Labman tqm -++

TOTAL QUALITY

MANAGEMENT

LEARNING OBJECTIVES

Appreciate the importance of TQM in the laboratory setting

Learn the different Quality System Essentials (QSE) and their importance in providing quality health services to the best level

What is Quality?

Essential to all aspects of health care are laboratory results that are:

accurate

reliable

timely

Achieving a 99% level of quality

accepting a error rate1%

In France a 1% error rate would mean everyday

14 minutes without water or electricity

50,000 parcels lost by postal services

22 newborns falling from midwives’

hands600,000 lunches contaminated by bacteria3 bad landings at Orly Paris airport

Result of 1% error

Laboratory errors cost in

personnel effort

patient outcomes

Negative consequences of laboratory error

unnecessary treatment; treatment complications

failure to provide the proper treatment

delay in correct diagnosis

additional and unnecessary diagnostic testing

Quality Management System

coordinated activities to direct and control an organization with regard to quality (ISO,CLSI)

ALL aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system

•Data & Laboratory Management•Safety•Customer Service

Patient/Client PrepSample Collection

Sample Receipt and Accessioning

Sample TransportQuality Control

Testing

Record Keeping

Reporting

Personnel CompetencyTest Evaluations

THE PATIENT Test selection Sample Collection

Sample Transport

Laboratory Analysis Examination Phase

Report CreationReport Transport

Preexamination Phase

Result Interpretation Postexamination Phase

Path of Workflow

Why is the path of workflow essential to consider in health

laboratories?

The entire process of managing a sample must be considered:• The beginning: sample collection• The end: reporting and saving of

results• All processes in between

Laboratory tests are influenced by:laboratory environment

knowledgeable & competent staff

reagents and equipment

quality control

communications

process management

occurrence management

record keeping 14

Twelve Quality System Essentials

Organization Personnel Equipment

Purchasing &

Inventory

Process Control

Information Management

Documents&

Records

Occurrence Management

Assessment

Process Improvement

Customer Service

Facilities &

Safety

Organization

ResponsibilitiesAuthorities

Communication

Provision

of Resources

Quality Policy

human resources

job qualifications

job descriptions

orientation

training

competency assessment

professional development

continuing education

Personnel

safe working environment

transport management

containment

security

waste managementlaboratory safety

ergonomics

Facilities and Safety

acquisition

installation

validation

maintenance

calibration

troubleshooting

service and repair

records

Equipment

vendor qualifications

supplies and reagents

critical services

contract review

inventory management

Purchasing and Inventory

quality control

sample management

method validation

method verification

Process Control

confidentiality

requisitions

logs and records

reports

computerized laboratory information systems (LIS)

creation

revisions and review

control and distribution

Documents Records

collection

review

storage

retention

complaints

mistakes and problems

documentation

root cause analysis

immediate actionscorrective actions

preventive actions

INTERNAL

Quality Indicators

Audit Program

Laboratory Assessment

EXTERNAL

Proficiency Testing (EQA)

Inspections

AccreditationsAudit Review

opportunities for improvement (OFIs)

stakeholder feedback

risk assessment

problem resolution

preventive actionscorrective actions

Process Improvement

customer group identification

customer feedback

customer needs

Customer Service

ImplementingQuality Management

does notguarantee

ERROR-FREELaboratory

But it detects errors that may occur and prevents them from recurring.

Organization

Personnel Equipment

Purchasing &

Inventory

Process Control

Documents&

Records

Occurrence Managemen

Assessment

Process Improvement

Customer Service

Facilities &

Safety

Laboratories notimplementing a

quality managementsystem guarantees

UNDETECTED ERRORS

Coordinated activities to direct and control an organization

with regard to quality.

---ISO 9000:2000

Laboratory Quality Management System

Innovators of Quality

Walter Shewhart1891-1967

W. Edwards Deming

1900-1993

Joseph Juran 1904-2008 (103 years) Philip Crosby

1926-2001

Robert Galvinb. 1922

Brief History of Quality Management

Innovator Date Cycle Walter A.Shewhart 1920s Statistical Process

Control

W. Edwards Deming 1940s Continual Improvement

Joseph M. Juran 1950s Quality Toolbox

Philip B. Crosby 1970s Quality by Requirement

Robert W. Galvin 1980s Micro Scale Error Reduction

Standards Organizations

ISO International Organization

for Standardization

CLSI Clinical and Laboratory

Standards Institute(formerly known as NCCLS)

Guidance for quality in manufacturing and service

industries

Standards, guidelines, and best practices for quality in medical laboratory testing

Broad applicability; used by many kinds of

organizations

Detailed; applies specifically to medical

laboratories

Uses consensus process in developing standards

ISO Documents - Laboratory

ISO 9001:2000 Quality Management System Requirements Model for QA in design, development production, installation, and servicing

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

ISO 15189:2007 Quality management in the clinical laboratory

CLSI Quality Documents

HS1-A2 A Quality Management System Model for Health Caredescribes quality system model, 12 essentialsaligns to ISO 15189 and parallels ISO 9000 applies to all health care systems

GP26-A3 Application of Quality Management System Model for Laboratory Servicesdescribes laboratory application of quality system modelrelates the path of workflow to the quality system essentials assists laboratory in improving processesrelates to HS1-A2 and ISO 15189

ORGANIZATION

Learning Objectivesdescribe organizational elements

needed for a quality management system

discuss management roles and responsibilities in a quality system

explain the process for implementing, maintaining, and improving the laboratory quality management system

Implementation

Planning Process

Monitoring: Maintenance

and Improvement

Leadership, Managerial Roles

Organizational Structure

Leadership

exercising responsible authority, while providing motivation and visioninfluencing and encouraging staff to good performance

Organizational Structure

establish a working structure thatensures sufficiency at all parts in thelaboratory work flow

designate responsibilities and roles; develop an organization chart

designate a Quality Manager

allocate sufficient resources41

LABORATORY DIRECTOR

CHARGETECHNOLOGIST

ASSISTANT CHARGE

TECHNOLOGIST TECHNOLOGIST

QUALITY MANAGER

NURSING DIRECTOR

NURSING

HOSPITAL DIRECTOR

Quality Manager

ISO 15189 requirement

has responsibility and authority to oversee compliance

reports directly to the decision-making level of laboratory management

Quality Manager Responsibilities

monitor quality management system

assure compliance

review all records

conduct, coordinate audits

investigate deficiencies

Planning for Quality Management System

approaches vary with local situation

many factors influencestarting point

include all quality elements in plan

may implement in stepwise process

Keep in mind

communicate, be transparent

set feasible timelines

develop realistic, measurable objectives

set priorities, proceed stepwise

determine the gaps, using quality management systems checklist

develop a task list

prioritize by:– quick fixes first

– determine what

would have the

greatest positive impact

— GAP ANALYSIS —

Conduct Gap Analysis

Gap Analysis: Common Problems Identified

test ordering

sample managementtraining level (competence)of technical staffquality control

analytical process

recording and reporting results

Quality Manual

a document describing the quality management system of an organization

essential organizational step

management responsibility

Quality Manual

communicates information

serves as a framework for meeting quality system requirements

demonstrates management’s commitment to quality

Maintaining the Quality Manual

communicates quality policy

needs management approval

requires updating

Successful Implementation Requires

having management commitment

understanding the benefits of a quality management system

engaging staff at all levels

striving to continually improve

having realistic expectations

Quality

Manual

Intent to Action

assign responsibility for implementation

allocate resources

develop and distribute a quality manualimplement quality system

monitor compliance with quality management system requirements

• Quality is not a science, it’s a way of thinking.

• Spend time today to gain rewards tomorrow:–quality results–efficiency–professional, personal

satisfaction–peer recognition

Remember:

FACILITIES AND

SAFETY

Learning Objectivesrelate how facility design impacts the

efficiency and safety of laboratory workers

describe practices to prevent or reduce risks

describe steps to take in response to emergencies

list personal protective equipment (PPE) that should be used routinely

Effects of Laboratory Accident

loss of staff confidence

loss of reputation

loss of customers

increased cost --- litigation, insurance

Negligence of laboratory safety is

costly!58

Everyone

is responsible for quality and safety 59

All diagnostic and health care laboratories must be designed

and organized for

Biosafety level 2 or above

Laboratory Designpath followed by the sample

• reception and registration of patients• sampling rooms• dispatch between different

laboratories• analysis of samples

report delivery, filing

service rooms61

Blood clotting

Hematology

Biochemistry

Washroo

Bacteriology

Gynaecological samples

Blood samples

Common room, stairs

to offices

Disinfection

Laboratory Design 62

Registration Desk

Safety During Service

no unauthorized personsno friendsno childrenno animals

Sample Collection Room

Blood clotting

Hematology

Biochemistry

Washroo

Bacteriology

Gynaecological samplescollection

Blood samples

collection

Common room, stairs to offices

Disinfection

Patient

Reception

ENTRANCE 66

Blood clotting

Hematology

Biochemistry

Washroo

Bacteriology

Gynaecological samplescollection

Blood samples

collection

Common room, stairs

to offices

Disinfection

SampleReception

ENTRANCE

Main Door

Doors and Large Equipment

Blood clotting

Hematology

Biochemistry

Washroom

Bacteriology

Gynaecological samples collection

Blood samples collection

Common room, stairs to offices

Disinfection

Reception

Premiseshigh ceiling with good ventilation

use washable, glossy painteasy to clean and disinfect

walls and ceiling

easy to clean and disinfect 70

Benchtopsnon-porous covering, easy to clean, resistant to chemicals and disinfectant

no wood, no steel

Scheduled Cleaningdaily

• bench tops• floors

weekly

• ceilings, walls

others

• refrigerators, freezers, storage areas72

General Safety Equipment

shower

eye washer fire safety PPE

waste disposal73

Standard Safety Practices

DO NOT

Standard Safety Practices

Safety Signs

Laboratory Hazards

physical

chemical

biological

needles,

syringes

broken glass, sharps

Aspiration

through pipettes

Spills, sprays

Bites, scratches animal or parasites Accidents,

injuries

Physical Hazards

do not recap needles

always use puncture-resistant, leakproof, sharps containers

always use specific waste disposal containers

never directly handle broken glass

Do you see anything wrong?

Do NOT reuse disposable injection equipment

separate cabinets for storage

spill containment cabinet

hazardous waste storage

Chemical Hazards

flammable liquids storage

Material Safety Data Sheet

aerosols and droplets

Biological Hazards

ocular invasion

inhalation

ingestion

skin penetration

Laboratory Fire Safety

PERSONNEL

Laboratory Staff

laboratory’s greatest asset

critical to quality

partners in public health

qualified professionals

Personnel Management

Job Descriptions

Orientation

Training

Competency Assessment

Continuing Education

Performance Appraisal

praise

recognition

bonuses

benefits

flexible time

Motivated employees are more committed to their work

Job Descriptions

“Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.”

ISO 15189:2007

Orientation

Task-specific Training

Competency Recognition

Job Description

Qualified New Employee

Retraining

Orientation

• Direct Observationchecklists

• Indirect Observations– monitoring records– re-testing– case studies

Technologist Name Technologist Title

Procedure for Evaluation

Evaluation Date Evaluator

Procedure item Accept Partial No Comment

Read procedure manual

Equipment set up appropriately

Work area neat

Reagent preparation

Perform task accurately

Perform task timely

Other: Specify

Competency Assessment Methods

• use standard forms • date and keep

confidential

Competency assessment documentation

Training

Continuing Education98

Performance Appraisal

Competency Assessmen

CONFIDENTIAL

John Smith

Training Records

Personnel Records

EQUIPMENT

Performance high level

Test resultsVariation/ Time

Lowers repair costs Lengthens

lifespan

Equipment Management Benefits

Reduces interruption of services

Increases safety

Greater customer

satisfaction

Equipment Management Benefits

Selecting and Acquiring Equipment

easy to use

language

warranty

safety

will it fit?

Negotiating Equipment Acquisition

wiring diagrams

software information

parts list

operator manual

installation by manufacturer

trial period105

Before Equipment Installation

confirm vendor’s responsibilities in writing

establish checklist

Equipment Installation

when possible, have manufacturer install and set up

do not attempt to use prior to proper installation

verify package contents

copy software, if part of system

After Equipment InstallationInventory

Record

Calibration Verification Operating

Procedures

Maintenance Program

Train ALL Operators108

• perform initial calibration– use calibrators or

standards– follow

manufacturer’s instructions

• determine frequency of routine calibrations

Equipment Calibration

Performance Evaluation

Test known samples, analyze data

Establish stability for temperature- controlled equipment

Validate performance with parallel samples

NEW EQUIPMENT

Preventive Maintenance

routine cleaning

adjustment, replacement of equipment parts

Function Checks

Monitor instrument parameters:

– periodically, daily, weekly, monthly

– after major instrument repair

Examples:– incubator temperatures– wavelength calibration– autoclave temperature chart

Create an Equipment Inventory Log

instrument type, model number, serial numberlocation in laboratorydate purchased

manufacturer and vendor contact info

warranty, spare parts

TroubleshootingWhat is the source of the problem?

• Sample?• Reagent?• Water,

Electricity?• Equipment?

When in-house efforts fail:

• call manufacturer orother technical expert

• look for options to continue service obtain back-up instrument

from central stores or manufacturer

refer sample to nearby laboratory 115

Do NOT use equipment that does not function properly

WARNING OUT OF ORDER

DO NOT USE

• manufacturerslaboratory must schedule routine

manufacturer’s maintenancewarranty may require repair handled by

manufacturer

• in-house biomedical service technicians

Service and Repair

Recording Problems

date problem occurred, equipment removed from service

reason for breakdown or failure

corrective actions taken

date returned to use

change in maintenance or in function checks

Example of logbook 1

PURCHASING AND INVENTORY

Benefits of an Inventory Management Program

Quality Maintained

Minimize waste

Stay within budget

Supplies and reagents always available

Inventory Management Challenges

balance between stock availability and expiration dates

life-span of laboratory reagents varies

In-stock

Expiry

Establish a System to Qualify and Select

Vendorsdefine criteria for supplies and services to be purchased

use information from other laboratories

evaluate before purchase and after receipt

Determine payment

mechanisms

Negotiate prices

Review Contracts

Understand government

requirements

Assure reliable

availability, delivery

Purchasing Considerations

INVENTORY

CONTROL

Assign

responsibility

Analyze

Establish

minimum stock

needsDevelop

forms and logs

Establish

system for

receiving, storing

Maintain

inventory system

in all storage

How to Implement Inventory Control

Analyze Needs

listing all tests in the laboratory

identifying all supplies needed for each test

using available information to estimate usage

Item Description

Unit of

Usage/

month (quantification)

Priority

Order lead

delivery

Storage

space,

conditions

Information Required for Analysis of Needs

Quantification: How?

consumption-based method

morbidity-based method

Quantification: Consumption-Based

based on actual usage

must take into account:• health-supplies actually used• waste: expired or spoiled supplies• supplies out of stock for more

than 15 days during any time of year 131

Quantification: Consumption-Based

0102030405060708090

1stQtr

2ndQtr

3rdQtr

4thQtr

Slides

Immersion Oil

Collectioncontainers

Quantification: Morbidity-Based

based on actual number of episodes

must take into account:• population size• disease incidence• accuracy of morbidity data• treatment guidelines

Quantification: Morbidity-Based

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

Influenza

Diarrhea

Inventory Control: Documentation

Maintain records: date received lot number pass or fail acceptance criteria date placed in service or disposition

May be useful to keep records in stockroom.

Stock Logbook

Includes: name and

signature date of receipt quantity date of expiry minimum stock stock balance

Other information:– shelf number– destination 136

inspect new orders at time of delivery• verify contents

• check integrity

• record date each item received

• record expiration date

• store new shipment behind existing shipment

• create or update records

Use clearly visible dating labels

date opened

date expired

Continuous Monitoring of Inventory

Inventory Control

Assign responsibility

Maintain inventory system

in all storage areas

Conduct weekly physical counts

Update records

Computerized Stock Management

advantages

• exact current state of stock• management of expiration dates• makes inventory tasks easier

drawbacks

• on-site computer is needed• requires trained staff 140

PROCESS CONTROL

The result of any laboratory examination is only as good as the sample received in the laboratory.

Components

LaboratoryHandbookPolicies & Practices

• contains information needed by those who collect samples

• available to all sample collection areas

• must be understood by all laboratory staff

• referenced in the quality manual

Laboratory Handbook

name and address of laboratory contact names and telephone

numbers hours of operation list of tests that can be ordered sample collection procedures sample transport procedures expected turn around times (TAT) how urgent requests are handled 146

Define a good labeling systemAssess all samples -

preexamination

Provide sample collection information

What- When- How

Provide appropriate containers and supplies

The Laboratory’s Responsibilities

• patient ID

• tests requested

• time and date of sample collection

• source of sample, when appropriate

• clinical data, where indicated

• contact information of requesting physician

Test Requisition

• patient preparation• patient identification• type of sample

required• type of container

needed• labeling• special handling• safety precautions

Collection Requirements

Labeling

patient’s name

patient’s unique ID numbertest ordered

time and date of collection

collector’s initials

Outcomes of Improper Collection

delays in reporting test results

unnecessary re-draws/re-tests

decreased customer satisfaction

increased costs

incorrect diagnosis / treatment

injury and death151

Preexamination Steps• Verify

–completeness of test request

–appropriateness of sample

–information on label

• Record in register or log

• Enforce sample rejection criteria 152

Labeled samples, completed requisitions

Spilled urine sample, a cause for rejection

Actions for Rejected Samples

inform authorized person

request another sample

record rejected samples

retain rejected sample based on preset criteria

extraordinary circumstances may require testing suboptimal samples

Sample Register or Log

date and time of collectiondate and time of receiptsample typepatient namedemographics as requiredlaboratory assigned

identificationtests to be performed

Sample Handling

Handle all samples as if infectious

Sample Disposal

• set policy for sample disposal• compliance with local and country

regulations • disinfection procedures

Sample Transport

Maintain integrity of sample– temperature– preservation of sample– special transport containers– time limitations

Assure safety regulationsare met

Classification of Infectious Substances

New Classification in 2005: based on two transport categories

Category A: infectious substances capable of causing • permanent disability

• life-threatening or fatal disease to humans or both human and animals

Packaging: most durable triple packaging with full dangerous goods documentation

Training of transport staff

Category B: infectious substances not included in Category A

less stringent triple packaging

no dangerous goods documentation required

Classification of Infectious Substances

Category A

Quality Control (QC) is part of quality management focused on fulfilling quality requirements ISO 9000:2000 (3.4.10)

QC is examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process.

The goal of QC is to detect errors and correct them before patients’ results are reported.

Quantitative Examinations

Measure the quantity of a particular substance in a sample.

Measurements should be both accurate and precise

Qualitative ExaminationsExaminations that do not have

numerical results

growth or no growthpositive or negativereactive or non-reactive color change

Semi-Qualitative Examinations

Results are expressed as an estimate of the measured substance

“trace amount”, “moderate amount,” or “1+, 2+, or 3+” number of cells per microscopic field titers and dilutions in serologic tests

QC Progra

m Steps

Establish written

policies and procedures

Train all staff

Assure complete

documentation

Review

QC data

include corrective actions

What is a Control?

material that contains the substance being analyzed

used to validate reliability of the test system

include with patient samples when performing a test

run after calibrating the instrumentrun periodically during testing

Calibrators vs. Controls

Calibrators

A substance with a specificconcentration. Calibrators are used to set(calibrate) the measuring points on a scale.

1 2 3 4 5

Controls

A substance similar to patients’ samples that has an establishedconcentration.

Controls are used to ensurethe procedure is working properly.

1 2 3 4 5

Characteristics of Control Materials

appropriate for the diagnostic sample

values cover medical decision points

similar to test sample (matrix)

available in large quantity; ideally enough for one year

can store in small aliquots

Types of Control Materials

may be frozen, freeze-dried, or

chemically preserved

requires very accurate

reconstitution if this step is necessary

Sources of Controls Materials

commercially prepared

made “in house”

obtained from another laboratory, usually central or reference

laboratory

Control Materials

ASSAYEDTarget value predeterminedVerify and use

UNASSAYEDTarget value not predeterminedFull assay required before using

“IN-HOUSE”In-house pooled seraFull assay, validation

Choosing Control Materials• values cover medical decision points

• similar to the test sample• controls are usually available in high,

normal, and low ranges

Steps in Implementing Quantitative QC

obtain control materialrun each control 20 times over 30 days

calculate mean and +/-1,2,3 Standard Deviations

Measurement of Variability

Variability is a normal occurrence when a control is tested repeatedly

Operatortechnique

Environmental

conditions

Performance

characteristics of

the measurement

The goal is to differentiate between variability due to chance from that due to error

Measures of Central Tendency Although variable, sets of data are

distributed around a central value

Frequency

Measurement178

Measures of Central Tendency

Mode the value which occurs with the greatest frequency

Median the value at the center or midpoint of the observations

Mean the calculated average of the values

Not all central values are the same.

Frequency

Measurement

Mean Mode

Median

Symbols Used in Calculations

∑ is the sum of (add data points)

n = number of data points

x1 - xn = all of the measurements (1 through n)

__ X represents the mean

Quality Control is used to monitor the accuracy and the precision of

the assay.

What are accuracy

and precision?

Accuracy

The closeness of measurements to the true value

Precision

The amount of variation in the measurements

The difference between the expectation of a test result and an accepted reference value

Accuracy and Precision

Accurate and Precise

Precisebut Biased Imprecise

Accurate = Precise but not Biased184

Standard Deviation and Probability

99.7%F

cy-3s - 2s -1s Mean +1s

+2s +3s

XFor a set of data with a normal distribution, a random measurement will fall within:

+ 1 SD 68.3% of the time

Levey-Jennings Chart

Graphically Representing Control Ranges

Statistics for Quantitative QC

assay control material at least 20 data points over a 20-30 day period

ensure procedural variation is represented

calculate mean and + 1, 2 and 3 SD

MEAN+1SD

Chart name: Lot number:

Draw lines for Mean and SDs(calculated from 20 controls)

Number of Controls

Interpretation depends on number of controls run with patients’

samples.

Good: If one control: accept results if control is within ± 2SDunless shift or trend

Better: If 2 levels of controls apply Westgard multirule system

Detecting Error• random error: variation in QC results

with no pattern- only a cause for rejection if outside 2SDs.

• systematic error: not acceptable, correct the source of errorExamples:– shift–control on one side of the mean 6

consecutive days– trend–control moving in one direction–

heading toward an “out of control” value

MEAN+1SD

Levey-Jennings Chart Shift

MEAN+1SD

Levey-Jennings Chart Trend

If QC is out of control

• STOP testing• identify and correct problem• repeat testing on patient

samples and controls after correction

• Do not report patient results until problem is solved and controls indicate proper performance

Solving out-of-control problems

identify problem

refer to established policies and procedures for remedial action

Possible Problems

• degradation of reagents or kits• control material degradation• operator error• failure to follow manufacturer’s

instructions• an outdated procedure manual• equipment failure• calibration error

Qualitative or Semi-quantitative tests

• microscopic examinations • dipsticks • serologic procedures • microbiological procedures • any reaction that produces non-

numeric results

Quality Control Materials

built-in controls

control materials that mimic patient samples

reference organisms

Built-in Controls

integrated into the design of a test kit device

automatically run with each test performed

assess certain aspects of kit performance

may not assess entire testing process 198

Stock Cultures for QC

reference strains

in-house developed strains

predictable reactions in stains and media

ensure media, reagents and supplies work as intended

Sources for Obtaining Reference Strains

ATCC-American Type Culture Collection

CIP- Pasteur Institute Collection (France)

NTCC-National Type Culture Collection (UK)

Stain Management

use established procedure for preparation or reconstitution

store appropriately

label: content, concentration, date prepared and placed in service, expiration, initials

Quality Control for Stains

check with known organisms or cells

examine for contaminants such as bacteria and fungi

examine for crystal shards or for precipitation

Left: Wright stain

Right: Gram stain

QC of Microbiology Media

verify performance of all media

commercially prepared: new lot only

in-house prepared: all batches

MacConkey Agar

Left: non-lactose fermenter

Right: lactose fermenter

Media Problems to Avoid

out-dated dried-out contaminated

Human blood should not be used because: too much batch to batch variationmay include inhibitory substances, including antimicrobialsmay contain biohazards (e.g., hepatitis virus)

DOCUMENTS AND RECORDS

Documents communicate

information via policies, processes, and procedures

need updating

Records capture information

on worksheets, forms, labels, and charts

permanent, do not change

RECORDS

Documents and Records—How do they differ?

Why do laboratories need to manage documents and records?

To find information whenever it is needed!

Information is the major product

of the laboratory.

Laboratory Documents

Policies

ProcessesProcedures

Policies - The “WHAT TO DO” A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” (CLSI HS1-A3)

Processes - The “HOW IT HAPPENS”

A “set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1)

Procedures - The “HOW TO DO IT”

Standard operating procedures (SOP)210

Hierarchy of Documents

“How to do it”

“How it happens”

“What to do”

Documents are the communicators of the quality management system

Verbal instructions often are:

• not heard• misunderstood• quickly forgotten• difficult to follow

Why are documents important?

• essential guidelines for laboratory

• quality manual• SOPs• reference materials

• required by formal laboratory standards 213

Documents are a reflection of the laboratory’s organization and its quality management.

A good rule to follow is:

“Do what you wrote and write what you are doing.”

Good Documents are:

• clear

• concise

• user-friendly

• explicit

• accurate

• up-to-date

Documents for work processes should be accessible to staff at the work site

• instructions on handling incoming samples• SOPs for each test• quality control charts

and trouble-shooting instructions

• safety manuals and precautions

Standard Operating Procedures (SOPs) are documents that:

describe how to perform a test using step-by-step instructions

written SOPs help ensure:–consistency–accuracy–quality

A Good SOP

• provides detailed, clear, and concise direction for testing techniques

• is easily understood by new personnel

• is reviewed and approved by management

• is updated on a regular basis218

Standardized SOP Format

• Computerized procedure• Standardization:

– Header– Version/chapter/

reference– Author/reader/validator– Recipients– Version date/Application

date– Typical outline

• Updating and storage of different versions is easy

Complete Standardized Header

Use at the top of the first page only

Reduced Standardized Header

• other pages of every procedure

• use at the top of all other pages

determineprocedure

to use

assess scientific validity

include each step

gather all documents

establish means for

updating

When Preparing SOPs

Suggested Outline for SOPs

• Title: Name of Test• Purpose: Medical use• Instructions:

– Preexamination – Examination– Postexamination

• References to verify the method is established

• Author’s name• Approval signature(s)–initial and date

Do not rely solely on manufacturer product inserts

Inserts do not provide specific information for test sites, such as:

• materials required, but not in kit

• specific safety requirements

• external quality control requirements

Job Aids

• shortened version of SOPs• hand written or printed • visible location at testing site• useful tool to assure all testing steps

are correctly performed

Job Aids

Document Controlassures that the

most current version is used

ensures availability when needed

Preparation

Review

Issue Distribution

Revision Approval

Document Preparation and Control Process

Common Document Control Problems

• outdated documents• too many documents are

distributed and the systemcannot be maintained

• lack of control of documentsof external and internal origin

Laboratory Records

Sample log book

or register

WorkbooksWorksheets

Instrument printouts

Maintenance records

Quality control

EQA / PT

records

Patient test

reports

More Records

Personnel records

Internal audits results

External audits results

Continuous improvement

User surveys

Customer feedback

Critical communications

Test Report Contents ISO 15189

• test identification• laboratory

identification• patient unique

identification and location

• name and address of requestor

• date and time of collection

• time of receipt in lab• date and time of

release of report

• primary sample type• results (SI units)• biological reference

intervals• interpretive

comments• person authorizing

release, with signature when possible

• note if reporting a corrected result

INFORMATION MANAGEMENT

Quality Lab Report

The test result is the final product of the laboratory.

Paper-based

Electronic

Establish processes for managing data

Patient information

accessible accurate timely secure confidential private

Quality Lab Report

ID 0905120047

Effective communication

Effective reporting systems

ConfidentialConfidentialData

protectionData

protection

Checking processesChecking processes

Logs, worksheets

Standardized request forms

Unique identifierssamples, patients

Important elements

Protect Confidentiality

safeguard a patient’s privacy

assure laboratory data confidentiality

Data Protection

Paper-based systems• use durable materials for

recording

• store records properly

Computerized systems• schedule regular backup of data

Computer systems

incompatible

Computer systems

incompatible

Transmission errors

Data organized

poorly

Data organized

poorly

Archivingpoor

Forms inadequate

IDinsufficient

Data incomplete

Common Problems

Integrate with other

Financial managementFinancial

management

Access control

Track,analyze trends

Track reportsTrack

reports

Detailed, legible reports

Data retrievaloptions

Error reductionError

reduction

Back-up requirements

Costs:purchase

and maintenance

Costs:purchase

and maintenance

Adapting to a new system

Training:time

and money

Training:time

and money

OCCURRENCE MANAGEMENT

What is an occurrence?Any event that has a negative impact

on an organization, includes personnel, product, equipment, or the environment.

Some Common Laboratory Occurrences

• proficiency testing error

• no action on out of range controls

• false negative result

• late reports

• missing reports

• complaints

• laboratory accident 244

equipment not properly maintained

QC, EQA not

performed

QC, EQA not

performed

test kits not stored

properly

test kits not stored

properlytranscription

errors checks

not done

transcription errors checks

not done

training not done

or not completed

training not done

or not completed

written procedures not followed

no written proceduresno written

procedures

individual responsibilities

unclear

individual responsibilities

unclear

Common CAUSES of Error

THE PATIENT Test selection Sample Collection

Sample Transport

Laboratory Analysis Examination Phase

Report CreationReport Transport

Preexamination Phase

Result Interpretation Postexamination Phase

Errors can occur throughout the testing process

wrong sample collected

Preexamination Errors

sample mislabeled or unlabeled

sample transported inappropriately

reagents or test kits damaged by improperstorage

incorrect timing of test

Examination Errors

results reported when control results out of range

improper dilution and pipetting of sample or

reagents

reagents stored inappropriately

transcription error in reporting

Postexamination Errors

report illegible

report sent to the wrong location

report not sent

Communicate

ACTION

Awareness

Investigate

The Occurrence Cycle

AccreditationCertification

Seeking OFIs

Quality indicators

External audits

PT / EQA

Internal audits

Monitoring complaints

Customer satisfaction

Management Review

How are occurrences detected?

EVENTSee the potential event and plan to avoid it

Preventiveactions

Address the eventand its consequences

Remedial actions

Correctiveactions

Learn from the eventand avoid its recurrence

ASSESSMENTS

Why perform an assessment?

• learn “where we are” in terms of quality management

• measure gaps• need information for:

planning and implementationmonitoring continuous improvement

Important Skills

for Auditors

Attention

to detail

Trained

Diplomatic

Technical/ Quality

management expertise

Communicate effectively

Continuous monitoring is

the key element to success in the Quality System

“It isn’t what you find…

it’s what you doabout what you

find.”

-Philip Crosby258

EQA Methods

ProficiencyTesting

Rechecking

Retesting

On-siteEvaluation

External Quality Assessment (EQA)

comparison among different test sites early warning for systemic problems objective evidence of testing quality areas that need improvement training needs 260

External Quality Assessment (EQA)

• important for improvement• a measure of laboratory

performance

Proficiency Testing

ISO/IEC Guide 43-1:1997

“Proficiency testing schemes (PTS) are interlaboratory comparisons that are organized regularly to assess the performance of analytical laboratories and the competence of the analytical

personnel.” 263

PT organization /provider

Laboratory

Analyze

Evaluation

PT performance report

Returnresults

PT samples sent regularly

ReceivePT report

Corrective Actions

Proficiency Testing

Laboratory 1 Laboratory 2

No discussion between labs

Final PT report received

ISO 15189

Analyze same manner with same personnel

Improvement

PT sample

Patient sample

Information received from PT participation must be directed toward improvement in the laboratory to receive the full value.

PT Limitations

PT results are affected by variables not related to patient samples

PT will not detect all problems in the laboratory

PT may not detect problems with pre- and post examination procedures

Retesting

tested by reference laboratory performed on dried blood spots or

serum not blinded statistically significant primarily used to assess HIV rapid

testing

Identifyproblems

TakeCorrective

Action

EQA Should Lead to Actions

Standardization Bodies

WHO 272

International Organization for Standardization

world's largest developer and publisher of international standards

standards are applicable to many kinds of organizations including clinical and public health laboratories

Clinical and Laboratory Standards Institute

global, nonprofit, standards-developing organization

promotes the development and use of voluntary consensus standards and guidelines within the health care community 274

European Committee for Standardization

national standards bodies in the European Economic Community and associated countries

general terms include openness and transparency, consensus, and integration

World Health Organization

has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles

Elements of an Accreditation Process

Accreditation BodyStandards

Assessors

User laboratory

Certification and

Accreditation Bodies

Competent staff

Objective

Standards-based

KnowledgeableApproved

Laboratory

Opening today!

Licensure

Laboratory

Certification

ISO 9001

Quality Manual

ReferenceLaboratory

ISO 15189WHO POLIO

ISO 9001

Quality Manual

Accreditation

Where is your Laboratory?

not one to be taken lightly or without forethought

Requirements

knowledge resources

commitment planning

Process for Accreditation

Accreditation does not guarantee success, it is only one step along the quality journey

CONTINUALIMPROVEMENT

QUALITYMANAGEMENT

CUSTOMERSATISFACTION

ACCREDITATION

ERRORREDUCTION

Accredited laboratories tend to:

perform better on proficiency testing

are more likely to have a working quality management

system283

MAINTAINED

PRIMARY

It is an ACHIEVEMENT

to maintain accreditation

It is an accomplishmentto receive accreditation

PRIMARY

COSTUMER SERVICE

Quality is meeting customer needs.

Philip CrosbyFour Absolutes of Quality

Management 1979

Who is responsible for Customer Service?

Everyone in the

laboratory!

Program for Improving Customer Satisfaction

Requires:• commitment from all staff• planning• knowledge of monitoring tools• resources

Community

Patients

Public Health

Laboratory

PhysiciansHealth care

provider

The Laboratory and Its Clients

Customer service is an integral part of a quality management

system

Good customer service provides:

• valuable information for best patient care

• valuable information to improve surveillance

• professional image of laboratory

interviews, focus groups

satisfaction surveys

management review

internal audit

qualityindicators

complaint monitoring

MONITOR

Methods for Assessing Customer Satisfaction

Complaints

Actual dissatisfied customers!

Monitoring quality indicators

Conducting internal audits

Reviewing by management

ACTION

Assessment Methods

analyzed in a timely

manner

analyzed in a timely

manner

no leading questions, unbiased

pre-testedpre-tested

organizedorganized

plannedplanned

Successful surveys

Customer Surveys

An active Quality Management Systemensures Laboratories Meet

ALL Client Requirements

PROCESS IMPROVEMENT

W. Edwards Deming14 Points for Quality

Two points address continual improvement:

• create constancy of purpose for improvement

• improve constantly and forever

The Deming Cycle

Continual Improvement(ISO 15189:2007)

develop plan for

improvementidentify potential sources of error

implement

review the effectiveness

of action

adjust the action plan

and modify the

system

Optimizing space, time, and activity to improve the physical paths of workflow.

New Trends-Improvement Tools

Organized processes to assist in decision making for continual improvement:

control define measure analyze improve

Structure in Six Sigma

Quality Indicators

• indicate performance

• determine quality

• highlight concerns

• identify areas needing further study

• track changes over time

Use an indicator only as long as it provides

useful information.

Don’t get tied to your indicators.

Quality Indicators and Timing

Use an indicator only as long as it provides

useful information.

Don’t get tied to your indicators.

Quality Indicators and Timing

References

Thank you!309

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