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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. 

  1. 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.

 

  1. 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. 

  1. 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.  

  1. 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.  

  1. 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.  
  1. 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.

  1. 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
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.

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?

   
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.    
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.   

 

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?    
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?   
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
Description of Data Being Collected   
Purpose of Data Collection   
Method for Withdrawal of consent for Data Collection   
Contact Details of Grievance Redressal Officer    
Consent Notice is in English and the Official Language of  the jurisdiction of the respective hospital   
If the patient is minor or disabled, whether there is a  provision for the guardian to consent on their behalf.   
“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 PradeshThe 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  PradeshThe 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. ManipurThe Manipur Medicare Service Personnel and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, 2015
23. Arunachal PradeshThe Arunachal Pradesh Protection Of Medical Service Personnel And Medical Service Institutions (Prevention Of Violence And Damage Or Loss Of Property) Act, 2019

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