dh ratnagiri quality manual

7/30/2019 DH Ratnagiri Quality Manual

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QUALITY MANUAL SDH/RAT/AQM/01

Issue Date: Version: 1.0 of 71

RATNAGIRI DISTRICT HOSPITAL

ISO 9001:2008

Based

Quality Management System

Quality Manual

PREPARED BY:RMO APPROVED BY: CS ISSUED BY: DCI

Dr.BHALCHANDRANILEGOUNKAR

Dr. BHALCHANDRANILEGOUNKAR

MR. ANANDA AABASOCHOUGULE



QUALITY MANUALDocument:DH/RAT/AQM/01


THIS DOCUMENT

Is the sole property of RATNAGIRI DISTRICT HOSPITAL.

Shall not be reproduced / photocopied either partly or wholly without approval of the

Management Representative (RMO)of RATNAGIRI DISTRICT HOSPITAL.

Is distributed to RATNAGIRI DISTRICT HOSPITALauthorized persons on the understanding

that it shall be kept up to date and maintained in good order.

Shall not be subjected to manual correction or amendments.

Requests for REVISION(S) to the DOCUMENT, if any:

Shall be submitted to the RMO for review.

Shall be made, only by the RMO.

Shall be incorporated in all the controlled copies only after its approval and entered in

Distribution list of control copy holders in Appendix 6.





RevisionRecords

Sl.No.

IssueDate

NewVersionNumber

ChangeDescription

Page Noaffected

Reference of Document

ChangeRequest Form

Approved by

1 1.0 All





TABLE OF CONTENT

1. SCOPE ..................................................................................................... 6

1.1. INTRODUCTION....................................................................................... 6

1.2. HOSPITAL PROFILE ................................................................................. 7

1.3. EXCLUSIONS ........................................................................................... 8

2. NORMATIVE REFERENCES ....................................................................... 9

3. TERMS & DEFINITION ........................................................................... 10

3.1. Abbreviation and Acronyms ............................................................... 10

4. QUALITY MANAGEMENT SYSTEM ........................................................... 11

4.1. General Requirements ....................................................................... 114.2. Documentation Requirements ............................................................ 144.2.1. General........................................................................................... 14

4.2.2. Quality Manual ................................................................................. 154.2.3. Control of Documents ....................................................................... 154.2.4. Control of Records ............................................................................ 18

5. MANAGEMENT RESPONSIBILITY ........................................................... 19

5.1. Management Commitment ................................................................. 19

5.2. Patient Focus ................................................................................... 19

5.3. Quality Policy ................................................................................... 215.4. Planning .......................................................................................... 225.4.1. Quality Objectives ............................................................................ 22

5.4.2. Quality Management System Planning ................................................ 235.5. Responsibility, Authority and Communication ....................................... 235.5.1. Responsibility and Authority .............................................................. 235.5.2. Management Representative ............................................................. 275.5.3. Internal Communication .................................................................... 285.6. MANAGEMENT REVIEW ..................................................................... 295.6.1. General........................................................................................... 295.6.2. Review Input ................................................................................... 295.6.3. Review Output ................................................................................. 31

6. RESOURCE MANAGEMENT ...................................................................... 31

6.1. Provision of Resources ...................................................................... 316.2. HUMAN RESOURCES ......................................................................... 326.2.1. GENERAL ........................................................................................ 326.2.2. Competence, Awareness and Training ................................................. 326.3. Infrastructure .................................................................................. 336.4. Work Environment ............................................................................ 33

7. SERVICE REALIZATION ......................................................................... 34

7.1. Planning of Service Realization ........................................................... 347.2. Patient-Related Processes .................................................................. 357.2.1. Determination of Requirements Related to the Service .......................... 35

7.2.2. Review of Requirements Related To the Service ................................... 357.2.3. Patient Communication ..................................................................... 36





7.3. Design and Development ................................................................... 377.4. Purchasing ....................................................................................... 38

7.4.1. Purchasing Process ........................................................................... 387.4.2. Purchasing Information ..................................................................... 397.4.3. Verification of Purchased Process ....................................................... 397.5. Service Provision .............................................................................. 407.5.1. Control of Service Provision ............................................................... 40

7.5.2. Validation of Processes for Service Provision ........................................ 417.5.3. Identification and Traceability ............................................................ 417.5.4. Patient Property ............................................................................... 42

7.5.5. Preservation of product ..................................................................... 427.6. Controlling Of Monitoring & Measuring Devices ..................................... 43

8. MEASUREMENT, ANALYSIS AND IMPROVEMENT .................................... 44

8.1. General ........................................................................................... 448.2. Monitoring and Measurement ............................................................. 458.2.1. Patient Satisfaction .......................................................................... 458.2.2. Internal Audit .................................................................................. 458.2.3. Monitoring and Measurement of Processes .......................................... 468.2.4. Monitoring and Measurement of Product ............................................. 478.3. Control of Nonconforming Service ....................................................... 478.4. Analysis of Data ............................................................................... 478.5. Improvement ................................................................................... 488.5.1. Continual Improvement .................................................................... 48

8.5.2. Corrective Action ............................................................................. 488.5.3. Preventive Action ............................................................................. 49

8.6. GUIDELINES / STANDARDS / OTHER DOCUMENTS ................................ 50

9. APPENDIX 1- ORGANISATION CHART ................................................... 51

10. APPENDIX 2- ROLES & RESPONSIBILITIES ........................................... 52

11. APPENDIX 3 : LIST OF STATUTORY REQUIREMENTS ............................. 61

12. APPENDIX 4 MASTER LIST OF CONTROL DOCUMENTS ........................... 62

13. APPENDIX 5 LIST OF RECORDS ............................................................. 63

14. APPENDIX 6 DISTRIBUTION LIST OF CONTROL COPY HOLDERS ........... 69

15. APPENDIX 7 LIST OF DOCUMENTS OF EXTERNAL ORIGIN ..................... 71





1. SCOPE

The Scope of the Quality Management System being practiced at RATNAGIRI DISTRICT

HOSPITAL covers the following:

“PROVISION OF HEALTH CARE SERVICES, IN A SECONDARY CARE SET UP “

1. OPD services

2. OPD Pharmacy

3. IPD services

4. Diagnostic Services

5. 24X7 Emergency Services

6. Surgical Services

7. 24X7 Delivery Services

8. Blood Bank Services

9. Hospital Support Services

10. Administrative Services

11. National Health Program

The scope of our Quality Management System encompasses all the identified processes performed

at the location of:

RATNAGIRI DISTRICT HOSPITAL

Address:

Ratnagiri Civil Hospital,

Near Jay Stambha, Ratnagiri, Maharashtra.

1.1. INTRODUCTION

The Quality Manual reflects the Quality Management System being practiced at, RATNAGIRI

DISTRICT HOSPITAL. This document is targeted for internal users who need to practice it and for

External users who want to know about the Quality Management System being practiced at

RATNAGIRI DISTRICT HOSPITAL.

This Quality Manual reflects the intentions and commitment of RATNAGIRI DISTRICT HOSPITALin

establishing and implementing Quality Management System as per the requirements of ISO

9001:2008 Standards.





The Quality Management System is also intended to ensure meeting the requirements of Internal

and External parties, including Certification Bodies, to assess the ability to meet Patient, Regulatory

and our own requirements.

This manual is an Auditable and Demonstrable document of RATNAGIRI DISTRICT HOSPITAL.

1.2. HOSPITAL PROFILE

RATNAGIRI DISTRICT HOSPITALcaters to the people living in Urban and Rural

areas in the district. This hospital is situated at Ratnagiri District Head Quater in the

Ratnagiri District of state of Maharashtra. This hospital is a Referral hospital for the

Community Health Centres, Primary Health Centres& Sub centres. It covers a

population of 1,612,672. It is a 200 bedded hospital.

The Departments and Services available on the facility are:

Specialist services available

1. General Medicine

2. General Surgery

3. Obstetric&Gynaecology: Family Planning, Antenatal checkup, Intranatal care 24 hour

Delivery services and Post Natal Care

4. Paediatrics including New Born Care

5. Emergency (Accident & other emergency/ Casualty)

6. Anaesthesia

7. Ophthalmology

8. ENT

9. Dermatology and Venerology (Skin & VD) RTI / STI

10. Orthopaedics11. Radiology

12. Dental Care

13. Public Health Management

Para Clinical Services

1. Laboratory services

2. Blood Bank

3. Drugs and Pharmacy

4. X-Ray





5. USG

Support Services

1. Medico-Legal/ Post -Mortem

2. Ambulance Services

3. Dietary Services

4. Laundry Services

5. Security Services

6. Nursing Services

7. Housekeeping Services

National Health program

1. Universal Immunization Program

2. Reproductive and Child Health

3. Revised National Tuberculosis Control Program

4. National AIDS Control Program

5. National Leprosy Eradication Program

6. National Program for Control of Blindness

7. Integrated Disease Surveillance Project (IDSP)8. National Vector Borne Disease Control Programme (NVBDCP)

9. National Iodine Defiency Control Programme

1.3. EXCLUSIONS

Exclusions: Nil





2. NORMATIVE REFERENCES

ISO - 9001:2008 Standard - Quality Management Systems - Requirements.

ISO - 9000:2005 Standard - Quality Management Systems -Fundamentals and Vocabulary

ISO - 9004:2009 Standard - Quality Management Systems - Guidelines for

Improvements





3. TERMS & DEFINITION

All terms and definitions provided in ISO 9001:2008 and ISO 9000:2005 hold good for the hospital

QMS at RATNAGIRI DISTRICT HOSPITAL.

3.1. Abbreviation and Acronyms

S. No. Acronyms Description

1 AQM Apex Quality Manual

2 ALOS Average Length of Stay

3 AERB Atomic Energy Regulatory Board

4 BARC Bhabha Atomic Research Centre

5 BMW Biomedical Waste Management

6 CMOH Chief Medical Officer of Health7 CSSD Central Sterile Supply Department

8 DCI Document Control In-charge

9 DRMO Deputy Management Representative

10 ENT Ear, Nose & Throat

11 GRN Goods Receipt Note

12 HAM Hospital Administrative Manual

13 HCM Hospital Clinical Manual

14 HMP Hospital Mandatory Procedures

15 HOD Head of Department

16 HRM Human Resource Manager

17 IA Internal Audit

18 IPD In Patient Department

19 IPHS Indian Public Health Standards

20 IQAI Internal Quality Audit In-charge

21 ISO International Organization for Standardization

22 CS Civil Surgeon

23 MIS Management Information System

24 MOU Memorandum of Understanding

25 RMO Management Representative

26 RMOD Medical Records Department

27 RMOM Management Review Meeting

28 MTP Medical Termination of Pregnancy

29 NACO National AIDS Control Organisation.

30 NC Non Conformity

31 NRHM National Rural Health Mission

32 OPD Out Patient Department

33 PNDT Pre-natal Diagnostic Techniques

34 QMS Quality Management System

35 OT Operation Theatre

36 RKS RogiKalyanSamiti

37 SOP Standard Operating Procedure

38 TI Training In-charge39 VD Venereal Disease





4. QUALITY MANAGEMENT SYSTEM

4.1. General Requirements

RATNAGIRI DISTRICT HOSPITAL has Established, Documented, Implemented and Maintained a

Quality Management System and continually improves its effectiveness in accordance with the ISO

9001:2008.

In accordance to the above, RATNAGIRI DISTRICT HOSPITAL has -

a. Identified the Processes needed for the Quality Management System and their application

throughout the organization (The identified processes include management activities,

provision of resources, service realization and measurement)

b. Determined the sequence and interaction of these processes,

c. Determined Criteria and Methods needed to ensure that both the operation and control of

these processes are effective, (Reference: HMP 1- HMP 1.6)

d. Ensured the availability of resources and information necessary to support the operation

and monitoring of these processes,( Reference: HAM:03, HAM:07,HAM:09)

e. Been monitoring, measuring and analyzing these processes, (Reference HMP:1.6 to

HMP:1.8 )

f. Implementing actions necessary to achieve planned results and continual improvement of

these processes. (Reference HMP:1.7 and HMP:1.8)

The various processes identified and established at RATNAGIRI DISTRICT HOSPITAL are as

detailed below. These processes have been defined upon identifying the criteria and methods to

ensure that both the operation and controls are effective.

Mandatory Procedures

1. HMP:1.5.2 Control of Documents – This procedure addresses Clause 4.2.3 of ISO 9001:2008

2. HMP:1.5 .5 Control of Records – This procedure addresses Clause 4.2.4 of ISO 9001:2008

3. HMP: 1.6 Internal Audit – This procedure addresses Clause 8.2.2 of ISO 9001:2008

4. HMP:1.7 Control of Non Conformity – This procedure addresses Clause 8.3.1 of ISO

9001:2008

5. HMP: 1.8. Corrective Action – This procedure addresses Clause 8.5.2 of ISO 9001:2008

6. HMP:1.8 Preventive Action – This procedure addresses Clause 8.5.3 of ISO 9001:2008

Clinical Procedures





1. HCM-01: Outdoor Patient Management

2. HCM-02: In-patient (IPD) Management ( General/ Critical/ Intensive Care)

3. HCM-03: Hospital Emergency and Disaster Management

4. HCM-04: Maternity and Child Health Management

5. HCM-05: Operation Theatre and CSSD Management

6. HCM-06: Hospital Diagnostic Management

7. HCM-07: Blood Bank/ Storage Management

8. HCM-08: Hospital Infection Control Management

9. HCM-09: Data And Information Management

10. HCM-10: Hospital Referral Management

11. HCM-11: Pharmacy Management

12. HCM-12: Management of Death

Hospital Administration Procedure

1. HAM-01: Patient Registration, Admission & Discharge Management

2. HAM-02:Hospital stores and Inventory Management

3. HAM-03:Procurement and Outsourcing Management

4. HAM-04:Hospital Transportation Management

5. HAM-05: Hospital Security and Safety Management

6. HAM-06: Hospital Finance and Accounting Management

7. HAM-07:Hospital Infrastructure/ Equipment Maintenance Management

8. HAM-08:Hospital Housekeeping and General upkeep Management

9. HAM-09:Human Resource Development and training Management

10. HAM-10:Dietary Management

11. HAM-11:Laundry Management

12. HAM-12:Hospital Waste Management

The Top Management has ensured that the necessary Resources and Information are available

to support the Operation and Monitoring of the QMS processes.

This Quality Manual and the process documents are defined and managed in accordance with the

requirements of ISO 9001: 2008 standards.





The interaction of various processes defined and established at RATNAGIRI DISTRICT

HOSPITAL is as follows

Front Office

Figure 1

Human Resource

Equipment Maintenance

Purchase

Stores

C u s

t o m e r

Custom

erService Realization

Calibration

Pharmacy

Measurement, Analysis andImprovement

Internal QualityAudit

Control of Non-Confirming Product

Corrective and

Preventive Action

Resource Management

Maintenance

Human Resource

Housekeeping

DocumentControl

Control of Records

Management Responsibilities

Management Review

LabNursing

Stores

Laboratory

OPD IPD Emergency

O.T

Purchase

Labourroom

Medical Records





4.2. Documentation Requirements

4.2.1. General

RATNAGIRI DISTRICT HOSPITAL has established well-defined documented system to ensure that

services rendered are conforming to Patient requirements which includes

a) Defined Quality Policy

b) Quality Objectives (specified in process documents)

c) Quality Manual (i.e., This Manual)

d) Documented Procedure and Records required by ISO 9001:2008 (i.e. process documents

and records).e) Documents needed by RATNAGIRI DISTRICT HOSPITAL.

The Quality Management System at RATNAGIRI DISTRICT HOSPITAL is documented,

implemented and evaluated for its effectiveness at once in a year. (Refer RMOM and Internal Audit

process document)

Four-tier QMS documentation has been established. The documented structure is well interlinked

between levels of documents. The hierarchical structure is as described below:

Figure 2

Fig.2

SOPs

Work Instructions

Formats & Records

QualityManual





4.2.2. Quality Manual

Quality Manual is a top-level document used to demonstrate or describe the documented Quality

Management System practiced at RATNAGIRI DISTRICT HOSPITAL.

Quality Manual is consistent with the Standard ISO 9001: 2008 Quality Management System –

Requirements (i.e., the sections of this manual are in line with the clause No. used in the ISO

standard 9001:2008 e.g. QMS 4.0 of the standard is dealt by section 4.0 of this manual).

Quality Manual has

Defined the scope of QMS in section 4.0

Furnished reference to the processes and interaction in section 4.2.1 along with outlines to the

structure of QMS documentation.

Processes identified in section 4.2.1 includes the Mandatory Procedure Requirements

4.2.3. Control of Documents

Documents required by the QMS are controlled. Records are a special type of Documents and is

controlled as mentioned under the clause 4.2.4

We have established a documented procedure to define the controls needed

a. To approve documents for adequacy prior to issue The procedure for approval

and issue of Quality Management System documents is as follows (

HMP:01/1.5)

Documents/Quality Record

Formats

Approved By Issued By

Quality Manual CS DCI

Process Documents CS DCI

Sample Quality Formats and Work

Instructions

CS DCI

b. To review and update as necessary and re-approve documents. MR

receives the Document Change Request Form. The Document

Change Request Form is scrutinized along with the concerned





Process Owner where applicable. The Change Request is reviewed

and approved. Based on the approved Document Change RequestForm, the appropriate Document/ Format is updated and controlled

as per document control process.(HMP 01/1.5)

c. To ensure that changes and the current revision status of documents are

identified. The revision status of the documents are identified by

Version Number and date of issue. The version numbering is as per

the following format Ver X.Y, X – Issue No. Starting from “0” for

initial draft, changed to “1” after first release. X shall be updated

during document issue/ major changes – Revision No. Starting from

“1”, Y shall be updated after each revision. Major – Any changes in the

document that has a cascading effect in the QMS or involves major

process modification would be referred to as a „Major‟ change. Minor –

Any changes in the document that relates to cosmetic changes

would be referred to as „Minor‟ change. (HMP 01/1.5)

d. To ensure that relevant versions of applicable documents are available at

points of use. Hard Copy of the documents is marked as obsolete by

stamping “OBSOLETE” seal on the documents. Old version of the

document is retrieved from the users and stored in a secured place.

Communication is sent to the concerned users regarding the

update. (HMP: 01/1.5).

e. To ensure that documents remain legible and easily identifiable. All records

are identified by its name. All Master Formats are reviewed and

approved in co-ordination with the Process Owners. The master

samples of formats are maintained. Master List of Records is

maintained, which includes the Name, Revision status and Minimum

Retention Time of records. The user ensures that the records in use

are easily retrievable (HMP:01/1.5)..





f. To ensure that documents of external origin are identified and their

distribution controlled. All external documents include National orInternational Standards and External Manuals etc. are recorded in

the List of External Documents. Latest releases of the documents

are obtained by periodic verification at the source, originating the

document. The copies of external documents are issued as required

and the details of issue is recorded and maintained through

distribution List of External Documents. External documents are

maintained and soft copies are stored in the server for shared, read

only access. ( HMP:01/1.5)

g. To prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose Old version of the

document is retrieved from the users and stored in a secured place. The

documents need to be stamped with date, department on the front (

HMP:01/1.5).

Issue of Documents

In case of Hard copy, ‘Controlled Copy’ stamp is affixed on front page of the document

before issuing to the concerned personnel

Identifying Obsolete documents

In case of Hard copy, ‘Obsolete’ identification is stamped on each page of the document.

Obsolete documents are retained for a period of six months. Obsolete versions like Clinical literature is maintained by HOD’s





Document Change

Changes to documents are initiated through document change requests.

RMO is authorized to review and modify documents and CS approves the changes.

The respective process owners are responsible to ensure that their process documents are

updated with the required amendments from time to time.

New issue is releasedafter 5 revisions or earlier as decided by the RMO.

Others

Control on external documents is limited to identification and issue. The extent of control on Patient-supplied document and data is as contractually agreed.

Service rendering team handles the service-related documents,

The preparation and approval of service related documents are mentioned in respective

processes

REFERENCE:

Hospital Quality Manual – Mandatory Procedure SOP.01-1.5

RESPONSIBILITY:

RMO

DCI

4.2.4. Control of Records

RATNAGIRI DISTRICT HOSPITAL has established documented processes for identifying,

collecting, indexing, accessing, filing, storing, maintaining and disposing quality records

Control

Each quality record is identified by the name. The footer has template issue date.

RMO maintains the list of formats indicating location and current revision status.

RMO also maintains the master list of quality records, which identifies the current revision

status and retention period.





1. All quality records are readily retrievable.

2. The minimum retention period is as specified for the documents.

3. Authority to release a quality documents is reflected in the Quality Records.

REFERENCE:

HCM 09 : Data and Information Management

RESPONSIBILITY:

RMO

DCI

5. MANAGEMENT RESPONSIBILITY

5.1. Management Commitment

The Top Management in RATNAGIRI DISTRICT HOSPITAL is committed to the Development and

Implementation of the QMS and continually improving its effectiveness through

a. Establishing Quality Policy (i.e., as specified in clause 5.3)

b. Ensuring, Quality Objectives (covered in process documents) are defined and communicated

to all besides detailing in the Quality Manual. (RAT/AQM/01/5.4.1)

c. Conducting Management Review Meetings at specified intervals as specified in the clause

No. 5.6.

d. Ensuring the availability of resources ( HAM:02, HAM:07, HAM:09). (HAM 02-The availability

of resource in stores can be ensured by maintaining the Minimum stock ,Maximum stock, Re

order level and Lead time , HAM 09- The availability of human resource is ensured by

communication of vacancies to the state authorities leading to recruitment of the staff.

e. Communicating to the Organization the importance of meeting :

i. Requirements of patients ( HCM:01, HCM:02,HCM:03,HCM:04)ii. Statutory and Regulatory Requirements

RESPONSIBILITY:RMO

5.2. Patient Focus





Top management of RATNAGIRI DISTRICT HOSPITAL has established processes for measuring the

Patient Satisfaction and taking actions to enhance the Patient Satisfaction, in addition to ascertaining

the Patient Requirements and meeting them (HCM:01, The OPD patient feedback should be taken

quarterly and the analysis should be done for the same .HCM:02. The IPD patient feedback

should be taken half yearly and the analysis should be done for the same).

RESPONSIBILITY:

RMO





5.3. Quality Policy

RATNAGIRI DISTRICT HOSPITAL management has defined and stands committed towards its

Quality Policy. The Quality Policy of RATNAGIRI DISTRICT HOSPITAL is:

FIGURE 3

Quality Policy

Ratnagiri district Hospital is a secondary care hospital & shall strive to provide

Preventive, Promotive and Curative Healthcare Services to the public in the

community with sustained efforts to ensure that it meets the people’s need &

expectations.

Date : CIVIL SURGEON

PLACE : Ratnagri district Hospital





Top management of RATNAGIRI DISTRICT HOSPITAL ensures that the Quality Policy

Is appropriate to satisfy and fulfil the purpose of the organization

Demonstrates top management commitment to quality and to requirements of quality

management system as per ISO 9001:2008 standard.

Provides a framework for defining quality objectives and permits quality objectives to be

understood and pursued throughout the organization

Is communicated through out the organization

Reflects a spirit of continual improvement in the QMS for its effectiveness.

Is reviewed once in a year for its relevance, efficacy and continued suitability to the organisation.

Is prominently displayed at appropriate locations.

This policy has been implemented by adhering to Quality Management System, complying with ISO

9001:2008 standards. It is ensured that Quality Policy is understood at all levels through training

programs.

5.4. Planning

5.4.1. Quality Objectives

The Quality Objectives of the RATNAGIRI DISTRICT HOSPITAL are specified at process level inrespective process documents.

Quality Objective:

1. To increase the patient satisfaction score of OPD from 3 to 4 by March 2013.

2. Increase the bed turnover rate by 15% by July 2013 ( from avg. bed turnover

rate of 6 )

3. Increase the total OPD attendance by 10% by March 2013 (from avg.9249

per month).

4. To increase the employee satisfaction score from 2 to 3 by March 2013

5. To increase the BMW score from 5 to 8 by March 2013

It is ensured that all the quality objectives are measurable and consistent with RATNAGIRI DISTRICT

HOSPITAL quality policy i.e., Measurable quality objectives have been established for respective

processes and ensured to be inline with the quality policy.

The achievement of quality objectives is measured through data collection by In-charges and is

reviewed in the RMOM.





REFERENCE:

ISO 9001:2008 5.3

RESPONSIBILITY:CS

5.4.2. Quality Management System Planning

The Quality Management System at RATNAGIRI DISTRICT HOSPITAL is planned to meet the

requirements of the following:

a) Requirements of ISO 9001:2008 Standards;

b) To achieve the quality policy and quality objectives;

c) To address the service model of RATNAGIRI DISTRICT HOSPITALi.e to provide services

within the scope of the hospital to the people, though token amount is taken for registration and

laboratory services. The services however, are free for BPL patients.

The Top Management at RATNAGIRI DISTRICT HOSPITAL has ensured that the integrity of QMS is

maintained, in circumstances like: Changes to the services rendered / Technology updation / Addition

of service locations etc. when review of the QMS is initiated and QMS is re-aligned / actions are

planned and implemented.

5.5. Responsibility, Authority and Communication

5.5.1. Responsibility and Authority

Management Representative

Deputy RMO

Document Control In-charge

Internal Quality Audit In-charge

Training In-charge

Top management of RATNAGIRI DISTRICT HOSPITAL has defined Responsibilities and Authorities

and communicated within the organization

Organization Chart is as specified in the Appendix 1

Roles and Responsibilities is as specified in the Appendix 2

More detailed Roles and Responsibilities are specified in respective process document

The Responsibility Matrix for the QMS system elements are as depicted in the matrix form.





Responsibility Matrix

Following table specifies the Responsibilities in relation to ISO 9001:2008 clauses.

Sl.No

ISOClause

No

ISO Clause Title QMS Documents Name Responsibility

RMO

CMO Process

owner 1. 4.1 General

RequirementsQMS documents P N S

2. 4.2.1 DocumentationRequirements – General

QMS documents P N S

3. 4.2.2 Quality Manual Quality Manual P S N

4. 4.2.3 Control of Documents

HMP1.5 :Process for Control of documents and records

P N S

5. 4.2.4 Control of Records Process for Management Review P N S

6. 5.1 ManagementCommitment

Quality Manual S P N

7. 5.2 Customer Focus Process for Management Review P P P8. 5.3 Quality Policy Quality Manual S P S9. 5.4.1 Quality Objectives Process for Management Review P S S10. 5.4.2 Quality

ManagementSystem Planning

QMS Documents P S N

11. 5.5.1 Responsibility and Authority

Quality Manual P S N

12. 5.5.2 ManagementResponsibility

Quality Manual P S N

13. 5.5.3 InternalCommunication

Quality Manual P S S

14. 5.6.1 ManagementReview – General

Process for Management Review P P P

15. 5.6.2 ManagementReview – ReviewInput


16. 5.6.3 ManagementReview – ReviewOutput


17. 6.1 Provision of

Resources

Process for Management Review P P N

18. 6.2.1 Human Resources – General

HAM- 09 Human ResourcesDevelopment and TrainingManagement

S N P

19. 6.2.2 Competence, Awareness andTraining

HAM- 09 Human ResourcesDevelopment and TrainingManagement

S N P

20. 6.3 Infrastructure HAM 07: Hospital Infrastructure/Equipment MaintenanceManagement

P N P

21. 6.4 Work Environment Quality Manual S N P22. 7.1 Planning of Product

RealizationQMS Documents S N P

23. 7.2.1 Determination of Requirements Process for Management Review

S N P





related to theService

24. 7.2.2 Review of Requirementsrelated to theService

Process for Management ReviewS N P

25. 7.2.3 Customer Communication

HAM 01: Patient Registration,admission & DischargeManagement

S N P

26. 7.3 Design andDevelopment

All SOP

27. 7.4.1 Purchasing Process HAM 03: Procurement andOutsourcing Management

S N P

28. 7.4.2 PurchasingInformation

HAM 03: Procurement andOutsourcing Management

S N P

29. 7.4.3 Verification of Purchased Product

HAM 02: Hospital Stores andInventory management

S N P

30. 7.5.1 Control of Production andService Provision

QMS Process Documents S N P

31. 7.5.2 Validation of Processes for Production andService Provision

HAM-07:Hospital

Infrastructure/Equipment

Maintenance Management

S N P

32. 7.5.3 Identification andTraceability

HCM 09: Data & InformationManagement

S N P

33. 7.5.4 Control of Customer Property

HCM 09: Data & Information

Management

S N P

34. 7.5.5 Preservation of Product

HCM 09: Data & InformationManagement

S N P

35. 7.6 Control of Monitoring andMeasuring Devices HAM-07:Hospital

Infrastructure/Equipment


S N P

36. 8.1 Measurement, Analysis andImprovement – General

Quality Manual S N P

37. 8.2.1 Customer Satisfaction

HAM 01- Patient Registration, Admission and DischargeManagement

P P P

38. 8.2.2 Internal Audit HMP 01:1.6 Process for Internal

audit

P N S





39. 8.2.3 Monitoring andMeasurement of

Processes


40. 8.2.4 Monitoring andMeasurement of Product


41. 8.3 Control of NonConforming Product

HMP 01.1.7 QMS ProcessDocumentsProcess for Control of non-conforming service

HMP 01:1.8 Process for Corrective and Preventive

Actions

S N P

42. 8.4 Analysis of Data QMS Process Documents S N P

43. 8.5.1 ContinualImprovement

HMP 01:1.8 Process for Corrective and PreventiveactionsProcess for Management Review

S N P

44. 8.5.2 Corrective Action HMP 01:1.8 Process for Corrective and Preventive

Actions

P N P

45. 8.5.3 Preventive Action HMP 01:1.8 Process for Corrective and Preventive

Actions

P N P





Note:

Primary (P)

Secondary (S)

Not applicable (N)

5.5.2. Management Representative

Top Management of RATNAGIRI DISTRICT HOSPITAL has appointed

Dr.BhalchandraNilegounkar, Civil Surgeon as the Management Representative and

following team members have been appointed for the quality team

1. Dr. BhalchandraNilegounkar– Management Representative

2. Dr. Nile Gaonkar - RMO.

3. Dr. D.P More - Internal Quality Audit In-charge

4. Dr. Sanghamitra Phule -Training In-charge

5. Mr. AnandaAabaso Chougule - Document Control In-charge.

6. Mr. Namdev Govind More - Deputy Management Representative

Irrespective of other responsibilities, RMO has additional responsibilities and authority to:

Ensure Establishment and Implementation of Quality Management System.

Regular Monitoring of QMS through Audits to ascertain the Implementation Efficacy and

Maintenance of Integrity of the QMS in varied conditions.

Reporting to the Top Management on performance of Quality Management System and any

need for improvement during Management Review Meeting.

Present Audit Reports, Process Performance Measure, Service Non-Conformances, Patient

Satisfaction Survey Reports and any need for improvement during Management Review

Meeting.

Ascertaining the awareness of Patient Requirements through Internal Audits and ensuring

that the information reaches all employees about Services and Patient Satisfaction levels.





5.5.3. Internal Communication

Top management of RATNAGIRI DISTRICT HOSPITAL ensures the communication about the

effectiveness of the QMS in the form of-

Trends in the Patient satisfaction levels, Quality objectives status, Continual improvement status,

Internal audit results, Product / Service process NCs/ Errors; Complaints redressal which are

available and discussed at the HOD’s levels. Action plans at HOD levels to be discussed to

improve continually.

Additionally the following communications are ensured to the concerned personnel to facilitate

and achieve consistent of results:

Minutes of Management Review Meeting.

Reports of Internal / External Quality Audits.

Process metrics, its analysis and the activities relating to continuous improvement.

Patient satisfaction survey reports.

Also any general information to the employees of RATNAGIRI DISTRICT HOSPITAL is

communicated time to time through verbal communication, meetings /notice boards, circulars,

Control copy of SOP etc.





5.6. MANAGEMENT REVIEW

5.6.1. General

RATNAGIRI DISTRICT HOSPITAL Management organizes Management Reviews of QMS at least

once in a month.

Management Review Meeting is coordinated by the Management Representative and the

Management Review Committee comprise of the following personnel:

1. Dr. BhalchandraNilegounkar– Management Representative

2. Dr. Nile Gaonkar - RMO.

3. Dr. D.P More - Internal Quality Audit In-charge

4. Dr. Sanghamitra Phule -Training In-charge

5. Mr. AnandaAabaso Chougule - Document Control In-charge.

6. Mr. Namdev Govind More - Deputy Management Representative

The Management Reviews are carried out at RATNAGIRI DISTRICT HOSPITAL

To ensure continuing Suitability, Adequacy and Effectiveness of the QMS, Quality Policy and

Quality Objectives;

To continuously improve the QMS;

By analyzing the inputs mentioned at section 5.6.2 of this Manual.

The following Quality Records are maintained for the RMOM conducted:

RMOM Agenda Form

RMOM Minutes Form

Action taken for the previous agenda

Attendance form

REFERENCE:

HMP 01-1.6 Process document for Internal Audits

RESPONSIBILITY:

RMO

5.6.2. Review Input





The inputs for the Management Review Meeting are as given below:

Follow-up actions from previous RMOM decisions;

Status of Corrective and Preventive actions taken;

Results of audit reports;

Training needs;

Status of Resources likes Human Resources, Infrastructure and Working environment,

Instruments status in wards and emergency;

Resource requirements;

Patient Feedback including complaints;

Repeated/ Serious non-conformances, if any;

Quality processes performance and process/ service conformity

Recommendations for improvement;

Monthly MIS of the facility as per MIS indicator sheet (Reference HCM 10: Data and Information

management)

Any other relevant points.

REFERENCE:

HMP.01 section 1.6 Process document for Internal Audits

RESPONSIBILITY:RMO





5.6.3. Review Output

In the RMOM, the various inputs received are reviewed with the following objectives and decisions.

Actions are decided as required:

To verify and improve effectiveness and efficiency of the quality system;

To take the appropriate actions so as to continuously improve the Service related to Patient

requirements;

To provide the necessary resources.

Corrective and preventive actions

Any changes needed for the QMS documentation.

REFERENCE:

HMP.01 section 1.6 Procedure document for Internal Audits

RESPONSIBILITY:RMO

6. RESOURCE MANAGEMENT

6.1. Provision of Resources

The resources required for the following have been provided at RATNAGIRI DISTRICT HOSPITAL as

defined by Indian Public Health Standards for District Hospital.

To Implement and Maintain the QMS based on ISO 9001:2008 Standards and continually

improve its effectiveness

To enhance Patient Satisfaction by meeting Patient Requirements.

REFERENCE:

IPHS Standards for District Hospital

RESPONSIBILITY:

CS

Assistant Superintendent





6.2. HUMAN RESOURCES

6.2.1. GENERAL

Process to ensure the following has been established and is being practiced:

All personnel performing work affecting service quality is competent on the basis of Education,

Training, Skills and Experience.

REFERENCE:

HAM 09: Human Resource Development and Training Management

RESPONSIBILITY:

CS


6.2.2. Competence, Awareness and Training

The organization

Determines the necessary training for competence of personnel performing work affecting

service quality

Provide training or take other actions to satisfy these needs

Evaluate the effectiveness of the actions taken

Ensure that its personnel are aware of the relevance and importance of their activities and how

they contribute in the achievement of the quality objectives and

Maintain appropriate records of training, skills and experience

Competence

The typical qualification, experience and skills set required for various assignments / positions

within RATNAGIRI DISTRICT HOSPITAL have been defined and documented and the same

will be used as the reference while recruiting new employees.

The competence level of all personnel is evaluated twice in a year in synchronization with the

appraisal process.

The personnel falling below the required competency level is identified and the concerned HOD

will plan appropriate measures to handle the situation.

Training





Appropriate training / any other corrective actions are identified and implemented to improve the

competency level of the personnel identified.

The effectiveness of the actions taken and training provided are evaluated.

Awareness

Records related to the Education, Training, Skills and Experience are maintained.

Adequate trainings are conducted to create the awareness of the relevance and importance of

employee’s activities and the way they contribute to the achievement of the quality objectives.

REFERENCE:

HAM 09: Human Resource Development and Training Management

RESPONSIBILITY:

CS

Training Incharge

6.3. Infrastructure

The CS of RATNAGIRI DISTRICT HOSPITAL has determined, provided and maintained the

infrastructure needed to achieve conformity to service requirements. Processes for maintaining the

infrastructure have been established.

REFERENCE:

HAM 07: Hospital Infrastructure / Equipment Maintenance Management

RESPONSIBILITY:

CS

Administration Clerk

6.4. Work Environment

The CS of RATNAGIRI DISTRICT HOSPITAL has determined and managed the Work environment

needed to achieve conformity to Service requirements. It has established a process for maintaining

the work environment.





REFERENCE:

HAM 05: Hospital security and Safety Management

HAM 08: Hospital Housekeeping and general Upkeep Management

RESPONSIBILITY:

CS


7. SERVICE REALIZATION

7.1. Planning of Service Realization

For services provided at RATNAGIRI DISTRICT HOSPITAL, a plan has been established. This is

periodically reviewed for updating. The plan developed for service realization is ensured to be

consistent with the requirements of the other processes of the quality management system.

District health Planning

• Mechanism to partner with community

• Planning based on local evidence and needs

• Area specific strategies to achieve NRHM goals

• Cost effective and practical solutions

General flow of service is as below:

Service Realization Planning for patients is documented in respective case sheet or prescription

from time to time right from initial stage of diagnosis till completion of treatment / discharge.

Pl. Note: The records are available with RMOD department

Processes have been established to meet the following:

a) Quality Objectives requirements for providing health care services covered in scope of this

hospital.b) Minimum Services Guarantees ensured by Indian public health standards.

c) Requirements to establish processes and documents and provide resources specific to the

service.

d) Requirements for Verification, Monitoring of activities specific to the service and the criteria for

service acceptance.

e) Records needed to provide evidence that the realization processes and resulting services

meet requirements.

Records kept showing that the services have met the Patient requirements.





RESPONSIBILITY:


7.2. Patient-Related Processes

7.2.1. Determination of Requirements Related to the Service

RATNAGIRI DISTRICT HOSPITAL has established the processes for determining:

1. Services and processes needed to provide Preventive, Promotive and Curative heath care to

patients and community .ie. OPD consultancy, Surgical services, Nursing care, Emergency care,

Diagnostic services, Family Planning services, Reproductive and Child health services, National

Health Programs

2. Specific requirements for Medication, Surgery, Nutrition are determined Doctors after consultation

with patients, examination and investigations.

3. Requirements stated by local/state government and National Rural Health Mission

4. Requirements that may not be stated by patients but are necessary for their well being and over

all operation of hospital like administrative and supportive services.

5. Requirements for statuary and Regulatory Compliance given in appendix 3.

Reference:

All Clinical and Administrative SOPs

Responsibility:

RMO

7.2.2. Review of Requirements Related To the Service

At RATNAGIRI DISTRICT HOSPITAL,

Patient’s requirements are reviewed for the following: a) Clarity

b) Completeness

c) Availability of services at Ratnagiri Civil Hospital to meet the service requirements as per

IPHS Standard

This review is prior to providing the service.

Requirements differing from those previously expressed are resolved.

1. Also any change to the Patient requirements are reviewed

2. The review and amendment details / records are maintained with Registration counter.

3. Upon service acceptance by patient, acknowledgement is communicated to the patient.





Reference:

HCM 01: Outdoor Patient Management

HCM 02: Inpatient Management

HCM 10: Hospital Referral Management

IPHS Standard for District Hospital

Responsibility:

RMO

7.2.3. Patient Communication

At RATNAGIRI DISTRICT HOSPITAL, methods are established for effective communication with

the Patients / Attendees relating to

a. Service / service information

b. Inquiries, service contracts including amendments.

c. Patient feedback, including Patient complaints.

Registration Desk In-charge maintains the details of Patients like Name of the contact

person, Address, Telephone, Fax etc. in order to establish effective communication.

Registration Desk In-charge maintain the details of Referral Hospitals also

Service Delivery Information in the form of Case Sheet are communicated to Patients and

also to the Referral doctor, if applicable

Patient feedback in form of satisfaction survey and complaints/suggestions are received

through Patient Response and analyzed.

Citizen Charter displayed

Implied and written consent taken

Display of user charges

Availability of drugs display

Way finding and cautionary Signages

Reference:

HCM 01: Outdoor Patient Management

HAM 01: Patient Registration, Admission and Discharge Management

Responsibility:

RMO





7.3. Design and Development

7.3.1 Design and Development planning:

The Ratnagiri District Hospital

a. Determines the design and development of the services provided by the hospital.

b. It reviews, verifies and validates that designs are appropriate

c. HOD is the authority of designing the service of his department and is responsible for its

verification and validation

7.3.2 Design and Development Inputs

Inputs relating to service requirements are determined and records are maintained. These inputs

include

a. Functional and performance requirements.

b. Applicable statutory and regulatory requirements.

c. Information from previous similar designs.

d. These inputs will be reviewed once in a year.

7.3.3 Design and Development outputs

a. Meet the input requirements for design and development

b. Provide the appropriate information for purchasing, production and service provisionc. Contain service product acceptance criteria

d. Specify the characteristics of the service that are essential for its safe and proper use

7.3.4 Design and Development review:

Systematic reviews of the design and development will be performed at annual basis in

accordance with the planned arrangements

a. To evaluate the ability of the results of design and development to meet requirements

b. To identify any problems and propose necessary actions

c. Participants in such reviews will include representatives of functions concerned with the

design and development stages being reviewed. Records of the results of the reviews and

any necessary actions will be maintained.

7.3.5 Design and Development verification:

Ratnagiri District Hospitalwill perform the verification in accordance with the planned

arrangements to ensure that the design and development outputs have met the design and

development input requirements. Records of the results of the verification and any necessary

actions will be maintained.

7.3.6 Design and Development validation:





It will be performed in accordance with the planned arrangements to ensure that the resulting

product is capable of meeting the requirements for the specified application or intended use.

Records of that will be maintained.

7.3.7 Control of Design and Development changes:

Design and development changes will be identified and records will be maintained. The

changes will be reviewed, verified and validated as appropriate and approved before

implementation. The review of the design and development changes will include evaluation of

the effect of the changes on constituent parts and products already delivered. Records of the

results of the review of changes and any necessary actions shall be maintained.

Please refer the document SOP: HMP: HCM: HAM

7.4. Purchasing

7.4.1. Purchasing Process

Process has been established for the purchasing activities at RATNAGIRI DISTRICT HOSPITAL

addressing the following.

Purchased service conforms to specified requirements of state government.

Selection, Evaluation, Re-evaluation of vendors for local purchase.

The CS& Assistant Superintendent evaluate the vendors and maintain the list of Approved

Vendors.

The steps to evaluate suppliers are as follows-

A list of suppliers are maintained and regularly updated.

Suppliers are selected for, and removed from, the list as per documented procedure.

Based on requirements, purchase orders are forwarded to the suppliers.

Prior to release, purchase orders / Delivery schedule are reviewed and approved as per

documented procedure

The suppliers are evaluated as per the schedule.

1. The purchase of required Drugs, Medicines, Consumables etc. are planned and provided on a

predefined period by Store In-charge / Pharmacist in accordance with the government policies.

2. The requisition for the purchase of any extra/ additionally required drugs, medicines consumables

are planned on a predefined period and forwarded to Purchase In-charge.

3. Purchase of support services (E.g. Annual Maintenance Contracts for Software, Computers,

Maintenance of Civil infrastructure, Support and Biomedical machineries etc) is decided on a

need basis from time to time.





4. The Assistant Superintendent evaluates (and re-evaluate at predefined periods) the suppliers

based on time and required quantity of receipt of drugs, medicines consumables and also that of

purchase of support services and maintains the following records:

a) List of Approved Suppliers

b) Approval Criteria

c) Supplier Rating Card

Reference:

HAM 02: Hospital Store and Inventory Management

HAM 03: Procurement and Outsourcing Management

HAM 11: Pharmacy Management

Responsibility:

RMO

7.4.2. Purchasing Information

Purchasing information / MOU includes-

a. Requirements for approval of Services, Procedures and Processes.

b. Quality management system requirements.

c. Requirement of any Personnel

All specifications and relevant technical details of the service to be purchased are

available with the purchase section.

The purchase order /MOU which is released after review and approval contains

Description / Specifications, Quality Requirements, Quantity ordered, Delivery Schedules

and other commercial and contractual details / also any other term and conditions.

Purchasing data also cover Statutory and Regulatory requirements wherever applicable.

REFERENCE:

HAM02 :Hospital Store and Inventory Management

HAM 03: Procurement and Outsourcing management

RESPONSIBILITY:

Store In-charge

7.4.3. Verification of Purchased Process

Capital Items: At RATNAGIRI DISTRICT HOSPITAL Inward Capital Items will be checked for quantity.





The respective users, indenting for the items, will verify the items for conformance to

specifications.

Records of verifications are maintained.

Service related items:

After receiving, the Drugs, Medicines and Consumables are checked for Quantity and

Expiry period by Stores Assistant / Pharmacist.

For Quality the Drugs, Medicines and Consumables Stores Assistant/ In-charge will have

sought the user approval.

The report of accepting the drugs, medicines and consumables is communicated to

supplier in the form of GRN.

Reference:

HAM-02 Hospital Store and Inventory Management

HCM-11 Pharmacy Management

Responsibility:

Store In-charge

Pharmacist

7.5. Service Provision

7.5.1. Control of Service Provision

1. Relevant processes have been established to effectively control the service delivery to the

patients at RATNAGIRI DISTRICT HOSPITAL

2. Service delivery is carried out under controlled conditions which includes the following:

a) Qualified, Registered and Experienced Doctors.

b) Qualified and trained Nursing Staff.

c) Defined system procedures for the services of the hospital

d) Clinical /Surgical/ Nursing / Laboratory /Dietary protocols necessary to maintain service

quality during the service delivery process.

e) Proper work environment and Housekeeping.

f) Routine and Preventive Maintenance of machineries (Civil, Support and Biomedical) to

ensure continuing process capability.

g) Wherever applicable, Work instructions, the manner in which service delivery should be

carried out is to be displayed.

3. The premises is maintained in a state of Order, Cleanliness and Housekeeping is given due

importance.





4. Relevant Work instructions are available displayed at point of use.

5. Patient is informed about Treatment Plan/ Surgery plan, other option available, Side effects of

Treatment and Morbidity/ Risk/ Cost involved if any, before starting the treatment.

6. All essential equipments are available and maintained as per needs and standards.

7. Monitoring and measuring equipments like the Thermometer, BP. Apparatus and Weighing

machines are available and maintained.

8. Control of Pre delivery and Delivery processes for realization of services are controlled through

Checklists and Work Instructions and Standard Treatment Guidelines while Post Delivery

Processes are controlled through mechanisms like Customer feedback, Medical and Death

Audits.

Reference:HAM :09: Human Resource Development & Training Management

HAM :07: Hospital Infrastructure/ Equipment Maintenance

HCM :05: Operation Theatre and CSSD Management

HAM :10: Dietary Management

Responsibility:

CS

7.5.2. Validation of Processes for Service Provision

Validation of the processes is performed in the Laboratory Services, Sterilization and

Radiology services. Validation of the processes is done to know the accuracy of the result.

Reference :

HCM 06: Hospital Diagnostic Management

HCM 05: Operation Theatre and CSSD Management

RESPONSIBILITY:

Pathologist

Radiologist

7.5.3. Identification and Traceability

Each Patient reviewed / services rendered have a Unique Identification number. All patients and

their history are identified with a unique RMOD number at all treatment stages right from initial

screening at Consultation chamber, during treatment-process (both OP and IP), and till until final

Discharge, and they are kept in safe condition for a predefined retention period, for easy





identification, traceability and for eliminating the possibility of confusion. However, provision for

additional identification is provided wherever required.

Reference:

HCM 04: Maternity & Child Health

HCM 09: Data and Information Management

HMP 01-1.5

Responsibility:

All employees associated with the Service Delivery / Medical Records

7.5.4. Patient Property

During service delivery process at RATNAGIRI DISTRICT HOSPITAL, Patient related property like

Investigation Reports and Previous History Records are given due care and are submitted with the

Patient/ Patient's attendant at the end of treatment.

The Medical Records/ Case History of Patient‘s whom External Doctor/s / Nursing home/ Hospitals

are referred to are kept safely with the Medical Records Department

During and after service delivery the Case History of the patient is maintained in a Safe Room.

Reference:


HCM 02: In-Patient (IPD) Management (General/ Critical/ Intensive Care)

Responsibility:

Medical records In-chargeNursing Superintendent

7.5.5. Preservation of product

At RATNAGIRI DISTRICT HOSPITAL, the conformity of service is preserved. This preservation

includes Identification, Handling, Storage and Protection of patient’s well being which is tracked to

the case sheets.

RATNAGIRI DISTRICT HOSPITAL has also defined and documented a process for Identification,

Handling, Filing, Storage and Protection of all Medical Records

Reference:

HCM01: Blood Bank Storage Management







HCM 08: Hospital Infection Control

Responsibility:

All Employees associated with the Service Delivery / Medical Records

7.6. Controlling Of Monitoring & Measuring Devices

1. Instruments and Equipments used for Measuring and Controlling parameters affecting quality

of service are Identified, Controlled, Calibrated and Maintained according to prescribed

schedules.

2. All equipments used for Measurements of Specifications and Parameters are appropriately

Identified, Maintained, Controlled and Calibrated to preserve their Fitness and Accuracy, so

that results obtained are true and reliable.

3. The Procedure and Frequency for calibrating Equipments and Instruments are documented

and are either based on Manufacturer’s Recommendation or traceable to National or

International Standard.

4. Actions to be taken when calibration results are unsatisfactory are also documented.

5. Calibration status of measuring and test equipment is indicated with stickers / labels and

calibration records are maintained.

6. Calibration of inspection, measuring or test equipment is conducted by a qualified commercial/ independent laboratory, in-house Personnel.

Reference:

HAM 07: Hospital Infrastructure/ Equipment Maintenance

HCM 06: Hospital Diagnostic Management

Responsibility:

RMO






8. MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1. General

At RATNAGIRI DISTRICT HOSPITAL, each process has been defined with Quality Objective(s) and

relevant Management Information System to measure the quality objective(s). Management

information System Data are collected on a monthly basis, analyzed and appropriate actions are

taken for continually improving the QMS.

The established processes besides demonstrating the service conformity-

Demonstrates conformity of the service to the requirement (through the Nursing Process).

Ensures conformity to Quality Management System (through the Internal Audit process).

To continually improve the effectiveness of the quality management system (through the process

for RMOM).

This includes and uses Statistical techniques (Process Metrics).

REFERENCE:

HMP 01 1.6 Procedure for Internal Audit

RESPONSIBILITY:RMO





8.2. Monitoring and Measurement

8.2.1. Patient Satisfaction

1. At RATNAGIRI DISTRICT HOSPITAL, the Patient Satisfaction is measured through:

a) Patient’s Referrals/ LAMA

b) Patient Satisfaction Surveys

c) Complaints and Suggestions received

d) Waiting Times

2. The Assistant Superintendentin assistance with Nursing Staff is responsible for Measuring and

Monitoring the Patient Satisfaction.

3. Patient Satisfaction survey is done monthly.

4. Complaints Redressal Time & Waiting Time measurement is done monthly.

Reference:

HCM 01: OPD Management


HCM 09: Data & Information Management

Responsibility:

Nursing In-charge


8.2.2. Internal Audit

At RATNAGIRI DISTRICT HOSPITAL, a Documented Process is established for conducting

Internal Audits to verify the quality-related activities and to determine the effectiveness of the

quality system.

Internal Audits is conducted at least once in six months. The RMO maintains the plan for audits.

Scheduling of audits is based on the status and importance of activity.

Schedules are also prepared considering the performance of the processes in earlier audits,

through the audit reports.

Personnel conducting the audit will be independent of the activity being audited.

The qualified auditors conduct audits. RMO arranges for training to Internal Quality Auditors.





Process has been established to record the results of the audits. These to be reflected in the

audit reports. The findings of audits are brought to the notice of personnel responsible for takingthe corrective actions.

RMO monitors the conducting of Follow-up Audits. The effectiveness of Corrective Actions

taken is verified in the follow-up audits.

The audit reports of Internal Audits are discussed in the RMOM.

REFERENCE:

HMP 01-1.6 (Internal Audit & Management Review)

8.2.3. Monitoring and Measurement of Processes

1. At RATNAGIRI DISTRICT HOSPITAL, Processes & Performance are measured through MIS

Management Information system Data are collected at defined intervals, analyzed and

appropriate actions are taken for continually improving the QMS besides demonstrating the

service conformity.

2. RMO collects the Quality Objective Target Data from each functional head periodically and

prepare Target Sheets.

3. The findings are analyzed with the Targeted Values and the results are discussed at the

RMOM.

4. Based on the performance of respective functions, the next target is decided for continual

Improvement.

5. HIC – Culture Surveillance is done monthly.

Reference:

QMS

HMP 1/1.6 Management Review

HAM: 09 Human Resource Development & Training Management

HMP.1/1.7 Controlling of Non-conforming services

Section 5.5.3 of QM

Responsibility:RMODRMO





8.2.4. Monitoring and Measurement of Product

At RATNAGIRI DISTRICT HOSPITAL, Reporting Structure has been established to monitor (case

sheet review done by higher up the organization ladder) and measure the service (through quality

objectives and Service Delivery Targets) during service delivery and after delivery.

Laboratory Reports and Case Sheet Review is done by the Consultant Doctor on every round and

constitutes methodical monitoring and measurement of the service and corrective actions there of.

MIS data is Analyzed & Discussed on a regular basis

Reference:

MIS

Responsibility:

RMO

8.3. Control of Non -Conforming Service

1 Any deviation from the Accepted Service Delivery / Procedure (Clinical or Non-Clinical), Patient

stated and/ or Implied needs, which may lead to a Non -conforming service to the Clients is

treated as a Non-conforming Service.

2 Any Critical or Repeated Patient Complaint (both In and Out Clients) relating to Clinical Care

and Operations is treated as a Non-Conforming service.

3 Documented Procedures have been established and practised to ensure the Identification,

Evaluation and Disposition of Non-Conforming Services and notifying the same to the

concerned persons.

4 It is ensured that the service that does not conform to the specified requirement is prevented

from delivery to the authorities.

Reference:HMP01-1.7 Procedure for Control of Non-Conforming Services and Corrective and Preventive

Actions

Responsibility:

RMO

8.4. Analysis of Data

1. At RATNAGIRI DISTRICT HOSPITAL, Data collected during Internal Audits, Process Monitoring

and Measurements through Management Information System, Performance of interested parties

(service providers) are analyzed periodically.





2. The suitability of the QMS and its effectiveness is analyzed based on the collected data during the

RMOM.

3. Suitable Statistical Techniques like Pie chart, Bar Chart, etc., is used wherever required.

4. The analysis of the data provides information relating to the following:

a) Customer Satisfaction

b) Service Conformity Requirements

c) Characteristics and Trends of Processes including opportunities for Preventive Action.

d) Service Providers Information (if required)

Reference:

HAM 07: Hospital Infrastructure/ Equipment MaintenanceHCM 09: Data and Information Management

HMP 01-1.6 Management Review Procedure

Responsibility:

RMO

8.5. Improvement

8.5.1. Continual Improvement

Continual improvement in QMS is achieved through the use of following.

a) Quality Policy and Quality Objectives.

b) Audit Results

c) Analysis of Data

d) Corrective and Preventive actions

e) Management Review

Reference:

HMP01-1.6 Management Review Procedure

HMP01-1.7 Procedure for Controlling of Non-Conforming Services and

HMP 01-1.8 Corrective and Preventive Actions

Responsibility:

RMO

8.5.2. Corrective Action

1. At RATNAGIRI DISTRICT HOSPITAL, Processes have been established for the effective

handling of Non-Conformities arising due to following:





a) Service Non-Conformances.

b) Internal Audit Non-Conformances.

c) Customer Complaints.

d) Any issue related to service delivery through any other source.

2. The RMOM Committee scrutinizes corrective actions already taken during the RMOM. Also the

RMOM Committee on the Non-Conformities as applicable may initiate corrective actions.

3. The personnel identified implements the corrective actions.

4. The RMO follows up the implementation of corrective actions taken and their effectiveness as

applicable.

5. Procedure for taking corrective action is documented in QSP for Corrective & Preventive Action.

6. Effective handling of customer complaints and reports of service non-conformities.

7. Investigating the cause of Non-Conformance relating to Service, Process and Quality

Management System and recording the results of the investigation.

8. Determination of the Corrective Action to eliminate the cause of Non-Conformance.

9. Exercise of controls to ensure that corrective action is taken and that it is effective.

Reference:

HMP 01-1.7 Procedure for Controlling of Non-Conforming services and

HMP 01-1.8 Corrective and Preventive Actions

Responsibility:

RMO

8.5.3. Preventive Action

At RATNAGIRI DISTRICT HOSPITAL, action is taken to eliminate the cause of Non- Conformities in

order to prevent their occurrence. Appropriate Preventive Actions are taken.

RATNAGIRI DISTRICT HOSPITAL has established process in line with defined requirements for-

Determining potential Non-Conformities and their causes,

Evaluating the need for action to ensure that Non-Conformities do not reoccur,

Determining and Implementing action needed,

Records of the Results of action taken, and

Reviewing Preventive Action taken.

Preventive Action taken to eliminate the causes of potential Non-Conformities is

commensurate with the magnitude of the problem and the risks involved.

Changes if any, to the documented procedures resulting from preventive action are recorded.





The use of appropriate sources of information, such as Patient needs and Expectations,

Satisfaction Measurements, Management review Outputs, to identify potential causes of

nonconformance.

Determination of the steps needed for prevention of non- conformances.

Initiation of preventive action and exercise of controls to ensure that it is effective.

Ensuring that information on Action Taken is submitted for Management Review.

REFERENCE:HMP01-1.8 Corrective and Preventive Actions

RESPONSIBILITY:RMO

8.6. GUIDELINES / STANDARDS / OTHER DOCUMENTS

ISO 9001: 2008 Standard





9. APPENDIX 1- ORGANISATION CHART

All Designated

Group D Staff

Civil Surgeon (CS)

Departmental HOD

Junior doctor

Clinical RMOOutreach RMO

Administrative

officer

Specialist doctor

Matron

Nurse IN-Charge

Staff Nurse

Ward Boy

Office

Superintendent

Assistant

Superintendent

Sr. Clerk

Clerk





10. APPENDIX 2- ROLES & RESPONSIBILITIES

10.1 C.S

Is the overall In-charge of the hospital

Reviewing the Growth Plan along with the CS

Monitoring the Performance of Clinical and Non-Clinical staff

Ensuring Calibration of equipment

Monitoring day today activities of the hospital

10.3 RMO (Management Representative Officer)

Reports to CS & is responsible for -

Performing and Interpreting all special procedures

Approvals of Interpretation where necessary

Performing surgery

Initial Assessment,

Prescription of required Diagnosis

Educating the patient on the Problems & Care

Ensure appropriate entries in the Patient Records

Providing Instructions,

Monitoring and Guiding the staff. Duty Doctors, Nurses and supporting staffs

Providing Assistance in Surgery and In-Patient Care and Follow up

10.4 Duty M.O


Assessing the patient's condition and communicating to the Consultant

Checking Initial Assessment

Reporting Emergency situations to the Consultant

Taking care of the Patient

10.5 Physiotherapist


Maintenance of the Physiotherapy equipments





Identifying , Planning and Indenting of the consumables needed for physiotherapy from the

stores

Providing Appointment to the patients

Ensuring the availability of skilled resources

Periodic follow of the assessment about the progress

Modifying treatment plan

10.6 Matron


Determining policies of the Nursing Department in accordance with those of the hospital.

Going on rounds daily in all the nursing departments in the hospital and giving instructions

when required.

Identifying needs and providing resources such as Physical facilities, Supplies and

Equipments as required by the Department of Nursing.

Determining Categories and Number of Nursing Service Personnel required to meet the

nursing needs of patients.

Defining Functions and Qualifications for nursing service personnel, preparing written Job

Descriptions and assigning of daily responsibilities, Initiates appointments, Transfers and

Promotions of nursing personnel in assigned areas of nursing responsibilities.

Develops and implements a Plan for Recruitment and Dismissing nursing service personnel.

Arranging for Optimum Utilization of Physical facilities, Supplies and Equipment.

Performing evaluation of nursing service personnel once a year.

Planning, checking and helping in maintenance of the records for the nursing departments.

Planning and implementing the In –Service Education for nursing personnel.

Updating all records in the department.

Assistant Matron

General Supervision of the nursing care given to the patients and all nursing activities withinthe nursing units.

Cleanliness and order in her department and environment.

Regular rounds including outpatient clinics and night rounds.

Receiving reports from the night staffs regarding the nursing care of the patient at night.

Analyzing/Evaluating the kind and amount of nursing services required in nursing units.

Rotation of the nursing staff in the department to ensure good nursing care.





Staff meeting with the department staff.

Planning in co-operation with the sisters of each unit for effective administration.

Interpreting the principles of good management to ward sister, especially to these who areinexperienced and orientating them to apply these principles to their daily work.

Helping the ward sister to ensure supplies and equipment and rechecking their use andcare.

Acting as the public relations officers for the unit and deal with problems if any especiallywith the DASS IV staff and patient attendants.

Keeping Matron informed of the needs of the nursing units and of any special problems.

Organizing the training programme in this particular specialty in consultation with the doctor Incharge and the Nursing Superintendent/Matron.

Taking the Medical Superintendent and Matron round the hospital.

10.7 Staff Nurse

Report to Nursing Head & is responsible for -

Schedules nursing personnel to ensure adequate staffing for each shift.

Collaborates with Nursing Supervisor in determining and obtaining equipment and supplies

needed for daily patient care.

Maintaining and updating Inventory

Counsels relatives when required at the waiting area.

Ensures that all Physicians’ orders are executed in accordance with established policies and

procedures.

Checks patient Case Files and counter signs all procedures done.

Plans staff work assignments and schedules.

Provides on job orientation to nursing personnel.

Provided for in-service education of the nursing staff.

Evaluates the work performance of the staff.

Ensure safe practices are carried out and staff follows the Regulations, Procedures and

Policies as laid out by the hospital.

To Teach, Supervise and Support staff in carrying out their duties.

Ensures that all equipment used in the department are in working condition and in case of

malfunctioning the same has to be informed to the concerned department.

Keeps up to date knowledge of the unit and drug changes and instructs staff of the same.

Ensures that all records maintained in the department are updated and counter signs the

same. Co ordinates with Billing Section for billing of patients





Co-ordinates with Front Office for registering patients.

10.9 Aaya

Report to Nursing Asst & is responsible for-

Dusting and cleaning of the nurse’s station.

Keeps all dressing trolleys clean and ensures that all material required on the trolley is

available on a daily basis.

Washes and cleans all instruments used in the department and keeps the same in place.

Ensures that bed linen for all patients are done on a daily basis.

Maintains inventory of the linen and reports the same to the Nursing Supervisor.

Ensures that the soiled linen goes to the laundry and fresh linen is received daily and count

of the same is duly taken and recorded.

Assists the staff nurse to see that the room is kept ready and clean for admission.

Ensures that all dressing material is made and kept ready to be sent for sterilization.

10.10 GENERAL (DEPARTMENT HODs)

Responsible for-

Implementation & Maintenance of Quality Systems in their Departments.

To Control documents related to the Quality Systems in their Departments.

To Monitor and ensure Implementation of Corrective & Preventive actions

To Control quality records related to Quality System of their departments.

To co-operate for Internal Quality Audits

To identify training needs for personnel in their departments.

To participate in management review committee meetings and to initiate action to prevent

occurrences of non-conformities.

To Initiate, Recommend or Provide Corrective and Preventive Action in Committee Meetings.

Verification of implementations of solutions in their functions and to subsequently monitor the

effectiveness.

10.11 X-RAYTECHNICIAN

Sets up and operates Radiographic equipment used in the Medical diagnosis and/or treatment

of patients.

Selects proper ionizing factors for radiological diagnosis.

Adjusts and sets radiographic controls, such as Kilo Voltage and Mili Amperage to prescribed

specifications for proper timing of exposure; regulates the length and intensity of film exposure.





Positions and restrains patients; and takes x-rays of patient’s chest, limbs or other parts of the

body as required by the physician.

Checks X-rays for clarity of image, and retakes x-rays when needed.

Develops, Fixes, Washes, and Dries exposed films using film processing and drying equipment.

Maintains required records such as Patient Records, Daily Logbooks, and Monthly reports.

Distribute films to appropriate medical staffs.

Cleans, maintains and makes minor adjustments to radiographic equipment, including

determining repairs needed to equipment.

Protects patient and other personnel from radiation hazards.

Maintains radiographic supplies, film and equipment.

10.12 ECG Technician

Performs various investigations as prescribed by doctors.

Develops / mounts the investigations out put as per work instructions for ECG

and sends the same to prescribing doctors.

10.13 BLOOD BANK TECHNICIAN

Responsible for collection, preservations and issue of blood as per work instructions provided. Performs various tests for the purpose of Cross Matching and ensuring quality and safety of

blood collected as per work instructions provided.

10.14 Senior Lab Tech. I/C

Reports to the Pathologist and is responsible for-

Operation of the laboratories

Preparing the patient for the lab procedure

Preparing and operating the lab equipments

Dispatching the Lab reports once the reports are processed

Intimating the concerned authorities about any non-conformity found in the procedure or

equipment

10.15

Overall in-charge is RMO (Clinical) of various support services like Housekeeping, BMW,

Security, Dietary etc.

Overall In-charge is RMO (Clinical) for follow-up on patient complaints pertaining to all

departments including Nursing, Housekeeping, Linen, Engineering, OPD etc.

Upkeep of all instruments / equipment in the hospital including Bio Medical Instruments under

RMO (Clinical) Inchargship.





Liaison with other Government departments concerned with Civil works, Power and Water supply

under AO.

10.16 M.R

Reports to CMOH& is responsible for

Interacting with departmental heads regarding non-conforming services for RMOM input data

Maintaining Master list of Documents and Records.

Issuing controlled documents and records.

Handling changes to the documents

Preparing Annual Audit Plan.

Preparing and intimating the Audit Schedule.

Preparing RMOM Agenda.

Coordinating with MD for conducting Management Review Meeting

Recording the RMOM Minutes.

Reviewing the status of action plan discussed in RMOM.

10.17 DRMO (Deputy Management Representative)

Reports to RMO and is responsible for

In absence or on leave of RMO , DRMO acts as RMO.

10.18 Document Control Incharge

Reports to RMO and is responsible for -

Issuing of controlled documents to the concern department

Correction of documents if any required by prior approval of RMO

Introduction of new forms and formats if required by prior approval of RMO

Control of external documents

10.19 Internal quality Audit Incharge


Planning and making schedule for the Internal Audit with the RMO.

Selection of Internal Auditor for the Internal Audit.

Facilitation of Internal audit.

10.20 Training Incharge

Training Need Assessment

Selection of Trainer

Formulation of comprehensive training calendar for all staff





Collection of Training Feedback

Evaluation of Training Program

10.21 Office Clerk


Overall in charge of the Office

Co-ordination for Statutory Clearance

Bank Transaction

Maintaining Accounting File

Assisting CS in any accounting or finance related activity

10.22 Registration Clerk

Reports to CS & is responsible for

Maintaining the registration area – Interaction with patients and guiding if any for preparations

needed for availing service

Interaction with ward staffs

Preparation of daily statistics

The person at the Registration department is responsible for collecting complete information

from the patient, providing guidance and maintaining records of registration

10.23 Ward Master

Reports to CS and is responsible for

For collection of user charges from diagnostic services and paying wards.

Allocation of duty to the housekeeping staff.

Monitoring of the dietary services in the hospital.

Supervising the activities of housekeeping staff.

Maintaining the duty roaster of the housekeeping staff.

Allotment of bed to the paying patients.

10.24 Pharmacist


Managing the Pharmacy Counter

Management of Pharmacy Inventory





Co-ordination with the vendor for on time supply

Maintaining Pharmacy Records

10.25 Accountant


Purchase Management

Ensuring on-time Procurement

Verification of Inward material

Maintaining day to day accounting transaction

Billing and Cash Management,

Reporting to CMOH on Revenue Status and Vendor Payment Status

Proper Accounting Practices

10.26 Cook

Reports to Diet/ Nursing I/C & is responsible for

Preparing food for the patient & staff

Ensuring Hygiene

10.27 AMBULANCE DRIVER

Reports directly to Assistant Superintendent/ CS and is responsible for maintaining the vehicles

To provide round the clock transportation service to patients.

Ensures that the Vehicle Log Book is updated before and after each trip and appropriate approvals

for each tip is obtained from the Emergency Department as the case may be and counter

signatures from the CS.

Ensures to reach the specified destination on time.

10.28RMOD CLERK

Maintains medical records manually

Maintains Privacy & Confidentiality of the patient records.

Keep the medical records in the safe custody & complete all the time.

Make the records available as and when required.

Communicates with the government departments/ officials for medico legal requirement on an

ongoing need basis





10.28 ATTENDANT

Responsible for transportation of patients to investigation departments and wards as per doctor’s

instruction.

To transport equipment, consumables and written information as and when required.

Transportation of samples from wards to labs and reports from lab and radiology back to wards.

Giving Bed Pans/Urinals to patients.

Shifting of patients to OT/ labor room etc

10.29 HOUSEKEEPING SUPERVISOR

His duties and responsibilities are as given below:

Report directly to Assistant Superintendent.

Follow up of the checklist for each & every areas

Prepare Duty Rosters and allocate duties for cleaning staff.

Manages the department staff and cleaning staff assigned under him.

Liaisons with the agencies assigned for supply of housekeeping staff.

Interacts with the patients / family regarding their problems in relation to housekeeping.

Defines and establishes cleaning standards and systems for the various areas of the hospital.

Issues and controls the housekeeping consumables and materials.

Maintains close coordination with Infection Control Committee, Condemnation Committee andNursing services.

Conducts planned and surprise inspection of all hospital areas to ensure cleanliness standards

are maintained.

10.30 SAFAI KARAMCHARI (CLEANING STAFF)

Assists in monitoring and maintaining cleaning standards in the wards.

Carries out spot cleaning and ensure spillages are dealt with swiftly and efficiently.

Ensures general and specialist equipment, e.g. drip stands, incubators and

commodes, are cleaned as per cleaning policy.

Ensures that the ward is safe and tidy at all times, e.g. remove clutter, tidy notice boards,

signage, etc.

Maintains upkeep of patients’ bed areas

Ensures specialist cleaning of surfaces and furnishings.

Ensures isolation nursing areas are cleaned appropriately.





11. APPENDIX 3: LIST OF STATUTORY REQUIREMENTS

Sl. No. Name of Legal Requirement Status whether present or

not

1

License under Bio- medical Management and

handling Rules, 1998. Present

3 AERB

Applied

4 Water and Electricity Present

5PNDT

Present

6MTP

Present

7License for Blood Bank

Applied

8Fire NOC

Applied





12. APPENDIX 4 MASTER LIST OF CONTROL DOCUMENTS

S No Name of the document Document no Revision period

1 Procedure for Control of Documents &Records

HMP 1.5 One year

2 Procedure for Internal Audit HMP 1.6 One year

3 Procedure for Control of NonConformities

HMP 1.7 One year

4 Procedure for Corrective Action HMP 1.8 One year

5 Procedure for Preventive Action HMP 1.8 One year

6 Outdoor Patient Management HCM -01 One year

7 IPD Management (General/ Critical/Intensive care)

HCM-02 One year

8 Hospital Emergency & Disaster Management

HCM-03 One year

9 Maternity & child health Management HCM-04 One year

10 Operation Theater & CSSDManagement

HCM-05 One year

11 Hospital Diagnostic Management HCM-06 One year

12 Blood Bank/ Storage Management HCM-07 One year

13 Hospital Infection Control Management HCM-08 One year

14 Data & Information Management HCM-09 One year

15 Hospital Referral Management HCM-10 One year

16 Pharmacy Management HCM 11 One year

17 Management of Death HCM-12 One year

18 Patient registration , Admission &Discharge Management

HAM-01 One year

19 Hospital Stores & InventoryManagement

HAM-02 One year

20 Procurement & OutsourcingManagement

HAM-03 One year

21 Hospital Transportation Management HAM-04 One year

22 Hospital Security & Safety Management HAM-05 One year

23 Hospital Finance & AccountingManagement

HAM-06 One year

24 Hospital Infrastructure/ Equipment


HAM-07 One year

25 Hospital Housekeeping and Generalupkeep Management

HAM-08 One year

26 Human Resource Development &Training Management

HAM-09 One year

27 Dietary Management HAM-10 One year

28 Laundry Management HAM-11 One year

29 Hospital Waste Management HAM-12 One year





13. APPENDIX 5 LIST OF RECORDS

Forms & Formats

S.NO SOP Name Formats Format

No.

HCM

01

Outdoor Patient (OPD)

Management

OPD slip FF/MAH/

RAT/OPD/

01

Investigation Requisition slip FF/OPD/0

2

Immunization card FF/OPD/0

3

OPD patient feedback form FF/OPD/0

4

HCM

02

In-Patient (IPD)

Management (General/

Critical/ Intensive Care)

Case sheet FF/IPD/01

Bed Head Ticket FF/IPD/01

Daily Clinical Notes FF/IPD/01

Nurses Daily Record FF/IPD/01

TPR Chart FF/IPD/01

Diagnostic Procedure FF/IPD/01

General Consent FF/IPD/01

Diet Sheet

FF/IPD/01

Discharge Summary FF/IPD/01

Record of Death FF/IPD/01

HCM

03

Hospital Emergency and

Disaster Management

Brought dead Certificate FF/ER/01

Emergency Medicine Slip FF/ER/02

HCM

04

Maternity and Child Health

Management

Referral slip FF/MCH/0

1

Birth Report FF/MCH/02

Death Report FF/MCH/03

Still birth report FF/MCH/04

Immunization Card FF/OP/03

HCM Operation Theatre and Consent form FF /OT/01

Surgery Note FF /OT /02

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/OPD%20slip.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Investigation%20requisition%20slip.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Immunisation%20card.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/OPD%20patient%20Feed%20back%20form.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Brought%20Dead%20Certificate.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Brought%20Dead%20Certificate.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/OPD%20patient%20Feed%20back%20form.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Immunisation%20card.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Investigation%20requisition%20slip.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/OPD%20slip.doc





05 sterilization unit

Management

Anesthesia Form FF /OT /03

HCM

06

Hospital Diagnostic

Management

Blood and Biochemistry Report FF/LB/01

IPD Report FF/LB/02

Urine Report FF/LB/03

Stool Report FF/LB/04

Radiology Requisition FF/LB/05

HCM

07

Blood bank/Storage

management

Blood bank requisition form FF/BB/01

Donor screening and registration card FF/BB/02

Blood transfusion reaction form FF/BB/03

Cross matching slip FF/BB/04

HCM

08

Hospital Infection Control

ManagementNil Nil

HCM

09

Data and Information

Management

MIS Sheet FF/DI/01

HCM

10

Hospital Referral

Management

Patient referral ticket FF/RM/01

HCM

11Pharmacy Management Nil Nil

HCM

12

Management of Death Medical certificate for cause of death FF/MD/01

HAM0

1

Patient Registration

Admission and Discharge

management

OPD Ticket

FF/OPD/0

1

Investigation Requisition slip for radilogy FF/0PD/02

Case Sheet FF/IP/01

Discharge Summary FF/IP/01

HAM

02

Hospital Stores and

Inventory management

Local Purchase indent form BIN CARD FF/SI/01

HAM0Procurement And

Annual Medicine and ConsumablesRequirement Plan

FF/POS/0

1

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Patient%20referral%20form.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Patient%20referral%20form.doc





3 Outsourcing Management Indent / Requisition FF/POS/0

2

List of registered Suppliers FF/POS/0

3

HAM0

4

Hospital Transportation

Management

Nil nil

HAM0

5

Hospital Security & Safety

Management

Nil Nil

HAM0

6

Hospital finance &

Accounts Management

Cash Book FF/FAM/0

1

Bank Reconciliation Statement FF/FAM/0

2

Utilization Certificate (GFR 7 A) FF/FAM/0

3

FROM FF/FAM/0

4

HAM0

7

Hospital Infrastructure/

Equipment Maintenance

Management

Nil Nil

HAM0

8

Hospital Housekeeping

and General Upkeep

Management Daily Housekeeping and Cleaning Schedule

FF/HK/01

HAM0

9

Human Resource

Development and Training

Management

Employee Satisfaction Survey Form FF/HR/01

Training feedback form FF/HR/02

HAM1

0

Dietary Management NIL NIL

HAM1

1

Linen & laundry

Management

Nil Nil

HAM1

2

Hospital Waste

Management

Form II Annual Report Format

Form III Accident Reporting Format

BMW Score card

Records

S.No SOP Name Record/ Files Record No.

HCM 01Outdoor Patient (OPD)

ManagementOPD Consultation Register

RR/MAH/DH/RAT/OPD/01





Immunization register RR/MAH/DH/RAT/

OPD/02

Dressing room register RR/MAH/DH/

RAT/OPD/03

Injection room register

RR/MAH/DH/RAT/

OPD/04

Registration Register

RR/MAH/DH/RAT/

OPD/05

Complaint Register

RR/MAH/DH/RAT/

OPD/06

HCM 02In-Patient (IPD)

Management (General/Critical/ Intensive Care)

Admission register RR/IPD/01

Discharge register RR/IPD/02

Death Record Register RR/IPD/03

Police Case (Injury Register) RR/IPD/04

IPD Indent register RR/IPD/05

Diet register RR/IPD/06

Linen register RR/IPD/07

HCM 03Hospital Emergency

and Disaster Management

Emergency register RR/ER/01

MLC register RR/ER /02

Police information register RR/ER/03

Brought in dead register RR/ER /04

HCM 04Maternity and ChildHealth Management

Labour room register RR/MCH/01

MTPregister RR/MCH/02

Maternal death register RR/MCH/03

Baby death register RR/MCH/04

HCM 05Operation Theatre and

sterilization unitManagement

OT register RR/OT/01

OT intimation register RR/OT/02

OT Booking Register RR/OT/03

Fumigation Register RR/OT/04

Anaesthesia register RR/OT/05

Operating list RR/OT/06

Sterilization log book RR/TSSU/01

HCM 06Hospital Diagnostic

Management

Laboratory Register for OPD RR/LB/ 01

Radiology register for IPD RR/LB/02

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Immunization%20Register.docx

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Admission%20discharge%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Inventory%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Labour%20room%20%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/OT%20booking%20register.doc


http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Fumigation%20Register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Laboratory%20Master%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/X-ray%20Master%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/X-ray%20Master%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Laboratory%20Master%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Fumigation%20Register.doc



http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Labour%20room%20%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Inventory%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Admission%20discharge%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Immunization%20Register.docx





X ray OPD register RR/LB/03

X ray IPD register RR/LB/04

USG register RR/LB/05

HCM 07Blood Bank StorageManagement

Donor’s register RR/BB/01

Issue Register RR/BB/02

Blood Units Discard Register RR/BB/03

Master Register for Blood RR/BB/04

HCV Rapid Test Register RR/BB/05

HIV Rapid Test Register RR/BB/06

VDRL register RR/BB/07

HbsAg Rapid Test Register RR/BB/08

Inventory Register RR/BB/09

HCM 08Hospital Infection

Control ManagementInfection control monitoring register RR/HIC/01

HCM 09Data and Information

Managementrecord Issue register RR/DIM/01

HCM 10Hospital Referral

ManagementNIL

NIL

HCM 11 Pharmacy Management

Drug store register RR/PS/01

Oxygen stock registers RR/PS/02

Daily expense registers RR/PS/03

Stock register RR/PS/04

Local Purchase Register RR/PS/05

HCM 12 Management of Death Mortuary Register RR /MD/01

HAM01Registration, Admission

and Dischargemanagement

OPD Consultation register RR/OPD/01

Admission Register RR/IPD/01

Discharge Register RR/IPD/02

X Ray IPD Register RR/LB/04

X Ray OPD Register RR/IPD/03

USG Register RR/LB/05

HAM02Hospital Store &

Inventory management

Stock Ledger for Medicines RR/SI/01

Stock Ledger for Equipments RR/SI/02

Stock Ledger for Contingency RR/SI/03

Maintenance Register RR/SI/04

Indent & Receiving register RR/SI/05

HAM03 Procurement and Indent & Receiving register RR/SI/05

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Master%20medical%20record%20register.doc

http://c/Users/Suporna/AppData/Local/Temp/Temp4_2nd%20deliverable.zip/Sunil/Desktop/Master%20medical%20record%20register.doc





OutsourcingManagement

Local Purchase Register RR/POS/01

HAM04Hospital Transportation

Management

Ambulance Movement Register / LogBook

RG/HTM/01

HAM05Hospital Security &Safety Management

Attendance register of security guard RG/SS/01

HAM06Hospital finance &

Accounts Management

Petty Cash Book RR/FAM/01

Cheque Issue Register RR/FAM/02

Register of Bank Drafts DispatchedRR/FAM/03

Ledger RR/FAM/04

Register for Staff Payments RR/FAM/05

Asset Register RR/FAM/06

HAM07

Hospital Infrastructure/Equipment Maintenance

Management

Master List of Equipments RR/IEM/01

Maintenance Register RR/SI/04

HAM08 Hospital Housekeepingand General Upkeep

Management

HK Attendant Attendance Register RG/HK/01

HAM09 Human ResourceDevelopment andTraining Management

Training Register RR/HR/01 Attendance Register for clerical staff RR/HR/02

Attendance Register for medical Officers RR/HR/03

Attendance Register for nursing staff RR/HR/04

Attendance Register for contractual staff RR/HR/05

HAM10 Dietary Management

Daily diet Register RG/DM/01

HAM11 Laundry Management Laundry register RR /LL/01

Linen stock register RR /LL/02

Condemnation register RR /LL/03

HAM12Hospital WasteManagement Nil

Nil





14. APPENDIX 6 DISTRIBUTION LIST OF CONTROL COPY HOLDERS

S no Name of the Document Document code Controlled copy holder

1

Quality Manual SDH/KAT/AQM/01 RMO, DRMO, IQA,

DCI, Training Incharge

2 Hospital Clinical Manual HCM 01 – 12 RMO, DRMO, IQA,


3 Hospital Administrative Manual HAM 01 – 12 RMO, DRMO, IQA,


4 Six Mandatory Procedures HMP/01 RMO, DRMO, IQA,DCI, Training Incharge

5 Outdoor Patient Management HCM -01 Hospital

manager/registration

clerk/MOIC

7 IPD Management (General/ Critical/

Intensive care)

HCM-02 Staff nurse/ANM

8 Hospital Emergency & Disaster

Management

HCM-03 MO

9 Maternity & Child Health Management HCM-04 Staff nurse/ANM

10 Operation Theater & CSSD

Management

HCM-05 Anesthetist/ANM

11 Hospital Diagnostic Management HCM-06 Pathologist

12 Blood Bank/ Storage Management HCM-07 Blood bank officer

13 Hospital Infection Control Management HCM-08 Pathologist/ANM

14 Data & Information Management HCM-09 Hospital manager

15 Hospital Referral Management HCM-10 MO

16 Pharmacy Management HCM 11 Pharmacist

17 Management of Death HCM-12 DMS/MO

18 Patient Registration ,Admission &

Discharge Management

HAM-01 Registration clerk

19 Hospital Stores & Inventory

Management

HAM-02 Pharmacist

20 Procurement & Outsourcing

Management

HAM-03 RKS

21 Hospital Transportation Management HAM-04 Hospital manager

22 Hospital Security & Safety Management HAM-05 Hospital manager





23 Hospital Finance & Accounting

Management

HAM-06 Accounts clerk

24 Hospital Infrastructure/ Equipment


HAM-07 Hospital manager

25 Hospital Housekeeping and General

Upkeep Management

HAM-08 Hospital manager

26 Human Resource Development &

Training Management

HAM-09 Administration officer

27 Dietary Management HAM-10 Nursing I/C

28 Laundry Management HAM-11 Hospital manager

29 Hospital Waste Management HAM-12 Hospital manager




15. APPENDIX 7 LIST OF DOCUMENTS OF EXTERNAL ORIGIN

1. Legal documents-Building Permit, PNDT Act, RTI Act,

2. IPHS

3. ISO 9001:2008

4. Blood Bank (NACO Guidelines)

5. Essential Drug List

6. Content of MOU of Outsourced Services

7. RKS Guidelines