NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)
GENERAL INFORMATION BROCHURE
FOR
MEDICAL LABORATORY CERTIFICATION PROGRAM
MARCH 2017
4th Edition
NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)
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© No part of this publication may be reproduced in any form without the prior permission, in writing,
of Quality Council of India
NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)
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Contents
1. Medical Laboratory Certification Program 4
2. Benefits of Certification 5
3. About NABH 6
4. Eligible Medical Laboratories 8
5. Laboratory Disciplines Covered 9
6. Values & Winning Edge for the Laboratory 10
7. Preparing of NABH Certification 11
8. NABH Certification Procedure 12
9. Assessment criteria, Fees structure & Payment details 15
10. Useful Terms and Definition 16
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1. Medical Laboratory Certification Program
Certification is the provision by an independent body of written assurance (a
certificate) that the product, service or system in question meets specific
requirements. (http://www.iso.org/iso/home/standards/certification.htm).
In India, Heath System currently operates within an environment of rapid social,
economical and technical changes. Such changes raise the concern for the quality
of health care. Blood storage centres are an integral part of health care system.
Certification of medical laboratories strives to improve the quality of test results.
The certification programme assesses the quality and operational systems in place
within the facility. The certification includes compliance with the NABH standards,
applicable laws and regulations.
This certification shall be applicable only to the site where sample processing,
testing and reporting of the results is being done and shall not be applicable to any
collection centres attached to the laboratory.
The certificate issued shall be for two years and the laboratories are encouraged to
show improvements and go for accreditation. In case, laboratory wishes to
continue with this certification program, they can apply for renewal.
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2. Benefits of Certification
Benefits for Users/ Patients
Users/ patients/ donors are the biggest beneficiary among all the stakeholders.
Test results are crucial for the management of a patient. Any error in the test
results may lead to wrong diagnosis and thus wrong treatment. Certification results
in improving the quality of test results and patient safety. They all are serviced by
credential medical staff and their rights are respected and protected.
Benefits for Laboratories
Certification to a medical laboratory stimulates continuous improvement. It enables
laboratories in demonstrating commitment to quality. It raises community
confidence in the services provided by them.
Benefits for Staff
The staff in a certified laboratory is satisfied lot as it provides for continuous
learning, good working environment and leadership. It improves overall
professional development of all the staff including medical and para medical staff.
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3. About NABH
National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent
board of Quality Council of India, set up to establish and operate accreditation programme
for healthcare organizations. The board is structured to cater to much desired needs of the
consumers and to set benchmarks for progress of health industry. The board while being
supported by all stakeholders including industry, consumers, government, have full
functional autonomy in its operation.
Structure of NABH:-
NABH is an institutional member of the International Society for Quality in Health Care
(ISQUA). ISQUA is an international body which grants approval to Accreditation Bodies
and their standards in the area of healthcare.
Currently, NABH offers Accreditation to Hospitals, Small Healthcare Organizations, Blood
Banks, Blood Storage Centres, PHC/CHC, Wellness Centres, AYUSH Hospitals, Medical
Imaging Services, Allopathic Clinics and Dental Facilities.
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In addition to the above accreditation programs, NABH also offers following Certification
programs:
A) NABH-Safe I certification program
B) Medical Laboratory certification program
C) Nursing Excellence certification program
This information brochure is specifically prepared to give information about laboratory
certification program.
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4. Eligible Medical Laboratories
This Programme is for laboratories that conduct biological, microbiological, immunological,
chemical, haematological, pathological, cytological or other examination of materials
derived from the human body for the purpose of providing information for the diagnosis,
prevention and treatment of disease.
Eligibility Conditions:
Medical Laboratories can only apply for NABH Certification, if meets any one of the
following condition:
A. Standalone laboratory
B. Based in a hospital which is either NABH Accredited or achieved Pre-Accreditation
Level (Entry or Progressive).
This program is open for all laboratories including those have only the most basic of
equipment (such as a microscope) and perform the most routine tests, such as:
Simple qualitative urine strip tests for sugar and protein.
Microscopic analysis.
Blood smear for MP (malarial parasite) and for TC (total leucocyte count) and DC
(differential leucocyte count), and/or blood grouping and Rh testing.
Scope of Certification:
A laboratory must apply for all its facilities (discipline and tests) as NABH certification is
based on the principle of All or None.
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5. Laboratory Disciplines Covered
i. Clinical Biochemistry
ii. Pathology
iii. Microbiology & Serology
iv. Genetics
v. Nuclear Medicine (in-vitro tests only)- Requirement as laid down by Atomic Energy
Regulatory Board (AERB)
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6. Values & Winning Edge for the Laboratory
Improve Safety, Accuracy of Laboratory Results and Patient Care
Through adherence to the Essential Standards, laboratory testing errors are
reduced, weaknesses in workflow, processes, and procedures are addressed, and
overall operations are aligned with accepted practices.
Earn a Credible Mark of Compliance with Standards
Your Laboratory will earn a mark of compliance (certification mark) on compliance
with the standards.
Achieve Greater Efficiency, Profitability, and More Productive Operations
The Internal Audit/Self-Assessment, continual learning, Onsite Assessment and
required improvement components of standards facilitate a thorough examination of
your Laboratory’s entire operation that improves “error detection”, reduces “false
rejections”, and relieves your entire organization from unnecessary tasks.
Become More Competitive, Gain Public Recognition, and Grow Revenue
Your laboratory’s name will be featured on NABH website. Your Laboratory will
become better positioned for potential medical tourism and clinical trial opportunities.
Improve Customer and Employee Satisfaction
Higher quality, more consistent test results with fewer delays and errors will lead to
increased trust and confidence from current patients and new patients, via word-of-
mouth and other marketing means. You will notice improved internal staff and
management work relations, commitment and staff retention.
Anticipate Government and Insurance Provider Policies and Regulations
There are many State, Centre and Insurance Provider standards, restrictions,
policies and regulations that are either in place or being considered across the
country, including the national Clinical Establishment Act. The NABH Programme
will be updated to continually meet these new requirements
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7. Preparing for NABH Certification
Obtain a copy of NABH Standard (from NABH office) &
other documents (from the website)
Prepare Quality Manual as per NABH standard (and implement the requirements)
Obtain a copy of Application Form (From NABH website)
Submit 2 copies of Application Form and copy
of Internal Audit Report & Minutes of Management Review Meeting along with
requisite fee (to NABH Secretariat)
Process Begins
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8. NABH Certification Procedure
Application Form + Internal Audit Report + Minutes of Management Review Meeting
(By Medical Laboratory)
Acknowledgment and Scrutiny of application
(By NABH Secretariat)
On-site Assessment of Medical Laboratory (By Assessment team)
Review of Assessment Report (By NABH Secretariat)
Recommendation for Certification (By Certification Committee)
Approval for Certification (Two years) (By Chairman, NABH)
Feedback To
Medical laboratory And
Necessary Corrective
Action Taken
By Medical Laboratory
Issue of Certificate (By NABH Secretariat)
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Application for Certification:
Medical Laboratory shall apply to NABH for certification by submitting the following:
Two copies of application form
Application fee as detailed in the application form
Copy of last internal audit report
Copy of minutes of last management review meeting
Scrutiny of application:
Application form is scrutinized at NABH Secretariat and if it is found to be complete in all
respects, a unique reference number is issued to the centre. The laboratory shall be
required to quote this reference number in all future correspondence with NABH.
Appointment of Assessor:
NABH shall appoint Assessor who shall have the overall responsibility of conducting the
assessment for the Medical Laboratory. He/ She will conduct the on-site assessment of
the laboratory.
On-site Assessment:
The date of on-site assessment shall be agreed upon by the laboratory
management and assessor. Assessment shall be conducted on all the
facilities/sections of the laboratory. The assessment team reviews the documented
management system and verifies its compliance to the NABH standards. The
documented quality system, SOPs, work instructions etc. shall be assessed for
their implementation and effectiveness. The technical competence of the
laboratory shall also be evaluated.
Based on the assessment by the assessment team, the assessment report is prepared in
a prescribed format.
The details of nonconformity observed any during the assessment are handed over to the
laboratory by the assessment team and detailed assessment report is sent to NABH.
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Follow up
Laboratory shall have a maximum of 60 days to close all the non conformities and
submit corrective actions to NABH. A copy of such corrective actions shall be
forwarded to Assessor for their comments, whether to accept or otherwise
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9. Assessment criteria, Fees structure & Payment details
Assessment criteria and Fee structure
Size of Laboratory Assessment Day(s) Application cum
Certification Fee
Micro sized Laboratory
(up to 25 Patients per day)
Half Day 12500
Small sized Laboratory
(26 – 100 Patients per day)
Half Day 25000
Medium sized Laboratory
(101 – 300 Patients per day)
One Day 50000
Large sized Laboratory
(301 & above Patients per day)
Two Days 80000
Service Tax: A service tax as applicable from time to time (currently 12.36%) will be
charged on all the above fees. You are requested to please include the service tax in the
fees accordingly while sending to NABH.
Fees to be paid through demand draft/ local cheque in favour of ‘Quality Council of India’
payable at New Delhi.
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14. Useful Terms and Definitions:
Acceptable Limits
How far from the mean (average) a value can be and still be acceptable.
Accuracy
The extent to which measurements agree with the true value of the quantity being
measured. Accuracy should not be confused with precision, which is a reference to how
much variance is there between results.
Analyte
A substance or chemical constituent that is assayed in a laboratory test (example:
glucose).
Batch Testing
Several samples tested for the same analyte(s) at the same time, in the same run,
whether tested manually or on an automated analyzer.
Bias
The condition that exists when the laboratory’s mean is different from the all-method
mean. A “positive” bias exists when the laboratory’s mean is significantly above the all-
method mean; a “negative” bias exists when the laboratory’s mean is significantly lower
than the all-method mean. Sometimes a methodology or instrument will give consistently
higher or lower values (i.e. demonstrate a positive or negative bias) for certain types of
control samples because of some constituent or artifact in the control; this type of bias is
called a “matrix effect.” There is no bias when actual patient samples are tested.
Calibration
The process of comparing the laboratory’s measurement equipment (analyzers, scales,
pipettes, etc.) against standards of known accuracy (traceable to national standards) in
order to detect, correlate, report or eliminate by adjustment any inaccuracy of the
instrument or measuring device, as compared to the standard..
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Coefficient of Variation
An index used to describe the precision (repeatability) of a laboratory method.
It is calculated with this formula: CV = standard deviation x 100/mean.
Competence
Ability of an individual to perform specific task according to established procedures. Ability
of a laboratory to demonstrate compliance with a set of established standards.
Control
A sample with a known value or range of values that is tested in the same way patient
samples are tested in order to ensure the laboratory’s methodology is working correctly.
Control Range
The allowable limits of variation in values.
Corrective Action
An activity performed to eliminate the cause of an existing nonconformity or other
undesirable situation in order to eliminate recurrence.
Critical Values
Values obtained on a patient sample from a list of selected laboratory tests that demand
attention by a clinician.
Cuvette
A small transparent vessel containing samples, controls, calibrators, or other liquids for
optical measurements used in laboratory testing.
Decision Value or Level
A threshold value of a test result above or below which a physician will respond with an
action.
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Document (as noun)
Written or electronically generated information and work instructions. Examples include
quality manuals, procedures, forms, and labels.
Document (as verb)
To capture information in writing or electronic media, including a confirmation of the date,
author, and any review of the information.
Drift
The condition of values moving away from the mean line over a period of time.
Examination (Analytic) Phase
Activities after pre-examination processes that include performing the examinations
test(s); verifying the reliability of the results; and interpreting the findings.
External Quality Assurance
A means of verifying results of laboratory testing using an external provider of samples
and evaluation, sometimes called Proficiency Testing (PT). Samples are sent from a
PT/EQA service for analysis by laboratories using the same methodology as for patient
samples. Laboratory results are submitted to the PT provider and compared to known
values, and the reports are issued to the laboratory showing its values compared to its
peer group.
Hemolysis
Rupturing of red blood cells and the consequent release of hemoglobin (and other
intracellular substances) into the plasma or serum.
Linearity
The ability of an instrument to measure an analyte at different concentrations without
distortion.
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Lyophilized
Freeze-dried.
Mean Value
The mean value or average is determined by testing the sample at least 20 times and
recording the results (values). Note: At least 20 data points are needed for statistical
analysis.
These values are added and then divided by the number of times the sample was tested
(20 in this case). This final calculation is called the mean value.
Median
The middle value of a set of recorded values, with as equal number of values above as
below.
Non conformity
Failure to meet requirement.
Personal Protective Equipment (PPE)
Specialized clothing or equipment worn by an employee for protection, including, but not
limited to, gloves, gowns, face shields, masks, eye shields, or other protective equipment.
Precision
The ability to get the same, or virtually the same, result when the same test is performed
repeatedly. A method may have a high degree of precision, but still not be accurate.
Preventive Action
Action taken to reduce or eliminate the potential for non conformities or other undesirable
situations.
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Post-Examination (post-analytical) Phase
Processes following the examination including review of results; retention and storage of
clinical material; sample (and waste) disposal; and formatting, releasing, reporting and
retention of results.
Pre-Examination (pre-analytical) Phase
Processes that start, in chronological order, from the clinician’s request and include the
examination request; preparation and identification of the patient; collection of the primary
sample(s); and transportation to and within the laboratory; and ending when the analytical
examination begins.
Qualitative
With respect to laboratory results, the type of results or values that describe attributes of
the analyte being tested; e.g. positive vs. negative; present vs. absent; low, medium, high,
etc.
Quality
Degree to which a set of inherent characteristics meets requirements and the needs and
expectations of customers.
Quality Control (QC)
Testing with a sample of a known composition performed before or at the same time
patient samples are tested to verify that the equipment, reagents, and test performed are
working as
expected. The control substance must be within the known range of the analyte being
tested for any patient test results to be valid.
Quality Improvement
Actions taken to increase the value to the customer by improving the efficiency and
effectiveness of processes and activities throughout the organization.
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Quality Indicators
Observations, statistics, or data defined by the laboratory that typify the performance of a
given work process and provide evidence that the laboratory is meeting its quality
intentions. An established measure used to determine how well an organization meets
user requirements and operational and performance targets.
Quality Policy
Overall intentions and direction of a laboratory related to quality as formally expressed by
laboratory management. Note: Generally the quality policy is consistent with the overall
policy of an organization and provides a framework for setting quality objectives.
Quality Management Systems (QMS)
The organizational structure, responsibilities, policies, processes, procedures, and
resources established by the organization’s management to achieve and sustain quality.
Quantitative
With respect to laboratory results, the type of results or values that describe how much of
a substance is present, usually reported as a numerical value.
Record (as noun)
Information captured in writing or through an electronically generated medium that
provides objective evidence of activities performed or results achieved, such as test
records. Records do not exist until the activity has been performed and documented.
Record (as verb)
To capture data and information for use in records through writing or in electronic media.
Referral Laboratory
External laboratory to which a sample is submitted for examination.
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Bio-Medical Waste
Any waste, which is generated during the diagnosis, treatment or immunisation of human
beings or animals or in research activities pertaining thereto or in the production or testing
of biologicals, and including categories mentioned in Schedule I (human anatomical waste,
animal waste, microbiology and biotechnology waste, waste sharps, discarded medicines
and cytotoxic drugs, solid waste, liquid waste, incineration ash, chemical waste)
(http://www.cpcb.nic.in/divisionsofheadoffice/hwmd/biomed-Rules-1998.pdf).
Reliability
A method’s capacity to maintain both accuracy and precision.
Corrective Action
Action taken to rectify the effects of a detected nonconformity. Note: Remedial action does
not necessarily remove the root cause of the nonconformity.
Running a Control
A sample with known results, tested on the same equipment before or at the same time as
patient samples.
Split Samples
Portions of one sample that are divided into two or more portions and sent to different
laboratories for performance of the same test on the same or similar instruments or
methods. Results are then compared. Split samples can also be divided and used in the
primary lab to allow comparison of equipment or methodologies.
Standard Deviation
Computed measure of variability that indicates the spread of the data set around the
mean, calculated as the square root of the sum of the deviations of the individual results
from the data set mean divided by the number of deviations in the data set.
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Traceability
The ability to follow the history of an activity by means of recorded information. Examples:
the history of a reagent from order to expiration; the history of a patient sample from test
order through results reporting; the history of a piece of equipment from acquisition
through decommission.
Standard Precautions
Actions taken with the consideration that all blood and body fluids and materials
contaminated with visible blood need to be treated as infectious materials.
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NATIONAL ACCREDITATION BOARD FOR HOSPITALS
& HEALTHCARE PROVIDERS (NABH)
Quality Council of India
6th Floor, ITPI Building; 4 A, Ring Road, IP Estate
New Delhi - 110 002, India.
Tel: 091-11- 2332 3416-20, Fax: 091-11- 2332 3415 Website: www.nabh.co