Bio Medical Waste Mgt Rules new.2016pptx

BMW rules

1. Bio Medical Waste Management Rules 2016

2. Bio Medical Waste - Definition Any waste, which is generated during the diagnosis, treatment or Immunization of human beings or Animals or research activities pertaining thereto or In the production or testing of biological or In health camps , including the categories mentioned in Schedule I appended to these rules.

3. What causes BMW to be Hazardous? Waste Chemical-medications, Solutions, Infectious microbes Chemicals such as formaldehyde waste anesthetic gases, etc. Used Disposables, wasted equipment &Chemotherapeutic agents Laser Smoke and aerosolized medications

4. Infectious wastes are also generated at: Dental Chambers, Nursing homes, Cosmetic clinics Path Laboratories, Blood Banks Ayush Hospitals Veterinary institutions Bio-Medical & Biotech Research centers Medical check-up & Surgical camps Mortuaries & Autopsy centres

5. Liquid wastes Approx. Quantity : 4 to 250 liters / bed / day Domestic Effluents and sewage Sewage from isolation wards, ICU’s toilets & urinals, Bed-bath, bathrooms and hospital’s laundry Wash waters from laboratories, OPD, Dressing rooms & Operation theaters.

6. Solid wastes Approximate Quantity : 0.3 to 3.5 kg/bed/day Garbage 55% (Moisture :40%) Bio-medical waste -13% Wasted body remains 05% (Blood, Cultures, Anatomicals ) Pharmaceutical & Chemical Wastes - 02% Pathological wastes (may be infectious) - 06% Sharp Objects - 20% Pressurized Containers & Discarded Instrument - 02% Radioactive Wastes - 0.3%

7. At Risk due to BMW Doctors and nurses Patients Hospital support staff Waste collection and disposal staff General public in the vicinity Environment

8. In Oct 2004 World Alliance for Patient Safety was formed and identified certain challenges with respect to safety of patients. A formal pledge committing to address health care associated infections in the country was signed by Govt of India. Health care Associated infections : 5-10% of admissions in acute care hospitals, 20 times higher in developing world.

9. 1.4 million people worldwide suffer from HAI, 50% preventable India contributes 25-35% of Global Injections, (3-6 Billion),nearly two thirds (62.9%) unsafe. Prevalence rate of blood borne diseases is on rise – Hep B 38/100, HIV 7/100, HCV also on rise.

10. Healthcare Waste is 85% Non-infectious 15% Infectious/ Hazardous According to the MoE,F&CC Gross generation of BMW in India is 484 TPD from 1,68,869 healthcare facilities (HCF), out of which 447 TPD is treated. Almost 38 TPD of the wastes is left untreated and not disposed finding its way in dumps or water bodies and re-enters our system.

11. Need for Regulation for Bio Medical Waste To minimize the potential for spread of disease from a medical settings to the general public. To reduce the overall amount of infectious medical waste produced. Infectious agents may become toys of terrorists, as Bioweapons of Mass Destruction. A tight control over BMW management can reduce the risk & response time.

12. The MoE,F&CC notified the new BMW (M) Rules, 2016 on 28th March, under the Environment (Protection) Act, 1986 to replace the earlier Rules (1998) and the amendments thereof. Published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section ( i )

13. These rules are called the Bio-Medical Waste Management Rules, 2016. They came into force on the date of their publication in the official Gazette.

14. Provide uniform guidelines and Code of practice for management and handling of biomedical wastes generated from: Hospitals, nursing homes, clinics, dispensaries, veterinary institutions, animal houses Pathological laboratories, blood banks Ayush hospitals, clinical establishments, research or educational institutions Health camps, medical or surgical camps, vaccination camps, blood donation camps, first aid rooms of schools, forensic laboratories Research labs.

15. The New Rules are : More comprehensive Contains important features of BMW (M & H) Rules, 1998 Several new provisions have been added in the new Rules. SCHEDULES- 1 to 4 FORMS- 1 to 5 Rules – 1 to 18

16. Schedules 1998 2016 Sch I- Cat of waste or Type of waste Sch I- Cat according to colour code and type of waste with treatment/disposal option Sch 2- Colour code, type of container, waste cat & treatment options Sch 2- Standard for treatment and disposal of BMW (Including plasma pyrolysis and dry heat sterilization) Sch 3- Label for BMW container Bags Sch 3- List of prescribed authorities and corresponding duties Sch 4- Label for tpt of BMW Sch 4 Part A- Label for BMW container Bags Part B- Label for transporting Sch 5- Std for treatment and disposal of BMW Sch 6- List of auth and corresponding duties

17. BMW categories, Segregation, Colour coding, Collection ,Treatment & Disposal - Schedule I Standards for Treatment & Disposal - Schedule II Prescribed Authorities & Responsibilities - Schedule III Labels for BMW containers & Bags - Schedule IV Accident Reporting - Form - I Application & Authorization Document - Form II & III Annual Reporting - Form IV APPEAL - Form V

18. The Bio Medical Waste Management Rules, 2016 Date of enforcement : Date of publication: 28/03/2016 Application & Exclusions Definition (a to p) Duties of the occupier [Generator] - (a to t) Duties of the occupier [Operator of CTDF] - (a to q) Duties of the Authorities[Operator of CTDF] - (a to q) Treatment & Disposal - (1 to 11) Segregation, packaging, Transportation & storage - (1 to 8) Prescribed authority (1 to 7)

19. Procedure for Authorization (1 to 4) Advisory committee (1 to 4) Monitoring & Implementation (1 to 6) Annual report, (1 to 4) Maintenance of records (1 to 2) Accident Reporting (1 to 2) Appeal (1 to 4) Site for CBMWTDF (1 to 2) Liability of the Occupier[Generator/Operator] (1 to 2)

20. Schedule-II Operational standards, Emission standards and Testing & Recording protocol for Treatment Technology Options Incinerator [Stack height/emission std ] Plasma Pyrolysis/Gasification system Autoclaving Microwaving Deep Burial Sterilization Chemical disinfection Liquid waste Routine test and validation by spore strip/Vials or Chemical vials

21. Schedule-III (Prescribed Authorities & Duties) MOEF & CC [Policy making/Training/Assistance/Monitoring Hearing Appeals/specify Stds & op Parameters] MOHFWF [Licensing/Listing/Coordinating PCB/ Monitoring/ Operational Research/Training & Awareness ] MOD [Authorization/Treatment & disposal/ Training/Review/ Advisory committee/ submission of reports to CPCB]

22. Schedule-IV: Container’s Colour /Markings/Label Colour tells other staff what is in the container Tells the contractor what to do with the waste Can apply to both sacks and rigid containers

23. Schedule -V STANDARDS FOR LIQUID WASTE pH 6.5 to 9.0 Suspended Solids 100 mg/l. Oil & grease 10 mg/l. BOD 30 mg/l. COD 250 mg/l. COD 250 mg/l. Bio assay 90 % Survival of fish after 96 hours in 100% effluent Send Domestic Effluents to municipal sewers Disinfect the infectious liquid waste and then send it to municipal sewers

24. Schedule -V STANDARD FOR DEEP BURIAL Entry of scavengers to the burial site be prevented may be by using covers of galvanized iron/wire mash. After every burial in the same secured pit a layer of 10 cm. soil be added . Burial must be performed under close and dedicated supervision.

25. Deep burial site should be relatively impermeable and distant from habitat. There should be no well, lake, river etc. close to the site to avoid contamination of surface water or ground water. Location of the deep burial site to be authorized by the Prescribed Authority. The occupier shall maintain record for all the pits

26. Duties of the Occupier A person having administrative control over the institution and the premises generating biomedical waste, which includes a hospital, nursing home, clinic, dispensary, veterinary institution, animal house, pathology laboratory, blood bank, health care facility and clinical establishment , irrespective of their system of medicine and by whatever name they clinical establishment, irrespective of their system of medicine and by whatever name they are called.

27. Duties of the Occupier[Generator] To ensure that there shall be no secondary handling , pilferage of recyclables or inadvertent scattering or spillage by animals and bio-medical waste from such place or premises shall be directly transported in the manner as prescribed in these rules to CBMWTF or for appropriate treatment & disposal, in manner prescribed in Schedule I. Phase out use of chlorinated plastic bags, gloves and blood bags within 2 yrs from the date of notification that is 28th March’ 2018. Provide within the premises a safe, ventilated & secured location for storage of Segregated biomedical waste in colored bags or containers in the manner as specified in Schedule I.

28. Duties of the Occupier[Generator] Pre-treat the laboratory waste, microbiological waste, blood samples and blood bags through disinfection or sterilisation on-site in the manner as prescribed by (WHO)/(NACO) guidelines & then sent CBMWTF for final disposal. Dispose of solid waste other than bio-medical waste in accordance with the provisions of respective waste management rules made under the relevant laws and management rules made under the relevant laws and amended from time to time

29. Provide training to all its health care workers & others, involved in handling of BMW at the time of induction and thereafter at least once every year and the details of training programmes conducted, number of personnel trained and number of personnel not undergone any training shall be provided in the Annual Report.

30. Duties of the Occupier[Generator] Not to give treated BMW or mix with general waste Immunise all its health care workers & others, involved in handling of bio-medical waste for protection against diseases including Hepatitis B and Tetanus prescribed in the National Immunisation Policy or the guidelines of MoH and FW

31. Establish a Bar- Code System for bags or containers containing bio-medical waste to be sent out of the premises or place for any purpose within one year from the date of the notification of these rules.

32. Duties of the Occupier[Generator] Ensure segregation of liquid chemical waste at source and ensure pre-treatment / neutralisation prior to mixing with other effluent generated from health care facilities Ensure treatment and disposal of liquid waste in accordance with the Water (Prevention and Control accordance with the Water (Prevention and Control of Pollution) Act, 1974 ( 6 of 1974)

33. Ensure occupational safety of all its health care workers and others involved in handling of bio- medical waste by providing appropriate and adequate personal protective equipment. Conduct health check up at the time of induction and at least once in a year for all its health care workers and others involved in handling of bio- medical waste and maintain the records for the same

34. Duties of the Occupier[Generator] Maintain and update, on day to day basis, the BMW management register and display the monthly record on its website Report major accidents including accidents caused by fire hazards, blasts during handling of BMW, the remedial action taken & the records relevant thereto, (including nil report) in Form I to the prescribed authority and also along with the annual report

35. Duties of the Occupier[Generator] Make available the annual report on its web-site and all the health care facilities shall make own website within two years from the date of notification of these rules Inform the prescribed authority immediately in case the operator of a facility does not collect the bio- medical waste within the intended time or as per the medical waste within the intended time or as per the agreed time.

36. Establish a system to review and monitor activities related to BMW management, either through an existing committee or by forming a new committee to meet once in every six months. Record of the minutes of the meetings of this committee shall be submitted along with the annual report to the prescribed authority

37. Duties of the Occupier[Generator] Healthcare establishments with less than 30 beds shall designate a qualified person to review and monitor the activities. Maintain all record for operation of incineration, hydro or autoclaving etc , for a period of 05 years

38. Duties of the Operator[CBMWTDF] Take all necessary steps to ensure that the bio-medical waste collected from the occupier is transported, handled, stored, treated and disposed of, without any adverse effect to the human health and the environment

39. Duties of the Operator[CBMWTDF] Provide training for all its workers involved in handling of Bio-medical waste at the time of induction and at least once a year thereafter Assist the occupier in training conducted by them for Bio-medical waste management

40. Undertake appropriate medical examination at the time of induction and at least once in a year and immunise all its workers and maintain records

41. Duties of the Operator[CBMWTDF] Ensure occupational safety of all its workers involved in handling of Bio-medical waste by providing appropriate and adequate personal protective equipment.

42. Report major accidents including accidents caused by fire hazards, blasts during handling of Bio-medical waste and the remedial action taken & records relevant thereto, (including nil report) in Form- I to the prescribed authority and also along with the annual report

43. Maintain a log book for each of its treatment equipment according to weight of batch; categories of waste treated; time, date and duration of treatment cycle & total hours of operation

44. Duties of the Operator[CBMWTDF] Allow occupier , who are giving waste for treatment to the operator, to see whether the treatment is carried out as per the rules Shall display details of authorisation , treatment, annual report etc. on its web-site

45. Recyclables from the treated bio-medical wastes such as plastics and glass, shall be given to recyclers having valid consent or authorisation or registration from the respective State Pollution Control Board or Pollution Control Committee

46. Duties of the Operator[CBMWTDF] Supply non-chlorinated plastic coloured bags to the occupier on chargeable basis, if required Common bio-medical waste treatment facility shall ensure collection of biomedical waste on holidays also

47. Maintain all record for operation of incineration, hydro or autoclaving for a period of five years; and autoclaving for a period of five years Upgrade existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin and Furans within two years from the date of this notification

48. BMW Treatment & Disposal In accordance with Schedule I, and in compliance with the standards provided in Schedule-II by the HCF & CBMWTDF Occupier shall hand over segregated waste as per the Schedule-I to common bio-medical waste treatment facility for treatment, processing and final disposal

49. Lab and highly infectious bio-medical waste generated shall be pre-treated by equipment like autoclave or microwave. No occupier shall establish on-site treatment and disposal facility, if a service of common bio-medical waste treatment facility is available at a distance of seventy-five kilometers.

50. Segregation, packaging, transportation & storage No untreated BMW shall be mixed with other wastes. BMW shall be segregated into containers or bags at the point of generation in accordance with Schedule I prior to its storage, transportation, treatment and disposal. These containers / bags to be labelled as per Schedule IV.

51. Bar code & global positioning system (GPS)to be installed by the Occupier & CBMWTF in 01 yrs time.(up till 28March 2017) The operator of CBMWTF to transport BMW from occupier’s premises to any off-site CBMWTF only in specified vehicles labelled as per part ‘A’ of the Schedule IV along with necessary information as specified in part ‘B’ of the Schedule IV.

52. Segregation, packaging, transportation & storage The vehicles used for transportation of BMW to comply with conditions specified by the PCB in addition to requirement of the Motor Vehicles Act, 1988 (59 of 1988), if any or the rules made there under for transportation of such infectious waste.

53. Untreated human anatomical waste, animal anatomical waste, soiled waste & biotechnology waste not be stored beyond a period of forty –eight hours

54. Different Formats & Applicability Application for Grant /Renewal of Authorization in form –II to PCB, the Prescribed Authority. Grant of Authorization in form –III by PCB to Occupier(BMW Generator/CBMWTDF).

55. Submission of Annual Report by Occupier in form –IV by 31st June Every year about the categories & quantities of BMW handling during the preceding year Application for Appeal against Refusal in Form V. Accident Reporting by the Occupier in Form-I

56. Contravention of the Act , Rules, Orders & directions May lead to legal action. The punishment may lead to the imprisonment up to 5 years with fine up to Rs . 1 lakh. For failure or continued contravention a fine @ Rs.5000 /Day may be charged. If the failure or the contravention continues beyond one year, the imprisonment may be extended up to 7 years.

57. BMW Mgt Issues Segregation of waste not taken seriously at generator level Non compliance with color coding Monitoring segregation at source Low budgets allocated Costs are not always known/nor worked out properly Cost of color coding, staff, transport and disposal is a major deterrent but must be met Quantification of waste generated is not done accurately

58. Protection of healthcare workers not given adequate thought Clinical waste dumped with non infectious waste Risk for healthcare workers and public Residual Waste disposal not effective, often dumped in open landfills

59. The disposal of solid wastes that are not infectious medical waste, is often done as if they were infectious Most commonly cited violation It increases the financial burden on patients and taxpayers in the form of increased disposal costs for health care facilities

60. When infectious waste and regular MSW mixes together, it can not be permitted to separate them Once combined, the entire contents are considered infectious waste. Increased Volumes of medical waste generation increases the risk of costly accidents and spills due to increased handling & Transportation required to haul the waste.

61. Challenges Establishing robust waste management policies within the Health Care Facility/organization Organization wide awareness about the health hazards Sufficient financial & Trained human resources needed Monitoring and control of waste disposal Clear responsibility and traceability for appropriate handling and disposal of waste

62. Hospital Waste Management is a real issue to be addressed The Primary responsibility of responsibility of the disposal of the Bio-Medical Waste lies with the Generator

63. THANK YOU