Licenses needed by a 10-bedded hospital ⁄ nursing home

( Courtesy eMedicalnews, Dr. KK Aggarwal : http://ijcpin.xcelmail.in/ijcp/vm.php?m=6015&u=8c454705ff0f132de329bbb8f3923002) 

Licenses needed by a 10-bedded hospital ⁄ nursing home with facility for cesarean ⁄ cholecystectomy under Clinical Establishment Act

1. Registration under Nursing Home Act ⁄ Medical  Establishment Act
2. Bio-medical Waste  Management Licenses, Authorization of HCO by  PCB MOU with Vendor
3. AERB Licenses
4. NOC from Fire Department
5. Ambulance. Commercial Vehicle Permit, Commercial Driver License, Pollution Control Licenses
6. Building Completion  Licenses
7. Lift license for each lift
8. DG Set Approval for Commissioning
9. Diesel Storage Licenses
10. Retail and bulk drug  license (pharmacy)
11. Food Safety Licenses
12. Narcotic Drug Licenses
13. Medical Gases Licenses ⁄  Explosives Act
14. Clinical Establishments  and Registration (if  applicable)
15. Blood Bank Licenses
16. Boilers Licenses
17. MoU ⁄ agreement with outsourced human resource agencies as per labor laws
18. Spirit License
19. Electricity rules
20. Provident fund⁄ESI Act
21. MTP Act
22. PNDT Act
23. Sales Tax registration
24. PAN
25. No objection certificate under Pollution Control Act (Air⁄Water)
26. Arms Act, 1950 (if guards )

Dr Neeraj Nagpal

Chhattisgarh sterilization deaths: Accident or Negligence or Administrative Failure

( Courtesy eMedicalnews, Dr. KK Aggarwal ;http://ijcpin.xcelmail.in/ijcp/vm.php?m=6064&u=8c454705ff0f132de329bbb8f3923002)

To err is human; error of judgment is not crime; difference of opinion is not crime, failure of outcome is not crime; routine complications are not crime; mere deviation from standard practice may not be crime, BUT what a crime is "not taking standard precautions, neglecting the patient or not taking proper consent. This can only be found out after proper investigations.

I have written to MCI to take this case suo moto and investigate. Punish the doctor if he is guilty or protect him and restore the image of the medical profession if he is not guilty.

The human rights commission should also take this case suo moto and if they find the government is responsible for the mishap (buying sub standard drugs, setting targets for such surgeries, not providing enough safe infra structure for such camps) it should be taken to task.

Following MCI ethics regulations clauses are applicable in such mishaps

2.4 The Patient must not be neglected: A physician is free to choose whom he will serve. He should, however, respond to any request for his assistance in an emergency. Once having undertaken a case, the physician should not neglect the patient, nor should he withdraw from the case without giving adequate notice to the patient and his family. Provisionally or fully registered medical practitioner shall not wilfully commit an act of negligence that may deprive his patient or patients from necessary medical care.

7.16 Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.

7.22 Research: Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.

Supreme Court of India

What are defined situations of negligence?

In one of the judgments SCI enlisted some guidelines for the doctors and the hospitals. "1. Current practices, infrastructure, paramedical and other staff, hygiene and sterility should be observed strictly.” (SCI: 3541 of 2002, dated 17.02.2009, Martin F. D'Souza vs Mohd. Ishfaq: Markandey Katzu and G S Singhvi, JJ.)

Death does not mean negligence?

In Dr Suresh Gupta vs Govt. of Delhi (AIR 2004 SC 4091) case the doctor was accused under 304A. The patient died during surgery of nasal deformity due to wrong incision and subsequent bleeding, choking & death. The high court said that adequate care was not taken to prevent seepage of blood resulting in asphyxia. The Supreme Court said that cause of death was stated to be ‘not introducing a cuffed ET tube of proper size as to prevent aspiration. The Supreme finally concluded that it is a case of negligence as there was a lack of care and precaution but for this the doctor can be held liable in a civil case but it is not that reckless or grossly negligent as to make him liable in a criminal case. For conviction in a criminal case the negligence and rashness should be of such a high degree which can be described as totally apathetic towards the patient. (SCI: 3541 of 2002, dated 17.02.2009, Martin F. D'Souza vs Mohd. Ishfaq: Markandey Katzu and G S Singhvi, JJ.)

Grass root facts

• Camps are common, standardized and happen with the knowledge of government authorities.
• Government pays incentives for patients, doctors and staff
• Day care surgeries are done in conveyer belt fashion

Issues to decide negligence or accident

• Proper consent
• How many laparoscopes were used?
• Time taken for laparoscope sterilization
• Time between two surgeries
• Type of anesthesia given
• Type of drugs used
• How many surgeries are done and in how much time
• Qualification of the surgeon
• Experience of the surgeon
• Autopsy reports
• CO2 used: quality
• Quality of instruments used

Government steps on the tragedy

• Meanwhile even as reports said that rusted equipment were used in the surgeries, a team of doctors from Delhi's premier AIIMS hospital is in Bilaspur to investigate what happened.
• The medicines used have been sent to a lab in Kolkata for analysis
• Autopsy reports are awaited

Media Trial

"Times Now" TV channel news at 7-15 p.m. on 13-3-2014 equated Dr. R K Gupta, surgeon, of Chhattisgarh as "Doctor Death", "Butcher of Bilaspur" and "Merchant of Death".

Comments by fellow colleagues

• "Till the results of the enquiry are released the doctors should not be harassed. The medic should not project the negative image of the profession" : Dr Narendra Saini Honorary Secretary general IMA
• "It is for the IMA to digest it and to be blind to it and to ignore it or to launch media blitz against this channel and to send a legal notice demanding within 72 hours an unqualified apology to be prominently telecast on the same channel, failing which the IMA should initiate appropriate legal proceedings. Please note that IMA has full locus standi to move on these lines because it represents the whole medical profession and ought to preserve its dignity and respect. Dr M C Gupta"
• " http://scdrc.up.nic.in/judgement/A-1893-2008.pdf: "Held that the tubectomy was done free at a primary health centre as part of government’s family planning programme without payment of any money and hence it was not within the ambit of consumer act…………………………………." M C Gupta
• The government has announced a relief of Rs. 2 lakhs only (Dr Mehra)
• " Here in Chhattisgarh, government pay Rs. 1400 to the patient for sterilization operations and if operation fails then Rs. 30000 as compensation are to be paid. They are not consumers, still so many cases are going on in consumer court for the same and our treating surgeon keeps on attending the trials on behalf of govt. I don't understand why consumer court accepted these cases" Vicky Bansal
• ”PAYING 30,000/- as compensation for failed tubectomy is in itself a wrong step as any procedure can fail. So what is the big deal?" Dr Sodhi
• "We are talking of doctors & doctors alone. Please remember that this is a government programme, government doctors, government everything. There is something called vicarious responsibility. There is another thing which is "owning up responsibility". And finally there is something (though rare) called "shame". Another rare item is "moral ground" Do you all not feel that the health minister should own up responsibility and resign on moral grounds? Dr Sodhi

Questions which need to be answered (Dr Neeraj Nagpal)

1. Is Surgeon responsible for deaths in a family planning camp?
2. Is setting of targets for family planning responsible for such mishaps? 3.
3. Is the team including nurses, helpers, OT assistants equally responsible?
4. Should the nurses, OT technicians and helpers who were part of team also be arrested?
5. Is arrest of Surgeon without finding cause of mishap correct?
6. What are various reasons one can think as cause of 14 deaths in a family planning camp?: Lack of sterilization of instruments by paramedical staff/ Reaction to medicines or anesthesia used/ Chemical contaminant in CO2 used for insufflation/ Poor skill of surgeon leading to bleeding/ Carelessness of surgeon while operating/ Carelessness of surgeon in preoperative and postoperative care/ Mischief by someone who is part of surgical team
7. Are Doctors pressurized to do more and more surgeries in Family Planning camps by their superiors?
8. Does the concept of medical and surgical camps in sub optimal settings need to be abolished
9. Should those who pressurize doctors to achieve 'targets' also be punished ?
10. Should compensation awarded by Govt to deceased not be raised to 20 lacs or more in such a mishap ?
11. How should such tragedies be avoided in future ?: Reduce number of surgeries which can be done in one camp to 10; Use minimum 3 Laproscopes and instrument sets for one camp; Qualified nurses and OT assistants to accompany doctor on such camps; Penalize superiors if more than 10 tubectomies are done in one camp; Abolish family planning camps totally or Punish surgeon severely to set an example.
12. Should awards be given as incentive to surgeons who perform more surgeries in family planning camps?
13. Is labelling the Surgeon 'Killer' by our print and electronic media appropriate ?
14. After such media condemnation if it is found later the surgeon was not at fault? Should he be compensated by his employers/should he be compensated by the Press/ should he be compensated by his professional Associations who did not support him?

Recent updates on the case.

1. Drug company which supplied those drugs had been earlier booked for five cases and all cases are still running but government didn't ban it before. Now after Bilaspur incident government banned that pharma company and this company was operating from a residential house still government bought all medicines like ciprofloxacin ibuprofen given to all camp patients.
2. Post Mortem report says no surgical fault seen; waiting for chemical lab report. No signs of inflammation present at surgical site.
3. An urgent notice by the government to ban these drugs with immediate effect in all government hospitals shows the actual reason for death in camps.
4. Government suspended few doctors on using branded medicine and here in this case using generic government supply also get the doctor arrested. Thinking where we doctors stand today?
5. Health officials are equally responsible but they arrested only a senior doctor who was about to retire in one year. Very unlawful. IMA must come forward and put doctor view in public and raise issues related to safety of cheap generic medicines. (Vicky Bansal, Medical officer)

From Jan 1, pharma companies can no longer gift freebies to doctors

( Courtesy eMedicalnews, Dr. KK Aggarwal ; http://ijcp.ft.mailguard.co.in/ijcp/vm.php?m=6137&u=8c454705ff0f132de329bbb8f3923002)

Excerpts from a report by Rupali Mukherjee in TOI news dated Dec 23.

1. Doling out freebies, cruise tickets, paid vacations and sponsorships to educational conferences and seminars for doctors by pharmaceutical companies has been banned from January.
2. The government has woken up belatedly to curb unethical marketing practices of pharma companies by spelling out a uniform code of conduct for the industry. The code will be voluntary to start with, and kicks in from January 1. It will be reviewed after six months; if not implemented "effectively", the government will "consider” making it mandatory, sources told TOI.
3. At present, the pharma industry follows a "self-regulatory'' code that curbs unethical sales promotion and marketing expenses, bans personal gifts, and all-expenses paid junkets for doctors and their families, but there have been several instances where companies have violated the code, industry experts say. They say the code exists only on paper as companies try to influence prescriptions through several ways.
4. This is the first time in years that the code has been finalized by the government, as earlier attempts to do so got mired in bureaucratic red tape.
5. Industry experts say that the government's Uniform Code of Pharmaceutical Marketing Practices has been modeled on the Medical Council of India (MCI) guidelines for doctors and healthcare professionals, which were further tightened in 2012.
6. The code clarifies the relationship with healthcare professionals. Regarding gifts, it says "no gifts, pecuniary advantages, or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharma company, or any of it agents including retailers, distributors or wholesalers".
7. It says "in any seminar, conference or meeting organized by a pharma company for promoting a drug or disseminating information, if a medical practitioner participates as a delegate, it will be on his/her own cost."
8. It further says that gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) such as tickets to entertainment events are also not to be offered or provided by pharma companies, nor cash or monetary grants for individual purposes. Hospitality should also not be extended to any doctor or their family members.
9. The industry associations have to upload the Uniform Code on their websites and will be responsible for informing its members, and the government in case of violations.
10. The code also adds that "where there is any item missing, the code of MCI as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 as amended from time to time, will prevail''.

eMedinewS Comments

• There is an MCI code of ethics s for doctors. Any violation of the same can only be challenged in High Court.
• Pharma companies until now were affected for any violation in the Act Now pharma companies will also be governed by a similar (like MCI) code of conduct.
• Unless both pharma and doctors group are covered in their respective codes of conduct, the problem will not end. Until now, the MCI code did not cover pharma companies violating MCI regulations.
• It is same like, if doctors violate any MCI code they are punished under violation of MCI ethics regulations but the same violations, if done by medical establishments are not punished. The need of the hour is to have a uniform code of conduct for medical establishments also.
• Another answer is to bring medical establishments as well as pharma companies under the preview of MCI ethics regulations.