LEGAL ISSUES PERTAINING TO THE DOCUMENTATION OF MEDICAL RECORDS

01 June, 2018

   
 

What is a medical record?
A medical record is a complete record of a patient’s key clinical data and consists of name of patient, address, age, sex, occupation, disease, modes of diagnosis and recommendations made thereafter by the concerned doctor in course of undergoing treatment.
It sets up a crucial road map to a patient's treatment regimen an also helps the Doctor plan out the required intervention, precautions, and prognosis of the medical case.
 
Components of Patient’s medical record
Medical records include the following:
  • Chief Signs and Symptoms with which the patient has presented with.
  • History of the present illness
  • Past medical history
  • Family history
  • Allergies
  • Medication history
  • Physical examination (e.g., vital signs, muscle power, organ system examinations)
  • Progress notes
  • Treatment notes
  • Test results (e.g., imaging results, pathology results, specialized testing)
 
IMPORTANCE OF MEDICAL RECORDS
  • Useful for monitoring of the patient's treatment and response to medication and procedures.
  • A fair overview of the condition of the patient for those consultants who get referrals or who have been attending the patient at the request of the family or general physician
  • For the nursing staff to carry out the daily instructions regarding the administration of medicines as they get their instructions and daily orders regarding which drugs are to be given and the frequency of each of them
  • Satisfy legal and ethical obligations: medical regulatory authority (College), hospital, and legislative requirements for clear and legible records
  • In the issue of alleged medical negligence, it is very often the most important evidence deciding on the sentencing or acquittal of the doctor
  • With the increasing use of medical insurance for treatment, the insurance companies also require proper record-keeping to prove the patient's demand for medical expenses. Improper record keeping can result in declining medical claims
  • It has evidentiary value in the court of law and can be exhibited and proved as Documentary evidence as per Section(s) 61-63, Indian Evidence Act 1872
 
CONFIDENTIALITY OF MEDICAL RECORDS
It is a universally accepted notion that the information found in medical records is confidential.
But when analysing the concept of confidentiality, the question arises as to whom is the record confidential & under what circumstances is it confidential.
 
Information in the medical record in basically of two types:
  1. Identification data: It consists of entries in the record which do not specifically relate to the patient care or treatment in the hospital. E.g., Name, sex, age, etc. These items are often found in the admission records and are generally not considered to be confidential information. This means that upon receipt of a legitimate request, it is generally acceptable to release the information without the patient’s permission
  2. Clinical data: This includes all items entered in the medical record relating to the patients diagnosis and treatment. E.g.: reports generated by physicians, nurses, allied health personnel etc.
 
Clinical information in medical records is considered as 'confidential' because it is held that the relationship between patient and physician is 'Privileged communication'.

WHO HAS ACCESS TO MEDICAL RECORDS?
Medical records are the property of the hospital or patient’s medical practitioner. However, the following can have access to the same:
  • Patient and his Legal Representative, as long as patient has signed a release of records to accompany any request from the legal representative
  • Other health care providers, if they are directly involved in the care and treatment of the patient
  • For research purposes, as far as the identity of the patient is not revealed and the confidentiality is maintained
  • Medical records are usually summoned in a court of law in certain cases like-road traffic accident, medical negligence, insurance claim etc
RELEASE OF RECORDS
  • Request for medical records by patient or authorized attendant should be acknowledged and documents should be issued within 72 hours of receipt of such a request.
  • Effort should be made to computerize the records for quick retrieval.
  • Certain documents must be given to the patient as a matter of right. Discharge summary, referral notes, or death summary are important documents for the patient. Therefore, these documents must be given without any charge. Failure to provide medical records to patients on demand will amount to deficiency in service
  • Doctors are not under any obligation to produce or surrender their medical records to the police in the absence of valid court warrant
  • A summon to produce clinical records is a form of court order. Failure to comply to such a summon is considered as 'contempt of court' and is a punishable offence.
 
HOW LONG TO MAINTAIN THE RECORDS
  • Under the provisions of the Limitation Act, 1963 and Section 24-A of the Consumer Protection Act 1986, it is advisable to maintain medical records for 2 years for outpatient records and 3 years for inpatient and surgical cases.
  • However, the provisions of the Consumer Protection Act allows for condoning the delay in appropriate cases. This means that the records may be needed even after 3 years.
  • Medical Council of India guidelines also insist on preserving the inpatient records in a standard proforma for 3 years from the commencement of treatment.
  • The records that are the subject of medico-legal cases should be maintained until the final disposal of the case even though only a complaint or notice is received
  • For mentally retarded patients, the documents pertaining to the treatment imparted, must be maintained till perpetuity (forever), till hospital/institution is working.
  • The documentation for perusal by the income tax point of view must be maintained for a period of 7 years.
 
ALTERING MEDICAL RECORDS
  • Prescription for drugs should be legible with the name of the patient, date and the signature of the doctor
  • An undated prescription is illegal and against set norms of medical practice, can land a doctor in trouble if the patient misuses it.
  • Proper recording of nursing care, laboratory data, reports of diagnostic evaluations, pharmacy records, and billing processes.
  • No overwriting, while writing the medical notes. In case any amendments have to be made, strike the whole sentence.
  • If any changes are made, sign after making the same and put the date and time below the signature.
  • In electronic record, amend by striking through rather than deleting and overwriting the original entry.
  • Do not alter the notes retrospectively. If something written was inaccurate, misleading or incomplete then insert an additional note as a correction thereto.
  • Entries in a medical record should be made on every line as skipping lines leaves space for tampering with the records.
  • Correction of the personal identification data of the patient like name, age, father/husband name, and address should only be made on the basis of affidavit attested by notary or 1st class magistrate.
 
POINTS TO REMEMBER WHILE ISSUING MEDICAL RECORDS/CERTIFICATES/DOCUMENTS
 
PRESCRIPTION
  • It should be preferably on the OPD slip of the institution or on the letter pad of the doctor. Drug company or chemist prescription pad should never be used.
  • Must contain patient’s name, age, sex, address and institution/hospital name. Prescribed drug should be preferably in capital letter or else clearly visible.
  • The medication prescribed should clearly mention its strength, its dose frequency, duration in days, and total quantity (number of tablets and capsules). Below the main drug- instructions/ precautions and contraindications should be clearly mentioned.
  • Any investigation required to be conducted, must be clearly mentioned in the prescription. If patient fails to keep follow update and if then some complication occurs, then patient is also considered negligent (contributory negligence)
 
REPORTS
  • All medical reports should be issued by a duly qualified person under his hand and seal.
  • Biopsy report should preferably be issued in duplicate so that the referring doctor/hospital can keep the original copy
  • If the pathologist does not give a duplicate copy the referring doctor should get it Xeroxed and should be handed over to the patient
 
 REFERRAL NOTES
  • They should include the date and time of issue, the patient's general condition, cause of reference, the treatment given and the course of action to be taken
  • Always keep the carbon copy of referral note especially in case of critically ill patient, with the patient’s signature. The fact that the patient did not go immediately on reference as advised could be proved by the duplicate copy of the referral note kept by the doctor. This could save a doctor who could be sued for alleged late referral after the patient's condition deteriorated
 
DISCHARGE CARD
  • It is important to give due importance to making a proper discharge summary as this is the summary document which reflects the treatment received by the patient.
  • Consultant in-charge should himself fill or supervise the discharge card
  • The discharge summary should mirror the case notes of the patient records with a brief summary, relevant investigations, operative procedures.
  • The date of admission, condition of the patient on the admission, investigation done, the treatment given and detail advice on discharge should be written on discharge card.
  • If any complication is expected after discharge ask the patient to report immediately. Instructions while discharge must be very clear and elaborate.
  • Do not use abbreviations or code messages in the discharge summary/card.
  • It is also important to include instructions to be followed by the patient after discharge including dietary advice and date of next follow-up. The doctor can be held negligent if proper instructions are not given regarding the medications to be taken after discharge, physical care that is required, and the need for urgent reporting if an untoward complication happens before the advised time of review
  • The discharge card should be signed or countersigned by the consultant. A copy of this must be preserved in the case file for future use if required
  • Discrepancies in the summary given to the patient and what is kept in the hospital records can cause suspicion about tampering with the medical records. These discrepancies should be avoided at all costs as the benefit of this usually goes in favour of the patient
  • It is not uncommon to have patients who gets discharged against the advice of the doctor. These patients are also entitled to have a discharge summary about the course of treatment. It is imperative to record the fact that the doctor has advised a course of action with all its implications if not followed. The fact that the patient has understood this and has refused it on his volition should be recorded. This should be signed by the doctor, patient, or relative and duly witnessed. This document has to be retained along with the patient records. It will help the doctor in situations where the patient alleges negligence later.
 
 MEDICAL CERTIFICATES
  • Medical certificate should be on institution/doctor letter pad.
  • Date, time, and place should be mentioned.
  • Medical certificates should be issued only for legitimate purpose and only when necessary.
  • It has to be true and clear without any ambiguity.
  • There should be an identification mark of the patient, preferably a thumb impression.
  • Period of illness should be clearly mentioned.
  • Disclosure of the diagnosis should be only after the patient’s express consent, unless required by the law
  • Doctor should maintain the duplicate copy of every certificate he has issued.
 
 
EMERGENCY DEPARTMENT REPORTS
A report is required for all Emergency Department visits and is expected to be completed within 24 hours of discharge/disposition from the Emergency Department.
 
Guidelines for Emergency Department Reports include the following:
  • Time and means of arrival.
  • Pertinent history of the illness or injury, including place of occurrence and physical findings including the patient’s vital signs and emergency care given to the patient prior to arrival, and those conditions present on admission.
  • Clinical observations, including results of treatment
  • Diagnostic impressions
  • Condition of the patient on discharge or transfer
  • Whether the patient left against medical advice(LAMA).
  • The conclusions at the termination of treatment, including final disposition, condition, and instructions for follow-up care, treatment and services.
 
PROGRESS NOTES
  • Must be documented/dictated on a daily basis, (patient must be seen by the physician at least once every 24 hours and recorded in form of the progress note)
  • Handwritten notes must be legible
  • Give a pertinent chronological report of patient’s course
  • Reflect any change in condition
  • Reflect the results of treatment / response to therapy
  • Exceptions may be given to an obstetrical patient that has a discharge order entered for the day before.
 
OPERATIVE AND PROCEDURE REPORTS
  • Name of the procedure/operation
  • Preoperative/Postoperative diagnosis
  • Name of primary surgeon and any assistants
  • Detailed account of the findings
  • Complications (if applicable)
  • Description of procedure(s) – technical procedures used
  • Specimens removed (if applicable)
  • Estimated blood loss
  • Condition after surgery
 
INFORMED CONSENT
  • Name/ Age/Sex and Address of the Patient should be provided
  • Name of the patient/guardian giving consent in the case of the minor
  • In case of guardian, the space should be provided for mentioning the details of the guardian including the relationship with the patient
  • Name and address of the Doctor/Hospital
  • Registration number, qualification and specialization of the doctor
  • Date of the consent given by the patient
  • The present condition/disorder/disease that the Patient is suffering from
  • Name of the procedure(s) to be followed
  • Statement that the relevant side-effects, risks and benefits have been explained
  • Reasonable alternatives to the proposed intervention and supporting information regarding those alternatives
  • Consequences of non-treatment including the effect on the prognosis and the material risks associated with no treatment
  • The expected outcome of the treatment administered
  • Should stipulate any measures/treatment/surgery that may have to be administered on an immediate basis in case the treatment/surgery for which the consent form is being issued is unsuccessful
  • Approximate duration and cost of treatment
  • Statement of the Patient that he got an opportunity to decide and take a second opinion
  • Statement of the Patient that the procedure was explained to the Patient or guardian and he/ she in his/ her capacity/ competence has voluntarily consented for the treatment on the basis of adequate information concerning the nature of the treatment
  • Signed declaration by the patient that all the information given by the patient are true to the best his knowledge and he will be liable for any misinformation and consequences ensuing from such misinformation
  • Signature of doctor who explained the procedure to the patient or guardian
 
JUDICIAL DECISIONS IN INDIA ON ISSUES OF MEDICAL RECORDS
 
There have been many judicial decisions pertaining to medical records from various courts in India and a review of some of the important ones is given in this section.
 
  • In Nisha Priya Bhatia v. Institute of Human Behaviour and Allied Sciences, GNCTD [CIC/AD/A/2013/001681­SA], decided 23 July 2014, RAW officer Nisha Priya Bhatia alleged a conspiracy by her organisation and an attempt to brand her as mentally sick just because she had filed several complaints, which she said were necessitated by compelling circumstances.  She was however detained for a month at the Institute of Human Behaviour and Allied Sciences because of a false medical report and suffered severe trauma. She then exercised her right under the Right to Information Act (R.T.I.ACT-2005), and filed an application seeking information such as certified copies of her case, correspondence, reports, commentaries, entries regarding diet, among others, however, she was not provided the same. Later, she filed an appeal and the CIC held that the   Patient   has   a   right   to   his/her   medical   record   and   Respondent Hospital Authorities have a duty to provide the same under Right to Information Act, 2005, Consumer Protection Act, 1986, The Medical Council Act as per world medical ethics and directed the Institute of Human Behaviour and Allied Sciences GNCTD to provide the information sought within 30 days and issued a notice to show cause why maximum penalty cannot be imposed on the then PIO for withholding the information saying that it comes under the non-applicable clause of the RTI Act.
 
  • In S.A. Quereshi v Padode memorial Hospital and Research Centre II. 2000. CPJ 463 (Bhopal), it was held that the plea of destroying the case sheet as per the general practice of the hospitals appeared to the court as an attempt to suppress certain facts that are likely to be revealed from the case sheet. The opposite party was found negligent as he should have retained the case records until the disposal of the complaint. If a hospital takes up a plea of records been destroyed, it could be considered as a case of negligence.
 
 
  • In Shyam Kumar v. Rameshbhai, Harmanbhai Kachiya, 2002; 1 CPR 320, I (2006) CPJ 16 (NC), the National Commission said that not producing medical records to the patient prevents the complainant from seeking an expert opinion and it is the duty of the person in possession of the medical records to produce it in the Court and adverse inference could be drawn for not producing the records.
 
  • The National Commission in Meenakshi Mission Hospital and Research Centre v. Samuraj and Anr., I (2005) CPJ (NC) held that the hospital was guilty of negligence on the ground that the name of the anesthetist was not mentioned in the operation notes though anesthesia was administered by two anesthetists. There were two progress cards about the same patient on two separate papers that were produced in Court.
 
TIPS FOR RECORD KEEPING
The following tips can help to ensure that the medical records are accurate:
  • Make sure all entries are clear and readable
  • Include all matters in your records that are relevant to the patient’s care, such as history, findings, diagnoses, treatments, care rendered and advice given
  • Draw diagonal lines through any blank spaces left after a written entry
  • If an error is made in a written entry, draw a line through it and write the time date and your initials in the margin. Never erase it or use white-out on it
  • Initial or sign all entries, include the date and time and make sure the patient’s name is on every page
  • Don’t use abbreviations, unless they are standard medical abbreviations
  • Do not make any derogatory references to the patient that might be misconstrued at a later date
  • Be specific at all times, and don’t use generalisations or subjective rather than objective language.
  • Ideally use a medical transcription service. This involves dictating your notes into a voice recorder or mobile device and then emailing or voice streaming them to an outside transcription service, often based in the cloud, for accurate transcription, storage and retrieval.
 
CONCLUSION
 
The above discussion and decisions of the Supreme Court establish the right of the patient and obligation of the hospitals or medical institutions to maintain and supply medical records as and when required.
It will not be out of place to mention that:
As a rule of thumb, it’s better to err on the side of caution and include too much information in your medical records rather than too little, because as the old saying goes, ‘If it’s not in the record, then it didn’t happen’.
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