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| Mr. Prashanth Kumar |
Let me begin with, what is Laboratory Accreditation? Everyone who already knows please excuse. This article is for those who are looking for quick information on the process and for them who are novices and budding in their career.
Laboratory Accreditation (ISO 15189) is an internationally accepted framework for increasing test quality and bringing down the frequency of laboratory errors. It determines the technical competence to perform specific types of testing, measurement and calibration. The process evaluates the laboratory's quality, performance, reliability and efficiency.
Why is it necessary? Accreditation stimulates higher standards of quality within laboratories, thereby leading to more consistent, reliable test data, thus contributing to more effective health and safety regulation and to products of more consistent quality. It gives confidence to the management and identifies the opportunities for improvement Certainly it gives you more business opportunities as well!
Nowadays, when it comes to customers, an accredited laboratory inspires confidence. Look at it from a customer's perspective. The thought process is similar to ours when it totals to a decision making on a purchase. Why do we choose a branded product over a local one? Do we trust tap water or Bottled water?
As more and more laboratories are becoming accredited, it results in more and more competition in quality. The end result has been improving the overall quality of care in healthcare facilities like specialty areas, accreditation programs, etc. This has assisted in ensuring that patients receive consistent, excellent care throughout the installation.
What is the process to obtain accreditation?
Many of you would be thinking of getting your laboratory /hospital accredited. I will brief you in a simple manner. Before you begin, you need to identify the scope of accreditation and training of employees and make the tests ready for accreditation and evaluating IQC (Internal Quality Control) / PT (Proficiency Testing) results, CAPA (Corrective Action - Preventive Action), conducting an internal audit, MRM (Medical Record Management), etc.
a. This is
nothing but identifying the readiness of the departments, tests, etc.
which you intend to apply for.
b. Next, is the application filing and
appropriate payment.
c. Thirdly, the application is reviewed by the body,
either there will be no inadequacies in the quality manual or else CAB
needs to present satisfactory corrective action.
d. Fourth, is a
pre-assessment visit (Optional for NABL and not applicable to QAI) of
the CAB by a lead assessor appointed by the accreditation body.
e. The
fifth is the final audit - either it is cleared successfully without
Non-conformities or else after satisfactory corrective action by the
CAB, the audit report will be discussed in the technical committee and
the certificate is issued.
The accreditation cycle is of 2 years. The Accreditation body will conduct a desktop audit to verify the compliance annually. Re-accreditation happens after 2 years and the laboratory has to apply 6 months prior to the validity completion date.
As an experienced person in this field, some of the areas I suggest to take care while applying for accreditation are as follows:
a) Calibrated equipment with traceability certificates
b) Method validation/verification
c) Temperature/ humidity monitoring,
d) %CV estimation
for quantitative testing,
e) Standardised technical SOPs and quality SOPs
f) Document control
g) Proficiency testing
h) Internal quality control
i) Trend
analysis, setting lab mean,
j) Set up quality indicators and monitor
regularly, and
k) Onboard training of technicians.
Many labs fail to qualify while applying for renewal of accreditation, Why?
- Lack of commitment from management and staff
- Unqualified employees (untrained)
- Local equipment loyalty (improper equipment)
- Non-monitoring of IQC/Proficiency testing (it could be because of lack of knowledge to do so)
- Unable to set the lab mean properly (many labs change the lab mean to pass the QC on a regular basis!!)
- Improper documentation
- Lack of SOPs to proceed
- Lack of leadership, etc.
Quality
is not a day’s result; it is a continuous improvement process. You
build it slowly, continuously and steadily.
A simple tip to keep the
success continuing is CONTINUAL MONITORING OF QUALITY SYSTEM.
It can be simply explained by the values of Medihelps:
> TRUST
> TECHNOLOGY
> TEAMWORK
> TRANSPARENCY; &
> TIME BOUNDNESS.
This article has been contributed by Mr. Prashanth Kumar, who is an expert in the field of Quality Management and Laboratory Operations with over 20 years of experience. His expertise in the accreditation process is commendable both as a NABL auditor and as an independent advisor. Mr. Kumar is based in Bengalaru.
He has previously served as an accreditation Officer at NABL, during which he had completed the transition of the standard from ISO/IEC 17025 to ISO 15189 for Medical Laboratories in India. He is also a qualified Auditor for ISO 15189. Furthermore, he has completed training for the implementation of Hospital Accreditation standards by NABH.
He has worked with many organizations, including startups and well-established ones to put their quality system in place. He has as well worked with Quest Diagnostics India, where he met the major purpose in preparing for CAP and NABL Accreditation and successfully finished the process within 7 months.
His strong knowledge and expertise have assisted many laboratories to fit themselves and become competent at a very fast pace, thereby equipping themselves to clear the audits without many non-conformities. He is also an advisor for many top leading laboratories and hospitals for their quality management and laboratory operations.
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