DH Ratnagiri Quality Manual

QUALITY MANUAL
SDH/RAT/AQM/01
RATNAGIRI DISTRICT HOSPITAL

ISO 9001:2008 Based Quality Management System
Quality Manual
PREPARED BY:RMO Dr.BHALCHANDRA NILEGOUNKAR
APPROVED BY: CS Dr. BHALCHANDRA NILEGOUNKAR
ISSUED BY: DCI MR. ANANDA AABASO CHOUGULE
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Document: 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.
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RevisionRecords Sl. No. Issue Date New Version Number Change Description Page No affected Reference of Document Change Request Form Approved by
1.0
All
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TABLE OF CONTENT 1. SCOPE ..................................................................................................... 6
1.1. INTRODUCTION....................................................................................... 6 1.2. HOSPITAL PROFILE ................................................................................. 7 1.3. EXCLUSIONS ........................................................................................... 8 2. 3. 4. NORMATIVE REFERENCES ....................................................................... 9 TERMS & DEFINITION ........................................................................... 10 3.1. 4.1. 4.2. 4.2.1. 4.2.2. 4.2.3. 4.2.4. 5. 5.1. 5.2. 5.3. 5.4. 5.4.1. 5.4.2. 5.5. 5.5.1. 5.5.2. 5.5.3. 5.6. 5.6.1. 5.6.2. 5.6.3. 6. 6.1. 6.2. 6.2.1. 6.2.2. 6.3. 6.4. 7. 7.1. 7.2. 7.2.1. 7.2.2. 7.2.3. Abbreviation and Acronyms ............................................................... 10 General Requirements ....................................................................... 11 Documentation Requirements ............................................................ 14 General........................................................................................... 14 Quality Manual................................................................................. 15 Control of Documents ....................................................................... 15 Control of Records ............................................................................ 18 Management Commitment ................................................................. 19 Patient Focus ................................................................................... 19 Quality Policy ................................................................................... 21 Planning .......................................................................................... 22 Quality Objectives ............................................................................ 22 Quality Management System Planning ................................................ 23 Responsibility, Authority and Communication ....................................... 23 Responsibility and Authority .............................................................. 23 Management Representative ............................................................. 27 Internal Communication .................................................................... 28 MANAGEMENT REVIEW ..................................................................... 29 General........................................................................................... 29 Review Input ................................................................................... 29 Review Output ................................................................................. 31 Provision of Resources ...................................................................... 31 HUMAN RESOURCES ......................................................................... 32 GENERAL ........................................................................................ 32 Competence, Awareness and Training ................................................. 32 Infrastructure .................................................................................. 33 Work Environment ............................................................................ 33 Planning of Service Realization ........................................................... 34 Patient-Related Processes .................................................................. 35 Determination of Requirements Related to the Service.......................... 35 Review of Requirements Related To the Service ................................... 35 Patient Communication ..................................................................... 36 QUALITY MANAGEMENT SYSTEM ........................................................... 11
MANAGEMENT RESPONSIBILITY ........................................................... 19
RESOURCE MANAGEMENT ...................................................................... 31
SERVICE REALIZATION ......................................................................... 34
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7.3. 7.4. 7.4.1. 7.4.2. 7.4.3. 7.5. 7.5.1. 7.5.2. 7.5.3. 7.5.4. 7.5.5. 7.6. 8. 8.1. 8.2. 8.2.1. 8.2.2. 8.2.3. 8.2.4. 8.3. 8.4. 8.5. 8.5.1. 8.5.2. 8.5.3.
Design and Development ................................................................... 37 Purchasing....................................................................................... 38 Purchasing Process ........................................................................... 38 Purchasing Information ..................................................................... 39 Verification of Purchased Process ....................................................... 39 Service Provision .............................................................................. 40 Control of Service Provision ............................................................... 40 Validation of Processes for Service Provision ........................................ 41 Identification and Traceability ............................................................ 41 Patient Property ............................................................................... 42 Preservation of product ..................................................................... 42 Controlling Of Monitoring & Measuring Devices ..................................... 43 General ........................................................................................... 44 Monitoring and Measurement ............................................................. 45 Patient Satisfaction .......................................................................... 45 Internal Audit .................................................................................. 45 Monitoring and Measurement of Processes .......................................... 46 Monitoring and Measurement of Product ............................................. 47 Control of Nonconforming Service ....................................................... 47 Analysis of Data ............................................................................... 47 Improvement ................................................................................... 48 Continual Improvement .................................................................... 48 Corrective Action ............................................................................. 48 Preventive Action ............................................................................. 49
MEASUREMENT, ANALYSIS AND IMPROVEMENT .................................... 44
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
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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.
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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. Orthopaedics 11. Radiology 12. Dental Care 13. Public Health Management
Para Clinical Services 1. Laboratory services 2. Blood Bank 3. Drugs and Pharmacy 4. X-Ray
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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
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2.
NORMATIVE REFERENCES
ISO - 9001:2008 Standard ISO - 9000:2005 Standard
- Quality Management Systems - Requirements. - Quality Management Systems -Fundamentals and Vocabulary
ISO - 9004:2009 Standard - Quality Management Systems - Guidelines for Improvements
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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. S. No. Abbreviation and Acronyms
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39
Acronyms AQM ALOS AERB BARC BMW CMOH CSSD DCI DRMO ENT GRN HAM HCM HMP HOD HRM IA IPD IPHS IQAI ISO CS MIS MOU RMO RMOD RMOM MTP NACO NC NRHM OPD PNDT QMS OT RKS SOP TI VD
Description Apex Quality Manual Average Length of Stay Atomic Energy Regulatory Board Bhabha Atomic Research Centre Biomedical Waste Management Chief Medical Officer of Health Central Sterile Supply Department Document Control In-charge Deputy Management Representative Ear, Nose & Throat Goods Receipt Note Hospital Administrative Manual Hospital Clinical Manual Hospital Mandatory Procedures Head of Department Human Resource Manager Internal Audit In Patient Department Indian Public Health Standards Internal Quality Audit In-charge International Organization for Standardization Civil Surgeon Management Information System Memorandum of Understanding Management Representative Medical Records Department Management Review Meeting Medical Termination of Pregnancy National AIDS Control Organisation. Non Conformity National Rural Health Mission Out Patient Department Pre-natal Diagnostic Techniques Quality Management System Operation Theatre RogiKalyanSamiti Standard Operating Procedure Training In-charge Venereal Disease
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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. c. Determined the sequence and interaction of these processes, 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
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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 to support the Operation and Monitoring of the QMS processes.
available
This Quality Manual and the process documents are defined and managed in accordance with the requirements of ISO 9001: 2008 standards.
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The interaction of various processes defined and established at RATNAGIRI DISTRICT HOSPITAL is as follows
Management Responsibilities Management Review
Resource Management Human Resource Maintenance Equipment Maintenance Human Resource Purchase Stores Housekeeping
Document Control Control of Records
Measurement, Analysis and Improvement Corrective and Preventive Action
Internal Quality Audit
Customer
Customer
Service Realization
Control of Non-Confirming Product
Pharmacy
Nursing
Lab
Medical Records
Front Office Calibration Purchase Stores
Laborat ory
OPD
IPD
Emergen cy
O.T
Labour room
Figure 1
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4.2. 4.2.1.
Documentation Requirements General
RATNAGIRI DISTRICT HOSPITAL has established well-defined documented system to ensure that services rendered are conforming to Patient requirements which includes a) b) c) d) Defined Quality Policy Quality Objectives (specified in process documents) Quality Manual (i.e., This Manual) 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:
Quality Manual
SOPs
Work Instructions
Formats & Records Figure 2 Fig.2
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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 Quality Manual Process Documents Sample Quality Formats and Work Instructions
Approved By
Issued By
CS CS CS
DCI DCI 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
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Process Owner where applicable. The Change Request is reviewed and approved. Based on the approved Document Change Request Form, 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)..
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f. To ensure that documents of external origin are identified and their distribution controlled. All external documents include National or International 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 HODs
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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.
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1. 2. 3.
All quality records are readily retrievable. The minimum retention period is as specified for the documents. 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
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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
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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:
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 peoples need & expectations.
Date PLACE
: :
CIVIL SURGEON Ratnagri district Hospital
FIGURE 3
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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. 5.4.1. Planning Quality Objectives
The Quality Objectives of the RATNAGIRI DISTRICT HOSPITAL are specified at process level in respective 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.
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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) b) c)
Requirements of ISO 9001:2008 Standards; To achieve the quality policy and quality objectives; 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. 5.5.1.
Responsibility, Authority and Communication 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.
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Responsibility Matrix Following table specifies the Responsibilities in relation to ISO 9001:2008 clauses. Sl. No ISO Clause No 4.1 4.2.1 ISO Clause Title QMS Documents Name Responsibility RM O General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records Management Commitment Customer Focus Quality Policy Quality Objectives Quality Management System Planning Responsibility and Authority Management Responsibility Internal Communication Management Review General Management Review Review Input Management Review Review Output Provision of Resources Human Resources General Competence, Awareness and Training Infrastructure QMS documents QMS documents P P CMO Proces s owner S S
1. 2.
N N
3. 4. 5. 6. 7. 8. 9. 10.
4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2
Quality Manual HMP1.5 :Process for Control of documents and records Process for Management Review Quality Manual Process for Management Review Quality Manual Process for Management Review QMS Documents
P P P S P S P P
S N N P P P S S
N S S N P S S N
11. 12. 13. 14. 15.
5.5.1 5.5.2 5.5.3 5.6.1 5.6.2
Quality Manual Quality Manual Quality Manual Process for Management Review Process for Management Review
P P P P P
S S S P P
N N S P P
16.
5.6.3
Process for Management Review
17. 18.
6.1 6.2.1
Process for Management Review HAM- 09 Human Resources Development and Training Management HAM- 09 Human Resources Development and Training Management HAM 07: Hospital Infrastructure/ Equipment Maintenance Management Quality Manual QMS Documents
P S
P N
N P
19.
6.2.2
20.
6.3
21. 22. 23.
6.4 7.1 7.2.1
Work Environment Planning of Product Realization Determination of Requirements
S S S
N N N
P P P
Process for Management Review
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24.
7.2.2
25.
7.2.3
related to the Service Review of Requirements related to the Service Customer Communication
S Process for Management Review
HAM 01: Patient Registration, admission & Discharge Management All SOP HAM 03: Procurement and Outsourcing Management
26. 27.
7.3 7.4.1
Design and Development Purchasing Process
28. 29. 30.
7.4.2 7.4.3 7.5.1
31.
7.5.2
Purchasing Information Verification of Purchased Product Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability Control of Customer Property Preservation of Product Control of Monitoring and Measuring Devices
HAM 03: Procurement and Outsourcing Management HAM 02: Hospital Stores and Inventory management QMS Process Documents
S S S
N N N
P P P
HAM-07:Hospital Infrastructure/Equipment Maintenance Management HCM 09: Data & Information Management HCM 09: Data & Information Management HCM 09: Data & Information Management
32. 33.
7.5.3 7.5.4
S S
N N
P P
34. 35.
7.5.5 7.6
S S
N N
P P
HAM-07:Hospital Infrastructure/Equipment Maintenance Management
36.
8.1
37.
8.2.1
Measurement, Analysis and Improvement General Customer Satisfaction
Quality Manual
HAM 01- Patient Registration, Admission and Discharge Management HMP 01:1.6 Process for Internal audit
38.
8.2.2
Internal Audit
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39.
8.2.3
Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Non Conforming Product
QMS Process Documents
40.
8.2.4
QMS Process Documents
41.
8.3
HMP 01.1.7 QMS Process Documents Process for Control of nonconforming service HMP 01:1.8 Process for Corrective and Preventive Actions QMS Process Documents HMP 01:1.8 Process for Corrective and Preventive actions Process for Management Review HMP 01:1.8 Process for Corrective and Preventive Actions HMP 01:1.8 Process for Corrective and Preventive Actions
42. 43.
8.4 8.5.1
Analysis of Data Continual Improvement
S S
N N
P P
44.
8.5.2
Corrective Action
45.
8.5.3
Preventive Action
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Note: Primary (P) Secondary (S) Not applicable (N)
5.5.2. Top
Management Representative 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.
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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 HODs levels. Action plans at H OD 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.
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5.6. 5.6.1.
MANAGEMENT REVIEW 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
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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
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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
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6.2. 6.2.1.
HUMAN RESOURCES 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 Assistant Superintendent
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
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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 employees 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.
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REFERENCE: HAM 05: Hospital security and Safety Management HAM 08: Hospital Housekeeping and general Upkeep Management RESPONSIBILITY: CS Assistant Superintendent
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.
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RESPONSIBILITY: Assistant Superintendent 7.2. 7.2.1. Patient-Related Processes 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, Patients 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.
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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
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7.3. 7.3.1
Design and Development 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 provision c. 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:
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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. 7.4.1.
Purchasing 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.
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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 includesa. b. c. Requirements for approval of Services, Procedures and Processes. Quality management system requirements. 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.
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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. 7.5.1.
Service Provision 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.
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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
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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 Patients 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 09: Data and Information Management HCM 02: In-Patient (IPD) Management (General/ Critical/ Intensive Care) Responsibility: Medical records In-charge Nursing 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 patients well being which i s 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 02: In-Patient (IPD) Management (General/ Critical/ Intensive Care) HCM 09: Data and Information Management
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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 Manufacturers 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
Assistant Superintendent
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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
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8.2. 8.2.1.
Monitoring and Measurement Patient Satisfaction
1. At RATNAGIRI DISTRICT HOSPITAL, the Patient Satisfaction is measured through: a) Patients 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 02: In-Patient (IPD) Management (General/ Critical/ Intensive Care) HCM 09: Data & Information Management Responsibility: Nursing In-charge Assistant Superintendent
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.
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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 taking the 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. 1.
Monitoring and Measurement of Processes 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. HIC Culture Surveillance is done monthly.
5.
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: RMO DRMO
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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. 1
Control of Non -Conforming Service 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.
Any Critical or Repeated Patient Complaint (both In and Out Clients) relating to Clinical Care and Operations is treated as a Non-Conforming service.
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.
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.
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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) b) c) d) Customer Satisfaction Service Conformity Requirements Characteristics and Trends of Processes including opportunities for Preventive Action. Service Providers Information (if required)
Reference: HAM 07: Hospital Infrastructure/ Equipment Maintenance HCM 09: Data and Information Management HMP 01-1.6 Management Review Procedure Responsibility: RMO
8.5. 8.5.1.
Improvement 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:
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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.
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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
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9.
APPENDIX 1- ORGANISATION CHART Civil Surgeon (CS)
Outreach RMO Clinical RMO Administrative officer
Departmental HOD All Designated Specialist doctor Group D Staff Assistant Superintendent Junior doctor Sr. Clerk Matron Office Superintendent
Clerk Nurse IN-Charge
Staff Nurse
Ward Boy
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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 Reports to CS & is responsible for 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 Reports to CS & is responsible for Maintenance of the Physiotherapy equipments
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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 Reports to CS & is responsible for 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 within the 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.
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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 are inexperienced and orientating them to apply these principles to their daily work. Helping the ward sister to ensure supplies and equipment and rechecking their use and care. Acting as the public relations officers for the unit and deal with problems if any especially with 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
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Co-ordinates with Front Office for registering patients.
10.9 Aaya Report to Nursing Asst & is responsible for Dusting and cleaning of the nurses 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 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. treatment
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Positions and restrains patients; and takes x-rays of patients 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.
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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 Reports to RMO and is responsible for 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
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Collection of Training Feedback Evaluation of Training Program
10.21 Office Clerk Reports to RMO and is responsible for 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 Reports to CS & is responsible for Managing the Pharmacy Counter Management of Pharmacy Inventory
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Co-ordination with the vendor for on time supply Maintaining Pharmacy Records
10.25 Accountant Reports to CS & is responsible for
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
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10.28 ATTENDANT Responsible for transportation of patients to investigation departments and wards as per doctors 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 and Nursing 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.
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11.
APPENDIX 3: LIST OF STATUTORY REQUIREMENTS
Sl. No.
Name of Legal Requirement License under Bio- medical Management and
Status whether present or not Present
handling Rules, 1998. AERB Water and Electricity PNDT MTP License for Blood Bank Fire NOC
3 4 5 6 7 8
Applied Present Present Present Applied Applied
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12.
APPENDIX 4 MASTER LIST OF CONTROL DOCUMENTS
S No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29
Name of the document Procedure for Control of Documents & Records Procedure for Internal Audit Procedure for Control of Non Conformities Procedure for Corrective Action Procedure for Preventive Action Outdoor Patient Management IPD Management (General/ Critical/ Intensive care) Hospital Emergency & Disaster Management Maternity & child health Management Operation Theater & CSSD Management Hospital Diagnostic Management Blood Bank/ Storage Management Hospital Infection Control Management Data & Information Management Hospital Referral Management Pharmacy Management Management of Death Patient registration , Admission & Discharge Management Hospital Stores & Inventory Management Procurement & Outsourcing Management Hospital Transportation Management Hospital Security & Safety Management Hospital Finance & Accounting Management Hospital Infrastructure/ Equipment Maintenance Management Hospital Housekeeping and General upkeep Management Human Resource Development & Training Management Dietary Management Laundry Management Hospital Waste Management
Document no HMP 1.5 HMP 1.6 HMP 1.7 HMP 1.8 HMP 1.8 HCM -01 HCM-02 HCM-03 HCM-04 HCM-05 HCM-06 HCM-07 HCM-08 HCM-09 HCM-10 HCM 11 HCM-12 HAM-01 HAM-02 HAM-03 HAM-04 HAM-05 HAM-06 HAM-07 HAM-08 HAM-09 HAM-10 HAM-11 HAM-12
Revision period One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year One year
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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 Case sheet Bed Head Ticket Daily Clinical Notes Nurses Daily Record HCM 02 In-Patient (IPD) Management (General/ Critical/ Intensive Care) TPR Chart Diagnostic Procedure General Consent FF/IPD/01 FF/IPD/01 FF/IPD/01 FF/IPD/01 FF/IPD/01 FF/IPD/01 FF/IPD/01 FF/IPD/01 Diet Sheet Discharge Summary Record of Death HCM 03 Hospital Emergency and Disaster Management Brought dead Certificate Emergency Medicine Slip Referral slip Birth Report HCM 04 Maternity and Child Health Management Death Report Still birth report Immunization Card HCM Operation Theatre and Consent form Surgery Note FF/IPD/01 FF/IPD/01 FF/ER/01 FF/ER/02 FF/MCH/0 1 FF/MCH/0 2 FF/MCH/0 3 FF/MCH/0 4 FF/OP/03 FF /OT/01 FF /OT /02
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05
sterilization unit Management Hospital Diagnostic Management
Anesthesia Form
FF /OT /03
Blood and Biochemistry Report IPD Report Urine Report Stool Report Radiology Requisition Blood bank requisition form
FF/LB/01 FF/LB/02 FF/LB/03 FF/LB/04 FF/LB/05 FF/BB/01 FF/BB/02 FF/BB/03 FF/BB/04 Nil FF/DI/01
HCM 06
HCM 07
Blood bank/Storage management
Donor screening and registration card Blood transfusion reaction form Cross matching slip
HCM 08 HCM 09 HCM 10 HCM 11 HCM 12
Hospital Infection Control Management Data and Information Management Hospital Referral Management Pharmacy Management Management of Death
Nil MIS Sheet
Patient referral ticket
FF/RM/01
Nil Medical certificate for cause of death
Nil FF/MD/01
FF/OPD/0 OPD Ticket Patient Registration HAM0 1 Admission and Discharge management Investigation Requisition slip for radilogy Case Sheet Discharge Summary 1 FF/0PD/02 FF/IP/01 FF/IP/01
Local Purchase indent form BIN CARD HAM Hospital Stores and 02 HAM0 Inventory management Procurement And Annual Medicine Requirement Plan and Consumables
FF/SI/01
FF/POS/0 1
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Outsourcing Management
Indent / Requisition
FF/POS/0 2 FF/POS/0 3 nil
List of registered Suppliers HAM0 4 HAM0 5 Hospital Transportation Management Hospital Security & Safety Management Cash Book Nil Nil
Nil
FF/FAM/0 1
Bank Reconciliation Statement Hospital finance & Accounts Management Utilization Certificate (GFR 7 A)
FF/FAM/0 2 FF/FAM/0 3
HAM0 6 HAM0 7 Hospital Infrastructure/ Equipment Maintenance Management Hospital Housekeeping HAM0 8 and General Upkeep Management Human Resource HAM0 9 HAM1 0 HAM1 1 Linen & laundry Management Development and Training Management Dietary Management
FROM
FF/FAM/0 4
Nil
Nil
FF/HK/01 Daily Housekeeping and Cleaning Schedule Employee Satisfaction Survey Form Training feedback form FF/HR/01 FF/HR/02
NIL
NIL
Nil
Nil
Form II Annual Report Format HAM1 2 Hospital Waste Management Form III Accident Reporting Format BMW Score card
Records S.No HCM 01 SOP Name Outdoor Patient (OPD) Management Record/ Files OPD Consultation Register Record No. RR/MAH/DH/RAT/ OPD/01
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Immunization register Dressing room register
RR/MAH/DH/RAT/ OPD/02 RR/MAH/DH/ RAT/OPD/03 RR/MAH/DH/RAT/ OPD/04
Injection room register
Registration Register
RR/MAH/DH/RAT/ OPD/05
RR/MAH/DH/RAT/ Complaint Register Admission register OPD/06
RR/IPD/01 RR/IPD/02 RR/IPD/03 RR/IPD/04 RR/IPD/05 RR/IPD/06
Discharge register HCM 02 In-Patient (IPD) Management (General/ Critical/ Intensive Care) Death Record Register Police Case (Injury Register) IPD Indent register Diet register Linen register Emergency register HCM 03 Hospital Emergency and Disaster Management MLC register Police information register Brought in dead register Labour room register MTPregister Maternal death register Baby death register OT register OT intimation register OT Booking Register Fumigation Register Anaesthesia register Operating list Sterilization log book Laboratory Register for OPD Radiology register for IPD
RR/IPD/07 RR/ER/01 RR/ER /02 RR/ER/03 RR/ER /04 RR/MCH/01 RR/MCH/02 RR/MCH/03 RR/MCH/04 RR/OT/01 RR/OT/02 RR/OT/03 RR/OT/04 RR/OT/05 RR/OT/06 RR/TSSU/01 RR/LB/ 01 RR/LB/02
HCM 04
Maternity and Child Health Management
HCM 05
Operation Theatre and sterilization unit Management
HCM 06
Hospital Diagnostic Management
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X ray OPD register X ray IPD register USG register Donors register Issue Register Blood Units Discard Register Master Register for Blood HCM 07 Blood Bank Storage Management HCV Rapid Test Register HIV Rapid Test Register VDRL register HbsAg Rapid Test Register Inventory Register HCM 08 HCM 09 HCM 10 Hospital Infection Control Management Data and Information Management Hospital Referral Management Infection control monitoring register record Issue register NIL Drug store register Oxygen stock registers Daily expense registers Stock register Local Purchase Register HCM 12 Management of Death Mortuary Register OPD Consultation register Registration, Admission and Discharge management Admission Register Discharge Register X Ray IPD Register X Ray OPD Register USG Register Stock Ledger for Medicines Stock Ledger for Equipments Stock Ledger for Contingency Maintenance Register Indent & Receiving register Indent & Receiving register NIL
RR/LB/03 RR/LB/04 RR/LB/05 RR/BB/01 RR/BB/02 RR/BB/03 RR/BB/04 RR/BB/05 RR/BB/06 RR/BB/07 RR/BB/08 RR/BB/09 RR/HIC/01 RR/DIM/01
RR/PS/01 RR/PS/02 RR/PS/03 RR/PS/04 RR/PS/05 RR /MD/01 RR/OPD/01 RR/IPD/01 RR/IPD/02 RR/LB/04 RR/IPD/03 RR/LB/05 RR/SI/01 RR/SI/02 RR/SI/03 RR/SI/04 RR/SI/05 RR/SI/05
HCM 11
Pharmacy Management
HAM01
HAM02 HAM03
Hospital Store & Inventory management Procurement and
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Outsourcing Management HAM04 HAM05 Hospital Transportation Management Hospital Security & Safety Management
Local Purchase Register Ambulance Movement Register / Log Book Attendance register of security guard Petty Cash Book Cheque Issue Register
RR/POS/01 RG/HTM/01 RG/SS/01 RR/FAM/01 RR/FAM/02 RR/FAM/03 RR/FAM/04 RR/FAM/05 RR/FAM/06 RR/IEM/01 RR/SI/04 RG/HK/01
HAM06
Hospital finance & Accounts Management
Register of Bank Drafts Dispatched Ledger Register for Staff Payments Asset Register Master List of Equipments
HAM07 HAM08
HAM09
Hospital Infrastructure/ Equipment Maintenance Management Hospital Housekeeping and General Upkeep Management Human Resource Development and Training Management
Maintenance Register HK Attendant Attendance Register
Training Register Attendance Register for clerical staff Attendance Register for medical Officers Attendance Register for nursing staff Attendance Register for contractual staff Daily diet Register
RR/HR/01 RR/HR/02 RR/HR/03 RR/HR/04 RR/HR/05 RG/DM/01 RR /LL/01 RR /LL/02 RR /LL/03 Nil
HAM10 HAM11
Dietary Management Laundry Management
Laundry register Linen stock register Condemnation register
HAM12
Hospital Waste Management
Nil
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14.
APPENDIX 6 DISTRIBUTION LIST OF CONTROL COPY HOLDERS
S no
Name of the Document Quality Manual
Document code SDH/KAT/AQM/01 HCM 01 12 HAM 01 12
Controlled copy holder RMO, DRMO, IQA, DCI, Training Incharge
1 2 Hospital Clinical Manual
RMO, DRMO, IQA, DCI, Training Incharge
Hospital Administrative Manual
Six Mandatory Procedures
HMP/01
Outdoor Patient Management
HCM -01
Hospital manager/registration clerk/MOIC
IPD Management (General/ Critical/ Intensive care)
HCM-02
Staff nurse/ANM
Hospital Emergency & Disaster Management
HCM-03
MO
9 10
Maternity & Child Health Management Operation Theater & CSSD Management
HCM-04 HCM-05
Staff nurse/ANM Anesthetist/ANM
11 12 13 14 15 16 17 18
Hospital Diagnostic Management Blood Bank/ Storage Management Hospital Infection Control Management Data & Information Management Hospital Referral Management Pharmacy Management Management of Death Patient Registration ,Admission & Discharge Management
HCM-06 HCM-07 HCM-08 HCM-09 HCM-10 HCM 11 HCM-12 HAM-01
Pathologist Blood bank officer Pathologist/ANM Hospital manager MO Pharmacist DMS/MO Registration clerk
19
Hospital Stores & Inventory Management
HAM-02
Pharmacist
20
Procurement & Outsourcing Management
HAM-03
RKS
21 22
Hospital Transportation Management Hospital Security & Safety Management
HAM-04 HAM-05
Hospital manager Hospital manager
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23
Hospital Finance & Accounting Management
HAM-06
Accounts clerk
24
Hospital Infrastructure/ Equipment Maintenance Management
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 28 29
Dietary Management Laundry Management Hospital Waste Management
HAM-10 HAM-11 HAM-12
Nursing I/C Hospital manager Hospital manager
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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
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QUALITY MANUAL

RATNAGIRI DISTRICT HOSPITAL

PREPARED BY:RMO Dr.BHALCHANDRA NILEGOUNKAR

APPROVED BY: CS Dr. BHALCHANDRA NILEGOUNKAR

ISSUED BY: DCI MR. ANANDA AABASO CHOUGULE

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

TABLE OF CONTENT 1. SCOPE ..................................................................................................... 6

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

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

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

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

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

ISO - 9001:2008 Standard ISO - 9000:2005 Standard

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

TERMS & DEFINITION

QUALITY MANAGEMENT SYSTEM

Management Responsibilities Management Review

Document Control Control of Records

Measurement, Analysis and Improvement Corrective and Preventive Action

Internal Quality Audit

Control of Non-Confirming Product

Front Office Calibration Purchase Stores

Documentation Requirements General

Formats & Records Figure 2 Fig.2

DCI DCI DCI

REFERENCE: HCM 09 : Data and Information Management

RESPONSIBILITY: RMO DCI

is a secondary care hospital & shall strive to provide

CIVIL SURGEON Ratnagri district Hospital

Responsibility, Authority and Communication Responsibility and Authority

4.2.2 4.2.3 4.2.4 5.1 5.2 5.3 5.4.1 5.4.2

11. 12. 13. 14. 15.

5.5.1 5.5.2 5.5.3 5.6.1 5.6.2

Process for Management Review

21. 22. 23.

6.4 7.1 7.2.1

Work Environment Planning of Product Realization Determination of Requirements

Process for Management Review

S Process for Management Review

Design and Development Purchasing Process

28. 29. 30.

7.4.2 7.4.3 7.5.1

HAM-07:Hospital Infrastructure/Equipment Maintenance Management

Measurement, Analysis and Improvement General Customer Satisfaction

QMS Process Documents

QMS Process Documents

Analysis of Data Continual Improvement

Note: Primary (P) Secondary (S) Not applicable (N)

Management Representative Management of RATNAGIRI DISTRICT HOSPITAL has appointed

MANAGEMENT REVIEW General

REFERENCE: HMP 01-1.6 Process document for Internal Audits

REFERENCE: HMP.01 section 1.6 Procedure document for Internal Audits

REFERENCE: IPHS Standards for District Hospital

RESPONSIBILITY: CS Assistant Superintendent

HUMAN RESOURCES GENERAL

RESPONSIBILITY: CS Assistant Superintendent

Competence, Awareness and Training

REFERENCE: HAM 07: Hospital Infrastructure / Equipment Maintenance Management

RESPONSIBILITY: CS Administration Clerk

Planning of Service Realization

RATNAGIRI DISTRICT HOSPITAL has established the processes for determining:

Reference: All Clinical and Administrative SOPs Responsibility: RMO

Review of Requirements Related To the Service