1. Developing a Quality Management System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London

2. Today’s Presentation LLSG profile Implementation Plan
Outline Quality System Essentials
Review: Where are we?
Outline the next steps

3. London Laboratory Services Group
Joint venture between LHSC and SJHC
Pathology and Laboratory Medicine Program
9 disciplines
55 laboratories
4 campuses
500 employees

4. What is a Quality Management System
ISO 9000 defines a QMS as:
“ Management system to direct and control an organization with regard to quality”
ISO- International Organization of Standardization

5. Why Quality Management System?
QMP-LS: Quality Management Program – Laboratory Services; Ontario Laboratory Accreditation (OLA)
Consistent with international trends and laboratory science
We are committed to providing the highest level of care to the patient
OLA has provided (over 500) requirements to meet and in essence once these are met, a Quality Management System will have been created.
OLA has provided the framework or structure…. each laboratory needs to develop their own plan or blueprint to develop and implement a system
International Organization of Standardization (ISO): New lab standard ISO 15189; QMPLS is one of the first organizations in North America to adopt this standard

6. How to Implement a Quality Management System?
I felt just like my friend Garfield, when Glen approached me about the Quality Coordinator position.
I needed to find one end of the yarn and start wrapping it up until I had something tangible to work with-Attended workshops, symposiums, meetings, read literature in order to create an implementation plan.

7. LLSG Implementation Plan
Quality Coordinator
Discipline Task Teams
Quality Team
Develop Policies
GAP analysis
Map Processes
Write procedures
Quality Manual
Communicate/Educate/Train
Audit
Accreditation
Quality Coordinator-
Appointed one year ago (Aug 2002)
Develop and implement a QMS to meet accreditation requirements
QDTT-
Each lab discipline has a task team
Deals with the operational issues
Includes technical and medical staff
QT-
One rep from each of the discipline teams
Members from our affiliated hospitals, STEGH, Tillsonburg, Ingersoll, CKHA, Middlesex HA
Deals with operational and administrative issues that are common to all labs

8. Pre-Analytic Analytic Post-Analytic Info Mgmt
Structure for a Quality system
Quality System Essentials
Organization
Personnel
Equipment
Purchasing/Inventory
Process Control
Documents/Records
Occurrence Mgmt
Internal Assessment
Process Improvement
Service and Satisfaction
Facilities and Safety
Information Management
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Quality system essentials apply to all operations in the path of workflow
QSE’s are described by NCCLS (HS1) and OLA also references QSE’s
Activities related to each QSE across the path of work and defined by policies, processes and procedures is the basis for the QMS.
A quality manual documents policies related to the QSE’s.
QSE’s can be applied to any healthcare service.
In order to define and get a clear understanding of how the QSE’s related to the OLA requirements, I referenced the requirements to each of the QSE’s.

9. QSE: Documents and Records
Document Management System
create
identify
change
approve
file
distribute
archive
Document Management System
Most time consuming and important system to develop
Paper or computerized- software available for managing documents
Documentation is key- need a standardized way to create, ID, Change etc
Document Control provides a means to ensure that only the current versions of documents are in use
LLSG- use of a corporate system for managing documents and publishing current documents on a web site

10. Hierarchy of Documents
Policy
What to do
Process
How it happens
Procedures
How to do it
Record Retention
QT and medical leaders have submitted information as to current practices
Lab Manager and Quality Coordinator are reviewing and comparing current practice to recognized standards and guidelines in order to publish LLSG record retention times
Records
Forms

11. Policy Development - included in procedures Quality Policies
QSE’s
Map OLA requirements
Policy statement
Responsibility
Supporting statements
Supporting processes
Operational Policies
- included in procedures
One policy for each of the QSE’s
QT drafted policies in two meetings
I mapped the sections of the OLA requirements to each of the QSE in order to understand and show the relationship of the OLA requirements to the QSE’s
Policy statement- briefly states the intent of the policy
Responsibility- designated through process mapping
Supporting statements- relate directly to the sections of the OLA requirements- one statement per section. These in turn determine the processes that are required to support the policy

12. POLICY STATEMENT:
PURPOSE:
This policy provides the direction for the processes and procedures to….
RESPONSIBILITY
(use those that apply)
Program Leader/Discipline Leader/Section Head is responsible for
Lab Manager is responsible for
Technical Specialist/Coordinator is responsible for
Staff members are responsible for
Other:
The following sections are derived from the OLA requirements. They determine the supporting statements for the policy. There should be one section and related statement for the major categories defined in the requirements. Make a broad statement about the Laboratory's intentions for the sections below.
SECTION
SUPPORTING STATEMENTS
Template developed as a result of attending CLMA workshop (Lucie Berte) and NCCLS HS1
References:
·          NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline
·          QMP-LS- Ontario Laboratory Accreditation Requirements
·          Others:
Supporting
Documents
List the processes that support this policy:

13. Process Mapping Address the path of workflow
Describe how things happen here
Flow Charts or Tables
QT- mapping processes identified when policies developed- lab management functions common to all disciplines
DTT- mapping those that are unique to the disciplines
Table identifies who is responsible for each step in the process as well as the procedures that are necessary to carry out each step.

14. What Happens
(List the steps)
Who’s responsible
Procedure (or another Process)
Results 1) 2) 3)
Template developed for QT and QDTT to assist with process mapping

15. Procedure Development
Identified from process mapping
Templates developed based on NCCLS guidelines
Used for analytical and non analytical procedures
Many procedures already documented
Developed Standardized templates for all lab disciplines to use
OLA says “move forward”- for now only new procedures will be in the new format and we will convert existing procedures at a later date

16. PURPOSE
This procedure gives instructions……
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS
APPENDICES
NB: SECTIONS NOT APPLICABLE TO A GIVEN DOCUMENT ARE DELETED FROM THAT DOCUMENT

17. Pocket procedure manual
Change documentation- post it notes

18. Procedures Accessible Up to date
User friendly- accurate, easy to follow

19. QSE: Process Control Laboratory processes and procedures Validation
Establishing Reference Intervals
Quality Control
Internal and External QA
Method Comparability
Accreditation
 The Laboratory ensures current procedures are available.
 The Laboratory ensures that all checks are in place to meet established performance expectations in all aspects of testing. Methods are validated before they are implemented
 The Laboratory determines requirements for the establishment of reference intervals.
 Quality Control processes and procedures are followed based on department specific requirements
 The Laboratory participates in, and monitors internal and external Quality Assurance and Quality Control programs.
 The Laboratory has a defined mechanism to verify the comparability of results produced, using different methods or equipment.
 The Laboratory participates in periodic accreditation assessments.

20. QSE: Occurrence Management
Quality Control: Corrective Action
External and Internal Quality Assurance
Turn Around Time (TAT) delay
Discrepant Results
Corrected Results
Specimen Rejection Criteria
Incidents or occurrences that fall outside defined expectations.
Examples: The Laboratory:
Takes corrective action on Quality Control results that fall outside of defined limits.
acts upon any deficiencies identified by internal and external quality assurance programs.
monitors and reports results outside of the expected TAT to the appropriate stakeholders.
 resolves discrepant results.
identifies corrected results.
 defines acceptance and rejection criteria of specimens.
QT- working on common occurrence form to report lab occurrences

21. QSE: Information Management
Results Reporting
Release of Results
Computer Procedures
Change Approval
Computer QA
Computer Security
Computer Validation 
The Laboratory has systems in place to manage all laboratory information generated. The Laboratory collaborates with the Information Management department in order to report patient results.
The laboratory has policies, processes and procedures for reporting all normal, abnormal and critical results.
The Laboratory ensures that released results are legible, properly identified and contain the appropriate results and interpretive information for the management of the patient. The identification of the individual releasing results is available.
The Laboratory has policies, processes and procedures for releasing results, which include who may release results, and to whom they may be released.
 The Laboratory director or designate approves all changes to the computer system which may affect patient care.
 The Laboratory ensures that computer policies, processes and procedures are defined and available to authorized users.
 The Laboratory has computer quality assurance methods.
 The Laboratory provides adequate protection for all aspects of computer security.
 The Laboratory ensures that computer programs are checked for performance and validated if changed, prior to implementation.

22. QSE: Purchasing and Inventory
Inventory Control System
External Services
Purchasing Documents
Material Resources
The Laboratory has an inventory control system for managing supplies.
 The Laboratory defines the criteria for the verification, inspection, acceptance, rejection and storage of consumables.Records of action are maintained.
 The Laboratory in consultation with HMMS establishes a system to qualify and select vendors of equipment, supplies and services.
 Purchasing documents describe the services and supplies ordered.
The laboratory reviews and approves purchasing documents/records for items affecting the quality of laboratory examinations.
 The Laboratory has adequate material resources to support laboratory activities. The Laboratory ensures that those resources will be maintained in functional and reliable condition.

23. QSE: Safety Safety Officer, Safety Committee Safety Manual
Audit and Inspections
Reporting Incidents, Accidents, Illness
Training
 Personnel Responsibilities
The Laboratory has access to the facility’s safety specialist to assist with safety issues.
The facility has a Joint Health and Safety committee.
 The Laboratory has a safety manual that is available in work areas to all employees.-soon to be published on LLSG web site
 The safety program is regularly audited and reviewed by Laboratory management or designated personnel.
 The Laboratory has a program for reporting and reviewing safety incidents/occurrences.
 London Health Sciences Centre implements a safety training program relevant to laboratory work practices.
 Staff members are responsible for consistently practicing standard/universal precautions or other safety processes to protect themselves, co-workers, patients or public from exposure to sources of danger.

24. QSE: Facilities Location and design Environmental Conditions Access
Communication Systems
Storage
Computer Environment
The location and identification of the laboratory meets specifications to ensure the safety of patients, hospital personnel and the general public in addition to providing the appropriate environment for equipment.
The design of the laboratory meets specifications to ensure the accessibility, safety and efficiency of the workspace.
 The Laboratory:
ensures that environmental conditions are monitored and recorded as appropriate.
ensures that access is controlled and incompatible activities are separated.
 communication systems meet established criteria to provide efficient transfer of information to clients.
ensures adequate storage space and conditions for samples, equipment, reagents, supplies, documents and records.
provides a well-maintained and stable environment for the operation of computers that comply with vendor specifications.

25. QSE: Equipment
Equipment selection, calibration, verification, validation
Inventory
Equipment operation maintenance and records
Defective Equipment
All equipment and supplies are validated prior to implementation for patient care use.
Each piece of equipment has a unique identification and label
Equipment is maintained to ensure proper functioning in acceptable environmental and operating conditions by authorized competent personnel.
Defective equipment is appropriately removed from service and only returned to service following repair and validation

26. QSE: Personnel Job Description and Qualifications Training Competence
Continuing Education
Personnel Records
Performance Appraisal
The Laboratory:
provides personnel with a job description outlining qualifications, duties, and responsibilities.
provides training prior to the performance of duties for all personnel.
assesses employee competence after completion of any training and periodically thereafter. provides support for continuing education and professional development.
periodically conducts a performance evaluation for each employee.
The facility maintains confidential personnel records for each employee

27. QSE: Organization License Mission Statement Accreditation
Organizational Structure
Resource Allocation
Referral Laboratories
 London Laboratory Services Group (LLSG) is part of London Health Sciences Centre which is a legally recognized entity.
 The current Laboratory License is posted within the laboratory.
 The Laboratory has a mission statement or statement of purpose.
 The Laboratory meets the criteria of accreditation set by the Ontario Laboratory Accreditation program.
 The Laboratory maintains organizational charts, which reflect the management structure and reporting relationships within the laboratory and relationships with other departments.
 Adequate resources will be provided to ensure that medical laboratory services meet the needs of the patients and the personnel responsible for patient care and other functions of the quality management system.
 The Laboratory abides by established processes for selection, monitoring and use of referral laboratories and consultants.
As a referral center, LLSG ensures that the laboratory and consultants maintain and demonstrate competence to perform requested examinations.

28. QSE: Assessment Quality Indicators Internal Audits Management Review
 The laboratory monitors quality indicators as they relate to proper calibration and function of instruments, reagents and analytical systems.
 The laboratory conducts internal audits regularly to ensure operations continue to comply with the quality management system.
 Laboratory management periodically reviews the quality management system.

29. QSE: Process Improvement
Quality Improvement Activities
Occurrence management
Problem Solving
 The Laboratory participates in quality improvement activities through the use of quality improvement tools
The Laboratory has processes and procedures in place for when any aspects of examinations do not conform to established protocols.
Continually improving…example…getting a 9/10 on a test….what happened to the other mark? Look closely at the outliers

30. QSE: Service and Satisfaction
Customer Satisfaction (Complaints)
Internal and external 
The Laboratory resolves complaints from patients or personnel responsible for patient care.
The Laboratory conducts surveys to determine customer satisfaction (internal and external customers)

31. Where are We? Quality Team Quality policies developed
Processes identified/mapped
Procedures written
Document Management System
Quality Manual
Web site for referral labs
Quality processes and procedures-developed, reviewed, critiqued at each meeting- changes made- approved by lab manager-posted to web site
DMS- framework described through processes and procedures
pilot site for corporate DMS- currently only being used by executive offices

32. Where are We? Discipline Task Teams GAP analysis Processes mapped
Procedures written
Revisit requirements and close GAP
Processes and procedures for pre analytical and analytical sections of the OLA requirements
Currently working on Post analytical and QC/QA
LIS team

33. What’s Next? Quality Team to continue to address QSE
Discipline Task Teams to complete sections of OLA requirements
Educate and train staff
Perform self assessment

34. Celebrate Success!

35. Resource Material ISO documents: 9001:2000 15189 NCCLS documents:
GP26-A
GP22-A
HS1- A
QMP-LS- OLA Consensus Requirements