laboratory accreditation

Laboratory accreditation

Gift Ajay SamDeputy Quality Manager

Department of Transfusion Medicine and ImmunohaematologyChristian Medical College, Vellore

[email protected]

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Accreditation‐What?

• A process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks.

• E.g. Joint commission on accreditation of healthcare organizations (JAHO), National committee on quality assurance (NCQA), NABL, CAP.

• India NABL authoritative body for testing and calibrating laboratories.

Department of Transfusion Medicine and Immunohaematology, CMC, Vellore‐

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Accreditation vs CertificationCertification Accreditation

A procedure by which a third party* gives a written assurance that a product, process or service confirms to specific requirements.*Third party‐ A person or a body that is recognized to be independent of the

laboratory or parent organization.

A procedure by which an authoritative body gives formal recognition that a body or a person is competent to carry out specific tasks (ISO/IEC guide 2).

eg. ISO 9000eg. ISO 15189; 2012, ISO 17043; 2010.


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Accreditation‐Why?

Acceptance of test results within & beyond borders.

Greater control of laboratory process.

Customer satisfaction. & Brand value.

Customer can easily find an accredited laboratory


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Accreditation‐ How?

• NABL embraces the ISO 15189 Medical laboratories‐ requirements for quality and competence.

• Accreditation given based on laboratories capability to perform tests and provide reliable results.

• Assessment based on the ISO 15189; 2012 standard.


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Requirements for accreditation

• Create a policy document (Quality Manual).• Appoint a Quality Manager.• Establish the Quality Management system• Appoint a technical manager.• Process breakdown & QI identification.• Monitor quality indicators and undertake appropriate CA/PA.

• Documentation. • Audits


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• Quality manual:– Satisfy every clause mentioned in the standard (ISO 15189).

– Greatest document of the QMS (Level 1).– Describes laboratory policies, organization structure, job descriptions and personnel interrelations.

Note:“Every lab policies traceable to its QM”.


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• Quality Manager:– Head of the QMS.– Reports directly to the lab director.– Keeps the laboratory audit fit.– Monitors process and continuously improves them various lab processes.

– Involved in educating and training staff.• Education‐ change the way people think.• Training‐ change the way personnel work.


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• Quality Management system– Quality: The degree to which a set of inherent characteristics fulfils requirements.

– Management: Plan, organize, staff, lead and control.


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• Technical Manager:– Usually a senior technical person.– Appointed by HOD.– Technical workload management and work distribution among existing staff.


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• Quality indicators:– “It measures how well an organization meets the needs and requirements of users and the quality of all operational processes”.


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• Establishing QI & continual improvement:– Lab process broken down to its components and micro components.

– Identify the common failures or errors that occur frequently.

– Log the most common errors and the reason behind the errors.

– Appoint a person to ensure the log is maintained and updated regularly.


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• Establishing QI & continual improvement:– Tabulate and identify the major causes for the errors.

– Present the data with recommended corrective measures.

– Implement the CA and measure the rate of success of the corrective action.


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• Properties of QI’s:– Measurable in terms of numbers. – Benchmarks should be predefined.– Results should be subjected to statistical analysis.


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Pre analytical

• Sample collection• Routing to appropriate location• Registration into LIS

Analytical

• QC• Sample processing• Result genera ration

Post analytical

• Result validation• Result transfer.

Lab work breakdown structure and QI identification

Sample rejection.Sample missingDouble poke

QC failure.Unscheduled Downtime.

Human error.Software crash


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Documentation

Indicators for good documentation:• Approved, reviewed and updated regularly.• Concise, legible, accurate and traceable.• Amendments & revision are identifiable. • Current version is available at points of use. • Follows change control procedure.• Obsolete documents separated, identified and retained for defined amount of time.


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Documents of the QMS

Quality Manual

QSP/ SOP

Forms, checklist, Records.


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Document classification in QMS

Internal documents External documents Records

Documents


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• Internal documents:– Documents/ reference material created by the laboratory for use within the laboratory.

– It is subject to the change control procedures created by the laboratory.

– It is approved by appropriate personal before release for use by the laboratory personnel.

– E.g. SOP, QM, QSP.


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• External documents:– Maintained by the laboratory for reference purposes.

– Created by a third party and is formally published for use.

– Not subject to the change control procedure of the laboratory.

– E.g. ISO 15189; 2012 standard, published book.


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Records• Proof/ evidence of activity.• They have a defined retention period.


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Other activities

• Quality Control– Goal to identify errors before they impact the real test.

– Also called as repeatability testing or precision. • Proficiency testing

– Ensure the laboratory tests are accurate.• Calibration

– All equipment's and instruments are produce accurate results.


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Reference

• http://www.nabl‐india.org• ISO 15189; 2012, 3.18.• http://www.qualityindicators.ahrq.gov

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laboratory accreditation

Healthcare