If you’ve ever spent time in a hospital — either as a patient, staff member, or visitor — then you know that institutional health care is extremely complicated by nature.

1. HOSPITAL ADMINISTRATION
INTRODUCTION
CHAPTER I - MANAGEMENT OF MEDICAL AND HEALTH SERVICES
CHAPTER II - HOSPITAL MANAGEMENT SYSTEM
CHAPTER III - ESSENTIAL ELEMENTS OF HOSPITAL ADMINISTRATION
CHAPTER IV - FUNCTIONAL HOSPITAL ORGANISATION
CHAPTER V - MEDICAL RECORDS & HOSPITAL
CHAPTER VI - HOSPITAL INVENTORY MANAGEMENT
CHAPTER VII - EPIDEMIOLOGY AND ENVIRONMENTAL HEALTH

2. HOSPITAL MAMAGEMENT
Introduction
Hospital Management is a new theory in management faculty. Earlier a senior doctor used to perform
the role of a hospital manager. However, nowadays everything demands a specialist. Almost all the
things related to hospital have changed. Many categories concerning medical sciences and hospital
have altered totally. There are various types of hospitals today, including ordinary hospitals, specialty
hospitals and super specialty hospitals. The categories are regarding to the types of facilities they
offer to the people. Eligible professionals are needed for the smooth operating of a hospital. Various
courses and training programs have been developed to find out eligible hospital managers.
A hospital manager is in a way responsible for administrative dealings of the hospital. He accepts the
charge of various aspects of hospital management and health administration reverencing to the
patients and healthcare.
Eligibility Required For Hospital Management
Bachelor of Hospital Administration is a three-year degree course for the undergraduate students.
The students should have finished their 10+2 with Biology with total 50% marks, for BHA degree.
Masters in Hospital Administration is a two-year duration postgraduate course. This course is
available for both medical and non-medical background candidates. Graduates in any stream can
apply for this program.
Personal skills required for Hospital Management
A number of potentials are required for a candidate for this field. The candidate must have rapid
judgment capability related to up-to-date management doctrines and techniques. Friendly attitude,
ability to handle public and pressure, ability of handling deadlines, brilliant communication skills and
leadership skills are required to an efficient hospital manager.
Job opportunities in the Hospital Management
There are plenty of job opportunities in the field of Hospital Management. Assistant Hospital
Administrator is the best option for the fresh degree holders. They can start their career as managers
of non-health departments like finance. Anyone having this degree can find job in large corporate and
public zonal hospitals, international and domestic healthcare institutes and health insurance
companies, nursing homes.

3. CHAPTER I
MANAGEMENT OF MEDICAL AND HEALTH SERVICES
Overview
Earnings of medical and health services managers are high, but long work hours are common.
A master's degree is the standard credential for most positions, although a bachelor's degree
is adequate for some entry-level positions in smaller facilities.
Employment will grow fastest in residential care facilities and practitioners' offices and clinics.
A. Nature of the Work
Healthcare is a business and, like every other business, it needs good management to keep it
running smoothly. The term "medical and health services manager" encompasses all individuals who
plan, direct, coordinate, and supervise the delivery of healthcare. Medical and health services
managers include specialists and generalists. Specialists are in charge of specific clinical
departments or services, while generalists manage or help to manage an entire facility or system.
The structure and financing of healthcare is changing rapidly. Future medical and health
services managers must be prepared to deal with evolving integrated healthcare delivery systems,
technological innovations, an increasingly complex regulatory environment, restructuring of work, and
an increased focus on preventive care. They will be called upon to improve efficiency in healthcare
facilities and the quality of the healthcare provided. Increasingly, medical and health services
managers will work in organizations in which they must optimize efficiency of a variety of interrelated
services, for example, those ranging from inpatient care to outpatient follow-up care.
Large facilities usually have several assistant administrators to aid the top administrator and to
handle daily decisions. They may direct activities in clinical areas such as nursing, surgery, therapy,
medical records, or health information.
In smaller facilities, top administrators handle more of the details of daily operations. For
example, many nursing home administrators manage personnel, finance, facility operations, and
admissions, and have a larger role in resident care.
Clinical managers have more specific responsibilities than generalists, and have training or
experience in a specific clinical area. For example, directors of physical therapy are experienced
physical therapists, and most health information and medical record administrators have a bachelor's

4. degree in health information or medical record administration. These managers establish and
implement policies, objectives, and procedures for their departments; evaluate personnel and work;
develop reports and budgets; and coordinate activities with other managers.
In group practices, managers work closely with physicians. Whereas an office manager may
handle business affairs in small medical groups, leaving policy decisions to the physicians
themselves, larger groups usually employ a full-time administrator to advise on business strategies
and coordinate day-to-day business.
A small group of 10 or 15 physicians might employ one administrator to oversee personnel
matters, billing and collection, budgeting, planning, equipment outlays, and patient flow. A large
practice of 40 or 50 physicians may have a chief administrator and several assistants, each
responsible for different areas.
Medical and health services managers in managed care settings perform functions similar to
those in large group practices, except their staffs may be larger. In addition, they may do more work
in the areas of community outreach and preventive care than managers of a group practice.
Some medical and health services managers oversee the activities of a number of facilities in
health systems. Such systems may contain both inpatient and outpatient facilities and offer a wide
range of patient services.
Work environment. Some managers work in comfortable, private offices; others share space
with other staff. Most medical and health services managers work long hours. Nursing care facilities
and hospitals operate around the clock; administrators and managers be called at all hours to deal
with problems. They also travel to attend meetings or inspect satellite facilities.
B. Working Conditions
Most medical and health services managers work long hours. Facilities such as nursing homes
and hospitals operate around the clock, and administrators and managers may be called at all hours
to deal with problems. They also may travel to attend meetings or inspect satellite facilities.
Some managers work in comfortable, private offices; others share space with other managers
or staff. They may spend considerable time walking, to consult with coworkers.

5. C. Employment
Medical and health services managers held about 250,000 jobs in 2000. Almost 2 out of 5 jobs
were in hospitals. About 1 in 5 were in nursing and personal care facilities or offices and clinics of
physicians. The remainder worked mostly in home health agencies, ambulatory facilities run by state
and local governments, offices of dentists and other health practitioners, medical and dental
laboratories, residential care facilities, and other social service agencies.
D. Education, Training & Qualifications
Medical and health services managers must be familiar with management principles and
practices. A master's degree in health services administration, long-term care administration, health
sciences, public health, public administration, or business administration is the standard credential for
most generalist positions in this field. However, a bachelor's degree is adequate for some entry-level
positions in smaller facilities and at the departmental level within healthcare organizations.
Physicians' offices and some other facilities may substitute on-the-job experience for formal
education.
For clinical department heads, a degree in the appropriate field and work experience may be
sufficient for entry. However, a master's degree in health services administration or a related field
may be required to advance. For example, nursing service administrators usually are chosen from
among supervisory registered nurses with administrative abilities and a graduate degree in nursing or
health services administration.
Bachelors, masters, and doctoral degree programs in health administration are offered by
colleges, universities, and schools of public health, medicine, allied health, public administration, and
business administration. In 2001, 67 schools had accredited programs leading to the master's degree
in health services administration, according to the Accrediting Commission on Education for Health
Services Administration.
Some graduate programs seek students with undergraduate degrees in business or health
administration; however, many graduate programs prefer students with a liberal arts or health
profession background. Candidates with previous work experience in healthcare also may have an
advantage. Competition for entry to these programs is keen, and applicants need above-average
grades to gain admission. Graduate programs usually last between 2 and 3 years. They may include
up to 1 year of supervised administrative experience, and course work in areas such as hospital

6. organization and management, marketing, accounting and budgeting, human resources
administration, strategic planning, health economics, and health information systems. Some
programs allow students to specialize in one type of facility - hospitals, nursing homes, mental health
facilities, or medical groups. Other programs encourage a generalist approach to health
administration education.
New graduates with master's degrees in health services administration may start as
department managers or as staff employees. The level of the starting position varies with the
experience of the applicant and size of the organization. Hospitals and other health facilities offer
postgraduate residencies and fellowships, which usually are staff positions. Graduates from master's
degree programs also take jobs in large group medical practices, clinics, mental health facilities,
multifacility nursing home corporations, and consulting firms.
Graduates with bachelor's degrees in health administration usually begin as administrative
assistants or assistant department heads in larger hospitals. They also may begin as department
heads or assistant administrators in small hospitals or nursing homes.
All States and the District of Columbia require nursing home administrators to have a
bachelor's degree, pass a licensing examination, complete a State-approved training program, and
pursue continuing education. A license is not required in other areas of medical and health services
management.
Medical and health services managers often are responsible for millions of dollars of facilities
and equipment and hundreds of employees. To make effective decisions, they need to be open to
different opinions and good at analyzing contradictory information. They must understand finance and
information systems, and be able to interpret data. Motivating others to implement their decisions
requires strong leadership abilities. Tact, diplomacy, flexibility, and communication skills are essential
because medical and health services managers spend most of their time interacting with others.
Medical and health services managers advance by moving into more responsible and higher
paying positions, such as assistant or associate administrator, or by moving to larger facilities.
E. Task
The medical and health service management performs many important tasks which include:
Planning the strategies implemented in the hospitals and supervising the daily mechanism under
which the medical staff of the hospital operates.

7. To coordinate with doctors and make plans for the betterment of the medical institution.
To monitor and manage the financial aspects of buying medications and equipments for the
hospital.
Managing of employees in the health organization.
The medical and health service management also makes sure that the patients and people
that are taking consultancy or treatment from their health care organizations are provided with all the
necessary facilities and health assistance that would be beneficial to the patients. The medical and
health service management also manages the financial aspects of running the medical organization
as they take into account all the medicals bills and treatment charges and maintain the accounts.
The medical and health service management has the major responsibility of managing all the
affairs of the business. Any lack of proficiency from the medical and health service management
would result in building bad reputation for the hospital or medical organization is affiliated with. The
health service management should make sure that the patients are treated by expertise doctors and
professional and all the health services being provided to the patients is the most advanced and
reliable.
The medical and health service management have a team of expert employees who are well
versed in managing the managerial aspects of the medical institutions. The hospitals and medical
firms are reluctant to hire any managerial staff and employees if they do not have experience in the
field of the medical and health service managers. Most hospitals require the managerial staff to take
special training and specialization courses before they are added to the department.
The medical and health service management also develop new policies and rules under which
the employees of the hospital have to operate. The medical and health service management
supervise employees and work on strategies to save financial assists of the organizations and to run
the health care industry more prominently.
The medical and health service management organize meetings and perform research
oriented assignments on behalf of the organizations. They also provide the doctors with all the latest
and up to date medical instruments so they can treat the patients professionally. The management is
also responsible for employee training and placement in the organization.

8. CHAPTER II
HOSPITAL MANAGEMENT SYSTEM
Overview
Medinous a flagship product of Nous is an integrated health information system, which
addresses the critical requirements of hospitals. MediNous system provides the benefits of
streamlining of operations, enhanced administration and control, improved response, cost control and
improved profitability.
Medinous can be easily customized to the requirements of any hospital.
Nous Enterprise Solutions Pvt Ltd has developed an integrated Hospital Management System
(HMS), which addresses all the major functional areas of modern multi-specialty hospitals. MediNous
HMS enables better patient care, patient safety, and efficiency and reduced costs. It provides easy
access to critical information there by enabling the management to take better decisions on time.
The package has been developed on the latest relational database system technology ORACLE.
MediNous system provides the benefits of streamlining of operations, enhanced administration and
control, improved response, cost control and improved profitability. MediNous can be easily
customized to the requirements of any hospital.
Other Features of MediNous Hospital Management System:
Medinous HMS is a fully integrated online system.
MediNous HMS supports multi currency system, which is converted to the base currency for
accounting purposes.
MediNous HMS Supports Multi Location implementation wherein the hospital has Outpatient,
Inpatient and other services in many physical locations.
Doctors can get the investigation reports online at their terminal (or any terminal) without
waiting for the physical report reaching them. Doctors can see the previous investigation
results for a patient for better diagnosis.
Doctors can view their daily appointment schedules for any day from any terminal.
MediNous HMS is highly secure and flexible. It allows the administrator to configure different
information access privileges for different individuals depending on their role in the Hospital.
Electronic signature of doctor is attached to the prescription.
Inventory valuation is done in FIFO with earliest expiry date in Pharmacy.

9. MediNous Hospital Management System provides the following reports and more at the click
of button daily cash collections, patient turnover, billing and medical records related reports
etc. Enabling management to take better decisions
Hospital Management System - Help desk
The Help Desk Module automates the day-to-day functions of the Front office management of
a hospital. This module helps in assisting patient with accurate information and supports in handling
patient related enquiries efficiently. This module having excellent features and advanced search
facilities improves the quality of services rendered to the user. It provides for queries relating to the
following:
i. Patient related enquiries
Bed Allotment
Admission Details
Demographic Details
Payment Details and
Discharge Details.
ii. Doctor related enquiries
Availability Details
OP Clinic Details
Appointment Schedules
Operation Schedules and
Charge Details
Hospital Management System – Registration
The Registration module is an integrated patient management system, which captures complete
and relevant patient information. The system automates the patient administration functions to have
better and efficient patient care process
Patient Registration Details

10. Inpatient and Outpatient Registration
Medical Alerts Details
Appointment Scheduling (Patient / Doctor wise)
Doctor's Schedule Summary
Doctors Daily Schedule List
Patient Visit History
Medical Record Movements
Appointments for Radiology tests and Operation Theatre
Patient Visit Slip
Sponsorship Details
It provides for enquiries about the patient, the patient's location, admission, and appointment
scheduling and discharge details. Furthermore, this system even takes care of package deals for a
patient for a fixed cost. Medical Record keeps an abstract of clinical data about patients. It allows
easy retrieval of medical records on patients.
Hospital Management System - Electronic Medical Record
The EMR Module is a fully integrated knowledge repository that caters to Medical and clinical records
of patients in the hospital. The system supports medical professionals of various departments of the
hospital with relevant information like medical examinations, diagnoses, treatment histories, test
results and so on. The module provides access to critical and complete patient data that leads to high
quality cost effective and efficient patient care. The EMR has the following features
Patient Search with Various Search Strings

11. Patient Demographic Viewing
Previous Visit Details
Medical History of the Patient
Billing Details of Patient
In addition the user can view investigation requests, prescriptions, reports and other clinical
details. The system provides separate access rights for each part of the EMR. The patient medical file
can be securely retrieved from this module and sent across LAN and WAN and also can be E-mailed.
Hospital Management System – Billing
The Patient Billing module handles all types of billing for long-term care. This module facilitates
cashier and billing operations for different categories of patients like Outpatient, Inpatient and
Referral. It provides automatic posting of charges related to different services like bed charges, lab
tests conducted, medicines issued, consultant's fee, food, beverage and telephone charges etc. This
module provides for credit partly billing and can be seamlessly integrated with the Financial
Accounting Module. The billing module is extensively flexible by which each of your billing plans can
be configured to automatically accept or deny. The system is tuned to capture room and bed charges
along with ancillary charges based on the sponsorship category. The Billing Screens is used for In-
patient and Outpatient Billing and Invoicing. Further more the charges for various services rendered
can be recorded through service module and this can be used for billing purpose,
Payment Modes / Details
Sponsorship Conditions Details
Patient Billing Details
Package Installment
Approval from Sponsor
Company Sponsorship Details
Package Registration
Sponsor Verification

12. Retroactive Processing
User-defined Billing cycles
Automatic Room and Board charges
Recurring Ancillary charge capability
Auto-generated Codes and Billing Criteria
Provision for Pre-billing
Extensive third-party Billing
The system supports multiple reports utilizing various print options with user-defined parameters.
Hospital Management System - Financial Accounting
The Financial Accounting Module deals with Cash/Bank, Receipt/Payments, Journal Voucher
and General Ledger etc. Books like Cashbook, Bankbook and Ledger book can be generated. This
module generates reports like Trail Balance, Balance Sheet and Profit and Loss statement. The
Financial Accounting Screens describe about the Account Payable, Account Receivable and General
Ledger. Also describe the activities related to IP, OP, Bank related activities and provision to clearing
the Supplier Invoice and keep track of the Account Receivable and Revenue related activities. The
services that are covered by the sponsor companies, Insurance Agencies, Family Accounts,
Individual Accounts, sponsorship details of the patient, Health Card Insurance are recorded in the
system.

13. Hospital Management System - Fixed Assets
The Fixed Assets Module deals with all the activities that are related to the Fixed Assets Part
of Financial Accounting.
This describes activities that are related to:
Identifying an item as a Fixed Asset
Allocating depreciation
Managing its movement
Maintenance
Revaluation and Disposal etc.,
Hospital Management System – Payroll
The Payroll & Personnel module deals with Pay (and deduction) calculation, printing of salary
slip, salary certificates, and PF statements, Gratuity Statement and provides a monthly analysis.
It deals with the maintenance of employee bio-data, Attendance / Overtime details.
It also reports on absenteeism, leave encasements etc. The Personnel & Payroll department is
responsible Employee Related Activities like appointing the staff, maintaining the employee database,
Fixing allowances and deductions, Leave entitlements, Leave sanctions, Loan, Termination Process,
Maintenance of Hospital documents, Insurance details, Tenancy Contracts and Vehicle Registration.

14. Hospital Management System - Outpatient Management
The Outpatient module serves as an entry point to schedule an appointment with the Hospital
Resident Doctor or Consultant Doctor for Medical Consultations and diagnosis. This module supports
doctors to take better and timely consultation decisions by providing instant access to comprehensive
patient information. Patient visits are divided into New, Follow-up and Review. This module also
handles requests and results of laboratory tests and other examinations. External Doctors visit to in
patients can be defined as "Call on". Some patients may avail only the hospital facilities like Lab,
Radiology, Nuclear Medicine, and Physiotherapy and so on.
Medical Alerts Details
Consultation Duty Roster
Diagnosis Details
Triage Parameters
Patient‘s Appointments
Daily / Weekly Schedule Summary
Appointment Scheduling / Rescheduling Facility
Outpatient Medical Observation Details
Investigation / Treatment History
Clinical Service Details
Group / Package Registration Facility
Common Billing Clinical Services
Doctor‘s Diagnosis Statistics
Further more, Confidentiality of Doctors Observation, Previous History of Patients Visit, Online
Prescription, Online Request for Investigations and so on, are the special features in Doctors

15. Observation screen. This system calculates the cost for the services rendered to the patient and
reflects in the billing module appropriately resulting in smooth billing process.
Hospital Management System - Inpatient Management
The inpatient module is designed to take care of all the activities and functions pertaining to
Inpatient Management. This module automates the day-to-day administrative actives and provides
instant access to other modules, which leads to a better patient care. It provides comprehensive data
pertaining to Admission of Patients & Ward Management: Availability of beds, Estimation, Agreement
preparation, Collection of advance, planned admission, Emergency admission and so on. The
Inpatient module also deals with Ward Management: Shifting from one ward to the other, Bed
availability, Surgery, Administration of drugs, nursing notes, charge slip and so on.
Admission Cost Estimation
Admission Approval
Admission Request
Doctor Transfer Details
Nursing Notes
IP Medical Observation
Pending Drug Request
Surgery Scheduling Details
Discharge Notification Summary
Expected Date and Time of Discharge
The module tracks every visit made by the patient and caters to follow-up visits of patients, along
with multiple appointments.
Hospital Management System – Pharmacy
Enquiry
Quotation
Purchase order
Online approval,
Pharmacy drug configuration
Pharmacy stores configuration
Drug issue to patients and billing
Unit dosage facility

16. Supplier information
Maintenance of drug inventory
Automatic reorder level setting
Purchase Requisitions
Purchase Order
Online request for stock from various sub-stores
Online stock transfer
Maintenance of stock at different sub-stores
Return of items nearing expiry
Destruction of expired items
Physical stock verification and adjustment
Goods receipt
Stock Transfer (inter store stock transfer)
Stock Adjustment
Stock in Hand reports
In addition the online prescription facility assists and facilitates the physicians to track the
patient's prescription details and as well reflects the medication billing details in the Billing module.
Hospital Management System - General Store & Inventory
General Stores and Inventory module deals with Purchase of Items, Issue of Items, Maintenance
of Stock, Automatic Reorder level Setting, Online request for stock from various sub-stores, Online

17. stock transfer, maintenance of stock at different sub-stores, Physical stock verification and
adjustment, Return of items to supplier etc
Stock management
Multi UOM and Multi currency system
Stock control
Stock Purchase through Enquiry generation
Sub stores issues and receipt of stocks
External hospital stock issues and receipt
Option to include and track gift or donation of stock
Stock requisitions from sub-stores and corresponding management
Quotations and Purchase Requisitions
Purchase order generation and processing- LPO, Emergency Purchase order, Principal and
Blanket PO
Advance payment requisitions to Finance
Goods Receipt Note and Purchase returns
Automatic stock updates on receipt of goods
Stock returns and destruction tracking
Invoice verification
Supplier management and supplier payment bucket facility available
Supplier invoice management
Hospital Management System – Laboratory
The Laboratory module automates the investigation request and the process involved in delivering
the results to the concerned department/doctor of the hospital. Laboratory module starts with
receiving the online request from doctors and also allows laboratory personnel to generate requests.
The Laboratory module supports to perform various tests under the following disciplines:
Biochemistry, Cytology, Hematology, Microbiology, Serology, Neurology and Radiology. Tests are
grouped under various sections and sample type (specimen). Based on the request the user can
input the sample and generate the sample number. Results can be entered based on the sample type
either to one test or multiple tests. If the test result requires approval, the supervisor has to approve
the result and it is made available to concerned doctors.
Sample Result Entry
Test Report Entry

18. Specimen Association Details
Antibiotic Details
Result Range for Test
Investigation Request
Bulk Sample Request
Sample Details
Samples Received from External Laboratory
Samples Dispatch to External Reference Laboratory
Investigation and Treatment History
Test report can be made confidential. Tests can be performed only after the billing is done. This
rule is exempted when the case is declared as Urgent. In addition, this module facilitates
investigations for referral patients.
Hospital Management System – Radiology
Radiology module caters to services such as X-ray, Scanning, Ultra sound etc. Scheduling of
Radiology resources is possible. The system stores all the result details of various tests and makes a
Report based on the Test Results.
These Tests are carried out both for Inpatient and Outpatient. The system stores all the details
(like patient number, Test Report like X-Ray, Scanning details) and for each scan the system
generates a unique number for the image.
Investigations can be done only after the billing is done. This rule is exempted when the case
is declared as Urgent.

19. Hospital Management System - Nuclear Medicine
The main function of this module is to conduct the various Tests and make a report based on the Test
Results and a unique number is generated for each image.
The tests are carried out for Inpatient and Outpatient.
Appointments have to be fixed by the Patient before the test.
The concerned consultant analyses the result and makes a report based on the findings.
Hospital Management System – Physiotherapy
This module facilitates tracking the services given to patients depending on the consultant's
recommendations. Physiotherapy sessions are carried out both for Inpatient and Outpatient.
Appointment has to be fixed by the patient for these sessions. All the Appointments to the
Physiotherapy will be through the consultant. There will be no direct appointment.
Hospital Management System – Dental
Dental module caters to the services rendered by the dentists. Treatment and follow-up
treatments are tracked using this module. Progress readings can be recorded through this module.
Hospital Management System – Service
The service module deals with all the services available in the hospital and the charges for these
services are stored through this module. There are various services that are available in the hospital
can be seen in
i. Service Master: This master gives the details about package details, Group detail

20. ii. Room Type Master: This gives the details about Room Type (Ex: Private, Semi-private,
Deluxe, ICU, Suite etc) and their charges.
iii. Consultation Charge Master: This gives the details about Doctor and the charges (like new
visit, Follow-up, Review and Call-on).
iv. Revenue Type Master: This gives the predetermine charges for various service given by
hospital (Like Ambulance, Anesthetists Fee, Baby Cot etc).
Hospital Management System - User Manager
The User Manager module basically deals with security through controlling the access to the
information available in the application. Any user associated with a user group can access only those
screens for which the user group has rights. It also deals with the System Related Activity like User
Monitor, Creating User Group Master, User Master and view the User Group Lookup of employee
database, Maintenance of company documents, User defined error message, Generating Daily
Statistical Summary

21. CHAPTER III
ESSENTIAL ELEMENTS OF HOSPITAL ADMINISTRATION
The healthcare industry is highly regulated by a complex statutory and regulatory framework at
every level. Electronic commerce in such a highly regulated industry presents some challenges to say
the least. States have approached e-commerce in a myriad of ways, leaving consumers and
businesses confused as to whose law applies. Electronic records and signatures are essential
elements of many electronic transactions, particularly in healthcare. Electronic signatures that can't
be forget. It is a computed digest of the text that is encrypted and sent with the text message.
A digital signature created by use of encryption keys can provide this high level of security
because it ties an originator's identity to an electronically transmitted message by means of an
algorithm. The digital signature is not a computer's "picture" of a handwritten signature, but a
condensed mathematical representation of the message itself that can be created only by the
originator using a private encypted key. Thus, a digital signature provides authentication of data and
user.
A. Signatures and Certificates:
A digital signature ensures that the document originated with the person signing it and that it
was not tampered with after the signature was applied. However, the sender could still be an
impersonator and not the person he or she claims to be. To verify that the message was indeed sent
by the person claiming to send it requires a digital certificate (digital ID) which is issued by a
certification authority
The sender uses a one-way hash function to compute a small digest of her text message.
Using her private key, she encrypts the digest, turning it into a digital signature. The signature and the
message are then encrypted using the recipient's public key and transmitted. The recipient uses his
private key to decrypt the text and derive the still-encrypted signature. Using his public key, he
decrypts the signature back into the sender's digest and then recomputed a new digest from the text
message. If the digests match, the message is authenticated. Digital signatures are a fundamental
component of business in cyberspace. And numerous laws, state and now federal, have codified
digital signatures into law. These laws are a mistake. Digital signatures are not signatures, and they
can't fulfill their promise. Understanding why requires understanding how they work.

22. i. Health cares information and its use
E-SIGN provides guidance on how records may be stored and retained electronically. If a
document is required to retain by law, an electronic version of the document will be acceptable. The
electronic document accurately reflects the information in the record and is accessible to all relevant
people in a form that may be accurately reproduced at a later date, whether by printing, electronically
transmitting or other means. No specific type of technology is mandated by E-SIGN. The law is
technology neutral; allowing individual parties to choose the technology that best suits their needs.
The term "electronic" is defined broadly in E-SIGN and means related to technology having electrical,
digital, magnetic, wireless, optical, electromagnetic or other similar capabilities. Under E-SIGN, the
term "transaction" means an action or set of actions relating to the conduct of business, consumer or
commercial affairs between two or more persons. The term "electronic record" means a contract or
other record created, generated, sent, communicated, received or stored by electronic means.
Health care records (HCR) include both information‘s relating to the physical or mental
health of patients, and information regarding the provision of health care by health care practitioners
or health care facilities. Relatives, social workers and other third parties may supplement personal
health information provided by the patient. The provision of health care is recorded in the professional
notes, observations and opinions of health care practitioners and administrative staff. These data are
entered into the health care record not only by the health care practitioners caring for the patient
(including physicians, dentists, nurses and professions allied to medicine) but also by professionals
providing support services, non-clinical staff acting on the professionals behalf and even by patients
themselves. This diversity of origin and use of health care data present problems of security in the
conventional and electronic health care records.
ii.Issues in security of electronic health care records
EHCR are health care records that are stored, processed or transmitted using computer
technology. The EHCR enables information to be used simultaneously by many individuals who may
be remote from each other and from the patient, but this can be achieved only by use of the
appropriate computer equipment. Thus the user who has no access to the necessary hardware or
lacks the skills to operate it may be denied the information. In contrast, it is possible for those with the
skills to examine and alter computer records without leaving any indication of their actions.
Computerized records can be stamped with the identity of the users who create or modify them,

23. although the mechanisms, by which most computers currently confirm the user's true identity, such as
through password control, leave much to be desired and impersonation is not difficult. To compound
the problem, identical copies of EHCR can be made at will, often without trace, readily transmitted
over networks that now encircle the globe and linked with other data about the same individual to
compile detailed profiles of their life style, health and financial status.
B.Ethical and legal aspects
The consequences of using an insecure information system in health care are far reaching.
Patients may be embarrassed by, or socially ostracised following, disclosure of sensitive information
about mental health, sexually transmitted diseases, adolescent care, drug addiction and genetic
fingerprints. Their clinical care may be compromised by inaccurate or missing data as a result of
unauthorised modification, from system malfunction or due to errors in program design. There is the
potential for serious harm or death should such errors remain unrecognised. The EHCR must
therefore be designed, implemented and run in such a way that the potential to harm the patient is
minimised. Information security is a complex and highly technical subject with which even computer
professionals are rarely fully conversant. Very few health care professionals have sufficient
understanding of the principles of information security to confidently assume responsibility for security
of information.
If properly designed, access to EHCR can be controlled more comprehensively than is
possible with the conventional HCR. The introduction of the EHCR thus offers the opportunity to
comply more closely with the ethical requirement to respect the individual's right to privacy while not
impeding the freedom of access to information needed by the clinicians involved in delivery of health
care.
In either case, we would suggest that the overall responsibility for security of health care data in
a health care facility rest with the most senior clinician (e.g. the medical director or Dean) or
delegated authority. There is no justification for access to health care records to be controlled by the
administrative staff who own or operate the computer system holding EHCR, even though they may
have the responsibility to ensure that the mechanisms controlling access are applied effectively.
Regular audits of these security measures should be conducted but physical controls such as
encryption may be necessary where regular monitoring is not considered feasible.

24. C.Special Consumer Protections
The term "consumer" means an individual who obtains, through a transaction, products or
services, which are used, primarily for personal, family or household purposes. E-SIGN imposes
special requirements on anyone obligated to provide written disclosures to consumers. Those special
requirements are imposed to ensure that consumers can make fully informed decisions about
electronic transactions and to provide some protection for consumers. Essentially, E-SIGN provides
that the consumer must have affirmatively consented to receive the required information
electronically.
Under E-SIGN, threshold questions in healthcare are whether a proposed arrangement is a
transaction for purposes of E-SIGN, whether the transaction is affecting or in interstate commerce,
whether a consumer is involved and what exceptions, if any, apply. If it is assumed that E-SIGN
applies to electronic healthcare transactions (and in most cases that may be a reasonable
assumption), there still are many unanswered questions about how electronic commerce in
healthcare should be conducted.
D. Product Liability in Medical Care Delivery
A person who alleges an injury caused by a defective product may elect to base his legal
cause of action on any of the three principles of products liability theories: negligence, warranty, or
strict liability. These may be the criteria in criminal, civil, or consumer case proceeding for product
liability in the court of law. However, the proceeding on a negligence theory in a products liability case
requires an injured party to show that a specific defendant failed to exercise proper care in designing,
testing, manufacturing, or marketing the allegedly defective medical product and that, as a reasonably
foreseeable and proximate result of such negligence, the patient suffered the injury.
The miraculous extension of life by high technology medical care, organ transplantation,
mechanical substitutes, newer antibiotics, anesthetic agent and prosthetic products show the
increase in powers of medical care delivery. Developing concurrently with the remarkable
achievements of modern medical science and technology has been a similarly profound legal
revolution in the body of law commonly known as products liability. Product liability describes the
physical agent, which caused the injury in a situation in which a person is under a legal duty to the
injured person. The injury or death of the patient may result unexpectedly by faulty, defective or
negligently designed medical or surgical instruments or inadequate operating instructions. The
manufacturer becomes responsible for injury or death in such case. The patient must prove that the

25. defendant manufacturer departed from standards of due care, with respect to negligent design,
manufacture, assembly, packaging, failure to test and inspect for defects or failure to warn or give
adequate instructions. If the instrument functioned satisfactorily in previous operations or for several
previous years in the hospital‘s possession, it is a proof that it was not defective at the time of
supplying. If subsequently the instrument develops a defect through ordinary and gradual wear and
tear, or if the physician or the hospital misuses the manufacturers, medical products, the negligence
liability would be imposed on the hospital or physician owner for the failure to inspect, test and repair
such defects. The manufacturer becomes responsible if the patients can prove that the subsequent
development of this defect was due to negligent design, structurally inferior component material, or
improper assembly. An adequate warning cautions the user to follow directions and may also notify
the risk of disregarding directions1. This article reviews the theories available to an individual who
alleges an injury cased by a defective product and sets forth the elements necessary to establish a
cause of action on any of the principal products liability theories and the potential liability of the
manufacturer of drug, blood products, medical equipments and various other product used in medical
care delivery when some thing goes wrong due to the use of these product and comment future of
product liability.
i. Theories of products liability
Whatever the danger and state of medical knowledge, and however rare the susceptibility of
the user, when the drug company positively and specifically represents its product to be free
and safe from all dangers, and when the treating physician relies upon that representation, the
drug company is liable when the representation proves to be false and harm results. The legal
doctrine of negligence may be defined in terms of the duty of the person of ―ordinary sense‖
grounds for products liability case requires an injured party to show that a specific defendant
failed to exercise proper care in designing, testing, manufacturing, or marketing the allegedly
defective product and that, as a reasonably foreseeable and proximate result of such
negligence, the patient suffered injury.
Historically, a purchaser of goods has also been able to claim a breach of warranty
against the immediate seller on the grounds that the goods were not as they were contracted
to be. If a buyer could show that a seller made representations either expressly or impliedly
about the quality of the goods that turned out to be inaccurate, the buyer would be allowed to
recover appropriate damage without establishing any negligence by the seller. In early
common law, the rule of cavent emptor, or ―buyer beware‖, prevailed. Changing social and
economic considerations resulted in warranties, but only in situations where there had been an

26. actual sale contract. ―Given the contractual underpinnings of this cause of action, courts were
reluctant to expand recovery for breach of warranty against anyone with whom the patient had
not directly contracted. The term ―privity‖ was given to the requirement that the parties have
had actual dealings among themselves. ―As the common law developed, however, certain
aspects of tort law were grafted onto warranty law. As a result of this commingling of tort and
contract law with breach of warranty actions, the privity requirement gradually eroded. Today,
most countries including India allow a suit for breach of warranty against a seller by the
ultimate consumer-under consumer protection act. An injured party proceeding on a warranty
theory of liability need not prove negligence. Instead, it must be shown that the manufacturer
or seller breached an expressed or implied promise that the product was both free from
defects and fit for the ordinary purposes in which such products are customarily used.
Many countries have evolved basis for liability on the part of the manufacturer of a
defective product. This is known as ―strict liability in tort‖. The theory behind strict liability is that
is better social policy for manufacturers, rather than injured consumers, to bear the economic
burdens, through products liability insurance or otherwise, for any injuries caused by defective
products. Under the strict liability theory, an injured party need not prove negligence or any
breach of warranty, but rather must establish only that the product causing the injury was
defective when it left the control of the manufacturer or the seller.
Generally, there are four fundamental types of product defects. The first may be
considered the ―manufacturing defect‖. An improperly manufactured product is one that has
been incorrectly manufactured or assembled and is thereby different from similar products
manufactured. The second category of defective products is the defectively designed product.
Such a products is identical to similar products manufactured by the defendant, all of which
bear a common design flaw that renders the product unreasonably dangerous. The third
category is a product that is defective because it has been inadequately tested. The fourth
category is a product that is considered defective because the manufacturer has failed to
provide the user with proper warnings or instructions regarding the product‘s use. This type of
claimed defect occurs frequently in cases involving pharmaceutical and medical products.
Under the strict liability theory, potential liability attaches not only to the product‘s
manufacturer, but also to its retailer and to any other person in the distribution chain who is ―in
the business of selling such a product‖. Development in products liability theories, from
negligence through strict liability, has made it easier for an injured party to establish a viable
theory of recovery. Each new theory has expanded the law rather than merely replaced its

27. predecessor. This broadening of recovery theories, however, has added new complexities to
the products liability field. Depending on the facts of the case and upon the theories advanced,
each products liability cause of action will have separate elements, varying burdens of proof,
and different potential defenses. The central theme, however-which runs throughout all
products liability causes of action in the existence or nonexistence of a product defect at the
time the product left the defendant‘s control. This theme is essential to products liability and
distinguishes it as a separate and unique field of law.
ii. The manufacturer’s liability
A manufacturer‘s liability for its products may be established under the three theories
discussed above negligence, warranty, and strict liability. For an injured party patient to
establish a successful cause of action in negligence it must be proved that the defendant
manufacturer departed from reasonable standards of due care with respect to the design,
testing, manufacture, assembly, inspection, packaging, or advertising of the product or failed to
warn or give adequate instructions with respect to its use. The manufacturer owes this duty of
due care to the ultimate user and not just to the immediate purchaser. A manufacturer‘s liability
on the theory of breach of warranty is often more closely linked with the contract of sale
between the parties involved, specifically the manufacturer and the injured buyer. Privity of
contract has been the principal hurdle in breach of warranty actions. Even if privity can be
established, traditional warranty theory also requires the patient‘s reliance, to his detriment, on
an express or implied assertion by the defendant about the nature of the defective product.
Without all of these elements, which are often difficult to establish, a warranty action will fail.
Strict liability is a more attractive theory for a patient because it eliminates the key requirement
of a negligence cause of action – the need for the patient to show that the defendant failed to
exercise proper care in the manufacturing or marketing of the product. It also avoids the need
for any contractual obligations between the manufacturer and the injured party as requirement
for recovery. Under the strict liability theory, a patient needs only to establish that the product
in question was so defective as to be unreasonably dangerous and that, as a result, injury was
suffered.
In developing drug theories, the courts have expressly recognized and taken into
account the fact that some products are ―unavoidably unsafe‖ given current scientific
knowledge. While there are very few decided cases, it would seem that this previously
developed liability jurisprudence is directly applicable to artificial medical aid and given the
embryonic nature of scientific understanding and experience in this field. To support the

28. analogy of artificial organ liability concepts in terms of established drug liability theories,
greater detail of a manufacturer‘s duty deserves review. The manufacturer has the duty to
warn of complications, side effects, and any potential hazards associated with its products.
This duty requires a manufacturer to warn of known hazards as well as those hazards that it
has a reasonable basis to suspect might occur. The courts have expressly recognized that
prescription drugs are ―unavoidably unsafe products‖ that can be dispensed only under a
physician‘s authorization. With extraordinary medical devices, there is no question that the
manufacturer has the duty to furnish full and complete warnings to any physician considering
implanting such a device. The question, which logically and necessarily follows, is whether the
manufacturer‘s duty to warn also extends to the patient-consumer. Although in the prescription
drug context a manufacturer‘s duty to warn generally extends only to the medical community, it
is unclear at present whether, with respect to extraordinary medical devices, the
manufacturer‘s duty to warn should also extend to the patient-consumer.
iii.Liability of the physician
A patient‘s suit against a physician for an injury resulting from the physician‘s treatment
is predicated on professional negligence or malpractice. Malpractice may be defined as ―bad or
unskillful practice on the part of a physician or a surgeon resulting in injury to a patient. : the
―failure of a physician to exercise the required degree of care, skill, and diligence,‖ or ―the
treatment by a surgeon or a physician in a manner contrary to accepted rules and with injuries
resulting to the patient,‖ are all base upon which malpractice claims may be founded.
To present a cause of action for malpractice successfully against a professional
practitioner, the patient must establish four essential elements. First, a cause of action must
show that the physician in question owed the patient-patient a particular duty or obligation.
This legal duty derives from the physician patient relationship, which requires the physician to
act in accordance with specific standards of care established by the profession for the
protection of the patient against unreasonable risks. Second, the patient patient must establish
that the physician failed to act in accordance with these standards. An act or omission violating
the standard of care owed to the patient is required. Third, the patient-patient must establish
that a causal and reasonably foreseeable connection exists between the acts or omissions of
the physician and the resulting injury. Fourth, the patient patience must prove that the
physician‘s or omissions caused some actual loss or damage. The failure to establish any one
of these four elements may defeat a malpractice claim.

29. Claims for breach of warranty provide an alternative approach for actions by patients
against medical practitioners resulting from injuries suffered from medical instruments, drugs,
or devices used in treatment. The determinative issue in this instance is whether a sale existed
upon which a warranty action could be based 7. A sale of goods, independent of the medical
services provided, is generally the touchstone for warranty recovery. Strict liability, has
become a frequent theory upon which attempts to establish a physician‘s liability are often
premised by a patient injured through the use of any medical instrument or device. However,
courts have been hesitant to apply strict liability against physician. Courts analyzing the
physician-patient relationship have noted that the primary purpose of this relationship is the
performance or rendition of professional medical service, distinguishing this from the sale of
medical products. Accordingly, most courts in various country have rejected the application of
the strict liability theory to the medical treatment provided by physicians.
Respond superior is a common law doctrine that imputes responsibility for an
employee‘s acts, carried out during the course of his employment, to the employer as the one
who derives advantage from the act and, therefore, must answer for any resultant injury. The
two requirements for application of this doctrine are specific. The person charged with liability
must be an employer, or someone in direct control of the party who allegedly caused the injury.
Further, the person charged with causing the injury must have been acting with the ―scope of
his employment‖ at the time the injury resulted. These two requirements have restricted
application of this doctrine in the health care context. A doctor is a professional and
traditionally was not classified as a hospital employee. Rather, the doctor was viewed as an
independent contractor – retained at the expense and will of the patient, not the hospital.
Although development in this area has been slow, some jurisdictions have changed the legal
status accorded hospitals. Hospitals have an integral role in the patient‘s overall treatment, and
patients assume that if an error is committed, the hospital will take responsibility. This is based
on the ―apparent authority‖ of the hospital to supervise the treatment given, and has become
another basis for attributing liability to hospitals.
The law is accepted in a majority of jurisdictions. That hospital‘s potential liability is to
encompass most, if not all, of the hospital‘s physicians, specialist, and staff. Another basis
adopted by some jurisdictions for hospital liability for negligent treatment is termed corporate
negligence. Under this doctrine, established by the USA Supreme Court in the leading case of
Darling v. Charleton Community Memorial Hospital, a hospital has a duty to provide adequate
medical care to its patients. This duty charged the hospital with responsibility for all treatment,

30. which takes place within its boundaries; extending liability beyond activities traditionally
considered under their direct control and governed by principles of respondents superior and,
thus, includes liability for acts or omissions of persons, such as physicians, who are not
hospital employees. These broad principles of negligence liability on the part of the hospital
would seem to be equally applicable in the specialized area of organ transplantation, although
it must be recognized that proof of negligence in this evolving scientific area may often be
difficult.
E. Essential Elements for Postabortion Case
Complications from spontaneous abortions and unsafely induced abortions pose a serious
global threat to women's health and lives. An estimated 46 million induced abortions are performed
annually; about 20 million are unsafe, and 95% of these take place in the developing world. Unsafe
abortion accounts for an estimated 13% of pregnancy- related deaths—representing approximately
67,000 women—every year. In many other cases, unsafe abortion causes such long-term
consequences as chronic pain, pelvic inflammatory disease, tubal occlusion and secondary infertility.
Hospital records from developing countries suggest that 38-68% of women treated for complications
of abortion are younger than 20; while these data suggest that abortion complications take a high toll
on adolescents, they represent only young women who make it to a hospital for treatment. The World
Health Organization (WHO) estimates that 10-50% of women who have an unsafe abortion need
medical care; some women who experience spontaneous abortion also need treatment.
The tragedy of unsafe abortion—which WHO defines as "any procedure for terminating an unwanted
pregnancy [carried out] either by persons lacking the necessary skills or in an environment lacking the
minimal medical standards, or both"—is that it is the most easily prevented cause of maternal death.
Unmet need for acceptable contraceptive services results in large numbers of unwanted or
unintended pregnancies. With one in four women living in countries where abortion is forbidden or
allowed only to save a woman's life, safe and legal abortion services are out of reach for many
women with an unwanted pregnancy.
Some barriers to addressing unsafe abortion and related maternal morbidity have been
reduced or eliminated over the last several decades—for example; some laws restricting access to
contraception have been lifted or liberalized. Other barriers, however, remain; these include limited
resources, restrictions on midlevel providers' performance of uterine evacuation and political
sensitivities about abortion-related issues. Although modern contraceptives have become
increasingly accessible, use remains low in many countries. An estimated 120-165 million women,
including 12-15 million unmarried women, want to prevent or space their pregnancies but are not

31. using a method; many resort to unsafe abortion. Even if all contraceptive users were to use methods
perfectly all the time, nearly six million unintended pregnancies would occur annually.
While most health systems provide treatment for abortion complications as part of emergency
obstetric care, the infrastructure to make these services widely available usually is lacking in
developing countries. Policies that prohibit midlevel providers from offering treatment for abortion
complications result in reduced services. Global initiatives with the potential to address unsafe
abortion as a preventable cause of maternal mortality—specifically, the Safe Motherhood Initiative,
launched in 1987—have been hindered by the perception that unsafe abortion is not a "core" safe
motherhood issue (because it is the result of an unwanted pregnancy and is not related to childbirth),
and by social and political sensitivities regarding abortion.
In this comment, we chronicle the development and expansion of a post abortion care model
designed to promote interventions that address abortion-related public health concerns even when
abortion laws and policies are restrictive. We review years of program experience with the original
model, which led to the development of an expanded and updated model, Essential Elements of
Postabortion Care (PAC). Implementing the model challenges global public health leaders, donors,
technical assistance agencies and ministries of health to work with communities to ensure that all
women who want to prevent or space pregnancies can obtain contraceptive services; that all women
have access to services to manage complications from abortion, whether induced or spontaneous;
and that all women receiving treatment also receive counseling and the reproductive and other health
services they need at the treatment visit, as well as follow-up care and contraceptive resupply.
F. Origins of Postabortion Care
Since the 1950s, many developed and some developing countries have liberalized their
abortion laws, although this trend is not much evident in Africa or Latin America. Arguments for legal
reform usually center on public health concerns such as reducing maternal mortality and improving
reproductive health, as well as on the recognition of reproductive rights as an essential element of
human rights. The political situation and commitment of advocacy groups in each country largely
determine the success of liberalization efforts. However, the Helms Amendment has prohibited the
direct use of U.S. foreign aid for most abortion-related activities since 1973. At the 1984 International
Conference on Population in Mexico City, the U.S. government further restricted population funding:
Under the "Mexico City policy," foreign nongovernmental organizations that used their own funds to
perform abortion (in cases other than those in which the pregnancy threatened the woman's life or
resulted from rape or incest), to provide counseling and referral for abortion, or to lobby to make
abortion legal or more available could no longer receive family planning support from the U.S. Agency

32. for International Development (USAID). That policy was lifted in 1993, under the Clinton
administration, but was reinstated in 2001 under the Bush administration.
As clarified by a presidential memorandum in 2001, the policy does not prohibit support for "treatment
of injuries or illnesses caused by legal or illegal abortions, for example, post-abortion care.‖ However,
with widespread restrictive abortion policies, a new language and a new strategy were needed to
enable agencies to implement programs and conduct operations research on abortion-related
treatment and related reproductive health services.
The term "postabortion care" was first articulated as a critical element of women's health initiatives in
Ipas's 1991 strategic planning document, which encouraged "the integration of postabortion care and
family planning services in health care systems" as a means of breaking the cycle of repeat unwanted
pregnancy and improving the overall health status of women in the developing world. In 1991, Ipas
listed postabortion family planning and other reproductive health care as essential elements of a
framework for providing quality abortion care, based on Bruce's quality of care framework; in 1998,
Ipas and PRIME published a framework for quality of postabortion care.
In 1993, AVSC International (now EngenderHealth), Ipas, the International Planned
Parenthood Federation (IPPF), the JHPIEGO Corp. and Pathfinder International formed the
Postabortion Care Consortium to educate the reproductive health community about the
consequences of unsafe abortion and promote postabortion care as an effective public health
strategy. In 1994, Ipas published the original postabortion care model, which comprised three
elements: emergency treatment services for complications of spontaneous or unsafely induced
abortion; postabortion family planning counseling and services; and links between emergency
abortion treatment services and comprehensive reproductive health care.
The original model presented postabortion treatment as an essential emergency obstetric
service. Health systems often relied on resource-intensive uterine evacuation methods, such as sharp
curettage (also known as dilation and curettage, or D&C), that prevented them from offering services
at every health care level. To reduce barriers to treatment for women, services needed to be high-
quality, locally accessible and sustainable by the health care system. Vacuum aspiration has a typical
effectiveness rate of more than 98% and, compared with sharp curettage, is associated with lower
rates of the four most common uterine evacuation complications. In 1991, a WHO technical working
group identified vacuum aspiration as an essential element of care at the first referral level (i.e., at
sites to which primary-level providers refer women needing treatment for abortion
complications).Electric vacuum and manual vacuum aspiration have equivalent effectiveness rates.
Manual vacuum aspiration, an accessible and low-cost method, enables midlevel providers and other

33. health professionals in primary-level facilities that do not have operating theaters, general anesthesia
or electricity to offer uterine evacuation on-site. Offering uterine evacuation at primary-level facilities
also creates an opportunity for providers (often the same ones who perform uterine evacuation) to
offer reproductive and other health services at the treatment visit.
Second, the model emphasized the need for postabortion family planning services. A working
group at a pivotal 1993 conference in Bellagio, Italy, recommended that "a range of contraceptive
methods, accurate information, sensitive counseling and referral for ongoing care should be made
available and accessible to all women who have undergone abortion." The group further
recommended that "at a minimum, women should leave abortion-care facilities understanding their
immediate return to fertility, that there are ways to prevent future unwanted pregnancies and where to
obtain contraceptive methods, if they so desire." Research has since demonstrated the benefits of
contraceptive services in preventing abortion.
The third element of the model linked emergency abortion treatment and comprehensive
reproductive health services. In many developing countries, a woman's first or only contact with the
formal health care system may be when she visits a facility for postabortion care. That visit creates an
opportunity for providers to assess her health needs and to offer appropriate reproductive health or
other services
.
Through the 1990s, international conferences and organizations increasingly began to press
population, safe motherhood and women's health initiatives to support women's right to postabortion
care. The 1994 International Conference on Population and Development (ICPD) Programme of
Action urged all governments and organizations to "strengthen their commitment to women's health"
and "deal with the health impact of unsafe abortion as a major public health concern" The Fourth
World Conference on Women, held in 1995 in Beijing, recognized that "unsafe abortions threaten the
lives of a large number of women, representing a grave public health problem as it is primarily the
poorest and youngest who take the highest risk," and referred to the ICPD Programme of Action for
solutions. IPPF and the International Federation of Gynecology and Obstetrics defined women's
rights related to sexual and reproductive health in 1995 and 1997, respectively. In 1996, the
International Confederation of Midwives passed a resolution promoting the participation of midwives
in the provision of Postabortion care services. The 1999 ICPD +5 Conference Programme of Action
strengthened the call to "recognize and deal with the health impact of unsafe abortion as a major
public-health concern by reducing the number of unwanted pregnancies through the provision of
family planning counseling, information and services and by ensuring that health services are able to
manage the complications of unsafe abortion."

34. Significantly, even though the Bush administration reinstated the Mexico City policy, the policy
explicitly permits the continuation of postabortion care programs Nonetheless; integrating
postabortion care into global and national programs has been a slow process.
G. Experience with the Original Model
As postabortion care gained global support, governments and agencies began to implement
programs; a USAID evaluation in 2001 confirmed that more than 40 countries had postabortion
activities. During the middle and late 1990s, programs following the original model focused mainly on
introducing manual vacuum aspiration at tertiary-level facilities and strengthening linkages between
treatment and family planning services. Results from a study in Kenya showed that the most effective
approach to integration in a hospital setting was for staff to provide family planning on the gynecologic
ward. A 1997 Population Reports provided recommendations for postabortion care service
improvements and expansion beyond hospital facilities. Although an increasing number of tertiary
facilities were offering services, only a small proportion of women who experienced complications
from unsafe or incomplete abortion were finding their way to hospitals for treatment and postabortion
family planning services. Operations research from several countries contributed significantly to
increased momentum for decentralized postabortion services.
To expand access, some ministries of health authorized midwives and other providers at
primary-level facilities to offer postabortion care services, including treatment with manual vacuum
aspiration. In many cases, this occurred once services at tertiary and other hospital facilities were
functional and could accept referrals for abortion complications that could not be managed by
primary-level providers. In the late 1990s, with funding from USAID and assistance from cooperating
agencies, the governments of Ghana, Kenya and Uganda demonstrated that midwives in primary-
level facilities could provide high-quality postabortion care services using manual vacuum aspiration
and that primary-level services increased postabortion family planning counseling and method
provision.
Essential Elements of Postabortion Care
Community and service provider partnerships
• Prevent unwanted pregnancies and unsafe abortion
• Mobilize resources to help women receive

35. appropriate and timely care for complications of
abortion
• Ensure that health services reflect and meet
community expectations and needs
Counseling
• Identify and respond to women's emotional and
physical health needs and other concerns
Treatment
• Treat incomplete and unsafe abortion and
potentially life-threatening complications
Family planning and contraceptive services
• Help women practice birth spacing or prevent an
unwanted pregnancy
Reproductive and other health services
• Preferably provide on-site, or via referrals to other
accessible facilities in provider's network
The momentum created by project results, together with revised country-level reproductive
health service policies and standards supporting postabortion care by mid- and primary-level
providers, led to the expanded availability of services. Results from a study with private-sector nurse-
midwives in Kenya, as well as anecdotal evidence from a pilot project in Uganda, illustrated that
additional health services should be offered or were being offered to women following the provision of
treatment and contraceptive services. During this time, several other agencies and countries
independently added to their postabortion care model a reproductive health counseling element to
support women in resolving issues related to abortion and a community element to promote
education for community members, reduce the need for abortion and improve reproductive health.
These well-documented efforts prompted further expansion of service delivery into primary health
care facilities and communities, and increased support for prevention-oriented postabortion care
activities. Results from the USAID global evaluation of postabortion care reinforced this momentum.
Inspired by the trend toward more comprehensive postabortion care services, in June 2000, PAC
Consortium participants formed a task force to initiate an update and expansion of the original
postabortion care model.

36. H. Essential Elements of Pac Model
The Essential Elements of PAC model, endorsed by the PAC Consortium in May 2002,
reflects, from a provider and a consumer perspective, an enhanced vision of high-quality, sustainable
services. The model's five elements (see box) shift the focus from facility-based medical treatment to
a public health approach that responds to women's broader sexual and reproductive health needs.
i. Community and Service Provider Partnerships
This element of the model recognizes community members' vital role in treatment, prevention
and advocacy efforts. Community health education and mobilization have been identified as key
strategies to combat unsafe abortion, increase access to and quality of postabortion care programs,
and improve women's reproductive health and lives. To achieve universal local access to sustainable,
high-quality postabortion care and related health services, community leaders and advocacy groups,
lay health workers, traditional healers and formally trained service providers must work in partnership.
Components of this partnership include the following:
• Education to increase contraceptive use and thereby help women prevent unwanted pregnancy,
space births and reduce unsafe abortion;
• Participation by community members in decisions about availability, accessibility and cost of
services;
• Education about obstetric emergencies and appropriate care-seeking behaviors;
• Mobilization of community resources, including transportation, to ensure that women experiencing
obstetric emergencies receive timely care;
• access to services for special populations of women, including adolescents, women with HIV or
AIDS, women who have experienced violence or genital cutting, women who have sex with women,
refugees, commercial sex workers, and women with cognitive or physical disabilities;
• Advocacy for holistic, human rights-based reproductive health policies and services that meet
community expectations, priorities and needs; and
• planning for sustainability.
ii. Counseling
Effective counseling enhances a woman's understanding of the psychosocial circumstances
surrounding her reproductive past and future, and increases her confidence in her ability to participate
in her health care. Client- centered counseling ensures that women, rather than their providers, make
voluntary choices about their treatment, contraceptive methods and other options. Postabortion care
counseling covers more than fertility and contraception—although it must emphasize these
elements—and consists of more than information provision and sensitive communication. This

37. counseling provides an opportunity to help women explore their feelings about their abortion, assess
their coping abilities, manage anxiety and make informed decisions.
Counseling is a vital element of care, moving postabortion services from being purely curative
to being preventive. It helps providers determine when women need special care because of extreme
emotional distress or circumstances such as young age, inexperience with the health care system or
fear of discrimination. Some expected benefits of counseling are that client-provider interactions will
be more respectful, treatment will be less painful and more effective, women's understanding and use
of other health services will increase, their satisfaction with the health care encounter will rise and
health outcomes will improve. The aims of counseling are to
• solicit and affirm women's feelings and provide emotional support throughout the
postabortion care visit;
• ensure that women receive accurate and appropriate information about their medical
conditions, test results, treatment and pain management options, and follow-up care;
• ensure that women understand how to prevent complications after the procedure and that
they know when and where to seek care for complications if they arise;
• help women clarify their thoughts and decisions about pregnancy, abortion, treatment,
resumption of ovulation and future reproductive health; and
• enable providers, by listening to and asking questions of women, to better understand and
respond to factors that can affect a woman's health care needs, such as experiences with
sexually transmitted infections (including HIV), violence-induced trauma or the effects of
female genital cutting.
iii.Treatment
The first element of the original model and the focus of many postabortion care activities,
treatment remains a critical part of care, because woman who has had an incomplete spontaneous or
unsafely induced abortion will, in many cases, need uterine evacuation and other medical
intervention. The revised model includes language recognizing that postabortion care does not
always involve complications and that complications are not always life-threatening but may be in the
absence of swift and appropriate medical attention. It further recognizes that safe, effective treatment
involves the use of vacuum aspiration wherever possible and includes standard infection prevention
precautions, informed consent, appropriate pain management, sensitive physical and verbal patient
contact, and follow-up care.

38. iv. Family Planning and Contraceptive Services
The revised postabortion care model recognizes that some women receiving postabortion
treatment need family planning services to help them space births, while others need contraceptive
services because they have no plans to conceive. Therefore the model emphasizes the importance of
overcoming barriers to offering family planning and contraceptive services during the same visit and
at the same location as postabortion treatment. When a facility does not provide these services at the
time of abortion-related treatment, the opportunity to provide them may be lost. Women may not
make another visit, to that facility or another, for such services. In addition, if the facility is not the one
that a woman would go to for resupply of her method, or if it does not have her method of choice,
providers need to link her to a referral site. Ideally, the woman would leave the treatment facility with
an interim method to use until she obtains her preferred method at a referral site. For this to happen,
facilities' contraceptive service infrastructure must be adequate, and providers must be
knowledgeable about which methods are appropriate for women following treatment.
Making a wide range of births pacing practices and contraceptive methods—including, where
authorized, emergency contraception—available to all women of reproductive age is an effective
strategy for preventing unwanted pregnancies and unsafe abortion, and for helping women achieve
their reproductive desires. Facilities must ensure that treatment is not contingent upon women's
acceptance of a contraceptive method.
v. Reproductive and Other Health Services
An important relationship in the new model is between effective counseling and increased use
of the reproductive and other health services women want. The model encourages the provision of all
appropriate health services at the time women receive postabortion care, preferably at the same
facility. When a facility is unable to provide needed services, it should have functional mechanisms in
place for making referrals (either within the facility or to another one), receiving feedback from referral
sites or providers, and performing follow-up; such mechanisms should include consistent and
accurate record-keeping. The following additional services might be offered:
• Education about the prevention of sexually transmitted infections, including HIV, as well as
screening, diagnosis and treatment;
• Services addressing gender-based violence, including screening, counseling and referral;
• Infertility diagnosis, counseling and treatment;
• Nutrition screening and education, and treatment of nutritional deficiencies;
• Hygiene education; and
• Screening, counseling and treatment for reproductive-related cancers.

39. I. CHALLENGES IN IMPLEMENTATION
Implementers of the Essential Elements of PAC model face some of the same obstacles that
hampered both the original model and new ones. Service delivery challenges include establishing
sustainable procurement and resupply mechanisms for uterine evacuation instruments,
contraceptives, and essential drugs and supplies; improving contraceptive method provision, infection
prevention and pain management practices; and ensuring that services are high-quality, accessible
and sustainable. Another challenge is meeting the growing expectation that community partnerships
and counseling can increase access to and use of reproductive health services, improve the quality of
clinical interventions and even prevent health problems from occurring.
Social, religious, policy and legal restrictions on abortion and contraception continue to pose
challenges to programs offering postabortion care. Advocacy will be needed to increase awareness
and implementation of postabortion care in Safe Motherhood, essential emergency obstetric care and
other global health initiatives. Continued advances in women's rights are necessary as opinion
leaders, partners and family members persist in limiting women's contraceptive, pregnancy and
childbirth choices. One of the greatest challenges will be finding creative ways to meet the increasing
need for high-quality contraceptive, postabortion care and other reproductive health services in a
context of stable or declining resources. As countries and organizations embrace the Essential
Elements of PAC model, they will need strategies such as introducing elements of the model in
prioritized order over time or altering service provider guidelines and networks to maximize the use of
already overburdened and limited resources.
J. .FUTURE DIRECTIONS
The PAC Consortium will reach out to global partner organizations to share best practices for
expanding postabortion care activities to include the five essential elements. As programs based on
the Essential Elements of PAC model are designed, implemented and evaluated, and our
understanding of high-quality, sustainable services is further informed, further revisions to the model
are likely. In communities implementing the model, we can expect to see increased use of
reproductive health and postabortion care services; earlier emergency care-seeking behavior;
increased contraceptive use; fewer unwanted pregnancies; fewer unsafe and repeat abortions; and,
most likely, fewer maternal deaths. Anticipated results at health care facilities include increased
quality and use of contraceptive, postabortion care and other reproductive health services that
respond to community needs and priorities; enhanced provider performance in meeting women's

40. postabortion care and other health needs; and improved referral systems and follow-up mechanisms
for contraceptive, postabortion care and other health services.
As health care evolves from a strictly medical to a broader public health focus, to reflect both
consumer and provider perspectives and to encompass curative and preventive services, leaders and
consumers should demand that women's sexual and reproductive health care be made still more
comprehensive and accessible. Leaders and consumers must also continue to strengthen advocacy
networks to promote women's broader health needs and concerns, and call on health systems to offer
a complete range of high-quality preventive, diagnostic and treatment services linked to social and
legal support systems. Implementing such a vision of comprehensive, integrated services will reduce
the need for treatment of abortion complications and enable women to exercise their full sexual and
reproductive rights.

41. CHAPTER IV
FUNCTIONAL HOSPITAL ORGANISATION
During the last decade, there has been a transition from viewing the company as a number of
functional departments to a business structure focusing more on the business processes being
performed (McCormack, Johnson, 2001) There are many reasons why this transition has taken place,
but the most important is that a process-oriented company should be more focused on the needs of
the customer and should be able to deliver better value in terms of end-to-end services.
In the hospital world, process orientation has been introduced through new organisation
models such as the patient-focused hospital (Lathrop et al., 1991) and the development and
implementation of new co-ordination mechanisms such as clinical pathways (Zander, 1992). A
change in the organizational structure or an implementation of clinical pathways does not
automatically lead to more process orientation culture. Therefore, it is important for management to
know to what extent the different changes compel an organisation towards process-orientation. This
paper looks at how process orientation can be measured using data from one large European
University hospital. After a restructuring in divisions and the implementation of the care programs and
clinical pathways, hospital management came to the conclusion that they had no tools to evaluate if
these changes were resulting in a process orientation on the work-floor. In agreement with hospital
management, an existing tool of business process orientation measurement was adopted and
adapted to the specific context of healthcare. This paper reports on how the measurement tool was
changed and validated in order to come up with a useful instrument (the Hospital Process Orientation
tool) to measure the process orientation of the employees in the hospital. The Hospital Process
Orientation (HPO) tool can be useful to measure the effects of changes which are assumed to lead to
more process-orientation or even patient focus. In this way the pay-off of these investments can be
made more tangible. The HPO tool offers hospitals a way to evaluate how they are evolving towards
more process orientation.
In the first part of the paper some more insights are given on what the meaning is of process
orientation, more specifically pertaining to hospitals. In the second part of the paper, the process
measurement tool, its adaptation, and validation for hospitals are described. Finally, some managerial
conclusions are put forward.

42. A. The process oriented company
i. Process orientation
The traditional way to structure an organization is through the formation of departments and
vertically functional units consisting of individuals with a similar area of expertise. Up to a few years
ago, this way of organizing was highly dominant: people can specialize themselves within their field of
expertise, the centralization of functions reduces costs, everyone knows which tasks they are
supposed to perform and the structure of the organization can easily be drawn and presented.
However, the functional organization no longer fits into these current characteristics of the rapidly
evolving and technologically deploying business world. During the last decade, there has been a
transition from viewing the company as a number of departments to focusing on the business
processes being performed. The abundant literature on Business Process Management highlights
this transition (Armistead, Rowland, 1998). The focus on business processes implies a strong
emphasis on how work is done within an organization, in contrast to a focus on what is done. A
process is defined as a specific ordering of work activities across time and place with a beginning, an
end, and clearly identified inputs and outputs: a structure for action (Davenport, 1993).
Processes are generally independent of formal organizational structures, crossing functions or
departments and involving people with different expertise and roles. However, formal organizational
structures can strongly influence the effectiveness of processes. Consequently, the main difficulty to
overcome organizational malfunctions and to break cultural barriers will be to identify an
organizational structure that allows the company to focus on processes and not functions. One
possibility to achieve this, is by evolving towards a more process based, horizontally oriented
organization. A more conservative approach would be to set up a matrix organization, in which
functional and process responsibilities interact with each other. A large survey in European
companies confirms that more than 50% of the companies change their structure in the early stage of
the implementation of business process management and that up to 70% do this in a well progressed
stage (Armistead, Pritchard, 1999). Very often, business process management implementations
result in a flatter organization, where people are given more responsibility, get increased decision
making capabilities, act more autonomous and are more flexible whenever needed. A flat
organization allows managers to be close to customers and have a ―first hand‖ awareness of the
reality of the business (Hammer, Champy, 1993). A flatter organization requires role modifications
and a careful consideration of how knowledge is created and transferred across the organization.
There are several other reasons to spend more attention on business processes (Andersen,
Fagerhaug, 2002):

43. • Focusing on processes ensures better focus on the customer;
• Value creation with regard to the end product takes place in horizontal processes;
• Defining process boundaries contributes to better communication and well-understood
process requirements across the functional areas;
• Managing entire processes, operating throughout different departments, reduces the
risk of sub optimization;
• Appointing process owners avoids fragmentation of responsibilities;
• Managing processes provides a better foundation for controlling time and resources.
In a process oriented organization, processes are mapped so that task responsibilities are
described with a focus on processes. This form of responsibilities exceeds the functional borders and
encourages all members of the different departments to collaborate and achieve common goals. It
also implies the use of process oriented performance indicators, obliging the members of an
organization to work together as one group. The process perspective provides an especially useful
framework for addressing a common organizational problem: fragmentation or the lack of functional
integration.
ii. Process orientation in a hospital
From a historical point of view, hospitals are considered as a collection of professional
functions, brought together to care and later cure for the patients. In this way it is not surprising that
historically these hospitals were organised along functional departments. The further evolution of the
hospital structure has been characterised by increasing specialisation(within the functions) and
centralisation(to capture economies of scales). The consequences by multiple ancillary and support
departments. Such a hospital organisation involves "multiple agents who have partial information,
disparate (local) goals and limited communication capabilities" (Kumar et al., 1993). According to
Galbraith (1973), there are two possible strategies to better co-ordinate the activities in such a
complex organisation: (a) reducing the need for information processing or (b) increasing the capacity
to process more information.
The first strategy of reducing the need for information processing has been strongly
emphasised in the so-called patient-focused hospital idea which has been promoted by several
American consultants. The basic idea of patient-focused hospital is that there is something wrong
with the operating structure of the hospital and that the health service delivery needs to be
restructured in such a way that it is centred on the patient and his needs. This involves creating more

44. or less autonomous departments which are treating resource homogeneous patient groups, and
redeploying resources to such departments and cross-training of personnel (Lathrop, 1993). The
development of more integrated information systems is a second approach to promote integration in a
complex organisation. Kumar and colleagues (1993) find that the greatest benefits of integrated
scheduling of ancillary services are realised when the personnel of the ancillary services do not
consider their intermediate production (e.g. laboratory test) as their final output, but when the patient
is placed central. In other words, accepting integration assumes a patient-focused hospital where the
smooth throughput of patients is more important than the high utilisation of facilities. These ideas are
further developed in the current ‗patient flow‘ literature.
Both strategies place the patient and his needs as the starting point of attention for structuring
the hospital organization. The development of clinical pathways or care maps in the nineties
introduced a new way of working in the hospital world. Clinical pathways (originally called critical
pathways) were originated from the project management methods developed during the 1950‘s for
the manufacturing industry. They can be seen as schedules of medical and nursing procedures,
including diagnostic tests, medications, and consultations designed to perform an efficient, co-
ordinated program of treatment. These clinical pathways were the start of the awareness that the
treatment of a patient must be considered (as a time-based) sequence of activities which are
performed in a team of different professional disciplines (input) to create a certain outcome (output)
(Coffey et al., 2005). The development and implementation of clinical pathways are considered as a
major step in the process orientation of a hospital (Vera et al., 2007). These clinical pathways can be
used in a traditional functional organisation whereby clinical pathways can be considered as projects
or programs which are superimposed on the functional hospital structure.
Based on the previous discussion, it can be concluded that process orientation in hospitals can
be achieved in two ways:
• By implementing coordination mechanisms (such as clinical pathways), horizontal
processes are put on top of the existing vertical structure, without changing the
functional organization.
• A second manner to achieve process oriented thinking is to consider the needs of the
patient as the basis of the creation of a new organizational structure.
This means that the ‗service line‘, which contains multiple services and disciplines, will have to
be optimally organized and integrated with reference to the real needs of the patient. In the extreme