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Take Control with the Complete QC Solution

A User's Perspective...

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 Regulations

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

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 Ref : AS 4633 (ISO 15189

Application document-Supplementary requirements for Accreditation in the field of Medical testing, 2005 ver1-NATA)

CLSI - Clinical and Laboratory Standards Institute & Quality Controls

The laboratories should establish their own mean and ranges rather than use product insert ranges (Ref CLSI

standard "Statistical Quality control for Quantitative Measurements: Principles & Definitions")

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

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.

(Ref CLIA -The Clinical Laboratory Improvement Amendments, Requirements)

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

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 NABL-112 guidelines Specific criteria for

Accreditation of Medical Laboratories)

What Our Users Have To Say .....

Dr. Maria Borges

Chief 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 Bhide

Consulting 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. Suhasini

Sr 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 Kumar

Director - EI Metropolis,Cochin Using Bio-Rad Quality controls has helped to improve the quality and thus increased the quantity of tests.

Dr. Sunita Upadhaya

Head 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 Kurup

Director 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 Furruqh

M.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 ?

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 Regulations

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

The use of control materials independent of those produced by the manufacturer of the test or analyzer should be considered. Ref : AS 4633 (ISO 15189 Application

document-Supplementary requirements for Accreditation in the field of Medical testing, 2005 ver1-NATA)

AABB-American Association of Blood Banks & Quality Controls

When in-kit controls are used to calculate the cutoff ranges, a third party control is needed to provide an unbiased assessment. (Ref External controls revisited. AABB

regulatory update, May 1998)

Control material need to be different from calibrator material (Ref CLSI standard "Statistical Quality control for

Quantitative Measurements: Principles & Definitions")

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

Laboratory is encouraged to use control material similar or identical with the patient sample matrix.

(Ref NABL-112 guidelines Specific criteria for Accreditation of Medical Laboratories)

What Our Users Have To Say .....

Mr. Vijay Bhatt

HOD- 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 Shah

Sr. 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 Acharaya

Managing 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 Bhambhani

Technical 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 Raste

HOD 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 Assessment Programs & Accreditation

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.

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

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 Ref: Ref : AS 4633

(ISO 15189 Application document-Supplementary requirements for Accreditation in the field of Medical testing, 2005 ver1-NATA)

CLSI - Clinical and Laboratory Standards Institute & EQAS

Laboratories should actively participate in interlaboratory comparison programs when available, because they make an important contribution to quality control. (Ref CLSI standard "Statistical Quality control for

Quantitative Measurements: Principles & Definitions")

NABL-National Accreditation Board for 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 .....

Dr. Puneet Nigam

Chief 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. Patole

Consultant 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 Banerjee

Director, 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 Abraham

Consultant 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. Sharada

Head -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.

Why Bio-Rad Quality Controls & Technical Support

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.

What Our Users Have To Say .....

Dr. S. Narayani

Pathologist- 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 Chaudhuri

Sr. 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 Dave

Consultant 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 Kumar

Consultant 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 Patwardhan

Head 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 Parasuram

Chief 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 Shah

Director- 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's QC Awareness Programs

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.

What Our Users Have To Say .....

Dr. Thuppil Venkatesh

Lead 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. Sawant

Chief 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 Vyas

Director ,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. Mani

Director & 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. Golwilkar

Managing 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.

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