3. Topics covered Introduction History Importance Legislative measure ( MTP, PNDT, COPRA) Medico legal aspects regarding CTG, sonography, analgesia, maternal mortality How to safe guard our self
4. INTRODUCTION IN the past doctors were considered next to god Scientific revolution have changed this opinion People r more aware Law as been implemented by the government to safe guard the health interest of people Information media helps the public to have information in their finger tips Patient comes and asks the doctor why was the other modality of treatment was not used
5. HISTORY Legal cases were filed as early as 1800 Cases in late 1800 and early 1900 were regarding medical complication Early obstetric cases were focused on maternal injuries and death due to instrumental deaths In today's era anticipation mother and child will not only survive child birth but will also remain unharmed Recent medico legal issue are on birth injury
6. WHY ARE WE VULNERABLE Obstetrician deal with two patient at a time one who can be seen and explained and other is not The duration is longer around 40 weeks Physiological condition which varies enormously It’s slow to start with and gradually ends with an acute episode Complications in pregnancy cannot always be predicted
7. REASON FOR INCREASED LITIGATION Nursing home as commercial hospital Patient losing trust Media and doctor CPA Trust and litigation Medical insurance
9. Acts of acts of omission commission Failure to provide antenatal care Attend at time of delivery Protect rectum and perineum at time of delivery Remove placenta completely Treat eclampsia Repair Birth canal injury Sterile technique Unnecessary cesarean section Instrumental injury to mother and child Hemorrhage from cord Misdiagnosis of pregnancy as tumor and tumor as pregnancy ignoring proper investigation such as UPT and USCAN Failure to asses cpd leading on to rupture uterus or undue death of baby
10. Areas of litigation Antenatal period Congenital anomaly and genetic testing Multiple pregnancy Concern for patients complaint Intra uterine death Prescribing medicine Aids in obstetrics Intranatal and postnatal period Lscs Instrumental and difficult vaginal delivery Analgesia and anesthesia Brain damage
11. Intranatal and antepartum fetal monitoring Points of importance Recognizing abnormal ctg Lawyers view Expectation of patient Archiving of records
12. How to minimize litigations Appropriate training Adequate labor ward supervision Adequate record keeping Good and effective communication Regular audit and teaching meeting Consultation Expert witness
13. Ultrasound scan New concept to fetal right area of litigation Failure to detect fetal anomaly Suboptimal scan performance Interventions leading to fetal death Failure to inform referring physician How to avoid this litigation
14. Analgesia and anesthesia Legal implication Death or irreversible brain damage Inhalation of foreign body Asphyxia Mechanical injuries Injuries from iv injection How to avoid this litigation
15. Maternal mortality four out of this five causes are preventable Un safe abortion Eclampsia Obstetric hemorrhage Obstructed labor Post partum hemorrhage
16. TUBAL LIGATION FAILURES WITH CASEREAN How to deal with them? What is the protocol to be followed? What should be done if repeat TL has come in private clinic after failure from Goverment/Municipal Hospital? What if Tubectomy failed & patient comes after 20 wks ?
17. DEATH FOLLWING CESAREAN WITH TUBECTOMY LSCS with Tubectomy? Death due to PPH or DIC Such a death will not be counted as Tubectomy death and does not enter the Tubectomy audit All you need is to inform the local quality assurance committee about the death and the cause
20. MTP ACT 1971 GUIDELINES REGARDING Who can terminate pregnancy Till what gestational age Place where termination is done Power to make rules Power to make regulations Protection of action taken in good faith
21. MTP Act 1971 (Act No.34 of 1971) (10th August 1971) Indication Person place
23. Niketa v/s Govt of Maharashtra Late mid term termination Congenital anomalies Forwarding of Mumbai High Court Refused appeal Niketa had a miscarriage
24. person GA < 12 wks - Registered Medical practitioners IPC GA >12 - 20wks –Opinion of two medical practitioners
25. Medico legal implications Termination done without women's consent punishable under section 511, higher p 313 Criminal or attempted criminal abortion as a serious anti social act under 312-316 IPC If pregnant women dies from an act intended to cause termination, offender liable for p 314.
26. place Hospital established or maintained by Government A place approved for the purpose of act by government
27. Consent for mtp Adult women 18 yrs & above can give a valid consent . In case of minor <18 yrs or mentally ill women, consent of guardian must be obtained. Her spouse consent is not required
28. Consent form c Details of the patient Reasons for MTP Consent Institution where done Doctors performing
29. Mtp amendment act , 2002 Modifications were Word lunatic to be substituted with mentally ill person IPC – Offence punishable with rigorous imprisonment for a term not <2yrs , may extend to 7yrs.
30. Mtp amendment act , 2003 Definitions Form for certifying opinions Custody of forms Maintenance of administer register Admission register not to be open to inspection Entries in register maintained in hospital or approved places
31. MTP (Amendment) Act, 2002MTP Rules, 2003 1. Government should be satisfied with safety & hygiene 2. The following facilities should be provided First trimester terminations Gynaecology / labour table, backup for treating shock & facilities for transportation Second trimester terminations OT table & instruments for abdominal & gynaecological surgery, anaesthetic equipment All terminations Resuscitation & sterilisation equipment, drugs & parental fluids
32. Pre- Conception & Pre- Natal Diagnostic Techniques Act, 1994 and Rules with Amendments
33. Pndt act An Act to provide for the prohibition of sex selection, before or after conception, and for regulation of pre-natal diagnostic techniques for the purposes of detecting abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female feticide and for matters connected therewith or incidental thereto.” The title of the Act has also been suitably amended to reflect this and the title of the Act now to read: “The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act.”
34. Pndt act 20th September 1994 To provide for the regulation of: the use of pre-natal diagnostic techniques for the purpose of detecting genetic or metabolic disorders or chromosomal abnormalities or certain congenital mal-formations or sex linked disorders; for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female feticide; and for matters connected there with or incidental thereto.
35. The PC PNDT Act is aimed at curbing sex selection through the misuse of technology and should not be confused with the MTP act Act that allows legal abortion as per the conditions outlined in the act.
36. Amendment 2002 explanation has been added by the amendments of 2002. The explanation provides that “for the purposes of this clause (definition of Genetic Laboratory), Genetic Laboratory includes a place where ultrasound machine or imaging machine or scanner or other equipment capable of determining sex of the fetus or a portable equipment which has the potential for detection of sex during pregnancy or selection of sex before conception, is used.” Genetic Counseling Centre/Genetic Laboratory/ Genetic Clinic would include an ultrasound center/ imaging center/ nursing home/ hospital/ institute or any other place, by whatever name called, where any of the machines or equipments capable of selection of sex before or after conception performing any procedure, technique or test for pre-natal detection of sex of fetus is used
37. A qualified person could be: - Gynaecologist - Medical Geneticist - Paediatrician - Registered Medical Practitioner - Radiologist - Sonologist - Imaging Specialist
38. For a genetic counseling center, the gynecologist must have - 6 months experience in genetic counseling; or - 4 weeks training in genetic counseling. For a genetic clinic, the gynecologist should least 20 procedures in chorionic villi aspirations per vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis, foetoscopy, fetal skin or organ biopsy or fetal blood sampling etc. under supervision of an experienced gynecologist
39. Sonologist or Imaging Specialist means a person who possesses- any one of the medical qualifications recognized under the Indian Medical Council Act, 1956 a post-graduate qualification in ultrasonography or imaging techniques of radiology
40. Pre natal diagnostic test is advised age of the pregnant woman is above thirty-five years; pregnant woman has undergone two or more spontaneous abortions or fetal loss; pregnant woman has been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals; the pregnant woman or her spouse has a family history of mental retardation or physical deformities such as, spasticity or any other genetic disease; any other condition specified by the Central Supervisory Board.
41. PROCEDURE FOR REGISTRATION Every application for registration shall be made: To the Chief Medical Officer of the district; or any other medical officer constituted as appropriate authority Medical officer constituted as appropriate authority for the sub-districtwithin whose area or jurisdiction the centre, clinic or laboratory is situated.2 Every application shall be made in duplicate in Form A which is appended to the (C) Every application shall be duly accompanied by an Affidavit containing
42. Rs.3000.00 for Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre. (b) Rs.4000.00 for an institute, hospital, nursing home, or any place providing jointly the service of a Genetic Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre or any combination thereof However, if an application for registration has been rejected by the Appropriate no fee shall be required to be paid on re-submission of the application by the applicant for the same body within 90 days of rejection
43. No person, including a specialist or a team of specialists in the field of infertility, shall conduct or cause to be conducted or aid in conducting by himself or by any other person, sex selection on a woman or a man or on both or on any tissue, embryo, conceptus, fluid or gametes derived from either or both of them. No person shall, by whatever means, cause or allow to be caused selection of sex before or after conception. No person including the person conducting a pre-natal diagnostic procedures shall communicate to the pregnant woman concerned or her relatives or any other person the sex of the fetus by words, signs or in any other manner whatsoever.
44. The FOGSI Resolution 2002 “In keeping with its principled stand against sex selective abortions, FOGSI condemns the use of procedures to pre-select sex without a valid medical indication as these promote an unfair and abhorrent bias on the basis of gender”.
45. CONSENT FORM FOR OBSTETRIC SURGERY I undersigned miss/mrs------- wife of Mr. ------of ----completed years residing at ------- give my free consent for the operation of to be performed by dr------- general/spinal/epidural/local -------anesthesia supplemented or combined as found necessary by dr ------ I also understand that other procedure than the proposed ones or in addition to them may be found necessary or desirable while operating or anestheting and I consent for them if the surgeon or the anesthetist finds its essential and is benefit able to me I have been explained and I have understood The necessity and the nature of the operation The procedure of the operation Risk and complications of the operation Consequences of the operation The procedure of administrating the anesthesia Risk and complications of the anesthesia Risk and complications possible for the unborn child of surgery and anesthesia Signed in my presence sign of the patient Sign of Witness Name and address of the witness and the above as been explained
46. How to safe guard our self Proper documentation Updating our knowledge Informed consent Effective communication
48. conclusion Medico legal litigations have become part and parcel of medical profession With recent media boom patient r also better acknowledged with law and medical field So lets up knowledge our self for the betterment of the society and ourself
