Newer documentary practices as per Mental Healthcare Act 2017.

Medical records form an integral part of patient care. Proper documentation and its maintenance are mandatory as part of the law. It is essential for a treating doctor to document the required details to avoid allegations of negligence. Proper documentation will not only help us to prove that particular services were provided but can also serve as a tool for communication with other professionals. This article draws together the standards and suggests some good clinical practices as per the Mental Healthcare Act 2017.

INTRODUCTION

A medical record is the documentation of the healthcare received by the patients. It consists of details about the history of the complaints, observation, investigations, medical or surgical management, and treatment outcome collected from the patient, their caregivers, and the medical practitioners. History-taking and documentation are integral components of clinical training at undergraduate and postgraduate levels. In the legal system too, documentation is regarded as an essential element. Extending the risk management dimension, failure to document relevant data is itself considered a significant breach and deviation from the standard of care.[123] Nothing is more devastating to an innocent physician's defense against the allegations of medical malpractice than an inaccurate, illegible, or skimpy record, except for a record that has been changed after the fact, and therefore inevitably compromises an otherwise defensible case.[4] Most medical malpractice litigation is built around the medical records, where they will be important for judicial scrutiny and the physician's defense. Adequate documentation provides the only objective record of the patient's condition during an intervention by the practitioner and the care that was provided in the Mental Health Establishment (MHE).

In the current era of modern medicine, adequate record keeping not only serves as a defense for the physician but also acts as the tool for communication with fellow practitioners and for future reference. Possible users of medical record are:[5]

Primary users: Attending physician (themselves), other physicians (for liaison and consultation)

Secondary users: Nursing/paramedical staff, patient (during consultation or referral/for future), hospital administrators, students and trainees, clinical researchers, those assessing the epidemiology or statistics, insurance companies, etc. The medical record can also be a tool for training of medical staff, for medical transcription, and for predicting future health problems. It can also serve as the basis for standard preventive measures

Third party users: Social workers, occupational therapists, auditors, the court of law (during a trial), investigating agencies (police, internal enquiry, criminal negligence enquiry), government agencies (Statutory bodies: Pre-Conception and Pre-Natal Diagnostic Techniques Act, Medical Termination of Pregnancy Act, Blood bank licensing, etc.). The medical record will also be needed for accreditation or approval by Medical Council of India (MCI), Clinical Establishments Act, etc.

A lot of research has been done on the benefits and drawbacks of facilitating patient access to medical records. Overall, studies of patient-accessible medical records suggest modest improvements in doctor–patient communication, adherence, patient empowerment, and patient education. Although patients find parts of the medical record difficult to understand, patients who are offered a chance to review their medical record are generally satisfied with the experience. However, a significant portion of psychiatric patients became more worried and pessimistic after reading their records.[6]

STIPULATIONS IN MHCA 2017

Mental Healthcare Act (MHCA) 2017 states the following in section 25:[7]

All persons with mental illness (PMI) shall have the right to access their basic medical records as may be prescribed

The mental health professional (MHP) in charge of such records may withhold specific information in the medical records if disclosure would result in (a) serious mental harm to the PMI or (b) likelihood of harm to other persons

When any information in the medical records is withheld from the person, the MHP shall inform the PMI of his right to apply to the concerned board for an order to release such information.

The mental healthcare rules[8] talks about the rights of a PMI to access basic medical records, as follows:

A PMI shall be entitled to receive documented medical information about his diagnosis, investigation, assessment, and treatment as per the medical records

A PMI may apply for a copy of his basic inpatient medical record by requesting in writing in Form-A, addressed to the medical officer or MHP in charge of the concerned MHE

Within 15 days from the date of receipt of the request under sub-rule,[2] basic inpatient medical records shall be provided to the applicant in Form-B

If an MHP or MHE, as the case may be, is unable to decide whether to disclose information or provide basic inpatient medical records or any other records to the applicant for ethical, legal or other sensitive issues, they may make an application to the Mental Health Review Board (MHRB) stating the issues involved and their views in the matter with a request for directions in the form of a written order

The Board shall, after hearing the concerned PMI, by order, give such directions, as it deems fit, to the MHP or MHE, as the case may be.

Form B contains the sample formats in which the basic records can be provided to the patient.[8] It has templates for:

Outpatient record

Inpatient record

Therapy record

Psychological assessment record.

CONTENTS OF MEDICAL RECORDS

As per the basic minimum requirement specified in the MHCA 2017, the medical record should contain information about hospital registration number, sociodemographic details of the patient, history of presenting complaints, advance directive (AD), nominated representative (NR), section of admission, investigation reports, treatment advice, psychological assessment, therapy sessions, condition at discharge, and follow-up recommendations. All these data can be divided as per the source from which it is obtained:

Information from the patient

Details collected from the patient should be recorded legitimately. It can be an interview, telephonic conversation, e-mail, SMS, or any other media in real or virtual space. It includes basic sociodemographic data and history related to mental illness and its onset, duration, and symptoms. Stress should be placed upon proofs of identity, inquiry about registered AD and NR, and the duties assigned to the client by the act to furnish a copy of the registered AD. It is advisable to attach identity proof or ID number with the record. It is desirable to document the information (personal, electronic, telephonic) from the patient using his/her own words. Occasionally, the findings and observations may not match. In such situations, screening tests, subjective questionnaires, etc., can be used to document the situation more objectively.

It will be a good practice if the patients themselves fill the necessary consent/procedure forms. Whenever applicable, such forms should be in the regional language. Further, the patients may be offered an opportunity to read the clinical findings themselves and sign them. Discussions about any particular doubt related to a procedure or treatment and the patient's agreement or disagreement about it should be documented.

When a person willingly comes to an MHE as an outpatient, we can assume that there is an implied consent. For the inpatients, however, the matter of “consent” requires serious consideration, and the capacity to consent needs to be assessed.[9] It is an assessment of what the patient understands about the illness and the need for treatment. A lack of insight into the illness does not necessarily mean that the capacity for consent is absent. No formal guidelines are currently available for the assessment of capacity. The admission procedure and the related sections for all the patients at an MHE depend on the presence or absence of capacity for consenting for psychiatric treatment. Thus, capacity assessment is fundamental, and its documentation is a must.

During the inpatient stay, daily assessment report and progress chart should be discussed with the patient, and their understanding about the same should be recorded. It is a good practice for the patient and the concerned persons participating in the decision-making or discussions to cross-sign the notes. Data related to physical or sexual abuse, deliberate self-harm, and unlawful activities should be handled carefully. The patient should be educated about the related laws, and necessary permission should be obtained about the release of such sensitive information. Documentation of such information is a must, but the release of such records should be done with utmost care to ensure the smooth progress of the treatment under consideration. The legal obligations we have as MHPs should also be catered to.

At the time of discharge, clarification about the access to/release of medical records should be made. The patient's attitude toward the discharge plan and willingness should be recorded. The patient should be encouraged to identify the primary caregiver, and we should involve them in the discharge planning, after obtaining the patient's consent and avail their emergency contact number for use in crises and document all the details.

Information from relatives

Collateral information is the information (personal, electronic, telephonic, etc.) or records provided by the family members, relatives, caregivers, NRs, neighbors, colleagues, staff, police, medical board members, and henceforth. Frequently, the patients are not able to provide an appropriate history due to the ongoing psychiatric illness. When the patient gets to know that the family members have shared certain information with the treating team, it may at times precipitate unpredictable and inappropriate behavior from the patient and may worsen the ongoing mental illness. As per the MHCA 2017, the patients are not entitled to get the collateral information entered in their medical records. Hence, an attempt should be made to document such information separately. The MHP has the right to restrict the release of such records with justification, whenever requested by the patient. When in conflict, the MHRB shall weigh the risk of releasing such information before it issues the order on appeal by the patient.

In case of admission under section 87, 89, or 90, and treatment under section 94, information and consent from the NR/primary caregiver/family are required. Admissions will be done on their request in the prescribed forms, with adequate documentation of informed consent, reasons, and justifications for such admission. Inpatient care should be provided as the least restrictive option, and discharge planning should be done after involving patients and the family.

Information from other mental health professionals/psychologists/other professionals

These details include information delivered by professionals to patient or relatives and the clinical observations, findings, and advice. Details obtained from such liaison consultation also become a part of professional documentation.

Documentation should be done on the psychoeducation given about the illness, course and prognosis, treatment options available, and the treatment plan at the time of the initial consultation itself. It should include the risks and benefits associated with the acceptance or refusal of treatment and the planning of AD and NR. As per the MHCA 2017, an MHP has to impart such knowledge to all the patients.

Along with this, all MHEs must maintain the basic medical record of outpatient and inpatient information in a hard copy format and better maintain a soft copy as well. As a good clinical practice, it may be recommended to follow the required norms and format as specified by MHCA 2017 and prevent unnecessary recording of too many details and overloading the case records. Only those pieces of information relevant to diagnosis and effective management may be given due importance. Inpatient record should include all details normally entered in the outpatient records and in addition should contain the details of the course in the hospital, condition at discharge, treatment advice at discharge, and future recommendations. Note on the physical examination is important, as it will help in identifying the medical conditions such as infections, cachexia, and marks of deliberate self-harm. We can also attach the assessments and rating scales, whenever necessary.

For patients admitted under sections 89 or 90, the MHP should review the capacity to give consent every 7 or 15 days, respectively, and whenever applicable, the patient should be considered for admission as an independent patient. The MHRB should be reported about the admission of minor, women, and others as and when applicable within the time frame specified.

The MHCA now mandates the documentation and release of the therapy records and psychological assessments in a prescribed format. Therapy record should include the type of therapy, duration, goals set, the technique used, and the therapist's observation, reflection, and plan. Documentation of psychological assessment should include the type of assessment, reason for the same, test/scale administered, salient behaviors noticed, impression, and recommendation.

Whenever another physician is consulted for other medical reasons, information should be added about the reason for reference, observations, and advice for investigations and treatment.

At the time of discharge, documentation of details should be patient-centered, and a copy of the same should be given to patient and caregiver, after receiving required authorization. Topics for discussions around discharge planning include the treatment advised, expected side effects, expected duration of treatment, warning signs of relapse, hospital emergency contact and other helpline numbers, AD, and NR. The discharge document should mention the type of discharge, i.e., leave of absence, discharge on request, discharge against medical advice, patient absconded without permission, or others. All the details should be signed, timed, dated, and named by the concerned practitioner.

Special attention should be given to prisoner/under trial patients. The observation and progress notes should be handled carefully. Most documentation would be based on objective cross-sectional examination, observation of behavior in the ward, rating scales, and other assessments, as we may not have adequate access to the history of illness or history, from a significant family member. Provisional diagnosis and management plan, with the limitations of such assessment, may be documented.

DEVIATION FROM OLD FORMAT AND ADOPTING THE EXPECTED FORMAT

We have been trained for over decades to assess, examine the patient in detail, document the findings, and record various histories related to mental illness in an elaborate template in a tedious manner. It may sometimes add up to 6–10 pages of a detailed psychiatric workup. Most of the times, it includes sensitive personal data without consent/authorization for documentation, which can breach the confidentiality of the patient–doctor relationship. The MHCA has mandated the basic format for the medical records, which the patient/NR/law has access to. Thus, students should be trained accordingly and sensitized on avoiding unnecessary work-up details, which further add to the burden of record maintenance and complication in the process of release of information. Once any data are documented, the patients will have rights to access their records and that will lead to unnecessary correspondence with MHRB when the treatment team has reservations about its release.

EXPECTED DUTIES FROM MENTAL HEALTH PROFESSIONAL

Registers to be kept

The MHE should keep the following registers: Case record register, outpatient attendance register, inpatient admission register, census register, treatment side effects, and adverse effect monitoring, certificate/medical record register, restraints register, medico-legal register, mortality register, and leave of absence/escape register

Application form notified

Mental healthcare rules have suggested MHPs and MHEs to use specified forms for the process of admission, discharge, and other procedures. They are:

Application for basic medical records

Request for independent admission

Request for admission of minor by NR

Request for admission with high support needs

Request for continuous admission with high support needs

Request for the discharge of an independent patient

Request for the discharge of minor by its NR

For leave of absence

Intimation to police about an unauthorized absence of prisoner from MHE.

Confidentiality of the records

The MHCA has mentioned rights to confidentiality under the rights of a PMI. Related sections are as follows:

Section 23

A PMI shall have the right to confidentiality in respect to his mental health, mental healthcare, treatment, and physical healthcare

All health professionals providing care or treatment to a PMI shall have a duty to keep all such information confidential which has been obtained during care or treatment with the following exceptions, namely:

The release of information to the NR to enable him to fulfill his duties under this act

The release of information to other MHPs and other health professionals to enable them to provide care and treatment to the PMI

The release of information if it is necessary to protect any other person from harm or violence

Only such information that is necessary to protect against the harm identified shall be released

Release only such information as is necessary to prevent a threat to life

The release of information upon an order by concerned Board or the Central Authority or High Court or Supreme Court or any other statutory authority competent to do so

The release of information in the interests of public safety and security.

Section 24

No photograph or any other information relating to a PMI undergoing treatment at MHE shall be released to the media without the consent of the PMI

The right to confidentiality of a PMI shall also apply to all information stored in electronic or digital format in real or virtual space.

Preservation of records

As per law, there is no specified time limit after which the medical record can be destroyed. Hence, they have to be preserved permanently. In view of the multitude of cases against the doctors under the Consumer Protection Act, it is advisable to preserve all the inpatient records for at least 5 years and outpatient records for at least 3 years.[10] As per the MCI provisions under regulations, 2002, every physician shall maintain the medical records of inpatients for 3 years from the date of commencement of treatment in a standard pro forma laid down by the MCI. However, MCI stays silent about the guidelines for outpatient records. If any request is made for medical records either by the patients/authorized attendants or legal authorities involved, the same may be duly acknowledged, and documents shall be issued within 72 h,[11] which conflicts with provisions of the MHCA 2017, where it mandates release within 15 days.

Display of information

As per the MHCA 2017, it is mandatory for all MHEs to display information about MHRB. Any PMI has the right to appeal or report to MHRB about the deficiency or breach in his/her rights. Further, each MHE needs to display the certificate of its registration and the details of free legal aid available. It is also advisable to display the psychiatry related laws (e.g., Protection of Children from Sexual Offences Act, MHCA, Narcotic Drugs and Psychotropic Substances Act, Rights of Persons with Disabilities Act, Consumer Protection Act, MCI guidelines) that need to be followed by the MHP so that the patient can expect a certain level of transparency. For example, reporting of child sexual abuse is mandatory as per the Protection of Children from Sexual Offences Act.

Good clinical records

There are specific do's and don’ts about maintaining quality records:

While obtaining consent and providing psychoeducation about the illness, one should stress about the risks and benefits equally. When the discussion of a decision, such as whether to prescribe medicines or not, includes both the risks and benefits of each path (prescribe or do not prescribe), the clinician's reasoning is viewed as more reasonable if both these aspects are documented. One way to visualize this issue is to consider a decision tree in which the tree's two branches represent each of the options: “prescribe” inhabits one branch and “do not prescribe” inhabits the other. Each branch then sprouts two twigs: One for risks and one for benefits. Thus, in a given case, there are both risks and benefits of prescribing and risks and benefits in not prescribing. A physician who has even briefly noted the pros and cons in each branch of this decision may be later portrayed by a fact-finder or perceived by a judge as having been wrong in the conclusion at which he or she arrived, but they might not conclude that the physician is negligent since the decision was, as supported by the physician's documentation, the result of a well-thought-out process[12]

Use clinical judgment at critical decision points. There are many possible definitions of clinical judgment, but a useful one for our purposes is “an assessment of the clinical situation and a response congruent to that assessment”[12]

Document the patient's capacity to participate in his or her own care. Examples include the patient's ability to understand the purposes of the various medications being prescribed, the patient's awareness of what symptoms to look for during an exacerbation of the condition, and the patient's knowledge of what symptoms or states of mind constitute an emergency[12]

Uniformity should be maintained in the medical records with regard to procedure, content, accuracy, and quality. The MHE should follow certain internationally accepted protocols and develop a standard operating procedure. There should be a systematic format accepted in the establishment for admission, procedure, and treatment, of which the patient should be made aware of. Special attention should be given to medico-legal cases. Computerizing the medical records will ease achieving this target, as computerization can help by easy and fast retrieval and reduced requirement for space[5]

The content of the records should be patient-friendly. Avoid the use of abbreviations and demeaning terminology.[12] The record should be transparent and in objective language. Manual records should contain legible handwriting[13]

Avoid making alterations in the record

Misleading information and malpractice should be forbidden. Ignorance cannot be used as a defense in the court of law. Maintaining confidentiality is a universally accepted law, and hence should never be breached.

EFFECTS OF POOR RECORD KEEPING

If the MHE does not comply with the orders or directions of the Authority or the Board or willfully neglects such order or direction, the Authority or the Board, as the case may be, may impose penalty which may extend up to 500,000 rupees on such MHE and the Authority on its own or on the recommendations of the Board may also cancel the registration of such MHE after giving an opportunity of being heard (Section 82.4)

Any person who contravenes any of the provisions of the Act, or of any rule or regulation made thereunder, shall, for the first contravention, be punishable with imprisonment for a term which may extend to 6 months, or with a fine which may extend to 10,000 rupees or with both, and for any subsequent contravention, with imprisonment for a term which may extend to 2 years or with fine which shall not be <50,000 rupees but which may extend to 500,000 rupees or with both (Section 108).

JUDICIAL DECISIONS IN INDIA ON ISSUES OF MEDICAL RECORDS

There have been many judicial decisions about medical records from various courts in India, and a review of some of the relevant ones is given in this section.[14]

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. (Poona Medical Foundation v Marutturao Tikare. 1995). However, the Bombay High Court held that doctors could not claim confidentiality when the patient or his relatives demand medical records. (Raghunath Raheja v The Maharashtra Medical Council and Ors AIR. Bombay: 1996). With the enforcement of the MCI regulations, 2002, it has been held that the patient has a right to claim his medical records on treatment availed and the hospitals are obliged to maintain them and provide them to the patient on their request.

Hospital and doctor were found guilty of deficiency in service as case records were not made available to the court to refute the allegation of a lack of standard of care. (Kanaiyalal Ramanlal Trivedi v Dr. Satyanarayan Vishwakarma. 1996-1998). The plea of destroying the case sheet as per the routine hospital practice appeared to the court as suppression of facts that were likely to be revealed from the case records. They were found negligent as they should have retained the case records until the final disposal of the complaint at the court. (Quereshi SA. Padode Memorial Hospital and Research Centre II. 2000).

Not producing patient's medical records prevents the complainant from seeking an expert or second opinion. It is the duty of a custodian of medical records to produce it in the court of law and adverse inference could be drawn for noncompliance with request to produce records. (Dr. Shyam Kumar v Rameshbhai, Harmanbhai Kachiya. 2002-2006). The State Commission had held that there was deficiency of services as there was inadequate history, history of prior treatment received, investigations done, and absence of consenting document and hence negligent. (Ganeswara Rao M. Force. 1998).

According to the State Commission, failure to deliver X-ray films was deficiency of service and the patient/his attendants were deprived of their right to be informed of the nature of the injury sustained. (Shanta VP. v. Cosmopolitan Hospitals (P) Ltd. 1997). The State Commission had disbelieved the evidence of the surgeon as photocopies were produced to substantiate the evidence without any plausible explanation for the absence of the original medical records. (Devendra Kantilal Nayak v Dr. Kalyaniben Dhruv Shah. 1996-1998).

The allegation of not informing the possibility of vocal cord palsy was negated by the detailed written informed consent that showed that it was explained and documented in detail and later consented with full awareness of the consequences. (C Anjani Kumar v Madras Medical Mission. 1998-1999). The allegation of the patient regarding the negligence of the doctor was set aside.

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, as the onus lies on the complainant to prove the allegations made. (Sethuraman Subramaniam Iyer v Triveni Nursing Home. 1997-1998).

Hospital was held for vicarious liability for the negligent action of the doctor employed by him 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. (Ismail PP, Radha KK. 1997-1999). The State Commission had held negligent on the basis of the available medical records, which seemed to be manipulated. (Nihal Kaur v. Director, PGI, Chandigarh. 1996). It was also noted that issues related to tampering of medical records needed detailed examination in a civil court rather than in Consumer Court. (Harenbalal Das v Dr. Ajay Paul. 2001).

The National Commission in yet another case held that the hospital was guilty of negligence for not mentioning the name of the anesthetist in the operative notes, though anesthesia was administered by two anesthetists. There were two progress cards about the same patient on two separate records that were produced to the court. (Meenakshi Mission Hospital and Research Centre v. Samuraj and Anr, ICPJ (NC); 2005).

Not maintaining the confidentiality of patient information can be an issue of medical negligence. The HIV status of a patient was disclosed to others without the consent of the patient, and the due procedures for disclosure were not followed. (Dr. Tokugha Yeptomi V Appollo Hospital Enterprises Ltd and Anr III. 1998).

CONCLUSION

Good medical records are an integral part of the quality health care and institutions. Maintaining an adequate medical record in the prescribed format is not just for the gain of the practitioner but also is mandated by the law. Any deviations from the standards of documentation can lead to harsh penalties. The MHPs are assigned the responsibility of maintenance of basic medical records in a hard copy format and to provide a copy to patients or NR on request, within 15 days. The quality and quantity of medical records need modifications in the background of the formats as suggested by the MHCA. Although more information can be helpful to clarify a situation, the same would also be accessible to third-party users. Hence, MHPs in training and current registered MHPs need to be reoriented to the newer expectations on the background of the MHCA 2017.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.