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What is Quality ?What is Quality Management System (QMS)?

Why Medical Laboratories need Quality

Management System?

 

 Accreditation

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Philip CrosbyPhilip Crosby (1926(1926--2001)2001)““ ua y means o ng r g e rs meua y means o ng r g e rs me””

“requirements” 

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Qualit Mana ement S stemQualit Mana ement S stem

“ Coordinated activities to direct and control an

”  .

( ISO 9000)

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Why Medical Laboratories needWhy Medical Laboratories need

 Achieving , Maintaining and

improving

 Accuracy

Timeliness andReliability

n y soun ua y anagemenSystem will enable the labs to

produce the results that the users

will trust.

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Why Medical Laboratories need

“70% of clinical medicine decision making isredicated u on or confirmed b or

documented by medical laboratory test

results”.

Dighe, A. S.,Medico legal liability in laboratory medicine,

,

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Why Medical Laboratories needWhy Medical Laboratories need

Consequences of Inaccurate

results/Laboratory errorsUnnecessary treatment

Treatment complications

Delayed patient recovery

 Additional and unnecessary diagnostic tests

Legal actions from patients and community

Increased cost in time and personnel effort

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Why Medical Laboratories needWhy Medical Laboratories need

Laboratory is capable

To demonstrate that the laborator 

Operates a Quality System 

Is capable of generating technically valid results

National and International recognition through Accreditation.

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Establishing QualityEstablishing Quality

2 Outline the Vision Statement , Mission Statement adopt the Guidingprinciples

3 Educate Upper-Level Management

4 Create Steering Committee

5 Establish Quality Improvement Teams

6 Flow Diagram of the Processes 

8 Consider the staff as an Internal Customer

9 Provide a Quality Training Program

 

11 Use the Tools of QMS

12 Know the Benefits of QMS

Continuous Improvement

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Implementation ProcessImplementation Process

Procure the Standards

Understand the 25 essentials (Clauses)Management requirement – 15

 –  

Prepare Quality System Manual covering

both requirements under ISO 15189 and

Implement the Quality System as per the

wr en, e ne an ocumen eQuality Management.

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anagemen equ remen

Organization & Management

 

Ethical Conduct

Laboratory Director 

Management commitment

Quality Policy

 

Communication

Quality Manager 

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anagemen equ remen

ua y anagemen sys em

Documentation

 

Implementation

Continual Im rovement

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anagemen equ remen

Document control

 

Establish and review

Examination by referral laboratories Selection

Evaluation and Provision of results

   Advisory Services

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Implementation ProcessImplementation Process

Management Requirement

Resolution of Complaints

Identification and Control of nonconformities

Corrective action reven ve ac on

Continual Improvement

 

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Implementation ProcessImplementation Process

Management Requirement

Evaluation and auditScope – All activities

User Feedback

Internal audits

Risk assessment

Quality Indicators

Registration errors

Unacceptable samples

No of corrected reports

Turn around time

Mana ement review

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 Technical requirement

Director/Head

Personnel ualifications

Job descriptions

Induction Training

Competence assessment

 

Continual education and professional development

Personnel Records

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Implementation ProcessImplementation Process

 Accommodation and Environmental Conditions

Laboratory and office facilities

Storage facilities

Staff facilities Patient sample collection facilities

Facility maintenance &

 

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Laborator E ui ment

Verification upon installation Instructions for use

a ra on an a n enance

Program

Equipment records◦ Manufacture’s name and serial no

◦ Date of installation

◦ Location

◦

qu pmen manua s◦ Daily/weekly/monthly maintenance records

◦ Defect logs

◦  

◦ QC and Calibration records

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Reagents and consumables

Reception and storage

 

Inventory management

Instructions for use

 Adverse incident reporting

Records

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Im lementation ProcessIm lementation ProcessPre-examination Procedure

Information for patients and users

Request form information

ns ruc on on pa en prepara on, co ec on an

transportation must be made available to all

Laboratory personnel and the users of the services.

Sample acceptance and rejection criteria must be

evolved and communicated to the users.

erv ces es rec ory

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Im lementation ProcessIm lementation ProcessExamination procedures

Selection Verification

Validation Procedures

Measurement uncertainty

Documentation of examination procedures

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Ensurin ualit of examination

results Internal QC program :

proce ures are o e su ec e o

quantitative and qualitative checks by

adoption of Quality control measuresua y on ro a er a s

Quality control data

policies

QC checks are to be documented and

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Review of results before release

,clinical samples CBC – 24 hrs at 2-8 degree Celsius

Histopathology Slides and Blocks – 5 years0ero ogy – ays a - egree e s us

Extracted DNA – 5 years at -20 Celsius

Molecular Diagnostics gel picture- 5 years)

0

Ensuring the stability and integrity ofthe sample.

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Im lementation ProcessIm lementation ProcessReporting of results

 Accurate

Clear

nam guous

Report content

 

 Authorized personnel

Interim re ort

Final report

 Automated selection and

reporting

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Im lementation ProcessIm lementation Process

Laboratory Information

Management

 

management should be

validated by supplier  Verified by the laboratory

Confidentiality of patient

 Authorities and responsibilities

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 Accreditation Bodies Accreditation Bodies

&&

u e nesu e nes

National Accreditation Board for Testin and Calibration

Laboratories (NABL) - Autonomous Body under Dept. of

Science & technology, Govt.Of India

 Accreditation Commission For Conformit Assessment 

Bodies (ACCAB) – First Private Sector Accreditation Body

in India

 

National Accreditation Board for Hospitals and

Healthcare providers (NABH)

 

Organizations (JCAHO)

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 Application to the Accreditation Board

Quality System Manual adequacy

re-assessmen

Final Assessment

 Accreditation Board will communicate the

laboratory about the accreditation status

 Accredited labs need to go in for periodicsurveillance and applicable

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Im ortance of AccreditationIm ortance of Accreditation

Recognition of competence

Exchange of service

Ensuring the needs and

requirements of all the users

c n c ans, pa en s

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Improved Efficiency andEffectiveness

Consistenc andContinuous Performance

Staff 

 Authority Levels andrespons es

Confident and focused

Users

Meeting their needsConfidence in Laboratory

Services.

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--

Management commitment is crucial.

Start implementing changes that can be easilyaccom lished and have the bi est im act.

Focus on continual improvement.

Consider accreditation as a form of audit – a

QMS and not the ultimate goal of the organization.

 

organization.

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QualitQualit

Quality is never an accident, It is always the result

of high intention, Sincere efforts by all, Intelligent

,

the wise choice of many alternatives

(Source – Bobs)

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