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ADVISORY- CLINICAL RISK MITIGATION
The aim of this document is to provide Medical Unit Heads insight into preventive measures to be taken to mitigate risk of potential litigation/ legal claims. The NABH Guidelines and other accreditation bodies already provide a comprehensive set of rules to be adhered to. The recommendations and SOPs in this document are formulated from a compliance/ legal perspective to strengthen the existing practices that hospital units apply in a clinical setting.
With the advent of Google providing limitless access to information, heightened awareness, and disgruntlement at rising medical costs, we are witnessing exponential rise in the number of medical negligence cases being filed and legal notices being issued by patients. Based on the trends observed for over a decade, an analysis of the legal notices received, medical negligence cases/complaints filed, principles applied by courts and consumer commissions in such cases to conclude whether or not there was medical negligence in the treatment provided, we have compiled these broad sets of guidelines. This document encloses Annexures A to C which are referenced below in the relevant sections.
- RECORDING OF HISTORY OF PATIENTS- ON ADMISSION/ EMERGENCY ROOM/ OPD.
- Care should be taken in recording medical history, since very often Insurance companies reject claims as the declarations in insurance documents do not match the history recorded in the medical records.
- If a patient is incapacitated and cannot provide his/her history and the attender does so, the attending physician/nurse should confirm from the attender that he/she is aware of the medical condition of the patient and pre-existing diseases.
- If the patient is being admitted/ consulting with an Apollo physician after being treated at a different hospital, they should provide the previous medical records, discharge summary, test reports, etc, and the findings should be referred to, and be recorded. Very often patients state they were treated elsewhere but do not provide sufficient documentation and this practice should be discouraged. Also, it is recommended that if the attending physician sees certain lacuna in the treatment provided elsewhere, this is also to be recorded.
- DOCUMENTATION
General recommendations
- Entries in medical records entered retrospectively by a physician should specifically state that they have been recorded retrospectively, with the accurate date and time.
- Patients may be treated by multiple specialists, and in such situations, there must be a record of each specialist’s time of visit, advice given, and such advice must take into consideration the advice of any specialist who previously saw the patient. If a recommendation is made, the reason why such recommendation is not being carried out should be recorded by subsequent specialists. Ideally specialists should not provide suggestions on treatment a doctor of a different speciality should provide. All they can suggest is the patient be seen by a physician of a particular specialty.
- Overwriting in medical records must be strictly avoided.
- Notes of any internal discussions, or subjective comments should not be recorded in patient medical records.
- The medical record of the patient has to be handed over to the patient/authorised attender at the time of discharge or if requested by the patient/authorised attender within 72 hours of the receipt of the request for the same.
OPD Consultations:
- General consent to be documented.
- More detailed and comprehensive examination notes, that include, diagnosis, prescription of medicines, confirmation that the risks and benefits have been explained, follow-up tests, to be recorded.
- If this practice is not already in place, it is recommended OPD notes, prescription, should find a place in the patient’s EHR.
Discharge summary:
- A comprehensive and accurate summary of patient’s history, initial diagnosis, subsequent diagnosis, treatment provided including accurate reference to surgery notes, reference to the prior medical history of the patient and the medical records that were provided at the time of admission.
- If the treating physician diagnoses a certain pre-existing condition that was not provided at the time of admission and found during treatment, the same is to be recorded and the complications in the treatment that arose as a consequence should also to be recorded.
- Medical records are to be verified before handing over to the patient/authorised attendant. There must be made a record of who and when, what time, the medical records were handed over to at the time of discharge.
- Any follow up visit required by patient post discharge must be recorded, the risks of not following post discharge advice, and risks of not attending follow-ups to be added as well. This should include diet, physical activity, medication, etc. in a manner more specific to a patient instead of the format presently used.
- A record of the insurance details if applicable is also to be made, along with who has given the history for the insurance purpose.
III. COUNSELLING PATIENTS/ FAMILY MEMBERS
- Undoubtedly counselling sessions with a patient and family is an important part of patient management. The need for counselling arises in several situations as per the discretion of the treating physician, Unit Medical Head. It is recommended that in situations which are grave and high risk, or crucial decisions are to be made in a treatment plan, recording of DAMA, DNR etc., an audio-video recording of the counselling session is carried out, which then becomes an integral part of medical records.
- The patient/authorised representative has to be informed about the recording of the counselling session, and such record should reflect the date, time, and place of recording.
CONSENT PROCESS
- The Consent Form Checklist drafted by Badsha Legal, is attached herewith as ANNEXURE A. Please rely on this document to ensure that a valid consent is obtained from the patient/attender/guardian, signed off by the treating physician, witness.
- The patient should indicate at the time of admission the details of an authorised attendee who has the right to make decisions on behalf of the patient in the event of the patient being unable to do so.
- Consent to be obtained before commencement of any treatment or procedure and not retrospectively.
- The Consent form must not be incomplete, and no space must be left blank. In case of non-applicability, the same must be mentioned as N/A.
- Signature of the patient/authorised attender should be recorded along with the date, and time, and relationship of the attender must be specified correctly.
- In case of a doctor or team member signing on behalf of the treating doctor/doctor performing the procedure, the same must be recorded and informed to the patient/relative.
- The Consent form has to be explained to the patient/authorised attender in the language they understand, and such fact must be clearly recorded in the Consent form, and additionally, the interpreter’s signature should also be included in the Consent Form.
- A patient/authorised attender will have to sign separate consent forms for each procedure/treatment to be conducted, for example Anaesthesia, surgery, ICU, etc.
- If a treating physician, Unit Medical Head is of the opinion that the consent process should be documented through an AV recording, the same should be ensured. This is recommended in cases that are high risk, patient/ family are problematic, or involves a guardian. Few basic elements of a valid Consent Form are as follows:
- Explanation of the proposed procedure, treatment or intervention, and potential risks involved if treatment is availed and if the patient refuses to follow the medical treatment plan.
- The patient must be informed about alternative options available along with the benefits, risks, and outcomes of the same.
- Patients must be allowed to post questions and feel confident in the answer they receive before providing consent.
- Consent must be given voluntarily and not under pressure or coercion. Consent must be obtained from:
- ○ Minor: Parent or Guardian.
- ○ Invitro fertilisation or artificial insemination – Female patient, spouse, and donor.
- ○ Operation resulting in sterility – Both husband and wife.
- In cases where a doctor wants to carry out a procedure not consented for since a complication arises during a treatment, which is an emergency and life threatening, and the physician has to act immediately he/she may do so but must inform the authorised attender during the procedure and the patient at the earliest point in time. This should be explicitly recorded. In non-emergency cases, before proceeding, the treating physician must obtain consent from an authorised attender and the same shall be recorded in the medical records. However, caution must be exercised in all these cases,
and if it affects the fertility of the patient as per Indian Medical Council (Professional Conduct, Etiquette And Ethics) Regulations, 2002, the consent of both the patient and their spouse is to be explicitly taken.
- DISCHARGE AGAINST MEDICAL ADVICE
It is a recommended practice that an audio/video recording of the counselling to be maintained as a part of the medical records in cases where patients want to be discharged against medical advice. This should mention the reason for refusal of treatment/early discharge by the patient/authorised attendant and the possible risks of the decision taken against the medical advice of the treating physician. The same must be dated and duly signed by the patient/authorised attendant and the treating physician.
- ISSUES RELATING TO INSURANCE AND BILLING
Insurance has become a significant part of the healthcare system. Oftentimes, the hospitals/doctors face challenges while handling billing and insurance claims, which very often result in medical negligence cases being filed against the hospital. Some of the major issues faced by doctors/hospitals are as follows:
- Missing or incorrect information: Insurance claims are denied on the basis of missing or incorrect information. It is therefore essential to have the information provided by the patient/ authorised attender signed off on, as recommended in the previous sections.
The recommendations regarding recording of medical history are especially significant in this context.
- Services not covered: In case of a patient willing to claim insurance for the expenses incurred, it is essential to inform them beforehand about the treatments and services that are not covered under insurance.
VII. RECOMMENDATIONS FOR HANDLING DISRUPTIONS/ MISBEHAVIOUR BY PATIENT/ FAMILY/ ATTENDERS
For advice on how to legally handle disruptions/misbehaviour of the patient/authorised attender or any family members/associates of the patient, please refer to the Advisory attached herewith as ANNEXURE B.
VIII. SOP FOR HANDLING MEDICAL NEGLIGENCE CASES
For advice on how to handle complaints submitted by patients alleging medical negligence, notices received in this regard, a flowchart to be followed by Medical Unit Heads, in handling of medical negligence matters on the new GOAL software is provided in ANNEXURE C attachment. The same will be updated and revised from time to time.
- DISPLAY OF ALL INFORMATION & MAINTENANCE OF REGISTERS MANDATED UNDER LAW & APPLICABLE GUIDELINES
- Sign that a counselling session is being recorded.
- Statutory requirements for PNDT display board.
- Any other statutory requirements for display of information to patients mandated under applicable laws, including NABH guidelines, Clinical establishments act, and others.
- ONGOING TRAINING PROGRAMS
It is essential to conduct regular orientation programs and training programs for medical and non- medical staff on statutory requirements and guidelines in a clinical setting.
- MONITORING OF COMMITTEES
It is important to oversee Committees mandated by Law – For example the Organ Donation Committee, Blood Bank, etc.
XII. END-OF-LIFE CARE
The SOP is being formulated on the basis of the Hon’ble Supreme Court judgment with respect to the End-of-Life care. The DNR and DNE process will have to be reviewed once we get clarity from the Govt, and it should be implemented across all centres. Apollo is also in the process of formulating an SOP for the same.
SOP to be followed by the Consent Manager for the offline consent process before initiating any procedure/medical treatment for a Patient. This is to form a part of hospital internal records and DOES NOT NEED TO BE SHARED with the patient.
FORM SHOULD CONTAIN THE FOLLOWING DETAILS:
Patient Details | |
Patient’s Name: | |
Age: | |
UHID: | |
Patient’s Address | |
Patient’s Contact Number | |
E-mail Id | |
Nominee/Attender’s Details | |
Attender’s Name: | |
Age: | |
Relationship to Patient: | |
Attender’s Address | |
Attender’s Contact Number | |
E-mail Id | |
Details of Person Giving Consent | |
Name: | |
Age: | |
Relationship to Patient: | |
Address | |
Contact Number | |
E-mail Id | |
S.No. | Checklist to completed by Consent Manager | Applicability/Completion | ||
PATIENT INFORMATION SHEET | YES | NO | N/A | |
1 | Does the Patient Information Sheet record that the Patient been informed of/that: | |||
– Nature of the procedure/treatment & what to expect; | ||||
– Serious or frequently occurring risks; | ||||
– The likely outcomes if complications arise; |
– The intended benefits; | ||||
– (If it is a interventional procedure) During the course of the proposed procedure, unforeseen conditions may be revealed requiring the performance of additional procedures including the implantation of medical devices, which the doctor may consider necessary or advisable in the course of the operation; | ||||
– The likely result if the Patient does not have the recommended procedure/intervention/treatment; – The available alternative treatments and their benefits and risks; | ||||
– (If it is a interventional procedure)- risks, benefits, and alternatives to the type and method of anesthesia or sedation recommended; | ||||
– Option to Withdraw Consent. | ||||
2 | Does the Patient Information Sheet record that the Patient was made aware that: Patient does not own the Specimens, or data derived from Specimens, and have no right to any research or research product using or derived from the Specimens. Specimen includes, but is not limited to, any tissues, organs, bones, bodily fluids, or medical devices? | |||
3 | Does the Patient Information Sheet record that the Patient was informed that he/she has the right to seek second opinion from an appropriate clinician of patients’/ caregivers’ choice. | |||
4 | Does the Patient Information Sheet record that the Patient has been informed of costs of treatment and any additional cost may be incurred due to change in the physical condition/course of treatment. |
7 | Does the Patient Information Sheet record that the Patient was able to ask questions and raise all concerns with the doctor, the procedure, its risks and treatment options? | |||
8 | Does the Patient Information Sheet record that if any dispute concerning the medical treatment provided arises, only the courts in whose jurisdiction the patient is receiving treatment, and no other court, shall have the jurisdiction over such dispute? | |||
9 | Does the Patient Information Sheet record that he/she is aware of the use of personal data/biological samples for research and marketing purposes? | |||
10 | Does the Patient Information Sheet record that Patient is aware of photographing or videotaping of the surgery or procedure(s) to be performed, including appropriate portions of body for medical, scientific, or educational purposes, provided that his/her identity is not revealed by the pictures or by descriptive texts accompanying them. | |||
ESSENTIAL ELEMENTS OF THE CONSENT FORM | ||||
11 | Accurate Date and Time of execution of the Consent Form, which is prior to the Procedure/treatment being carried out. | |||
12 | Name of Doctor, Patient’s attender/ nominee/ patient with signatures and date & time which are contemporaneous, on all sheets. | |||
13 | Clear record of any medication to be administered. | |||
14 | Clear record of Vitals pre/post procedures. | |||
15 | Record of any vital information shared orally. | |||
16 | Record of any prior health issues (allergies/illnesses) | |||
17 | Interpreter’s signature if Consent Process/Documents were explained in any language apart from English. | |||
18 | Provide a link to AHEL website with its Privacy Policy |
19 | The presence of the following authorisation at the end from the Patient- “I have read the above information and am aware of the risks, benefits, and alternatives of [name of procedure]. I have been provided with the opportunity to have questions answered and therefore give my free and voluntary consent for [name of procedure]. I acknowledge that I have had an opportunity to discuss and understand this procedure, as stated above with my practitioner in the language I understand and hereby consent to this procedure.” | |||
20 | Separate consent forms for every single procedure, including separately for anaesthesia administered. | |||
21 | Separate form to be filled to document the refusal of consent with reasoning of refusal by Patient. | |||
22 | Procedures of infertility treatment like In-vitro fertilisation, Artificial insemination, embryo-transfer, or procedures that could lead to the sterilisation of a person, all require the signature of the spouse, apart from the Patient. | |||
I. If Minor or Incapacitated or Disabled: | ||||
23 | Patient Representative Consent to be sought. | |||
24 | Relationship of Representative to be recorded. | |||
25 | Signature of Representative with mention of Relationship to the Patient on all sheets. | |||
26 | Signature of a Witness to be added. | |||
II. For Complex/High-risk procedures: | ||||
27 | Consent for AV recording of Consultation/procedure | |||
28 | Clearly marked and dated storage of AV recording. | |||
29 | High Risk Consent form for each procedure to be separate. | |||
30 | Comments (if any): | |||
Additional Checklist – Online Consent SOP
S.No. | Is the Following Included? | Applicability/Completion | ||
YES | NO | N/A | ||
1 | Description of Data Being Collected | |||
2 | Purpose of Data Collection | |||
3 | Method for Withdrawal of consent for Data Collection | |||
4 | Contact Details of Grievance Redressal Officer | |||
5 | Consent Notice is in English and the Official Language of the jurisdiction of the respective hospital | |||
6 | If the patient is minor or disabled, whether there is a provision for the guardian to consent on their behalf. | |||
7 | “Apollo will not be held responsible for breach of confidentiality or privacy of the Patient if there is reasonable evidence to believe that the patient’s privacy and confidentiality has been compromised by a technology breach or by a person/organisation other than Apollo or its affiliates. This is despite Apollo, to its best ability, and as per all applicable laws, following the highest standards of digital safety and security.” |
Note: For data protection-related consents, it is advisable that a link to a comprehensive privacy policy and terms and conditions such as https://www.apollo247.com/privacy and https://www.apollo247.com/terms is provided within the consent form.
Signature:
Designation: Consent Manager
Date:
Time:
Advisory Regarding Violence/Harassment/Abuse towards Doctors and the Hospital
The escalating incidents of violence against healthcare service personnel such as doctors and nurses, and the damage or loss to the property of healthcare service institutions in the country, demand our collective attention and immediate action. There have been recent incidents in Apollo centres where patients or their attenders/relatives have displayed abusive, unruly, or violent behaviour and have refused to leave the hospital despite the patient recovering and fit for discharge.
In order to combat such behaviour of such persons, several State governments have enacted laws to protect hospital property and medical personnel from damage/harm. 23 States/Union Territories have enacted specific legislation on the topic as listed out below.
The Government of Tamil Nadu has enacted the Tamil Nadu Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage or Loss to Property) Act, 2008 (“The Act”), which provides for specific punishments in the case of “any harm, injury or endangering the life or intimidation, obstruction or hindrance” to any medicare service person or property.
Under the Act, violence to hospital personnel are offences which are cognizable, non-bailable, and may lead to punishment with imprisonment for a term which shall not be less than three years, but which may extend to ten years and with a fine. Further, in case of damage to property, the person shall be liable to pay compensation for the damage or loss caused to the property.
Thus, whenever there is unnecessary harassment that is being caused by a patient/family/attenders due to any issue, we recommend that in consultation with Group legal Advisor, Corporate Compliance & Management, that (i) an FIR is filed with the Police clearly documenting the abusive/ unruly/ violent/ intimidatory behaviour of the patient/ attenders/
relatives, invoking the provisions of the relevant legislation (ii) steps are taken with the support of the police to discharge the patient or shift the patient to a government hospital or one of their choice. If the Apollo centre is transferring the patient in their ambulance, please ensure adequate medical care is provided enroute.
Please note that if the case is an emergency, then the patient must be treated, and discharge cannot happen until stabilisation of the medical issue. Also, please ensure that nowhere is it recorded whether in the complaint before the police or the discharge summary that the patient was being discharged/transferred due to non-payment of hospital bills.
Please further note that in case of a patient causing issues due to non-payment, the same is NOT to be recorded in the discharge summary but rather in the organization’s internal billing records. Further, the remedies provided in the advisory are independent of any civil suit for recovery of money etc. which should be pursued in parallel by the relevant stakeholders.
Annex 1: List of States
S.No. | State | Act |
1. | Andhra Pradesh | The Andhra Pradesh Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property) Act, 2008. |
2. | Delhi | The Delhi Medicare Service Personnel and Medicare Service Institutions. (Prevention of Violence and Damage to Property) Act, 2008 |
3. | Punjab | Punjab Protection of Medicare Service Persons and Medicare Service Institutions (Prevention of Violence & Damage tocProperty) Act, 2008 |
4. | Tamil Nadu | Tamil Nadu Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence & Damage Or Loss to Property) Act, 2008 |
5. | Madhya Pradesh | Chikitsak Tatha Chikitsa Sev Se Sambaddha Vyaktiyon KiSuraksha Adhiniyam, 2008 |
6. | Orissa | Orissa Medicare Service Persons & Medicare Service Institutions (Prevention of Violence & Damage to Property) Act, 2008 |
7. | Haryana | Haryana Medicare Service Personnel & Medicare Service Institutions Act, 2009 |
8. | Karnataka | Karnataka Prohibition of Violence against Medicare Service Personnel & Damage to Property in Medicare Service Institutions Act, 2009 |
9. | Maharashtra | Maharashtra Medicare Service Persons & Medicare Service Institutions (Prevention of Violence & Damage or Loss to Property) Act, 2010 |
10. | Chhattisgarh | Chhattisgarh Medicare Service Persons & Medicare Service Institutions Act, 2010 |
11. | Assam | Assam Medicare Service Persons & Medicare Service Institutions Act, 2011 |
12. | Puducherry | Puducherry Medicare Service Persons & Medicare Service Institutions (Prevention of Violence and Damage or loss to Property) Act, 2011 |
13. | Bihar | Bihar Medical Service Institution & Person Protection Act, 2011 |
14. | Gujarat | Gujarat Protection of Medicare Service Persons and Medicare Service Institutions (Prevention of Violence & Damage to Property) Act, 2012 |
15. | Goa | Goa Medicare Service Personnel & Medicare Service Institutions Act, 2013 |
16. | Uttarakhand | Medicare Service Persons and Institutions (Prevention of Violence and Damage to Property) Act, 2013 |
17. | West Bengal | The West Bengal Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property) Act, 2009. |
18. | Uttar Pradesh | The Uttar Pradesh Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2013 |
19. | Kerala | The Kerala Healthcare Service Persons and Healthcare Service Institutions (Prevention of Violence and Damage to Property) Act, 2012 |
20. | Himachal Pradesh | The Himachal Pradesh Medicare Service Persons And Medicare Service Institutions (Prevention Of Violence And Damage To Property), Act, 2009 |
21. | Rajasthan | The Rajasthan Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2008 |
22. | Manipur | The Manipur Medicare Service Personnel and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2015 |
23. | Arunachal Pradesh | The Arunachal Pradesh Protection Of Medical Service Personnel And Medical Service Institutions (Prevention Of Violence And Damage Or Loss Of Property) Act, 2019 |