Quality Improvement Manual

A Purpose:
• To provide an environment which assures safety for patients/clients, staff and the public,
within a framework of continuously improving quality of care.
• To promote a quality culture and place quality at the core of service delivery.
• To encourage attainment of best practice.
• To promote a patient/client-centered organization and delivery of service

B Scope: Hospital Wide

C Responsibility:
Medical Officer, I/c MO and Quality Assurance Officer.

TYPES OF COMMITTEES

Quality Assurance Team

Quality Assurance Team will be the Highest Executive Quality Improvement Authority in the
hospital. The committee will, in summary, reflect hospital endless Top Management Commitment
to Continuous Quality Improvement. Chaired by Chief MEDICAL OFFICER Quality Control
Officer Department Heads, Hospital Quality Committee will be responsible for overall planning,
directing, prioritizing, implementing and follow up of all CQI Initiatives and activities in the
hospital. On the other hand, The Quality Committee will assure that, all necessary resources
required for successful QM Plan Implementation are devoted at all functional levels.
Scope
Responsibilities, as pertinent to Quality Improvement include but not limited to the followings:
1. Develop (in coordination of Quality Management Department) / approve a Facility wide
Quality Management Plan.
2. Integrate the overall Quality Management Plan and serve as a clearing house for
improvement activities.
 3. Oversee, coordinate, direct and prioritize Quality improvement activities. A high priority
for the QAT will be the monitoring of the delivery of care whenever a new service is
developed with particular emphasis on the transition and development period.
4. Assure the formation of cross-organizational work groups (Departmental Quality
Improvement Teams (DQIT) to assess each function and identify the processes and
activities within that function that are high volume, high risk and/or problem prone.
5. Receive reports monthly or quarterly from each department/service as appropriate and team
reports on organizational Quality improvement activities.
6. Enforce the implementation of Plan, Do, Check, and Act methodology.
7. Review monitoring results that reflect the functions and activities provided by the staff in
different disciplines (administrative, medical and non-medical) within the facility.

8. In coordination with Quality Management Department, QAT will provide reports to the
hospital CMS
9. Receive and evaluate Quality improvement team reports concerning specific activities for
improving organizational Quality.
10. Oversee, coordinate and provide appropriate Quality Improvement information to the
concerned departments and sections (both external & internal)
11. Review and revise the performance indicators and standards/thresholds periodically based
on evidence/data collated over a period of time to as to continuously improve the quality
of Services provided
12. Appointment of the position of quality assurance and improvement coordinator to oversee
the obtaining and maintaining the quality standards and dealing with complaints
13. Initiate regular reviews by the independent specialist in the relevant fields of clinical
practices used in the Hospital in providing the Healthcare Services
Problems that are referred to the QAT through any of the quality management activities, or
identified by the QAT from a study of reports or communications, will be reviewed by the QAT.
The committee will ensure that the responsible department, service or team is taking appropriate
corrective action plans, prioritization and monitoring steps, and activities. Departmental Quality
improvement teams will report on their activities for improving organizational Quality to QMD
Such written and verbal reports are due at the time of presentation at QAT meeting.
Presentation of reports of all Quality improvement activities will include
1. The kinds of Quality Improvement activities that took place during the reporting
period.
 2. Departmental Performance Indicators as defined. The problems, quality issues or
opportunities to improve, if any, that were identified.
4. Evidence of ongoing organizational Quality efforts.
5. Method(s) of problem resolution or referral.
6. The monitoring required including the schedule, method and individual(s) responsible for
monitoring.

The QAT agenda and minutes will include the following:

1. Call to order and approval of minutes.
2. Committee reports (e.g. Transfusion, Pharmacy & Therapeutics).
3. Risk Management reports.
4. Review of previously identified opportunities for improvement, quality issues, analysis,
actions and follow-up.
5. Reports from the Departmental Quality Improvement Teams.
6. Scope of Services reports.
7. Multidisciplinary team reports on improving organizational Quality.
8. Departments’ Quality Improvement reports that integrates disciplines/departments along
the continuum of care.
9. Safety reports.
10. Resource Management reports.
11. Patient Satisfaction Survey Report.
12. Ambulatory Care Services report.
13. Cardiac Arrest report.
14. Medical Audit reports
15. Conclusions and recommendations regarding actions or follow up.

The QAT will assist in planning for improving organizational Quality or evaluating new services.
The following steps will be established:

Organize teams: (multidisciplinary groups/committees, focus groups, task forces) The members
of which will be empowered to implement decisions over the key elements in the process(es) of
delivering services for which improvement efforts are to be made.
Identify the customers): Patients, Relatives, Doctors, Nurses, Clinics, Departments, and
Operating room staff any other individual or group of individuals who will be the recipients of
products and/or services.
Identify the products and/or services of importance to the customers: The patient's and
family/significant other's perception of the quality of health care rendered and staff's opinion will
be considered. Examples of areas for improvement may include: A warm meal, a parking space,
an improved perceived quality of life, a short wait for pain medication, a nice atmosphere in the
waiting area, and privacy in discussions with providers. Additional areas for improvement may
include faster test results, improved communication between nurses and doctors, or any other
variable or relationships subjective or objective that may be important to the customers). Identify
the process(es) that affect important products and/or services: This can be any of the tasks and
activities which affect the customers), e.g., delivering pain medication, transporting food, ordering
tests, cleaning rooms, calling and paging procedures, planning discharge procedures or examining
sentinel events.
Delineate scope of care/service: Each department will delineate the scope of care/services in
hospital through the Plan for Patient Services.
D SCOPE OF SERVICES at Hospital;

1. Services Available
The services provided at Hospital are displayed and the staff are trained and oriented to this
information a. Multi- Specialty services
• General medicine
• Obstetrics & Gynecology
• Laboratory Medicine
b. 24 hr services
• Emergency
• Delivery Facility
• Ambulance
• Pharmacy
c. 24 hr on call services
• Laboratory
2. Services not Available Hospital
(All super specialty services)
• Cardiac Surgeries
• Pediatric Surgery
• Neurology & Neuro Surgery
• Nephrology
• Gastrointestinal Surgery, etc.
E. QUALITY POLICY
We are committed to provide high quality health care services to the people in districts with
sustainable efforts to ensure that it is equitable, accountable, ethical and delivered in dignified
manner. Continuous improvement shall be the guiding principle of all endeavors.

F. SAFETY POLICY
We at Hospital will ensure that all the best practices are adopted for the provision of the highest
quality of healthcare, to guard the overall safety of patients and their attendants, employees,
facilities & the environment.
▪ The Safety of All Patients Is the Primary Responsibility of all the Hospital staff
members.
▪ The Safety of Facility, Assets & the Environment is Important to ensure the provision
of quality services.
▪ Highest Levels of Comfort should be Maintained by Ensuring Occupational Safety so
that the Effective & Efficient Healthcare Practices are Followed.
G. QUALITY PLAN
All services and Departments utilize the established Quality Plan throughout the facility to improve
targeted areas of concern.
The quality improvement plan has been prepared by a multidisciplinary committee of the hospital
under the chairmanship of the hospital .The Committee invited inputs from the staff members and
has established the quality plan in collaboration with staff representatives , hence its has support
and acceptance from the staff members at various level.
QMS documents are established, implemented and maintained to meet the quality objectives of
National standard requirements. Documented QMS comprises of the Quality Policy, Quality
Objectives, Quality Manual, Procedure Manual, and Formats. Records are maintained to
demonstrate that the Medical service conforms to specify patients requirement. QMS meets all the
relevant requirements of the Quality standards. The documentation has been done depending upon
the complexity of processes and also on the competence of personnel performing the tasks.
Quality Manual is the apex document that broadly describes the QMS of Hospital Quality Manual
makes a reference to the standard operating procedures adopted in the hospital.
Formats have been standardized for effective control of operations. Some of these formats, become
records to demonstrate the status on compliance of the QMS and service provision that are
designated as quality records. These are controlled as control of quality records procedures.

H. OBJECTIVES
1. To focus on Quality of patient care.
2. To improve the performance of all professionals & protect patients
3. To monitor, measure, assess and improve performance and to enhance patient satisfaction.
4. To guard, measure and improve patient safety.
5. To inculcate an excellent hygienic treatment process
6. To involve all employees to participate in improving Quality
7. To search for pattern of non-compliance with goals, objectives & standards through:
• Problem identification
• Problem assessment
• Finding the root cause
• Solution Generation
• Plan for the solution implementation
• Implementation of corrective action
• Monitoring
SCOPE:
1. Patient satisfaction
2. Improved Clinical Outcome
3. Reduction in Morbidity and Mortality
4. Improved service quality of the hospital through increased efficiency & effectiveness.
5. Optimum Utilization of resources
 Assurance and Quality Improvement (QA/QI) initiative in the organization in line with the
quality policy of the company
• To develop Annual plan for QA/QI in line with quality Assurance and Improvement
plan as per the Quality policy of the hospital to develop Continuous Quality
Improvement

J. CONTINUOUS QUALITY IMPROVEMENT (CQI)

Quality improvement is about ensuring that our focus is on improving, not just maintaining our
services at Hospital. Quality improvement involves a focus on the safety, effectiveness, efficiency,
acceptability, accessibility and appropriateness of services for consumers (who might be patients,
relatives/parents, or the hospital and other health care professionals).

1. Purpose of continuous quality improvement is to-

1. Monitor patient and staff satisfaction
2. Monitor of quality indicators
3. Monitor of Adverse Drug reactions and medication errors
4. Monitor patient safety indicators
5. Monitor of medical audit results
6. Monitor Utilization of Facilities
7. Monitor Patient Satisfaction Rate
8. Monitor Employee Satisfaction Rate
9. Ensuring fire safety mock drill twice in a year.
10. Ensuring facility safety round twice a year in patient care areas and once a year in non-
patient care areas
2. Goals of Continuous quality Improvement -
A. To utilize an interdisciplinary hospital-wide team approach to Quality improvement
activities
B. To maintain a Quality improvement team to be responsible for each key function and will
evaluate the need for Quality improvement activities for the function on an ongoing basis
by reviewing policies and procedures relating to that function and make necessary revisions
as well as to establish priorities for measuring Quality to initiate Quality improvement
measures in a prioritized manner.
 C. To improve patient care guidelines relating to operative and other procedures, in a
collaborative effort.
D. To utilize a standard format for documenting and reporting all Quality measures hospital-
wide
E. To collect data on staff views regarding Quality improvement activities
F. To establish priorities for Quality improvement activities
G. To develop a formal tool for prioritizing Quality improvement activities

H. To strive to raise the benchmark in all aspect of service delivery and meet the quality
standard expected for the same.
I. To ensure optimum utilization of resources in terms of human resource , infrastructural
resource and financial resource.

K. AUTHORITY AND ACCOUNTABILITY

1. MEDICAL OFFICER (MS)
• The MS is responsible for providing support for the proper functioning of hospital-wide
Quality improvement activities.
• The MS provides support, direction, and/or assists with the resolution of problems or
opportunities to improve care or services as needed.
• The MS provides the corporate office with pertinent information regarding Quality
improvement activities.
2- JOB DISCRIPTION OF QUALITY MANAGER
This position carries responsibility for administration (smooth and quality services) of all non-
direct patient care services and departments in a DH. Manage non-clinical services (like
infection prevention, security, diet etc.), staff and facilitate Rogi Kalyan Samiti meetings and
actions. Specific duties and responsibilities will include:

1. Ensuring good quality non-clinical services like infection prevention, security, diet etc.
2. Ensuring clean surroundings, OPD areas, Wards, Labour room, OT and Patient amenities.
3. Periodical assessment of hospitals on quality check list and arrive at a score for the
facility.
4. Identification of gaps, develop action plan under the guidance of in-charge of the hospital
and monitor compliance.
5. Facilitate conduct of meeting of Rogi Kalyan Samiti. It would include ensuring
preparation of agenda notes, action taken report and minutes of the meeting.
6. Management of out-sourced services such diet, security, laundry, BMW management.
 7. Ensuring that the hospital meets all regulatory compliances such as BMW, Blood
Bank/storage license, AERB regulations, etc.
8. Hospital manager is to take a round of the hospital daily and look at the functioning of
departments, equipment and ambulance. Facilitation of activities for gap closure,
corrective and preventive action.
9. Keep a record of non-functional equipment and time line for its repair along with AMC
for all equipment’s.
10. Supervising punctuality, day-to-day working, supervision of other staff members, work
output and channel the work input to improve overall efficiency and keep unit’s morale
up.
11. Planning and work-out modalities towards upliftment, preventive maintenance of
equipment and vehicles and modernization of the hospital.
12. Analyze utilization of various hospital services and equipment etc.
13. Periodic information and Assessment on utilization of untied grants, AMGs, RKS grant
etc. and timely submission of SOEs and UCs.
14. Analyze financial outlays and its effective utilization.
15. Prepare yearly plan for expenditure after assessment.
16. Carrying out exit interviews, satisfaction surveys (external and internal customer), time
motion studies etc. to keep hospital services up to quality standards.
17. To institute an effective grievance redressal system both for the employees and the
patients.
18. Computerization of DH functions.
19. Strengthen DH MIS, KPI and report actions taken.
20. Prepare monthly/quarterly and yearly report of hospital progress.
21. Perform other duties and work assigned by the hospital in charge.
22. Reporting Team in the District – DPO, DPMO, MEDICAL OFFICERs & DCHS
23. Reporting Team in the State – State programme officer – Quality Assurance (Nodal
Officer), State programme officer - Quality Assurance & State programme officer- Public
health.
24. Weekly progress report on analysis has to submit to the State Team.

[Link] of Departments
The HODs of the respective departments shall review all documents issued to personnel in the
laboratory in the laboratory as a part of management system annually and the shall approve it for
the use.
The HOD’s are responsible for the following:
• Developing and implementing mechanisms designed to ensure the uniform quality of
patient care processes within their department.
 • Developing and implementing an effective and continuous program to measure, assess,
and improve Quality.

• Continuously assessing and improving the Quality of care and services provided.
• Adopting an approach to Quality improvement that includes planning the process for
improvement, setting priorities for improvement, assessing Quality systematically,
implementing improvement activities based on assessment, and maintaining achieved
improvements.
• Participating intra and interdepartmental activities to improve organizational Quality
as appropriate.
• Communicating information relevant to cross-organizational Quality improvement
activities to appropriate individuals.
• Allocating adequate resources for assessing and improving the organization’s
governance, managerial, clinical, and support processes, by assigning personnel, as
needed, to participate in Quality activities; providing adequate time for personnel to
participate in Quality improvement activities, creating and maintaining information
systems and appropriate data management processes to support collecting, managing,
and analyzing data to facilitate ongoing improvement in Quality, and providing for
training of staff in Quality improvement methods.
a. Analyze and assess the effectiveness of their contributions to improving Quality.

[Link] TO DESIGNING, MEASURING, ASSESSING AND IMPROVING

QUALITY at Hospital:
The Hospital has:
• Identified the processes needed for the QMS and their application throughout the
hospital
• Determine the sequence and interaction of these processes.
• Determine criteria and methods needed to ensure that both the operation and control of
these processes are effective.
• Ensure the availability of resources and information necessary to support the operation
and monitoring of these processes.
• Monitor, measures and analyses these processes and
• Implement the actions necessary to achieve planned results and continual improvement
of these processes.
M. PLANNING
Planning for the improvement of patient care and health outcomes includes a hospital-wide
approach.
• The hospital maintains a plan that describes the hospital’s approach, processes, and
mechanisms that comprise the hospital’s Quality improvement activities.

• The Team approach serves as a means of collaboration between departments and

disciplines in planning and providing systematic organization-wide improvements.

N. DESIGNING
Processes, functions or services are designed effectively based on:
• Mission and vision of Hospital
• Needs and expectations of patients, staff, and others.
• Baseline Quality expectations are utilized to guide measurement and assessment activities

O. MEASUREMENT -
• Data is collected for a comprehensive set of Quality measures
• To Establish a baseline when a process is implemented or redesigned
• To Describe process Quality or stability
• To Describe the dimensions of Quality relevant to functions, processes, and
outcomes
• To Identify areas for improvement
• To Determine whether changes in a process have met objectives
• Data is collected as a part of continuing measurement, in addition to data collected
for priority issues.
• Data collection considers measures of processes and outcomes.
• Data collection includes at least the following processes or outcomes:
• Patient assessment
• Operative and other invasive and noninvasive procedures that place patients at risk
 • Laboratory safety & quality
• Diagnostic Radiology safety & quality
• Processes related to medication use
• Processes related to anesthesia
• Processes related to the use of blood and blood components’
• Processes related to medical records content, availability and use
• Processes related to timely procurement of supplies
• Reporting as required by law
• Risk management activities
• Needs, expectations, and satisfaction of patients
• Staff expectations and satisfaction
• Processes related to patient and staff safety
• Process related to optimum utilization of resources.

P. ASSESSMENT-
The assessment process involves the necessary departments to draw conclusions about the need
for more intensive measurement. A systematic process is used to assess collected data in order to
determine whether specifications for newly designed processes were met & the level of Quality
and stability of important existing processes, priorities for possible improvement of existing
processes, actions taken to improve the Quality Improvement processes, and whether changes in
the processes resulted in improvement.
1. Collected data is assessed at least quarterly by the quality assurance committee and findings
are documented and are forwarded through the proper channels.
2. A pre-determined level of Quality, or threshold, which would trigger a more in-depth
review, is established for each Quality measure to assist in the assessment of the data
collected. The reference used may include the following:
a. Internal comparisons in Quality of processes and outcomes are made over time
b. Quality comparison of data is made about processes with up-to- date information
c. Quality comparison of data is made about processes and outcomes with other
hospitals utilizing reference databases when possible
3. The assessment process includes the use of statistical process control techniques/tools as
appropriate. Training for use of statistical process control is provided to the hospital leaders
 where needed; team members/staff are educated regarding statistical process control
techniques on an ‘as needed’ basis.
4. When assessment of data indicates, a variation in Quality, more intensive measurement and
analysis will be conducted and in addition, the department/service or team will reassess its
Quality measurement activities and re-prioritize them as deemed necessary. Intensive
assessment is initiated when statistical analysis shows the following:

a. Important single events, levels of Quality, and patterns or trends that vary
significantly and undesirably from those expected
b. Quality that varies significantly from other organizations
c. Quality that varies significantly and undesirably from recognized standards
5. Intense assessment is performed on the following:
a. Confirmed major transfusion reactions
b. Significant adverse drug reactions
c. Adverse events or patterns of adverse events during anesthesia use
d. Unexpected patient death
e. Wrong site/side/patient surgery
6. When findings of the assessment process are relevant to an individual’s Quality, the
pertinent information will be provided to the Medical Director for determining their use in
peer review and/or periodic evaluations of a licensed independent practitioner’s
competence at reappointment
7. When a Quality measurement does not reach the predetermined acceptable level of Quality,
or if it is reached, but evaluation indicates the Quality is not acceptable, the Quality
improvement process should continue. If the level of Quality shows no improvement for
the time frame established by the department/service team plan, an intensive evaluation is
conducted with input from the Quality Steering Committee regarding the need for
continued measurement or reprioritization.

Q. INTERNAL COMMUNICATION -
The top management has defined and implemented an effective and efficient process for
communicating the Quality Policy, Objectives, QMS requirements and accomplishments. This
helps the hospital to improve the performance and directly involves its people in the achievement
of the Quality Objectives. The Management actively encourages feedback and communication
from people in the hospital as a means of involving them through the following modes.
 ❑ Weekly, fortnightly & monthly meets
❑ Management Review Meetings
❑ Team briefings and other meetings.
❑ Notice Board, Email

R. KEY PROCESSES identified are -

1. Service Delivery
2. Resource Management
3. Management Responsibility
4. Continual Improvement
1) Service Delivery
Planning and development of processes required for the service delivery has been developed and
documented in process map in accordance with the other requirements of QMS. While planning
for any new service, hospital shall determine the following.
i. Quality Objectives and requirements for the services
The need to establish processes, documents and provide resources specific to the service. Required
verification, validation, monitoring, inspection and test activities, specific to the service and the
criteria for service acceptance. Record needed to provide evidence that the service delivery
process meet the requirement. ii. Patient/s – Related Process
Determination of requirements related to the Services Patients/their relatives’ stated and implied
requirements (including if any additional requirements determined by the hospital, legal &
regulatory requirements) are identified before delivery of the service, initiating action to provide
necessary treatment to the patient which are as per the documented procedures. iii. Review of
requirements related to the service
The type of treatment (OPD or indoor) is reviewed for its adequacy based on the information
available for the concerned patient or accompanying relative along with the records of vital
parameters and investigation results. Any changes required subsequently, its communication to
the concerned patient/ relative and to the relevant department is done as per the documented
procedures.
Records of type of treatment identified/ provided are maintained as per the documented
procedures.
Where the patient is unable to provide enough details the statement of requirements as capture by
the concerned doctors are taken as base for providing necessary service and same is conveyed to
the patient and/ or the relatives before providing the treatment for acceptance.
During the course of the treatment of at the end of one set of treatment the consent of the
patient/relative is taken for subsequent treatment, subject to the willingness of the patient and in
case of their unwillingness they may be discharged or referred to other hospital as the case may
be.
iv. Patient Communication
The arrangements for communication on enquiries and service related information, approximate
charges are carried out at the time of registration or at the time of admission of treatment by the
concerned authorities.
Patient feedbacks including complaints are handled as per the various service procedures for the
different type of treatments.
v. Design and Development
The hospital is not directly involved in design and development of devices, equipment or drugs.
Clinical use of established treatment modalities is adopted designed individually for each patient.
As each patient is unique the outcomes are documented and monitored individually and
modifications carried out in the treatment plan. Deviations from expected outcome are
documented in the patient record and discussed by the concerned department. The frequency of
such a review depends upon critically of the disease vi. Quality Objectives and requirements
for the services

The need to establish processes documents and provide resources specific to the service. Required
verification, validation, monitoring, inspection and test activities, specific to the service and the
criteria for service acceptance. Record needed to provide evidence that the service delivery
process meet the requirement.
vii. Patient(s) – Related Process
Patients/their relatives’ stated and implied requirements (including if any additional requirements
determined by the hospital, legal & regulatory requirements) are identified before delivery of the
service, initiating action to provide necessary treatment to the patient, which are as per the
documented procedures.
x. Control of Service Delivery
1. All Medicare service operations are taken care as per the documented procedures manual.
2. Relevant information for norms and acceptable criteria are provided through internal/ external
standards.
3. Suitable infrastructure facilities are provided to ensure the conformity of service/ process
requirements.
4. The necessary instruction manual & protocols are available.

Red tags - (immediate) are used to label those who cannot survive without
immediate treatment but who have a chance of survival.

Yellow – (observation) for those who require observation (and

tags possible later re-triage). Their condition is stable for the moment
and, they are not in immediate danger of death. These victims will still need
hospital care and would be treated immediately under normal circumstances.

Green – (wait) are reserved for the "walking wounded" who will need
tags medical care at some point, after more critical injuries have been
treated.

White tags – (dismiss) are given to those with minor injuries for whom a doctor’s
care is not required.

Black - (expectant) are used for the deceased and for those whose
tags injuries are so extensive that they will not be able to survive given
the care that is available.

xii Patient’s Property -

Service Delivery procedures address the requirement of any items brought in by the patient or the
relative to ensure.
1. Verification on receipt
2. Immediately handing over the patient’s personal belongings to his/her relative. Incase of
absence patient’s relatives, the ward nurse will ensure proper storage of patient’s personal
belongings.
3. Recording of any nonconformity observed such as loss, damaged, unsuitable for use etc.
4. Reporting of non-conformities to customers
5. Trace ability of these items to respective patient by excising control by the attending nurses
6. At the time of admission for specific type of treatment, the valuables of the patient are taken
from the patient & handed over to the relative prior to the commitment of the treatment
 xiii. Preservation of items required for service delivery & patient handling-
The requirements of preservation is primarily identified for the medicine and other disposable
which are meant for administering to the patients are kept duly identified in proper packaging and
storage condition throughout the period of treatment of the patients to protect them safely and
necessary controls are exercised on them so that they are fit for use. After use proper method of
disposals are followed for unusable and disposables.
Proper care is taken for the handling of patients at different stages, locations appropriate for the
type of patients, their age, type of illness and conditional requirement of the patients from time to
time.
Adequate arrangement is made for samples of body fluids, and X-rays etc.
Procedures are defined for handling patient in ICCU& OT and areas of sensitivity. Procedures are
defined for handling dead body and mortuary.
xiv. Control of Monitoring Devices
This requirement of control of measuring and monitoring instrument require for providing different
treatments to the patients are detailed in procedure of the respective function where calibration
activity is carried out to ensure that these instruments are reliable for providing necessary service.
Example anesthesia, radiology, Laboratory etc. The list of equipments and calibration process,
calibration records are detailed in the instruction manuals, wherever applicable.
Members:
1. MEDICAL OFFICER /Medical officer
2. Physician.
3. Nursing I/C
4. Quality manager /Consultant
Objective:
• To evaluate the clinical care given to the patient by the care providers of the hospital by
assessing the patients file (following random sampling of patients medical record).
• To take up and investigate any patient’s grievance in relation to the clinical care given to
the patient in the hospital.
• To suggest remedial measures to the concerned clinician in case any discrepancy in clinical
practices is noted and ensure their immediate implementation.

Frequency of Meeting: Monthly

2. Resource Management.
i. Provision of Resource
Resources required are identified and provided as defined in the organization chart given in the
Quality Manual and documented procedure to ensure that
Implementation, maintenance and continual improvement of
QMS To enhance patient satisfaction.

ii. Human Resources

a. General
Skill requirements for all the positions in the organization chart have been identified. The
competence of personnel is judged at the time of appointment and later on through appraisal
system.
b. Competence Awareness and Training
Competence of the personnel is assessed on the basis of the education, experience, skill and
training before they are assigned the responsibilities in the QMS.
Training needs of all the personnel are identified, established and reviewed to ensure competence
for the responsibility to be assigned. The responsibility for these lies with the department heads
while the MEDICAL OFFICERs (M&F wings) does the overall coordination.
Training needs of the new recruits and personnel transferred from other hospitals are identified
and established as per the requirements. The responsibility of general training program is with the
Administrative department, while specific job-related training is the responsibility of the
department head.
Department In-charge along with the MEDICAL OFFICERs (M&F wings) is responsible for
ensuring the training on identified needs is provided to the employees. MEDICAL OFFICERs
(M&F wings) evaluates the effectiveness of training conducted.
A consolidated database of training records of all the employees is maintained.

Records of personnel qualified for performing specific assigned tasks and activities also
maintained by the MEDICAL OFFICERs (M&F wings) & the individual department In-charge.
iii. Infrastructure
Infrastructure required by all personnel to achieve the conformity of the service requirements are
identified and provided before the commencement of the work/ activity and are maintained and
improved regularly as per the documented procedure.
iv. Work Environment
Work environment needed by all personnel to achieve the conformity of the service requirements
are identified and provided before the commencement of the work/activity and are maintained and
improved regularly.

v. Purchasing
a. Purchasing Process
Purchase activity is carried out as per the documented procedure. Suppliers are evaluated by the
Purchase committee at the time of selection and at regular intervals thereafter, based on their ability
to meet the specific requirements including that of the QMS and any specific quality assurance
requirements. In the process they may seek help of relevant departments. Appropriate controls
are exercised on the supplier only by the Purchase Committee.

b. Purchasing Information
Relevant clerks in the administrative wing and the pharmacy wing is responsible for ensuring that
the purchase orders are reviewed and approved for adequacy of specified requirements.
Purchase orders provide complete details of the materials ordered. Where appropriate attachments
are sent along with the Purchase Orders

c. Verification of Purchased Product

On receipt, the material is inspected by store against the specifications as given in the Purchase
Order. There is no requirement for any customer verification of the Purchase product. Anyhow in
future if any such requirement is there, a suitable system shall be developed

S. QUALITY MANAGEMENT SYSTEM (QMS)

Quality Management System of hospital is established, documented, implemented and maintained
for continual improvement in accordance with requirements of Quality Objectives.
The hospital has established, implemented and maintains a Quality Management System
appropriate to the scope mentioned earlier. Hospital has documented its policies, process, program,
procedure, and instructions and has communicated this to all relevant personnel and has ensured
that these documents are understood and implemented.
The respective Department Head/ In Charge ensure that all the personnel working in the Hospital
have understood the Quality Policy, Quality Assurance system and the objective for adopting the
Quality Assurance System.
Hospital outlines its Quality Assurance System through three-tier documentation structure as
below.
1. Quality Manual- An outline of Hospital and functioning of its management system.
2. Quality System Procedures- The system’s functioning is detailed in separate documents
that are maintained by the quality assurance officer as controlled documents. The quality
manual makes continuous references to system procedures in the relevant sections.
3. Work instructions/Standard-operating procedure: A higher degree with regard to
activities and standards maintained are also maintained with the quality assurance officer
as controlled documents.
❑ Establishing and maintaining a management system
❑ Document control
❑ Documentation of all management system activities
❑ To ensure that quality manual is up to date
❑ Schedule and conduct of internal audit
❑ Schedule and conduct of management review meeting
❑ Ensuring corrective and preventive action arising from the above

T. DOCUMENT CONTROL
1. Documents such as regulations, standards, and other normative documents a well as drawings,
software, and specifications, instructions and manuals form part of the Hospital Management
System. A copy of each of these controlled documents shall be archived for future reference and
the documents shall be retained in their respective department .The procedures and equipment
details are retained in respective as long as he machine is being or until condemned .The documents
are maintained in paper or electronic media as appropriately required.
Documents are identified and established as three levels namely:
Quality manual
SOP/ instruction manuals
Records
Title and naming of documents as outlined in SOP The
Quality Control Officer issues the finalized document.
The Quality Assurance Officer ensures that:
 Authorized editions of appropriate documents are available at all locations where
operations essential to the effective functioning of the Hospital are performed.
Documents are periodically reviewed and revised where necessary to ensure
suitability and compliance with applicable requirements.
Invalid or obsolete documents are promptly removed from all pints of issue or use,
or otherwise assured against unintended use.
Obsolete documents are retained for either legal and / or knowledge preservation
purposes are suitably marked or destroyed or the record and the record of this
maintained in a separate register.
Management system documents are uniquely identified.
Date of issue
Identification of revision status
Page numbering with the total number of pages
Identification of the end of the document
Issuing authority

2. DOCUMENT CHANGES
Revision of management systems documents is carried out when necessary by the original author.
When alternate persons are designated for review, they shall first familiarize themselves with
pertinent background information upon which to base their review and approval.
Any alteration in the text is documented on the document or by way of maintenance of obsolete
documents issued prior to review.
Document control system does not follow for the amendments by hand unless there is extenuating
circumstances .These amendments shall be marked, initialed and dated only by the HOD, .The
amendment shall be brought to the notices of the Chief MEDICAL OFFICER and Quality
Assurance Officer and the same shall be reissued in 7 working days of the change being in effect.
Hospital maintains documentation status currently in hard and soft versions. Hospital describing
the changes in documents, its maintenance and its control in the computerized system establishes
adequate procedures.
U. PREVENTIVE ACTION
The MEDICAL OFFICER is perpetually vigilant and identify potential sources of non-compliance
and areas that need improvement. These may include trend analysis of specific markers such as
turnaround time, risk analysis and introducing proficiency testing for self-assessment.
Where preventive action is required, a plan is prepared and implemented. All preventive actions
must have control mechanisms and monitor for efficacy in reducing any occurrence of non-
compliance or producing opportunities for improvement.

V. CORRECTIVE ACTION
The MEDICAL OFFICER takes all necessary corrective action when any deviation is detected in
Quality Management System.

i. Cause Analysis
Deviations are detected by:
❑ Patient complains/feedbacks
❑ Non-compliance receipt of items/sample
❑ Non-compliance at Internal/external Quality Audit
❑ Management Reviews

The CMS conducts and coordinates the detailed analysis of the nature and root cause of non-
compliance along with the responsible persons from the respective sections.

ii. Selection and Implementation of Corrective Actions

Potential corrective actions are identified and the one that is most likely to eliminate the problem
is chosen for implementation. Corrective action is taken into consideration the magnitude and
degree of impact of the problem. All changes from corrective action is documented and
implemented.

iii. Monitoring Of Corrective Actions

The MS, shall monitor the outcome parameters to ensure that corrective actions taken have been
effective in eliminating the problem.
iv. Additional Audits
When the magnitude of non-compliance cases doubts on the departments’ overall compliance with
documented procedure, additional audits are conducted.
W. FLOW CHART-

Internal audit

Root cause Analysis

Corrective action /Preventive action

Process Reengineering, Protocol

Reconstitution & implementation

Prepared By Quality Team

Dr Noor Fatime SIGN:
Approved & Issued By Medical Superintendent
Dr Faisal Arshad SIGN: