with due respect to Gp Capt (Dr) Sanjeev Sood ,Hospital Administrator and NABH Assessor, the following informative points are taken from Modern Medicare (Network18)
With as many as many as eighty licenses and statutory obligations that govern the activities of Healthcare Organisations (HCOs), and have to be fully complied with, the healthcare sector is one of the most regulated ones.
Some of these laws are as archaic as Indian Epidemic Diseases Act 1897; some apply to all
industries (Minimum Wages Act 1948) and some are unique to healthcare (PCPNDT Act 2003);
and some are yet to be enacted - Indian Health Bill 2010.
Further, some of these legal obligations are towards the patient and others towards the institutions, employees, society and state.No wonder, most medicos ar not comfortable with these medico-legal procedures and pitfalls, and HCOs find these a tricky minefield to navigate.
Discussed here are ten medico-legal obligations that most medicos and HCOs falter on, but must fulfil to prevent any untoward situations and remain hassle free.
1.Under PCPNDT Act 2003 - the most restrictive of all,failure to register all ultrasound
machines, scanning equipment,personnel competent to conduct ultrasound with appropriate authority,
display notice,obtain consent of pregnant woman,maintenance and submission of complete
records shall invite punitive action not only for violation of the Act, but also penalties for
the unintentional procedural lapses.
2.Patient are educated about possible adverse effects,drug, food or activity interactions. Patients can play a vital role in preventing medication errors when they have been encouraged to ask questions and seek answers about their medications.
3. Failure to mandatorily report medico-legal cases to the authorities (u/s 39 of CrPC)
may invite prosecution (u/s 176 and / or 202 of IPC). Thus, all cases of unnatural death, accidents and
injuries where foul play is suspected need to be brought under the notice of law enforcement agencies for further investigations.
4. Failure to provide emergency treatment to a victim of roadside accident and to refuse blood in
absence of donors in terms of the Supreme Court judgement (Pt Parmanad Katara vs
Union of India 1989). Further, the Clinical Establishments (Registration and Regulation)
Act 2010 mandates that all emergency cases have to be rendered first aid treatment till
stabilised or transferred to another HCO, irrespective of the patient’s capacity to pay.
5. Failure to obtain appropriate consent prior to any invasive procedure that must be written,
informed and separate for anaesthesia, surgery and blood transfusion. Any major
complication likely to arise during the course of procedure should be included in consent
(S Kohli vs Dr P Manchanda, 1998). A proper consent is a way of communicating
with the patient and offers a strong legal defence for the care providers.
6.Failure to maintain medical records (Bombay High Court judgement - R Raheja
vs MMC), and provide them to the patient on demand within 72 hours (RTI Act 2005). Medical records should be preserved for OPD/IPD/medico legal cases for unspecified period/ 3/25 years,
respectively, as per MCI Act 2002 and for 5/10/10 years, respectively (as per the
DGHS vide letter No. 10-3/68-MH dated 31 Aug 68). Failure to collect, destruction or loss of such an exhibit is also punishable (u/s 201 of IPC).
7. Under Transplantation of Human Organs Act 1994, failure to register the facility, unlawful removal,
storage and transplantation of human organs and/or any commercial dealings in organs shall invite
stringent punishments.
8.When some services such as waste disposal or security, have been outsourced, the principal employer, ie, the HCO is not absolved of any non-compliances to all the legal statutes.
9. Under IMC (professional conduct, etiquette and ethics amendment) Regulations 2002, the physician shall
not indulge in any act of professional misconduct meaning thereby they shall not prescribe branded medicine, issue false certificates, display unrecognised qualifications or accept gift, grant or hospitality from commercial sources.
10. Under BMW (Management and Handling) Rules 1998, failure to collect, segregate,store, transport and dispose of waste in any manner that causes harm to human health or environment by the
HCF serving 1000 or more patients per month shall invite punitive action under the various provisions of the Rule
With as many as many as eighty licenses and statutory obligations that govern the activities of Healthcare Organisations (HCOs), and have to be fully complied with, the healthcare sector is one of the most regulated ones.
Some of these laws are as archaic as Indian Epidemic Diseases Act 1897; some apply to all
industries (Minimum Wages Act 1948) and some are unique to healthcare (PCPNDT Act 2003);
and some are yet to be enacted - Indian Health Bill 2010.
Further, some of these legal obligations are towards the patient and others towards the institutions, employees, society and state.No wonder, most medicos ar not comfortable with these medico-legal procedures and pitfalls, and HCOs find these a tricky minefield to navigate.
Discussed here are ten medico-legal obligations that most medicos and HCOs falter on, but must fulfil to prevent any untoward situations and remain hassle free.
1.Under PCPNDT Act 2003 - the most restrictive of all,failure to register all ultrasound
machines, scanning equipment,personnel competent to conduct ultrasound with appropriate authority,
display notice,obtain consent of pregnant woman,maintenance and submission of complete
records shall invite punitive action not only for violation of the Act, but also penalties for
the unintentional procedural lapses.
2.Patient are educated about possible adverse effects,drug, food or activity interactions. Patients can play a vital role in preventing medication errors when they have been encouraged to ask questions and seek answers about their medications.
3. Failure to mandatorily report medico-legal cases to the authorities (u/s 39 of CrPC)
may invite prosecution (u/s 176 and / or 202 of IPC). Thus, all cases of unnatural death, accidents and
injuries where foul play is suspected need to be brought under the notice of law enforcement agencies for further investigations.
4. Failure to provide emergency treatment to a victim of roadside accident and to refuse blood in
absence of donors in terms of the Supreme Court judgement (Pt Parmanad Katara vs
Union of India 1989). Further, the Clinical Establishments (Registration and Regulation)
Act 2010 mandates that all emergency cases have to be rendered first aid treatment till
stabilised or transferred to another HCO, irrespective of the patient’s capacity to pay.
5. Failure to obtain appropriate consent prior to any invasive procedure that must be written,
informed and separate for anaesthesia, surgery and blood transfusion. Any major
complication likely to arise during the course of procedure should be included in consent
(S Kohli vs Dr P Manchanda, 1998). A proper consent is a way of communicating
with the patient and offers a strong legal defence for the care providers.
6.Failure to maintain medical records (Bombay High Court judgement - R Raheja
vs MMC), and provide them to the patient on demand within 72 hours (RTI Act 2005). Medical records should be preserved for OPD/IPD/medico legal cases for unspecified period/ 3/25 years,
respectively, as per MCI Act 2002 and for 5/10/10 years, respectively (as per the
DGHS vide letter No. 10-3/68-MH dated 31 Aug 68). Failure to collect, destruction or loss of such an exhibit is also punishable (u/s 201 of IPC).
7. Under Transplantation of Human Organs Act 1994, failure to register the facility, unlawful removal,
storage and transplantation of human organs and/or any commercial dealings in organs shall invite
stringent punishments.
8.When some services such as waste disposal or security, have been outsourced, the principal employer, ie, the HCO is not absolved of any non-compliances to all the legal statutes.
9. Under IMC (professional conduct, etiquette and ethics amendment) Regulations 2002, the physician shall
not indulge in any act of professional misconduct meaning thereby they shall not prescribe branded medicine, issue false certificates, display unrecognised qualifications or accept gift, grant or hospitality from commercial sources.
10. Under BMW (Management and Handling) Rules 1998, failure to collect, segregate,store, transport and dispose of waste in any manner that causes harm to human health or environment by the
HCF serving 1000 or more patients per month shall invite punitive action under the various provisions of the Rule
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