GENERAL INFORMATION BROCHURE FOR MEDICAL … · NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH) Page 12 8. NABH Certification Procedure Application Form +

NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)

GENERAL INFORMATION BROCHURE

FOR

MEDICAL LABORATORY CERTIFICATION PROGRAM

MARCH 2017

4th Edition


Page 2

© No part of this publication may be reproduced in any form without the prior permission, in writing,

of Quality Council of India


Page 3

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


Page 4

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.


Page 5

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.


Page 6

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.


Page 7

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.


Page 8

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.


Page 9

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)


Page 10

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


Page 11

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


Page 12

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)


Page 13

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.


Page 14

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


Page 15

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.


Page 16

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..


Page 17

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.


Page 18

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.


Page 19

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.


Page 20

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.


Page 21

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.


Page 22

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.

http://www.cpcb.nic.in/divisionsofheadoffice/hwmd/biomed-Rules-1998.pdf


Page 23

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.


Page 24

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

Documents

GENERAL INFORMATION BROCHURE FOR MEDICAL … · NATIONAL ACCREDITATION BOARD FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH) Page 12 8. NABH Certification Procedure Application Form +