1. Module 4
Assuring the Quality of Testing: A Systems Approach to Quality (ISO 15189:2012)
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

2. Learning Objectives At the end of this module, you will be able to:
Explain the systems approach to lab quality and its benefits.
Identify the essential elements of a lab quality system.
Recognize key factors that may compromise the quality of laboratory testing.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

3. Learning Objectives At the end of this module, you will be able to:
Compare the Quality Essentials in a Quality Management System to the ISO Checklist sections
Apply each Quality Essential in review, revision or development of a Laboratory Quality Manual
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

4. Content Overview The approach we take to achieve quality
Essential elements of a lab quality system
Quality assurance procedures in the medical laboratory testing site
How the laboratory documents its program of quality for all phases of testing - before, during and after testing
Total quality management of laboratory testing is very important. Quality assurance procedures including quality control measures are part of total quality management.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

5. What is “Quality?”
The ability of a product or service to satisfy stated or implied needs of a specific customer
In the lab: accuracy, precision and timeliness
Achieved by conforming to established requirements and standards
What kinds of standards should be used in the laboratory?
Answers: Standards in this case mean procedures and supplies used to guarantee continuity in the analysis
A standard operating procedure for instrument maintenance, quality control procedure and analysis
Standardized method for reporting routine and urgent results
Purified standard reference materials or solutions should be used to calibrate the instrument
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

6. Discussion – Dining Out: A Quality Experience
Think about your expectations for quality
What might you expect for a quality experience at a restaurant?
Answers should be collected from several participants and could include: 1) good tasting food, 2) food the correct temperature (hot or cold as expected), 3) food served on a clean plate and given clean eating utensils and drinking glass 4) not having to wait an exceptionally long time for food 5) friendly food servers 6) having the food bill receipt match the published price on the menu 7) other examples may be provided.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

7. Why Quality? Test Site Quality Accurate, Reliable Testing Quality in
All Aspects
of Health Care
Quality is important to the patient, the clinician and others since laboratory results provide important diagnostic and treatment information.
One possible activity: Quality Assurance for HIV Rapid Test
A patient who is known to be HIV–Positive has their blood drawn and later a Rapid HIV Test is done. The HIV Rapid Test result was reported to the clinician as negative.
In order to troubleshoot the problem, work on your own or with a partner and list two possible reasons for this unexpected test result with regard to the a) pre-analytic, b) analytic and c) post-analytic phases, which could have contributed to this unexpected result.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

8. A Systems Approach to Quality
Considers all components within a system
Such as organs working together as a system in
the body
To produce quality service in the laboratory, all facets are needed to work together
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

9. A System...
Identifies the connection and relationship (e.g., cause and effect) among the components
Example of cause and effect: Anemia may be caused by many reasons including lack of iron; but lack of energy and fatigue is often the effect
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

10. Definition of a Lab Quality System
A system with an organizational structure of management and staff who carry out their responsibilities using good laboratory practices and procedures including the resources necessary for providing quality laboratory test results.
In other words…all activities which contribute to quality tests, directly or indirectly.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

11. Benefits of a Quality System
Patient benefits with accurate results for the clinician to diagnose, treat and monitor their health
Proactively detects and reduces errors before results are released
Improves consistency of results between testing sites and increases clinician confidence
Ultimately is the most cost effective
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

12. Interactive Opportunity
What does a Quality System mean for the laboratory?
How is a quality laboratory established?
Take time to gather input from participants.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

13. Lab Quality Systems: The 12 Quality Essentials
Organization
Personnel
Equipment
Purchasing & Inventory
Information Management
Process Control Quality Control & Specimen Management
Documents & Records
Occurrence Management
Each of these 12 aspects, organization, personnel, equipment, purchasing and inventory of reagents and supplies, process control, information management, documents and records, occurrence management, assessment, process improvement, customer service and facilities safety, need to pay attention to quality so that laboratory service (lab test results) are high quality. Established by CLSI (Clinical Laboratory Standards Institute)
Assessment
Process Improvement
Customer Service
Facilities & Safety
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

14. Activity Break into four groups and define the specific
laboratory needs that each of the
Quality Essentials include.
Secondly, relate the Quality Essentials to
The ISO Checklist Sections. Are they
essentially the same?
One possible activity: Divide into small groups and have each group take 1or 2 of the 12 essential elements – discuss challenges within their own labs and then give 10 minute presentations explaining their element(s), and how to implement best lab practices for the element(s). (This way, the participants will be presenting a part of the lesson and sharing their experiences, challenges, and solutions!) Each group can also relate their element to the ISO Checklist section!
JOB AIDS AVAILABLE FOR THIS ACTIVITY:
The 12 Quality Essentials
The ISO Checklist
Activity Sheet for participants to record notes on
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

15. WHO Checklist Sections
ISO Aligns with
WHO Checklist Sections
1. Documents and Records
2. Management Reviews
3. Organization and Personnel
4. Client Management & Customer Service
5. Equipment
6. Internal Audit
7. Purchasing & Inventory
8. Process Control and Internal and External Quality Assessment
9. Information Management
10. Corrective Action
11. Occurrence/Incident Management & Process Improvement
12. Facilities and Safety

16. ISO 15189:2012
Based upon ISO/IEC and ISO 9001, specifies requirements for competence and quality particular to medical laboratories
A country could have its own specific regulations or requirements applicable to its professional personnel, their activities, & responsibilities
Medical laboratory services are essential to patient care and must meet the needs of all patients and the clinical personnel responsible for the care of those patients.

17. ISO 15189:2012 Such services include:
Arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, with interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work

18. Requirements for a Quality Laboratory
Documents and Records
Quality Manual - Describes YOUR Quality System
Document Control with Master Index and ensures they are current by annual review
System for Document Archive, Retrieval and Record Retention
SOP for all Laboratory Processes and Procedures

19. Requirements for a Quality Laboratory
Management Reviews
Laboratory Manager and/or Quality Officer:
Review of all Quality and Technical Records
Review and Improvement of Quality Management System
Developed Laboratory Workplan and Budget

20. Requirements for a Quality Laboratory Organization & Personnel
Organization authority hierarchy - internal and external
Lab Manager & Quality Officer assigned with roles
and responsibilities
Commitment to Quality - by entire facility
Adequate Staff
Personnel Files

21. Requirements for a Quality Laboratory Organization & Personnel
Tasks Defined - Duty Roster
Job Descriptions
Orientation and Training
Competency Checks
Staff Communication

22. Requirements for a Quality Laboratory
Client Management/Customer Service
Qualified and Available Staff for Customer Advice
Handbook for Clients
Communication with Clients and Patients
Customer Survey & Improvement
Who is a customer? Answer: The patient, clinicians, doctors, nurses and anyone who interacts with the laboratory and receives laboratory reports is a “customer”. Customer satisfaction may be determined from error reports, surveys and other methods to directly ask the “customer”. Process improvement-once a problem situation is discovered, a plan is set in place to improve the system to prevent it from happening again. Rewards or recognition can be given to lab employees who show improvement in customer service.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

23. Requirements for a Quality Laboratory
Equipment
Equipment Installation
Correlations
Linearity studies
Method validation
Book of Life
Routine maintenance
Repair records
Equipment failure
Operator manual available
Calibration as necessary
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

24. Requirements for a Quality Laboratory
Internal Audit
What is happening inside your own laboratory:
Personnel competency
Cross-checking results within a department
Checking that instrument maintenance is performed each day & that logs are initialed each day
Are all staff following SOPs?
Are temperature charts completed each day?
Are safety policies in place & do staff use PPE?
Invite participants to add to this list- use a flip chart to record their responses! This is an important component of QA and one that the lab director has control over! Stress that Internal Audits are NOT meant to humiliate an employee that is not following protocol, but rather to find your own lab weaknesses/errors BEFORE harm is caused to a patient.
Laboratory technical sections examined for best practices and processes
Safety, Quality Management, Customer Service audited for compliance to Standards.
Appropriate sections of WHO AFRO standards used to audit or guide
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

25. Requirements for a Quality Laboratory Purchasing & Inventory
Forecasting needs and usage
Adequate Budgeting with upper Management
Tracking and documenting orders and receipts
Inventory Control Management to prevent stock
outs
Adequate and monitored storage

26. Requirements for a Quality Laboratory
Process Control and Internal & External Quality Assessment
Written and available standard operating procedures
Specimen management
Quality control materials and rules
Process control directly relates to analysis in the laboratory. Testing requires having the correct specimen, which is preserved properly until analysis occurs. Testing needs to follow the standard operating procedures for the instrument and method and quality control specimens should be analyzed and evaluated based on a set QC procedure and evaluated based on a standard set of rules.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

27. Requirements for a Quality Laboratory
Process Control and Internal & External Quality Assessment
Record Lot Numbers for reagents & test kits
Environmental Checks
Management review of records for all processes
EQA Proficiency Testing
Reference Specimen Tracking
Results cross checked before release

28. Requirements for a Quality Laboratory
Information Management
Test report system with required information, cross checked and validated before release
Organized archival system with retention of records, patient reports and all laboratory support documentation
Timeliness of results to the clinician
Patient privacy and
confidentiality
Information management is part of the post-analytical process. Patient lab results are the main data that are generated by the lab. Lab results are reported to clinicians, patients and other care givers to help in their diagnosis, treatment and care management. Since lab reports are so important, they should be stored and retrieved for future needs but should maintain patient privacy. Laboratory or hospital information systems are helpful in long term storage and retrieval of lab data which require specialized computer skills and software. However, paper systems can also be used to store and retrieve lab data.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

29. Requirements for a Quality Laboratory
Corrective Action
Written policies and procedures for addressing errors
Error resolution by root cause analysis
All non-conformances reviewed and tracked
for trends

30. Requirements for a Quality Laboratory
Occurrence Management & Process Improvement
All occurrences recorded and addressed
Ongoing Quality Indicators (QI) monitored
QI monitors and/or trending occurrences used
for improvements in operations and processes
PDCA used to implement improvements

31. Process Improvement On-Going Data Collection Improvement Measures
Process improvement means that once a problem situation is discovered, a plan is set in place to improve the system to prevent it from happening again. Problem situations can be determined from collecting data, surveys, reports to fine-tune where improvement should be made. This is an important follow up to assessment for errors.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

32. Requirements for a Quality Laboratory
Facilities & Safety
Appointed Safety Officer
Facility and environment adequate
Workstations uncluttered
Essential Safety Equipment available
Setting and following safety rules are important to maintain the health of patients and workers. Although they cost money to set in place, not following safety rules leads to loss of money through injured people and loss of time and work.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

33. Requirements for a Quality Laboratory
Facilities & Safety
Staff trained in safety policies and procedures
Waste disposal to country standard
Policies on staff exposure prevention and/or prophylaxis
Accidents reported and followed up on
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

34. Quality Manual
All Sections of the Checklist (and therefore the Quality Essentials) should be addressed in the Laboratory Quality Manual
This details YOUR laboratory’s policies for YOUR Quality System
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

35. Policies verses Procedures
Definition
Policies are statements of WHAT the laboratory will do
Procedures are SOPs on HOW policies are implemented
Examples
The laboratory will maintain an orderly system for all documents and records so that all documents and records can easily be located, are current and available to staff, and are retained or disposed of according to law.
SOP for Document Control:
All procedures are numbered
A master index is maintained
All SOPs are reviewed annually
Records are retained for X years, etc……..
The difference between quality assurance and quality control is shown. Quality control is part of process control in the 12 aspects of a quality system. Quality assurance includes quality control and other measures of process control, assessment, document control, etc.
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

36. Writing YOUR Quality Manual
Begin with a Quality Statement or Objective for YOUR laboratory to have a commitment to a culture of Quality
Outline YOUR Scope of Service
Outline the roles and responsibilities of YOUR management and staff
Outline the organization of the Manual i.e. how the manual is arranged by addressing Quality Essentials.
*See ISO 15189: 4.2.3/4.2.4

37. Examples Management Review:
“It shall be the policy of xxxxxx Laboratory to establish an annual workplan and budget in coordination with and approval of upper management. This plan will be communicated to all laboratory staff.” (See File: Lab Workplan and Budget - Lab Manager Office)
“ At least annually, the laboratory manager will review with upper management (summary of items listed in ISO 15189:2012 (Meeting minutes) “
Faciliator: Use Flip Chart to embellish these policy statements. Each statement requires a way to document that these are being carried out by reference to files, minutes or procedures. If procedures, the document number of the procedure should also be listed so the document (procedure) can be located.

38. Examples Management Review (cont)
“There shall be an annual review of Laboratory Quality Improvement to ensure that data in the form of Quality Indicators are collected and Improvement Projects are identified and undertaken.”
“The Laboratory Manager or supervisor shall review monthly (or quarterly if more appropriate), the following quality and technical records: (see ISO 15189:2012 as it applies to your lab)”
Again, facilitator should use flip chart to demonstrate and/or embellish this

39. Another Example Facilities and Safety
“XXXXX Laboratory will provide, with the approval and oversight of upper management, a safe environment for its clients and staff. This includes the physical structure, the necessary safety equipment and supplies for specimen handling and testing, defined procedures for waste disposal, prophylaxis for staff upon specific exposure and training for all safety procedures.
Reference: See Safety Manual Document #XXXX located in the LM office and all lab sections”
This example shows how, if the laboratory has a separate Safety Manual, the SOPs in that manual do not have to be repeated in the Quality Manual. A more extensive list of safety statements as policy can be listed and referenced with a specific safety SOPs referred to by document number.
The sentence “This includes the physical structure,…… should include all safety policies for a particular lab with the specific SOP document number and title referenced.

40. Activity and Homework
Divide in groups and with the Quality Essential you previously worked with, begin a plan on how to incorporate this essential into YOUR Quality Manual.
Note: You should use the ISO 15189:2012 Checklist as your guide n

41. Who Is Responsible for Quality?
Laboratory management and supervisory staff establish quality assurance policies procedures
Test site personnel implement the quality assurance procedures
EVERYONE!
One possible activity: Divide into small groups and have each group take 1or 2 of the 12 essential elements – discuss challenges within their own labs and then give 10 minute presentations explaining their element(s), and how to implement best lab practices for the element(s). (this way, the participants will be presenting a part of the lesson and sharing their experiences, challenges, and solutions!) Each group can also relate their element to the WHO Checklist section!
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

42. Why is the Quality System Important to Patient Sample Testing?
Ensures that quality is the foundation of everything we do
Sets the standard for level of quality
Meets/exceeds customer expectations
Provides means to prevent, detect and correct problems
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

43. Why is the Quality System Important to Patient Sample Testing?
Becomes the core of a monitoring, evaluation, and improvement system
Reduces costs
Even the simplest Rapid Test is not foolproof
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality

44. Summary After completing this module, the participant can:
Explain the systems approach to lab quality & its benefits
Identify the essential elements of a lab quality system
Recognize key factors that may compromise the quality of laboratory testing
Compare the 12 Quality Essentials in a Quality Management System to the ISO 15189:2012 checklist sections
Apply each Quality Essential in review, revision or development of a Laboratory Quality Manual
Assuring the Quality of Laboratory Testing: A Systems Approach to Quality