U.S.
and Worldwide Quality
Management System Models
for Quality POCT Results
SHARON S. EHRMEYER, PH.D., MT(ASCP),
PROFESSOR, DEPARTMENT OF PATHOLOGY AND
LABORATORY MEDICINE
UNIVERSITY OF WISCONSIN SCHOOL OF
MEDICINE AND PUBLIC HEALTH, MADISON WI, USA
= Quality
Meeting the requirements or needs of the
testing site’s customers
-- doctors and patients –
and satisfying their expectations
2
Characteristics of Quality
POCT Results
Useful
Accurate
Precise
Reliable
Timely
3
Under the best of
circumstances…
“Things” happen!
4
“We” need “Quality” Results 5
and Quality Practices!
Criteria for Quality POCT in 2012:
Correct test ordered
Correct patient
Correct time for collection
Correct specimen and processing
Correct (accurate) test result
Correct patient record
Correct clinical interpretation (leading to the)
Correct and timely clinical response
“Wrongs” instead of “Corrects”
jeopardize quality and patients’ safety
Quality in POCT Requires:
Planning
Planning
Planning
7
Quality Management System
Addresses all aspects that
can impact testing
to assure quality
8
Quality Management System
•Coordinated activities to direct and control
an organization with regard to quality*
•Provides the basic structure for testing with a
focus on quality
•Describes, documents, implements, measures,
and monitors the effectiveness throughout the
path of workflow
* ISO 9000:2005 -- Quality management systems -- Fundamentals and
vocabulary
Path of Workflow
Preanalytical Analytical Postanalytical
Quality Management System: A Model for Laboratory Services (GP26), CLSI, Wayne, PA
Clinician – Patient – Testing -- Link
CLINICIAN CLINICIAN
PATIENT PATIENT
Testing process
REQUEST Pre-analytical REPORT
clinical request Analytical clinical information
input Post-analytical output
Mario Plebani, MD, Depart Lab Medicine, University Hospital, Padova,Italy
QMS’ Building blocks -- Quality
System Elements (QSE)
Interrelated elements
Direct and control how quality policies are
implemented and quality objectives are achieved
Ensure that processes fulfill quality objectives
Meet customer, organizational and
regulatory/accreditation requirements
www.praxiom.com/iso-definition.htm; CLSI Quality Management System: A Model
for Laboratory Services (GP-26-A4) 2011 www.clsi.org; ISO 9001
Quality Essential Elements in QMS
1. Documents and 7. Information management
records 8. Occurrence management
2. Organization 9. Internal and external
3. Personnel assessment
4. Equipment 10. Process improvement
5. Purchasing and 11. Customer service/
inventory satisfaction
6. Process control 12. Facilities and safety
QSE and Path of Workflow
Preanalytical Analytical Postanalytical
QSE apply to all operations
in the path of workflow
Quality Management System: A Model for Laboratory Services (GP26), CLSI, Wayne, PA
Quality Management System
Quality Management System: A Model for Laboratory Services (GP26), CLSI,
Wayne, PA
ISO’s and CLIA’s
Quality Management System Models
The “Devil is in the Details”
ISO15189 (2007) and
ISO 22870 (2006)
Medical Laboratories –
Particular requirements
for quality
and competence
POCT – Requirements
for quality
and competence
ISO 15189/22870
Incorporates Quality System Essentials
into:
Management and Technical Requirements
ISO 15189/22870
4. Management requirements 5. Technical requirements
4.1 Organisation and management 5.1 Personnel
responsibility 5.2 Accommodation and environmental
4.2 Quality management system conditions
4.3 Document control 5.3 Laboratory equipment, reagents and
4.4 Service agreements consumables
4.5 Examination by referral laboratories 5.4 Pre-examination processes
4.6 External services and supplies 5.5 Examination processes
4.7 Advisory services 5.6 Ensuring quality of examination results
4.8 Resolution of complaints 5.7 Post examination processes
4.9 Identification and control of non - 5.8 Reporting results
conformities 5.9 Information systems
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement Management requirements
4.13 Control of records provide the strength and
4.14 Evaluation and internal audits
4.15 Management review
support for the technical
requirements
U.S. CLIA Regulations: CLIA
(Clinical Laboratory Improvement Amendments)
In U.S. ALL clinical testing
must be under CLIA
(www.cms.gov/CLIA/)
U.S. POCT Sites –
This means you too!
CLIA (2003): QMS Requirements and
QSEs
A: General Provisions
H: Participation in proficiency testing (EQA)
K: Quality Systems
Specialties/subspecialties
General laboratory systems
Pre-analytic
Analytic
Post-analytic
M: Personnel
Q: Inspection
CLIA’s Quality System section focuses
only on technical requirements
Patient
Prepare
Transmit Record
request Phlebotomy
result Result form
Doctor
Report Transport
result Time
Validate Quality Analyze Prepare Register
result control sample sample sample
Preanalytical Analytical Postanalytical
22
§§493.1241 - 493.1249:
Pre-analytical requirements
Electronic or written request
Oral requests must be followed by above
Test request information
Patient identifier, gender and age, test ordered, specimen
source (if appropriate) and date and time (if appropriate) of
collection, and required additional information
Specimen submission, handling and referral
policies
Assessment of processes
Follow policies to monitor, assess and correct problems
§§493.1251 - 493.1289:
Analytical requirements
Procedure Manual Calibration and
Test systems, equipment, calibration verification
instruments, reagents, Control procedures
materials, supplies Comparison of test
Establishment and results
verification of performance Corrective actions
specifications Test records
Maintenance and function Assessment and
checks correction of problems
§§493.1290 - 493.1299:
Post-analytical requirements
Test report
System in place to ensure test results and patient data
are accurately sent from the point of data entry to final
report
Appropriate reference intervals available to those who
ordered the test and using test results
Assessment
Follow policies to monitor, assess and correct problems
U.S. CLIA Regulations
A: General Provisions
H: Participation in proficiency testing (EQA)
K: Quality Systems
Specialties/subspecialties
General laboratory systems
Pre-analytic
U.S. Government (CLIA)
Analytic
Post-analytic assumes:
M: Personnel
Q: Inspection
Testing sites complying with
ALL CLIA requirements
have a QMS in place
The ISO and CLIA QMS Models
You say "either" and I say "either"
You say "neither" I say "neither"
"Either" "either", "neither" "neither"
You say "potato," I say "patattah"
You say "tomato", I say “ tomata”
Oh, let's call the whole thing off!
Both CLIA and ISO mandate a QMS
QMS Model: ISO 15189 vs CLIA
QMS ISO 15189 CLIA
QSE Clauses Sections
Organization 4.1 Organization and §§493.1200-493.1299 Subpart K –
Management Quality System for Non-Waived
4.2 Quality management Testing
system
4.15 Management review
Personnel 5.1 Personnel §§493.1351 – 493.1495 Subpart M
– Personnel for Non-Waived
Testing
Equipment 5.3 Laboratory Equipment §§493.1252 – 493.1255
Equipment, performance
verification, maintenance and
function checks, calibration
Purchasing & 4.4 Contract review §493.1242(8)(c) Specimen referral
4.5 Referral Laboratories §493.1252 Test systems,
Inventory 4.6 External Services and equipment, instruments, reagents,
Supplies materials, and supplies
D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation:
QMS International Guidelines & Standards
QMS Model: ISO 15189 vs CLIA
QMS ISO 15189 CLIA
QSE Clauses Sections
Process Control 5.4 Pre-examination procedures §§493.1240 - 493.1249 Pre-
5.5 Examination procedures analytic systems
5.6 Assuring quality – §§493.1250 - 493.1289 Analytic
examination systems
5.7 Post-examination procedures §§493.1290 - 493.1299 Post-
analytic systems
Documents and 4.3 Document Control §493.1101(e) Facilities
4.13 Quality and Technical §493.1105 Retention
Records Records Requirements
Information 5.8 Reporting of results §§493.1290 – 493.1291 Post
Annex B: LIS analytic Systems
management Annex C: Ethics
Occurrence 4.8 Resolution of complaints §493.1299 Post-analytic systems
4.9 Identification and control of quality assessment
management nonconformities §§493.1256 – 493.1282 Control
4.10 Corrective action procedures
D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation:
QMS International Guidelines & Standards
QMS Model: ISO 15189 vs CLIA
QMS ISO 15189 CLIA
QSE Clauses Sections
Assessments: 4.11 Preventive action §§493.1250 - 493.1289
4.14 Internal audits Analytical Systems
Internal & External 5.6.4 External quality §§493.801 – 493.865
assessment Participation in Proficiency
Testing Subpart Q – Inspection
Process 4.12 Continual improvement §§493.1200, 493.1239,
493.1249, 493.1289, 493.1299
improvement Quality Systems assessments
Customer service 4.7 Advisory services §§493.1407, 493.1419
4.8 Resolution of complaints Consultation
Annex C: ethics §493.1233 Complaint
investigation
§493.1234 Communication
Facilities and Safety 4.6 External services and §§493.1100 – 493.1101
supplies Facility Administration for Non-
5.2 Accommodation and waived Testing
environmental conditions §493.1252 Standard: Test
5.3 Laboratory equipment systems, equipment, etc.,
D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation:
QMS International Guidelines & Standards
10 Key Factors for Quality POCT*
Start with a plan, e.g., Quality Management System
Establish a framework, e.g., Quality System Essentials
Train
Make procedures easy to follow
Make any needed “tools” understandable and available
Automate where possible
Assess for overall quality – feedback from quality indicators
Track events/occurances for continuous quality improvement
Have a very “visible” POCT coordinator
Nurture a quality and patient safety culture
Santrach P. Mayo Clinic’s 10 key factors for creating and maintaining a quality POC Program, October
2006, http://acutecaretesting.org/journalscanner?TId=61290154281
Quality Is Never An Accident!
“it is always the result
of intelligent effort…”
QMS for doing
“things” right throughout the
testing process
Merci
beaucoup
