Health Care Market In INDIA
The healthcare market in India
India's secondary and tertiary care, especially in terms of the private sector, is primarily concentrated in urban areas. While no accurate up-to-date statistics are available, as of 2005 the nation had over 15,900 hospitals containing 875,000 beds. More than 70% of secondary care facilities derive from private hospitals, which contain 40% of the country's hospital beds. Half of all the nation's hospital admissions are the responsibility of private hospitals.
Between 2000 and 2006, public hospitals rose by more than two thirds from less than 4,600 to over 7,660. During that period, bed capacity in government-run facilities rose by a modest 14%, reaching just over 430,000 in 2006. According to IMS, the disparity between the two figures can be attributed to efforts to broaden the country's hospital sector, particular through establishing more small community and district inpatient facilities.
Similar to the situation in Brazil and China, India's primary care sector suffers from shortages of staff, equipment and supplies. Overcrowding and poor facilities means many middle income patients seek an initial diagnosis in public hospitals before opting for treatment in private facilities in spite of the obvious financial implications. Efforts are, however, being made to address some of these issues and in particular quality standards were introduced to help drive improvements. IMS has identified that mechanisms which penalise poor performers and reward those providing good quality are badly needed.
Public private partnerships (PPP) are being targeted as a means of improving India's public hospital management. According to IMS, government hospitals are increasingly contracting private operators to manage their facilities, and this is a trend which looks set to continue. Critics, however, claim patients face more substantial payments in PPP-managed facilities while the involvement of private players is also likely to have an impact on hospital procurement strategies, which will begin to affect manufacturers supplying the public hospital sector.
"Similar to the situation in Brazil and China, India's primary care sector suffers from shortages of staff, equipment and supplies."A scheme supported by the World Health Organization aims to bridge the gap between primary health centres and large city-based public hospitals in India by developing a network of 100-bed facilities in smaller towns. Yet again, recruiting and retaining qualified staff has proved a major problem to the progress of the scheme and IMS expects a shortage of fully trained health professionals will continue to prevent improvements to healthcare outside major cities.
Aware of the public hospital sector's shortcomings, successive Indian governments have actively promoted the expansion of the private hospital sector, which has also been strongly driven by the nation's growing middle class. IMS predicts this growth will continue in the long term.
A range of tax exemptions from central and state governments has allowed private providers to purchase land at preferential rates in return for commitments to meet quotas for free treatment of poor outpatients and inpatients. Private hospitals also provide treatment to central state government employees and their families, which is substantially reimbursed under government-backed health insurance programmes for public sector workers.
Leading hospital chains have already invested heavily in expansion programmes in India, particularly by establishing speciality and tertiary care facilities in major metros and tier I cities and constructing new facilities in tier II cities. Some of the most prominent private hospital chains operating in India include Apollo, Fortis, the Global Hospitals Group and Manipal Health Systems. While such leading hospital chains operate to world-class standards, the standards of practice in private facilities elsewhere in India vary widely.
According to IMS, tighter regulations on private providers could trigger a restructuring of the private hospital market and force the closure of smaller poor quality facilities. At state levels, initiatives are currently being pursued that are designed to regulate private providers but draft legislation aimed at imposing minimum standards at national level is still on its way through parliament
Government is pushig hard for medical health insurance to the population. Differnet type of healthcare cards are now initiatted to provide health insurance to poor economic sections
India's secondary and tertiary care, especially in terms of the private sector, is primarily concentrated in urban areas. While no accurate up-to-date statistics are available, as of 2005 the nation had over 15,900 hospitals containing 875,000 beds. More than 70% of secondary care facilities derive from private hospitals, which contain 40% of the country's hospital beds. Half of all the nation's hospital admissions are the responsibility of private hospitals.
Between 2000 and 2006, public hospitals rose by more than two thirds from less than 4,600 to over 7,660. During that period, bed capacity in government-run facilities rose by a modest 14%, reaching just over 430,000 in 2006. According to IMS, the disparity between the two figures can be attributed to efforts to broaden the country's hospital sector, particular through establishing more small community and district inpatient facilities.
Similar to the situation in Brazil and China, India's primary care sector suffers from shortages of staff, equipment and supplies. Overcrowding and poor facilities means many middle income patients seek an initial diagnosis in public hospitals before opting for treatment in private facilities in spite of the obvious financial implications. Efforts are, however, being made to address some of these issues and in particular quality standards were introduced to help drive improvements. IMS has identified that mechanisms which penalise poor performers and reward those providing good quality are badly needed.
Public private partnerships (PPP) are being targeted as a means of improving India's public hospital management. According to IMS, government hospitals are increasingly contracting private operators to manage their facilities, and this is a trend which looks set to continue. Critics, however, claim patients face more substantial payments in PPP-managed facilities while the involvement of private players is also likely to have an impact on hospital procurement strategies, which will begin to affect manufacturers supplying the public hospital sector.
"Similar to the situation in Brazil and China, India's primary care sector suffers from shortages of staff, equipment and supplies."A scheme supported by the World Health Organization aims to bridge the gap between primary health centres and large city-based public hospitals in India by developing a network of 100-bed facilities in smaller towns. Yet again, recruiting and retaining qualified staff has proved a major problem to the progress of the scheme and IMS expects a shortage of fully trained health professionals will continue to prevent improvements to healthcare outside major cities.
Aware of the public hospital sector's shortcomings, successive Indian governments have actively promoted the expansion of the private hospital sector, which has also been strongly driven by the nation's growing middle class. IMS predicts this growth will continue in the long term.
A range of tax exemptions from central and state governments has allowed private providers to purchase land at preferential rates in return for commitments to meet quotas for free treatment of poor outpatients and inpatients. Private hospitals also provide treatment to central state government employees and their families, which is substantially reimbursed under government-backed health insurance programmes for public sector workers.
Leading hospital chains have already invested heavily in expansion programmes in India, particularly by establishing speciality and tertiary care facilities in major metros and tier I cities and constructing new facilities in tier II cities. Some of the most prominent private hospital chains operating in India include Apollo, Fortis, the Global Hospitals Group and Manipal Health Systems. While such leading hospital chains operate to world-class standards, the standards of practice in private facilities elsewhere in India vary widely.
According to IMS, tighter regulations on private providers could trigger a restructuring of the private hospital market and force the closure of smaller poor quality facilities. At state levels, initiatives are currently being pursued that are designed to regulate private providers but draft legislation aimed at imposing minimum standards at national level is still on its way through parliament
Government is pushig hard for medical health insurance to the population. Differnet type of healthcare cards are now initiatted to provide health insurance to poor economic sections
Friday, October 30, 2009
Hospital Information System (HIS)
DEFINATION AND IMPORTANCE :
Hospital Information System (HIS) is vital to decision making and plays a crucial role in the success of the organization. Computerization of the medical records and documentation has resulted in efficient data management and information dissemination for the users. Managers, Clinicians and other healthcare workers can now access the information without delay or errors. Studies has revealed, the existing system in our hospitals defenately requires up gradation to meet the requirements of the managers and the clinicians. Health care team feels HIS assists in decision making, and medical audit. HIS helps in education and research.
INTRODUCTION
Over the last few decades, medical sciences have made great strides leading to radical improvements in the modes of investigations, therapeutic activities and surgical procedures. This has enhanced the imperative need to have authentic and accurate medical records.
Every department and subsystems in an institution can be viewed basically as an information-processing agency. The Medical Records Department (MRD) is no exception. It is not a place where patient charts, complete or incomplete, are dumped and forgotten thereafter. The administration can actively use this department for monitoring and controlling the quality of patient care; in assessing of the performance of the medical staff; in keeping check on how some of the hospital’s resources are being put to use; and in gathering data for short term and long term decisions.
Most of the present Medical Records Departments have been changed into departments of hospital information management in order to take up responsibilities to function more effectively and efficiently in this regard. This new drift will support the need for an improved Hospital Information System making the Medical Records Department the main source of health information. It is no doubt that a carefully planned Hospital Information System and intelligently used information will be a great asset to any health care industry. The Hospital Information managers must have the necessary skills to facilitate and manage this transition and bridge the gap in the changing patterns switch over to 21st century.
Statement of the Problem:
A study of Medical Records Department of a tertiary care ABC hospital with special reference to the Hospital Information System.
Objectives:
1.To study the existing Hospital Information System in the medical records department.
2.To identify the shortcomings, if any, in the existing Hospital Information System in the Medical Records Department.
3.To suggest the necessary steps to improve the existing Hospital Information System in the Medical Records Department.
Methodology:
The study was conducted in 554 bedded multispecilaity tertiary care hospital. The Medical Records Department of the hospital was studied for assessing the Hospital Information System. Descriptive research approach as adopted for this study. Descriptive statistics have been used to find out the deficiencies, if any, in the existing Hospital Information System. The target population consisted of managers, doctors and patients in the hospital. The data were collected from a sample of 60, consisting of 05 managerial heads, 10 doctors and 40 patients selected by the disproportionate stratified sampling technique. The inclusive criteria for selecting the sample, were the managers who involved in decision making process, doctors with experience of more than one year, and the computer literate patients, willing to participate in the study.
The tool used to collect the data was a structured, closed ended questionnaire. The questionnaire was constructed with emphasis on the content, clarity and simple language. The scoring for the managers and the doctors has been done on a four-point scale and the scoring for the patients is on a three-point scale. The scoring has been given according to the nature of the questions.
A pilot study was conducted for the patients, to check the validity and feasibility of the study. The tool was administered to subjects, for ascertaining the reliability. The reliability calculated by using split method r = 0.73, 0.86 and 0.76, for managers, doctors an the patients respectively, which was high and satisfactory.
Observation & Discussion:
It was observed that decentralizaed filing system is being followed in the Medical Records Department of the teritary care hospital i.e. the department is divided into two units – Out Patient (OP) and In-Patient (IP) MRD.
The other information available to the hospital management include
1.OP and IP Statistics
2.Death cases
3.Left against Medical Advise (LAMA) cases
4.Long standing cases
5.Cash and Collection reporting
Structured questionnaires were used to find out the deficiencies in the existing system. The various studies conducted earlier, shows the importance of Management Information System (MIS) in an organization. It lays emphasis on the nature of the modern organization, the current legal and social environment; advancing technology and the expanding role of management that have created information needs which cannot be satisfied by traditional means. A closer examination of these four areas will reveal the demand for more sophisticated management information1.
Table – 1 Opinion about the existing Hospital Information System
Category
(n=60) Response
Good Moderate Poor Total
Managers — 7(70%) 3(30%) 10
Doctors — 16(80%) 4(20%) 20
Patients — 25(87%) 5(13%) 30
Totalresponse(%) — 48(80%) 12(20%) 60
This hospital does not have a separate admission department and all the registration and admission procedures are through the Medical Records Department. The Medical Records Department is partially computerized. In addition, an in-hour Hospital Information System exists in this hospital.
The study reveals that the department is providing information to the health authorities regularly. The overall opinion of the managers, doctors and patients about the existing Hospital Information System in the hospital is satisfactory (80%) and 20% feel that the system is poor. (Table-1)
Table – 2 Opinion about the existing Hospital Information System
Role of HIS in Manager’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Decision making — 5 (50%) 4 (40%) 1 (10%)
Utilization of resources — 4 (40%) 6 (60%) —
Enhances communication — 2 (20%) 4 (40%) 4 (40%)
Strategic planning — 4 (40%) 3 (30%) 3 (30%)
Quality assurance — 2 (20%) 8 (80%) —
Reduces waiting time — 4 (40%) 6 (60%) —
Utilization process 1 (10%) 4 (40%) 3 (30%) 2 (20%)
Medical audit 2 (20%) 5 (50%) 3 (30%) —
Role of HIS Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Reduces the cost 2 (10%) 5 (25%) 13 (65%) —
Shorten the stay — 3 (15%) 13 (65%) 4 (20%)
Continuity of patient care — 2 (10%) 3 (15%) 15 (75%)
Effective referral system 1 (5%) 6 (30%) 12 (69%) 1 (5%)
The purpose of the Hospital Information System is to raise “managing” from the level of piecemeal spotty information, intuitive guesswork and isolated problem solving to the level of systems insight, systems information and systems problem solving. It is, thus, a powerful method for aiding administrators in solving and making decisions2.
However, it was found that the majority of the managers (70%), disagree with the statement that the HIS of the hospital helps in discharging effectively their managerial responsibilities as well as in enhancing the inter and intra hospital communication (80%) Half of the managerial heads (50%) agree that the statistical information from the Medical Records Department helps in decisionmaking. With an increase in the number of third party payer’s utilization requirements, the admitting and utilization management are in frequent communication3.
The majority of the managers (80%) agree that the existing Hospital Information System does not help in the Quality Assurance Programme (QAP) as well as in enhancing the functions of the supportive services. Half of the managerial heads agree that the Hospital Information System does not help as a tool in the various utilization processes.
The various studies conducted earlier regarding information system reveals the benefits for doctors and nurses and includes, qualitatively better data, more available data on patients, direct consultations of colleagues and experts, use of decision based systems, reduced work load, the gain of time, and the availability of administrative support4.
Majority of the doctors do not believe that the existing Hospital Information System can help to reduce the cost of patient care (65%) or shorten the stay of the patient in the hospital (65%)5. (Table-2).
Table 3 – Disadvantages of the existing Hospital Information System – HIS
Disadvantages of existing
Hospital Information System Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Non-Existence of ward
Computers is affecting
patient care — 17 (85%) 3 (15%) —
OPD consultations take
longer time — 16 (80%) 1 (5%) 3 (15%)
Delay in getting
longer time 1 (5%) 14 (70%) 5 (25%) —
The majority of the doctors (85%) feel that the nonexistence of ward computers is a hinderance in providing the expected patient care. They also feel that the existing Hospital Information System does not help either in making the OPD consultations quicker or in generating quick laboratory reports6. (Table-3)
Table – 4. Opinion about current HIS with respect to Internal and Personnel Performance
Internal Performance of the Hospital Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Infection Control — 7 (35%) 12 (60%) 1 (5%)
Defining Community needs — 2 (10%) 14 (70%) 4 (20%)
Majority of the doctors disagree that the Hospital Information System helps in infection control (65%) and in defining the community needs (90%). Majority of them agree that the Hospital Information System helps in education and research (60%)7.
The different benefits of information system to the community are, to prepare a programme of health education for the area (with priorities for the health activities), information on the indicators of health which can help to focus attention on target group for specific health services, and, help to prevent epidemics8,9.
CONCLUSION
The present scenario in India is that most of the Medical Records Department are partially computerized10. This system exists in some Health Care facilities, where entries are made by different Health care providers, such as Physicians, Nurses and therapists, into the computer in different nodes in a local area network. The survey conducted in the hospital reveals the importance of information networking between the departments. Majority of the beneficiaries of Hospital Information System, are aware about the advantages of computerisation in the HIS in providing better health care. All of them agree that only in an efficient system the information can be readily available. The exciting possibility of a modern and computerised information system is not too far. In the coming years we can visualize the patient record existing in electronic medium, where a patient can have a single record from birth to death that can be assessed from any where in the world11.
Hospital Information System (HIS) is vital to decision making and plays a crucial role in the success of the organization. Computerization of the medical records and documentation has resulted in efficient data management and information dissemination for the users. Managers, Clinicians and other healthcare workers can now access the information without delay or errors. Studies has revealed, the existing system in our hospitals defenately requires up gradation to meet the requirements of the managers and the clinicians. Health care team feels HIS assists in decision making, and medical audit. HIS helps in education and research.
INTRODUCTION
Over the last few decades, medical sciences have made great strides leading to radical improvements in the modes of investigations, therapeutic activities and surgical procedures. This has enhanced the imperative need to have authentic and accurate medical records.
Every department and subsystems in an institution can be viewed basically as an information-processing agency. The Medical Records Department (MRD) is no exception. It is not a place where patient charts, complete or incomplete, are dumped and forgotten thereafter. The administration can actively use this department for monitoring and controlling the quality of patient care; in assessing of the performance of the medical staff; in keeping check on how some of the hospital’s resources are being put to use; and in gathering data for short term and long term decisions.
Most of the present Medical Records Departments have been changed into departments of hospital information management in order to take up responsibilities to function more effectively and efficiently in this regard. This new drift will support the need for an improved Hospital Information System making the Medical Records Department the main source of health information. It is no doubt that a carefully planned Hospital Information System and intelligently used information will be a great asset to any health care industry. The Hospital Information managers must have the necessary skills to facilitate and manage this transition and bridge the gap in the changing patterns switch over to 21st century.
Statement of the Problem:
A study of Medical Records Department of a tertiary care ABC hospital with special reference to the Hospital Information System.
Objectives:
1.To study the existing Hospital Information System in the medical records department.
2.To identify the shortcomings, if any, in the existing Hospital Information System in the Medical Records Department.
3.To suggest the necessary steps to improve the existing Hospital Information System in the Medical Records Department.
Methodology:
The study was conducted in 554 bedded multispecilaity tertiary care hospital. The Medical Records Department of the hospital was studied for assessing the Hospital Information System. Descriptive research approach as adopted for this study. Descriptive statistics have been used to find out the deficiencies, if any, in the existing Hospital Information System. The target population consisted of managers, doctors and patients in the hospital. The data were collected from a sample of 60, consisting of 05 managerial heads, 10 doctors and 40 patients selected by the disproportionate stratified sampling technique. The inclusive criteria for selecting the sample, were the managers who involved in decision making process, doctors with experience of more than one year, and the computer literate patients, willing to participate in the study.
The tool used to collect the data was a structured, closed ended questionnaire. The questionnaire was constructed with emphasis on the content, clarity and simple language. The scoring for the managers and the doctors has been done on a four-point scale and the scoring for the patients is on a three-point scale. The scoring has been given according to the nature of the questions.
A pilot study was conducted for the patients, to check the validity and feasibility of the study. The tool was administered to subjects, for ascertaining the reliability. The reliability calculated by using split method r = 0.73, 0.86 and 0.76, for managers, doctors an the patients respectively, which was high and satisfactory.
Observation & Discussion:
It was observed that decentralizaed filing system is being followed in the Medical Records Department of the teritary care hospital i.e. the department is divided into two units – Out Patient (OP) and In-Patient (IP) MRD.
The other information available to the hospital management include
1.OP and IP Statistics
2.Death cases
3.Left against Medical Advise (LAMA) cases
4.Long standing cases
5.Cash and Collection reporting
Structured questionnaires were used to find out the deficiencies in the existing system. The various studies conducted earlier, shows the importance of Management Information System (MIS) in an organization. It lays emphasis on the nature of the modern organization, the current legal and social environment; advancing technology and the expanding role of management that have created information needs which cannot be satisfied by traditional means. A closer examination of these four areas will reveal the demand for more sophisticated management information1.
Table – 1 Opinion about the existing Hospital Information System
Category
(n=60) Response
Good Moderate Poor Total
Managers — 7(70%) 3(30%) 10
Doctors — 16(80%) 4(20%) 20
Patients — 25(87%) 5(13%) 30
Totalresponse(%) — 48(80%) 12(20%) 60
This hospital does not have a separate admission department and all the registration and admission procedures are through the Medical Records Department. The Medical Records Department is partially computerized. In addition, an in-hour Hospital Information System exists in this hospital.
The study reveals that the department is providing information to the health authorities regularly. The overall opinion of the managers, doctors and patients about the existing Hospital Information System in the hospital is satisfactory (80%) and 20% feel that the system is poor. (Table-1)
Table – 2 Opinion about the existing Hospital Information System
Role of HIS in Manager’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Decision making — 5 (50%) 4 (40%) 1 (10%)
Utilization of resources — 4 (40%) 6 (60%) —
Enhances communication — 2 (20%) 4 (40%) 4 (40%)
Strategic planning — 4 (40%) 3 (30%) 3 (30%)
Quality assurance — 2 (20%) 8 (80%) —
Reduces waiting time — 4 (40%) 6 (60%) —
Utilization process 1 (10%) 4 (40%) 3 (30%) 2 (20%)
Medical audit 2 (20%) 5 (50%) 3 (30%) —
Role of HIS Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Reduces the cost 2 (10%) 5 (25%) 13 (65%) —
Shorten the stay — 3 (15%) 13 (65%) 4 (20%)
Continuity of patient care — 2 (10%) 3 (15%) 15 (75%)
Effective referral system 1 (5%) 6 (30%) 12 (69%) 1 (5%)
The purpose of the Hospital Information System is to raise “managing” from the level of piecemeal spotty information, intuitive guesswork and isolated problem solving to the level of systems insight, systems information and systems problem solving. It is, thus, a powerful method for aiding administrators in solving and making decisions2.
However, it was found that the majority of the managers (70%), disagree with the statement that the HIS of the hospital helps in discharging effectively their managerial responsibilities as well as in enhancing the inter and intra hospital communication (80%) Half of the managerial heads (50%) agree that the statistical information from the Medical Records Department helps in decisionmaking. With an increase in the number of third party payer’s utilization requirements, the admitting and utilization management are in frequent communication3.
The majority of the managers (80%) agree that the existing Hospital Information System does not help in the Quality Assurance Programme (QAP) as well as in enhancing the functions of the supportive services. Half of the managerial heads agree that the Hospital Information System does not help as a tool in the various utilization processes.
The various studies conducted earlier regarding information system reveals the benefits for doctors and nurses and includes, qualitatively better data, more available data on patients, direct consultations of colleagues and experts, use of decision based systems, reduced work load, the gain of time, and the availability of administrative support4.
Majority of the doctors do not believe that the existing Hospital Information System can help to reduce the cost of patient care (65%) or shorten the stay of the patient in the hospital (65%)5. (Table-2).
Table 3 – Disadvantages of the existing Hospital Information System – HIS
Disadvantages of existing
Hospital Information System Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Non-Existence of ward
Computers is affecting
patient care — 17 (85%) 3 (15%) —
OPD consultations take
longer time — 16 (80%) 1 (5%) 3 (15%)
Delay in getting
longer time 1 (5%) 14 (70%) 5 (25%) —
The majority of the doctors (85%) feel that the nonexistence of ward computers is a hinderance in providing the expected patient care. They also feel that the existing Hospital Information System does not help either in making the OPD consultations quicker or in generating quick laboratory reports6. (Table-3)
Table – 4. Opinion about current HIS with respect to Internal and Personnel Performance
Internal Performance of the Hospital Doctor’s responses regarding the existing system
Strongly
Agree Agree Disagree Strongly
disagree
Infection Control — 7 (35%) 12 (60%) 1 (5%)
Defining Community needs — 2 (10%) 14 (70%) 4 (20%)
Majority of the doctors disagree that the Hospital Information System helps in infection control (65%) and in defining the community needs (90%). Majority of them agree that the Hospital Information System helps in education and research (60%)7.
The different benefits of information system to the community are, to prepare a programme of health education for the area (with priorities for the health activities), information on the indicators of health which can help to focus attention on target group for specific health services, and, help to prevent epidemics8,9.
CONCLUSION
The present scenario in India is that most of the Medical Records Department are partially computerized10. This system exists in some Health Care facilities, where entries are made by different Health care providers, such as Physicians, Nurses and therapists, into the computer in different nodes in a local area network. The survey conducted in the hospital reveals the importance of information networking between the departments. Majority of the beneficiaries of Hospital Information System, are aware about the advantages of computerisation in the HIS in providing better health care. All of them agree that only in an efficient system the information can be readily available. The exciting possibility of a modern and computerised information system is not too far. In the coming years we can visualize the patient record existing in electronic medium, where a patient can have a single record from birth to death that can be assessed from any where in the world11.
Thursday, August 20, 2009
BioMediCal Waste Disposal
New Delhi, 20th July, 1998
S.O. 630 (E).-Whereas a notification in exercise of the powers conferred by Sections 6, 8 and 25 of the Environment (Protection) Act, 1986 (29 of 1986) was published in the Gazette vide S.O. 746 (E) dated 16 October, 1997 inviting objections from the public within 60 days from the date of the publication of the said notification on the Bio-Medical Waste (Management and Handling) Rules, 1998 and whereas all objections received were duly considered..
Now, therefore, in exercise of the powers conferred by section 6, 8 and 25 of the Environment (Protection) Act, 1986 the Central Government hereby notifies the rules for the management and handling of bio-medical waste.
1. SHORT TITLE AND COMMENCEMENT:
(1) These rules may be called the Bio-Medical Waste (Management and Handling) Rules, 1998.
(2) They shall come into force on the date of their publication in the official Gazette.
APPLICATION:
These rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form.
3. DEFINITIONS: In these rules unless the context otherwise requires
(1) "Act" means the Environment (Protection) Act, 1986 (29 of 1986);
(2) "Animal House" means a place where animals are reared/kept for experiments or testing purposes;
(3) "Authorisation" means permission granted by the prescribed authority for the generation, collection, reception, storage, transportation, treatment, disposal and/or any other form of handling of bio-medical waste in accordance with these rules and any guidelines issued by the Central Government.
(4) "Authorised person" means an occupier or operator authorised by the prescribed authority to generate, collect, receive, store, transport, treat, dispose and/or handle bio-medical waste in accordance with these rules and any guidelines issued by the Central Government;
(5) "Bio-medical waste" means any waste, which is generated during the diagnosis, treatment or immunisation of human beings or animals or in research activities pertaining thereto or in the production or testing of biologicals, and including categories mentioned in Schedule I;
(6) "Biologicals" means any preparation made from organisms or micro-organisms or product of metabolism and biochemical reactions intended for use in the diagnosis, immunisation or the treatment of human beings or animals or in research activities pertaining thereto;
(7) "Bio-medical waste treatment facility" means any facility wherein treatment. disposal of bio-medical waste or processes incidental to such treatment or disposal is carried out;
(8) "Occupier" in relation to any institution generating bio-medical waste, which includes a hospital, nursing home, clinic dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called, means a person who has control over that institution and/or its premises;
(9) "Operator of a bio-medical waste facility" means a person who owns or controls or operates a facility for the collection, reception, storage, transport, treatment, disposal or any other form of handling of bio-medical waste;
(10) "Schedule" means schedule appended to these rules;
4. DUTY OF OCCUPIER:
It shall be the duty of every occupier of an institution generating bio-medical waste which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathological laboratory, blood bank by whatever name called to take all steps to ensure that such waste is handled without any adverse effect to human health and the environment.
5. TREATMENT AND DISPOSAL
(1) Bio-medical waste shall be treated and disposed of in accordance with Schedule I, and in compliance with the standards prescribed in Schedule V.
(2) Every occupier, where required, shall set up in accordance with the time-schedule in Schedule VI, requisite bio-medical waste treatment facilities like incinerator, autoclave, microwave system for the treatment of waste, or, ensure requisite treatment of waste at a common waste treatment facility or any other waste treatment facility.
6. SEGREGATION, PACKAGING, TRANSPORTATION AND STORAGE
(1) Bio-medical waste shall not be mixed with other wastes.
(2) Bio-medical waste shall be segregated into containers/bags at the point of generation in accordance with Schedule II prior to its storage, transportation, treatment and disposal. The containers shall be labeled according to Schedule III.
(3) If a container is transported from the premises where bio-medical waste is generated to any waste treatment facility outside the premises, the container shall, apart from the label prescribed in Schedule III, also carry information prescribed in Schedule IV.
(4) Notwithstanding anything contained in the Motor Vehicles Act, 1988, or rules thereunder, untreated biomedical waste shall be transported only in such vehicle as may be authorised for the purpose by the competent authority as specified by the government.
(5) No untreated bio-medical waste shall be kept stored beyond a period of 48 hours
Provided that if for any reason it becomes necessary to store the waste beyond such period, the authorised person must take permission of the prescribed authority and take measures to ensure that the waste does not adversely affect human health and the environment.
7. PRESCRIBED AUTHORITY
(1) The Government of every State and Union Territory shall establish a prescribed authority with such members as may be specified for granting authorisation and implementing these rules. If the prescribed authority comprises of more than one member, a chairperson for the authority shall be designated.
(2) The prescribed authority for the State or Union Territory shall be appointed within one month of the coming into force of these rules.
(3) The prescribed authority shall function under the supervision and control of the respective Government of the State or Union Territory.
(4) The prescribed authority shall on receipt of Form 1 make such enquiry as it deems fit and if it is satisfied that the applicant possesses the necessary capacity to handle bio-medical waste in accordance with these rules, grant or renew an authorisation as the case may be.
(5) An authorisation shall be granted for a period of three years, including an initial trial period of one year from the date of issue. Thereafter, an application shall be made by the occupier/operator for renewal. All such subsequent authorisation shall be for a period of three years. A provisional authorisation will be granted for the trial period, to enable the occupier/operator to demonstrate the capacity of the facility.
(6) The prescribed authority may after giving reasonable opportunity of being heard to the applicant and for reasons thereof to be recorded in writing, refuse to grant or renew authorisation.
(7) Every application for authorisation shall be disposed of by the prescribed authority within ninety days from the date of receipt of the application.
(8) The prescribed authority may cancel or suspend an authorisation, if for reasons, to be recorded in writing, the occupier/operator has failed to comply with any provision of the Act or these rules :
Provided that no authorisation shall be cancelled or suspended without giving a reasonable opportunity to the occupier/operator of being heard.
8. AUTHORISATION
(1) Every occupier of an institution generating, collecting, receiving, storing, transporting, treating, disposing and/or handling bio-medical waste in any other manner, except such occupier of clinics, dispensaries, pathological laboratories, blood banks providing treatment/service to less than 1000 (one thousand) patients per month, shall make an application in Form 1 to the prescribed authority for grant of authorisation.
(2) Every operator of a bio-medical waste facility shall make an application in Form 1 to the prescribed authority for grant of authorisation.
(3) Every application in Form 1 for grant of authorisation shall be accompanied by a fee as may be prescribed by the Government of the State or Union Territory.
9. ADVISORY COMMITTEE
The Government of every State/Union Territory shall constitute an advisory committee. The committee will include experts in the field of medical and health, animal husbandry and veterinary sciences, environmental management, municipal administration, and any other related department or organisation including non-governmental organisations. The State Pollution Control Board/Pollution Control Committee shall be represented. As and when required, the committee shall advise the Government of the State/Union Territory and the prescribed authority about matters related to the implementation of these rules.
10. ANNUAL REPORT
Every occupier/operator shall submit an annual report to the prescribed authority in Form 11 by 31 January every year, to include information about the categories and quantities of bio-medical wastes handled during the preceding year. The prescribed authority shall send this information in a compiled form to the Central Pollution Control Board by 31 March every year.
11. MAINTENANCE OF RECORDS
(1) Every authorised person shall maintain records related to the generation, collect ' ion, reception, storage, transporation, treatment, disposal and/or any form of handling of bio-medical waste in accordance with these rules and any guidelines issued.
(2) All records shall be subject to inspection and verification by the prescribed authority at any time.
12. ACCIDENT REPORTING
When any accident occurs at any institution or facility or any other site where bio-medical waste is handled or during transportation of such waste, the authorised person shall report the accident in Form Ill to the prescribed authority forthwith.
13. APPEAL
Any person aggrieved by an order made by the prescribed authority under these rules may, within thirty days from the date on which the order is communicated to him, prefer an appeal to such authority as the Government of State/Union Territory may think fit to constitute :
Provided that the authority may entertain the appeal after the expiry of the said period of thirty days if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.
SCHEDULE I
(See Rule 5)
CATEGORIES OF BIO-MEDICAL WASTE
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Option Waste Category Treatment & Disposal
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Category No. I Human Anatomical Waste
(human tissues, organs, body parts) incineration@/deep burial*
Category No. 2 Animal Waste
(animal tissues, organs, body parts carcasses, bleeding parts, fluid, incineration@/deep burial*
blood and experimental animals used in research, waste generated
by veterinary hospitals colleges, discharge from hospitals, animal
houses)
Category No 3 Microbiology & Biotechnology Waste
(wastes from laboratory cultures, stocks or specimens of micro- local autoclaving/micro-
organisms live or attenuated vaccines, human and animal cell waving/incineration@
culture used in research and infectious agents from research
and industrial laboratories, wastes from production of biologicals,
toxins, dishes and devices used for transfer of cultures)
Category No 4 Waste sharps
(needles, syringes, scalpels, blades, glass, etc. that may cause disinfection (chemical treat-
puncture and cuts. This includes both used and unused sharps) ment@01/auto claving/micro-
waving and mutilation/
shredding"
Category No 5 Discarded Medicines and Cytotoxic drugs
(wastes comprising of outdated, contaminated and discarded inc ineratio n@/destruct ion and
medicines) drugs disposal in secured
landfills
Category No 6 Solid Waste
(Items contaminated with blood, and body fluids including cotton,
dressings, soiled plaster casts, lines, beddings, other material incineration@
contaminated with blood) autoclaving/microwaving
Category No. 7 Solid Waste
(wastes generated from disposable items other than the waste shaprs disinfection by chemical
such as tubings, catheters, intravenous sets etc). treatment@@ autoclaving/
microwaving and mutilation/
shredding##
Category No. 8 Liquid Waste
(waste generated from laboratory and washing, cleaning, house- disinfection by chemical
keeping and disinfecting activities) treatment@@ and discharge
into drains.
Category No. 9 Incineration Ash
(ash from incineration of any bio-medical waste) disposal in municipal landfill
Category No. 10 Chemical Waste
(chemicals used in production of biologicals, chemicals used in chemical treatment@@ and
disinfection, as insecticides, etc.) discharge into drains for
liquids and secured landfill
for solids
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@@ Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent. It must be ensured that chemical treatment ensures disinfection.
## Multilation/shredding must be such so as to prevent unauthorised reuse.
@ There will be no chemical pretreatment before incineration. Chlorinated plastics shall not be incinerated.
* Deep burial shall be an option available only in towns with population less than five lakhs and in rural areas.
SCHEDULE II
(see Rule 6)
COLOUR CODING AND TYPE OF CONTAINER FOR DISPOSAL OF BIO-MEDICAL WASTES
Colour Conding
Type of Container -I Waste Category
Treatment options as per
Schedule I
Yellow
Plastic bag Cat. 1, Cat. 2, and Cat. 3,
Cat. 6.
Incineration/deep burial
Red
Disinfected container/plastic bag Cat. 3, Cat. 6, Cat.7.
Autoclaving/Microwaving/
Chemical Treatment
Blue/White
translucent
Plastic bag/puncture proof Cat. 4, Cat. 7.
Container
Autoclaving/Microwaving/
Chemical Treatment and
destruction/shredding
Black
Plastic bag Cat. 5 and Cat. 9 and
Cat. 10. (solid)
Disposal in secured landfill
Notes:
1. Colour coding of waste categories with multiple treatment options as defined in Schedule I, shall be selected depending on treatment option chosen, which shall be as specified in Schedule I.
2. Waste collection bags for waste types needing incineration shall not be made of chlorinated plastics.
3. Categories 8 and 10 (liquid) do not require containers/bags.
4. Category 3 if disinfected locally need not be put in containers/bags.
SCHEDULE III
(see Rule 6)
LABEL FOR BIO-MEDICAL WASTE CONTAINERS/BAGS
HANDLE WITH CARE
Note : Lable shall be non-washable and prominently visible.
SCHEDULE IV
(see Rule 6)
LABEL FOR TRANSPORT OF BIO-MEDICAL WASTE CONTAINERS/BAGS
Day ............ Month ..............
Year ...........
Date of generation ...................
Waste category No ........
Waste class
Waste description
Sender's Name & Address Receiver's Name & Address
Phone No ........ Phone No ...............
Telex No .... Telex No ...............
Fax No ............... Fax No .................
Contact Person ........ Contact Person .........
In case of emergency please contact
Name & Address :
Phone No.
Note :
Label shall be non-washable and prominently visible.
SCHEDULE V
(see Rule 5 and Schedule 1)
STANDARDS FOR TREATMENT AND DISPOSAL OF BIO-MEDICAL WASTES
STANDARDS FOR INCINERATORS:
All incinerators shall meet the following operating and emission standards
A. Operating Standards
1. Combustion efficiency (CE) shall be at least 99.00%.
2. The Combustion efficiency is computed as follows:
%C02
C.E. = ------------ X 100
%C02 + % CO
3. The temperature of the primary chamber shall be 800 ± 50 deg. C°.
4. The secondary chamber gas residence time shall be at least I (one) second at 1050 ± 50 C°, with minimum 3% Oxygen in the stack gas.
B. Emission Standards
Parameters Concentration mg/Nm3 at (12% CO2 correction)
(1) Particulate matter 150
(2) Nitrogen Oxides 450
(3) HCI 50
(4) Minimum stack height shall be 30 metres above ground
(5) Volatile organic compounds in ash shall not be more than 0.01%
Note :
• Suitably designed pollution control devices should be installed/retrofitted with the incinerator to achieve the above emission limits, if necessary.
• Wastes to be incinerated shall not be chemically treated with any chlorinated disinfectants.
• Chlorinated plastics shall not be incinerated.
• Toxic metals in incineration ash shall be limited within the regulatory quantities as defined under the Hazardous Waste (Management and Handling Rules,) 1989.
• Only low sulphur fuel like L.D.0dLS.H.S.1Diesel shall be used as fuel in the incinerator.
STANDARDS FOR WASTE AUTOCLAVING:
The autoclave should be dedicated for the purposes of disinfecting and treating bio-medical waste,
(I) When operating a gravity flow autoclave, medical waste shall be subjected to :
(i) a temperature of not less than 121 C' and pressure of 15 pounds per square inch (psi) for an autoclave residence time of not less than 60 minutes; or
(ii) a temperature of not less than 135 C° and a pressure of 31 psi for an autoclave residence time of not less than 45 minutes; or
(iii) a temperature of not less than 149 C° and a pressure of 52 psi for an autoclave residence time of not less than 30 minutes.
(II) When operating a vacuum autoclave, medical waste shall be subjected to a minimum of one pre-vacuum pulse to purge the autoclave of all air. The waste shall be subjected to the following:
(i) a temperature of not less than 121 C° and pressure of 15 psi per an autoclave residence time of not less than 45 minutes; or
(ii) a temperature of not less than 135 C° and a pressure of 31 psi for an autoclave residence time of not less than 30 minutes;
(III) Medical waste shall not be considered properly treated unless the time, temperature and pressure indicators indicate that the required time, temperature and pressure were reached during the autoclave process. If for any reasons, time temperature or pressure indicator indicates that the required temperature, pressure or residence time was not reached, the entire load of medical waste must be autoclaved again until the proper temperature, pressure and residence time were achieved.
(IV) Recording of operational parameters
Each autoclave shall have graphic or computer recording devices which will automatically and continuously monitor and record dates, time of day, load identification number and operating parameters throughout the entire length of the autoclave cycle.
(V) Validation test
Spore testing :
The autoclave should completely and consistently kill the approved biological indicator at the maximum design capacity of each autoclave unit. Biological indicator for autoclave shall be Bacillus stearothermophilus spores using vials or spore Strips; with at least 1X104 spores per millilitre. Under no circumstances will an autoclave have minimum operating parameters less than a residence time of 30 minutes, regardless of temperature and pressure, a temperature less than 121 C° or a pressure less than 15 psi.
(VI) Routine Test
A chemical indicator strip/tape the changes colour when a certain temperature is reached can be used to verify that a specific temperature has been achieved. It may be necessary to use more than one strip over the waste package at different location to ensure that the inner content of the package has been adequately autoclaved
STANDARD FOR LIQUID WASTE:
The effluent generated from the hospital should conform to the following limits
PARAMETERS PERMISSIBLE LIMITS
PH 63-9.0
Susponded solids 100 mg/l
Oil and grease 10 mg/l
BOD 30 mg/l
COD 250 mg/l
Bio-assay test 90% survival of fish after 96 hours in 100% effluent.
these limits are applicable to those, hospitals which are either connected with sewers without terminal sewage treatment plant or not connected to public sewers. For discharge into public sewers with terminal facilities, the general standards as notified under the Environment (Protection) Act, 1986 shall be applicable.
STANDARDS OF MICROWAVING
1 Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated animal car casses, body parts and large metal items.
2. The microwave system shall comply with the efficacy test/routine tests and a performance guarantee may be provided by the supplier before operation of the limit.
3. The microwave should completely and consistently kill the bacteria and other pathogenic organisms that is ensured by approved biological indicator at the maximum design capacity of each microwave unit. Biological indicators for microwave shall be Bacillus Subtilis spores using vials or spore strips with at least 1 x 101 spores per milliliter.
STANDARDS FOR DEEP BURIAL
1. A pit or trench should he dug about 2 meters deep. It should be half filled with waste, then covered with lime within 50 cm of the surface, before filling the rest of the pit with soil.
2. It must be ensured that animals do not have any access to burial sites. Covers of galvanised iron/wire meshes may be used.
3. On each occasion, when wastes are added to the pit, a layer of 10 em of soil shall be added to cover the wastes.
4. Burial must be performed under close and dedicated supervision.
5. The deep burial site should be relatively impermeable and no shallow well should be close to the site.
6. The pits should be distant from habitation, and sited so as to ensure that no contamination occurs of any surface water or ground water. The area should not be prone to flooding or erosion.
7. The location of the deep burial site will be authorised by the prescribed authority.
8. The institution shall maintain a record of all pits for deep burial.
SCHEDULE VI
(see Rule 5)
SCHEDULE FOR WASTE TREATMENT FACILITIES LIKE INCINERATOR/ AUTOCLAVE/ MICROWAVE SYSTEM
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A Hospitals and nursing homes in towns with population of 30 lakhs by 31st December, 1999 or earlier
and above
B. Hospitals and nursing homes in towns with population of below
30 lakhs,
(a) with 500 beds and above by 31st December, 1999 or earlier
(b) with 200 beds and above but less than 500 beds by 31st December, 2000 or earlier
(c) with 50 beds and above but less than 200 beds by 31st December, 2001 or earlier
(d) with less than 50 beds by 31st December, 2002 or earlier
C. All other institutions generating bio-medical waste not included by 31st December, 2002 or earlier
in A and B above
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FORM I
(see rule 8)
APPLICATION FOR AUTHORISATION
(To be submitted in duplicate.)
To
The Prescribed Authority
(Name of the State Govt/UT Administration)
Address.
1. Particulars of Applicant
(i) Name of the Applicant
(In block letters & in full)
(ii) Name of the Institution:
Address:
Tele No., Fax No. Telex No.
2. Activity for which authorisation is sought:
(i) Generation
(ii) Collection
(iii) Reception
(iv) Storage
(v) Transportation
(vi) Treatment
(vii) Disposal
(viii) Any other form of handling
3. Please state whether applying for resh authorisation or for renewal:
(In case of renewal previous authorisation-number and date)
4.
(i) Address of the institution handling bio-medical wastes:
(ii) Address of the place of the treatment facility:
(iii) Address of the place of disposal of the waste:
5.
(i) Mode of transportation (in any) of bio-medical waste:
(ii) Mode(s) of treatment:
6. Brief description of method of treatment and disposal (attach details):
7.
(i) Category (see Schedule 1) of waste to be handled
(ii) Quantity of waste (category-wise) to be handled per month
8. Declaration
I do hereby declare that the statements made and information given above are true to the best of my knowledge and belief and that I have not concealed any information.
I do also hereby undertake to provide any further information sought by the prescribed authority in relation to these rules and to fulfill any conditions stipulated by the prescribed authority.
Date : Signature of the Applicant
Place : Designation of the Applicant
FORM II
(see rule 10)
ANNUALREPORT
(To be submitted to the prescribed authority by 31 January every year).
1 . Particulars of the applicant:
(i) Name of the authorised person (occupier/operator):
(ii) Name of the institution:
Address
Tel. No
Telex No.
Fax No.
2. Categories of waste generated and quantity on a monthly average basis:
3. Brief details of the treatment facility:
In case of off-site facility:
(i) Name of the operator
(ii) Name and address of the facility:
Tel. No., Telex No., Fax No.
4. Category-wise quantity of waste treated:
5. Mode of treatment with details:
6. Any other information:
7. Certified that the above report is for the period from
Date ............................... Signature ...........................................
Place.............................. Designation..........................................
FORM III
(see Rule 12)
ACCIDENT REPORTING
1. Date and time of accident:
2. Sequence of events leading to accident
3. The waste involved in accident :
4. Assessment of the effects of the accidents on human health and the environment,.
5. Emergency measures taken
6. Steps taken to alleviate the effects of accidents
7. Steps taken to prevent the recurrence of such an accident
Date ............................... Signature ...........................................
Place.............................. Designation..........................................