Hospital administration by mahboob ali khan MHA CPHQ USA HARVARD
HOSPITAL ADMINISTRATIONINTRODUCTIONCHAPTER I - MANAGEMENT OF MEDICAL AND HEALTH SERVICESCHAPTER II - HOSPITAL MANAGEMENT SYSTEMCHAPTER III - ESSENTIAL ELEMENTS OF HOSPITAL ADMINISTRATIONCHAPTER IV - FUNCTIONAL HOSPITAL ORGANISATIONCHAPTER V - MEDICAL RECORDS & HOSPITALCHAPTER VI - HOSPITAL INVENTORY MANAGEMENTCHAPTER VII - EPIDEMIOLOGY AND ENVIRONMENTAL HEALTH
HOSPITAL MAMAGEMENTIntroductionHospital Management is a new theory in management faculty. Earlier a senior doctor used to performthe role of a hospital manager. However, nowadays everything demands a specialist. Almost all thethings related to hospital have changed. Many categories concerning medical sciences and hospitalhave altered totally. There are various types of hospitals today, including ordinary hospitals, specialtyhospitals and super specialty hospitals. The categories are regarding to the types of facilities theyoffer to the people. Eligible professionals are needed for the smooth operating of a hospital. Variouscourses 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 thecharge of various aspects of hospital management and health administration reverencing to thepatients and healthcare.Eligibility Required For Hospital ManagementBachelor 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 isavailable for both medical and non-medical background candidates. Graduates in any stream canapply for this program.Personal skills required for Hospital ManagementA number of potentials are required for a candidate for this field. The candidate must have rapidjudgment 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 andleadership skills are required to an efficient hospital manager.Job opportunities in the Hospital ManagementThere are plenty of job opportunities in the field of Hospital Management. Assistant HospitalAdministrator is the best option for the fresh degree holders. They can start their career as managersof non-health departments like finance. Anyone having this degree can find job in large corporate andpublic zonal hospitals, international and domestic healthcare institutes and health insurancecompanies, nursing homes.
CHAPTER I MANAGEMENT OF MEDICAL AND HEALTH SERVICESOverview Earnings of medical and health services managers are high, but long work hours are common. A masters degree is the standard credential for most positions, although a bachelors 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 itrunning smoothly. The term "medical and health services manager" encompasses all individuals whoplan, direct, coordinate, and supervise the delivery of healthcare. Medical and health servicesmanagers include specialists and generalists. Specialists are in charge of specific clinicaldepartments 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 healthservices managers must be prepared to deal with evolving integrated healthcare delivery systems,technological innovations, an increasingly complex regulatory environment, restructuring of work, andan increased focus on preventive care. They will be called upon to improve efficiency in healthcarefacilities and the quality of the healthcare provided. Increasingly, medical and health servicesmanagers will work in organizations in which they must optimize efficiency of a variety of interrelatedservices, 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 tohandle 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. Forexample, many nursing home administrators manage personnel, finance, facility operations, andadmissions, and have a larger role in resident care. Clinical managers have more specific responsibilities than generalists, and have training orexperience in a specific clinical area. For example, directors of physical therapy are experiencedphysical therapists, and most health information and medical record administrators have a bachelors
degree in health information or medical record administration. These managers establish andimplement 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 mayhandle business affairs in small medical groups, leaving policy decisions to the physiciansthemselves, larger groups usually employ a full-time administrator to advise on business strategiesand coordinate day-to-day business. A small group of 10 or 15 physicians might employ one administrator to oversee personnelmatters, billing and collection, budgeting, planning, equipment outlays, and patient flow. A largepractice of 40 or 50 physicians may have a chief administrator and several assistants, eachresponsible for different areas. Medical and health services managers in managed care settings perform functions similar tothose in large group practices, except their staffs may be larger. In addition, they may do more workin 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 inhealth systems. Such systems may contain both inpatient and outpatient facilities and offer a widerange of patient services. Work environment. Some managers work in comfortable, private offices; others share spacewith other staff. Most medical and health services managers work long hours. Nursing care facilitiesand hospitals operate around the clock; administrators and managers be called at all hours to dealwith 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 homesand hospitals operate around the clock, and administrators and managers may be called at all hoursto 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 managersor staff. They may spend considerable time walking, to consult with coworkers.
C. Employment Medical and health services managers held about 250,000 jobs in 2000. Almost 2 out of 5 jobswere in hospitals. About 1 in 5 were in nursing and personal care facilities or offices and clinics ofphysicians. The remainder worked mostly in home health agencies, ambulatory facilities run by stateand local governments, offices of dentists and other health practitioners, medical and dentallaboratories, residential care facilities, and other social service agencies.D. Education, Training & Qualifications Medical and health services managers must be familiar with management principles andpractices. A masters degree in health services administration, long-term care administration, healthsciences, public health, public administration, or business administration is the standard credential formost generalist positions in this field. However, a bachelors degree is adequate for some entry-levelpositions in smaller facilities and at the departmental level within healthcare organizations.Physicians offices and some other facilities may substitute on-the-job experience for formaleducation. For clinical department heads, a degree in the appropriate field and work experience may besufficient for entry. However, a masters degree in health services administration or a related fieldmay be required to advance. For example, nursing service administrators usually are chosen fromamong supervisory registered nurses with administrative abilities and a graduate degree in nursing orhealth services administration. Bachelors, masters, and doctoral degree programs in health administration are offered bycolleges, universities, and schools of public health, medicine, allied health, public administration, andbusiness administration. In 2001, 67 schools had accredited programs leading to the masters degreein health services administration, according to the Accrediting Commission on Education for HealthServices Administration. Some graduate programs seek students with undergraduate degrees in business or healthadministration; however, many graduate programs prefer students with a liberal arts or healthprofession background. Candidates with previous work experience in healthcare also may have anadvantage. Competition for entry to these programs is keen, and applicants need above-averagegrades to gain admission. Graduate programs usually last between 2 and 3 years. They may includeup to 1 year of supervised administrative experience, and course work in areas such as hospital
organization and management, marketing, accounting and budgeting, human resourcesadministration, strategic planning, health economics, and health information systems. Someprograms allow students to specialize in one type of facility - hospitals, nursing homes, mental healthfacilities, or medical groups. Other programs encourage a generalist approach to healthadministration education. New graduates with masters degrees in health services administration may start asdepartment managers or as staff employees. The level of the starting position varies with theexperience of the applicant and size of the organization. Hospitals and other health facilities offerpostgraduate residencies and fellowships, which usually are staff positions. Graduates from mastersdegree programs also take jobs in large group medical practices, clinics, mental health facilities,multifacility nursing home corporations, and consulting firms. Graduates with bachelors degrees in health administration usually begin as administrativeassistants or assistant department heads in larger hospitals. They also may begin as departmentheads or assistant administrators in small hospitals or nursing homes. All States and the District of Columbia require nursing home administrators to have abachelors degree, pass a licensing examination, complete a State-approved training program, andpursue continuing education. A license is not required in other areas of medical and health servicesmanagement. Medical and health services managers often are responsible for millions of dollars of facilitiesand equipment and hundreds of employees. To make effective decisions, they need to be open todifferent opinions and good at analyzing contradictory information. They must understand finance andinformation systems, and be able to interpret data. Motivating others to implement their decisionsrequires strong leadership abilities. Tact, diplomacy, flexibility, and communication skills are essentialbecause 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 higherpaying positions, such as assistant or associate administrator, or by moving to larger facilities.E. TaskThe 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.
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 peoplethat are taking consultancy or treatment from their health care organizations are provided with all thenecessary facilities and health assistance that would be beneficial to the patients. The medical andhealth service management also manages the financial aspects of running the medical organizationas 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 theaffairs of the business. Any lack of proficiency from the medical and health service managementwould result in building bad reputation for the hospital or medical organization is affiliated with. Thehealth service management should make sure that the patients are treated by expertise doctors andprofessional and all the health services being provided to the patients is the most advanced andreliable. The medical and health service management have a team of expert employees who are wellversed in managing the managerial aspects of the medical institutions. The hospitals and medicalfirms are reluctant to hire any managerial staff and employees if they do not have experience in thefield of the medical and health service managers. Most hospitals require the managerial staff to takespecial training and specialization courses before they are added to the department. The medical and health service management also develop new policies and rules under whichthe employees of the hospital have to operate. The medical and health service managementsupervise employees and work on strategies to save financial assists of the organizations and to runthe health care industry more prominently. The medical and health service management organize meetings and perform researchoriented assignments on behalf of the organizations. They also provide the doctors with all the latestand up to date medical instruments so they can treat the patients professionally. The management isalso responsible for employee training and placement in the organization.
CHAPTER II HOSPITAL MANAGEMENT SYSTEMOverview Medinous a flagship product of Nous is an integrated health information system, whichaddresses the critical requirements of hospitals. MediNous system provides the benefits ofstreamlining of operations, enhanced administration and control, improved response, cost control andimproved 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. MediNousHMS enables better patient care, patient safety, and efficiency and reduced costs. It provides easyaccess 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 andcontrol, improved response, cost control and improved profitability. MediNous can be easilycustomized 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.
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 decisionsHospital Management System - Help desk The Help Desk Module automates the day-to-day functions of the Front office management ofa hospital. This module helps in assisting patient with accurate information and supports in handlingpatient related enquiries efficiently. This module having excellent features and advanced searchfacilities improves the quality of services rendered to the user. It provides for queries relating to thefollowing: 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 DetailsHospital Management System – Registration The Registration module is an integrated patient management system, which captures completeand relevant patient information. The system automates the patient administration functions to havebetter and efficient patient care process Patient Registration Details
Inpatient and Outpatient Registration Medical Alerts Details Appointment Scheduling (Patient / Doctor wise) Doctors 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 patients location, admission, and appointmentscheduling and discharge details. Furthermore, this system even takes care of package deals for apatient for a fixed cost. Medical Record keeps an abstract of clinical data about patients. It allowseasy retrieval of medical records on patients.Hospital Management System - Electronic Medical RecordThe EMR Module is a fully integrated knowledge repository that caters to Medical and clinical recordsof patients in the hospital. The system supports medical professionals of various departments of thehospital with relevant information like medical examinations, diagnoses, treatment histories, testresults and so on. The module provides access to critical and complete patient data that leads to highquality cost effective and efficient patient care. The EMR has the following features Patient Search with Various Search Strings
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 clinicaldetails. The system provides separate access rights for each part of the EMR. The patient medical filecan 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 facilitatescashier and billing operations for different categories of patients like Outpatient, Inpatient andReferral. It provides automatic posting of charges related to different services like bed charges, labtests conducted, medicines issued, consultants fee, food, beverage and telephone charges etc. Thismodule provides for credit partly billing and can be seamlessly integrated with the FinancialAccounting Module. The billing module is extensively flexible by which each of your billing plans canbe configured to automatically accept or deny. The system is tuned to capture room and bed chargesalong 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 renderedcan 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
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 BillingThe 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 Voucherand General Ledger etc. Books like Cashbook, Bankbook and Ledger book can be generated. Thismodule generates reports like Trail Balance, Balance Sheet and Profit and Loss statement. TheFinancial Accounting Screens describe about the Account Payable, Account Receivable and GeneralLedger. Also describe the activities related to IP, OP, Bank related activities and provision to clearingthe Supplier Invoice and keep track of the Account Receivable and Revenue related activities. Theservices that are covered by the sponsor companies, Insurance Agencies, Family Accounts,Individual Accounts, sponsorship details of the patient, Health Card Insurance are recorded in thesystem.
Hospital Management System - Fixed Assets The Fixed Assets Module deals with all the activities that are related to the Fixed Assets Partof 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 salaryslip, 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 isresponsible 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.
Hospital Management System - Outpatient Management The Outpatient module serves as an entry point to schedule an appointment with the HospitalResident Doctor or Consultant Doctor for Medical Consultations and diagnosis. This module supportsdoctors to take better and timely consultation decisions by providing instant access to comprehensivepatient information. Patient visits are divided into New, Follow-up and Review. This module alsohandles requests and results of laboratory tests and other examinations. External Doctors visit to inpatients 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, OnlinePrescription, Online Request for Investigations and so on, are the special features in Doctors
Observation screen. This system calculates the cost for the services rendered to the patient andreflects 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 toInpatient Management. This module automates the day-to-day administrative actives and providesinstant access to other modules, which leads to a better patient care. It provides comprehensive datapertaining to Admission of Patients & Ward Management: Availability of beds, Estimation, Agreementpreparation, Collection of advance, planned admission, Emergency admission and so on. TheInpatient module also deals with Ward Management: Shifting from one ward to the other, Bedavailability, 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, alongwith 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
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 thepatients 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, Maintenanceof Stock, Automatic Reorder level Setting, Online request for stock from various sub-stores, Online
stock transfer, maintenance of stock at different sub-stores, Physical stock verification andadjustment, 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 managementHospital Management System – Laboratory The Laboratory module automates the investigation request and the process involved in deliveringthe results to the concerned department/doctor of the hospital. Laboratory module starts withreceiving 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 aregrouped under various sections and sample type (specimen). Based on the request the user caninput the sample and generate the sample number. Results can be entered based on the sample typeeither to one test or multiple tests. If the test result requires approval, the supervisor has to approvethe result and it is made available to concerned doctors. Sample Result Entry Test Report Entry
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. Thisrule is exempted when the case is declared as Urgent. In addition, this module facilitatesinvestigations for referral patients.Hospital Management System – Radiology Radiology module caters to services such as X-ray, Scanning, Ultra sound etc. Scheduling ofRadiology resources is possible. The system stores all the result details of various tests and makes aReport 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 systemgenerates a unique number for the image. Investigations can be done only after the billing is done. This rule is exempted when the caseis declared as Urgent.
Hospital Management System - Nuclear MedicineThe main function of this module is to conduct the various Tests and make a report based on the TestResults 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 consultantsrecommendations. 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 thePhysiotherapy 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-uptreatments 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 theseservices are stored through this module. There are various services that are available in the hospitalcan be seen in i. Service Master: This master gives the details about package details, Group detail
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 theinformation available in the application. Any user associated with a user group can access only thosescreens for which the user group has rights. It also deals with the System Related Activity like UserMonitor, Creating User Group Master, User Master and view the User Group Lookup of employeedatabase, Maintenance of company documents, User defined error message, Generating DailyStatistical Summary
CHAPTER III ESSENTIAL ELEMENTS OF HOSPITAL ADMINISTRATION The healthcare industry is highly regulated by a complex statutory and regulatory framework atevery level. Electronic commerce in such a highly regulated industry presents some challenges to saythe least. States have approached e-commerce in a myriad of ways, leaving consumers andbusinesses confused as to whose law applies. Electronic records and signatures are essentialelements of many electronic transactions, particularly in healthcare. Electronic signatures that cantbe 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 securitybecause it ties an originators identity to an electronically transmitted message by means of analgorithm. The digital signature is not a computers "picture" of a handwritten signature, but acondensed mathematical representation of the message itself that can be created only by theoriginator using a private encypted key. Thus, a digital signature provides authentication of data anduser.A. Signatures and Certificates: A digital signature ensures that the document originated with the person signing it and that itwas not tampered with after the signature was applied. However, the sender could still be animpersonator and not the person he or she claims to be. To verify that the message was indeed sentby the person claiming to send it requires a digital certificate (digital ID) which is issued by acertification 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 themessage are then encrypted using the recipients public key and transmitted. The recipient uses hisprivate key to decrypt the text and derive the still-encrypted signature. Using his public key, hedecrypts the signature back into the senders digest and then recomputed a new digest from the textmessage. If the digests match, the message is authenticated. Digital signatures are a fundamentalcomponent of business in cyberspace. And numerous laws, state and now federal, have codifieddigital signatures into law. These laws are a mistake. Digital signatures are not signatures, and theycant fulfill their promise. Understanding why requires understanding how they work.
i. Health cares information and its use E-SIGN provides guidance on how records may be stored and retained electronically. If adocument is required to retain by law, an electronic version of the document will be acceptable. Theelectronic document accurately reflects the information in the record and is accessible to all relevantpeople in a form that may be accurately reproduced at a later date, whether by printing, electronicallytransmitting or other means. No specific type of technology is mandated by E-SIGN. The law istechnology 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, theterm "transaction" means an action or set of actions relating to the conduct of business, consumer orcommercial affairs between two or more persons. The term "electronic record" means a contract orother record created, generated, sent, communicated, received or stored by electronic means. Health care records (HCR) include both information‘s relating to the physical or mentalhealth of patients, and information regarding the provision of health care by health care practitionersor health care facilities. Relatives, social workers and other third parties may supplement personalhealth information provided by the patient. The provision of health care is recorded in the professionalnotes, observations and opinions of health care practitioners and administrative staff. These data areentered 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 professionalsproviding support services, non-clinical staff acting on the professionals behalf and even by patientsthemselves. This diversity of origin and use of health care data present problems of security in theconventional 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 computertechnology. The EHCR enables information to be used simultaneously by many individuals who maybe remote from each other and from the patient, but this can be achieved only by use of theappropriate computer equipment. Thus the user who has no access to the necessary hardware orlacks the skills to operate it may be denied the information. In contrast, it is possible for those with theskills 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,
although the mechanisms, by which most computers currently confirm the users true identity, such asthrough password control, leave much to be desired and impersonation is not difficult. To compoundthe problem, identical copies of EHCR can be made at will, often without trace, readily transmittedover networks that now encircle the globe and linked with other data about the same individual tocompile 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 informationabout mental health, sexually transmitted diseases, adolescent care, drug addiction and geneticfingerprints. Their clinical care may be compromised by inaccurate or missing data as a result ofunauthorised modification, from system malfunction or due to errors in program design. There is thepotential for serious harm or death should such errors remain unrecognised. The EHCR musttherefore be designed, implemented and run in such a way that the potential to harm the patient isminimised. Information security is a complex and highly technical subject with which even computerprofessionals are rarely fully conversant. Very few health care professionals have sufficientunderstanding of the principles of information security to confidently assume responsibility for securityof information. If properly designed, access to EHCR can be controlled more comprehensively than ispossible with the conventional HCR. The introduction of the EHCR thus offers the opportunity tocomply more closely with the ethical requirement to respect the individuals right to privacy while notimpeding the freedom of access to information needed by the clinicians involved in delivery of healthcare. In either case, we would suggest that the overall responsibility for security of health care data ina health care facility rest with the most senior clinician (e.g. the medical director or Dean) ordelegated authority. There is no justification for access to health care records to be controlled by theadministrative staff who own or operate the computer system holding EHCR, even though they mayhave 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 asencryption may be necessary where regular monitoring is not considered feasible.
C.Special Consumer Protections The term "consumer" means an individual who obtains, through a transaction, products orservices, which are used, primarily for personal, family or household purposes. E-SIGN imposesspecial requirements on anyone obligated to provide written disclosures to consumers. Those specialrequirements are imposed to ensure that consumers can make fully informed decisions aboutelectronic transactions and to provide some protection for consumers. Essentially, E-SIGN providesthat the consumer must have affirmatively consented to receive the required informationelectronically. Under E-SIGN, threshold questions in healthcare are whether a proposed arrangement is atransaction 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-SIGNapplies to electronic healthcare transactions (and in most cases that may be a reasonableassumption), there still are many unanswered questions about how electronic commerce inhealthcare 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 legalcause of action on any of the three principles of products liability theories: negligence, warranty, orstrict liability. These may be the criteria in criminal, civil, or consumer case proceeding for productliability in the court of law. However, the proceeding on a negligence theory in a products liability caserequires 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 reasonablyforeseeable 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 theincrease in powers of medical care delivery. Developing concurrently with the remarkableachievements of modern medical science and technology has been a similarly profound legalrevolution in the body of law commonly known as products liability. Product liability describes thephysical agent, which caused the injury in a situation in which a person is under a legal duty to theinjured person. The injury or death of the patient may result unexpectedly by faulty, defective ornegligently designed medical or surgical instruments or inadequate operating instructions. Themanufacturer becomes responsible for injury or death in such case. The patient must prove that the
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 giveadequate instructions. If the instrument functioned satisfactorily in previous operations or for severalprevious years in the hospital‘s possession, it is a proof that it was not defective at the time ofsupplying. If subsequently the instrument develops a defect through ordinary and gradual wear andtear, or if the physician or the hospital misuses the manufacturers, medical products, the negligenceliability would be imposed on the hospital or physician owner for the failure to inspect, test and repairsuch defects. The manufacturer becomes responsible if the patients can prove that the subsequentdevelopment of this defect was due to negligent design, structurally inferior component material, orimproper assembly. An adequate warning cautions the user to follow directions and may also notifythe risk of disregarding directions1. This article reviews the theories available to an individual whoalleges an injury cased by a defective product and sets forth the elements necessary to establish acause of action on any of the principal products liability theories and the potential liability of themanufacturer of drug, blood products, medical equipments and various other product used in medicalcare delivery when some thing goes wrong due to the use of these product and comment future ofproduct 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
actual sale contract. ―Given the contractual underpinnings of this cause of action, courts werereluctant to expand recovery for breach of warranty against anyone with whom the patient hadnot directly contracted. The term ―privity‖ was given to the requirement that the parties havehad actual dealings among themselves. ―As the common law developed, however, certainaspects of tort law were grafted onto warranty law. As a result of this commingling of tort andcontract 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 theultimate consumer-under consumer protection act. An injured party proceeding on a warrantytheory of liability need not prove negligence. Instead, it must be shown that the manufactureror seller breached an expressed or implied promise that the product was both free fromdefects 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 adefective product. This is known as ―strict liability in tort‖. The theory behind strict liability is thatis better social policy for manufacturers, rather than injured consumers, to bear the economicburdens, through products liability insurance or otherwise, for any injuries caused by defectiveproducts. Under the strict liability theory, an injured party need not prove negligence or anybreach of warranty, but rather must establish only that the product causing the injury wasdefective when it left the control of the manufacturer or the seller. Generally, there are four fundamental types of product defects. The first may beconsidered the ―manufacturing defect‖. An improperly manufactured product is one that hasbeen incorrectly manufactured or assembled and is thereby different from similar productsmanufactured. 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 whichbear a common design flaw that renders the product unreasonably dangerous. The thirdcategory is a product that is defective because it has been inadequately tested. The fourthcategory is a product that is considered defective because the manufacturer has failed toprovide the user with proper warnings or instructions regarding the product‘s use. This type ofclaimed defect occurs frequently in cases involving pharmaceutical and medical products. Under the strict liability theory, potential liability attaches not only to the product‘smanufacturer, but also to its retailer and to any other person in the distribution chain who is ―inthe business of selling such a product‖. Development in products liability theories, fromnegligence through strict liability, has made it easier for an injured party to establish a viabletheory of recovery. Each new theory has expanded the law rather than merely replaced its
predecessor. This broadening of recovery theories, however, has added new complexities tothe 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 allproducts liability causes of action in the existence or nonexistence of a product defect at thetime the product left the defendant‘s control. This theme is essential to products liability anddistinguishes 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 theoriesdiscussed above negligence, warranty, and strict liability. For an injured party patient toestablish a successful cause of action in negligence it must be proved that the defendantmanufacturer departed from reasonable standards of due care with respect to the design,testing, manufacture, assembly, inspection, packaging, or advertising of the product or failed towarn or give adequate instructions with respect to its use. The manufacturer owes this duty ofdue care to the ultimate user and not just to the immediate purchaser. A manufacturer‘s liabilityon the theory of breach of warranty is often more closely linked with the contract of salebetween the parties involved, specifically the manufacturer and the injured buyer. Privity ofcontract has been the principal hurdle in breach of warranty actions. Even if privity can beestablished, traditional warranty theory also requires the patient‘s reliance, to his detriment, onan 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 requirementof a negligence cause of action – the need for the patient to show that the defendant failed toexercise proper care in the manufacturing or marketing of the product. It also avoids the needfor any contractual obligations between the manufacturer and the injured party as requirementfor recovery. Under the strict liability theory, a patient needs only to establish that the productin question was so defective as to be unreasonably dangerous and that, as a result, injury wassuffered. In developing drug theories, the courts have expressly recognized and taken intoaccount the fact that some products are ―unavoidably unsafe‖ given current scientificknowledge. While there are very few decided cases, it would seem that this previouslydeveloped liability jurisprudence is directly applicable to artificial medical aid and given theembryonic nature of scientific understanding and experience in this field. To support the
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 towarn 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 ithas a reasonable basis to suspect might occur. The courts have expressly recognized thatprescription drugs are ―unavoidably unsafe products‖ that can be dispensed only under aphysician‘s authorization. With extraordinary medical devices, there is no question that themanufacturer has the duty to furnish full and complete warnings to any physician consideringimplanting such a device. The question, which logically and necessarily follows, is whether themanufacturer‘s duty to warn also extends to the patient-consumer. Although in the prescriptiondrug context a manufacturer‘s duty to warn generally extends only to the medical community, itis unclear at present whether, with respect to extraordinary medical devices, themanufacturer‘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 treatmentis predicated on professional negligence or malpractice. Malpractice may be defined as ―bad orunskillful 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 ―thetreatment by a surgeon or a physician in a manner contrary to accepted rules and with injuriesresulting to the patient,‖ are all base upon which malpractice claims may be founded. To present a cause of action for malpractice successfully against a professionalpractitioner, the patient must establish four essential elements. First, a cause of action mustshow 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 toact in accordance with specific standards of care established by the profession for theprotection of the patient against unreasonable risks. Second, the patient patient must establishthat the physician failed to act in accordance with these standards. An act or omission violatingthe standard of care owed to the patient is required. Third, the patient-patient must establishthat a causal and reasonably foreseeable connection exists between the acts or omissions ofthe physician and the resulting injury. Fourth, the patient patience must prove that thephysician‘s or omissions caused some actual loss or damage. The failure to establish any oneof these four elements may defeat a malpractice claim.
Claims for breach of warranty provide an alternative approach for actions by patientsagainst 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 existedupon which a warranty action could be based 7. A sale of goods, independent of the medicalservices provided, is generally the touchstone for warranty recovery. Strict liability, hasbecome a frequent theory upon which attempts to establish a physician‘s liability are oftenpremised 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 thephysician-patient relationship have noted that the primary purpose of this relationship is theperformance or rendition of professional medical service, distinguishing this from the sale ofmedical products. Accordingly, most courts in various country have rejected the application ofthe strict liability theory to the medical treatment provided by physicians. Respond superior is a common law doctrine that imputes responsibility for anemployee‘s acts, carried out during the course of his employment, to the employer as the onewho derives advantage from the act and, therefore, must answer for any resultant injury. Thetwo requirements for application of this doctrine are specific. The person charged with liabilitymust 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 ofhis employment‖ at the time the injury resulted. These two requirements have restrictedapplication of this doctrine in the health care context. A doctor is a professional andtraditionally was not classified as a hospital employee. Rather, the doctor was viewed as anindependent 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 legalstatus accorded hospitals. Hospitals have an integral role in the patient‘s overall treatment, andpatients assume that if an error is committed, the hospital will take responsibility. This is basedon the ―apparent authority‖ of the hospital to supervise the treatment given, and has becomeanother basis for attributing liability to hospitals. The law is accepted in a majority of jurisdictions. That hospital‘s potential liability is toencompass most, if not all, of the hospital‘s physicians, specialist, and staff. Another basisadopted by some jurisdictions for hospital liability for negligent treatment is termed corporatenegligence. Under this doctrine, established by the USA Supreme Court in the leading case ofDarling v. Charleton Community Memorial Hospital, a hospital has a duty to provide adequatemedical care to its patients. This duty charged the hospital with responsibility for all treatment,
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 seriousglobal threat to womens health and lives. An estimated 46 million induced abortions are performedannually; about 20 million are unsafe, and 95% of these take place in the developing world. Unsafeabortion accounts for an estimated 13% of pregnancy- related deaths—representing approximately67,000 women—every year. In many other cases, unsafe abortion causes such long-termconsequences as chronic pain, pelvic inflammatory disease, tubal occlusion and secondary infertility.Hospital records from developing countries suggest that 38-68% of women treated for complicationsof abortion are younger than 20; while these data suggest that abortion complications take a high tollon adolescents, they represent only young women who make it to a hospital for treatment. The WorldHealth Organization (WHO) estimates that 10-50% of women who have an unsafe abortion needmedical care; some women who experience spontaneous abortion also need treatment.The tragedy of unsafe abortion—which WHO defines as "any procedure for terminating an unwantedpregnancy [carried out] either by persons lacking the necessary skills or in an environment lacking theminimal 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 orunintended pregnancies. With one in four women living in countries where abortion is forbidden orallowed only to save a womans life, safe and legal abortion services are out of reach for manywomen with an unwanted pregnancy. Some barriers to addressing unsafe abortion and related maternal morbidity have beenreduced or eliminated over the last several decades—for example; some laws restricting access tocontraception have been lifted or liberalized. Other barriers, however, remain; these include limitedresources, restrictions on midlevel providers performance of uterine evacuation and politicalsensitivities about abortion-related issues. Although modern contraceptives have becomeincreasingly 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
using a method; many resort to unsafe abortion. Even if all contraceptive users were to use methodsperfectly all the time, nearly six million unintended pregnancies would occur annually.While most health systems provide treatment for abortion complications as part of emergencyobstetric care, the infrastructure to make these services widely available usually is lacking indeveloping countries. Policies that prohibit midlevel providers from offering treatment for abortioncomplications result in reduced services. Global initiatives with the potential to address unsafeabortion 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" safemotherhood 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 modeldesigned to promote interventions that address abortion-related public health concerns even whenabortion laws and policies are restrictive. We review years of program experience with the originalmodel, which led to the development of an expanded and updated model, Essential Elements ofPostabortion 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 allwomen who want to prevent or space pregnancies can obtain contraceptive services; that all womenhave 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 healthservices 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 theirabortion laws, although this trend is not much evident in Africa or Latin America. Arguments for legalreform usually center on public health concerns such as reducing maternal mortality and improvingreproductive health, as well as on the recognition of reproductive rights as an essential element ofhuman rights. The political situation and commitment of advocacy groups in each country largelydetermine the success of liberalization efforts. However, the Helms Amendment has prohibited thedirect use of U.S. foreign aid for most abortion-related activities since 1973. At the 1984 InternationalConference 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 toperform abortion (in cases other than those in which the pregnancy threatened the womans life orresulted from rape or incest), to provide counseling and referral for abortion, or to lobby to makeabortion legal or more available could no longer receive family planning support from the U.S. Agency
for International Development (USAID). That policy was lifted in 1993, under the Clintonadministration, but was reinstated in 2001 under the Bush administration.As clarified by a presidential memorandum in 2001, the policy does not prohibit support for "treatmentof 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 toenable agencies to implement programs and conduct operations research on abortion-relatedtreatment and related reproductive health services.The term "postabortion care" was first articulated as a critical element of womens health initiatives inIpass 1991 strategic planning document, which encouraged "the integration of postabortion care andfamily planning services in health care systems" as a means of breaking the cycle of repeat unwantedpregnancy and improving the overall health status of women in the developing world. In 1991, Ipaslisted postabortion family planning and other reproductive health care as essential elements of aframework for providing quality abortion care, based on Bruces 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 PlannedParenthood Federation (IPPF), the JHPIEGO Corp. and Pathfinder International formed thePostabortion Care Consortium to educate the reproductive health community about theconsequences of unsafe abortion and promote postabortion care as an effective public healthstrategy. In 1994, Ipas published the original postabortion care model, which comprised threeelements: emergency treatment services for complications of spontaneous or unsafely inducedabortion; postabortion family planning counseling and services; and links between emergencyabortion treatment services and comprehensive reproductive health care. The original model presented postabortion treatment as an essential emergency obstetricservice. Health systems often relied on resource-intensive uterine evacuation methods, such as sharpcurettage (also known as dilation and curettage, or D&C), that prevented them from offering servicesat 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 typicaleffectiveness rate of more than 98% and, compared with sharp curettage, is associated with lowerrates of the four most common uterine evacuation complications. In 1991, a WHO technical workinggroup identified vacuum aspiration as an essential element of care at the first referral level (i.e., atsites to which primary-level providers refer women needing treatment for abortioncomplications).Electric vacuum and manual vacuum aspiration have equivalent effectiveness rates.Manual vacuum aspiration, an accessible and low-cost method, enables midlevel providers and other
health professionals in primary-level facilities that do not have operating theaters, general anesthesiaor electricity to offer uterine evacuation on-site. Offering uterine evacuation at primary-level facilitiesalso creates an opportunity for providers (often the same ones who perform uterine evacuation) tooffer reproductive and other health services at the treatment visit. Second, the model emphasized the need for postabortion family planning services. A workinggroup at a pivotal 1993 conference in Bellagio, Italy, recommended that "a range of contraceptivemethods, accurate information, sensitive counseling and referral for ongoing care should be madeavailable and accessible to all women who have undergone abortion." The group furtherrecommended that "at a minimum, women should leave abortion-care facilities understanding theirimmediate return to fertility, that there are ways to prevent future unwanted pregnancies and where toobtain contraceptive methods, if they so desire." Research has since demonstrated the benefits ofcontraceptive services in preventing abortion. The third element of the model linked emergency abortion treatment and comprehensivereproductive health services. In many developing countries, a womans first or only contact with theformal health care system may be when she visits a facility for postabortion care. That visit creates anopportunity for providers to assess her health needs and to offer appropriate reproductive health orother services . Through the 1990s, international conferences and organizations increasingly began to presspopulation, safe motherhood and womens health initiatives to support womens right to postabortioncare. The 1994 International Conference on Population and Development (ICPD) Programme ofAction urged all governments and organizations to "strengthen their commitment to womens health"and "deal with the health impact of unsafe abortion as a major public health concern" The FourthWorld Conference on Women, held in 1995 in Beijing, recognized that "unsafe abortions threaten thelives of a large number of women, representing a grave public health problem as it is primarily thepoorest and youngest who take the highest risk," and referred to the ICPD Programme of Action forsolutions. IPPF and the International Federation of Gynecology and Obstetrics defined womensrights related to sexual and reproductive health in 1995 and 1997, respectively. In 1996, theInternational Confederation of Midwives passed a resolution promoting the participation of midwivesin the provision of Postabortion care services. The 1999 ICPD +5 Conference Programme of Actionstrengthened the call to "recognize and deal with the health impact of unsafe abortion as a majorpublic-health concern by reducing the number of unwanted pregnancies through the provision offamily planning counseling, information and services and by ensuring that health services are able tomanage the complications of unsafe abortion."
Significantly, even though the Bush administration reinstated the Mexico City policy, the policyexplicitly permits the continuation of postabortion care programs Nonetheless; integratingpostabortion 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 implementprograms; a USAID evaluation in 2001 confirmed that more than 40 countries had postabortionactivities. During the middle and late 1990s, programs following the original model focused mainly onintroducing manual vacuum aspiration at tertiary-level facilities and strengthening linkages betweentreatment and family planning services. Results from a study in Kenya showed that the most effectiveapproach to integration in a hospital setting was for staff to provide family planning on the gynecologicward. A 1997 Population Reports provided recommendations for postabortion care serviceimprovements and expansion beyond hospital facilities. Although an increasing number of tertiaryfacilities were offering services, only a small proportion of women who experienced complicationsfrom unsafe or incomplete abortion were finding their way to hospitals for treatment and postabortionfamily planning services. Operations research from several countries contributed significantly toincreased momentum for decentralized postabortion services. To expand access, some ministries of health authorized midwives and other providers atprimary-level facilities to offer postabortion care services, including treatment with manual vacuumaspiration. In many cases, this occurred once services at tertiary and other hospital facilities werefunctional and could accept referrals for abortion complications that could not be managed byprimary-level providers. In the late 1990s, with funding from USAID and assistance from cooperatingagencies, the governments of Ghana, Kenya and Uganda demonstrated that midwives in primary-level facilities could provide high-quality postabortion care services using manual vacuum aspirationand that primary-level services increased postabortion family planning counseling and methodprovision. Essential Elements of Postabortion Care Community and service provider partnerships • Prevent unwanted pregnancies and unsafe abortion • Mobilize resources to help women receive
appropriate and timely care for complications of abortion • Ensure that health services reflect and meet community expectations and needs Counseling • Identify and respond to womens 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 providers network The momentum created by project results, together with revised country-level reproductivehealth service policies and standards supporting postabortion care by mid- and primary-levelproviders, 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 thatadditional health services should be offered or were being offered to women following the provision oftreatment and contraceptive services. During this time, several other agencies and countriesindependently added to their postabortion care model a reproductive health counseling element tosupport women in resolving issues related to abortion and a community element to promoteeducation for community members, reduce the need for abortion and improve reproductive health.These well-documented efforts prompted further expansion of service delivery into primary healthcare facilities and communities, and increased support for prevention-oriented postabortion careactivities. 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, PACConsortium participants formed a task force to initiate an update and expansion of the originalpostabortion care model.
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, sustainableservices. The models five elements (see box) shift the focus from facility-based medical treatment toa public health approach that responds to womens broader sexual and reproductive health needs.i. Community and Service Provider Partnerships This element of the model recognizes community members vital role in treatment, preventionand advocacy efforts. Community health education and mobilization have been identified as keystrategies to combat unsafe abortion, increase access to and quality of postabortion care programs,and improve womens 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 ofservices;• Education about obstetric emergencies and appropriate care-seeking behaviors;• Mobilization of community resources, including transportation, to ensure that women experiencingobstetric emergencies receive timely care;• access to services for special populations of women, including adolescents, women with HIV orAIDS, 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 meetcommunity expectations, priorities and needs; and• planning for sustainability.ii. Counseling Effective counseling enhances a womans understanding of the psychosocial circumstancessurrounding her reproductive past and future, and increases her confidence in her ability to participatein her health care. Client- centered counseling ensures that women, rather than their providers, makevoluntary choices about their treatment, contraceptive methods and other options. Postabortion carecounseling covers more than fertility and contraception—although it must emphasize theseelements—and consists of more than information provision and sensitive communication. This
counseling provides an opportunity to help women explore their feelings about their abortion, assesstheir coping abilities, manage anxiety and make informed decisions. Counseling is a vital element of care, moving postabortion services from being purely curativeto being preventive. It helps providers determine when women need special care because of extremeemotional distress or circumstances such as young age, inexperience with the health care system orfear of discrimination. Some expected benefits of counseling are that client-provider interactions willbe more respectful, treatment will be less painful and more effective, womens understanding and useof other health services will increase, their satisfaction with the health care encounter will rise andhealth outcomes will improve. The aims of counseling are to • solicit and affirm womens 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 womans 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 orunsafely induced abortion will, in many cases, need uterine evacuation and other medicalintervention. The revised model includes language recognizing that postabortion care does notalways involve complications and that complications are not always life-threatening but may be in theabsence of swift and appropriate medical attention. It further recognizes that safe, effective treatmentinvolves the use of vacuum aspiration wherever possible and includes standard infection preventionprecautions, informed consent, appropriate pain management, sensitive physical and verbal patientcontact, and follow-up care.
iv. Family Planning and Contraceptive Services The revised postabortion care model recognizes that some women receiving postabortiontreatment need family planning services to help them space births, while others need contraceptiveservices because they have no plans to conceive. Therefore the model emphasizes the importance ofovercoming barriers to offering family planning and contraceptive services during the same visit andat the same location as postabortion treatment. When a facility does not provide these services at thetime of abortion-related treatment, the opportunity to provide them may be lost. Women may notmake another visit, to that facility or another, for such services. In addition, if the facility is not the onethat 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 withan 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 beknowledgeable about which methods are appropriate for women following treatment. Making a wide range of births pacing practices and contraceptive methods—including, whereauthorized, emergency contraception—available to all women of reproductive age is an effectivestrategy for preventing unwanted pregnancies and unsafe abortion, and for helping women achievetheir reproductive desires. Facilities must ensure that treatment is not contingent upon womensacceptance of a contraceptive method.v. Reproductive and Other Health Services An important relationship in the new model is between effective counseling and increased useof the reproductive and other health services women want. The model encourages the provision of allappropriate health services at the time women receive postabortion care, preferably at the samefacility. When a facility is unable to provide needed services, it should have functional mechanisms inplace for making referrals (either within the facility or to another one), receiving feedback from referralsites or providers, and performing follow-up; such mechanisms should include consistent andaccurate 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.
I. CHALLENGES IN IMPLEMENTATION Implementers of the Essential Elements of PAC model face some of the same obstacles thathampered both the original model and new ones. Service delivery challenges include establishingsustainable procurement and resupply mechanisms for uterine evacuation instruments,contraceptives, and essential drugs and supplies; improving contraceptive method provision, infectionprevention and pain management practices; and ensuring that services are high-quality, accessibleand sustainable. Another challenge is meeting the growing expectation that community partnershipsand counseling can increase access to and use of reproductive health services, improve the quality ofclinical interventions and even prevent health problems from occurring. Social, religious, policy and legal restrictions on abortion and contraception continue to posechallenges to programs offering postabortion care. Advocacy will be needed to increase awarenessand implementation of postabortion care in Safe Motherhood, essential emergency obstetric care andother global health initiatives. Continued advances in womens rights are necessary as opinionleaders, partners and family members persist in limiting womens contraceptive, pregnancy andchildbirth choices. One of the greatest challenges will be finding creative ways to meet the increasingneed for high-quality contraceptive, postabortion care and other reproductive health services in acontext of stable or declining resources. As countries and organizations embrace the EssentialElements of PAC model, they will need strategies such as introducing elements of the model inprioritized order over time or altering service provider guidelines and networks to maximize the use ofalready overburdened and limited resources.J. .FUTURE DIRECTIONS The PAC Consortium will reach out to global partner organizations to share best practices forexpanding postabortion care activities to include the five essential elements. As programs based onthe Essential Elements of PAC model are designed, implemented and evaluated, and ourunderstanding of high-quality, sustainable services is further informed, further revisions to the modelare likely. In communities implementing the model, we can expect to see increased use ofreproductive 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 increasedquality and use of contraceptive, postabortion care and other reproductive health services thatrespond to community needs and priorities; enhanced provider performance in meeting womens
postabortion care and other health needs; and improved referral systems and follow-up mechanismsfor contraceptive, postabortion care and other health services. As health care evolves from a strictly medical to a broader public health focus, to reflect bothconsumer and provider perspectives and to encompass curative and preventive services, leaders andconsumers should demand that womens sexual and reproductive health care be made still morecomprehensive and accessible. Leaders and consumers must also continue to strengthen advocacynetworks to promote womens broader health needs and concerns, and call on health systems to offera complete range of high-quality preventive, diagnostic and treatment services linked to social andlegal support systems. Implementing such a vision of comprehensive, integrated services will reducethe need for treatment of abortion complications and enable women to exercise their full sexual andreproductive rights.
CHAPTER IV FUNCTIONAL HOSPITAL ORGANISATION During the last decade, there has been a transition from viewing the company as a number offunctional departments to a business structure focusing more on the business processes beingperformed (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 ofthe 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 organisationmodels such as the patient-focused hospital (Lathrop et al., 1991) and the development andimplementation of new co-ordination mechanisms such as clinical pathways (Zander, 1992). Achange in the organizational structure or an implementation of clinical pathways does notautomatically lead to more process orientation culture. Therefore, it is important for management toknow to what extent the different changes compel an organisation towards process-orientation. Thispaper looks at how process orientation can be measured using data from one large EuropeanUniversity hospital. After a restructuring in divisions and the implementation of the care programs andclinical pathways, hospital management came to the conclusion that they had no tools to evaluate ifthese changes were resulting in a process orientation on the work-floor. In agreement with hospitalmanagement, an existing tool of business process orientation measurement was adopted andadapted to the specific context of healthcare. This paper reports on how the measurement tool waschanged and validated in order to come up with a useful instrument (the Hospital Process Orientationtool) to measure the process orientation of the employees in the hospital. The Hospital ProcessOrientation (HPO) tool can be useful to measure the effects of changes which are assumed to lead tomore process-orientation or even patient focus. In this way the pay-off of these investments can bemade more tangible. The HPO tool offers hospitals a way to evaluate how they are evolving towardsmore process orientation. In the first part of the paper some more insights are given on what the meaning is of processorientation, more specifically pertaining to hospitals. In the second part of the paper, the processmeasurement tool, its adaptation, and validation for hospitals are described. Finally, some managerialconclusions are put forward.
A. The process oriented companyi. Process orientation The traditional way to structure an organization is through the formation of departments andvertically functional units consisting of individuals with a similar area of expertise. Up to a few yearsago, this way of organizing was highly dominant: people can specialize themselves within their field ofexpertise, the centralization of functions reduces costs, everyone knows which tasks they aresupposed 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 rapidlyevolving and technologically deploying business world. During the last decade, there has been atransition from viewing the company as a number of departments to focusing on the businessprocesses being performed. The abundant literature on Business Process Management highlightsthis transition (Armistead, Rowland, 1998). The focus on business processes implies a strongemphasis on how work is done within an organization, in contrast to a focus on what is done. Aprocess is defined as a specific ordering of work activities across time and place with a beginning, anend, and clearly identified inputs and outputs: a structure for action (Davenport, 1993). Processes are generally independent of formal organizational structures, crossing functions ordepartments and involving people with different expertise and roles. However, formal organizationalstructures can strongly influence the effectiveness of processes. Consequently, the main difficulty toovercome organizational malfunctions and to break cultural barriers will be to identify anorganizational structure that allows the company to focus on processes and not functions. Onepossibility to achieve this, is by evolving towards a more process based, horizontally orientedorganization. A more conservative approach would be to set up a matrix organization, in whichfunctional and process responsibilities interact with each other. A large survey in Europeancompanies confirms that more than 50% of the companies change their structure in the early stage ofthe implementation of business process management and that up to 70% do this in a well progressedstage (Armistead, Pritchard, 1999). Very often, business process management implementationsresult in a flatter organization, where people are given more responsibility, get increased decisionmaking capabilities, act more autonomous and are more flexible whenever needed. A flatorganization allows managers to be close to customers and have a ―first hand‖ awareness of thereality of the business (Hammer, Champy, 1993). A flatter organization requires role modificationsand 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):
• 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 aredescribed with a focus on processes. This form of responsibilities exceeds the functional borders andencourages all members of the different departments to collaborate and achieve common goals. Italso implies the use of process oriented performance indicators, obliging the members of anorganization to work together as one group. The process perspective provides an especially usefulframework for addressing a common organizational problem: fragmentation or the lack of functionalintegration.ii. Process orientation in a hospital From a historical point of view, hospitals are considered as a collection of professionalfunctions, brought together to care and later cure for the patients. In this way it is not surprising thathistorically these hospitals were organised along functional departments. The further evolution of thehospital structure has been characterised by increasing specialisation(within the functions) andcentralisation(to capture economies of scales). The consequences by multiple ancillary and supportdepartments. Such a hospital organisation involves "multiple agents who have partial information,disparate (local) goals and limited communication capabilities" (Kumar et al., 1993). According toGalbraith (1973), there are two possible strategies to better co-ordinate the activities in such acomplex organisation: (a) reducing the need for information processing or (b) increasing the capacityto process more information. The first strategy of reducing the need for information processing has been stronglyemphasised in the so-called patient-focused hospital idea which has been promoted by severalAmerican consultants. The basic idea of patient-focused hospital is that there is something wrongwith the operating structure of the hospital and that the health service delivery needs to berestructured in such a way that it is centred on the patient and his needs. This involves creating more