rt lqm 2 quality partnerships and standards development

7/31/2019 Rt Lqm 2 Quality Partnerships and Standards Development

1/45

1

Medical Laboratoriesand

Standards Development

Michael Noble MD FRCPCUBC Program Office for Laboratory Quality Management

January 2009


2/45

Outline

Quality Partners

Standards Development

ISO 15189

Case Study Quest Diagnostics and Vm D


3/45

3

A quality story

EQALM 2007

A Pathologist from London gave a presentationon how he felt the great responsibility for being

the sole person responsible for the quality ofhis medical laboratory.


4/45

4

A quality story

EQALM 2007

A Pathologist from London gave a presentationon how he felt the great responsibility for being

the sole person responsible for the quality of hismedical laboratory.

He felt no relief when he was informed thatwhile he was clearly important he was far frombeing the sole driver of his laboratorys quality.


5/45

5

Quality Partnerships

Standards

Development

Bodies

Accreditation

Bodies

Laboratory

Management

Laboratory

Quality

Management


6/45

6


Reagents

Supplies

Manufacturers

Laboratory

Management

Professions

Guidelines

Committee

Standards

Development

Bodies

Accreditation

Bodies

External

Quality

Assessment

Bodies

Equipment

Manufacturers

Laboratory

Quality

Management


7/45

7


EquipmentManufacturers

Laboratory

Management

ReagentsSupplies

Manufacturers Professions

Guidelines

Committees

Standards

Development

Bodies

ExternalQuality

AssessmentBodies

Accreditation

Bodies

THEPUBLIC

Laboratory

Quality

Management


8/45

8


EquipmentManufacturers

Laboratory

Management

Reagents

SuppliesManufacturers Professions

Guidelines

Committees

Standards

DevelopmentBodies

ExternalQuality

AssessmentBodies

Accreditation

Bodies

THE

PUBLIC

Laboratory

Quality

Management

When the Public shines a light on laboratory quality,

smartlaboratories listen


9/45

9

Partners who can provide help
http://www.dap.org/Default.aspx


10/45

10

Organizations: the quality network

ASQ US www.asq.org Website information (Free), documents ($)

CLSI US www.clsi.org Document access ($)

CMPT BC www.cmpt.ca Website information (Free),

CSA CAN www.csa.ca Website information (Free), documents ($)

DAP BC www.dap.org Website information (Free)

ISO INT www.iso.org Website information (Free), documents ($)

POLQM BC www.polqm.ca Website information (Free),

QMPLS ONT www.qmpls.org Website information (Free),documents (Free),

SCC CAN www.scc.ca Website information (Free), documents ($)


11/45

11

Organizations: the quality network

ASQ US www.asq.org Website information (Free), documents ($)

CLSI US www.clsi.org Document access ($)

CMPT BC www.cmpt.ca Website information (Free),

CSA CAN www.csa.ca Website information (Free), documents ($)

DAP BC www.dap.org Website information (Free)

ISO Int www.iso.org Website information (Free), documents ($)

POLQM BC www.polqm.ca Website information (Free),

QMPLS ONT www.qmpls.org Website information (Free),documents (Free),

SCC CAN www.scc.ca Website information (Free), documents ($)


12/45

12

Terms and Definitions

Standard:Broad consensus document.

Authorized by an authoritative body.

Guideline:Consensus document.

Regulation:

A regulatory (licensure) requirement.A regulator can cite any sourcedocument.


13/45

Many jurisdictions set their own standards,guidelines, regulations, requirements

Advantages

Fast

Local Orientation

Local Expertise

Local Logic

Disadvantages

Too introspective

Expertise Gap

Inconsistent with neighbours

Lost trade opportunities

Lost research opportunities

Credibility Gap

May exclude opportunities

for progress and growth.


14/45

Many jurisdictions set their own standards,guidelines, regulations, requirements

Advantages Fast

Local Expertise

Local Circumstance

Disadvantages Too introspective

Expertise Gap

Inconsistent with neighbours

Lost trade/researchopportunities

Credibility Gap

May become to detailed(vertical)

LOTS OF ADVANTAGES TO SHARED DOCUMENTS


15/45

15

A Brief History

1995The International Organization forStandardization (ISO) (at the request of the

United States) invited the international medicallaboratory community to a meeting inPhiladelphia to discuss the possibility of a singleharmonizing standard for medical laboratories

Attended by 33 countries from North America, SouthAmerica, Europe, Asia, Australasia.


16/45

16

ISO Technical Committee 212Clinical laboratory testing and in vitro diagnostic test systems

33 participating countries Argentina ( IRAM ) Australia ( SA ) Austria ( ON ) Belgium ( NBN ) Brazil ( ABNT )

Canada ( SCC ) Chile ( INN ) China ( SAC ) Czech Republic ( CNI ) Denmark ( DS ) Finland ( SFS )

France ( AFNOR ) Germany ( DIN ) Iran, Islamic Republic of ( ISIRI ) Ireland ( NSAI )

Israel ( SII ) Italy ( UNI ) Jamaica ( BSJ ) Japan ( JISC ) Korea, Republic of ( KATS )

Malaysia ( DSM ) Mexico ( DGN ) Netherlands ( NEN ) New Zealand ( SNZ ) Norway ( SN ) Portugal ( IPQ ) Singapore ( SPRING SG )

Spain ( AENOR ) Sweden ( SIS ) Trinidad and Tobago ( TTBS ) Turkey ( TSE ) United Kingdom ( BSI )
http://www.iso.org/iso/about/iso_members/iso_member_body.htm?member_id=2168http://www.iso.org/iso/about/iso_members/iso_member_body.htm?member_id=2168


17/45

17

ISO Technical Committee 212Clinical laboratory testing and in vitro diagnostic test systems

18 observingcountries

Bulgaria ( BDS ) Croatia ( HZN ) Cuba ( NC ) Cyprus ( CYS ) Egypt ( EOS ) Estonia ( EVS )

Hong Kong, China (ITCHKSAR ) Hungary ( MSZT )

India ( BIS )

Luxembourg ( ILNAS ) Malta ( MSA )

Mongolia ( MASM ) Russian Federation (

GOST R ) Saudi Arabia ( SASO ) Switzerland ( SNV ) Thailand ( TISI ) Uruguay ( UNIT ) Zimbabwe ( SAZ )


18/45

The meeting was attended the byinternational community of laboratorians

Laboratorians

Accreditation bodies

Medical Device Manufacturers Metrologists

Calibration authorities

Medical Laboratory Consultants Organizational Representatives

CAP, WHO, WASP, OECD,EDMA, IBWM,ELM,IFCC, ILAC


19/45

ISO Technical Committee 212

Working Groups

1 - Quality and competence in the medical laboratory

2 - Referencesystems 3 - Invitrodiagnosticproducts

4 -Antimicrobialsusceptibilitytesting


20/45

Canadian Participation inISO Technical Committee 212 Canadian Advisory Committee to ISO TC 212

Required by Standards Council of Canada

Hosted by Canadian Standards Association

Participates in all four working groups

Representatives from all laboratory disciplines.

Regional representation

Also responsible for CSA standards for medicallaboratories (fume hoods, safety cabinets, sharps containers).


21/45

21

Standards Developed by ISO TC 212

Seventeen standards in the areas of Laboratory Quality Management

Safety

Risk

Point of Care

Calibrators

Validation

Susceptibility Testing

Traceability

Label Symbols Canadian lead writing teams


22/45

22

ISO 15189

Theinternational standard

for medicallaboratory

quality and

competence


23/45

23

Laboratories and their standards:similar but different


24/45

24

Not all laboratories are the same

Medical A laboratory of many integrated proceduresintended for diagnosis, confirmation,documentation of human health information

CommunityHospital

Public Health

Testing A laboratory of limited stand-alone procedures

intended to confirm conformity of a product to itsexpected target or goal

Manufacturing

ElectricalWater

Food

Mining

Public Health

Calibration A laboratory of a very limited range ofprocedures intended to ensure traceability ofequipment or material to highest level possible.

ReferenceNIST


25/45

25

ISO 15189:2007Medical Laboratories particular requirements forquality and competence.

First published in 2003

Adopted as a Canadian National Standard

Adopted as the basis for provincial accreditation inOntario, Quebec, Atlantic Canada

Recognized as the source for quality management inrequirements Alberta, Saskatchewan, Manitoba.

Recognized as a source of quality management

requirements in British Columbia Quality and competence are holistic issues.

15189 is not laboratory discipline specific.


26/45

26

ISO 15189 requirements

Management Requirements1. Organization2. Quality Management System3. Document Control4. Review of Contracts

5. Referral Laboratories6. External Services and Supplies7. Identification and control of

non-conformities8. Corrective Actions9. Preventive Actions

10. Continual Improvement11. Quality and Technical Records12. Internal Audits13. Management Review

Technical Requirements1. Personnel2. Accommodation / environment3. Laboratory Equipment4. Pre-examination procedures

5. Examination procedures6. Assuring quality of examinations7. Post-examination procedures8. Reporting Results


27/45

27

15189 Examples

Organization A medical laboratory shall be a legal entity.

Medical laboratories shall be designed to meet patient needs.

Laboratory personnel responsibilities shall be defined.

Laboratory management shall provide personnel with theresources and authority to perform their duties.

Laboratory policies and procedures shall protect confidentialinformation.

The laboratory shall appoint a quality manager.

The laboratory shall have technical management for overallresponsibility of technical operations and the provision ofresources needed to ensure the required quality of laboratoryprocedures.


28/45

28

15189 and the Laboratory Director

The laboratory shall be directed by a person or persons havingexecutive responsibility and the competence to assumeresponsibility for the services provided. (note: competence is theproduct of basic, academic, postgraduate, continuing education, andtraining and experience of several years in a medical laboratory).

The laboratory director shall be responsible forprofessional,scientific, consultative or advisory organization, administrativeand educational matters.

The laboratory director need not perform allresponsibilities personally. However it is the laboratorydirector who remains responsible for the overalloperation and administration of the laboratory, forensuring quality services provided for patients.


29/45

29

15189 and Management Review

Laboratory management shall review the laboratorys qualitymanagement system and all of its medical services, includingexamination and advisory activities to ensure their continuingsuitability and effectiveness in support of patient care and tointroduce any necessary changes or improvements.

The results of the review shall be incorporated into a plan thatincludes goals, objectives and action plans.

The typical period for conducting a management review is onceevery twelve months.

Management review shall take into account, follow-up of previousreview, status of corrective actions, reports from managers and

supervisors, internal audits, assessments of external bodies, qualityindicators, outcome of EQA, feedback (complaints), non-conformities, continual improvement processes, evaluation ofsuppliers.


30/45

30

15189 and Personnel

Laboratory management shall have an organization plan, personnelpolicies andjob descriptionsthat define qualifications and dutiesfor all personnel.

Laboratory management shall authorize personnelto performparticular tasks.

Personnel shall have training specificto quality assurance andquality management for services offered.

There shall be a continuing educationprogram available to staff atall levels.

Employees shall be trained to prevent or containthe effects ofadverse incidents.

The competencyof each person to perform assigned tasks shall beassessed following training and periodically thereafter. Retrainingand reassessment shall occur when necessary.


31/45

31

15189 and the Quality Manager

The laboratory shall appoint a quality manager withdelegated responsibility and authoritytooverseecompliance with the requirements of the qualitymanagement system.

The quality manager shall report directly to the level oflaboratory management at which decisions are madeon laboratory policy and resources.

The quality manager shall plan, organize and conduct

internal audits.


32/45

32

15189 and assuring the quality ofexamination procedures The laboratory shall design internal quality control. It is important that the control system provide staff with clear and

easily understood information. The laboratory shall determine the uncertainty of results where

relevant and possible.

A programme for calibration of measuring systems and verificationof trueness shall be designed and performed so as to ensure thatresults are traceable to SI units

The laboratory shall participate in a suitable inter-laboratorycomparison.

The laboratory shall use suitable reference materials, certified toindicate the characterization of the material.

For those examinations performed using different procedures orequipment at different sites, there shall be a defined mechanism forverifying the comparability of results throughout the clinicallyappropriate intervals.


33/45

33

15189 and the Internal Audit

Internal audits shall address all elements of thesystem, both management and technical, andemphasize areas critically important to patient care.

Audits shall be planned, organized and carried out by

the quality manager Procedures of the audits shall be documented and

carried out within an agreed upon time.

The main elements of the quality system should besubject to internal audit once every 12 months.

The results of internal audits shall be submitted tolaboratory management for review.


34/45

15189 Continuous Improvement

Laboratory management shall have a policy and procedure to beimplemented when it detects that any aspect of its examinationsdoes not conform with its own procedures or the agreed uponrequirements of the quality management system, or therequesting physician.

Procedures for corrective action shall include an investigativeprocess to determine the underlying cause or causes of theproblem.

Corrective action shall be appropriate to the magnitude of theproblem and commensurate with the risk.

These shall lead, where appropriate to preventive actions.

34


35/45

and

All operational procedures shall be systematically reviewed bylaboratory management at regular intervals in order to identifypotential sources of non-conformance.

Action plans for improvement shall be developed, documented andimplemented.

After the action has been implemented, management shall evaluatethe effectiveness of the action.

Management shall implement quality indicators for systematicallymonitoring and evaluating the laboratorys contribution to patient

care.

When opportunities for improvement are detected, managementshall address them regardless of where they occur.


36/45

Addressing error

EstablishMechanisms of Detection

Investigate for:Impact Underlying Cause - Risk

REMEDIALCORRECTIVE

PREVENTIVE

EVALUATEEFFECTIVENESS

MANAGEMENTREVIEW


37/45

So, what can you say about qualitymanagement and ISO15189?

Very broad document.

Consistent with the history and tradition of

quality management(PDCA, 14 Essentials, 4

Absolutes). Gaining much international use and respect.

In one form or another, all laboratory physicianswill be dealing directly and indirectly with therequirements cited in this document.


38/45

A case study on

finding and correcting error


39/45


40/45


41/45


42/45


43/45


44/45

44

In conclusion:

Medical laboratories have a requirement and anexpectation for quality.

Medical laboratories have a network of qualitypartners with whom to interact.

Medical laboratories have a history of qualitymanagement from other sectors from whom theycan learn.

Medical laboratories have an internationalstandard upon which they can base their qualitymanagement.


45/45

45

Every Laboratorian has aresponsibility and an obligation tobe informed about quality and itsmanagement.

rt lqm 2 quality partnerships and standards development

Documents