Tuesday, 1 February 2011

Medical records and issues in negligence

SYMPOSIUM

Year : 2009 \| Volume : 25 \| Issue : 3 \| Page : 384-388

Medical records and issues in negligence

Joseph Thomas
Department of Urology, Kasturba Medical College, Manipal 576 104, India

Date of Web Publication

1-Oct-2009

Correspondence Address:
Joseph Thomas
Kasturba Medical College, Manipal 576 104
India

DOI: 10.4103/0970-1591.56208
PMID: 19881136

Abstract

It is very important for the treating doctor to properly document the management of a patient under his care. Medical record keeping has evolved into a science of itself. This will be the only way for the doctor to prove that the treatment was carried out properly. Moreover, it will also be of immense help in the scientific evaluation and review of patient management issues. Medical records form an important part of the management of a patient. It is important for the doctors and medical establishments to properly maintain the records of patients for two important reasons. The first one is that it will help them in the scientific evaluation of their patient profile, helping in analyzing the treatment results, and to plan treatment protocols. It also helps in planning governmental strategies for future medical care. But of equal importance in the present setting is in the issue of alleged medical negligence. The legal system relies mainly on documentary evidence in a situation where medical negligence is alleged by the patient or the relatives. In an accusation of negligence, this 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 is disheartening to note that inspite of knowing the importance of proper record keeping it is still in a nascent stage in India. It is wise to remember that "Poor records mean poor defense, no records mean no defense". Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, post operative care, and daily notes of a patient's progress and medications. A properly obtained consent will go a long way in proving that the procedures were conducted with the concurrence of the patient. A properly written operative note can protect a surgeon in case of alleged negligence due to operative complications. It is important that the prescription for drugs should be legible with the name of the patient, date, and the signature of the doctor. An undated prescription can land a doctor in trouble if the patient misuses it. There are also many records that are indirectly related to patient management such as accounts records, service records of the staff, and administrative records, which are also useful as evidences for litigation purposes. Medical recording needs the concerted effort of a number of people involved in patient care. The doctor is the prime person who has to oversee this process and is primarily responsible for history, physical examination, treatment plans, operative records, consent forms, medications used, referral papers, discharge records, and medical certificates. There should be proper recording of nursing care, laboratory data, reports of diagnostic evaluations, pharmacy records, and billing processes. This means that the paramedical and nursing staff also should be trained in proper maintenance of patient records. The medical scene in India extends from smaller clinics to large hospitals. Medical record keeping is a specialized area in bigger teaching and corporate hospitals with separate medical records officers handling these issues. However, it is yet to develop into a proper process in the large number of smaller clinics and hospitals that cater to a large section of the people in India.

Keywords: Medical records, medical negligence

How to cite this article:
Thomas J. Medical records and issues in negligence. Indian J Urol 2009;25:384-8

How to cite this URL:
Thomas J. Medical records and issues in negligence. Indian J Urol [serial online] 2009 [cited 2010 Dec 2];25:384-8. Available from: http://www.indianjurol.com/text.asp?2009/25/3/384/56208

Methods of Record Keeping

The traditional method of keeping records that is followed in most of the hospitals across India is the manual method involving papers and books. There are serious limitations of manual record keeping including the need for large storage areas and difficulties in the retrieval of records. However, it is legally more acceptable as a documentary evidence as it is difficult to tamper with the records without detection. The present era has seen the computerization of medical records that are neat and tidy, and can be easily stored and retrieved. However, the possibility of easy manipulation without detection is a serious concern; hence, they may not be universally accepted at face value as a documentary evidence. If it is demanded during court proceedings, it is the duty of the hospital and the doctor to prove that these computer documents were not altered. Another major concern is maintaining confidentiality of the patient records as the patient can hold the doctor and the hospital negligent for breaking confidentiality of his medical records. Video tapes of endoscopic procedures, electronic fetal heart monitor charts, continuous ECG or Pulse oximeter charts could become important evidence in a court of law. Electronic medical recording is in the process of evolution and is being increasingly used. Though the total avoidance of paper records is the ideal aim, there are many areas that need to be sorted out. For example, an important issue is the electronic signature of the patient, doctors, and witnesses on informed consent forms.

Discharge notes
This is a crucial piece of evidence regarding the inpatient treatment of a patient. It is important to give due importance to making a proper discharge summary as this is the summary document that will be kept by the patient which reflects the treatment received. The discharge summary should mirror the case notes of the patient records with a brief summary, relevant investigations, and operative procedures. The dates of admission, discharge, and surgery are useful when the sequence of events is an important issue in litigation later. 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. As a urologist, it is common to see patients who are not aware of stents that should have been removed at its appropriate time, though mentioned properly in the discharge summary. The discharge summary 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 favor 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.

Referral notes
Referral notes are an important component of patient records. They should include the date and time of issue, the patient's general condition, cause of reference, and the course of action to be taken. It is wise to keep a duplicate copy of the referral note 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.

Confidentiality of Medical Records

Medical records can be used as a personal or impersonal document. 1) Personal document - this information is confidential and should not be released without the consent of the patient except in some specific situations. 2) Impersonal document - the record looses its identity as a personal document and patient permission is not required. These records could be used for research purposes. Confidentiality is an important component of the rights of the patient. The hospital is legally bound to maintain the confidentiality of the personal medical records. The patient can claim negligence against the hospital or the doctor for a breach of confidentiality. However, there are certain situations where it is legal for the authorities to give patient information. They are as follows: 1) during referral, 2) when demanded by the court or by the police on a written requisition, 3) when demanded by insurance companies as provided by the Insurance Act when the patient has relinquished his rights on taking the insurance, and 4) when required for specific provisions of Workmen's Compensation cases, Consumer Protection cases, or for Income tax authorities. The maintenance of confidentiality is an important issue in the era of electronic data storage. There should be checks in place so that only those who are authorized can access the patient data.

The impersonal documents have been used for research purposes as the identity of the patient is not revealed. Though the identity of the patient is not revealed, the research team is privy to patient records and a cause of concern about the confidentiality of information. Historically, such research has been exempt from an ethics review and researchers have not been required to obtain informed consent from patients before using their records. Recently, a need has been felt to regulate the use of medical records in research, effectively restricting the manner in which this type of research is conducted. An ethics review is required for using the patient data. However this is not widely followed all over India.

Categories of Medical Records

The different categories of medical records are as follows:

Certain records must be given to the patient as a matter of right. Discharge summary, referral notes, and death summary in case of natural death are important documents for the patient. Hence, these have to be given without charge for all including patients who leave against medical advice. The hospital bill cannot be tied up with these sensitive documents that are necessary for continuing patient care. Thus, the above documents cannot be legally refused even when the hospital bill has not been paid.
Certain records may be issued after the patient or authorized attendant fulfills the due requirements as stipulated by a hospital. This requires a formal application to the hospital requesting for the records. It is necessary that the hospital bills are cleared and the necessary processing fee has been paid. The documents in this group include copies of inpatient files, records of diagnostic tests, operation notes, videos, medical certificates, and duplicate copies for lost documents. It is important that the duplicate copies should be marked appropriately. It is not unusual for an unscrupulous patient to use it for multiple insurance claims without the knowledge of the doctor.
Certain records cannot be given to patients without the direction of the Court. The outpatient file, inpatient file, and files of medico-legal cases including autopsy reports cannot be handed over to the patient or relatives without the direction of the Court. But if these medico-legal cases are being referred to another center for management, copies of records could be given. However, X-rays are given only after a written undertaking by the patient or relatives that these will be produced in the Court as and when required.

Medical Council of India Guidelines on Medical Records

The issue of medical record keeping has been addressed in the Medical Council of India Regulations 2002 guidelines answering many questions regarding medical records. The important issues that have been addressed are as follows:

Maintain indoor records in a standard proforma for 3 years from commencement of treatment (Section 1.3.1 and Appendix 3).
Request for medical records by patient or authorized attendant should be acknowledged and documents issued within 72 hours (Section 1.3.2).
Maintain a register of certificates with the full details of medical certificates issued with at least one identification mark of the patient and his signature (Section 1.3.3).
Efforts should be made to computerize medical records for quick retrieval (Section 1.3.4).

How long should Medical Records be Preserved?

There are no definite guidelines in India regarding how long to retain medical records. The hospitals follow their own pattern retaining the records for varied periods of time. Under the provisions of the Limitation Act 1963 and Section 24A of the Consumer Protection Act 1986, which dictates the time within which a complaint has to be filed, it is advisable to maintain 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. It is important to note that in pediatric cases a medical negligence case can be filed by the child after aquiring the age of majority.The 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. It is necessary that the Government frames guidelines for the duration for which medical records are preserved by the hospitals so that hospitals are protected from unnecessary litigation in issues of medical records.

The provisions of specific Acts like the Pre Conception Prenatal Diagnostic Test Act, 1994 (PNDT), Environmental Protection Act, etc. necessitate proper maintenance of records that have to be retained for periods as specified in the Act. Section 29 of the PNDT Act, 1994 requires that all the documents be maintained for a period of 2 years or until the disposal of the proceedings. The PNDT Rules, 1996 requires that when the records are maintained on a computer, a printed copy of the record should be preserved after authentication by the person responsible for such record.

Ownership of Medical Records

An important issue of dispute between the patient and the treating hospital is about the ownership of the medical records. By and large medical records are the property of the hospitals and it is the responsibility of the hospitals to maintain it properly. The hospitals and the doctors have to be careful with medical records as these can be stolen, manipulated, and misused for malafide reasons by any interested parties. Hence, the records should be in safe custody. It is the primary responsibility of the hospital to maintain and produce patient records on demand by the patient or appropriate judicial bodies. However, it is the primary duty of the treating doctor to see that all the documents with regard to management are written properly and signed. An unsigned medical record has no legal validity. The patient or their legal heirs can ask for copies of the treatment records that have to be provided within 72 hours. The hospitals can charge a reasonable amount for the administrative purposes including photocopying the documents. Failure to provide medical records to patients on proper demand will amount to deficiency in service and negligence.

Summoning Medical Records by Courts

Medical records are acceptable as per Section 3 of the Indian Evidence Act, 1872 amended in 1961 in a court of law. These are considered useful evidence by the courts as it is accepted that documentation of facts during the course of treatment of a patient is genuine and unbiased. Medical Records that are written after the discharge or death of a patient do not have any legal value. Erasing of entries is not permitted and is questionable in Court. In the event of correction, the entire line should be scored and rewritten with the date and time.

Medical records are usually summoned in a court of law in the following cases:

Criminal cases for proving the nature, timing, and gravity of the injuries. It is considered important evidence to corroborate the nature of the weapon used and the cause of death
Road traffic accident cases under the MACT Act for deciding on the amount of compensation
Labor courts in relation to the Workmen's Compensation Act
Insurance claims to prove the duration of illness and the cause of death
Medical negligence cases- these can be in criminal courts when the charge against the doctor is for criminal negligence or under the Consumer Protection Act for deficiency in the doctor's or hospital's care

It is usual to summon a doctor to appear in court to testify and to bring all the medical documents. When the court issues summons for medical records, it has to be honored and respected as it is a constitutional obligation to assist in the administration of justice. The records can also be produced in court by the medical records officer of the hospital. If the doctor is required to be present for giving evidence based on the medical records, he has to be present in the court to give evidence. The court may require these documents to be submitted for which a record is issued by the court. However, if the records are required for continuation of the medical treatment of the patient, copies can be kept by the hospital.

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.

The National Commission had held that there was no question of negligence for failure to supply the medical records to patients unless there is a legal duty on the hospital to give the records. The alleged hospital had provided a detailed discharge summary to the patient.^[1]However, the Bombay High Court held that doctors cannot claim confidentiality when the patient or his relatives demand medical records.^[2]With the enforcement of the MCI Regulations, 2002 it has been held without confusion that the patient has a right to claim medical records pertaining to his treatment and the hospitals are under obligation to maintain them and provide them to the patient on request.

The hospital and doctor were guilty of deficiency in service as case records were not produced before the court to refute the allegation of a lack of standard care.^[3] 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.^[4]

Not producing medical records to the patient prevents the complainant from seeking an expert opinion. 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.^[5] The State Commission held that there was negligence as the case sheet did not contain a proper history, history of prior treatment and investigations, and even the consent papers were missing.^[6]

The State Commission held that failure to deliver X-ray films is deficient service. The patient and his attendants were deprived of their right to be informed of the nature of injury sustained.^[7] The State Commission disbelieved the evidence of the surgeon because only photocopies were produced to substantiate the evidence without any plausible explanation regarding the absence of the original.^[8]

The allegation of not informing the possibility of vocal cord palsy was negated by the detailed written consent that showed that it was explained properly and consented.^[9] The allegation of the patient regarding negligence of the doctor was rejected.

The allegation of tampering with the operation notes was negated by the State Commission in a case of intraoperative death as the complainant could not prove the allegation.^[10]

The hospital was held vicariously liable for the negligent action of the doctor on the basis of the bill showing the professional fees of the doctor and the discharge certificate under the letterhead of the hospital signed by the doctor.^[11] The State Commission held negligence on the basis of the records, which seemed to be manipulated.^[12] Issues of tampering of medical records need detailed examination in a civil court rather that in Consumer Court.^[13] The National Commission in another case 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.^[14]

Not maintaining confidentiality of patient information can be an issue of medical negligence. The HIV status of a patient was known to others without the consent of the patient.^[15]

References

1.	Poona Medical Foundation v Marutturao Tikare. 1995 (1) CPR 661(NC).
2.	Raghunath Raheja v The Maharashtra Medical Council and Ors AIR 1996 Bombay 198.
3.	Kanaiyalal Ramanlal Trivedi v Dr. Satyanarayan Vishwakarma 1996 (3) CPR 24 (Guj); I (1997) CPJ 332 (Guj); 1998 CCJ 690 (Guj)
4.	S.A.Quereshi v Padode memorial Hospital and Research Centre II (2000) CPJ 463 (Bhopal).
5.	Dr. Shyam Kumar v Rameshbhai, Harmanbhai Kachiya, 2002 (1) CPR 320, I (2006) CPJ 16 (NC).
6.	Force v. M Ganeswara Rao . 1998 (3) CPR 251; 1998 (1) CPJ 413 (AP SCDRC).
7.	V P Shanta v. Cosmopolitan Hospitals (P) Ltd 1997 (1) CPR 377 (Kerala SCDRC).
8.	Devendra Kantilal Nayak v Dr. Kalyaniben Dhruv Shah 1996 (3) CPR 56; I (1997) CPJ 103; 1998 CCJ 544 (Guj).
9.	C Anjani Kumar v Madras Medical Mission 1998 (2) CPR (Chennai); I (1998) CPJ 533 (Chennai); 1998 CTJ 504 (CP) (SCDRC); 1999 CCJ 915 (TN).
10.	Sethuraman Subramaniam Iyer v Triveni Nursing Home 1997 (2) CPR 144 (NC); I (1998) CPJ 10 (NC); 1998 CTJ 7 (CP) (NCDRC); 1998 CCJ 1532 (NC).
11.	P.P. Ismail v K.K. Radha 1997 (2) CPR 171 (NC); I(1998) CPJ 16 (NC); (1997) 5 CTJ 685 (CP) (NCRDC); 1999 CPJ 99 (NC).
12.	Nihal Kaur v. Director, PGI, Chandigarh . 1996 (3) CPJ 112 (Chandigarh (U.T.) CDRC).
13.	Harenbalal Das v Dr. Ajay Paul, 2001 (2) CPR 498
14.	Meenakshi Mission Hospital and Research Centre v. Samuraj and Anr., I(2005) CPJ 33 (NC)
15.	Dr. Tokugha Yeptomi V Appollo Hospital Enterprises Ltd and Anr III (1998) CPJ 132 (SC).

http://www.indianjurol.com/article.asp?issn=0970-1591;year=2009;volume=25;issue=3;spage=384;epage=388;aulast=Thomas

Rules regarding retention of indoor medical records

Posted by: “Dr.M.C. Gupta” mcgupta44@gmail.com mcgupta44

Sat Sep 11, 2010 11:10 am (PDT)

*Rules regarding retention of indoor medical records*

* *

*QUESTION—Is the MCI regulation that physicians need to retain documents for 3 years applicable to institutions also? If not, what are the rules for institutions?

*ANSWER–*

1—One should not confuse the scope of MCI regulations. The MCI concerns only individual practitioners and has no jurisdiction over institutions.

2– As per Regulation 1.3.1 of the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, “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”.

This regulation would apply in case of those patients whom you might be treating / operating in hospitals / nursing homes. Please note that the
above regulation concerns only indoor records.

3–The proforma as per Appendix 3 referred above has the following items:

“Name of the patient:

Age :

Sex :

Address :

Occupation :

Date of 1st visit :

Clinical note (summary) of the case:

Prov. : Diagnosis :

Investigations advised with reports:

Diagnosis after investigation:

Advice :

FOLLOW UP:

Date(s):

Observations:

Signature in full ………………………….

Name of Treating Physician”

4—There are no legal rules for institutions. Different institutions may have their own guidelines. The guidelines for the government hospitals have been
published by the DGHS vide letter No. 10-3/68-MH dated 31-8-68 as follows:

For inpatient medical records (case sheets)……………….10 years

For medico-legal registers…………………………………….10 years

For outpatient records………………………………………….5 years

The above requirement can be found in the “Hospital Manual” published in 2002 by the Directorate General of Health Services, MOHFW, GOI, in chapter
12 titled “Medical Record Services”.

http://aimdda.wordpress.com/2010/09/12/rules-regarding-retention-of-indoor-medical-records/

http://delhimedicalcouncil.nic.in/mcihiv.pdf

http://www.thaindian.com/newsportal/uncategorized/income-tax-returns-medical-records-not-under-rti-court_100302797.html

Dr Savio Pereira
Associate Medical Superintendent
St John's Medical College Hospital
Bangalore -560034

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'Medical Record Must Remain Legible'

It covered topics highlighting the challenges, elucidations and policies surfacing within the healthcare sector related to medical records and health information management

The 10th Annual National Conference on 'Health Information, Medico Legal Management and Documentation' was held on 9th and 10th of April at Aditya Birla Memorial Hospital, Pune. This two-day conference organised by Aditya Birla Memorial Hospital was graced by the stalwarts and experts from medical and legal fraternity all over India. It covered topics highlighting the challenges, elucidations and policies surfacing within the healthcare sector related to medical records and health information management. The topics were broad ranged, and provided information about the primary concerns and issues within the healthcare systems nationally as well as globally.

Day I

Dr SP Singh

Dr Suganthi Iyer

Ranjith R Menon

Dr Virendar Pal Singh

The first session of the seminar was on challenges in EMR implementation and international healthcare documentation. The first speaker Dr GD Mogli, Sr Consultant eHealth Management, HEARTCOM INC. (USA) spoke on challenges of HIM professionals in EHR implementation in 21st century. "Having the uninterrupted blessings of policy/decision makers, the challenge in front of HIM professionals is to take the lead in transforming manual records to electronic or paperless by planning, organising, directing, implementing and evaluating to ensure the EHR system is implemented as planned and functioning effectively and efficiently. The electronic health record should meet aforesaid characteristics scrupulously, and then only, one can be sure that overwhelming and comprehensively the expected results could be accomplished," said Dr Mogli. He further said that if EHR to occur in any institution, local, or state, or federal level, there is a need for fundamental shift in 'attitude', awareness, habits and capabilities in the area of privacy and security.

The next speaker T Nithiya Kirubakaran, Manager - Medical Records, NMC Specialty Hospital, Abu Dhabi, UAE spoke on 'International Healthcare Documentation and Common Practices'. Nithiya said that hospitals should improve the safety of using medications and medical devices. Complete assessment of the patient includes medical, nursing and paramedical assessment. Pain assessment is given more importance and it should be documented in the records. Patient and family members' education regarding the use of medications and medical devices is crucial too. The hospital should adopt currently published and generally accepted hand hygiene guidelines. "Medical record must remain legible by using a single line to score out the information to be corrected. Medical Records must not include abbreviations other than those approved, published and made available to all staff," added Nithiya.

Dr SP Singh, CEO, Aditya Birla Memorial Hospital, Pune spoke on role of health records in accreditation. "Accreditation has improved public trust in the hospital and provides a safe and efficient work environment that contributes to employee satisfaction. In such a scenario, health information and medico legal management and documentation which is an evolving area in the industry in India, needs the attention of experts," he said.

Ranjith R Menon, Co-Founder & Senior Consultant, Isos Consultancy Services, Bangaluru gave a presentation on the role of medical records in quality assurance. Speaking on what needs to change at the medical records management level, he said, "Hospitals must invest in health information processes. If you do not classify and code; your data is worthless. Health information management doesn't mean IT, it means robust records management. Retrieving / turnaround time of our case sheets (Record Room to Physicians Desk) is not a QI worth tracking; how you use your patient care related data scientifically is the true measure of how good your quality programme."

The second session was on forensic nursing documentation and legal issues in medical records documentation. Dr Ajay Patil, Medico Legal Consultant, Medi-shield, Mumbai, while speaking on forensic nursing documentation, said, "Nursing document is an important link for understanding the untowered/ unexpected/ unexplained event in the treatment. In views of this, nursing document should be precise, prompt and with accuracy." He said that there are many tools used for client documentation, including worksheets, patient care plans, flow sheets and checklists, care maps, clinical pathways and monitoring strips. These tools may be written or electronic in format. Regardless of the tool used, pertinent information specific to an individual client resides within the client's health record.

The next speaker Dr Suganthi Iyer, Assistant Director (Legal & Medical), Hinduja Hospital, Mumbai threw light on the legal aspects of medical records. Said Dr Iyer, "Medical records are medico-legal documents and a doctor can be crossed-examined against the same. However, it is a strong evidence of proof of administration of standard medical care, provided documentation is complete." D Sanna Veerabhadrappa, Medical Record Officer, VIMS, Bellary spoke on statutory acts, rules and regulations for health records. He said that a resolution is to be passed at the end of the conference of 'International Healthcare Documentation and Common Practices' for the destruction of records which are more than 10 years old. A sufficient and specified space should be provided to the professionals of medical records department wherever they exist, all over India.

Niranjan Kumar Ramakrishnan, Chief Operating Officer, MEDTECH Health Solutions Private limited, Chennai spoke on clinical data integration. While talking on prerequisites for clinical data, he said that medical data is complex and requires precision. Standard health vocabulary is required to ensure consistency and interoperability. National standards for record structures, data formats, and protocols used to exchange information. Various standards development organisations have emerged to classify and organise health information, but national standards have yet to emerge.

The third session was on EMR privacy and strengthening Public Health Information System. Madhu Mohan Maddirala, Medical Records Officer, Tata Memorial Centre, Advanced Centre for Treatment, Research & Education in Cancer (ACTREC) spoke on medico-legal and EMR privacy. "Data are not of same utility and importance. It varies from one another on the basis of utility. So we require framing separate categories of data having different utility values as the US have. Moreover the provisions of IT Act deal basically with extraction of data, destruction of data etc," said Maddirala.

Next speaker Rajesh Kumar Sinha, Associate Professor, Department of Health Information Management, Manipal College of Allied Health Sciences, Manipal University, Manipal spoke on 'Strengthening Public Health Information System- Needs, Challenges and Strategies for success'. "A good health information system should present and disseminate data in appropriate formats for all audiences. Sound health information is a global public good and requires public and media support to ensure continued investment," said Sinha. Dr Vinoy Singh, Head - Health Informatics, Srishti Software Applications Pvt Ltd, Bangaluru spoke on 'Hospital Management to Healthcare Management'. Public Healthcare is promotion and protection of health at cohort level, through organised efforts of society. It is managed by public institutions and is usually led by Government. Talking about eHealth he said that it can significantly and positively change the way health services are delivered. Other key benefits achieved through a comprehensive eHealth strategy are improved health care quality, safety, and outcomes; increased service efficiency, productivity, and cost effectiveness and enhanced service availability and satisfaction for citizens, patients, and providers. Boser Raja, Centre Head, Vasan Eye Care Hospitals, Bangaluru gave a presentation on employee motivation and benefits of EMR and its implementation process.

Day II

Dr Rajendra Bangal

Dr GD Mogli

Dr Swati Gadgil

Dr Arjun Rajagopalan

The second day started with the session on skills and standards for auditing health records, statutory rules and regulations and forensic medical documentation. Mallika Kothandaraman, Medical Records Officer, JIPMER, Puducherry spoke on improving documentation skills and standards by auditing medical records. "Documented data used for decision making about a given individual in providing clinical care must be of far greater accuracy and completeness rather than for administrative purpose. Databases used for clinical decision making in describing an individual, should describe accurately about the details required for decision making. For instance, missing or out-of-date data or files that commingle data for more than one individual under single identifier have grave potential for harm," said Mallika.

Dr G D Mogli, Sr Consultant eHealth Management, HEARTCOM INC. (USA) gave a presentation on documentation standards and auditing methods for evaluation of medical care. "One of the foremost important ingredients to have a good documentation system in the hospital or health institution, is to have a well designed with appropriate content -standardised and rationalised medical records forms; not more, not less philosophy not only meets the needs of healthcare providers but also the needs of administration and other associated agencies including insurance and legal," said Dr Mogli.

Next speaker was Vandana Aravind, Asst Professor, Padmashree College of Hospital Administration, Bangaluru. Dr Rajendra Bangal, Medico Legal Consultant, Medishield, Mumbai spoke on 'Forensic Statutory Documentation'. "The forensic statutory documentation comprises of all documents written or printed to be produced before court of law for examination during the course of trial. Document means, any matter expressed or described upon a substance by means of letters, figures or marks, or by more than one of those means, intended to be used, or which may be used, for the purpose of recording that matter," said Dr Bangal.

The next session was on forensic documentation of injuries in a Trauma cases and role of medical records in medico legal cases. Dr Virendar Pal Singh, Medico-legal Consultant & Assoc. Prof, Forensic Medicine, Dayanand Medical College & Hospital, Ludhiana spoke on forensic documentation of injuries in a trauma case. Dr Singh said that the preparation of a medico-legal report is a task that should be approached with a desire to accurately communicate the clinical situation encountered. Guidelines for medico-legal reports and checklist should be followed while documenting and interpreting the injuries. A structured format and objective opinion will enhance both the reliability and accuracy of the report.

Raju Yohunna, Junior Medical Record Officer, AIIMS, Delhi, said, " Medico-legal case have to be dealt with properly prevailing guidelines therefore prepare a manual, give orientation to the staff dealing with MLCs and do proper documentation."

Dr Swati Gadgil, Director Ishwar Hospital, Mumbai spoke on ethical issues and documentation. "Any act which is illegal is definitely unethical and thus the ethics and list of professional misconduct for medical professionals in India are defined in the Indian Medical Council Act 1956 and Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The regulations were amended in 2003, 2004 and latest on 10th of December 2009, catering to the needs of the changing times. These regulations extensively cover the guiding principles, which any medical professional is to follow," said Dr Gadgil.

Dr Arjun Rajagopalan, Trustee & Medical Director, HOD - Surgery, Sundaram Medical Foundation, Chennai spoke on the impact of IT on healthcare. Said C Govindarajan, President (HERAI), "Winds of change have swept through the Indian Hospital scenario in the recent years and the medical records management is not an exception to it. The advancement in IT, stringent quality control measures in accreditation process of the healthcare institutions and legal implications have made it imperative for the maintenance of medical records in each and every hospital."

For the past eleven years, the national seminar has attracted around 1,000 doctors, lawyers and other healthcare professionals from various verticals of the healthcare sector including hospitals, pharma, insurance, IT, manufacturing units, CROs, NGOs, public/ private institutions and organisations from all over India and abroad.

http://www.expresshealthcare.in/201005/market19.shtml

http://www.indianjournals.com/ijor.aspx?target=ijor:mlu&volume=9&issue=2&article=006

Healthcare sites may see a funding boost

Possibility of electronic health records linked to the unique ID project make medical portals attractive to investors

Shraddha Nair

font size

Mumbai: The nascent healthcare portals industry is up for a funding boost, given its attractiveness for private equity, or PE, and venture capital, or VC, investors, as well as the Unique Identification Number, or UID, project that will collate digital data on the nation’s population.

Web dose: Portals that maintain electronic health records could play a critical role as hospitals invest in improving data management.

“The holy grail in this space would be personal medical records,” says Alok Mittal, managing director at VC firm Canaan Advisors Pvt. Ltd, referring to the automation of hospital records, a possibility through the UID project.
The Apollo Hospitals group has offered to manage health records through the Nandan Nilekani-led Unique Identification Authority of India. It has also invested in a company called Health Highway that, according to group executives, connects doctors, hospitals and pharmacies who would be able to communicate with each other and access health records.
Sangita Reddy, executive director (operations) at Apollo Hospitals, cites the hypothetical case of a car accident victim being rushed to a hospital emergency room.
“You could physically identify who that person is but you wouldn’t know his blood group, his allergies or anything about his health,” Reddy says. “Whereas, if his UID number was linked to a UHID (unique healthcare identification number), and there was something called emergency access, you could go into that and identify his complete record. So, there are all kinds of instances as to how we could use this to help save lives and improve quality of care and reduce cost.”
Apollo Hospitals has written to the Unique Identification Authority and to the Knowledge Commission to link the Unique Identification Number with health profiles of those provided the ID number, and offered to manage the health records, Business Standard reported in August.
Formed this year, the authority under Nilekani, co-founder of software services firm Infosys Technologies Ltd, is tasked with building a database of details on every Indian citizen.
“A lot of hospitals are making a fair amount of investment in information technology for improving the efficiency of workflow management and data processing or management,” says Amit Chander, investment head (healthcare and education), Baring Private Equity Partners India Ltd.
Healthcare portals that maintain electronic health records will thus play a critical role.
The industry is divided into four broad categories: firms that maintain electronic health records such as Yoscare.in and Healthizen.com; those that provide diet, fitness and nutrition counselling such as NutritionVista.com; firms that are focussed on disease management such as Wellinformed.in; and online doctor-patient consultation firms such as Healthcare Magic and online health content firms such as WebMD in the US.
Some VC firms that invested in such firms early on include Accel Partners, which put $2.5 million (Rs11.68 crore) in HealthcareMagic in February, and Seedfund, which wagered $1 million on Healthizen.com in January last year.
The technology is already in use in Bangalore, where YosCare Technologies has launched smart cards that, when swiped at a hospital, fax the holder’s medical history to the hospital.
“We are already in talks with the RTO (road transport organization) in Karnataka to issue Yos smart cards as driving licences,” said Vijaya Verma, founder of YosCare Technologies.
Muralidharan Nair, partner (lifesciences practice), Ernst and Young Pvt. Ltd, said healthcare had caught the fancy of many investors given that healthcare reform is going to be big on state governments’ agendas.
“Also, in terms of demand assessment there is a lack of credible health information, so to have comprehensive health information and records system would be sought after,” he said, but added that healthcare portals would be an area of interest more for venture capital firms than private equity.
PE firms which provide growth capital are more likely to invest in hospitals or diagnostic centres, while VC firms are more likely to invest in technology-driven start-ups that they can associate with from the beginning.
“Companies which embrace this model (of maintaining electronic health records) first will be able to build a big brand around it,” says Chander. “Not only will it reduce the problem of data storage but later on when it (the model) is fully developed they can run analytics on the data and use it for preventive measures.”
Chander also points out that while the global marketplace is overcrowded, with US-based WebMd and Google Health being key players, India has the option of customizing content for local needs.
However, a number of obstacles still remain.
Kunal Sinha, founder of Healthcare Magic, which provides patients a 24/7 interface where they can chat live with a doctor, admits that starting off was not easy. “I had to convince doctors to work for a start-up rather than a hospital. They were on my (company’s) payroll. So, right from Day 1, it was capital intensive.”
Market and consumer acceptance is another issue. “The need to maintain health records is not immediate and important for people as of now, so it is difficult to educate them and make them aware,” says Anand Anupam, founder of Healthizen, which maintains electronic health records that can be accessed anywhere.
Tie-ups with insurance firms, such as the one that HealthCare Magic has with ICICI Lombard General Insurance Co. Ltd, are also critical, since this allows access to a much larger pool.
Healthizen provides value-added services such as diet planning or skin care to holders of specific policies of ICICI Lombard and Royal Sundaram Alliance Insurance Co. Ltd.
Low Internet penetration is another obstacle, but that is more easily overcome.
Chander argues that the mobile phone is to India what the Internet is to the US, and that an application that can be accessed via mobile phones would enable these portals to increase their reach.
http://64.74.118.102/2009/12/29203506/Healthcare-sites-may-see-a-fun.html

Apollo Hospitals to build medical health records repository

Our Bureau

Chennai, Sept. 18 Apollo Hospitals Enterprise Ltd is “keen to be pioneers” in establishing a National Electronic Medical Records repository. The repository will store all medical details of a person from his birth to death, according to Ms Sangitha Reddy, Executive Director, Apollo Hospitals.
Addressing a press conference here on Thursday, Ms Reddy said access to medical records is essential to help patients in emergencies.
Universal id

Recently, the Chairman of the Apollo group, Dr Pratap Reddy, had spoken of a project that would give each of Apollo’s patients a unique Universal Hospital Identification Number (UHIN). The number would enable any doctor anywhere in the world to access the medical history of the patient. Dr Reddy had said that Apollo was working with Tata Consultancy Services for the project.
The repository would be the storage point from where the UHIN would access the records.
Ms Reddy observed that in India, one could transfer money electronically, but there was no system of transferring medical records.
Aragonda project

Addressing the media, Dr Reddy said that Apollo Hospitals would set up an integrated Health Knowledge City in Aragonda, Andhra Pradesh at an investment of about Rs 1,000 crore.
He said that the Apollo would partner with a couple of players to develop the Apollo Aragonda Health Knowledge City in 100 acres. It would have an integrated facility with simulation of lab, classroom, hospital, medical college and residential.
Industry forecast

According to a McKinsey study the Indian healthcare industry is expected to grow $190 billion in the next two decades. To meet this demand the country would require trained medical workforce, cheaper technology and better infrastructure. At present, India has about 5 lakh doctors and 7.3 lakh nurses, but the country requires an additional 6.71 lakh doctors and 18.7 lakh nurses.
http://www.thehindubusinessline.com/2008/09/19/stories/2008091951890200.htm

On Thu, Dec 2, 2010 at 1:02 PM, Savio Pereira <saviopereira7@gmail.com> wrote:

'Medical Record Must Remain Legible'
It covered topics highlighting the challenges, elucidations and policies surfacing within the healthcare sector related to medical records and health information management
The 10th Annual National Conference on 'Health Information, Medico Legal Management and Documentation' was held on 9th and 10th of April at Aditya Birla Memorial Hospital, Pune. This two-day conference organised by Aditya Birla Memorial Hospital was graced by the stalwarts and experts from medical and legal fraternity all over India. It covered topics highlighting the challenges, elucidations and policies surfacing within the healthcare sector related to medical records and health information management. The topics were broad ranged, and provided information about the primary concerns and issues within the healthcare systems nationally as well as globally.
Day I

Dr SP Singh

Dr Suganthi Iyer

Ranjith R Menon

Dr Virendar Pal Singh

The first session of the seminar was on challenges in EMR implementation and international healthcare documentation. The first speaker Dr GD Mogli, Sr Consultant eHealth Management, HEARTCOM INC. (USA) spoke on challenges of HIM professionals in EHR implementation in 21st century. "Having the uninterrupted blessings of policy/decision makers, the challenge in front of HIM professionals is to take the lead in transforming manual records to electronic or paperless by planning, organising, directing, implementing and evaluating to ensure the EHR system is implemented as planned and functioning effectively and efficiently. The electronic health record should meet aforesaid characteristics scrupulously, and then only, one can be sure that overwhelming and comprehensively the expected results could be accomplished," said Dr Mogli. He further said that if EHR to occur in any institution, local, or state, or federal level, there is a need for fundamental shift in 'attitude', awareness, habits and capabilities in the area of privacy and security.
The next speaker T Nithiya Kirubakaran, Manager - Medical Records, NMC Specialty Hospital, Abu Dhabi, UAE spoke on 'International Healthcare Documentation and Common Practices'. Nithiya said that hospitals should improve the safety of using medications and medical devices. Complete assessment of the patient includes medical, nursing and paramedical assessment. Pain assessment is given more importance and it should be documented in the records. Patient and family members' education regarding the use of medications and medical devices is crucial too. The hospital should adopt currently published and generally accepted hand hygiene guidelines. "Medical record must remain legible by using a single line to score out the information to be corrected. Medical Records must not include abbreviations other than those approved, published and made available to all staff," added Nithiya.
Dr SP Singh, CEO, Aditya Birla Memorial Hospital, Pune spoke on role of health records in accreditation. "Accreditation has improved public trust in the hospital and provides a safe and efficient work environment that contributes to employee satisfaction. In such a scenario, health information and medico legal management and documentation which is an evolving area in the industry in India, needs the attention of experts," he said.
Ranjith R Menon, Co-Founder & Senior Consultant, Isos Consultancy Services, Bangaluru gave a presentation on the role of medical records in quality assurance. Speaking on what needs to change at the medical records management level, he said, "Hospitals must invest in health information processes. If you do not classify and code; your data is worthless. Health information management doesn't mean IT, it means robust records management. Retrieving / turnaround time of our case sheets (Record Room to Physicians Desk) is not a QI worth tracking; how you use your patient care related data scientifically is the true measure of how good your quality programme."
The second session was on forensic nursing documentation and legal issues in medical records documentation. Dr Ajay Patil, Medico Legal Consultant, Medi-shield, Mumbai, while speaking on forensic nursing documentation, said, "Nursing document is an important link for understanding the untowered/ unexpected/ unexplained event in the treatment. In views of this, nursing document should be precise, prompt and with accuracy." He said that there are many tools used for client documentation, including worksheets, patient care plans, flow sheets and checklists, care maps, clinical pathways and monitoring strips. These tools may be written or electronic in format. Regardless of the tool used, pertinent information specific to an individual client resides within the client's health record.
The next speaker Dr Suganthi Iyer, Assistant Director (Legal & Medical), Hinduja Hospital, Mumbai threw light on the legal aspects of medical records. Said Dr Iyer, "Medical records are medico-legal documents and a doctor can be crossed-examined against the same. However, it is a strong evidence of proof of administration of standard medical care, provided documentation is complete." D Sanna Veerabhadrappa, Medical Record Officer, VIMS, Bellary spoke on statutory acts, rules and regulations for health records. He said that a resolution is to be passed at the end of the conference of 'International Healthcare Documentation and Common Practices' for the destruction of records which are more than 10 years old. A sufficient and specified space should be provided to the professionals of medical records department wherever they exist, all over India.
Niranjan Kumar Ramakrishnan, Chief Operating Officer, MEDTECH Health Solutions Private limited, Chennai spoke on clinical data integration. While talking on prerequisites for clinical data, he said that medical data is complex and requires precision. Standard health vocabulary is required to ensure consistency and interoperability. National standards for record structures, data formats, and protocols used to exchange information. Various standards development organisations have emerged to classify and organise health information, but national standards have yet to emerge.
The third session was on EMR privacy and strengthening Public Health Information System. Madhu Mohan Maddirala, Medical Records Officer, Tata Memorial Centre, Advanced Centre for Treatment, Research & Education in Cancer (ACTREC) spoke on medico-legal and EMR privacy. "Data are not of same utility and importance. It varies from one another on the basis of utility. So we require framing separate categories of data having different utility values as the US have. Moreover the provisions of IT Act deal basically with extraction of data, destruction of data etc," said Maddirala.
Next speaker Rajesh Kumar Sinha, Associate Professor, Department of Health Information Management, Manipal College of Allied Health Sciences, Manipal University, Manipal spoke on 'Strengthening Public Health Information System- Needs, Challenges and Strategies for success'. "A good health information system should present and disseminate data in appropriate formats for all audiences. Sound health information is a global public good and requires public and media support to ensure continued investment," said Sinha. Dr Vinoy Singh, Head - Health Informatics, Srishti Software Applications Pvt Ltd, Bangaluru spoke on 'Hospital Management to Healthcare Management'. Public Healthcare is promotion and protection of health at cohort level, through organised efforts of society. It is managed by public institutions and is usually led by Government. Talking about eHealth he said that it can significantly and positively change the way health services are delivered. Other key benefits achieved through a comprehensive eHealth strategy are improved health care quality, safety, and outcomes; increased service efficiency, productivity, and cost effectiveness and enhanced service availability and satisfaction for citizens, patients, and providers. Boser Raja, Centre Head, Vasan Eye Care Hospitals, Bangaluru gave a presentation on employee motivation and benefits of EMR and its implementation process.
Day II

Dr Rajendra Bangal

Dr GD Mogli

Dr Swati Gadgil

Dr Arjun Rajagopalan

The second day started with the session on skills and standards for auditing health records, statutory rules and regulations and forensic medical documentation. Mallika Kothandaraman, Medical Records Officer, JIPMER, Puducherry spoke on improving documentation skills and standards by auditing medical records. "Documented data used for decision making about a given individual in providing clinical care must be of far greater accuracy and completeness rather than for administrative purpose. Databases used for clinical decision making in describing an individual, should describe accurately about the details required for decision making. For instance, missing or out-of-date data or files that commingle data for more than one individual under single identifier have grave potential for harm," said Mallika.
Dr G D Mogli, Sr Consultant eHealth Management, HEARTCOM INC. (USA) gave a presentation on documentation standards and auditing methods for evaluation of medical care. "One of the foremost important ingredients to have a good documentation system in the hospital or health institution, is to have a well designed with appropriate content -standardised and rationalised medical records forms; not more, not less philosophy not only meets the needs of healthcare providers but also the needs of administration and other associated agencies including insurance and legal," said Dr Mogli.
Next speaker was Vandana Aravind, Asst Professor, Padmashree College of Hospital Administration, Bangaluru. Dr Rajendra Bangal, Medico Legal Consultant, Medishield, Mumbai spoke on 'Forensic Statutory Documentation'. "The forensic statutory documentation comprises of all documents written or printed to be produced before court of law for examination during the course of trial. Document means, any matter expressed or described upon a substance by means of letters, figures or marks, or by more than one of those means, intended to be used, or which may be used, for the purpose of recording that matter," said Dr Bangal.
The next session was on forensic documentation of injuries in a Trauma cases and role of medical records in medico legal cases. Dr Virendar Pal Singh, Medico-legal Consultant & Assoc. Prof, Forensic Medicine, Dayanand Medical College & Hospital, Ludhiana spoke on forensic documentation of injuries in a trauma case. Dr Singh said that the preparation of a medico-legal report is a task that should be approached with a desire to accurately communicate the clinical situation encountered. Guidelines for medico-legal reports and checklist should be followed while documenting and interpreting the injuries. A structured format and objective opinion will enhance both the reliability and accuracy of the report.
Raju Yohunna, Junior Medical Record Officer, AIIMS, Delhi, said, " Medico-legal case have to be dealt with properly prevailing guidelines therefore prepare a manual, give orientation to the staff dealing with MLCs and do proper documentation."
Dr Swati Gadgil, Director Ishwar Hospital, Mumbai spoke on ethical issues and documentation. "Any act which is illegal is definitely unethical and thus the ethics and list of professional misconduct for medical professionals in India are defined in the Indian Medical Council Act 1956 and Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The regulations were amended in 2003, 2004 and latest on 10th of December 2009, catering to the needs of the changing times. These regulations extensively cover the guiding principles, which any medical professional is to follow," said Dr Gadgil.
Dr Arjun Rajagopalan, Trustee & Medical Director, HOD - Surgery, Sundaram Medical Foundation, Chennai spoke on the impact of IT on healthcare. Said C Govindarajan, President (HERAI), "Winds of change have swept through the Indian Hospital scenario in the recent years and the medical records management is not an exception to it. The advancement in IT, stringent quality control measures in accreditation process of the healthcare institutions and legal implications have made it imperative for the maintenance of medical records in each and every hospital."
For the past eleven years, the national seminar has attracted around 1,000 doctors, lawyers and other healthcare professionals from various verticals of the healthcare sector including hospitals, pharma, insurance, IT, manufacturing units, CROs, NGOs, public/ private institutions and organisations from all over India and abroad.
http://www.expresshealthcare.in/201005/market19.shtml
http://www.indianjournals.com/ijor.aspx?target=ijor:mlu&volume=9&issue=2&article=006
Healthcare sites may see a funding boost
Possibility of electronic health records linked to the unique ID project make medical portals attractive to investors
Shraddha Nair
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Mumbai: The nascent healthcare portals industry is up for a funding boost, given its attractiveness for private equity, or PE, and venture capital, or VC, investors, as well as the Unique Identification Number, or UID, project that will collate digital data on the nation’s population.

Web dose: Portals that maintain electronic health records could play a critical role as hospitals invest in improving data management.

“The holy grail in this space would be personal medical records,” says Alok Mittal, managing director at VC firm Canaan Advisors Pvt. Ltd, referring to the automation of hospital records, a possibility through the UID project.
The Apollo Hospitals group has offered to manage health records through the Nandan Nilekani-led Unique Identification Authority of India. It has also invested in a company called Health Highway that, according to group executives, connects doctors, hospitals and pharmacies who would be able to communicate with each other and access health records.
Sangita Reddy, executive director (operations) at Apollo Hospitals, cites the hypothetical case of a car accident victim being rushed to a hospital emergency room.
“You could physically identify who that person is but you wouldn’t know his blood group, his allergies or anything about his health,” Reddy says. “Whereas, if his UID number was linked to a UHID (unique healthcare identification number), and there was something called emergency access, you could go into that and identify his complete record. So, there are all kinds of instances as to how we could use this to help save lives and improve quality of care and reduce cost.”
Apollo Hospitals has written to the Unique Identification Authority and to the Knowledge Commission to link the Unique Identification Number with health profiles of those provided the ID number, and offered to manage the health records, Business Standard reported in August.
Formed this year, the authority under Nilekani, co-founder of software services firm Infosys Technologies Ltd, is tasked with building a database of details on every Indian citizen.
“A lot of hospitals are making a fair amount of investment in information technology for improving the efficiency of workflow management and data processing or management,” says Amit Chander, investment head (healthcare and education), Baring Private Equity Partners India Ltd.
Healthcare portals that maintain electronic health records will thus play a critical role.
The industry is divided into four broad categories: firms that maintain electronic health records such as Yoscare.in and Healthizen.com; those that provide diet, fitness and nutrition counselling such as NutritionVista.com; firms that are focussed on disease management such as Wellinformed.in; and online doctor-patient consultation firms such as Healthcare Magic and online health content firms such as WebMD in the US.
Some VC firms that invested in such firms early on include Accel Partners, which put $2.5 million (Rs11.68 crore) in HealthcareMagic in February, and Seedfund, which wagered $1 million on Healthizen.com in January last year.
The technology is already in use in Bangalore, where YosCare Technologies has launched smart cards that, when swiped at a hospital, fax the holder’s medical history to the hospital.
“We are already in talks with the RTO (road transport organization) in Karnataka to issue Yos smart cards as driving licences,” said Vijaya Verma, founder of YosCare Technologies.
Muralidharan Nair, partner (lifesciences practice), Ernst and Young Pvt. Ltd, said healthcare had caught the fancy of many investors given that healthcare reform is going to be big on state governments’ agendas.
“Also, in terms of demand assessment there is a lack of credible health information, so to have comprehensive health information and records system would be sought after,” he said, but added that healthcare portals would be an area of interest more for venture capital firms than private equity.
PE firms which provide growth capital are more likely to invest in hospitals or diagnostic centres, while VC firms are more likely to invest in technology-driven start-ups that they can associate with from the beginning.
“Companies which embrace this model (of maintaining electronic health records) first will be able to build a big brand around it,” says Chander. “Not only will it reduce the problem of data storage but later on when it (the model) is fully developed they can run analytics on the data and use it for preventive measures.”
Chander also points out that while the global marketplace is overcrowded, with US-based WebMd and Google Health being key players, India has the option of customizing content for local needs.
However, a number of obstacles still remain.
Kunal Sinha, founder of Healthcare Magic, which provides patients a 24/7 interface where they can chat live with a doctor, admits that starting off was not easy. “I had to convince doctors to work for a start-up rather than a hospital. They were on my (company’s) payroll. So, right from Day 1, it was capital intensive.”
Market and consumer acceptance is another issue. “The need to maintain health records is not immediate and important for people as of now, so it is difficult to educate them and make them aware,” says Anand Anupam, founder of Healthizen, which maintains electronic health records that can be accessed anywhere.
Tie-ups with insurance firms, such as the one that HealthCare Magic has with ICICI Lombard General Insurance Co. Ltd, are also critical, since this allows access to a much larger pool.
Healthizen provides value-added services such as diet planning or skin care to holders of specific policies of ICICI Lombard and Royal Sundaram Alliance Insurance Co. Ltd.
Low Internet penetration is another obstacle, but that is more easily overcome.
Chander argues that the mobile phone is to India what the Internet is to the US, and that an application that can be accessed via mobile phones would enable these portals to increase their reach.
http://64.74.118.102/2009/12/29203506/Healthcare-sites-may-see-a-fun.html

On Thu, Dec 2, 2010 at 12:44 PM, Savio Pereira<saviopereira7@gmail.com> wrote:

SYMPOSIUM

Year : 2009 |  Volume : 25 |  Issue : 3 |  Page : 384-388

Medical records and issues in negligence

Joseph Thomas
Department of Urology, Kasturba Medical College, Manipal 576 104, India

Date of Web Publication 1-Oct-2009

Correspondence Address:
Joseph Thomas
Kasturba Medical College, Manipal 576 104
India

DOI: 10.4103/0970-1591.56208
PMID: 19881136

   Abstract

It is very important for the treating doctor to properly document the management of a patient under his care. Medical record keeping has evolved into a science of itself. This will be the only way for the doctor to prove that the treatment was carried out properly. Moreover, it will also be of immense help in the scientific evaluation and review of patient management issues. Medical records form an important part of the management of a patient. It is important for the doctors and medical establishments to properly maintain the records of patients for two important reasons. The first one is that it will help them in the scientific evaluation of their patient profile, helping in analyzing the treatment results, and to plan treatment protocols. It also helps in planning governmental strategies for future medical care. But of equal importance in the present setting is in the issue of alleged medical negligence. The legal system relies mainly on documentary evidence in a situation where medical negligence is alleged by the patient or the relatives. In an accusation of negligence, this 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 is disheartening to note that inspite of knowing the importance of proper record keeping it is still in a nascent stage in India. It is wise to remember that "Poor records mean poor defense, no records mean no defense". Medical records include a variety of documentation of patient's history, clinical findings, diagnostic test results, preoperative care, operation notes, post operative care, and daily notes of a patient's progress and medications. A properly obtained consent will go a long way in proving that the procedures were conducted with the concurrence of the patient. A properly written operative note can protect a surgeon in case of alleged negligence due to operative complications. It is important that the prescription for drugs should be legible with the name of the patient, date, and the signature of the doctor. An undated prescription can land a doctor in trouble if the patient misuses it. There are also many records that are indirectly related to patient management such as accounts records, service records of the staff, and administrative records, which are also useful as evidences for litigation purposes. Medical recording needs the concerted effort of a number of people involved in patient care. The doctor is the prime person who has to oversee this process and is primarily responsible for history, physical examination, treatment plans, operative records, consent forms, medications used, referral papers, discharge records, and medical certificates. There should be proper recording of nursing care, laboratory data, reports of diagnostic evaluations, pharmacy records, and billing processes. This means that the paramedical and nursing staff also should be trained in proper maintenance of patient records. The medical scene in India extends from smaller clinics to large hospitals. Medical record keeping is a specialized area in bigger teaching and corporate hospitals with separate medical records officers handling these issues. However, it is yet to develop into a proper process in the large number of smaller clinics and hospitals that cater to a large section of the people in India.

Keywords: Medical records, medical negligence

How to cite this article:
Thomas J. Medical records and issues in negligence. Indian J Urol 2009;25:384-8

How to cite this URL:
Thomas J. Medical records and issues in negligence. Indian J Urol [serial online] 2009 [cited 2010 Dec 2];25:384-8. Available from: http://www.indianjurol.com/text.asp?2009/25/3/384/56208

   Methods of Record Keeping

The traditional method of keeping records that is followed in most of the hospitals across India is the manual method involving papers and books. There are serious limitations of manual record keeping including the need for large storage areas and difficulties in the retrieval of records. However, it is legally more acceptable as a documentary evidence as it is difficult to tamper with the records without detection. The present era has seen the computerization of medical records that are neat and tidy, and can be easily stored and retrieved. However, the possibility of easy manipulation without detection is a serious concern; hence, they may not be universally accepted at face value as a documentary evidence. If it is demanded during court proceedings, it is the duty of the hospital and the doctor to prove that these computer documents were not altered. Another major concern is maintaining confidentiality of the patient records as the patient can hold the doctor and the hospital negligent for breaking confidentiality of his medical records. Video tapes of endoscopic procedures, electronic fetal heart monitor charts, continuous ECG or Pulse oximeter charts could become important evidence in a court of law. Electronic medical recording is in the process of evolution and is being increasingly used. Though the total avoidance of paper records is the ideal aim, there are many areas that need to be sorted out. For example, an important issue is the electronic signature of the patient, doctors, and witnesses on informed consent forms.

Discharge notes
This is a crucial piece of evidence regarding the inpatient treatment of a patient. It is important to give due importance to making a proper discharge summary as this is the summary document that will be kept by the patient which reflects the treatment received. The discharge summary should mirror the case notes of the patient records with a brief summary, relevant investigations, and operative procedures. The dates of admission, discharge, and surgery are useful when the sequence of events is an important issue in litigation later. 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. As a urologist, it is common to see patients who are not aware of stents that should have been removed at its appropriate time, though mentioned properly in the discharge summary. The discharge summary 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 favor 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.

Referral notes
Referral notes are an important component of patient records. They should include the date and time of issue, the patient's general condition, cause of reference, and the course of action to be taken. It is wise to keep a duplicate copy of the referral note 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.

   Confidentiality of Medical Records

Medical records can be used as a personal or impersonal document. 1) Personal document - this information is confidential and should not be released without the consent of the patient except in some specific situations. 2) Impersonal document - the record looses its identity as a personal document and patient permission is not required. These records could be used for research purposes. Confidentiality is an important component of the rights of the patient. The hospital is legally bound to maintain the confidentiality of the personal medical records. The patient can claim negligence against the hospital or the doctor for a breach of confidentiality. However, there are certain situations where it is legal for the authorities to give patient information. They are as follows: 1) during referral, 2) when demanded by the court or by the police on a written requisition, 3) when demanded by insurance companies as provided by the Insurance Act when the patient has relinquished his rights on taking the insurance, and 4) when required for specific provisions of Workmen's Compensation cases, Consumer Protection cases, or for Income tax authorities. The maintenance of confidentiality is an important issue in the era of electronic data storage. There should be checks in place so that only those who are authorized can access the patient data.

The impersonal documents have been used for research purposes as the identity of the patient is not revealed. Though the identity of the patient is not revealed, the research team is privy to patient records and a cause of concern about the confidentiality of information. Historically, such research has been exempt from an ethics review and researchers have not been required to obtain informed consent from patients before using their records. Recently, a need has been felt to regulate the use of medical records in research, effectively restricting the manner in which this type of research is conducted. An ethics review is required for using the patient data. However this is not widely followed all over India.

   Categories of Medical Records

The different categories of medical records are as follows:

Certain records must be given to the patient as a matter of right. Discharge summary, referral notes, and death summary in case of natural death are important documents for the patient. Hence, these have to be given without charge for all including patients who leave against medical advice. The hospital bill cannot be tied up with these sensitive documents that are necessary for continuing patient care. Thus, the above documents cannot be legally refused even when the hospital bill has not been paid.

Certain records may be issued after the patient or authorized attendant fulfills the due requirements as stipulated by a hospital. This requires a formal application to the hospital requesting for the records. It is necessary that the hospital bills are cleared and the necessary processing fee has been paid. The documents in this group include copies of inpatient files, records of diagnostic tests, operation notes, videos, medical certificates, and duplicate copies for lost documents. It is important that the duplicate copies should be marked appropriately. It is not unusual for an unscrupulous patient to use it for multiple insurance claims without the knowledge of the doctor.

Certain records cannot be given to patients without the direction of the Court. The outpatient file, inpatient file, and files of medico-legal cases including autopsy reports cannot be handed over to the patient or relatives without the direction of the Court. But if these medico-legal cases are being referred to another center for management, copies of records could be given. However, X-rays are given only after a written undertaking by the patient or relatives that these will be produced in the Court as and when required.

   Medical Council of India Guidelines on Medical Records

The issue of medical record keeping has been addressed in the Medical Council of India Regulations 2002 guidelines answering many questions regarding medical records. The important issues that have been addressed are as follows:

Maintain indoor records in a standard proforma for 3 years from commencement of treatment (Section 1.3.1 and Appendix 3).

Request for medical records by patient or authorized attendant should be acknowledged and documents issued within 72 hours (Section 1.3.2).

Maintain a register of certificates with the full details of medical certificates issued with at least one identification mark of the patient and his signature (Section 1.3.3).

Efforts should be made to computerize medical records for quick retrieval (Section 1.3.4).

   How long should Medical Records be Preserved?

There are no definite guidelines in India regarding how long to retain medical records. The hospitals follow their own pattern retaining the records for varied periods of time. Under the provisions of the Limitation Act 1963 and Section 24A of the Consumer Protection Act 1986, which dictates the time within which a complaint has to be filed, it is advisable to maintain 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. It is important to note that in pediatric cases a medical negligence case can be filed by the child after aquiring the age of majority.The 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. It is necessary that the Government frames guidelines for the duration for which medical records are preserved by the hospitals so that hospitals are protected from unnecessary litigation in issues of medical records.

The provisions of specific Acts like the Pre Conception Prenatal Diagnostic Test Act, 1994 (PNDT), Environmental Protection Act, etc. necessitate proper maintenance of records that have to be retained for periods as specified in the Act. Section 29 of the PNDT Act, 1994 requires that all the documents be maintained for a period of 2 years or until the disposal of the proceedings. The PNDT Rules, 1996 requires that when the records are maintained on a computer, a printed copy of the record should be preserved after authentication by the person responsible for such record.

   Ownership of Medical Records

An important issue of dispute between the patient and the treating hospital is about the ownership of the medical records. By and large medical records are the property of the hospitals and it is the responsibility of the hospitals to maintain it properly. The hospitals and the doctors have to be careful with medical records as these can be stolen, manipulated, and misused for malafide reasons by any interested parties. Hence, the records should be in safe custody. It is the primary responsibility of the hospital to maintain and produce patient records on demand by the patient or appropriate judicial bodies. However, it is the primary duty of the treating doctor to see that all the documents with regard to management are written properly and signed. An unsigned medical record has no legal validity. The patient or their legal heirs can ask for copies of the treatment records that have to be provided within 72 hours. The hospitals can charge a reasonable amount for the administrative purposes including photocopying the documents. Failure to provide medical records to patients on proper demand will amount to deficiency in service and negligence.

   Summoning Medical Records by Courts

Medical records are acceptable as per Section 3 of the Indian Evidence Act, 1872 amended in 1961 in a court of law. These are considered useful evidence by the courts as it is accepted that documentation of facts during the course of treatment of a patient is genuine and unbiased. Medical Records that are written after the discharge or death of a patient do not have any legal value. Erasing of entries is not permitted and is questionable in Court. In the event of correction, the entire line should be scored and rewritten with the date and time.

Medical records are usually summoned in a court of law in the following cases:

Criminal cases for proving the nature, timing, and gravity of the injuries. It is considered important evidence to corroborate the nature of the weapon used and the cause of death

Road traffic accident cases under the MACT Act for deciding on the amount of compensation

Labor courts in relation to the Workmen's Compensation Act

Insurance claims to prove the duration of illness and the cause of death

Medical negligence cases- these can be in criminal courts when the charge against the doctor is for criminal negligence or under the Consumer Protection Act for deficiency in the doctor's or hospital's care

It is usual to summon a doctor to appear in court to testify and to bring all the medical documents. When the court issues summons for medical records, it has to be honored and respected as it is a constitutional obligation to assist in the administration of justice. The records can also be produced in court by the medical records officer of the hospital. If the doctor is required to be present for giving evidence based on the medical records, he has to be present in the court to give evidence. The court may require these documents to be submitted for which a record is issued by the court. However, if the records are required for continuation of the medical treatment of the patient, copies can be kept by the hospital.

   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.

The National Commission had held that there was no question of negligence for failure to supply the medical records to patients unless there is a legal duty on the hospital to give the records. The alleged hospital had provided a detailed discharge summary to the patient.^[1]However, the Bombay High Court held that doctors cannot claim confidentiality when the patient or his relatives demand medical records.^[2]With the enforcement of the MCI Regulations, 2002 it has been held without confusion that the patient has a right to claim medical records pertaining to his treatment and the hospitals are under obligation to maintain them and provide them to the patient on request.

The hospital and doctor were guilty of deficiency in service as case records were not produced before the court to refute the allegation of a lack of standard care.^[3] 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.^[4]

Not producing medical records to the patient prevents the complainant from seeking an expert opinion. 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.^[5] The State Commission held that there was negligence as the case sheet did not contain a proper history, history of prior treatment and investigations, and even the consent papers were missing.^[6]

The State Commission held that failure to deliver X-ray films is deficient service. The patient and his attendants were deprived of their right to be informed of the nature of injury sustained.^[7] The State Commission disbelieved the evidence of the surgeon because only photocopies were produced to substantiate the evidence without any plausible explanation regarding the absence of the original.^[8]

The allegation of not informing the possibility of vocal cord palsy was negated by the detailed written consent that showed that it was explained properly and consented.^[9] The allegation of the patient regarding negligence of the doctor was rejected.

The allegation of tampering with the operation notes was negated by the State Commission in a case of intraoperative death as the complainant could not prove the allegation.^[10]

The hospital was held vicariously liable for the negligent action of the doctor on the basis of the bill showing the professional fees of the doctor and the discharge certificate under the letterhead of the hospital signed by the doctor.^[11] The State Commission held negligence on the basis of the records, which seemed to be manipulated.^[12] Issues of tampering of medical records need detailed examination in a civil court rather that in Consumer Court.^[13] The National Commission in another case 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.^[14]

Not maintaining confidentiality of patient information can be an issue of medical negligence. The HIV status of a patient was known to others without the consent of the patient.^[15]

   References

1. Poona Medical Foundation v Marutturao Tikare. 1995 (1) CPR 661(NC).

2. Raghunath Raheja v The Maharashtra Medical Council and Ors AIR 1996 Bombay 198.

3. Kanaiyalal Ramanlal Trivedi v Dr. Satyanarayan Vishwakarma 1996 (3) CPR 24 (Guj); I (1997) CPJ 332 (Guj); 1998 CCJ 690 (Guj)

4. S.A.Quereshi v Padode memorial Hospital and Research Centre II (2000) CPJ 463 (Bhopal).

5. Dr. Shyam Kumar v Rameshbhai, Harmanbhai Kachiya, 2002 (1) CPR 320, I (2006) CPJ 16 (NC).

6. Force v. M Ganeswara Rao . 1998 (3) CPR 251; 1998 (1) CPJ 413 (AP SCDRC).

7. V P Shanta v. Cosmopolitan Hospitals (P) Ltd 1997 (1) CPR 377 (Kerala SCDRC).

8. Devendra Kantilal Nayak v Dr. Kalyaniben Dhruv Shah 1996 (3) CPR 56; I (1997) CPJ 103; 1998 CCJ 544 (Guj).

9. C Anjani Kumar v Madras Medical Mission 1998 (2) CPR (Chennai); I (1998) CPJ 533 (Chennai); 1998 CTJ 504 (CP) (SCDRC); 1999 CCJ 915 (TN).

10. Sethuraman Subramaniam Iyer v Triveni Nursing Home 1997 (2) CPR 144 (NC); I (1998) CPJ 10 (NC); 1998 CTJ 7 (CP) (NCDRC); 1998 CCJ 1532 (NC).

11. P.P. Ismail v K.K. Radha 1997 (2) CPR 171 (NC); I(1998) CPJ 16 (NC); (1997) 5 CTJ 685 (CP) (NCRDC); 1999 CPJ 99 (NC).

12. Nihal Kaur v. Director, PGI, Chandigarh . 1996 (3) CPJ 112 (Chandigarh (U.T.) CDRC).

13. Harenbalal Das v Dr. Ajay Paul, 2001 (2) CPR 498

14. Meenakshi Mission Hospital and Research Centre v. Samuraj and Anr., I(2005) CPJ 33 (NC)

15. Dr. Tokugha Yeptomi V Appollo Hospital Enterprises Ltd and Anr III (1998) CPJ 132 (SC).

http://www.indianjurol.com/article.asp?issn=0970-1591;year=2009;volume=25;issue=3;spage=384;epage=388;aulast=Thomas

Rules regarding retention of indoor medical records
Posted by: “Dr.M.C. Gupta” mcgupta44@gmail.com mcgupta44
Sat Sep 11, 2010 11:10 am (PDT)
*Rules regarding retention of indoor medical records*
* *
*QUESTION—Is the MCI regulation that physicians need to retain documents for 3 years applicable to institutions also? If not, what are the rules for institutions?
*ANSWER–*
1—One should not confuse the scope of MCI regulations. The MCI concerns only individual practitioners and has no jurisdiction over institutions.
2– As per Regulation 1.3.1 of the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002, “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”.
This regulation would apply in case of those patients whom you might be treating / operating in hospitals / nursing homes. Please note that the
above regulation concerns only indoor records.
3–The proforma as per Appendix 3 referred above has the following items:
“Name of the patient:
Age :
Sex :
Address :
Occupation :
Date of 1st visit :
Clinical note (summary) of the case:
Prov. : Diagnosis :
Investigations advised with reports:
Diagnosis after investigation:
Advice :
FOLLOW UP:
Date(s):
Observations:
Signature in full ………………………….
Name of Treating Physician”
4—There are no legal rules for institutions. Different institutions may have their own guidelines. The guidelines for the government hospitals have been
published by the DGHS vide letter No. 10-3/68-MH dated 31-8-68 as follows:
For inpatient medical records (case sheets)……………….10 years
For medico-legal registers…………………………………….10 years
For outpatient records………………………………………….5 years
The above requirement can be found in the “Hospital Manual” published in 2002 by the Directorate General of Health Services, MOHFW, GOI, in chapter
12 titled “Medical Record Services”.
http://aimdda.wordpress.com/2010/09/12/rules-regarding-retention-of-indoor-medical-records/

http://delhimedicalcouncil.nic.in/mcihiv.pdf

http://www.thaindian.com/newsportal/uncategorized/income-tax-returns-medical-records-not-under-rti-court_100302797.html

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Res ipsa loquitur

Res ipsa loquitur

http://en.wikipedia.org/wiki/Res_ipsa_loquitur

In the common law of negligence, the doctrine of res ipsa loquitur (Latin for "the thing speaks for itself") states that the elements of duty of care and breach can be sometimes inferred from the very nature of the accident, even without direct evidence of how any defendant behaved. Although modern formulations differ by jurisdiction, the common law originally stated that the accident must satisfy the following conditions:

... a "duty" exists for a person to act "reasonably"; and

... a "breach" of this duty occurs because a person acted outside this duty, or "unreasonably"; and

... there was "causation in fact"...the result would not have occurred "but for" the "breach" of this duty; and

... there were actual damages suffered by the plaintiff who did nothing wrong (i.e., no contributory negligence).

Upon a proof of res ipsa loquitur, the plaintiff need only establish the remaining two elements of negligence—namely, that the plaintiff suffered damages, of which the accident was the legal cause.

http://www.duhaime.org/LegalDictionary/R/ResIpsaLoquitur.aspx

Generally, in tort, the mere fact of an accident is not proof of negligence. But in some cases, negligence is presumed on the defendant since the object causing injury was in or under his or her control. This is the res ipsa loquitur doctrine.

Res ipsa loquitur is a rebuttable presumption rebutted by showing that the event was an inevitable accident and had nothing to do with the defendant’s responsibility of control or supervision.

Examples of res ipsa loquitur, not all of which can be assumed to apply today or in all jurisdictions, but which illustrate the doctrine:

Getting hit by a rock which flies off a passing dump truck;
A ship in motion collides with an anchored ship;
Damages occasioned by the collision of two trains of a same railway;
Hit or injured in an attack by a known-to-be vicious domestic dog;
Hit from cargo falling from a crane; or
Hit by bricks falling from a private bridge.

These events imputes negligence (res ipsa loquitur) and can only be defeated if the defendant can show that the event was a total and inevitable accident.

Judicial consideration of the doctrine has, and continues to this day to be, varied.

In the US Supreme Court, 1912, San Juan Light & Transit Co. v. Requena (224 US 89):

"When a thing which causes injury, without fault of the injured person, is shown to be under the exclusive control of the defendant, and the injury is such as, in the ordinary course of things, does not occur if the one having such control uses proper care, it affords reasonable evidence, in the absence of an explanation, that the injury arose from the defendant's want of care."

In 1947, Jesionowski v. Boston & MRR (329 US 452) purported to:

"... cut through the mass of verbiage built up around the doctrine of res ipsa loquitur, that (it) means that the facts of the occurrence warrant the inference of negligence, not that they compel such an inference; that they furnish circumstantial evidence of negligence where direct evidence of it may be lacking, but it is evidence to be weighed, not necessarily to be accepted as sufficient; that they call for explanation or rebuttal, not necessarily that they require; that they make a case to be decided by the jury, not that they forestall the verdict."

In 1998, Canada's Supreme Court (Justice Major), in Fontaine v ICBC (oddly indexed as "Fontaine v BC"), said that we cannot even continue to call it a "doctrine"; that it is "expired" and has only "limited use".

But other Canadian courts have been more receptive.

In a 1997 Alberta case which does not appear to have been published on the Internet (Naicken v City of Edmonton), Justice Langston of the Court of QB adopted these words at paras 28-32 (edited extract):

"The doctrine of res ipsa loquitur has its foundation in the concept that the defendant should not be able to thwart a legitimate claim by the plaintiff by means of his silence or his unilateral control over those matters which would otherwise provide evidence. Today the doctrine is generally accepted as having three elements....

• When the thing that inflicted the damage was under the sole management and control of the defendant, or someone for whom he is responsible or whom he has a right to control;

• The occurrence is such that it would not have happened without negligence. If these two conditions are satisfied it follows, on a balance of probability, that the defendant, or the person for whom he is responsible, must have been negligent. There is, however, a further negative condition;

• There must be no evidence as to why or how the occurrence took place. If there is, then appeal to res ipsa loquitur is inappropriate, for the question of the defendant's negligence must be determined on that evidence.

"The (first two) elements harken back to the historical roots of this doctrine.

"The remaining element relating to the drawing of an inference as to negligence, is in essence a common sense application of circumstantial evidence."

http://www.answers.com/topic/res-ipsa-loquitur

[Latin, The thing speaks for itself.] A rebuttable presumption or inference that the defendant was negligent, which arises upon proof that the instrumentality or condition causing the injury was in the defendant's exclusive control and that the accident was one that ordinarily does not occur in the absence of negligence.

Res ipsa loquitur, or res ipsa, as it is commonly called, is really a rule of evidence, not a rule of substantive law.

Negligence is conduct that falls below the standard established by law for the protection of others against an unreasonable risk of harm. In order to prevail in a negligence action, a plaintiff must establish by a preponderance of evidence that the defendant's conduct was unreasonable in light of the particular situation and that such conduct caused the plaintiff's injury. The mere fact that an accident or an injury has occurred, with nothing more, is not evidence of negligence. There must be evidence that negligence has caused the event. Such evidence can consist of direct testimony by eyewitnesses who observed the defendant's unreasonable conduct and its injurious result.

Negligence can also be established by circumstantial evidence when no direct evidence exists. Circumstantial evidence is evidence of one recognized fact or set of facts from which the fact to be determined can be reasonably inferred, because it is the logical conclusion that can be drawn from all the known facts. For example, skid marks at the scene of an accident are circumstantial evidence that a car was driven at an excessive speed. The reasoning process must be based upon the facts offered as evidence, together with a sufficient background of human experience, to justify the conclusion. Evidence that merely suggests the possibility of negligence is insufficient, since negligence must appear more likely than not to have occurred. This inference must cover all the necessary elements of negligence: that the defendant owed the plaintiff a duty, which the defendant violated by failing to act according to the required standard of conduct, and that such negligent conduct injured the plaintiff.

Res ipsa loquitur is one form of circumstantial evidence that permits a reasonable person to surmise that the most probable cause of an accident was the defendant's negligence. This concept was first advanced in 1863 in a case in which a barrel of flour rolled out of a warehouse window and fell upon a passing pedestrian. Res ipsa loquitur was the reasonable conclusion because, under the circumstances, the defendant was probably culpable since no other explanation was likely. The concept was rapidly applied to cases involving injuries to passengers caused by carriers, such as railroads, which were required to prove they had not been negligent. Res ipsa loquitur, as it is currently applied by nearly all of the fifty states, deals with the sufficiency of circumstantial evidence and, as in some states, affects the burden of proof in negligence cases.

Elements

Three basic requirements must be satisfied before a court can submit the question of negligence to the jury underres ipsa loquitur.

Inference of Negligence

The plaintiff's injury must be of a type that does not ordinarily occur unless someone has been negligent. This requirement, which is the inference of negligence, allows res ipsa to be applied to a wide variety of situations, such as the falling of elevators, the presence of a dead mouse in a bottle of soda, a human toe found in a wad of chewing tobacco, or a streetcar careening through a restaurant. Although many of the cases involve freakish and improbable situations, ordinary events, such as where a passenger is injured when a vehicle stops abruptly, will also warrant the application of res ipsa. Commercial air travel has become so safe in recent years that planes engaged in regularly scheduled commercial flights generally do not crash unless someone has been negligent. Vehicular accidents caused by a sudden loss of control, such as a car suddenly swerving off the road or a truck skidding on a slippery road and crossing into the wrong lane of traffic, justify the conclusion that such an event would not normally occur except for someone's negligence.

This inference of negligence does not mean that all other possible causes of the injurious event must be eliminated. A plaintiff using res ipsa to enable her case to go to the jury must prove that the defendant's negligence is the most probable cause of her injuries. The particular nature of the defendant's negligence need not be pinpointed. For instance, where a bottle of soda explodes in a supermarket immediately after its delivery by the bottler, the injured person does not have to prove that the bottler failed to notice a defect in the bottle or that the soda was overcarbonated. It is sufficient to establish that the explosion would not have occurred unless the bottler had been negligent.

Where the inference of negligence depends upon facts beyond the common knowledge of jurors, expert testimony is necessary to furnish this information. Such testimony is usually presented in cases of professional negligence, such as medical malpractice. An expert witness can testify directly in regard to the inferred fact itself, such as when the expert testifies that the plaintiff's injury would not have occurred if the doctor had not been negligent.

Exclusive Control by the Defendant

The plaintiff's injury or damage must have been caused by an instrumentality or condition that was within the exclusive control of the defendant. Some courts interpret this requirement to mean that exclusive control or management must have existed at the time of the injury. This interpretation has led to harsh results. In one case, a customer sat down in a chair in a store while waiting for a salesperson. The chair collapsed and the customer was injured. The court denied recovery to the customer in her negligence action against the store because it found that the chair was not within the exclusive control of the store, but rather was under the exclusive control of the customer at the time of injury.

This application of the rule has been regarded as inflexible by many courts, since it severely restricts the type of case to which res ipsa can be applied. In response, many states prescribe that the negligence must occur while the defendant has control over the instrumentality. In the example of the exploding soda bottle, the negligence of the bottler occurred somewhere in the bottling process. The fact that the bottle was sitting on a supermarket shelf and was no longer in the immediate possession of the bottler does not prevent the reasonable conclusion that the injury resulted from the negligence of the bottler. The injured plaintiff must first show that the bottle was not cracked by mishandling after it left the plant of the bottler. This does not mean, however, that the plaintiff must account for every minute of the existence of the bottle from the time it left the plant. If the plaintiff can substantiate the fact of careful handling in general and the absence of unusual incidents, such as the deliberate tampering of the bottled goods by an unknown person, such facts would permit reasonable persons to conclude that the injury was more likely than not to have been caused by the defendant's negligence while he had exclusive control of the bottle.

Since there must be exclusive control by the defendant, res ipsa cannot be used against multiple defendants in a negligence case where the plaintiff claims he has been injured by the negligence of another. For example, a pedestrian is injured when he is struck by a car that had just collided with another vehicle. The pedestrian institutes a negligence action against one driver, and seeks to have res ipsa applied to his case. An inference of negligence does not arise from the mere fact of the collision, since neither driver is in exclusive control of the situation. If, however, one driver is cleared of fault by some specific evidence, the jury is justified in inferring that the injury was the result of the other driver's negligence.

The requirement of exclusive control by the defendant is not applied in cases involving vicarious liability or shared responsibility for the same instrumentality or condition. In one case, a person was injured when an elevator in which she was riding fell very rapidly. She brought a negligence action against both the owner of the building and the elevator company that manufactured the elevator and had the maintenance service contract for the building. The plaintiff relied completely on res ipsa. The jury found for the plaintiff since a falling elevator is not the type of accident that usually occurs without negligence, so that the negligence of those in control can be inferred. The service contract between the elevator company and the building owner established the fact that they exerted joint control over the elevator. The requirement of exclusive control by a defendant of the instrumentality causing injury does not mean that only a single entity has control. Where two or more defendants are acting jointly, the doctrine of res ipsacan be applied to establish their negligence.

Some state courts have departed from the requirement of exclusive control and applied res ipsa loquitur against multiple defendants. In one case, while an anesthetized patient was undergoing an operation for appendicitis, he suffered a traumatic injury to his shoulder. Res ipsa was applied against all of the doctors and hospital employees connected with the operation, although not all of them were negligent. The court based its decision on the special responsibility for the plaintiff's safety undertaken by everyone concerned.

Freedom from Contributory Negligence

The event in question must not have been attributable to any cause for which the plaintiff is responsible. The plaintiff must not have done anything that significantly contributed to the accident that caused the injury. In one case, a water skier was injured when the propeller of the boat that had been towing him struck his arm as the boat was attempting to pick him up. He sued the driver and the owner of the boat for negligence, which could be found ifres ipsa was applied. The plaintiff attempted to dive underwater when he saw the boat approaching him, but he was unsuccessful in escaping injury. The defendants claimed that the attempted dive caused the accident and, therefore,res ipsa was inapplicable.

The trial court accepted this argument, which was later rejected by the appellate court. The appellate court decided that the question of whether the attempted dive caused the accident should have been presented to the jury underres ipsa. It stated that a plaintiff may rely upon res ipsa loquitur even though he has participated in the events leading to the accident if the evidence excludes his conduct as the responsible cause. In light of the skier's testimony that he was about to be struck by the boat, as well as the testimony of other eyewitnesses, the jury could logically conclude that the attempted dive was not a cause of the accident.

Accessibility of Evidence

In addition to the three basic requirements, a few states apply res ipsa in negligence cases where the evidence of the facts of the event is more accessible to the defendant than to the plaintiff. In one state, for example, a plaintiff was injured when the bleacher section in which she was sitting collapsed during a basketball game under the management and supervision of the defendant high school athletic association. She sued the association for negligence under the doctrine of res ipsa. The appellate court, reviewing a verdict for the plaintiff, affirmed it because "the underlying reason for the res ipsa rule is that the chief evidence of the true cause of the injury is practically accessible to the defendant but inaccessible to the injured person."

The Effect of Res Ipsa

Res ipsa loquitur is usually used when there is no direct evidence of the defendant's negligence. The facts presented to the court must meet the three basic requirements. Once the court decides that the facts of a particular case warrant the application of res ipsa, it instructs the jury on the basic principles, but it is the function of the jury to decide the credibility and weight of the inference to be drawn from the known facts. The jury can conclude that the defendant was negligent, but the jury is not compelled to do so. Everything depends upon the particular facts of each case. An inference of negligence might be so clear that no reasonable person could fail to accept it. If the defendant offers no explanation, the court can direct a verdict for the plaintiff if the inference is so strong that reasonable jurors could not reach any other conclusion. Where the jury considers the question of negligence, it can decide that the facts do not logically lead to an inference of the defendant's negligence, even if the defendant did not offer any evidence in her defense. If the defendant presents evidence that makes it unlikely that she has acted negligently, the plaintiff will lose his case unless he can rebut the evidence, since such evidence destroys the inference of negligence created by res ipsa.

A minority of courts hold that res ipsa creates a rebuttable presumption of negligence. Unless the defendant offers sufficient evidence to contradict it, the court must direct a verdict for the plaintiff. Some states have gone as far as to shift the burden of proof to the defendant, requiring her to introduce evidence of greater weight than that of the plaintiff.

MedicalLawEthics

Tuesday, 1 February 2011

Medical records and issues in negligence

Rules regarding retention of indoor medical records

Posted by: “Dr.M.C. Gupta” mcgupta44@gmail.com mcgupta44

Sat Sep 11, 2010 11:10 am (PDT)

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Rules regarding retention of indoor medical records

Posted by: “Dr.M.C. Gupta” mcgupta44@gmail.com mcgupta44

Sat Sep 11, 2010 11:10 am (PDT)

Res ipsa loquitur

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