic) Biomic 99 Sensitivity Reader BD-Probe tech Mini-Vidas EIA Smart Cycler



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Molecular Microbiology

Applied Biosystems 2720 Thermal Cycler MagNa Pure Light Cycler 2.0 Nuclisens Easy MAG Qiaxcel Roche Light Cycler 2.0 Roche Light Cycler 480 See Amp

Specialty Labs

HPLC Waters and Agilent 1100 series Artel Pipette Calibrator Immulite 2000 Alisei Automated ELISA Cobra II Gamma counter Packard Canberra Coulter TQ-Prep Workstation Cytomics Flow Cytometer 500 Hydrasys LC - Protein electrophoresis Hyrys II Densitometer Hitachi U-1800 Spectrophotometer IFPrep Seac Sirios S Plate reader and washer

Transfusion Services Ortho Provue Blood Type and Antibody Screen



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Repertoire A full repertoire of the available tests can be found on the JGH website. Test availability The laboratory operates 24 hours a day 7 days a week. Requests for tests with turnaround times of 24 hours are performed Monday to Friday between 08h00 and 16h00, excluding statutory holidays. However, most tests can be performed on an urgent basis 24 hours a day in consultation with the laboratory physician on call.

Restricted assays Some assays are restricted and not all physicians are allowed to order every test e.g. paraneoplastic antibody screen can be freely ordered by a staff neurologist but all other physicians require the approval of either the medical biochemist or clinical biochemist on call. These restrictions are based on:

Lack of evidence of clinical usefulness, Usefulness under certain limited conditions Price of the test.

Tests that normally would never be allowed may be permitted due to inclusion in a research protocol. The cost of these tests must be covered by the investigators. Clinical departments or doctors eligible to override these restrictions can be found in the LIS. This information is linked to the test or in the case of research protocols requisitions are specifically designed to include these tests.




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Consultation Services Available

Area Days Times available Whom to contact Phone

Biochemistry

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Biochemist On Call

Biochemist On Call

Biochemist On Call

x5094

Routine Hematology

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Dr. Gyger

Hematologist On Call


Locating x8232

Coagulation

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Dr. Blostein



Locating x8232

Special Hematology

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Dr. Gyger



Locating x8232

Microbiology

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Microbiologist On Call



Locating x8232

Transfusion

Monday to Friday

Monday to Friday

Weekends

08.00-16.00

16.00-08.00

08.00-08.00

Dr. Caplan



Locating x8232



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The laboratory's planning processes. These planning processes are documented in the Diagnostic Medicine Executive Meetings minutes and based on:

The availability of resources Best-practice knowledge Information on errors and adverse events, and associated corrective action

taken; and Results of quality improvement activities.

The laboratory is unique in the fact that all its laboratory physicians also work as clinicians in their specialties and therefore are intrinsically involved in both using and implementing laboratory services. In addition, many of them work as Attending Physicians in charge of wards and are therefore acutely aware of both patient and health care provider needs. The laboratory collects information from clients, service providers, and other organizations about the services it provides on an as needs basis e.g. Physician satisfaction survey, Patient satisfaction survey. In addition, the laboratory actively encourages feedback from its users. It promotes this by involving the complainant in the investigation and solution of the problem. The laboratory physicians, as academic teachers, clinicians and researchers are au fait with current best practices and ensure that they are in place in their laboratory. In addition, many of these physicians have been presidents of their national associations, are leaders in their fields and have acted as consultants to governments on health care policies.

Procedure for Review of Contracts Contracts are established between institutions that provide the Department of Diagnostic Medicine with a service. These services can be defined as supplying the department with such things as: reagents, analyzers, analyses of tests, courier service for transport of specimens etc. The Laboratory Manager documents and maintains all reviews of contracts and relevant documentation. The contracts are kept by the hospital in a centralized area in the DPS Office. See Procedure: Review of contracts (Sale of Services) and Procedure: Review of contracts for services providers (diagnostic companies).

Selection of referral laboratories The selection criteria of referral laboratories fall into two major related areas:

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1. Quality of Referral laboratory Service: a. Facilities and Equipment

i. Determine whether the equipment, supplies, and instrumentation are consistent with the scope and volume of testing being conducted.

ii. In exceptional circumstances, an on-site visit can be scheduled to examine the physical facility, general level of housekeeping, adherence to sound laboratory safety principles, and general demeanour of the laboratory staff.

b. Availability of Documents

i. The referral laboratory should willingly demonstrate the quality of its service by supplying the information in several categories of laboratory operation. Personnel Internal Quality Control External Quality Assurance activities Instrument Maintenance Client satisfaction

2. Efficiency of Referral laboratory Service:

a. Scope of Available Testing b. Specimen collection and test ordering c. Transportation d. Turnaround Time e. Reporting of results and Interpretations

Referral Laboratories must be accredited by an internationally recognised accrediting organisation and any deviations from the contract are communicated to the client by the Laboratory Manager.

The Section Head, Division Chief or the designated specialist at the referral laboratory must complete the Referral Laboratory Evaluation Checklist, which takes into consideration all of the above. A separate checklist is completed for each test at each referral laboratory. Selection Selection of the referral laboratory is then made by the Chief of Diagnostic Medicine in conjunction with the Section Head and Laboratory Manager. Periodic review of services: The evaluation of a referral laboratory is an ongoing process, and it is important that meetings are set up at regular intervals with the reference laboratory to review the relationship. The interval varies depending on circumstances, but should rarely extend beyond 5 years.



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Arrangements with referral laboratories are reviewed periodically to ensure that 1. requirements, including pre-examination and post-examination procedures are

adequately defined, documented and understood 2. the referral laboratory is able to meet the requirements and that there are no

conflicts of interest 3. selection of test procedure is appropriate for the intended use 4. respective responsibilities for the interpretation of the test results are clearly defined Records of these reviews are kept in the department secretariat. Register of referrals A daily record of all referred out tests is recorded in the LIS. In addition the Send-out Binder contains a record of all referred out tests including where the sample was sent and for which investigation. On receipt of results from the referral laboratory, they are entered into the LIS by a technologist and verified by a second technologist. In addition a pending list of referred out work is regularly checked to ensure that results are received within the specified turnaround times.

The laboratory's services are integrated and coordinated to ensure continuity of service for clients and service providers.

The laboratory as an integral part of patient care The laboratory is a vital member of the patient care team. Therefore it has an equal responsibility, with the other team members, for good patient care. In order to achieve this every member of the laboratory is responsible for:

Effectively working with colleagues both within and outside the laboratory Understanding the role each member of the laboratory team plays and their

responsibilities as defined in their job descriptions. Effectively communicating results, problems, concerns, incidents and relevant

information to their colleagues both inside and outside the laboratory Evaluating the laboratorys performance in providing good patient care. This

evaluation should be conducted in a safe environment with a view to rectify problems and not punishing individuals. In most instances these evaluations can be performed solely within the laboratory. However, any issue that directly

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involves physicians, affiliated medical personnel, or patients should involve their participation e.g. the choice of an instrument to do near patient testing of glucose must involve the people who use the instrument (nurses), the physicians who interpret the results, the people responsible for admitting the patients and the informatics department responsible for supporting the interface and server. These meetings are by necessity on an ad hoc basis.

Evaluating incident reports when the problem is in their area of responsibility. As the laboratory is only one member of the patient care team, it is the responsibility of the other members of the patient care team to advise the laboratory on how it can improve its services. Moreover, in the event that the laboratory is requested to expand its services, the requesting physician, nurse or allied health care worker is expected to be an active participant in the projects evaluation and implementation. This cooperation includes meetings with the appropriate laboratory personnel and participating in doing a literature search with references supporting the request from evidence based medicine point of view, cost benefit analyses, evaluating clinical requirements including present usage, expected increases and impact on other health care personnel such as nursing, porters, developing reference ranges etc. In the event that the request is agreed to, it is the responsibility of both the laboratory and the requesting physician to ensure the service is implemented correctly and subsequently evaluated.

Methods of communication An electronic users handbook is available on the Hospital website. This handbook contains information about what tests are available, turnaround time, reference intervals, specimen collection, special procedures etc. The Hospital e-mail (Lotus Notes) is used when necessary to communicate with internal and external laboratory users. In addition, all laboratory staff have an LIS e-mail, which is activated when they log on to the LIS. This is the usual method to communicate between all members of staff. There are other formal means of communication within the laboratory. These involve log books, which are instrument or work bench specific, and a general "Communication Book". These are used by the staff to communicate pertinent information with each other between shifts. In case of emergencies, all communication within the laboratory is direct person to person. Such emergencies usually involve the shutdown or problem with a major analyzer or the LIS. Communication outside the laboratory involves one or all of the following methods depending on the severity and duration of the problem:

mass faxing to all floors and clinics effected telephoning to all floors and clinics effected discussing the problem in person with the clinicians, nurses, secretaries directly

effected




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All laboratory staff are expected, where necessary, to participate in intra-laboratory, hospital, McGill University, affiliated institutional, provincial and national committees. During the past five years, the following committees represent areas where the laboratory has worked with other clinical colleagues to improve services. Committees on which laboratory technologists and managers have recently served: Jewish General Committees:

JGH Multi-Disciplinary Council Purchasing Committee JGH Accreditation Committee Diagnostic Medicine Executive Committee Diagnostic Medicine Health and Safety Committee DPS Committee JGH Transfusion Medicine Committee CQI (Continuous Quality Improvement) - JGH Quality and Risk Management Committee Failure Modes and Effect Analysis sessions (spin off from the PT. ID CQI

Committee) Medical Advisory Committee Committee for Implementation of Law 90 under the auspices of the MEC Clinical Council Committee Medical Executive Committee (MEC) Credentials Committee of the MEC Management Committee Policy Committee Ad Hoc Commitee Search and Selection Committee for Chief of Division of Infectious Diseases. SMSST (Systme de Management de sant et scutit au travail commitee) Patient ID Committee Transformational Change in Health Care Systems- Executive Committee Transformational Change Patient Flow Executive Committee Strategic Planning Committee-Representative of the Laboratories and Critical

Support Services Pavilion K Project Committee Microbiology Project Commitee

Provincial Committees:

Association des Mdecins Biochimistes du Qubec Comit aviseur rgional pour lorganisation territoriale des activits de laboratoire

Montral Central Executive Committee of the Council of Physicians, Dentists and

Pharmacists on MUHC Practice Plans



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Federation of Medical Specialists of Quebec Dawson College Advisory Committee Dawson College Disciplinary Committee Directors Committee Program Rseau-McGill Representative for Medical

Biochemistry Hema-Quebec Users Committee, McGill RUIS Laboratory Sub-Committee (Regional Distribution of Laboratory

Services) McGill Residency Program in Medical Biochemistry McGill, Pathology Search and Selection Committee Ministre de la Sant et des Services sociaux, Comit aviseur de Biochimie-

Reprsentant pour les quatres RUIS Ministre de la Sant et des Services sociaux, Comit dOptimisation des

Laboratoires de Biologie Mdicale du Rseau de Sant du Qubec-Representative for the AMBQ

RUCAL TechnoMed Traceline Undergraduate Medical Education Committee

National/International Commitees :

American Association of Blood Banks Canadian Alliance of Laboratory Medicine Canadian Association of Medical Biochemists Canadian Society of Transfusion Medicine Ortho Provue Users Group Ortho-North American Advisory Committee Royal College of Physicians & Surgeons (Canada) Royal College of Physicians (Ireland) Royal College of Pathologists (Britain)

Laboratory Specialists The laboratory is unique in the fact that all its laboratory physicians also work as clinicians in their specialties and therefore are intrinsically involved in both using and implementing laboratory services. Every physician has a cross appointment to the Department of Medicine, JGH due to their clinical activities. In addition, all laboratory professionals:

Perform routine work (clinical advising, technical and method selection and evaluation, quality assurance)

Participate in research activities of the laboratory Participate in educational and training activities

All of the laboratory professional staff have fulfilled the necessary provincial training requirements to work as specialists in Quebec.



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Medical Biochemistry

Dr. Elizabeth MacNamara MD, FRCP(I), MRCPath(UK), FRCP(C)

Chief of Diagnostic Medicine and Division Chief, Medical Biochemistry, Dept Medicine, Medical Biochemist Associate Professor, Faculty of Medicine McGill University

Dr. Shaun Eintracht MD, DTM&H, FCPath(SA), FRCP(C)

Medical Biochemist Assistant Professor, Faculty of Medicine McGill University

Microbiology

Dr. Andre Dascal MD, FRCP(C)

Medical Microbiologist Division Chief, Microbiology, Associate Professor, Faculty of Medicine McGill University

Dr. Christina A. Greenaway MD, FRCP(C) Medical Microbiologist Associate Professor, Faculty of Medicine McGill University

Dr. Joseph Portnoy MD, FRCP(C) Medical Microbiologist Associate Professor, Faculty of Medicine McGill University

Dr. Jerry Zaharatos MD, FRCP(C) Medical Microbiologist Assistant Professor, Faculty of Medicine McGill University

Dr. Matthew Oughton MD, FRCP (C)

Attending Physician, Division of Infectious Diseases Assistant Professor, Department of Medicine, McGill University

Hematology and Transfusion Services

Dr. Stephen Caplan MD, FRCP(C)

Division Chief, Transfusion Service and Hematology Associate Professor, Faculty of Medicine, McGill University

Dr. Arthur Rosenberg MD, FRCP(C) Medical Hematologist, Associate Professor, Faculty of Medicine, McGill University.

Dr. Martin Gyger MD, FRCP(C) Medical Hematologist, Professor, Faculty of Medicine, McGill University.

Dr. April Shamy MD, FRCP(C) Medical Hematologist, Assistant Professor, Faculty of Medicine, McGill University.

Dr. Francois Patenaude MD, FRCP(C) Medical Hematologist, Assistant Professor, Faculty of



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Medicine, McGill University.

Dr. Mark Blostein MD, FRCP(C) Medical Hematologist, Associate Professor, Faculty of Medicine, McGill University.

Dr. Sarit Assouline MD, FRCP(C) Medical Hematologist, Assistant Professor, Faculty of Medicine, McGill University.

Dr. Nathalie Johnson MD, FRCP(C) Medical Hematologist, Assistant Professor, Faculty of Medicine, McGill University.



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Clinical and laboratory advice Service users can obtain expert advice from the laboratory on:

Suitability of the requested procedure to solve the clinical problem in question Analytical performance of methods used in the laboratory (precision and

accuracy) Statistical significance of results and their relation to reference ranges Scientific basis and the clinical significance of the results

Documentation and management of complaints, errors and deviations from SOPs In order to improve the quality of laboratory services, a record of all errors, complaints (incidents) and deviations from SOPs is kept. These form the basis of rectifying problems, understanding processes and educating staff. The purpose of these records is not to apportion blame and is not used for this purpose except in the case of deliberate and/or repeated refusal to follow SOPs. Hospital Procedures There are three hospital-wide procedures for the registration (Incident report form) and handling of complaints and deviations from SOPs which also apply in the laboratory. These are as follows: 1. The patients' complaint procedure 2. The faults, accidents and near-accidents procedure 3. The staff complaint procedure These procedures cover most complaints and errors. Laboratory Procedures In addition to the hospital-wide procedures a number of systems are in place to record problems that occur within the laboratory. This includes log books specific for each work station, these log books are reviewed daily by the technical co-ordinator of each section and where necessary discussed with the Section Head responsible for that area. In the event that the coordinator or Section Head feel the problem requires further investigation a laboratory Quality Improvement Form is filled out. In some instances a Hospital incident report form may need to be completed as well. Any member of staff may directly contact the chief technologist if an error occurs which originates in the laboratory e.g. pending list not reviewed per shift, unacceptable turnaround times for analyses, samples left unprocessed, amending released results, patient complaints directly to a member of the laboratory staff and does not want to go to the hospital ombudsman etc. a laboratory Quality Improvement Form is filled out.

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Completed forms are submitted to the chief technologist with all necessary documentation. All forms are retained by the Quality Officer for 1 year. An investigation is performed by the chief technologist who then decides if the Section Head needs to be involved or he/she can deal with the problem themselves. Corrective action is taken if necessary. The rest of the form is then completed documenting this. Complaints made by telephone If a complaint is made by telephone, the person is put through to the chief technologist or Laboratory Manager who completes the appropriate form during the telephone call. Evaluation of complaints and suggestions All members of the departments management committee are expected to bring complaints for discussion and possible solutions to the DMEM. The minutes of the DMEM contain these discussions and relevant actions. Suggestions which are considered practical and likely to be effective are incorporated into the departments SOPs.

The patient's rights The hospitals statement on patients rights may be viewed here. Patients right to receive information The users handbook, available on the Hospital website, contains information for patients regarding the Test Centre location and opening hours, special collection procedures, etc. This website has unrestricted access. Patients may also telephone the Laboratory directly at 514-340-8212 to obtain information. Patients who have had their samples analysed in the Department Medicine may request to have a hardcopy of their results. See Procedure: Release results directly to the patient. These results can be provided by the laboratory secretariat under the following conditions and limitations. To safeguard both the results from use by unauthorized individuals and to guard the confidentiality of information, all requests for access to a patients results require that the patient complete and sign the Authorization to Release Information form and provide photo ID such as the RAMQ card. Patients requiring results from an in-hospital stay, Emergency, or other JGH Clinic must obtain their results from the Medical Records Department.

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Microbiology results: The Division of Clinical Microbiology discourages the distribution directly to patients or their representative(s) of microbiological and serological results for any and all Infectious Diseases. This is due to the fact that almost all such results require often-complex interpretation, and individualized application of the results to the patients' circumstances. Patients right to have personal information kept confidential All professional, technical and clerical personnel are legally obligated to maintain the confidentiality of patient data. New employees must attend the JGH orientation session, at which confidentiality is emphasised. Every reasonable precaution is taken to preserve confidentiality. Patient data is recorded in accordance with "La loi sur l'accs aux documents des organismes publics sur la protection des renseignements personnels". Moreover, all procedures in the laboratory are compliant with the Hospital's policy on confidentiality. Test requisition The laboratory requisition contains information on personal, medical and clinically sensitive data which requires the Hospital's rules on confidentiality to be strictly adhered to. This applies to all information which may appear on a requisition form. Acquisition of Specimens The laboratory tries to guarantee the patients privacy during their registration into the laboratory information system and while undergoing phlebotomy. Access to patient results The laboratory tries to ensure patient confidentiality in dealing with reporting, access and removal of all laboratory documents and computer files containing patient data. Access to patient data held in the computer system is controlled by a password system. Reporting of results The Procedure: Reporting of results and the Procedure: Assurance of Test Report Confidentiality contain information about the different ways the laboratory reports results and how confidentiality is assured. The Procedure: Release results directly to the patient contains information on how patients may obtain their results directly. Access to data for research purposes

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Anonymized patient results, i.e. results which have been separated from the patients identification, may be used for epidemiological, demographic or statistical research.



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The laboratory's staff are qualified and competent.

Staffing Plan The Chief of Diagnostic Medicine on an annual basis reviews the staffing required, taking into account:

The number of positions (FTEs) (professional staff, technologists and administrative personnel)

Shift work Sick days Statutory holidays Staff vacations Leave of absences Economic feasibility

Recruitment and Selection of New Personnel The recruitment and selection is performed according to Hospital policy, see Procedure: Hiring Personnel and is based on education and professional qualifications, training and expertise, and evidence of competency. Requirements for positions are found in each of the job descriptions. In the event of a vacancy arising, internal candidates (including trainees) are considered first. If there is no suitable internal candidate, a candidate is recruited externally from within the hospital and only then is an external candidate from outside the hospital. Exceptions to this include positions for departmental chiefs when full search and selection committees are formed according to the by laws of the hospital. Vacancies are filled by applicants whose training and qualifications make them suitable for the position in question. The Chief of Diagnostic Medicine, Division Chief, Laboratory Manager, Chief Technologist and the Hospitals Personnel Department are involved in the recruitment and selection process. The Chief of Diagnostic Medicine makes final decisions regarding appointments.

Working Hours

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The core laboratory is open 24 hours a day 7 days a week and has no after hours. However, the microbiology laboratory is closed between midnight and 8 am. During this time all specimens for culture are put in the incubator (e.g. Blood cultures and CSF cultures) or refrigerator (e.g. Urines and swabs) located directly below the reception window of microbiology. Samples to be sent out during weekends or night shift are processed as normal i.e. they are sent out with other samples if routine and if STAT the receiving laboratory is notified beforehand e.g. toxicology. All samples stored for batch analyses are stored according to the necessary requirements and are kept for 1-2 months post analysis before discarding. Routine corelab tests performed on serum/plasma are archived at 4C for 4-5 days before being discarded. Whole blood for CBC and coagulation is archived and kept for 24 hours before being discarded. Normal working hours for unionised or unionisable staff

Hours Break length Number of breaks Pertinent staff

08h00 - 16h00 30 min 60 min 1 1 All day staff

Evening, Night and Weekend Shifts

Days Hours Title Break length Number of breaks Pertinent

staff

Sunday to Sunday

16h00 - 00h00 Evening

30 min 60 min

1 1

All evening staff (except

Specialty sections)

Sunday to Sunday

00h00 - 08h00 Night

30 min 60 min

1 1 All night staff

Other shifts The laboratory ensures that there is enough staff at all times to carry out the work required. Other shifts (i.e. 6h30-14h30; 9h00-17h00 etc...) are therefore staffed in order to optimize workflow and decrease bottlenecks. Peak times are:

September, October to November 15 January 03 to January 31 March 15 to May 15

Extra staff will be scheduled as required.



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Statutory holidays in the laboratory are scheduled as a weekend shift. Test Center

Days Hours Title Break length Number of breaks Pertinent

staff Monday to Thursday 7h30 - 20h00 Day/Evening

30 min 60 min

1 1 Day Staff

Friday 7h30 - 16h00 Day 30 min 60 min 1 1 Day Staff

The Test Center is closed on weekends and statutory holidays. Out-of-hours Management Cover The Core laboratory chief technologist or assistant chief technologist is on call 24 hours a day and can be contacted via the Core laboratory cell phone 514-802-2905 or by calling the Core laboratory (x5094) to obtain the pagette number of the on call person. The Microbiology chief technologist can be contacted through pagette number 514-413-1119. The Transfusion Services chief technologist can be contacted through pagette number 514-413-1211. The Medical Biochemist or Clinical Chemist on call can be contacted by calling the Core laboratory (x5094). The Hematologist, Medical Biochemist or Microbiologist on-call can be contacted by telephoning the hospital switchboard (Locating x8232). Absenteeism Planning In the event of an unexpected occurrence e.g. maternity leave, illness, early retirement, new requirements for tests etc. the laboratory re-evaluates its staffing requirements and tries to meet these needs as promptly as possible. Vacations Vacation Lists are posted in March and September in accordance with the relevant provisions of the current collective agreement. Final approval by the Chief Technologist is required. Special Leave and Study Leave These are given in accordance with the relevant provisions of the current collective agreement. Availability



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Availability shift duties are as required by the laboratory and take into account staff availability and the collective agreement. Sick Leave This is taken in accordance with the relevant provisions of the current collective agreement.



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Laboratorys organizational chart 0

Chief of Professional Services

Chief of Diagnostic Medicine

Division Chief: Microbiology

Division Chief: Hematology and Transfusion

Division Chief: Biochemistry

Quality & Safety Officer

Microbiologists

Hematologists

Biochemists

Chief Technologist Microbiology

Assistant Chief Technologist

Chief Technologist Transfusion

Chief Technologist Corelab

Technical Coordinators

Phlebotomists Clerks Medical Technologists Graduate Technologists

Medical Technologist t Clerks

Transfusion Safety Nurse and Technologist

Medical Technologists Graduate Technologists

Medical Technologist (BG)

Laboratory Manager

Technical Coordinators (BG)



Test Center



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Manual of job descriptions All staff members have the necessary authority and resources to carry out their duties as reflected in their job descriptions. All staff members have access to the job descriptions, which are listed in the Manual of job descriptions. Job descriptions are reviewed on a frequent basis and if there has been any change in the requirements of the position. The laboratory annually reviews the roles and responsibilities of each staff, and monitors whether position profiles are being followed. See Procedure: Staff Performance Appraisal. In the event that the role and the job description have a discrepancy then the job description is updated. The Laboratory Management team consists of:

The Chief of Diagnostic Medicine Laboratory Physicians and PhDs Laboratory Manager Quality and Safety Officer Chief Technologists

The Laboratory Management team and all of the staff members of the Department of Diagnostic Medicine are responsible for ensuring compliance with the International Standard ISO 15189:2007. When any member of the laboratory team is absent another member is designated to replace them and performs their managerial functions during their absence

Responsibilities of the Chief of Diagnostic Medicine The Chief of Diagnostic Medicine has general and executive responsibility for all laboratory operations: administrative, analytical, consultative, educational and scientific. The Chief of Diagnostic Medicine delegates part of her responsibilities to the Division Chiefs according their areas of responsibility. The Chief of Diagnostic Medicine has the following responsibilities:

1. Ensuring that advice about analytical services, selection of tests and interpretation of results is available to all physicians and laboratory users.

2. Serving as an active member of the Hospital's medical staff

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3. Ensuring appropriate relationships with accreditation bodies, the hospital administration, healthcare community and the patient population.

4. Defining, implementing, maintaining and monitoring standards of performance and quality improvement of laboratory services

5. Developing the laboratory Quality System and ensuring that it is implemented

6. Oversees, manages and supervises all Point-of-care testing throughout the hospital and affiliated centers.

7. Ensuring participating in the different hospital committees for quality improvement

8. Monitoring of the laboratory work in order to ensure medically reliable data is generated

9. Ensuring that there are sufficient qualified, trained and experienced personnel to meet the needs of the laboratory

10. Ensuring that the laboratory's objectives and resources are used according to the medical needs

11. Managing laboratory finances and accounts according to the Hospital's assignment of these responsibilities

12. Providing educational programs for professional staff, technicians and other laboratory personnel, and participate where necessary in the Hospital's educational programs

13. Planning and directing research and development appropriate to the facility

14. Ensuring that referral laboratories are selected and monitored for quality of their services

15. Implementing a safe laboratory environment according good practice and applicable regulations and guidelines

16. Addressing any complaint, request or suggestions arising from users of the laboratory's services

17. Ensuring good staff morale Responsibilities of the Division Chief and Medical Staff

1. Serving as an active member of the Hospital's medical staff 2. Performing routine work (clinical advising, technical and method selection

and evaluation, quality assurance) 3. Directing clinical issues 4. Communicating directly with their Divisional Chief and the Chief of

Laboratories. 5. Providing advice on the choice of tests 6. Providing advice on the use of laboratory services 7. Interpretation of laboratory data 8. Participate in research activities of the laboratory 9. Participate in educational and training activities



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Responsibilities of the Laboratory Manager The Laboratory Manager is responsible for the financial and administrative functioning of the Department of Diagnostic Medicine. These responsibilities include the following:

1. Submitting the yearly budget proposal to the DPS 2. Managing laboratory finances and accounts according to the Hospital's

assignment of these responsibilities 3. Communicating directly with the Chief Department of Diagnostic Medicine 4. Ensuring appropriate relationships with the Ministry of Health,, Agence,

public and private health institutions 5. Addressing all Human Resource issues regarding staff and grievances,

working directly with HR an participating in the necessary meetings 6. Responsible for the Chief Technologists following the rules and

responsibilities to ensure the smooth functioning of the Department.

Responsibilities of the Laboratory Quality and Safety Officer The Quality and Safety Officer is responsible for the maintenance of the Quality System and Safety Program in the department. She reports directly to the Chief of Diagnostic Medicine. These responsibilities are performed in conjunction with all the members of the Department of Diagnostic Medicine and the JGH CQI Coordinator and the JGH Biosafety Officer. The Laboratory Quality and Safety Officer has the following responsibilities:

1. Implementation and management of the Quality System; 2. Producing, maintaining, amending and updating the Quality Manual 3. Producing, maintaining, amending and updating the Quality and General

Procedures Manual 4. Convening and chairing meetings for Document Review, Audits, and

Safety 5. Convening and chairing internal audits 6. Reporting to the Chief of Diagnostic Medicine all audit analysis and

conclusions 7. The Quality Officer has overall responsibility for each section performing

the required quality control but it is the responsibility of each section to implement, interpret and trouble shoot quality issues.

8. Planning and organizing audits and reviews 9. Ensuring the completion of corrective actions resulting from audits within

the appropriate timescale



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10. Ensuring control and maintenance of the documentation of the quality management system

11. Other responsibilities and functions attributed by the Chief of Diagnostic Medicine or assigned in the Quality Manual.

The Quality and Safety Officer has, in conjunction with the Chief Technologists, the following safety related responsibilities:

1. Establishing the preventative safety procedures in reference to laboratory activities according the current standards and regulations.

2. Ensuring observance with safety regulations 3. Ensuring the regular monitoring of safe work practices 4. Ensuring the regular monitoring and evaluation functions in the safety

program, including annual audits 5. Ensuring an annual review of its risk reduction strategies 6. Collecting suggestions from laboratory staff 7. Ensuring that the laboratory staff are trained in safety matters 8. Recommend/organize courses on risk prevention, safety and related

topics for the laboratory staff Responsibilities of the Chief Technologist Under the direction of the Chief of Diagnostic Medicine and the Division Chief/Section head, the Chief Technologist has the responsibility of organizing, supervising and coordinating various technical, clinical, quality and safety activities of their section. Under the direction of the Laboratory Manager, the Chief Technologist has the responsibility for the administrative duties of their designated areas of the Department of Diagnostic Medicine. The Chief Technologist has the following responsibilities:

1. Ensuring an efficient, well-coordinated and effective operation of their section

2. Evaluating the needs of their section with regards to staffing 3. Interviewing and selecting laboratory personnel through selection criteria 4. Assisting in the development of laboratory information systems 5. Providing effective collaboration with other areas within the hospital and

with external clients 6. Investigating and documenting complaints / incidents regarding staff and

laboratory service 7. Performing Performance Appraisals of the Staff 8. Participating in committees related to the functioning of the department



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9. Reporting to the Laboratory Manager and Chief of Diagnostic Medicine/Division Chief/Section Headas needed

Training of residents Training is performed in accordance with provincial guidelines and laws, McGill university guidelines and requirements and follows CanMeds concepts. At the midpoint of every 4 week rotation the resident is given verbal feedback as to any areas requiring improvement. At the end of each rotation, residents have a written assessment completed by their supervisor. In the event that there is a problem the Program Director must be involved, if the problem is serious the Associate Post Graduate Dean at McGill must be immediately informed. All written assessments are to be discussed with the resident and returned to the Program Director within two weeks of completing the rotation.

Training of student technologists Student technologists from Dawson College are trained in the Department of Diagnostic Medicine during their stage. These students receive practical and theoretical instruction by clinical instructors specifically trained for this purpose. They follow the guidelines laid down by the provincial government and Dawson College.

Training of technical personnel All new technologists have passed the provincial requirements for practising technologists. However, there are many grandfathered technologists who do not meet current registration needs. All technologists employed in the Department of Diagnostic Medicine are familiar with and perform their work according to the Instrument, Analytical and Administrative procedures. Staff training requirements are carefully assessed and the appropriate training planned, with a view to ensuring that the laboratory has and will continue to have sufficiently well qualified and competent personnel to meet is changing needs. The training of technologists is made in accordance with the needs for each work station and it consists of: One-on-one training with the technical coordinatorr (or designated staff

member) and Hands-on operation All these activities are recorded in the training checklist for each workbench.

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The chief technologist assesses basic training of the technologists. The chief technologist is responsible for:

1. Assessing the knowledge and correct performance of the general procedures (related with the production, validation, issuing of laboratory results) by all the technologists

2. Ensuring that the knowledge is up to date 3. Maintaining records of the training undertaken, symposia attended, etc

The technical coordinator or Section Head (when necessary) supervises new staff for a variable period. The length depends on their experience and skill. Adequate theoretical and practical training is given to any member of staff to whom additional duties are assigned.

Continuing Education Programs All members of the laboratory keep their knowledge and skill updated by performing continuing education activities as required by their professional organisations. Physicians must meet the Royal College of Physicians and Surgeons of Canada and the Collge des Mdecins du Qubec requirements. Technologists and other staff are encouraged and helped financially to attend the multitude of opportunities offered. These activities are recorded in their personal files in the Departments secretariat.

Competency The laboratory has a formal program to assess competence which is based on direct observation of the technologists by their co-ordinator. A Technical performance re-assessment form is completed by the Technical Coordinator (or Chief Technologist) and given to the Chief Technologist. In the event future or corrective training is required, it is provided. In addition there is a formal staff evaluation program, see Procedure: Staff Performance Appraisal. This document describes the procedure for performance appraisal of all staff. The hospital maintains an accurate, complete, and confidential record for each staff member according to hospital, provincial and collective agreement guidelines. The laboratory keeps an additional file where requests for shift change, training, vacation requests etc. This is an adjunct file which is kept in addition to the main file in Human Resources but also is governed by the laws and regulations of the province and hospital.

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Laws relating to laboratory practice in Quebec The laboratory follows all relevant laws where appropriate. Copies of the laws are not kept by the laboratory but are available to all staff by following the links below. In addition the laboratory complies with, where appropriate recommendations of professional bodies such as the Royal College of Physicians and Surgeons of Canada, the Collge des Mdecins du Qubec, the Federation of Medical Specialists of Quebec, the Clinical and Laboratory Standards Institute guidelines and other professional groups such as the OPTMQ. Compliance with the law is not a choice. The laws where possible are implemented in the functionality of the computer system and procedures within the laboratory. Where individuals could break the law e.g. health and safety, patient confidentiality it is impossible to effectively monitor. It is a professional responsibility of all staff members to adhere to the laws relating to their work

1. Code de Construction du Qubec 2. Code de dontologie Technologues professionnels du Qubec 3. Code of Professional Conduct CSMLS 4. Loi sur l'accs aux documents des organismes publics et sur la protection

des renseignements personnels 5. La Loi sur le tabac 6. La Loi 90 7. Loi sur les laboratoires mdicaux, la conservation des organes, des tissus,

des gamtes et des embryons et la disposition des cadavres 8. Loi sur les produits dangereux 9. National Building Code of Canada 10. National Fire Code of Canada 11. Recueil de rgles de conservation des documents des tablissements de

sant et de services sociaux du Qubec 12. Rglement sur les produits contrls (description des catgories du

SIMDUT) 13. Quebec occupational health and safety requirements for the workplace 14. WHMIS (SIMDUT) regulations

Other links 1. Association sectorielle paritaire 2. Canadian Nuclear Safety Commission 3. CanMeds 4. Carnet d'adresses de lUQTR ddi la sant, la scurit au travail, la

protection de l'environnement relatif aux substances dangereuses et aux rayonnements ionisants et non ionisants

5. Clinical and Laboratory Standards Institute 6. Collge des Mdecins du Qubec 7. Commission de la sant et de la scurit du travail

http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=//B_1_1/B1_1R0_01_01.htmhttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=3&file=/C_26/C26R258.HTMhttp://www.csmls.org/About-CSMLS/Who-We-Serve/Code-of-Conduct.aspxhttp://www.csmls.org/About-CSMLS/Who-We-Serve/Code-of-Conduct.aspxhttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/A_2_1/A2_1.htmlhttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/A_2_1/A2_1.htmlhttp://www.msss.gouv.qc.ca/loi-tabac/http://emploiquebec.net/entreprises/formation/loi-competences/index.asphttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/L_0_2/L0_2.htmlhttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/L_0_2/L0_2.htmlhttp://laws-lois.justice.gc.ca/fra/lois/H-3/http://laws-lois.justice.gc.ca/fra/lois/H-3/http://irc.nrc-cnrc.gc.ca/pubs/codes/index_f.htmlhttp://irc.nrc-cnrc.gc.ca/pubs/codes/nrcc47667_e.htmlhttp://www.aqesss.qc.ca/docs/public_html/document/Documents_deposes/recueil_conservation_2009.dochttp://www.aqesss.qc.ca/docs/public_html/document/Documents_deposes/recueil_conservation_2009.dochttp://laws.justice.gc.ca/fr/H-3/DORS-88-66/index.htmlhttp://laws.justice.gc.ca/fr/H-3/DORS-88-66/index.htmlhttp://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=//S_2_1/S2_1_A.htmhttp://www.hc-sc.gc.ca/hecs-sesc/simdut/http://www.preventionenligne.com/http://www.suretenucleaire.gc.ca/http://rcpsc.medical.org/canmeds/CanMEDS2005/CanMEDS2005_e.pdfhttps://oraprdnt.uqtr.uquebec.ca/pls/public/gscw035?owa_no_site=1855&owa_no_fiche=26&owa_page=1&owa_bottin=&owa_apercu=N&owa_imprimable=Ohttps://oraprdnt.uqtr.uquebec.ca/pls/public/gscw035?owa_no_site=1855&owa_no_fiche=26&owa_page=1&owa_bottin=&owa_apercu=N&owa_imprimable=Ohttps://oraprdnt.uqtr.uquebec.ca/pls/public/gscw035?owa_no_site=1855&owa_no_fiche=26&owa_page=1&owa_bottin=&owa_apercu=N&owa_imprimable=Ohttp://www.clsi.org/http://www.cmq.org/http://www.csst.qc.ca/



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8. Federation of Medical Specialists of Quebec 9. Guide pour la prophylaxie post exposition (PPE) aux personnes exposes

des liquides biologiques dans le contexte du travail 10. National Firefighters Prevention Association 11. OPTMQ 12. Royal College of Physicians and Surgeons of Canada 13. Service du rpertoire toxicologique de la CSST 14. The Xchange database for MSDS of many companies

http://www.fmsq.org/http://msssa4.msss.gouv.qc.ca/fr/document/publication.nsf/LienParId/24578EA647005722852571480070070F?opendocumenthttp://msssa4.msss.gouv.qc.ca/fr/document/publication.nsf/LienParId/24578EA647005722852571480070070F?opendocumenthttp://www.nfpa.org/http://www.optmq.org/http://rcpsc.medical.org/http://www.reptox.csst.qc.ca/http://www.msdsxchange.com/



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Laboratory Ethics

General Statement The patients welfare is the main objective of the Department. Their interest is always the first consideration and priority. The Department treats all patients fairly, equally and without discrimination. The professional staff are bound by the code of ethics of their professions. The laboratory is not engaged in any practice restricted by law. All staff of the Department will not be influenced by outside parties when they are consulted about the appropriateness of:

(a) Purchasing equipment, materials, reagents etc. (b) Selecting referral laboratories. (c) Any other laboratory business.

Ethical Aspects of Information Collection The laboratory collects information necessary for the proper identification of the patient which enables the requested tests and other laboratory procedures to be carried out. Unnecessary personal information, however, is not collected in any way. Patients are aware of the information collected and the purpose for which it is collected. Information about communicable diseases or other conditions which concern the safety of staff and other patients may also be collected where deemed necessary by the attending laboratory staff. Other legitimate management concerns for which information may be collected include billing purposes, financial audit, resource management and utilization reviews. Samples which are part of research protocols must have had the protocol approved by the hospital IRB with informed patient consent.

Ethical Aspects of Specimen Collection For most routine laboratory procedures (e.g. venipuncture), consent can be inferred when the patient presents at the laboratory with a request form and willingly submits to the usual collection procedure.



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Information collected at registration, during phlebotomy and primary specimen reception adheres to patient privacy rights. Samples arriving at the laboratory in an unsuitable condition for the requested tests are discarded and the referring physician notified. This information is entered into the LIS and a report is sent to the requesting physician. More details are available in the Procedure: Sample Reception and Registration and the Procedure: Patient Registration in the Test Centre.

Ethical Aspects of Assay Performance All laboratory tests are carried out according to appropriate standards and with the level of skill and competence expected by the profession. Any fabrication of results, QC etc. is illegal, unethical and totally unacceptable. The use of samples for purposes other than for what they were specifically obtained for, without previous written consent of the patient, is only possible if they are converted to anonymous specimens or pooled and are used to improve laboratory performance or interpretation of test results e.g. establishing reference ranges, internal pool for QC.

Ethical aspects of reporting laboratory results The results of laboratory tests attributed to a specific patient are confidential (unless disclosure is explicitly authorized). Results are reported to the requesting physician or physician group practice. If the patient gives consent or if required by law, results may be reported to other parties. The laboratory is committed to accurate reporting of test results. Moreover, it is the laboratorys responsibility to ensure that, where needed, tests which require interpretation e.g. serum protein electrophoresis are correctly interpreted by the reviewing physician or clinical chemist. In addition the laboratory provides advice on the selection and interpretation of tests.

Ethical Aspects of laboratory Records Storage and Retention The laboratory information is stored in such a way (electronic and paper) according to the Procedure: Records Filing, where the appropriate safeguards against loss, unauthorized access or tampering and other misuse are taken.

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The Procedure: Records Filing describes the retention of laboratory results, QC, requisitions etc. according to provincial requirements and / or the hospitals regulations.

Ethical aspects of access to laboratory records Access to laboratory records is described in the Procedure: Assurance of Test Report Confidentiality. Laboratory records are available to: 1. The patient either through their physician or from the Department according to

the Release of Results Policy 2. The requesting clinician. 3. Laboratory staff, if required in the performance of their duties. 4. Other authorized individuals, according the Hospital's confidentiality policy.

The Chief of Diagnostic Medicine can restrict access to records:when it would be contrary to the patient's best interests The laboratory does not enter into financial arrangements with referring practitioners; companies providing reagents, instruments or laboratory material; or any funding agencies, if these arrangements can act as an inducement for examinations or patients, or interferes with the physicians independent assessment of what is best for the patient or choice of supplier. The laboratory avoids situations which give rise to a conflict of interest. Where this is not possible, the interests are declared and steps are taken to minimize the impact.

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Documentation All methods and procedures necessary for the proper performance of assays are readily available to all staff. These are available in an electronic format through any of the hospital computers or thin client servers connected to the JGH intranet. In addition, the Transfusion Services laboratory has one paper copy of all its policies and procedures.

Identification Documents are clearly identified, with header and footer containing:

title unique database identification number author(s) authorization date of authorization revision history file name date last reviewed page number

Document Structure General Quality Procedures are organized under the following headings:

Quality and General Procedures Manual Instrument Manual Test Manual Forms, flowcharts, etc Schedules Transfusion Service LIS Manual Health and Safety, Waste Manual Job Descriptions Requisitions Search Document Titles ( search engine for finding documents)

All Documents in the P&P can be searched using any word found in the document titles.



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Document Control All documentation (including the Quality Manual) is subject to strict management control. The key internal document describing the document control system is Document Creation, Modification, Review, Approval and Destruction: A174.3. The Chief of Diagnostic Medicine is responsible for the final approval of the Quality Manual. The relevant Section Heads authorize the administrative, analytical, instrumental documentation applicable to their section. The Health and Safety manual and other manuals may be approved by a designated senior member of the laboratory on behalf of the Chief of Diagnostic Medicine. Only valid, approved versions of the manuals are in use. There are no unapproved manuals, policies or procedures available as only one current copy of any of these is available at any given time. All personnel are instructed on the use of our P&P software as part of their initial orientation in the laboratory. In addition all staff are required to read the necessary sections of the P&P for their area of responsibility. All staff must read the Quality Manual as part of their initial orientation and be able to access all links. Requests for amendments to existing documents and for new procedures are brought to the attention of the Chief Technologist and Section Head. These may approve the proposed amendments if the amendments affect their section alone. In the event the amendment affects more than one section of the laboratory the amendment must be approved by the DMEM. However, only the Chief of Diagnostic Medicine can approve changes to the Quality Manual. No changes can be made by any member of staff except via this method as it is impossible to alter any document, procedure, register form etc. as they are in a read only format. In addition, written notes are not allowed to over ride these documents except under emergency conditions with the Chief of Diagnostic Medicine (or designate) explicit written authorization. Transfusion Services are an exception to this as they use one paper copy of all policies and procedures. They have a separate system of documenting changes. Instrument log books and communication books are available beside all instruments and laboratory sections. These are used to document in a real time basis problems, communication etc.. between different shifts, coordinators, chief technologists, technologists and clerks. All relevant communication books must be read on arrival to a work bench by all staff before their shift. Notifications of any changes made in the P&P are automatically sent to staff effective by the changes All laboratory manuals are reviewed on both an ad hoc and tri-annually basis. The responsibility for these reviews lies with the appropriate Division Chief/ Section Head and Technical Coordinators. However,



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the Quality Manual is reviewed on a yearly basis by the Quality and Safety Officer and the Chief of Diagnostic Medicine. All staff are required to read and understand the appropriate sections of the policies and procedures applicable to the section in which they will be working. In addition, all staff are responsible for ensuring the SOPs that they review are kept up-to-date by reporting errors, obsolete practices etc. to the Quality Officer or Chief Technologist.

The laboratory keeps up-to-date, complete, accurate and secure records. All requests for examinations performed by the laboratory are recorded in the LIS. All relevant information is entered into the LIS on reception of the specimen or at the time of registration in the Test Centre. See Entering new orders for in-patients or ER patients in the LIS and Entering new orders for out-patients in the LIS. Quality controls performed and any corrective actions are linked to the record. Once resulted (verified), the record is secure and may only be amended by authorised staff. All amendments and the staff member making the amendments are recorded in the LIS. The fact that a change has been made is visible to all reviewing the results. See ethics section above for information on how the record is used and by whom. All samples are traceable via the LIS to their location once they are received in the laboratory. The length of time the different records are retained comply with legislative and regulatory requirements.

Validation of methods Validation is performed on every new test or when there is a change in the lot number, calibration or standard for a test prior to it being used for diagnostic purposes. All equipment and associated software must be installed and validated according to the manufacturers requirements. In addition, the functioning of the equipment and software must be validated before its initial use. The validation procedure must be approved by the Section Head. See Procedure: Installation and Method Validation.

Validation of Test Results Most instruments in our laboratory are interfaced to the Laboratory Information System (LIS). The LIS is programmed to perform automatic validation of all results that meet QC criteria, are not flagged with an error code or are not a

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panic value. All of these exceptions require manual validation by a trained medical technologist. See Procedure: Reporting of Results.

Amendments to results Once data has been validated and released, it is protected against unauthorized revision. Revision includes any changes to results, interpretations or accompanying reference intervals. A password-permission system based on laboratory hierarchy allows authorized access to the data for correction purposes. Authorized staff may make corrections to previously published results; however, the original data must remain legible. The person responsible for correcting the report signs out such corrections electronically by virtue of their password protected login. When a report is corrected the following information will be available (print