doctore.indoctore.in/wp-content/uploads/2018/08/Lab-Quality-Manual_Print-cop… · 2. NABL 133 : NABL Policy for use of NABL logo/ claim of accreditation by laboratories 3. NABL 160

5.8mmol/L

lab qualitymanual

This Quality Manual is released under the authority of Dr. Vimarsh Raina, Chief Executive Officer of Doctor E Health Services Private Limited who is a well-qualified and competent Pathologist. This document is the property of Doctor E Health Services Private Limited - Aakash Hospital.

Foreward

doctor.e is a global healthcare company bringing global diagnostics expertise to healthcare facilities that desire to harness the benefit of excellence towards enhancing the efficiency of patient care. doctor.e is working to solve basic health care problems of accessibility and affordability. Our domain expertise and knowledge of underdeveloped markets has helped us create an advance system that can virtually connect healthcare providers to pathologists, radiologists and diagnostic specialists for analysing test results globally, in real time. The company works on the principle of scientific & evidence based diagnostics which empowers communities to access high quality healthcare services in real time. We call this “e-health”; e-Health = Information + Communication + Diagnostics + Intervention.

1. Abbreviations

2. Introduction of Laboratory

3. Scope & Field of Application

4. Normative References

5. Distribution of Quality Manual

6. Terms & Definitions

7. Management Requirements

7.1 Organization and Management Responsibilities

7.2 Quality Management System

7.3 Document Control

7.4 Service Agreements

7.5 Examination by Referral Laboratories

7.6 External services and Supplies

7.7 Advisory Services

7.8 Resolution of complaints

7.9 Identification and Control of Non Conformities

7.10 Corrective Action

7.11 Preventive Action

7.12 Continual Improvement

7.13 Control Of Records

7.14 Evaluation & Audits

7.15 Management Review

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Contents

8. Technical Requirements

8.1 Personnel

8.2 Accommodation and Environmental Conditions

8.3 Laboratory Equipment, Reagents and Consumables

8.4 Pre-Examination Processes

8.5 Examination Processes

8.6 Ensuring Quality of Examination Results

8.7 Post Examination Processes

8.8 Reporting of Results

8.9 Release of Results

8.10 Laboratory Information Management

9. Amendment Sheet

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LABORATORY QUALITY MANUAL : VERSION 1

PREPARED BY : APPROVED BY : AUTHORIZED BY :

EFFECTIVE DATE : 02/06/2017

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Abbreviations

•NOC – Network Operating Centre

•AQI – Air Quality Index

•WAC – World Automation Congress

•UPS – Uninterruptible Power Supply

•NABL – National Accreditation Board for Testing and Calibration Laboratories

•KVA- Kilo-Volt Ampere

•ISO – International Standard of Organization

•IEC - International Electrotechnical Commission

•SOP - Standard Operating Procedure

•QSP - Quality Standard Program

•QMS - Quality Management System

•DOS - Directory of Services

•IPD - In Patient Department

•OPD – Out Patient Department

•QM – Quality Manager

•FIFO – First In First Out

•QA – Quality Assurance

•EQA - External Quality Assurance

•UHID – Unique Hospital Identification

•DIS – Doctor.e Information System

•LIS – Lab Information System

•MRM - Management Review Meeting

•HR - Human Resources

•PPE - Personal Protective Equipment

•IQ - Installation Qualification

•OQ - Operational Qualification

•PQ - Performance Qualification

•GDA – General Duty Attendant

•EDTA - Ethelene Diamine Tetra-acetic Acid

•MU - Measurement of Uncertainty

•IQC - Internal Quality Control

•RCA - Root Cause Analysis

•CAPA - Corrective Action Preventive Action

•TAT - Turn Around Time

•SOP - Standard Operating Procedure

•IPD - In Patient Department

•OPD - Out Patient Department

•GDA - General Duty Attendant


POLICY NUMBER: REFERENCE NUMBER: NABL - ISO15189: 2012

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1. Introduction to the LaboratoryDoctor E Health Services Pvt Ltd is a professionally managed service provider operative in the premises of Aakash Hospital Diagnostic Centre with its Network Operating System (NOC) at 209-C, First Floor, Masjid Moth, South Extension Part II, New Delhi 110049.

doctor.e is functional with predefined roles and responsibilities for both the Party A (Aakash Hospital) as well as the Party B (Doctor E Health Services Pvt Ltd).

Roles And Responsibilities of Party A:

Adequate provision to be provided by Party A which includes,

1. Infrastructure Requirements 3. Air Quality

4. Water Quality

5. Restroom Facilities2. Power Supply Requirements

Space: Well ventilated space with separate area for Reception, Sample collection and Sample Processing each.

Well ventilated area preferably dust free and away from sunlight for all the laboratory equipment’s.Room should be air conditioned with regulated temperature of 15-250˚C and relative humidity preferably less than 70%

Rodent and pest control facilities should be available as and when required.

Air Quality Index as per United States Environmen-tal Protection Agency AQI should be in acceptable range i.e. between 0-100.

Water Quality Index as per criteria specified in World Automation Congress (WAC) 173-201A WQI for the water of use should be within acceptable range i.e. 80-100.

If the laboratory output is of more than 50 samples per day (Medium Sized Laboratory) separate re-stroom facilities for both Males and Females should be available.

If the samples are less than 50 per day then single restroom facility is sufficient with proper working safety bars to the doors.

Mains Voltage of 220-240V/15A/50 Hz sine waveA dedicated mains single phase line is essential and prefer dedicated earthing

a. Spike buster

b. Proper earthing is essential

c. Earthing to neutral voltage should be less than 3 V but not zero

Generator facility with proper earthing as mentioned previously.Adequate power points for all the equipment’s.

6. Communication Facilities

Appropriate ways of communication including telephone services and network facilities (which in-cludes all artificial neural network ways and updat-ed internet facilities) important for on-site trouble shooting.




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Roles And Responsibilities of Party B:• Functional and Maintained Laboratory Equipment’s

• UPS of minimum 2 KVA or 3 KVA. Online UPS must be with isolation transformer

• Power factor not less than 0.8

• Mandatory 15 minutes minimum battery backup

• UPS is strongly recommended for 3 reasons

a. Heavy voltage fluctuation and frequent power

failures

b. Hospital in Industrial area

c. To avoid wastage of reagents

• Accredited laboratory services

• Quality Reports with help of well-developed cloud based laboratory information management soft-ware

• Trained Staff for all the laboratory work starting from patient registration to sample processing

• Intellectual pathological opinion for analysing the reports by qualified and competent pathologist

• If any of the requirements are not fulfilled by Party A all will be provided by Party B at the expenses of Party B itself and vice a versa

2. Scope and Field of Application

Quality Manual is compliant to the ISO 15189:2014 and NABL 160.

The scope of the laboratory services in Doctor E Health Services Pvt Ltd is to provide comprehensive service in

- Biochemistry, Hematology , Clinical Pathology, Microbiology & Serology and CytopathologyThe above tests are performed using various method-ologies. In addition, various ancillary activities such as specimen collection, storage of specimens, waste disposal, etc. are also controlled by strict quality norms.



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3. Normative ReferencesReference to existing recognised standards;

1. NABL 112 : Specific criteria’s for accreditation of medical Laboratories

2. NABL 133 : NABL Policy for use of NABL logo/ claim of accreditation by laboratories

3. NABL 160 : Guide for preparing the quality manual

4. NABL 100 : General information Boucher

5. NABL 161 : Guide for internal audit and management review for laboratory

6. NABL 141 : Guidelines for estimation and expression of uncertainty measurements

7. NABL 142 : Policy on calibration and traceability of measurements

8. NABL 163: Guide for External Quality Assurance System

9. ISO /IEC 15189 : 2012 : Medical Laboratories requirements for quality competence

10. ISO/IEC 17025 : 2005: General requirements for the competence of testing and calibration

11. ISO/IEC 9001: Quality Management system requirements

12. ISO/IEC 17000: Conformity Assessment - vocabulary and general principles

13. ISO/IEC Guide 2: Standardisation and related activities- General Vocabulary

14. ISO/IEC Guide 99: International Vocabulary of Metrology- basic and general concepts and associated terms (VIM)




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4. Revision ProcedureRevision of the quality manual will be done every yearly either in handwritten with signature format or in printed format under the supervision of the Medi-cal Director, Doctor E Health Services Pvt Ltd and the Quality Manager.

The authority to change and revise the contents of quality manual is solely given to Quality Manager and is approved by Medical Director, Doctor E Health Services Pvt Ltd.

5. Distribution Of Quality Manual

Distribution of both controlled and uncontrolled documents;

•Controlled Document : Only for NABL •Uncontrolled Document : For Internal Audit

Controlled copy number

Name of the holder of controlled copy Designation of the holder of controlled copy



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6. Terms And Definitions

1. Accreditation : Procedure by which an authorita-tive body gives formal recognition that an organi-sation is competent to carry out specific tasks.

2. Alert Intervals/ Critical Interval: Interval of examination results for an alert (critical) test that indicates an immediate risk to the patient of injury or death.

3. Automated selection and reporting of results: Process by which patient examination results are sent to the laboratory information system and compared with laboratory defined acceptance criteria, and in which results that fall within the de-fined criteria are automatically included in patient report formats without any additional intervention.

4. Biological reference interval: Specified interval of the distribution of values taken from a biological reference population.

5. Competence: Demonstrated ability to apply knowledge and skills.

6. Documented procedure : Specified way to carry out an activity or a process that is documented, implemented and maintained.

7. Examination: Set of operations having the object of determining the value or characteristics of a property.

8. Interlaboratory Comparison: Organisation, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions.

9. Laboratory Director: Person(s) with responsibility for, and authority over, a laboratory.

10. Laboratory Management: Person(s) who direct and manage the activities of a laboratory.

11. Medical/ Clinical Laboratory: Laboratory for the biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, genetic, or

other examination of materials derived from the human body for the purpose of providing informa-tion for the diagnosis, management, prevention, and treatment of disease in or assessment of human beings and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation.

12. Nonconformity: Nonfulfillment of a requirement.

13. Point of care testing: Testing performed near or at the site of a patient with the result leading to possible change in the care of the patient.

14. Post examination Processes: Processes following the examination including review of results, reten-tion, and storage of clinical material, sample (and waste) disposal, and formatting releasing, report-ing and retention of examination results.

15. Pre-examination processes: 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 end when the analytical examination begins.

16. Primary Sample: Discrete portion of a body fluid, breath, hair or tissue taken for examination, study or analysis of one or more quantities or properties assumed to apply for the whole.

17. Process: Set of interrelated or interacting activities which transform inputs into outputs.

18. Quality: Degree to which a set of inherent charac-teristics fulfills requirements.

19. Quality Indicator: Measure of the degree to which a set of inherent characteristics fulfills require-ments.

20. Quality Management System: Management system to direct and control an organisation with regard to quality.




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21. Quality Policy: Overall intensions and direction of a laboratory related t quality as formally expressed by laboratory management.

22. Quality Objective: Something sought, or aimed for, related to quality.

23. Referral Laboratory: External laboratory to which a sample is submitted for examination.

24. Sample: One or more parts taken from a primary sample.

25. Turnaround Time: Elapsed time between two specified points through pre-examination, exam-ination, and post-examination processes.

26. Validation: Confirmation, through provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.

27. Verification:Confirmation, through provision of objective evidence that specified requirements have been fulfilled.

7. Management Requirements7.1 Organisation and Management Responsibility

7.1.1 ORGANISATION

7.1.1.1 General

7.1.1.2 Legal Entity

Doctor E Health Services Pvt Ltd and Aakash Hospital hereinafter referred to as ‘the laboratory’ meet the requirements of ISO 15189:2012 International standard when carrying out work at its permanent facilities, or in associated or mobile facilities. The NOC is located at 209-C, First Floor, Masjid Moth, South Extension Part II, New Delhi 110049.

The Aakash Hospital as the organisation is a part is legally entitled system with Licence number ……........

Doctor E Health Services Pvt Ltd is working as a part of the organisation with Licence number.................

7.1.1.3 Ethical Conduct

Laboratory management ensures that,

a. There is no involvement in any activities that would diminish confidence in the laboratory’s competence, impartiality, judgement or operation-al integrity

b. Management and personnel are free from any un-due commercial, financial, or other pressures and influences that may adversely affect the quality of their work

c. Where potential conflicts in competing interests may exist, they shall be openly and appropriately declared

d. There are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements

e. Confidentiality of information is maintained at all times in accordance with lab polices

f. Acceptable practices are well defined

g. Laboratory is not engaged in practices restricted by law



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7.1.2 MANAGEMENT RESPONSIBILITY

7.1.1.4 Laboratory Director

7.1.2.1 Management Commitment

The laboratory is directed by a Laboratory Director with the competence and delegated responsibility for the services provided

The responsibilities of the Laboratory Director include professional, scientific, consultative or adviso-ry, organizational, admirative and educational matters relevant to the services offered by the laboratoryThe laboratory director;

a. Provide effective leadership of the medical labora-tory service, including budget planning and finan-cial management, in accordance with institutional assignment of such responsibilities

b. Relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community and the patient population served and providers of formal agreements when required

c. Ensure that there are appropriate numbers of staff with the required education, training and compe-tence to provide medical laboratory services that meet the needs and requirements

d. Ensure the implementation of quality policy

e. Implement a safe laboratory environment in compliance with good practice and applicable requirements

f. Serve as a contributing member of the medical staff for those facilities served, if applicable and appropriate

g. Ensure the provision of clinical advice with respect to the choice of examinations, use of the service

h. Select and monitor laboratory suppliers

i. Select referral laboratories and monitor the quality of their service

j. Provide professional development programmes for laboratory staff and opportunities to participate scientific and other activities of professional labo-ratory organisations

k. Define, implement and monitor standards of performance and quality improvement of the medical laboratory service or services

Laboratory management provides evidence of its commitment to the development and implementation of the Quality Management System at the manage-ment level and continually improve the effectiveness by;

a. Communicating to the laboratory personnel the importance of meeting the needs and requirements of users as well as regulatory and accreditation requirements every 6 monthly with minutes of meeting been well document by Quality Manager

b. Medical Director is responsible for establishment of the quality policy and ensuring that quality objec-tives are well established

c. Medical Director is solely responsible for defining responsibilities, authorities and interrelationships of all personnel

d. Management system is responsible for establishing effective communication processes either virtually or digitally or in person with all the ways been well documented

e. At doctor.e the management review meetings are conducted every yearly with maintaining records of minutes of meeting by quality manager

f. Management is responsible for ensuring that all personnel are competent to perform their assigned activities

l. Monitor all work performed in the laboratory to determine that clinically relevant information is being generated

m. Address any complaint, request or suggestion from staff and/or users of laboratory services

n. Design and implement a contingency plan to ensure that essential services are available during emergency situations or other conditions when laboratory services are limited or unavailable

o. Plan and direct research and development, where appropriate




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7.1.2.2 Needs of Users

7.1.2.3 Quality Policy

7.1.2.4 Quality Objectives and Planning

Laboratory management ensures that laboratory services, including appropriate advisory and interpre-tative services, meet the needs of patients and those using the laboratory services by

a. Having a documented standard operating proce-dure for establishment of service agreements and by reviewing the agreements and developing. For detailed SOP of service agreements refer SOP/NO/

b. Having a documented procedure for assessing the user feedback annually and reviewing the points observed in annual management meeting.

QUALITY POLICY:

Doctor E Health Services Pvt Ltd & Aakash Hospital believes in developing an effective Quality Manage-ment System in order to virtually connect the health-care providers to pathologist for analysing the test results globally and to develop the ecosystem which helps to provide new generation healthcare to all the patients. 1. Developing next generation digital/

virtual healthcare infrastructure to

provide the digital quality healthcare

2. Develop and monitor for quality

system in order to ensure continuous

quality improvement in delivering the reports to the patients

3. Augment diagnostic capabilities of

thousands of healthcare facilities

worldwide

4. To provide quality reports and meet

the expectations of the treating physicians

QUALITY OBJECTIVES

1. Developing next generation digital healthcare infrastructure

2. Develop and monitor for quality

system in order to ensure continuous

quality improvement in delivering the reports to the patients

3. Augment diagnostic capabilities of

thousands of healthcare facilities

worldwide

QUALITY OBJECTIVES

The Quality Policy of doctor.e is working in order to provide quality laboratory services to patients virtu-ally. Overall responsibility is that of Medical Director, doctor.e who from time to time ensures that the protocols for Quality Assurance are being followed.

The quality control of the doctor.e is under the overall supervision of Medical Director. Quality Manager on daily basis supervises the quality control & assists Medical Director in maintaining the quality of all test performed in the doctor.e laboratory. Non-conformance or any deviation from the SOP is invariably brought to the notice of the Medical Director, who is authorized to decide on these issues.

The Quality Manager reviews the SOP annually to ensure that the Quality Systems are in place and will be the person who could amend or introduce any new SOPs or guidelines.

All the standard operating procedures are communi-cated within the organisation and the documented protocol is established about the understanding and implementation of the SOP within the organisation.

g. Management system is responsible for ensuring availability of adequate resources to enable the proper



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4.1.2.7 Quality Manager

7.1.2.5 Responsibility, authority and interrelationships

7.1.2.6 Communication

Quality Manager under the supervision of Medical Lab-oratory Director is responsible for defining the respon-sibilities, authorities and interrelationships within the laboratory organisation

Laboratory organogram is as per ANNEXURE ..

Individual Job responsibilities and authorities are defined clearly and is as per ANNEXURE…

The laboratory management conducts monthly meeting virtually through video conferencing/ Skype entire staff on every second Saturday of every month. The Quality Manager shall record the minutes of this meeting. On-site laboratory management meeting is conduct-ed bi-monthly on every first Monday or first month. The minutes of this meeting are recorded by quality manager. The agenda of both the meetings includes;

1. The performance of laboratory

2. Review of records for analysing adherence to quality policy

3. Any amendments readdress of users

4. Complaints and Feedbacks

5. Key Performance indices

All the communication with the staff or management is done preferably through the official lab email ID that is password protected. Any urgent communication may also be done telephonically.

Reference: Procedure” Internal Communication”, SOP/

Job descriptions for quality manager are predefined and are as per Annexure..

Planning to Achieve Quality Objectives:

Medical Director and Quality Manager are responsible for planning to achieve Quality objectives they;

1. Ensures to bring together all the areas of the labo-ratory together to deliver quality health services

2. Conduct yearly management review meetings with documented agenda about the development, improvement and implementation of the quality policy and quality management system

3. Maintenance of documented evidence about ori-entation and understanding by all the members of organisation of the quality objectives and policy

4. Annual assessment of user feedback and develop-ing the key performance indices for the laboratory

5. Reviewing annually/6 monthly the service agree-ments with reference laboratories

6. Conducting annual user meetings with predefined agenda for planning on implementation of lab-oratory quality policy in order to achieve quality objectives

7. Development of effective communication system within the organisation to maintain the integrity




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7.2 Quality Management System

7.2.1 GENERAL REQUIREMENTS

7.2.2 DOCUMENTATION REQUIREMENTS

doctor.e are committed to establish, document, implement, maintain and continuously improve the Quality Management System (QMS) in accordance with ISO15189:2012 and NABL 112.

The laboratory undertakes to perform clinical testing of the highest standards by observing:

Use of reagents and kits procured from standard, established, reputed and accepted companies. Employing qualified medical and other staff with impeccable credentials and adequate experience for conducting and supervising laboratory tests.

Appointing a Quality Manager with thorough knowl-edge of quality systems and processes and their im-plementation as to establish, monitor record and guide the quality of laboratory testing towards excellence.

7.2.2.1 General

7.2.2.2 Quality Manual

Quality policy is documented in the Quality ManualThe Laboratory operates as per the ISO15189; 2012 and NABL 112. All tests are performed as per the technical SOPs. The staff performing the tests are familiarized / trained on the contents of SOPs

Quality Manual is prepared and includes the following:

• Quality policy of the lab• Scope of Quality Management System • Job descriptions of various staff in the lab• Organization and management structure of the lab

available with HR• Policies established for Quality Management System

All instruments and analytical systems in the labora-tory are covered by a program to ensure calibration and preventive maintenance on schedule. These would follow manufacturer’s instructions where available.

The purpose of this quality manual is to outline the Quality Management System of the laboratory and to document in details all guidelines and policies required to be observed by all staff members of the labo-ratory, scientific and ancillary, with an aim towards stringent adherence to desired quality norms.

At the time of employment each staff member is given a written job description, which clearly defines the extent and limitations of her / his responsibilities. Signature of the person is obtained on a copy of the same as acceptance of the above. Amendments to the person’s duties and responsibilities are made known to all key administrative personnel as well as the persons concerned.

Any additional details with respect to the work profile are recorded in the form of a work schedule issued either to the individual or to the section on a period-ic basis. Such work schedules issued can be altered depending on the specific needs of the organization within the broad work profile defined.



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7.3 DOCUMENT CONTROL

7.2.1 GENERAL REQUIREMENTS

All Policies, Procedures and Work Instructions in lab are under stringent control.

All the relevant documents (Quality Manual, QSPs, SOPs, Work Instructions and any other reference doc-uments) are available at all the stations in lab.The documents are prepared by the experience and qualified personnel /Quality Manager, reviewed and approved by Medical Director. All these documents are

controlled and revised by authorised personnel onlyNo photocopying or removing of these documents is allowed under any circumstance once “controlled”. All hard copies of procedures are single copy controlled documents and are labeled as such. All the staff working in the lab use the controlled documents for carrying out the work.

THE PROCEDURES ADOPTED ENSURE THAT:

Documents are handled in such a way that they are reviewed, approved and retained.

• A master list of documents is maintained

• Only standardized formats are used.

• Only current and valid documents are in use

• Any new and revised documents are reviewed and approved before use.

• All the documents are identified to include a title, a unique identifier, current edition, total no of pages and the person who is authorized to issue such documents.

Invalid or obsolete documents are promptly removed from all points of issue or use.

Retained obsolete documents are suitably marked so as to prevent their inadvertent use.

The laboratory document control system does not permit any changes by hand. In exceptional circumstances, any minor changes / amendments to documents may be done by hand, but need to be clearly marked, initialled and dated. A revised document is formally re-issued as soon as practicable.

The document control system in the laboratory is paper based. Computer access to these controlled documents and their amendment is restricted to the Quality Manager and Medical Director.

The quality system documents generated by the laboratory are uniquely numbered as per the laboratory policy

Reference: Procedure” Control of Documents, SOP/Policy “Review of Documents” PP/




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7.4 SERVICE AGREEMENTS

7.4.1 Establishment of Service Agreements

All tests performed at the laboratory are as described in the Laboratory Directory of Services (DOS). This listing details the test name, test code, methodology, specimen requirements, price and turnaround time. This listing covers single / multiple parame-ter tests as well as panels specific to the di-agnosis of certain disease conditions. Unless mentioned otherwise, this list is the contract between the laboratory and the customer.

doctor.e provides medical laboratory services to the patients / customers who approach them through IPD / OPD. The patients / customers’ requirements are understood and their adequacy ensured. The main reception staff reviews the tests written by the doctors on the prescription / slip of respective patient / customer as per the available list of tests (DOS on computer) along with the rates and the details of the patient preparation for respective tests.

Medical Director is responsible for all the tests / processes that are sub-contracted completely or par-tially to external agency. The work is outsourced to a competent organization, which has good facility meet-ing the organizational quality requirement, complies with the national lab quality standards, alternatively, has been certified by third party for quality standards like ISO 15189:2012 and NABL 112. The arrangements with referral laboratories and consultants are reviewed and evaluated at least once in 12 months by quality manager under the supervision of Medical Director. The audit is as per checklist 2 of NABL. The report is prepared and submitted to the management for fur-ther action. Services of any other laboratory are used only if their result is reliable and acceptable.



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a. The tests to be performed are properly written and understood. In case of any doubt, the recep-tion staff asks the consultant in charge virtually through skype/ telephonically or confirms from the patient’s consulting doctor about the test. In general, the methods to be used for perform-ing the tests are not specified by the patient / customer or their referring doctor. However, these are documented in the list of tests and the patient can refer to these on demand.

b. For those tests for which the facility does not exist in-house, the samples are collected and sent to the outsourced / external laboratories. This is done after an evaluation as given above as to whether the laboratory has the capability and resources to meet the requirements of test-ing. Resources would include but not be limited to; infrastructural, equipment, reagents, quality control, personnel, their competence and training and all other aspects related to pre-analytical, analytical and post-analytical phases of testing.

c. doctor.e has installed state-of-the-art equipment for testing, which uses the internationally ap-proved and time-tested methods of testing. This ensures to meet patient’s / customer’s interest of correct & accurate reports.

d. There is no written contract besides the registra-tion SGS issued to the customers. The contract starts or becomes effective once the patients / customers agree to the tests mentioned in the registration SGS and makes the payment in full

/ part. The organization is committed to give the report once the customers have made the full payment.

e. In case of any doubt or differences in opinion about the tests to be performed, verbal clarification from the referring doctor is taken.

f. All inquiries are carefully checked, to identify that all requirements are adequately defined and there is no requirement, which is beyond the organi-zational capability in terms of service capability, requirements, time schedule, etc. The organization accepts the request to provide only those medical laboratory services, which it can cater for.

g. Any requirement that is necessary for the service but not stated / specified by the patient / customer is clarified and followed. This also covers the in-struction for preparation of the patient / customer prior to investigation.

h. All statutory and regulatory requirements, related to the medical laboratory services, published by related governing bodies are adhered to and imple-mented in practice by the laboratory.

i. If there is any additional information required to process the medical laboratory investigation but not stated by the patient / customer, it is clari-fied so that the accuracy and quality of medical investigation results are maintained. The patient’s / customer’s doctors are also consulted, whenever necessary, to ensure correct investigations.




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7.4.2 Review of Service Agreements:

The service agreements based on evaluation of referral laboratories are reviewed once in a year and discussions along with changes made are documented. The review would also cover any work referred by the laboratory. The customer would be informed of any deviation from the contract.Those tests for which facility does not exist, the samples are sent to referral laboratories. The original report is assessed for its accuracy and a new report issued on our letter head ensuring the details of the lab to which the sample was outsourced is mentioned.

Any kind of deviation from the contract, e.g. tests not performed as per contract (case registration slip), the customers (patients, clinicians, health insurance companies etc.) are informed accordingly either over phone or when they come for report collection and the charges for the tests not performed are refunded.

In cases where a contract needs to be amended after commencement of work, the same contract review process would be repeated and any amendments communicated to all affected parties.

7.5 EXAMINATION BY REFERRAL LABORATORIES

7.5.1 SELECTING AND EVALUATING REFERRAL LABORATORIES AND CONSULTANTS

The laboratory has an effective documented proce-dure for evaluating and selecting the referral labo-ratories as well as consultants who provide second opinions. The arrangements with the referral laboratory ensure that the following requirements are met:

a. All requirements including pre-examination and post-examination procedures are adequately defined, documented and understood.

b. The referral laboratories are NABL accredited and are able to meet the requirements, with no conflicts of interest.

c. Selection of examination procedures is appropriate for the intended use.

d. Results and interpretations reported by the refer-ral laboratory are reported as such without any amendment.

e. The laboratory maintains a record of any referral test. A register / excel sheet is kept for all samples that have been referred to another laboratory. The name and address of the laboratory responsible for the examination result is provided to the user of laboratory services. A duplicate of the laboratory report is retained in both the patient record and in the permanent file of the laboratory.

doctor.e provides medical laboratory services to the patients / customers who approach them through IPD / OPD. The patients / customers’ requirements are understood and their adequacy ensured. The main reception staff reviews the tests written by the doctors on the prescription / slip of respective patient / customer as per the available list of tests (DOS on computer) along with the rates and the details of the patient preparation for respective tests.

Medical Director is responsible for all the tests / processes that are sub-contracted completely or par-tially to external agency. The work is outsourced to a competent organization, which has good facility meet-ing the organizational quality requirement, complies with the national lab quality standards, alternatively, has been certified by third party for quality standards like ISO 15189:2012 and NABL 112. The arrangements with referral laboratories and consultants are reviewed and evaluated at least once in 12 months by quality manager under the supervision of Medical Director. The audit is as per checklist 2 of NABL. The report is prepared and submitted to the management for fur-ther action. Services of any other laboratory are used only if their result is reliable and acceptable.



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7.5.2 PROVISION OF EXAMINATION RESULTS

The laboratory takes accountability for tests performed at the referral laboratory and ensures that reports for tests done at referral labs are delivered to the requester. The tests which are performed by the external laboratories are not in the scope of our NABL accreditation. The original report is assessed for its accuracy and a new report issued ensuring the details of the lab to which the sample was outsourced.

Laboratory ensures that the clients are given reports with interpretation whenever the need arises. In such cases referral laboratory’s identity is mentioned in the report. If additional remarks are added author of such remarks is mentioned in the report.

A list of referrals centres and facilities currently in use is available in the lab record Reference: REC/

Reference: Procedure ‘Referral Laboratory” SOP/

7.6 EXTERNAL SERVICES AND SUPPLIES

The Quality Manger/Management Board decides upon the selection and use of purchased external services, equipment and consumable supplies that affect the quality of its services. Purchased items consistently meet the laboratory quality requirements. There is record of purchased items. There are procedures and criteria for inspection, acceptance/ rejection, and storage of consumables.

Purchased equipment and consumable supplies that affect the quality of the service is not to be used until they have been verified as complying with standard specifications or requirements defined for the proce-dure concerned.

All reagents used are stored at proper temperature in a safe and hygienic place in a proper manner. Supplies and reagents are stored in a manner that the oldest is used first (FIFO). Supplies and reagent are used in a manner consistent with instructions provided by the manufacturer.

• Supplier is qualified to ensure a reliable source of materials by the QM.

• The ability of suppliers to consistent-ly meet specifications for a supply or service is evaluated along with perfor-mance related to availability, delivery and support

• Examples of factors that are considered to qualify suppliers are

a. Licensure, certification, or accredi-

tation.

b. Review of quality summary reports

c. Review of experience with suppliers

d. Cost of materials or services

e. Delivery arrangements

f. Financial security, market position,

and customer satisfaction

g. After sales support

• Documented failure of supplies or sup-

pliers to meet defined requirements re-sult in immediate action by the facility.

• Suppliers may need to be replaced until

all quality issues have been resolved.

SUPPLIER PERFORMANCE EVALUATION

The critical supplies, Quality Control / Installation /Calibration certificates are kept as records for checking.




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7.7 ADVISORY SERVICES

a. The front desk staffs, technicians as well as the lab doctors are all responsible for providing advisory services to the patients and customers. The front desk staff is trained to answer patients / custom-er’s queries regarding the test to be undertaken and specimen to be collected. In case of any doubt, they refer to the in-house senior technicians or doctors and if need be, to the referring doctor of the patient. This is to ensure that the correct test is undertaken and appropriate sample is collected.

b. Confidentiality is maintained at all levels to protect patient information.

c. The patients / customers are free to ask the labo-ratory doctor, the interpretation of the results. The doctor informs the patient regarding the interpre-tation of the result obtained. However, no opinion regarding the course of treatment / suggestions based on the interpretation of the test is given to the customer. The patient is advised to consult their referring doctor for treatment.

d. The laboratory staff is actively involved in regular meetings that are held to appraise or discuss the technical and quality system requirements and practices in the laboratory.

Reference: Procedure ‘Advisory services’ SOP/

AGREEMENTS

The laboratory maintains preferably written contracts or agreements with outside suppliers.

Samples of issues that are addressed in an agreement or a contract include responsibility of a product during shipment; responsibility of the supplier to promptly notify the facility whenever there are changes that could affect the safety/quality of blood directly or indi-rectly.

Before acceptance the materials and supplies are inspected and tested. Corrective actions include returning the material to the vendor or destroying it. Receipt and inspection records provide the facility with a means to trace materials that have been used in a particular process and also provide information for ongoing supplier qualification.

INVENTORY CONTROL

• There is an inventory control system for supplies. Appropriate records of external services, supplies and purchased product is established and maintained for period of one year.

• This system includes the recording of lot number of all relevant reagents, control materials and calibra-tors, the date of receipt in the laboratory and the date of the material was placed in service.

Reference: Procedure ‘Selection and evaluation of supplier” SOP/ Reference: Procedure ‘Inventory management” SOP/



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7.9 IDENTIFICATION AND CONTROL OF NON-CONFORMITIES

7.8 RESOLUTION OF COMPLAINTS

The policy of the laboratory related to the above is extremely stringent and is outlined in the Reporting of Results Policy of the laboratory. All patient results are released only after satisfactory test calibration and control values (if applicable) are obtained.

The laboratory is committed to ensure total patient’s / customer’s satisfaction and effectively handles their feedback / complaints, if any, in best possible way as the patient’s / customer’s feedback is an important tool in continually improving the quality of the services offered and thus increase their loyalty.

The Quality Manager under the supervision of Medical Director is solely responsible for resolving the patient’s / customer’s complaints.

The procedure for handling and resolution of client complaints includes classification and nature of complaints, identity and designation of the person docu-menting the complaint, direction of movement of such a complaint investigation, documentation of corrective action with date and signature.

An analysis of customer satisfaction is done for feedback received from customers, both positive and negative and areas of improvement are outlined.

• All members are advised to speak politely with the patient / clients and try to make them at ease during the course of investigation. To improve interpersonal relationship the training is imparted from time to time by the in-house senior member.

• Hospital wide policy on handling customer complaint is followed for out-patient and in-patient for com-plaints related to labs.

Reference: Procedure ‘Client Complaints” SOP/

These tests are performed by the technical staff and preliminary review conducted by the Sr. Lab Tech-nologists. The Lab consultant reviews all the results. In cases where results are found to be unacceptable, these are withheld and suitable corrective action/mea-sures are employed.

Non-conformities are classified as to whether the occurrence of non-conformity is pre-analytical, analytical and post-analytical phase so that corrective action may be taken accordingly.

An evaluation of the significance of the non-conform-ing work is performed and an investigation with regard to the causes conducted. This includes quality control, instrument calibration, check of reagents, etc.The medical evaluation of relevance of the non-conforming examination is conducted and the clinician is informed if necessary.

Corrective actions are taken immediately and theresults of analysis are reviewed.The results of non-conforming examinations already released are identified, reviewed and recalled if necessary.

Each episode of non-conformity is recorded (pre-an-alytical / analytical / post analytical) and reviewed by the Medical Director to detect trends and initiate preventive action.

Where such activities result in a delay in turn around time the same is communicated to the customer in a timely manner by technical staff in the sample collection. In the event of detection of a non-con-forming result subsequent to release of test result through customer complaints, staff observations, test report checks or internal / external audits the result is recalled from the customer, an investigation institut-ed and an amended report issued as needed be after result re-confirmation.

Reference: Procedure ‘Control of non-conformities” SOP/




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7.10 CORRECTIVE ACTION 7.11 PREVENTIVE ACTION

The laboratory would institute corrective action (pre-analytical, analytical and post-analytical) when non-conforming work or departure from quality system policies or technical operations has been identified.

The procedure for corrective action starts with an investigation to determine the root cause(s) of the problem. Potential cause analysis would include but not limited to, test requisition forms, specimen col-lection, techniques, specimen quality, methods and procedures, staff competency, reagents, equipment and its calibration.

The emphasis at doctor.e being on Quality Improve-ment, Preventive action plays a major role in improve-ment of processes. It aims at identifying potential improvements and sources of non-conformances, either technical or concerning the quality system and competency. Wherever improvement is required, quality focus monitors are identified, implemented and monitored to reduce the likelihood of occurrence of such non-conformance and to take advantage of opportunities for improvement.

Procedures for preventive actions include the initiation of such actions and application of controls to ensure that they are effective. Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk anal-ysis and external quality assurance results. Records of preventive action are maintained and reviewed.

Reference: Procedure ‘Corrective and preventive Action’ SOP/

Where needed, the Medical Director would identify potential corrective actions. In addition, the action(s) most likely to eliminate the problem and prevent recurrence would need to be implemented. Corrective actions are to a degree appropriate to the magnitude and risk of the problem.

All problems and the corrective action implemented are documented in the log book.

The laboratory monitors results to ensure that corrective actions taken have been effective and have overcome the problem and prevent the recurrence.

All corrective actions taken are documented and recorded with root causes analysis and submitted to management review meeting. The results of the corrective actions are also recorded.

Reference: Procedure ‘Corrective and preventive action’ SOP/

ROOT CAUSE ANALYSIS:

IMPLEMENTATION OF CORRECTIVE ACTION:

DOCUMENTATION OF CORRECTIVE ACTION:

7.12 CONTINUAL IMPROVEMENT

All technical procedures are reviewed annually at a minimum by the Medical Director of the laboratory in order to identify any potential sources of non-con-formance’s or other opportunities for improvement in technical practices. All SOPs / policies and procedures are also reviewed annually and any changes / im-provements in national / international standards are incorporated during review. Action plans for improve-ment are developed, documented and implemented as appropriate.

After action has been taken resulting from the review, laboratory management evaluates the effectiveness of the action through a focused review or audit of the area concerned.

Results of these focused reviews are submitted to management for review and implementation of



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7.13 CONTROL OF RECORDS

The laboratory has an established procedure for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records include reports from internal audits and management reviews as well as records of corrective and preventive ac-tions.

All records are legible and are stored in facilities that provide a suitable environment to prevent dam-age or deterioration and to prevent loss and retained in such a way that they are readily retrievable. Retention times of records are as per NABL 112. Records may be hard copy or electronic media.

RECORDS RESPONSIBLE PERSON

Quality Assurance Records, Internal Audits & QA Related Documents

Quality Manager and Medical Director

Records of Electrical maintenance

Logistic Manager

Worksheets and engineering records Sr. Laboratory Technologists

Calibration records Quality Manager

Corrective / Preventive action records, Pro-ficiency records

Quality Manager and Medical Director

Customer complaints / queries and related records

Quality Manager

Purchase and logistic Records

Logistic Manager

changes to the system.

Laboratory management has implemented quality indi-cators for systematically monitoring and evaluating the laboratory’s contribution to patient care. The Medical Director and Quality Manager, address the areas for improvement. The laboratory participates in quality improvement activities that deal with relevant areas and outcomes of patient care. The lab objectives are monitored and reviewed to evaluate the effectiveness of the action taken for achievement of the objective leading to the patient / customer satisfaction. Some of the parameters are monitored through the feedback

form. Lab participates in EQA, which gives a rating and comparison of lab performance.

The Quality Manager under supervision of Medical Director organizes regular training sessions for the members to improve their skill and performance. All laboratory personnel and relevant users of laboratory services are provided access to suitable educational and training opportunities.




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The organization has procedures to protect and back-up records stored electronically and to prevent unau-thorized access to or amendment of these records.Quality Manager and Laboratory Director are responsi-ble for the security of the documents. The documents stored electronically are password protected to prevent unauthorized access or amendment of these records.The patient’s records are preserved in individual files in the Medical Record Department as per laboratory policy (for 5 years accept in medico legal cases). These are easily retrieved by patient’s UHID no. both as a hard copy as well as on DIS.

When mistakes occur in records, each mistake is crossed out, not erased, made illegible or deleted and the correct value entered alongside. All such alterations to records are signed and dated by the person making the correction. In case of records stored electronically, equivalent measures are taken to avoid loss or change of original data.

The data retention and archiving procedure outlines details w.r.t. various records and timelines for storage. Retention time is defined by the nature of the exam-ination or specifically for each record as per the nation-al, regional and local regulations.

• Staff Qualification, Training and Competency

Records

• Vendor Selection, performance and change records

• Test requisition forms

• Test reports (on DIS)

• Instrument print-outs

• Laboratory worksheets

• Accession records (on DIS)

• Calibration records

• Quality control records

• Complaints and corrective & preventive actions

• Records of internal and external audits

• External Quality Assessment records / Inter- laboratory comparisons / Split sample testing records

• Quality improvement records

• Instrument maintenance records including calibration data

• Reagent verification, new lot verification, validation records and package inserts

• Incident / accident records

• Risk management reports

• Records of management review

• Non-conformities

• Customer complaint and feedback

RECORDS STORED AND MAINTAINED INCLUDE:



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7.14 EVALUATION AND AUDITS

All technical procedures are reviewed annually at a minimum by the Medical Director of the laboratory in order to identify any potential sources of non-con-formance’s or other opportunities for improvement in technical practices. All SOPs / policies and procedures are also reviewed annually and any changes / im-provements in national / international standards are incorporated during review. Action plans for improve-ment are developed, documented and implemented as appropriate.

After action has been taken resulting from the review, laboratory management evaluates the effectiveness of the action through a focused review or audit of the area concerned.

Results of these focused reviews are submitted to management for review and implementation of changes to the system.

7.14.1 General

7.14.2 Periodic Review of Requests, and

Suitability of Procedures and Sample Requirements

Internal audits are conducted by authorized personal to verify that operations continue to comply with the requirements of the QMS.

The laboratory periodically and in accordance with a predetermined schedule and procedure, conducts internal audits of its activities to verify that its opera-tions continue to comply with the requirements of the quality system and the ISO 15189:2012 Standard and NABL 112. The internal audit programme addresses all elements of the quality system, including the testing activities. It is the responsibility of the Quality Manager to plan and organize audits as required by the sched-ule and requested by management. The auditors are independent of the activity to be audited. The cycle for internal auditing is completed in one year. The pro-cedure for internal audit describes the types of audit, frequencies and required documentation. Deficiencies or opportunities for improvement observed are noted, appropriate corrective and preventive action undertak-en and documented.

When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test results, the laboratory takes timely corrective action and notifies customers in writing if investigations show that the laboratory results may have been affected.

The area of activity audited, the audit findings and corrective actions that arise from them are recorded. Records of Internal Audits are maintained by Quality manager and reviewed in Management Review Meetings.

The Laboratory Directory of Services (DOS) contains the volume of sample required for testing.

The laboratory periodically reviews the sample volume required for different tests, collection devices and pre-servative requirements to ensure neither insufficient nor excessive amounts of sample are collected and the sample is properly collected to preserve the measures


APPROVED BY : AUTHORIZED BY :


PREPARED BY :

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7.15 MANAGEMENT REVIEW

7.14.4 Staff Suggestions

7.15.2 Review Input

7.14.5 Internal Audit

7.14.6 Risk Management

7.14.7 Quality Indicators

7.14.8 Reviews by External Organizations

7.14.3 Assessment of User Feedback

7.15.1 General

Laboratory management encourages staff to make suggestions for the improvement of the laboratory services, with records maintained of the suggestions and action taken.

The review would take into account the following:

a. The periodic review of request

b. Assessment of user feedback

c. Staff suggestions

d. Internal audit

e. Risk management

f. Use of quality indicators

g. Review by external organizations

h. Results of participation in interlaboratory compari-son programmes

i. Monitoring and resolution of complaints

j. Performance of suppliers

k. Identification and control of non-conformities

l. Results of continual improvement including current status of corrective actions

m. Follow-up actions from previous management review

n. Changes in the volume and scope of work, per-sonnel and premises that could affect the quality management system

o. Recommendations for improvement, including technical requirements.

Refer 4.14.1

Reference: Procedure” Internal Quality audit” SOP/

The laboratory reviews its impact of work processed so as to eliminate or minimize the identified risks that affect patient and personnel safety. All decisions and actions taken are documented.

The laboratory has established its quality indicators for critical aspects of pre-examination, examination and post examination processes. These are periodically reviewed to ensure their continued appropriateness. (Annexure: C)

The laboratory takes appropriate immediate actions / corrective or preventive action to non-conformities or potential non-conformities identified by the external organizations in the course of external audit. All such records are maintained by the department.

The laboratory obtains information relating to user perception as to whether the services have met the needs and requirements of users. Records of information collected and actions taken are kept.

The Quality Manager conducts a review of the quality management system and examination and advisory activities of the lab to ensure their continuing suitabil-ity and effectiveness in support of patient care and to introduce appropriate changes or improvements. The results of the review are incorporated in plans for improvement.



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7.15.3 Review Activities

7.15.4 Review Output

8.1.2 Personnel Qualifications

8.1.3 Job Descriptions

Effectiveness and appropriateness of lab services to patient care is monitored and evaluated. The infor-mation for the cause of non-conformities, trends and patterns that point to a process problem analysed and corrective and preventive action is taken. MRM also discusses opportunities for improvement and need for changing quality managing system. MRM are conduct-ed annually.

Findings from management reviews, internal audits and the actions that arise from them are document-ed. Quality Manager is responsible for monitoring and implementation of the action points of management review meeting as appropriate.

Reference: Procedure “Management Review” SOP/

8.0 TECHNICAL REQUIREMENTS

8.1 PERSONNEL

The personnel responsible for the opinions and inter-pretation included in test reports, in addition to the appropriate qualification, training, experience and satisfactory knowledge of the testing carried out have:

• Relevant knowledge of the technology used for testing and troubleshooting.

• Knowledge of the general requirements expressed in the legislation and standards.

• An understanding of the significance of deviations found.

• Interpretation of results obtained.

Laboratory HR Department maintains a list of all employees covering their educational qualification, special training, past experience and current job responsibilities.

A personnel file of all employees is maintained which contains educational qualification and past experience certificates, etc.

The personnel making professional judgments with reference to examinations have the applicable the-oretical and practical background as well as recent experience. Tests requiring opinions, interpretations, predictions and comments are reported as required.The laboratory activities are managed and performed under the supervision of the Medical Director, who is well qualified and experienced. Medical Director will be responsible for all clinical services provided by the laboratory.

(Annexure D)




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8.1.4 Personnel Introduction to the

Organizational Environment

8.1.5 Training

8.1.6 Competence Assessments

8.1.7 Review of Staff Performance

8.1.8 Continuing Education and Professional Development

The laboratory has a programme to introduce new staff to the organization, department in which the person will work, staff facilities, health and safety requirements, etc.

The laboratory has adequate staff to undertake the required work and to carry out other functions of the quality management system.

All technical and scientific staff undergo regular and extensive hands on training with respect to testing, quality control and quality assurance as relevant.The laboratory staff is authorized to perform the particular tasks they are competent such as sampling, examination and operation of particular types of equipment, including use of computers in the labora-tory information system.

All the laboratory staff is allowed to use the comput-er system and enter the patient results. The Quality Manager under supervision of Medical Director is allowed to make any modifications in the patient data or patient results. The members authorized to operate the computer are provided with their unique access password.

There is continuing education program available to staff at all levels.

Employees are trained to prevent or contain the effects of adverse incidents, which may be biological, chemical or fire hazard.

The competency of each person to perform assigned tasks is assessed following trainings and periodically thereafter. Retraining and reassessment occurs when necessary. Competency evaluation is both theoreti-cal and practical done through written test, hands on exercises and observations.

All lab staff maintains confidentiality of patient’s information.

After appropriate training, the lab assesses the com-petence of each person to perform assigned tasks. Reassessment takes place at regular intervals.

Competence assessment is done by different methods:

• Direct observation of routine work processed and

procedures, including all safety practices.

• Direct observation of equipment maintenance and function checks.

• Monitoring the recording and reporting of examina-

tion results.

• Review of work records.

• Assessment of problem solving skills.

• Examination of specially provided samples.

• General attitude and behaviour.

The laboratory reviews staff performance regularly to consider the manpower needs of the laboratory and the needs of the user.

Details of staff training & education are available via the staff training and education policy. The Manage-ment requires that all staff participate in continuing mandatory education for elements such as fire safety, information governance, hand hygiene, child protec-tion training, protection of vulnerable adults, equality and diversity awareness training. In addition, the labo-ratory provides programmes of on-going professional development that all staff are given the opportunity to attend. A review of the effectiveness of these pro-grammes is done.

Reference: Policy “Evaluation of continual improvement” PP/



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8.1.9 Personnel Records

8.2.2 Laboratory and Office Facilities

8.2.3 Storage Facilities

8.2.1 General

The personnel records comprising of professional qual-ifications, trainings and experience are available with HR. These records include

• Qualification Certificate

• Records of all the training undertaken, past professional experience

• Health Status

• Institute Appraisal

• Any Untoward Incidents

• Job Description

The laboratory is designed for optimum utilization of space with clear emphasis on separating the patient area with work area but still providing the patients a view of the activities carried out in the lab in a profes-sional way to give them a level of comfort.

• A brief description of the facilities includes:

• Consistent reliable electric supply.

• Twenty-four hours water supply .

• Diesel generator set-up as a standby in case of

electricity failure.

• All laboratory instruments and computers connected to the UPS (Uninterrupted Power Supply).

• Smoke and fire detection system along with fire hydrants for the safety of the employees and the premises.

• Mobile numbers of all the doctors and supervisory administrative staff is available in the laboratory directory for immediate location of an employee.

• Communication systems within the laboratory are appropriate and include, telephone and e-mail facility for key personnel.

Appropriate designated storage space and conditions have been provided to ensure the continuing integrity of samples, slides, retained micro-organisms, docu-ments, files, manuals, equipment, reagents, laboratory supplies, records and results.

A brief on the policy of the laboratory with respect to accommodation and environment is as follows:

• All facilities aim at providing optimal conditions for performing tests. Environmental conditions are not permitted to invalidate results or adversely affect quality of measurement. The laboratory is main-tained at a temperature of 23+/-2 degree Centi-grade, which is optimum for lab operations.

• The laboratory is maintained impeccably clean and the environment relatively dusts free.

• The laboratory is well illuminated for good visibility and comfortable work atmosphere.

• The staff uses appropriate PPE while working in the lab, handling and operating instrument, while han-dling hazardous reagents and patient samples (white coat, gloves, mask etc).

• The probable risks (lab), safety practices, standard work precautions and Bio-Medical Waste Manage-ment are practiced as per the laboratory policy (Lab-

8.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

oratory safety manual, Laboratory Biomedical Waste Management and Laboratory Operations Manual).

• All other relevant safety precautions to be observed in accordance with policy of the laboratory. The lab has spill management kit, eyewash and fire safety kits to manage any accidents/incidents. Their func-tionality is verified during the lab safety audit.




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8.2.4 Staff Facilities

8.2.5 Patient Sample Collection Facilities

8.3.1 Equipment

8.2.6 Facility Maintenance and Environmental Conditions

There is adequate access to washrooms, supply of drinking water and facilities for storage of personal protective equipment and clothing

For primary sample collection facilities, consideration is given to the patients with disabilities, and their comfort and privacy, patients, employees and visitors are protected from recognized hazards like exposure to blood borne pathogen, needle stick injury etc.The laboratory is designed to optimize performance of the tasks carried out therein.This also extends to its areas related to specimen collection both within the laboratory and at external sites. Laboratory facilities for examination permit cor-rect performance of examinations and include energy sources, light, ventilation, water, waste and refuse disposal and environmental conditions. Equipment temperature conditions mandated are maintained as required.

The laboratory is well equipped with state of the art testing equipment required for the correct perfor-mance of tests (primary sample collection, preparation of tests, processing, examination and storage). When selecting equipment, account of the use of energy and future disposal is taken.

The computer and LIS are used for accessioning, processing, recording, reporting, storage and retrieval of test data. The laboratory ensures that:

• Manufacturer developed computer software is doc-umented in sufficient detail and is suitably validated as being adequate for use. The software is updated as required.

• Procedures are available and implemented for protecting the data. Such procedures include, but are not limited to integrity and confidentiality of data, data storage, data transmission and data processing.

• Computer and automated equipment are maintained to ensure proper functioning and are provided with the environmental and operating conditions neces-sary to maintain the integrity of test and calibration data.

• Computer programs are adequately protected to prevent access, alteration or destruction by casual or unauthorized personnel.

Laboratory sections are segregated as per require-ments of analysis / techniques in a manner to sepa-rate incompatible activities and to prevent cross-con-tamination.

Access to and use of areas affecting the quality of the examinations is controlled. Appropriate measures are taken to safeguard samples and resources from unau-thorized access.

Sufficient protection is taken to avoid occupational illness and recognized hazards.

The laboratory monitors, controls and records environ-mental conditions, with respect to sterility, dust, elec-tromagnetic interference, radiation, humidity, electri-cal supply, temperature, sound and vibration levels, as appropriate to the technical activities concerned.

8.3 LABORATORY EQUIPMENT, REAGENTS AND CONSUMABLES

8.3.1.1 General

Work areas are kept clean and well-maintained; mea-sures are taken towards good housekeeping. Storage and disposal of waste, particularly infectious waste is done in accordance with hospital biomedical waste disposal guidelines. Continuous training of laboratory staff as well as housekeeping personnel, is being car-ried out. Procedures for the same are available.



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Equipment used for testing is selected with a view towards complying with accuracy and precision re-quirements of testing. All quantitative tests have an established calibration frequency as described in the relevant technical procedure. Prior to being placed in service, instruments are calibrated and validation of tests performed extensively for all reagents and analytical systems. There is a documented record of preventive maintenance, which follows the manufac-turer’s instructions at a minimum. IQ, OQ and PQ of each instrument is verified before putting into routine use.

Each item of major equipment used for testing is uniquely identified.

Equipment is operated by authorized laboratory technologists in the section. Personnel under train-ing are permitted to operate equipment under the supervision of the senior in the section. Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) are readily available for use by the appropriate laboratory personnel.

All lab equipment is calibrated by an external agen-cies accreditated by NABL and each equipment has a calibration status sticker.

Where calibrations give rise to a set of correction factors, the laboratory has procedures for ensuring that copies of prior correction factors are correctly updated.

Record the meteorological traceability of the calibra-tion standard and traceable calibration of the item of equipment.

When for whatever reason, equipment goes outside the direct control of the laboratory or is repaired or serviced, the laboratory ensures that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.

The lab has documented programme of preventive maintenance of equipments.

Any equipment found to be defective is taken out of service and clearly labeled so.

The laboratory has procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration. Manufacturer’s instructions or specifications are used as appropriate.

Equipment that gives erroneous results, or has been shown to be defective or outside specified limits, is taken out of service. It is clearly labeled as being `Not in use’ until it has been repaired and shown to perform correctly. The laboratory examines the effect of the defect or departure from specified limits on previous tests and institutes an investigation with regard to any results which may have been released.

Decontamination procedures as applicable are described in the safety procedures. Engineers are offered space and appropriate personal protective equipment for repairs of equipment.

Equipment, including hardware, software, reference materials, consumables, reagents and analytical sys-tems are safeguarded from adjustments or tampering that might invalidate examination results.

Adverse incidents and accidents attributed directly to specific equipment are investigated and reported to the manufacturer and appropriate authority. Corrective and preventive action is taken such that the incidents and accidents are not repeated again.

8.3.1.2 Equipment Acceptance Testing

8.3.1.3 Equipment Instructions for Use

8.3.1.4 Equipment Calibration and Metrological Traceability

8.3.1.5 Equipment Maintenance and Repair

8.3.1.6 Equipment Adverse Incident Reporting




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Records are maintained of each item of equipment significant to the tests performed. The records include at least the following where applicable:

• The identity of the equipment

• The manufacturer’s name, type identification and serial number or other unique identification

• Manufacturer’s contact person and telephone number, as appropriate

• Date of receipt and placing in service

• Current location (where appropriate)

• Condition when received

• The manufacturer’s instructions, if available, or reference to their location

• Validation of the equipment confirming suitability of use, the maintenance plan, where appropriate and maintenance carried out to date and planned in future

• Any damage, malfunction, modification or repair to the equipment

• Predicted replacement date where applicable

• There records are maintained for the life span of the equipment and in accordance with the data storage and archival procedure as applicable.

The laboratory has a documented procedure for reception, storage, acceptance testing and inventory management of reagents and consumables.

Each new lot of kit and reagent (product from differ-ent vendor) is verified for performance before use in examinations. Any change in reagent using a different procedure is validated before putting it into use.

The laboratory has an inventory control system for supplies. The supplies requirement is monitored based on the consumption and the lead period for the material. Whenever the stock falls below the mini-mum level, the material is ordered. The lot number is monitored through the invoice and wherever possi-ble, in the equipment itself. On receipt, the material is checked for expiry date as well as for any physical damage. Date of opening the kit is written on the kit itself.

The system for inventory control segregates unin-spected and unacceptable reagents and consumables from those accepted for use.

Instructions for use of reagents and consumables are readily available in each section of the lab.

The laboratory ensures that reagents and consum-ables are stored according to the manufacturer’s instructions and specifications.

8.3.1.7 Equipment Records

8.3.2.1 General

8.3.3.3 Reagents and Consumables-Acceptance Testing

8.3.2.4 Reagents and Consumables-Inventory Management

8.3.2.5 Reagents and Consumables-Instructions for Use

8.3.2.2 Reagents and Consumables-Reception and Storage

8.3.2 Reagents and Consumables



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Any adverse incidents / accidents which are attribut-ed directly to specific reagents and consumables are investigated and reported to the manufacturer and quality manager. The appropriate corrective and pre-ventive actions are taken.

Records for each reagent would have the following information:

• Identity of reagent

• Manufacturer’s name and lot number

• Contact information of manufacturer

• Date of receiving, expiry date, date of entering into service

• Date of opening the reagents

• Manufacturer’s instructions

• For in-house reagents : Persons undertaking their preparation and date of preparation

Specific instructions for the proper collection and han-dling of primary samples is documented in the sample collection manual and implemented by laboratory management and staff involve in sample collection in laboratory. The manual is available to the staff in-volved in the sample collection area (sample collection department and elsewhere the patient samples are collected). The sampling procedure describes the rele-vant aspects of patient preparation, specimen with-drawal, processing, packaging and transport require-ments in comprehensive detail. Wherever required, the informed consent of the patient is taken before the sample is drawn.

8.3.2.6 Reagents and Consumables-Adverse Incident Reporting

8.3.2.7 Reagents and Consumables-Records

8.4.4.1 General

8.4 PRE-EXAMINATION PROCESSES

All tests are requisitioned through the DIS. The ordered tests are recorded, a bar coded label generated which contains sufficient information to identify the patient, section where the test is to be performed and test to be done.

Data related to the same is available in the DIS and contains the following:

• • Name of the patient, age, gender, unique hospital identification and contact details (telephone number or email etc.) of the patient – UHID No. (The unique identifier of the patient) – generated at the main reception.

• Lab Accession number/Sample number – generated at the time of sample collection

• Name and other details of the ordering physician

• Type of primary sample(s) and anatomic site of origin

• Tests ordered

• Clinical information in respect of the patient.

• Date and time of sample collection

• Date and time of receipt in the laboratory

8.4.1 General

8.4.3 Request Form Information

8.4.4 Primary Sample Collection and Handling

8.4.2 Information for Patients and Users

The laboratory has documented procedures and in-formation for pre-examination activities to ensure the validity of the results of examinations.

The Primary sample collection manual contains all in-formation mandated by this clause of ISO 15189:2012 (a-n).




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Pre-sample collection instructions to the patients are given as appropriate (collection of urine, sputum, blood for blood sugar etc.). All the details are docu-mented in the Primary Sample Collection Manual mandated by the clause of ISO 15189:2012.

An OPD patient comes to the lab phlebotomy area and is assigned unique identification no. i.e. the UHID no. on his requisition slip, generated at the billing desk as per the laboratory policy. The patient is at the phle-botomy desk and is given a lab sample no. The UHID no. is the unique identifier and serves to follow the sample throughout or for retrieving actual data at a later date through the system.

Specimen requirements for each assay with respect to the amount of sample, preservative required for the sample as well as the temperature interval are specified in detail in the test list available at the collec-tion room in the laboratory. The quality of laboratory results depends greatly on the proper collection and handling of the specimen’s clinical specimens coming to the laboratory could include whole blood plasma serum, cerebrospinal fluid, pleural fluid, ascitic fluid, urine, pus, sputum etc.

All specimens are collected in appropriate containers (e.g. vacutainers: evacuated collection tubes contain-ing EDTA / heparin / fluoride or plain tubes etc).The laboratory has a written policy concerning add on / verbal requests for sample examinations.

The phlebotomist collecting the primary sample re-cords the date and collection time of the sample. The lab ensures that samples are stored under appropriate conditions before they are dispatched to the lab.

The specimens are collected by the phlebotomist on duty and transported manually through the general duty attendant (GDA) to the laboratory. On receipt in the laboratory, the specimen is registered and preced-ed to the bench for the requisite tests after generating the worksheet containing the information for the test to be performed.

Samples to be set aside for future examination (e.g., viral antibodies, metabolites relevant to the clinical syndrome) are also properly labelled and stored.The SOP for transportation of samples covers how the laboratory monitors the transportation of samples to the designated sections such that:

• They are transported within a period appropriate to the nature of the requested examinations and section concerned,

• within a temperature interval specified in the prima-ry sample collection manual and with the designated preservatives to ensure the integrity of samples,

• and in a manner, that ensures safety for the carri-er, the general public and the receiving section, in compliance with national, regional or local regulatory requirements.

All primary samples received are logged onto the lab management system in the computer. The date and time of receipt of samples, as well as the identity of the technician receiving the samples are recorded.Criteria have been developed and documented for acceptance or rejection of primary samples. If com-promised primary samples are accepted, the final report indicates the nature of the problem and if applicable, that caution is required when interpreting the result, e.g. haemolysed specimen is identified as problem specimen and is taken up for necessary follow up action.

The Laboratory Directory of Services contains the quantity of sample required for testing. It also men-tions the minimum quantity of sample required.Senior Laboratory Technologists systematically review

8.4.4.2 Instructions for Pre-Collection Activities

8.4.4.3 Instruction for Collection Activities

8.4.5 Sample Transportation

8.4.6 Sample Reception



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requests and samples and ensure that tests are per-formed in compliance with the validated methods in the laboratory.

The laboratory has a documented procedure for the receipt, labeling, processing and reporting of the pri-mary samples received by the laboratory and specifi-cally marked as urgent. The procedure includes details of any special labeling on the request form and prima-ry sample, the mechanism of transfer of the primary sample to the examination area of the laboratory, any rapid processing mode to be used and any special reporting criteria to be followed.

All sample aliquots / secondary samples are traceable to the original primary sample.

5.4.7 Pre-Examination Handling, Preparation and Storage

8.5.1 Selection, Verification and Validation of

Examination Procedures

Samples are stored for a specified time as described in the procedure under conditions that ensure stability of sample properties to enable any retesting or add on of tests if required. The lab has defined retention time for different samples as per NABL 112 and add on test can be ordered as long as the primary sample is available in the lab.

8.5 EXAMINATION PROCESSES

The laboratory employs examination procedures which are compliant with the NABL standards, published, approved and the Kit inserts where relevant. Details regarding each and every procedure are described in the SOP’s.

The laboratory use only validated procedures for test-ing. Any new test / instrument is put through an ex-tensive validation. The new test validation procedure outlines the protocol required to be followed. The re-sults of the validation are recorded and the test is put on board after the validation is deemed acceptable. Every new lot of reagents and kits are verified using standard reference material before putting in use. The verification must confirm that the performance claims for the procedure have been met. The procedures used for verification are all documented.

Validation is performed for all non-standard methods, laboratory developed methods, standard methods used outside their scope and validated methods sub-sequently modified. All modified methods are reviewed by the concerned authority and such changes are documented.

The laboratory has determined uncertainty of mea-surement (MU) for each measurement procedure in the examination phase used to report measured quantity values.

The performance requirements for the MU of each procedure is defined and the estimates regularly reviewed. MU estimates are available to the laboratory users.

Biological reference intervals are always reported, most of them being age and gender specific. They are periodically reviewed for acceptability. A review of biological reference intervals also happens whenever the laboratory changes an examination procedure or pre-examination procedure, if appropriate.

8.5.1.1 General

8.5.1.2 Verification of Examination Procedures

8.5.1.3 Validation of Examination Procedures

8.5.1.4 Measurement Uncertainty of Measured Quantity Values

8.5.2 Biological Reference Intervals or Clinical Decision Values




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All procedures are well documented and available at the workstation for relevant staff. Equipment kit in-serts and quick references based in whole or in part on the instructions for use written by the manufactures are available at the workbench.

The lab in-charge is responsible for ensuring that the contents of examination procedures are complete, current and have been thoroughly reviewed.Procedures used are derived from the package insert

8.5.3 Documentation of Examination

Procedures

as applicable. Any update in manufacturer instructions of a significant nature is incorporated in the proce-dure and is version controlled. In the absence of any changes, all procedures are reviewed at least annually. Any updates are made after relevant authorization. All procedures are coded in accordance with the doc-ument control system. All new lots of reagents are verified for acceptability with appropriate controls or patient material.

• Purpose of the examination

• Principle and method of the procedure used for examinations

• Performance characteristics (see 5.5.1.2 and 5.5.1.3)

• Type of sample (e.g. plasma, serum, urine)

• Patient preparation

• Type of container and additives

• Required equipment and reagents

• Environment and safety controls

• Calibration procedures (metrological traceabil-

ity)

• Procedural steps

• Quality control procedures

• Interferences (e.g. lipaemia, haemolysis, biliru-binemia, drugs) and cross reactions

• Principle of procedure for calculating results

including, where relevant the measurement uncertainty of measured quantity values

• Biological reference intervals or clinical decision values

• Reportable interval of examination results (TAT)

• Instructions for determining quantitative re-sults when a result is not within the measure-ment interval

• Alert / critical values, where appropriate

• Laboratory clinical interpretation

• Potential sources of variation

• Safety precautions

• Management of waste generated

• Review of SOP once in a year / as an when required

• References

DOCUMENTATION SHALL INCLUDE THE FOLLOWING AS AND WHEN APPROPRIATE:



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8.6 ENSURING QUALITY OF EXAMINATION RESULTS

All the tests are performed under defined conditions using standard published procedures (as per SOPs).

The laboratory follows stringent internal control proce-dures for monitoring the validity of tests reported. The resulting data is recorded in such a way that trends are detectable and where practicable, statistical techniques are applied to reviewing of the results. All attempts are made to prevent any kind of mistakes in the process of handling samples, requests, examina-tion and reports.

• Regular use of certified reference materials for IQC.

• Biochemistry department ensures quality by running two level controls: one in the morning. In addition, replicate testing is done i.e. one morning sample is re-run again in the evening and the values com-pared.

• Preparation of monthly Levy Jenning’s chart.

8.6.1 General

8.6.2 Quality Control

• Inter laboratory comparisons with NABL accredi-tated labs at defined frequencies. The results are compared and in case of discordance RCA done and CAPA is taken.

• Participation in proficiency-testing programs: The laboratory is extensively enrolled in several profi-ciency-testing programs The results are analyzed and action as appropriate is taken.

• Re-testing of retained specimens: This is done to -a. To assessed reproducibility of resultsb. Competency c. Storage adequacy / Integrity of stored sample

• Split samples testing are done simultaneously as a measure of verification of result and competency evaluation.

• Testing is done for inter equipment validation.

• The laboratory has an extensive in-house internal quality control program, which verifies the attain-ment of the intended quality of results.

• Several mechanisms of control exist and pertain to the pre-examination, examination and post-exam-ination phase of testing.

Standard reference materials with traceability are used for internal quality control.These are periodically examined with a frequency based on stability of the materials.

The laboratory follows stringent internal quality control procedures as explained under section 8.6.2.

8.6.2.1 General

8.6.2.2 Quality Control Materials

8.6.2.3 Quality Control Data




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8.6.3 Inter-Laboratory Comparisons 8.6.4 Comparability of Examination Results

8.7.1 Review of Results

8.7.2 Storage, Retention and Disposal of Clinical Samples

Lab has defined procedure for carrying out the inter laboratory comparisons with other NABL accreditat-ed labs. Lab also participate in the external quality assessment / proficiency testing program conducted by various approved centers. The results are analyzed and CAPA is taken.

External quality assessment programs involve clinically relevant challenges that mimic patient based sample analysis and have the effect of checking the pre-ex-amination, examination and post-examination phases of testing.

Where formal inter-laboratory comparisons are not available, the laboratory employs split sample testing / testing of stored samples for verification of the per-formance of those procedures. Results of the analysis are monitored by the laboratory management and corrective actions taken and recorded.

Inter-laboratory comparison samples are integrated into the routine work-flow in a similar manner as that of handling patient samples. The laboratory does not communicate with other participants until after sub-mission dates.

Performance in inter-laboratory comparison are reviewed and discussed with the relevant staff. Any necessary corrective and preventive action required are undertaken with adequate documentation.

8.6.3.1 Participation

8.6.3.2 Alternative Approaches

8.6.3.3 Analysis of Inter-Laboratory Comparison Samples

8.6.3.4 Evaluation of Laboratory Performance

For tests performed on different instruments or by different techniques, a comparison is performed as define by lab.

All authorized signatories are allowed to review, modify (as required) and release the result (results of examination evaluate them in conformity with clinical information available and authorize the release of results).

Storage of the primary sample and other laboratory aliquots is done in accordance with the laboratory procedure.

Period of retention of samples for re-testing and additional request is as defined by the respective section of the lab.

The samples are disposed as per the waste disposal policy of the laboratory in accordance with the statuary requirements.

8.7 POST-EXAMINATION PROCESSES



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8.8.1 General

8.8.2 Report Attributes

8.8.3 Report Content

The report is formatted so as to contain all the relevant information requested by the doctors and necessary for the interpretation of the test results.

Test reports are released through the LIS. These can be viewed by the clinical consultants on the DIS. Hard copies to both the OPD as well as IPD patients (placed in patient files) are provided on the lab letter-head. For the OPD patients, reports once verified are available in the sample collection area.

The result of each test, or series of tests carried out by the laboratory are reported accurately, clearly and in accordance with specific instructions in the test order.

It is the laboratory management’s responsibility to ensure that the appropriate individuals receive reports within an agreed-upon time interval.

In case a sample is compromised, the lab requests for a fresh sample. However, in certain critical conditions and at the request of the customer, the laboratory processes the sample and reports the result if feasible with a disclaimer indicating if the quality of the prima-ry sample received was unsuitable as per the sample acceptance and rejection criteria for examination or could have compromised the result.

The formatted report includes:

• Patient identification (Name and UHID)

• Name of the ordering physician

• Test requested

• Type of primary sample

• Method / procedure undertaken

8.8 REPORTING OF RESULTS • Examination result

• Reference range

• Date and time of receipt of samples and release of reports

• Biological reference interval as applicable

• Interpretation of results wherever required

• Identification of the persons who review and release the report.

• Page number (e.g 1 of 4)

• Any other comment which will help the physician in patient care

8.9.1 General

The laboratory has clearly documented procedures for the release of examination results, including details of who may release results. Briefly the reports includes:

• The integrity / quality of sample receive

• Critical alert value

• Results are legible

• Reports are released to persons who are authorized to receive and use the information

In case the result is communicated verbally (critical alert / urgent) is always followed by a written report. The reports are communicated to the consulting / referring doctors on phone if required but never to the patients. As per policy, no test related to HIV testing is reported by phone, FAX or E-mail to protect patient confidentiality.

Results are legible, without any transcription errors and reported to persons authorized to receive and use medical information.

In case of patient queries / complaints about a partic-ular result, a repeat sample is requested and the test repeated.

The laboratory has a procedure for reporting critical

8.9 RELEASE OF RESULTS




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8.10.1 General

8.10.3 Information System Management

5.10.2 Authorities and Responsibilities

8.9.2 Automated Selection and Reporting of Results

8.9.3 Revised Report

The lab has excess to data and information needed to provide a service which meets the needs and require-ments of the user.The laboratory ensures that the confidentiality of pa-tient information is maintained at all times as per the laboratory policy.

The system used for collection processing, recording, reporting, storage or retrieval of examination data and information is validated and verified for functioning by the lab.

Interfacing of all the equipment in the lab (wherever applicable) has been done by the IT department. The data is protected from unauthorized access and is safe guarded against tampering or loss. Integrity of data and information is ensured as per lab policy and is in compliance with national or international require-ments regarding data protection.

The laboratory has defined the authorities and respon-sibilities of all personnel who would use the system to:

• Access patient data and information

• Enter patient data and examination results

• Change patient data or examination results

• Authorize the release of examination results and reports

The lab has no automated selection and reporting of results.

In case of revision of a report:

• The revised report is clearly identified as revision and includes reference to date and patient’s identity in

original report.

• Revised report shows the time and date of change and name of the person responsible for the change.

• The changes in the report are communicated to the user.

• Original report entries remain in the record / DIS.

8.10 LABORATORY INFORMATION MANAGEMENT

result values. The laboratory immediately notifies a physician (or other clinical personnel responsible for patient care) when examination results for critical properties fall within established “alert” or “critical” intervals. This includes results received on samples sent to referral laboratories for examination. Critical limits for tests are described in the relevant SOP where applicable.

A report of critical call-outs is maintained which in-cludes date and time of call-out, name of the labora-tory staff member making the call out, the name of the person notified and examination result.



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Serial

no

Page no

Section/clause/para/line

Date of

amendment

Amendment made

Reasons for

amendment

Authorised signatory

9. Amendment Sheet

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