Medical Laboratories need Quality Management Systems as they carry out highly complex operations which need an equally high degree of accuracy, confidentiality, timeliness and cost effectiveness.
It is first the job of the
laboratory technical staff to perform preanalytic activities (blood sample
collection, receiving, accessing); analytic activities (testing, examinations,
interpretation); and post-analytic activities (reporting results, archiving
samples, charge capture) that transform a clinician's order for a laboratory
test or examination into the results used by the clinician to diagnose and
treat patients. It is likewise the job of the laboratory supervisory and
managerial staff to design and implement the supportive infrastructure that is
necessary for the technical work to proceed unimpeded.
As over seventy percent of
clinical medicine decision making is predicated upon, or confirmed by or
documented by medical laboratory test results, it is essential that there is a
Quality Management System in place in the Laboratory to ensure that there is an
integrated coordination between technical and managerial activities for
realizing timely, high-quality, error-free, efficient, and effective laboratory
operations. It is estimated that roughly 15% of patients receive either incorrect
or delayed reports on abnormal results, severely impacting on the quality of
treatment that they receive.
Meaning of Accreditation:
Accreditation is the formal
recognition, authorization and registration of a laboratory that has
demonstrated its capability, competence and credibility to carry out the tasks
it is claiming to be able to do. It provides feedback to laboratories as to
whether they are performing their work in accordance with international criteria
for technical competence.
Why Accreditation is Needed:
The concept of laboratory
accreditation was developed to provide third-party certification that a
laboratory is competent to perform the specific test or type of tests.
Laboratory accreditation is a
means to improve customer confidence in the test reports issued by the laboratory
so that the clinicians and through them the patients shall accept the reports
with confidence.
What is NABL:
The National Accreditation
Board for Testing and Calibration Laboratories (NABL) is an autonomous body
under the aegis of the Dept. of Science & Technology, Govt. of India, and
is registered under the Societies Act. NABL, which was initially established with
the objective to provide accreditation to testing & calibration
laboratories, later on extended its services to the clinical laboratories in
our country.
Medical laboratories can be
accredited to ISO 15189:2007, the first Quality Management System developed
exclusively for Medical Testing Laboratories, based on the ISO 17025:1999, a
general requirement for testing and calibration laboratories.
In India Testing Laboratories
including Medical Labs can try for accreditation under the NABL- National
Accreditation Board for Testing & Calibration Laboratories - Standards. The
laboratory management and all levels of staff need to be involved in the
implementation.
Stake Holders:
Patients, insurance companies,
referring clinicians Laboratories Other Benefits
Accreditation benefits all
stake holders. Benefits to the customers can search laboratories:
Customers can search and
identify the laboratories accredited by NABL for their specific requirements
from the NABL website or Directory of accredited laboratories.
Increased confidence in
reports:
- The labs are required to participate in proficiency testing which is again demonstration of competence. So, there is increased confidence in the reports released by the laboratory.
- The customers get services by credential staff.
- Savings in terms of time and money as it reduces or eliminates the need of re-testing.
Benefits for the laboratory:
Use of NABL symbol:
The accredited laboratories
can issue test reports bearing the accreditation body’s symbol or endorsement,
as an indication of accreditation.
International Recognition:
Lab accreditation is highly
regarded both nationally and internationally as an indicator of technical
competence
Satisfaction of the staff:
The staff in an accredited
laboratory is satisfied as it provides for continuous learning, good working
environment, leadership.
Continuous improvement:
Accreditation to a laboratory
stimulates continuous improvement. It enables the laboratory in demonstrating
commitment to quality test reports.
Systematic Control of lab work:
Better control of laboratory
operations and feedback to laboratories
Benchmark with best
laboratories:
It also provides opportunity
to the laboratory to benchmark with the best
Rise in business:
There is marked increase in
the business of the labs as the accredited status can be seen by the clients on
NABL website.
Other Benefits:
It raises community confidence
in the services provided by the laboratory.
Finally, Accreditation
provides an objective system of empanelment by insurance and other third
parties.
It encourages medical tourism.
CGHS Empanelment In year 2009,
mandatory NABL accreditation for CGHS empanelment gave a push which caused
increased influx of application for accreditation. The impact could be seen in
year 2010 & 2011 as increase in number of labs which were granted
accreditation.
Planning for Implementation of
NABL Standards:
A well planned implementation of such Quality
Standards will help medical laboratories to comply with regulatory
requirements, to meet the expectations of their clients and, most importantly,
to improve and maintain the quality of their service to their patients.
Important Points for Preparation of NABL Accreditation:
It is very important for a laboratory to make a definite plan for
obtaining accreditation and nominate a responsible person as quality manager
(who should be familiar with the laboratory’s existing quality system) to
co-ordinate all activities related to seeking accreditation. The laboratory
should carry out the following important tasks towards getting ready for
accreditation:
- Contact NABL Secretariat with a request for procuring relevant NABL documents
- Get fully acquainted with all relevant documents and understand the assessment Procedure and methodology of making an application.
- Train a person on Quality Management System and Internal Audit (4-day residential training courses conducted by NABL. Contact NABL Secretariat for details).
- Prepare Quality Manual as per ISO 15189 standards.
- Prepare Standard Operating Procedure for each investigation carried out in the laboratory.
- Ensure effective environmental conditions (temperature, humidity, storage placement, etc.).
- Ensure calibration of instruments / equipment. Only NABL Accredited Calibration Lab. are authorized to provide calibration. NABL website gives the names of NABL accredited calibration laboratories in the various fields of Accreditation.
- Impart training on the key elements of documentation, such as document format, authorization of document, issue and withdrawal procedures, document review and change, etc. Each document should have ID No., name of controlling authority, period of retention, etc.
- Ascertain the status of the existing quality system and technical competence with regard to NABL standards and address the question “Is the system documented and effective OR does it need modification?”.
- Remember Quality Manual is a policy document, which has to be supplemented by a set of other next level documents. Therefore, ensure that these documents are well prepared.
- Ensure proper implementation of all aspects that have been documented in the Quality Manual and other documents.
- Incorporate Internal Quality Control (IQC) practice while patients’ samples are analysed.
- Document IQC data as well as uncertainty of measurements. Maintain Levy Jennings charts.
- Document IQC data as well as uncertainty of measurements. Maintain Levy Jennings charts.
- Document corrective actions on IQC / EQA outliers.
- Conduct Internal Audit and Management Review.
- Apply to NABL along with appropriate fee.
Accreditation Process:
- An applicant laboratory is expected to submit to NABL 5 copies of the application and 5 copies of Quality Manual.
- The Quality Manual will be forwarded by NABL to a Lead Assessor to judge the adequacy of the Quality Manual as to whether it is in compliance with ISO 15189 standards.
- Thereafter the Lead Assessor will conduct a Pre- Assessment of the laboratory for one day. Based on the Pre-Assessment report the laboratory may have to take certain corrective actions, so as to be fully prepared for the final assessment.
- It is essential for the
applicant as well as accredited laboratories to satisfactorily participate
in
Proficiency testing/ Interlaboratory comparisons/External quality assessment programme
as Asia Pacific Laboratory Accreditation Cooperation (APLAC) Mutual Recognition
Arrangement calls for mandatory participation in such programmes.
- Finally, when the laboratory is ready, the Lead Assessor and a team of technical assessors will conduct the final assessment. The number of technical assessors will depend on the number of disciplines applied for.
- The accreditation process involves a thorough assessment of all the elements of the laboratory that contribute to the production of accurate and reliable test data. These elements include staffing, training, supervision, quality control, equipment, recording and reporting of test results and the environment in which the laboratory operates. The laboratory may have to take certain corrective actions, after the final assessment.
- After satisfactory corrective actions are taken by the laboratory (within a period of 3 months), the Accreditation Committee will examine the report and if satisfied recommend accreditation.
- The time required for the process of accreditation will depend upon the preparedness of the laboratory and its response to the non - conformances raised during the pre-assessment and final assessment. The total duration ranges between 6 and 8 months.
Surveillance and Re-Assessment:
Accreditation to a laboratory
shall be valid for a period of three years. NABL shall conduct annual
surveillance of the accredited laboratories. The laboratories may enhance or
reduce the scope of accreditation during surveillance.
The laboratories need to apply
for renewal of accreditation, at least six months before the expiry of validity
of accreditation for which a re-assessment shall be conducted.
Written by:
Dr. Praveen Bajpai
Director of Ingenious Healthcare Consultants Pvt. Ltd.
Founder of Skill Sathi
MBA in Hospital administration, PG Diploma in Quality Accreditation, PG Diploma in Medico Legal System, M. Phil in Hospital Mgmt. from BITS Pilani, P.hD in Management, Certified NABH Auditor, Certified NABL Auditor, Certified Auditor for Clinical Audits, Green Belt in Six Sigma, Certified in Hospital Infection Control Practices, Certified trainer for International Patient Safety Goals, Certified Auditor for JCI 7th Edition Standards
www.skillsathi.in
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