A User's Perspective... A User's Perspective...

Take Control with the Complete QC SolutionTake Control with the Complete QC Solution

Why Quality Control?Why Quality Control?

Most aspects of patient care take place far

beyond the walls of your laboratory.

However your laboratory provides test

results that allow health care providers to

make life saving diagnostic and therapeutic

decisions that are only as good as your

laboratory data.

These test results, in turn, are only as

reliable as the instruments and reagent

systems behind them. That is why quality

control of those instruments and reagents is

more than an exercise in good laboratory

practice - It's critical to the care of each

and every patient.

The RegulationsThe Regulations

The QC material used must cover the analytical

concentrations encountered.

Acceptable ranges (confidence intervals) must be

defined for the control material.

The laboratory must have a system of long term

monitoring of internal quality control results to assess

the method performance

The laboratories should establish their own mean and

ranges rather than use product insert ranges

Laboratories must test controls at prescribed intervals.

When control materials are tested, at least two different

concentrations should be used.

Laboratories must have established and well

characterized criteria for acceptable QC performance.

The laboratory shall include a minimum of one level QC

at least once a day. However, where the number of

patient samples analyzed for any parameter exceeds

25 per day, the laboratory shall employ 2 levels of QC at

least once a day for such parameters. Further, if the

number of patient samples analyzed for any parameter

exceeds 75 per day, the laboratory shall employ 2

levels of QC at least twice a day at appropriate

intervals.

Ref : AS 4633 (ISO 15189

Application document-Supplementary requirements for

Accreditation in the field of Medical testing, 2005 ver1-NATA)

(Ref CLSI

standard “Statistical Quality control for Quantitative Measurements:

Principles & Definitions”)

(Ref CLIA -The Clinical Laboratory Improvement Amendments,

Requirements)

(Ref NABL-112 guidelines Specific criteria for

Accreditation of Medical Laboratories)

NATA-National Association of Testing Authorities (Australia) & Quality Controls

CLSI - Clinical and Laboratory Standards Institute & Quality Controls

CLIA- The Clinical Laboratory Improvements Ammedments (U.S) & Quality Controls

NABL-National Accreditation Board forcalibration and testing Laboratory (India)& Quality Controls

What Our Users Have To Say …..What Our Users Have To Say …..

Dr. Maria BorgesChief Quality Officer- SRL Ranbaxy - Mumbai

Our Laboratory has traditionally used Quality control since inception and QC forms the backbone of testing in ensuring accurate and precise patient data. All the tests done in the laboratory, whether qualitative or quantitative are covered by extensive QC. We use Bio-Rad's third party controls. These are run on a daily basis on several instrument platforms and have practically replaced the manufacturer's controls in several instances. These controls are particularly useful as there is no element of internal manufacturer's bias. Further in kit controls may not detect changes that occur with new calibrator and reagent lots.

Dr. Milind BhideConsulting Pathologist Bhide Laboratory-Mumbai

Use of quality control has helped us in improving overall quality and in meeting accreditation requirements. Moreover use of third party controls is better as they give lots with longer expiry. We use only Third party controls. Bio-Rad team is excellent.

Dr. D. SuhasiniSr Consultant & HOD Dept of Biochemistry- Apollo Hospital, Hyderabad

Use of Quality control gives us the confidence that we are giving right results to our patients. Most of the controls run in our laboratory are third party controls which give better evaluation of the method performance than in-kit controls. Bio-Rad's complete QC solution can be described in one word as wholesome.

Dr. Ramesh KumarDirector - EI Metropolis,Cochin

Using Bio-Rad Quality controls has helped to improve the quality and thus increased the quantity of tests.

Dr. Sunita UpadhayaHead Clinical Laboratory-Jubilant Clinsys LTD ,NOIDA

Use of internal quality control samples has benefited us by keeping a check on method performance, validating test results and check on analytical precision. Participation in Bio-Rad QC Unity program has greatly helped in comparing the lab analytical precision with the peer group precision.

Mr. Prajeesh KurupDirector Ashwini Diagnostic Services-Calicut

Initially long back we had problems when doing testing and faced patient complaints on reported values however once we started using Bio-Rad's Quality controls, the complaints and problems decreased, there by decreasing repeat cost.

Dr. Sultana FurruqhM.D. (Biochem)-Prof & Lab In- charge -St John's Medical College & Hospital-Bangalore

Using Bio-Rad quality controls has greatly benefited us. It has helped us improve the quality systems and facilitated the process of accreditation.

Why Third Party Control ?Why Third Party Control ?

Even if you diligently test your instruments

on a regular basis, quality assurance

depends on the control material used.

Manufacturer's control / In kit controls are

often made from the same raw material as

the kit calibrators or other kit components,

and may fail to detect shifts in patient values.

Third party controls are not designed or

optimized for one specific test method or

instrument and thus provides an unbiased

assessment of that test system. The RegulationsThe Regulations

The use of control materials independent of those

produced by the manufacturer of the test or analyzer

should be considered.

When in-kit controls are used to calculate the cutoff

ranges, a third party control is needed to provide an

unbiased assessment.

Control material need to be different from calibrator

material

Laboratory is encouraged to use control material

similar or identical with the patient sample matrix.

Ref : AS 4633 (ISO 15189 Application

document-Supplementary requirements for Accreditation in the field

of Medical testing, 2005 ver1-NATA)

(Ref External controls revisited. AABB

regulatory update, May 1998)

(Ref CLSI standard “Statistical Quality control for

Quantitative Measurements: Principles & Definitions”)

(Ref NABL-112 guidelines Specific criteria for Accreditation of

Medical Laboratories)

NATA-National Association of Testing Authorities (Australia) & Quality Controls

AABB-American Association of Blood Banks & Quality Controls

NABL-National Accreditation Board forcalibration and testing Laboratory (India)& Quality Controls

What Our Users Have To Say …..What Our Users Have To Say …..

Mr. Vijay BhattHOD- Biochemistry - Manipal Hospital, Bangalore

We use Bio-Rad's Third party controls regularly. By using this there is an unbiased assessment. Since it is control not provided by the kit manufacturer it acts similar to patient samples.

Human matrix controls are useful to set up dealing with patient samples of various kinds.

Dr. Nilesh ShahSr. V.P- Operations- Metropolis Health Services, Mumbai

We use Third party controls every day. These controls increase the confidence level of the technician to report the results. Bio-Rad's complete range of QC products helps us in monitoring the quality of results, error detection and management. The long shelf life of controls is very useful and helps check the systematic and random errors. Human matrix controls are useful and desirable too and important for error detection.

Mr. Sanjib AcharayaManaging Director - Serum Analysis Centre (P) Ltd, Kolkata

We use Bio-Rad third party controls. It improves our performance as it is not optimized for any particular instrument. We run the controls daily.

Ms. Kajal BhambhaniTechnical Director- Clinical Laboratory- Lambda Therapeutics Research centre, Ahmedabad

We use two levels of Third Party controls every 24 hours. Use of QC gives us confidence in results reporting. Bio-Rad's Controls with long shelf life are very useful as we do not have to establish ranges frequently.

Dr. Asha RasteHOD Biochemistry- Tata Memorial Hospital-Mumbai

We use Bio-Rad controls as third party controls for all the analytes such as chemistry, immunoassays urine chemistry, blood gas analysis. This has helped the lab to ensure the reliability of the lab results and has given the lab confidence in lab test results. Controls are run three times a day, once in the morning after daily maintenance and before starting patients samples, second time during the afternoon, third time just before shut down along with the last sample run.

External Quality programs are accepted

around the world as invaluable tools used by

the laboratories to periodically assess the

performance of their testing systems.

Results are objectively compared to

other laboratories using the same

methodologies, instruments and reagents.

When used in conjunction with daily quality

control, these external programs can give

laboratories added confidence in their

patient test results.

Most of the accreditation / certifications

depend heavily on the laboratory's EQAS /

PT data and is seen as a very useful tool to

monitor relative accuracy.

The laboratory must participate in external quality

assurance programs (QAP's) to cover the range of

tests performed, where available. Should there be no

program available; laboratories are encouraged to

investigate a sample exchange program with another

laboratory performing similar testing. The laboratory is

encouraged to select a QAP that is part of an accredited

proficiency testing provider program

Laboratories should actively participate in

interlaboratory comparison programs when available,

because they make an important contribution to quality

control.

Ref: Ref : AS 4633

(ISO 15189 Application document-Supplementary requirements for

Accreditation in the field of Medical testing, 2005 ver1-NATA)

(Ref CLSI standard “Statistical Quality control for

Quantitative Measurements: Principles & Definitions”)

External Quality Assessment Programs & AccreditationExternal Quality Assessment Programs & Accreditation

NATA-National Association of Testing Authorities (Australia) & EQAS

CLSI - Clinical and Laboratory Standards Institute & EQAS

NABL-National Accreditation Boardfor calibration and testing Laboratory(India) & EQAS

The laboratory shall participate in External Quality

Assessment Scheme (EQAS) / Inter laboratory

comparison as defined in NABL 163. The laboratory

shall document any corrective actions taken based on

the EQAS evaluation report. For those analytes where

a formal EQAS is not available the laboratory shall

exchange samples with other NABL accredited

laboratories. The laboratory shall adopt alternate

methods to validate performance for certain tests for

which inter-laboratory comparisons are not possible. (Ref NABL-112 guidelines Specific criteria for Accreditation of

Medical Laboratories)

What Our Users Have To Say …..What Our Users Have To Say …..

Dr. Puneet NigamChief Technical Officer- Lal Path Labs Delhi

We use Bio-Rad EQAS programs in our labs. Using EQAS has enabled our labs to get a measure of the consensus true value and there by helped us estimate the total error in each assay and hence achieving the quality goals. The single window contact point of Bio-Rad has resulted in faster and better service.

Dr. Monika Prabhakar Pathologist and Quality Manager- Lister Metropolis Laboratory & Research Centre Pvt Ltd. Chennai

We use Bio-Rad EQAS programs. The comprehensive reports obtained from EQAS programs have helped us understand our performance vis-à-vis our peers both at national and international levels.

Dr. K.D. PatoleConsultant Pathologist- Rajiv Gandhi Cancer Research institute, Delhi

We use Bio-Rad EQAS. It helps us monitor and check our performance by an unbiased examiner.

Dr. Abhijit BanerjeeDirector, Pathologist -Ashok Laboratory, Kolkata

Using Bio-Rad EQAS program, has helped me to evaluate my labs performance in broader arena and fine tune to deliver improved and accurate results. The single window contact point, Bio-Rad's EQAS coordinator has been helpful. Bio-Rad is a comprehensive “one stop shop” an irresistible supermarket of QC management.

Dr. George AbrahamConsultant Pathologist- Laboratory Services-Trivandrum

Use of EQAS has helped us in knowing where we stand in comparison to our peers and method group.

Mrs. G. SharadaHead -Clinical Laboratory.- Dr Mohan's Diabetes Specialities Centre Pvt Ltd.,Chennai

I am using Hb EQAS from Bio-Rad. This is very useful for my analytical interpretation.

By using Bio-Rad's comprehensive

product line of third party controls, you

take a decisive and measurable step

towards ensuring the reliability of test

results. Using Bio-Rad's quality data

management solutions in conjunction

with the third party controls, allows your

laboratory to continuously compare test

method performance, generate useful,

reliable information and increase

confidence in your reported test results.

Bio-Rad's strong technical support

group works towards providing you

prompt responses to your queries and

concerns.

Why Bio-Rad Quality Controls & Technical SupportWhy Bio-Rad Quality Controls & Technical Support

What Our Users Have To Say …..What Our Users Have To Say …..

Dr. S. NarayaniPathologist- Wockhardt Hospital,Mumbai

I think Bio-Rad has a very good team and I completely attribute my obsession with quality to them. I would like this service to be enhanced and sustained. The complete QC solution from Bio-Rad is excellent.

Dr. Subimal ChaudhuriSr. Biochemist - AMRI Hospital,Kolkata

We are dedicated Bio-Rad QC and EQAS users and it goes without saying that our management of QC with Bio-Rad's technical support is far more than satisfactory.

Dr. Kartik DaveConsultant pathologist - Lambda Therapeutics Research centre, Ahmedabad

Bio-Rad's complete range of products is very helpful to us as it is single point of purchase & chase!

Dr. Dilip KumarConsultant Pathologist & Quality Manger - Max Superspeciality Hospital-Delhi

Bio-Rad's QC technical support has been excellent. They have provided help whenever we needed. With the use of quality controls the confidence levels of technicians and doctors has gone up and the reliability of the test results has increased.

Dr. Manisha PatwardhanHead Operations & QA officer-Golwilkar Metropolis Health services-Pune

Bio-Rad's IQC, EQAS and QC OnCall - data management solution is a three pronged approach which enables a laboratory to establish complete Quality control, analyze and trouble shoot data / problems and then compare with the peers. Only when all these is implemented, total quality control can be expected.

Ms. Mailini ParasuramChief of Lab services - Hitech Diagnostic Centre, Chennai

Bio-Rad is the name which comes in my mind first when I think of Quality control in diagnostics. They don't walk away after selling their control material and give complete guidance and support regarding QC and EQAS whenever required. I am proud that we are one of the users of their QC and EQAS programs.

Dr. Sanjeev ShahDirector- Pathology Dept. Sterling Hospital, Ahmedabad

The QC data management solutions form Bio-Rad has greatly helped in managing the QC records and managing Quality control data.

Bio-Rad endeavors to address your

educational needs and helps you

keep abreast of the latest technical

developments in the filed of Quality

control. Bio-Rad conducts various QC

awareness programs throughout

the country in association with

organizations such as Quality Council of

India / COLA / local chapters of ACBI &

IAPM.

Bio-Rad also conducts the Annual QC

meets which allows you to interact with

the international experts from the filed of

Quality controls.

Bio-Rad's QC Awareness Programs Bio-Rad's QC Awareness Programs

What Our Users Have To Say …..What Our Users Have To Say …..

Dr. Thuppil VenkateshLead Assessor of NABL, assessor NABH, NABCB of QCI and Faculty member of NABL ISO 15189, Bangalore

I have found great interest and enthusiasm amongst the participating delegates in all Bio-Rad QC workshops and awareness program. These programs have served purely as an academic activity apart from creating lot of interest amongst the laboratory personnel going in for the NABL accreditation under ISO 15189 system. Laboratories who had found the accreditation work boring and tedious have realized the significance and ease with which they could go in for NABL accreditation process after attending the QC awareness workshops.

Dr. P. D. SawantChief of Quality Nicholas Piramal India Ltd, Mumbai

Bio-Rad's educational programs are quite informative and useful. These programs open up new vistas and make you think on QC differently.

Dr. Bhaskar VyasDirector ,M.D. Pathologist - Ashish Pathology, Ahmedabad

Bio-Rad's educational programs / QC seminars are very useful in developing QC awareness. It allows exchange of information regarding methods of practice, problem solving & other related issue. Use of quality controls helps us achieving the QC goals and standards, identifying analytical errors, trend & bias and there by taking appropriate corrective actions. Additionally use of QC builds laboratory's confidence in reporting of the results.

Mr. M. ManiDirector & Chief of Laboratory services -Microbiological Laboratory, Coimbatore

The educational programs are very useful and help us understand the recent concept in QC interpretation.

Dr. Ajit S. GolwilkarManaging Director - Golwilkar Metropolis Health services-Pune

Bio-Rad's educational programs have given us a platform to interact with very knowledgeable people. In fact we have contributed to these in Pune and are very happy about the feedback we have received.