India - Bio-Medical Waste And Liability Of Hospitals In Wake Of The Covid-19 Pandemic.

Legal News & Analysis - Asia Pacific - India - Regulatory & Compliance

17 July 2020

 

Introduction:  
               

The handling, disposal and management of bio-medical waste (“BM Waste”)in India is government by inter-alia, the Biomedical Waste Management & Handling Rules, 1998 (“1998 Rules”) were notified by the Central Government in exercise of the powers conferred by Section 6,8 & 25 of the Environmental Protection Act, 1986. These rules provide for the framework of the management and Handling of disposal and scientific management of BM Waste
 

In wake of the COVID-19 pandemic, the Centre Pollution Control Board (“CPCB”) recently issued guidelines dated March 27, 2020 for handling, treatment and safe disposal of BM Waste generated during treatment, diagnosis and quarantine of patients confirmed or suspected to have COVID-19 (“Guidelines”). The Guidelines have been necessitated due to the super infectious nature of the Novel corona virus and provide for a mechanism for the segregation, packaging, transportation, storage and disposal of BM Waste in order to avoid further spread of the virus through BM Waste.
 

1. What is BM Waste and what categorises of BM Waste do hospitals generate? 
 

1.1 The Bio-Medical Waste Management Rules 2016[1] (“2016 Rules”) define BM Waste as any waste, which is generated during the diagnosis, treatment or immunisation 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 the 2016 Rules. The 2016 Rules apply to all persons who generate, collect, receive, store, transport, treat, dispose, or handle bio medical waste in any form.
 

1.2 BM Waste generated from a hospital could be human anatomical waste, animal waste- microbiology & biotechnology, waste sharps, discarded medicines and cytotoxic drugs, solid & liquid waste. 
 

2. How is BM Waste being treated and disposed of by hospitals in India during the ongoing COVID-19 pandemic?  
 

2.1 While hospitals in their usual course deal with segregation, management and storage of BM Waste, the situation in times of COVID-19 is typical due to the highly contagious nature, transmission cycle and multiplicity rate of the virus. Due to hospitals being flooded with suspected and confirmed cases, the Ministry of Health and family welfare (“MoHFW”) and the CPCB have issued various guidelines for handling and management of waste generated from COVID-19 facilities.
 

2.2 Under the 2016 Rules, while the hospitals are required to ensure that there is a secured location within its premises for a spill/pilferage free storage of segregated BM Waste in labelled/coloured bags or containers, the duty to transport the stored BM Waste from the hospital premises onwards to the common BM Waste treatment and disposal facility is of an ‘operator’ as defined in the Rules.
 

2.3 Specifically, in wake of COVID-19, the CPCB has issued Revision 1 to the Guidelines dated March 25, 2020 for Handling, Treatment and Disposal of Waste Generated during Treatment/Diagnosis/ Quarantine of COVID-19 Patients (“CPCB Guidelines”).[2] The said CPCB Guidelines inter-alia, state that hospitals are required to depute separate BM Waste sanitation workers to COVID-19 isolation wards, maintain records of all waste generated in such isolation wards and ensure that the BWM generated is collected and separately stored in separate leakproof color-coded double layered bags or bins /containers labelled as “COVID-19 waste” as per the 1998 Rules and the Guidelines.
 

2.4 In fact, the Bombay High Court in a pending public interest litigation has, while issuing notices to local municipal corporations and the State Pollution Control Board, also directed the Maharashtra government to clarify whether it was ensuring that all COVID-19 related biomedical waste generated in the state was being disposed of in a safe manner[3].
 

3. What are the measures a hospital is required to take for the safety of its employees (doctors, nurses and other support staff (“healthcare personnel”)) from diseases such as COVID-19?
 

3.1 Healthcare personnel have a high risk of contracting COVID-19. While the hospitals are taking precautions and measures to control any spread of infection within the premises, it is particularly difficult given the super-infectious nature and hyper-speed of transmission to contain it in an over-crowded environment. The first steps towards controlling the spread of a virus is personal protective equipment (preferably a two-layered fluid-resistant apron) and basic items like N-95 masks, face shield, full cover gowns  and sanitisers but the same are rendered ineffective against the COVID-19 if the quality of these equipments is not up to the mark.
 

3.2 Greater emphasis is also laid upon proper training and awareness of the healthcare personnel towards proper use and disposal for the equipment. The spread of the COVID-19 virus is also particularly fast due to the heavy load of asymptomatic patients coming into the hospital and hence a greater need for the formulation of national COVID-19 protocol.
 

3.3 The MoHFW has vide its revised guidelines for clinical management of COVID-19 dated March 31, 2020[4] (“Clinical Management Guidelines”) impressed upon strict compliance of Infection prevention control (IPC) protocol for Hospitals and a consequent effect of the same is prevention and management of COVID-19 in the hospital staff. This protocol inter-alia,  standard precautions such as hand hygiene, use of PPE to avoid direct contact with patients’ blood, body fluids, secretions (including respiratory secretions) and non-intact skin, prevention of needle-stick or sharps injury, safe waste management, cleaning and disinfection of equipment and cleaning of the environment around a COVID-19 patient.
 

3.4 The 2016 Rules provide that for ensuring the safety of the healthcare workers and others involved in the segregation and pre-treatment of BM Waste, the hospital is required to train to all its healthcare workers, immunise them for protection against diseases which likely to be transmitted by handling of BM Waste, in the manner as prescribed in the National Immunisation Policy[5]. Also, hospitals are required to ensure occupational safety of all its health care workers and others involved in handling of BM Waste by providing appropriate and adequate personal protective equipments and conduct health check up at the time of induction and at least once in a year maintain the records for the same.
 

 4. Legal obligations of the hospital, if and when an employee of the hospital tests positive for COVID-19?
 

4.1 The present COVID-19 pandemic is an unprecedented event and is unlike any other infectious disease known to mankind and the medical world is yet to fully decipher its modus operandi of infecting humans. In a hypothetical situation wherein a hospital employee contracts COVID-19, it will be imperative for the employee in such a situation to establish that his possible exposure to COVID-19 was in the Hospital itself not in the community (considering that the employee is also spending time outside hospital premises).
 

4.2 While in an ideal case, if it is proved that a hospital staff has contracted ‘a hospital acquired infection’, the hospital would be ordinarily liable. However, in the case of COVID-19 since it is seemingly impossible to trace down the exact source of infection, in absence of such proof and in light of utmost precautions taken by the hospitals as per the guidelines, fastening of any liability on the hospital would be peculiarly difficult.
 

4.3 The defence available to the hospital may be culpability and negligence of the employee and proving that the hospital itself took all possible measures to avoid any mass spread of the infection.
 

5. Legal obligations of the hospital, if and when a Non-COVID patient of the hospital contracts COVID during his term of being admitted in the hospital?
 

5.1 The National Consumer Dispute Redressal Commission in the matter of Apollo Emergency Hospital vs Dr. Bommakanti Sai Krishna & Anr.[6] observed that “As already observed, the infection occurred during the stay of the Complainant at the hospital. On the other hand, there is nothing to show that the source of infection lay outside the hospital. Thus, there is preponderance of possibilities of the infection having been acquired in the hospital itself. We therefore, do not accept the contention that it was necessary for the Complainant to produce expert evidence to prove negligence on the part of the concerned doctors in the hospital.
 

5.2 The afore-stated judgement implies a presumption of liability on the hospital in cases where the probability of acquiring the infection is much higher inside the hospital than from other sources. However, the same may not apply in COVID cases in light of the peculiar difficulty of tracing the source of acquiring the COVID-19 infection. Therefore, the presumption rendered by the aforesaid judgement will not be ipso facto applicable to cases of COVID patients. 
 

6. Legal obligations of the hospital, if and when a patient is misdiagnosed positive or negative for COVID-19 by the hospital due to a fault in the COVID-19 rapid testing kit (“testing kits”)?
 

 6.1 The liability of a hospital in cases of misdiagnosis depends on the methodology of procuring of testing kits. A hospital may procure testing kit either from third party manufacturer or may manufacture them internally i.e. by itself or its subsidiary. In cases where the misdiagnosis is on account of faulty testing kit procured externally, the hospital cannot be held directly liability as the liability may be shifted upon the manufacturer.
 

6.2 In cases where the misdiagnosis is on account of faulty testing kit is due to testing kits produced internally the hospital may be liable subject to it being proved that the misdiagnosed patient was indeed positive. However, factors such success rate of any testing kit not being 100% may have an interplay in determining liability.
 

7. Legal liability of a hospital, in a situation where the hospital discharges a mild/very mild/pre-symptomatic COVID patient to ramp up capacity for serious COVID patients.
 

 7.1 A hospital will not be liable for a systematic discharge of a mild/very mild/pre-symptomatic/moderate COVID patient as the same is directed by the Central Government. On May 8, 2020, the MoHFW released its revised policy for the discharge of COVID-19 patients.[7] This revised policy provides that hospitals can discharge mild/very mild/pre-symptomatic in accordance with the protocols given therein. In the earlier advisory[8], COVID-19 patients could be discharged only after chest radiograph clearance, viral clearance in respiratory samples, and if two of the patient’s specimens were negative within a period of 24 hours. The discharged patient would then have to home quarantine themselves in accordance with the revised policy.
 

8. What is the protocol to be followed by a Hospital while disposal of dead bodies of COID-19 patients?
 

8.1 The corpses are a source of infection for healthcare personnel/ other patients and cannot be disposed of by usual methods of disposal and therefore, the MHFW issued guidelines dated March 15, 2020 on dead body management in COVID-19.[9] The guidelines provide inter-alia, the protocol to be followed at the time of removal from the isolation room or area, put in bio-hazard bag and disinfection. Further, all surfaces of the isolation area (floors, bed, railings, side tables, IV stand etc.) should be wiped with 1% Sodium Hypochlorite solution; allowed contact time of 30 minutes, and then allowed to air dry.
 

9. Is there a protocol for treatment of COVID-19 patients?
 

9.1 The All India Institute of Medical Sciences (AIIMS) has issued clinical protocol dated April 21, 2020 for treatment of Covid-19 patients and states such as Madhya Pradesh and Delhi have directed Hospitals and health centres dedicated to treating COVID-19 patients to follow the said clinical protocol.[10]
 

10. Is there a standardisation of costs of treatment of a COVID-19 for private hospitals?
 

10.1 Government hospitals are reaching their intake capacities and for that reason COVID-19 patients have been resorting to treatment in private hospitals. While some private hospitals are charging exorbitant amounts as costs of treatment, the same is worrying not just the patients but also the insurers.[11] In a first, the State government of Maharashtra has capped treatment costs in private hospitals for people without medical insurance and for other patients, the capped prices will come into effect once they exhaust their medical insurance cover.[12]
 

The Gujarat high has vide its order dated May 22, 2020 directed the state government to issue a notification making it mandatory for all multi-speciality hospitals private/ corporate hospitals in Ahmedabad and on its outskirts to reserve 50% of their beds (or such other capacity as maybe specified by the state government) for COVID-19 patients. In view of the same, the Government of Gujarat may come up with similar caps on costs as Maharashtra.[13]  The Gujarat High Court also observed that certain private hospitals authorised by the government to treat COVID-19  patients in Ahmedabad are charging exorbitant  fees which is unaffordable for a massive section of the society and directed the state government to ensure that private hospitals do not  charge exorbitant fees. [14]
 

10.2 The Bombay High Court recently directed a charitable hospital to make court deposit of monies in a case pertaining to levy of exorbitant charges for treatment of COVID-19 patients belonging to poor strata despite reserving 20% of its beds for poor and the needy.[15]

 

 

For further information, please contact:

 

Ankoosh Mehta, Partner, Cyril Amarchand Mangaldas

ankoosh.mehta@cyrilshroff.com

 

[1] Available at – https://dhr.gov.in/sites/default/files/Bio-medical_Waste_Management_Rules_2016.pdf last accessed on June 27, 2020 at 1000 hours.

[2] Available at https://www.mohfw.gov.in/pdf/63948609501585568987wastesguidelines.pdf last accessed on June 26, 2020 at 1243PM.

[3] https://www.hindustantimes.com/mumbai-news/bombay-hc-seeks-state-govt-s-reply-on-disposal-of-covid-19-biomedical-waste/story-ivVDDnsp6yMKgfqIYk2TEN.html last accessed on July 03, 2020 at 1243PM. As per reports, replies have to be filed by July 14, 2020.

[4]https://www.mohfw.gov.in/pdf/RevisedNationalClinicalManagementGuidelineforCOVID1931032020.pdf ; pre-revision guidelines are at https://www.mohfw.gov.in/pdf//National%20Guidelines%20for%20IPC%20in%20HCF%20-%20final%281%29.pdf

[5]Available at https://main.mohfw.gov.in/sites/default/files/108481119000.pdf last accessed on June 26, 2020 at 1400Hours.

[6] The Apollo Emergency Hospital vs Dr. Bommakanti Sai Krishna & Anr., MANU/CF/0051/2013

[7] Available at https://www.mohfw.gov.in/pdf/ReviseddischargePolicyforCOVID19.pdf

https://www.mohfw.gov.in/pdf/FAQsonRevisedDischargePolicy.pdf last accessed on May 12, 2020 at 1300 Hours.

[8] Available at https://www.mohfw.gov.in/pdf/Corona%20Discharge-Policy.pdf ;

also refer to https://www.mohfw.gov.in/pdf/FinalGuidanceonMangaementofCovidcasesversion2.pdf l

ast accessed on May 13, 2020 at 1800 Hours.

[9]Available  at https://www.mohfw.gov.in/pdf/1584423700568_COVID19GuidelinesonDeadbodymanagement.pdf 

last accessed on May 4, 2020 at 1200Hours.

[10] Available at https://health.economictimes.indiatimes.com/news/hospitals/mp-hospitals-to-follow-

aiims-protocol-for-covid-19-care/75470554; last accessed on May 23, 2020 at 1200Hours; Available at https://timesofindia.indiatimes.com/city/

bhopal/mp-hospitals-to-follow-aiims-protocol-for-covid-19-care/articleshow/75463520.cms last accessed on May 23, 2020 at 1300Hours.

[11] Available at  https://www.livemint.com/money/personal-finance/insurers-want-standard-covid-19-treatment-cost-11589734285328.html 

last accessed on May 23, 2020 at 0214Hours.

[12]Available at  https://economictimes.indiatimes.com/news/politics-and-nation/regulate-fees-of-private-

hospitals-treating-covid-19-patients-hc/articleshow/75758648.cms?from=mdr last accessed on May 23, 2020 at 1200Hours.

[13] Refer to order dated May 23, 2020 passed by the Hon’ble Gujarat High Court passed in  W.P.PIL No. 42 of 2020.

[14] Refer to order dated May 14, 2020 passed by the Hon’ble Gujarat High Court passed in  W.P.PIL No. 42 of 2020.

[15]https://www.thehindu.com/news/cities/mumbai/cant-expect-patients-to-submit-proof-of income/article31936388.ece ; https://www.thehindu.com/news/cities/mumbai/coronavirus-mumbai-charitable-hospital-treated-just-four-poor-patients-bombay-high-court-told/article31877330.ece  last accessed on July 3, 2020 at 2000 hours.