1. Medical Documentation and it’s legal aspects
Prof.(Dr) Litan Naha Biswas
Senior Consultant Oncologist
Apollo Gleanagles Cancer Hospital
Kolkata

2. One patient in the peri-menopausal age group was diagnosed with T2N1MO Breast cancer and referred to the clinical oncologist after MRM, for adjuvant systemic therapy. ICH had revealed that the pt. was ER-ve, PR-ve, Her-2 triple +ve. The patient was advised 3 cycles of FEC and 3 cycles of Taxanes along with Trastuzumab (after confirming it with FISH test) , but the patient ‘s husband expressed his financial inability to afford the cost of Trastuzumab. So, the doctor completed the chemotherapy followed by local radiation and the patient was kept in follow-up. After 3 yrs, she came back with liver secondaries and attended a second doctor for his opinion. When the doctor enquired about why trastuzumab not given earlier, patient and her relatives told that they did not know about the benefits of the drug . They went to complain to the Court they were not explained properly about the benefits of the drug and blamed the first doctor. The doctor told the truth, but unfortunately it was not written over the prescription, and the doctor could not prove his points to the learned Judge

3. 1. Failure to inform the patient of the benefits of the particular drug in writing 2. failure to document non-compliance 3. lack of informed refusal

4. One 50 yr old pt. went to her primary care physician with c/o post-menopausal hot flushes. The doctor performed a complete gynoecological exam. including a bilateral breast exam. Although the breasts were normal, he advised a screening mammogram and put the patient on HRT to relieve the menopausal symptoms. The mammogram was reported normal but it noted ‘dense and fibrocystic breast tissue’. After 3 yrs. The patient returned to the doctor with c/o suspicious lump in her rt. Breast. On exam, the doctor suspected a fibrocystic like irregularity and ordered a diagnostic mammogram and USG of breast. Mammogram did not show any mass but showed architectural distortion from previous breast reduction surgery. Patient was also counseled about the current approach to hormone therapy, and she wanted to continue the HRT. She was advised to come after 6 months for a thorough exam. of the breasts and Gynae check-up.

5. After 8 months, she returned with c/o suspicious breast mass and it was finally diagnosed as Invasive carcinoma. The patient then filed a suit that her primary care physician was negligent in his exam. And failed to send her to the breast surgeon in time, resulting in delayed diagnosis. The case went to trial where a verdict was given in favour of the physician. How? Because it was the well documented records that helped the doctor to prove his points. The doctor had documented all the discussions he had with the patient after each visit and also the thought processes , which influenced the jury to think that the doctor was not negligent .

6. Poor records mean poor defense and No records mean no defense

7. Why Medical Documentation ?

8. Why medical documentation ?
Provides all the relevant informations about a specific patient , a
doctor would need to treat him
only way for the doctor to prove that the treatment was carried
out properly.
Helps in the scientific evaluation of the patient profile, helping in
analysing the treatment results and plan treatment protocols.
Equally important in the present setting, is the issue of medical
negligence, because the legal system relies mainly on the
documentary evidence
most important factor deciding on sentencing or acquittal of a
doctor in a malpractice or medical negligence suit.

9. Purpose of Medical Documentation
A)Clinical: provides the necessary information for correct diagnosis and treatment of the patient
B) Research: provides the data set for analysis and auditing of the treatment results and an important source for research and publication
C) Legal: provides only documentary evidence deciding on sentencing or acquittal of a doctor
D) Financial: for re-imbursement of medical claims

10. Three principles of documentation
First, the risk-benefit analysis of important decisions should be recorded.
Second essential point is the use of clinical judgment at critical decision points, which is defined as an assessment of the clinical situation and a response congruent to that clinical assessment
Last principle relates to the patient’s capacity to participate in his or her care.

12. Quality parameters of documentation
With documentation of medical records, particular emphasis must be placed on the five factors that improve the quality and usefulness of charted information.
–Accuracy
–Relevance
–Completeness
–Timeliness
–Confidentiality

13. Time schedule of Medical Records
Timeliness–There are specific time requirements for completion of the medical record:
•History and Physical –completed and signed within 24 hours of admission
•Post-Operative Note –written immediately following surgery
•Operative Note –dictated and signed within 24 hours of operation/procedure
•Medical Record –must be completed within 7 days of discharge or outpatient visit

14. COMPONENTS OF MEDICAL RECORD
Front Sheet or identification Summary Sheet
Consent Form for Treatment
Legal Documents like referral letter, request for Information etc
Discharge Summary, referral slip
Admission notes, clinical progress notes, Nurses progress note
Operation report if operation has been performed
Investigation reports like, X-ray, pathology etc
Orders for treatment and medication forms listing daily medications ordered and given with signatures of the doctor prescribing the treatment and the nurse administering it

15. Methods of Record Keeping
Manual: Traditional method of record keeping involving Papers and Books: followed in most hospital in India
Limitations: need for large storage areas and difficulties in the
retrieval of records
Advantages: legally more acceptable as a documentary evidence as it is difficult to tamper with the records without detection
B) Computerized: in most Corporate hospitals in India
Advantages: a) Neat and tidy
b) Can be easily stored and retrieved
Disadvantages: a) easy manipulation without detection
b) another major concern is maintaining the confidentiality of records, as very easy to manipulate.

16. FUNCTIONS OF MEDICAL RECORD DEPARTMENT
Filing of Medical records.
Retrieval of medical records for patient care and other authorized use.
Completion of medical records after an inpatient has been discharged or died.
Coding diseases and operations of patients discharged or having died
Evaluation of the Medical Record Service.
Completion of monthly and annual statistics.
Medico-legal issues relating to the release of patient information and other legal matters.

17. SEQUENCE OF MEDICAL RECORD
Information & identification sheet
Clinical Notes
Diagnostic reports
Surgical/ other procedural notes
Nurse Notes
Referral notes
Informed Consent
X-ray/CT/MRI Films are stored Separately

18. Discharge Summary
Crucial evidence regarding inpatient treatment of a patient
Summary document kept by the patient, which reflects the
treatment received
Should include the case notes of the patient with a brief summary,
relevant investigations and operative procedures or radiotherapy
and chemotherapy details, in specific cases
Dates of admission, discharge and any procedure undertaken
should be recorded sequentially - crucial for litigation later.
Must include instructions to be followed after discharge, including
dietary advice and date of next follow-up.
Should always be signed or countersigned by the consultant and a
copy must be preserved for future reference.

19. Discharge Summary
A copy of the discharge summary should be preserved in the case file for future reference
any discrepancy in the summary given to the patient and the hospital record should be avoided at all costs.
DAMA pts are also entitled to get a discharge summary about the course of their treatment. However, the whole conversation about the advice of the doctor and refusal of the patient should be recorded in the case file and duly signed by the doctor, patient and the relative for future protection against medical negligence.

20. Referral Notes Important component of patient’s records
should include date and time of issue, patient’s G.C, cause of referral and course of action to be taken
Better to keep a duplicate copy of the referral note, to protect against allegation of late referral after the patient deteriorates

21. Confidentiality of Medical Records
Important component of the rights of the patient
2 types of documents:
a) Personal: strictly confidential and should not be released without
pt’s consent
b) Impersonal: permission not required and could be used for research
purposes
Situations when records can be given without consent:
a) during referral
b) demanded by the Court or Police on written requisition
c) required for specific provisions of CPA or Income Tax authorities
d) when demanded by the insurance companies

22. Pitfalls in Documentation
Attempted alteration: never attempt to change an existing record
If any correction required, begin a new entry, record the current date and time and then describe the correction
Avoid insertion of words, little arrows or non-standard abbreviations during writing of notes.
The record should maintain a professional tone. (sarcastic comments, jokes or even too casual tone of the writings may reflect badly on the clinician)
Try to mention complete names and titles of staff members in the records.
All notes should bear dates and time with complete signatures

23. Categories of Medical Records
Records that must be given to the patient as a matter of right:
like ‘Discharge summary’, ‘Referral notes’ and ‘Death summary’ (in case of natural death)
B) Records that may be issued after payment of bills and meeting the due requirements of the hospital:
Copies of Inpatient files, pathology test reports, operation notes, chemotherapy and radiotherapy summaries etc.
*** Duplicate copies should always be marked ‘Duplicate’.
C) Records that can not be given to the patients without consent of the court:
‘The outpatient file’, Inpatient file and autopsy reports of medico-legal cases

24. MCI Guidelines
Maintain indoor records in a standard proforma for 3 yrs from the commencement of treatment.
On request from the patient or authorized attendant, documents should be issued within 72 hrs
To maintain a register of certificates with full details of medical certificates issued with at least one identification mark of the patient and his signature
Efforts should be made to computerize medical records for quick retrieval

25. Issues relating to Medical Records
How long to maintain the records ?
2 yrs for outpatients and 3 yrs for inpatients and surgical cases (CPA Act, 1986)
MCI Regulation: 3 yrs
Ownership of Medical Records:
By and large, it is Hospital property, and it is their responsibility to maintain and produce the patient records on demand by the patient or the Court, within 72 hrs

26. Summoning Medical Records by Courts
Medical records are acceptable under section 3 of the Indian Evidence Act.
Documentation of facts during the course of treatment considered genuine and unbiased
Records written after discharge or death of a patient do not have any legal value
Erasing of entries not permitted and questionable in court
Common causes of summons by Courts are Road traffic accidents, Insurance claims, criminal cases and most importantly
Medical Negligence cases under consumer protection act.

27. Do’s and Don’ts of Medical Documentation
Don’t destroy evidence
Don’t ever change the record
Label any addition to the chart as a ‘late entry’
Time and date your entries in the record
Don’t rely on memory, as recall is often faulty
Make your notes legible
Include relevant positive and negative points in your note from
the patient’s history and physical exam.
Describe your management plan well with rationale
Avoid making personal comments
Don’t use phrases like ‘ not enough beds were available’ or ‘Dr
X did not see the patient in time’

28. CHECKLIST OF MEDICAL RECORDS
The consent form for treatment has been signed by the patient;
Patient identification details (name and medical record number) are correct and entered on all forms
Doctors have recorded all essential information
Doctors have signed and dated all clinical entries
The front sheet has been completed and signed by the attending doctor
Nurses have recorded and signed all daily notes regarding the condition and care of the patient;
All treatment orders recorded in the medication form and signed;

29. Checklist of Medical Records
Medication administration has been recorded and signed
The anesthetic form (if any) has been completed and signed
The operation form (if any) has been completed and signed
The main condition/principle diagnosis has been recorded on
the front sheet
Operations and/or procedures have been recorded on the front
sheet
Diagnostic reports have been attached
Discharge/referral summary is duly filled and signed.

30. Many physicians complain that they do not have the time to write so many records! Would you rather spend the time in court for 12 weeks, 5 days a week from 9 am to 5 pm ?

31. ‘ The palest ink is better than the strongest memory’

32. REFERENCES
Medical records and issues in negligence: Joseph Thomas, Indian J Urol 2009; 25(3):
2. Fundamentals of Medical Record Documentation: Thomas G Gutheli, Psychiatry, Nov 2004; 1(3): 26-28
3. The importance of documentation: The Medical and Legal issues: Sameer Kanaan, M.D
4. Clinical record systems in Oncology. Experiences and Developments on Cancer Registers in Eastern Germany: Bernd BLOBEL
5. Intelligent Judging- Evolution in the Classroom and the Courtroom: George J. Annas J.D. New England Journal of Medicine 354 (21); May 25, 2006
6. Legal issues pertaining to Medical Documentation: Deborah C.Lacombe Esq; Lindsey M et al , Current Orthopaedics. Jan 1992 Vol 6 (1): 65-67