EVERYTHING A DOCTOR SHOULD KNOW ABOUT DOCUMENTATION & RECORD KEEPING IN MEDICAL PRACTICE

by Dr. (Prof.) Mahesh Baldwa,

M.D,D.C.H, FIAP, MBA, LL.B,LL.M , Ph. D(law)

SENIOR PEDIATRICIAN & MEDICOLEGAL ADVISOR

Formerly Assistant Professor of Pediatrics at T.N. Medical College and Nair Hospital, Mumbai-400008

Ex. Asst. Professor JJ Hosp, Grant medical college

Ex.Professor, paper setter & examiner of law to postgraduate students of University Department of Law, University of Mumbai

Baldwa Hospital, Sumer Nagar,S.V. Road,

Borivali (West)Mumbai 400 092

drbaldwa@yahoo.com

drbaldwa@gmail.com

m_baldwa@rediffmail.com

Cell 09322990138

PATIENTS AND DOCTORS MAY FORGET BUT RECORDS WILL ALWAYS REMEMBER.

INTRODUCTION

It is best defence against litigation. It is a known fact that Good records deliver quality medical care. Medical records are our best defence against allegations of negligence, deficiency of service and unfair trade practice and medical malpractice. Records should be transparent, correct, clear, comprehensive, chronological manner written with use of contemporaneous method of abbreviations so the accountability becomes apparent.

Records must have been kept in a variety of ways since the inception of medicine. One can hypothesize that initially the records may have been kept more for the physician’s interest rather than anything else. But rarely may they have created so much interest as they have in modern medicine. Just as advances in modern medicine are progressing in leaps and bounds, the need for good hospital records is also ever increasing. Medical records serve many functions for good patient care. Good quality records are desirable because of their importance in clinical management of patients and value in professional training.

HISTORY OF RECORD KEEPING

Historically medical record keeping has received patchy support and inconsistent application. The records have been kept in a variety of ways. Medical records carved on wood, stone and hieroglyphics have been discovered. The earliest documentation of medical records in India is found in Athervaveda. In 1880s physicians at Mayo Clinic Minnesota kept the patient records in a personal leather bound ledger. This was replaced in 1907 with patient based records, a method still used today. In the UK the first major attempt to standardize medical records came in 1965 with the publication of the Tunbridge report. In this report Tunbridge also described the problems of extracting information from records for secondary purposes. It proposed that medical records should be standardized so that the new methods of sorting and storing information could be used to the fullest advantage. In 1968 Weed described the problem oriented medical record (POMR). He proposed that the clinical record should be structured around the patient’s problem rather than medical problems and be updated in detail on a daily basis.

IMPORTANCE OF RECORD KEEPING:

If any legal problem arises than properly maintained records are of utmost importance. They are proof of what one has done actually for his patient.

WHAT DOES MEDICAL RECORD INCLUDES?

Following is purported to be exhaustive list of various records yet it may vary from case to case

Outdoor case paper / register / booklet /card/ letterhead/loose prescription sheet/chit
Under treatment certificate/sick certificate / fitness certificate
Referral to other doctor /pathology lab/ x-ray / Sonography / CAT/ MRI
Record of Informed consent with patient name, name of procedure/surgery/anesthesia, date, place, duly signed and witnessed
1. Is consent required for giving injections / immunization/internal examination like PV examination of breasts and PR ? routinely NO but presence of relative in the room is required, it does not mean the relative has to supervise doctor. Presence of female attendant is must for examination of females.
1. In case of known allergy or hypersensitivity or specific contraindications in patient administration of injections need test dose and consent
1. Allergy to egg protein or neurological disorder children may require consent for immunizations.
Record of Indoor case paper showing
Chronological order of progress of disease and treatment given
Monitoring of vitals, Minimum pulse, BP, RR and Temp. In patients with diabetes monitoring of blood sugar levels, CAD serial ECG’s or continuous monitoring
Pathological test, when ordered and what are the positive findings to be recorded on case paper
X-Ray, Sonography with report, when ordered and what is the positive finding on case paper
Pre invasive procedure or pre-operative treatment or preparation, which is usually aimed at avoiding vagal shock averted by inj Atropine, aspiration during anesthesia averted by NBM, Ranitidine, Inj Metaclopramide
Details of invasive procedure or surgery or anesthesia given
Post procedure or post operative treatment
1. Date wise record of investigations be it radiological, pathological or reports of CAT or MRI or any other opinion of specialist or consultant
1. Record includes record of refusal of treatment or investigation or surgery
PM doctors give Postmortem notes

COMMON PROBLEMS OF RECORD RETENTION: SHOULD IT BE WITH PATIENT OR WITH DOCTOR?

Customarily patient retains OPD records

In India outpatient records, vast majority of doctors, write the history, clinical findings, and positive finding in investigation reports on letter heads and hand over to the patient.

Customarily patient retains investigation and imaging records

Reports of blood, stool urine and imaging investigation are retained by patient party in original.

Doctors loss is patients gain

Private medical practitioners are left with no documentation regarding of the patients. As a result, in most cases, no record whatsoever remains with the Private medical practitioner / consultant in their clinic. The patient is expected to bring this paper on each follow-up visit. This includes post-admission or post-op follow-up visits in OPD time and again, in the event of a medico-legal problem occurring in a particular case, the absence of OPD records hampers the defence of the case if any prosecution is launched against them.

Doctors are at mercy of patient party for OPD and investigations records

Since no records are available with doctors and he is at the mercy of the patient to provide with his treatment papers. Some vital record, which may prove doctors point, may not be given with by the patient, since it may not be in his best interest to do so as far as his legal case of doctor is concerned. Also, if there is a considerable time lag, doctor may not be able to reconstruct the circumstances of the case in litigation because of lack of the documents and fading memory.

Apart from the medico-legal angle, there is another aspect that needs to be recognized. Theoretically, when records are handed over to the patient, if retained by doctor then records will be readily available to the litigant doctor.

Storage problems of OPD records

No doubt if all OPD patient’s records are retained by doctor then it shall create shortage of storage space in doctors clinic if maintained in physical form. The solution is to maintain records in electronic format. It is allowed as evidence under section 65 B of Indian Evidence Act as well as Information Technology Acts.

Loss of OPD record

At the same time even if you observe retention of records by patients it practically is observed that a majority of patients, when asked for their records (especially after some length of time), they will very casually inform you that they have has lost the papers. This is what happens to your painstakingly taken history and physical findings written on OPD case papers.

The standard explanations are: paper lost from in rickshaw, taxi, motorcar, bus. OPD case papers are also lost in shifting of residence and eaten by rats. More sophisticated patients will give more plausible replies. But the fact of the matter is, that very few patients place a value on the medical records and may not produce them when required, so that the very purpose of using them for future treatment is defeated. This is the non-medico legal dimension of parting with the records, which is helpful to a litigant doctor.

solution

Therefore, the dilemma that has to be resolved is- Should OPD records be kept by the doctor /clinic or should they be handed over to the patient with the doctor having no record? Should you leave it to the good sense of the patient to preserve his records and retrieve them when called for or should it be the other way round? The ideal answer may be, there should be two copies of the records and both patient and doctor/clinic should have the same. The other solution is to maintain records in electronic format. It is allowed as evidence under section 65 B of Indian Evidence Act as well as Information Technology Acts.

If that is not feasible, then the record should be in the clinic, copy of which can be availed by the patient on request. Personally, I like this option though it means more effort and resources on the part of the ‘health care provider’. Of course, computerization of records alters the picture totally and one can come up with easier solutions. But widespread use of this is a long way off.

But the bottom line, in view of medico-legal concerns is, avoid a situation wherein you as the doctor of the patient do not have access to all records of the patient, more particularly out patient records, both initial and follow-up and whether post-admission or post-op. Indoor records are generally invariably accessible. Hence, the stress on OPD records the absence and irretrievability of which have lowered the quality of defense in a number of cases.

Tailor made solutions

It is of course understandable that consultants practicing in multiple clinics/polyclinics might find it more difficult to preserve OPD records, but having understood the need for it, one may have to innovate and devise tailor-made solutions. As a matter of fact, even general practitioners, who are most notorious for not maintaining any records of their outpatients, are now becoming more conscious of this fact, particularly because of their increasing involvement in medico-legal tangles.

To summarize, remember medical records are our best defense when we have to reply to allegations against us. We have to give more importance to OPD records. If the choice is between the patient and you having the records, it is better for you to have the records. If both can have them, it is ideal. EMR or electronic medical record keeping is a also good option. And finally, as always, better to be safe than to be sorry in maintaining proper records.

HOW LONG TO MAINTAIN RECORDS

Ideally records of adult patients are maintained for 3 years and children, for 21 years. (3+18 years). Mentally retarded forever till the person is practicing.
From Income tax point of view for seven years
As per code of medical ethics April 2002 for 3 years

HOW TO DESTROY RECORDS:

Give a public notice in one English and one vernacular newspaper, with a time limit of usually one month from date of publication in which any one wants the relevant paper can come and take a copy of record needed.
1. After one month destroy record for every one save and except,
  1. Where litigation is going on
  1. Pre-litigation process of notice exchange is going on
  1. Mentally ill or retarded patients
  1. Where you expect that there could be future trouble.

AVOID ELECTRONIC FORMAT OF RECORD KEEPING IN FOLLOWING SITUATIONS?

They are
1. Frequent monitoring of vitals parameters and investigations are required.
1. Moribund patient
1. Patient who develop complications of disease, drug, surgery, anesthesia or procedure
1. Patient who suddenly take a serious turn
1. Patient which are transferred or referred to other hospitals/doctors
1. Accident / suicide / attempted homicide /poisoning/ burns /fracture / tetanus and cases involving violence causing disease or injury
Consent needs to be on hard copy
Transfer to other hospital needs hard copy
Referral to doctor / investigations need hard copy
Police cases need hard copy
Certificate of leave / sick certificate /fitness certificate needs hard copy
All registers needed by various authorities like birth, death, MTP,PNDT, tubal ligation / vasectomy registers, Indoor admission, Outdoor registers, police information, OT registers, sterilization of registers /autoclave registers/ notifiable disease / Nursing /order book or register, bill books etc need hard copy
Highlight Risks and warnings – This is vital information which the physician is to be made aware of quickly. These need to be highlighted before seeing or treating the patient; for example, allergies, and drug sensitivities or high risk medical conditions. This should also include legal status of the patient. An important risk would also be history of violent tendencies, HIV status or known abuser of health care services.

RECORDS OF REGISTRATION, APPROVALS, LICENCES, NURSING HOME / SHOP ESTABLISHMENT.

Ready Record of Degree certificates, MMC/MCIM Registration, approvals, licenses, Nursing home / Shop establishment. registration etc.

Relevance of application of law of medical negligence or deficiency of service to legality of registration of Nursing home or hospital under nursing home act, shop establishment act, biomedical waste act, MTP act, PNDT act, spirit licence, Narcotic drugs licence etc.

Some times while proving negligence and deficiency of service records of registration of Nursing home or hospital under nursing home act, shop establishment act, biomedical waste act, MTP act, PNDT act, spirit licence, Narcotic drugs licence etc. become corroborative evidence of deficiency of service.

WHICH RECORDS BE KEPT IN DUPLICATE

Patients that are referred to other doctors with signature of patient/rep.
Patients that are transferred to other hospitals with signature of patient/rep.
Information to police / MLC cases with signature of patient

TO COVER THE EVENTUALITIES OF:

Patient alleging that he kept on taking treatment to overcome the legal limitation clause for time bar.
1. Some case papers of particular date are not annexed with complaint to suit allegations.
1. Allegations that investigations, referral to doctor, transfer or MLC case registration was not done

THE RIGHT TO RETAIN MEDICAL DOCUMENTS

This is a vexed question and needs to be addressed. Does a physician or a hospital have the right to retain documents that contain information relating to the patient? There is one view, which holds that since information contained in a document is privileged the physician/hospital has the right to retain such document. A contrary view holds that the information, for future reference should be given when specifically sought. It is submitted that information, though privileged, is about the patient who seeks the document. The same cannot be withheld since there cannot be a privilege against a person who seeks information about him contained in a document. A physician or hospital may retain a photocopy of the document given to the patient Alternately; the patient could be supplied with a photocopy of the document sought while retaining the original with the physician/hospital. A similar approach should be adopted regarding X-ray plates and other information about a patient. A physician/hospital is bound to disclose information when ordered by a court or agencies concerned in the administration of justice. Bombay High court decision in Radhyeshyam Raheja v. Maharastra Medical council[1] that the patient should be supplied with required Xeroxed documents at reasonable charge.

CASE LOSS ON RECORD KEEPING

NOT SUPPLYING DOCUMENTS IS NOT NEGLIGENCE[2] It has held that there can be no question of negligence by reason of failure to supply hospital records pertaining to the surgical operation performed (unless a legal duty was cast on the hospital to furnish such documents to a patient. It would be sufficient if a discharge card wherein the particulars of diagnosis and treatment administered were mentioned.

PROPER DOCUMENTATION MAY SAVE FROM NEGLIGENCE

RECORDS SHOW SURGEON OPERATED EVEN THOUGH HE DENIED HAVING OPERATED

Owner of nursing home called surgeon to perform operation -patient died during operation -surgeon contended that he never operated -record contrary -only surgeon was held liable and not the Nursing Home. Also ” observed that even fee promised would be enough to make the patient a consumer.[3]

RECORDS SHOW NO PAIN HENCE NO XRAY TAKEN OUT

Accidental injury -O.P. doctor did not take x-ray of shoulder, so after 15 days consulted orthopedic surgeon, who also did not advise x-ray. O.P. doctor contended patient never complained pain. Patient alleged negligence of O.P. doctor, complainant also alleged no record given by doctor. District Forum dismissed the case. It was observed by district forum that record was not asked by O.P. Hence adverse inference could not be drawn. As complainant did not specify which facts were overlooked by doctor in caring for him so District Forum dismissed the case. [4]

RECORDS SHOW NO CONSENT, SURGEON WAS NOT GYNEC

A patient had cancer cervix, for, which consulted many doctors, and told that she is inoperable. O.P., a Surgeon, operated under L.A. without doing investigations. Complication of burst abdomen occurred, re-operated and after that instructions regarding chemotherapy was not followed by Nursing Home. it was found that surgeon visited thrice only. Patient died. It was held that O.P. was a surgeon and no gynaec degree and the case sheet did not contain consent form, not showing administration of drugs which amounts to negligence it was the bounden duty of Nursing Home to record the previous history of patient, summary of Laboratory reports and sensitivity reports. Held negligence[5]

NO RECORD OF OTHER HOSPITAL SHOWED THAT PATIENT DIES OF RENAL FAILURE

Patient was operated for Duodenal ulcer. Patient alleged that because hemoglobin was low and pain persisted so he went to other hospital- Patient died of renal failure as per discharge summary given by doctor, Urine Albumin was three plus ( +++ ), but blood Urea was not mentioned. Alleged intentionally not written. Doctor pleaded that Blood Transfusion was given before operation and Barium study x-ray showed ulcer, which needed emergency surgery. Non-reporting of Blood Urea was a computer limitation of machine. Observed that no record of other hospital produced that patient died of renal failure. Renal failure occurred during treatment of O .P. was not proved so case dismissed. [6]

HOSPITAL REFUSED TO GIVE DEATH SUMMARY

A patient was admitted in critical condition died after 2 weeks – alleged wrong diagnosis and treatment -supported by an evaluation report of an institute. -Patient asked for record but hospital refused and gave death summary. It was held that evaluation of case must be done in correlation with clinical condition of patient mere data cannot be interpreted without studying patient then and there -dismissed. [7]

BILL SURGESTED THAT TREATMENT WAS GIVEN

A patient had accidental fracture-leg -admitted in a hosp.- surgeon operated- during operation left drill bits -later removed by other surgeon -hospital contended that the surgeon was not attached to the hospital. It was held that surgeon was negligent and overwriting in muster roll, could not be relied upon and surgeon charges included in bill suggest O.P. 1 was attached to hospital –vicariously liable.[8]

RECORDS DESTROYED

Arthroscopy of Right knee -deformity -certificate produced -doctor failed to explain the cause also contended that record destroyed. Held: liable & observed that an educated person would not eliminate the record of a pending case. [9]

Essentials of the record –

Inpatient:- A complete medical record for in-patients should show the following features.

Personal data of patient with detailed postal address
Complaints ( patient’s language )
Detailed history of present illness
Past history – patient’s medical history
Family history
Socioeconomic history
Developmental history and Immunization ( Pediatrics )
Dietetic, Socioeconomic
Detailed physical examination
Diagnosis
Differential Diagnosis
Plan of Investigations
Report of investigations
Final diagnosis
Empirical treatment
Change in treatment after final diagnosis is reached

(Published in Part III, Section 4 of the Gazette of India, dated 6^th April, 2002)

MEDICAL COUNCIL OF INDIA

NOTIFICATION

New Delhi, dated 11^th March, 2002

No. MCI-211(2)/2001/Registration. In exercise of the powers conferred under section 20A read with section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of India, with the previous approval of the Central Government, hereby makes the following regulations relating to the Professional Conduct, Etiquette and Ethics for registered medical practitioners, namely:-

Short Title and Commencement: (1) These Regulations may be called the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.

(2) They shall come into force on the date of their publication in the Official Gazette.

1.3 Maintenance of medical records:

1.3.1 Every physician shall maintain the medical records pertaining to his/her indoor patients for a period of 3 years from the date of commencement of the treatment in a standard proforma laid down by the Medical Council of India and attached as Appendix 3.

7. MISCONDUCT: The following acts of commission or omission on the part of a physician shall constitute professional misconduct rendering him/her liable for disciplinary action –

7.1 Violation of the Regulations: If he/she commits any violation of these Regulations.

7.2 If he/she does not maintain the medical records of his/her indoor patients for a period of three years as per regulation 1.3 and refuses to provide the same within 72 hours when the patient or his/her authorised representative makes a request for it as per the regulation 1.3.2.

APPENDIX-3

FORMAT FOR MEDICAL RECORD

(see regulation 3.1)

Name of the patient:

Age:

Sex:

Address:

Occupation:

Date of 1^st visit:

Clinical note (summary) of the case:

Prov: Diagnosis:

Investigations advised with reports: