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- What is informed consent and who is responsible for procuring it?
Informed consent is the legal doctrine affirming a patient’s right to determine and control his/her own medical treatment. In essence, it is the discussion that takes place between the physician who is rendering care and the patient. The informed consent discussion may not be delegated to any staff member. It is the responsibility of the treating physician to provide information and explanations that will assist patients in their decision-making process. In other words, the patient must be afforded the opportunity to evaluate adequate information before making a decision. The treating physician must advise the patient of the usual risks, benefits, and alternatives of the proposed treatment or procedure, including the option of no treatment, the risks of the alternatives and, specifically, a few of the most severe and most frequent risks. Failure to procure an adequate informed consent from the patient can lead to both malpractice litigation and charges of professional misconduct. This also may be an indication of inadequate physician-patient communication. The patient’s consent must be voluntary, competent, and informed. The patient must have capacity, i.e. the ability to understand the nature and consequences of the treatment. Although a signed consent form is helpful in defense, a patient’s signature is not conclusive evidence of an informed consent discussion. The signed consent document merely confirms that such a discussion took place. A witness to the consent document, merely confirms that the patient has read and understood the document, appeared to have capacity for the purpose of giving consent, and has signed the form.
- For what procedures should an informed consent be obtained?
Although it is always good practice and important for a physician to explain to a patient the treatment he/she is rendering, obtaining an informed consent in New York State is only statutorily necessary for a non-emergency treatment, procedure, or surgery, or if the diagnostic procedure involves an invasion or disruption of the integrity of the body. A physician is not required to obtain an informed consent if the procedure is an emergency and necessary treatment would be delayed by trying to obtain consent. If a physician is in doubt as to whether a diagnostic procedure falls into the second category, it is a good idea to err on the side of obtaining an informed consent.
- What is the legal definition of a minor, and can minors give informed consent?
Generally, the New York statute states that persons under the age of 18 are minors. And, when the patient is a minor, consent for his/her medical treatment must be obtained from the parent or legal guardian. There are some exceptions: (1) if there is an emergency and the person is in need of medical attention, and an attempt to secure consent would result in delay of treatment which would increase the risk to a person’s life or health, parental consent is not necessary; (2) if a person is married or has borne a child, he/she can give consent for his/her self as well as for the child; and (3) if a person is pregnant or sexually active, or has questions relating to sexual behavior, the person can give his/her own consent to the care and treatment rendered, i.e. abortion, contraception or treatment of STDs; (4) any person in a parental relationship to the child (as defined by the statute) may give consent for the immunization of a child, unless this person knows the child's parent objects to the immunization; (5) a minor may also consent for treatment or testing in other limited situations, i.e. for HIV testing and treatment, voluntary out-patient mental health assessment and treatment under certain circumstances, and a 17-year old may consent to give blood; and (6) any medical provider who acts in good faith, based on the representation by a person that he/she is eligible to consent, shall be deemed to have received effective consent.
- In addition to having the consent formed signed, should I write a note in the chart after I have an informed consent discussion with a patient?
Absolutely, yes. The note should be dated and should state the following: “The risks, benefits, and alternatives, including no treatment, were discussed with the patient. The risks discussed included, but were not limited to . . .” and you list a few of the most severe and a few of the most frequent risks or complications. “The patient understood, had all his/her questions answered, and consented to the treatment or procedure.” This type of documentation will confirm and be evidence that a discussion actually took place with the patient.
The Doctor/Patient Relationship
- When does the doctor/patient relationship officially begin?
Today, it is often unclear when the doctor/patient relationship begins, and with the advent of managed care, this issue has become even more complex. Managed Care Organizations (MCOs) may deem the doctor/patient relationship to begin when the physician receives a list of patients who have chosen the physician as their primary attending. Thus, physicians must carefully review the lists received and protest to the MCO those patients the physician does not wish to accept. The relationship may otherwise be determined to begin when an appointment has been made, or when some other mechanism occurs by which an expectation of care arises, for example when an on-call physician treats a patient in the Emergency Department and advises the patient to be seen for a follow-up visit in his/her office at a defined time. If a doctor on-call has neither been called in for a consultation by the Emergency Department physician, nor treated the patient in the Emergency Department, the receipt of a courtesy copy of the Emergency Room record does not create a doctor/patient relationship. However, hospital bylaws may require such a follow-up appointment.
- How do I discharge a patient from care?
To discharge a patient from care, you must notify the patient in writing. You have the option of giving the patient a defined reason. If the patient has been non-compliant with treatment or appointments, or if the dentist/patient relationship has been disturbed by litigation, non-payment, or threats and abusive behavior by the patient or a family member you may state a reason for discharge, i.e. there has been a disruption in the doctor/patient relationship. You should document if the patient is being discharged for non-compliance, i.e. “you have been non-compliant with my recommendations for care and treatment.” If you have received a request for records from an attorney, have been sued by the patient, or are merely uncomfortable in continuing to treat the patient, a reason does not have to be stated or you may use the relationship disruption as the reason. Do give the patient a reasonable amount of time to seek a new physician, e.g. 30 days from the date of the letter, during which time you will be available for emergencies only. The letter should provide resources which will assist the patient in obtaining a new physician, such as the names and phone numbers of the county medical society. We do not recommend that you list the names of specific physicians. If the patient belongs to an HMO, review their rules regarding initiation and discontinuance of the doctor/patient relationship. Fager Amsler Keller & Schoppmann, LLP has sample form letters which can be modified for your use for discharging patients from your care. Remember, patients with urgent or serious dental conditions should not be discharged without immediate access to alternative care.
- Must I continue to see a patient whose insurance I do not accept merely because I have seen the patient once in the Emergency Department as the on-call physician?
The answer to this depends both on the patient’s condition and the hospital by-law requirements. If the patient’s immediate problem has been resolved, unless the by-laws require you to provide a follow-up visit, you are not obligated to see that patient in your office. However, if the patient is in need of further care and the problem can be resolved in one or two office visits, you should probably see the patient and then discharge him/her from care by letter. If the patient continues to have an urgent or serious medical problem which requires continued care, you must be sure he/she has alternative and uninterrupted treatment prior to discharging him/her. If you are unable to do so, then you must complete the course of treatment for that medical problem, before discharging the patient from care.
Documentation in the Medical Record
- Why is the appearance of the medical record so important in a malpractice dispute?
The medical record is the actual record of treatment provided to the patient, and its appearance is extremely important to your defense. It specifically describes the complete history, evaluation, diagnosis, treatment, and care of a patient; and, therefore, it is of maximum value in terms of its accuracy and credibility, especially when used in legal proceedings. Remember, if you didn’t chart it, you didn’t do it. The medical record should be precise, neat, complete, and legible, and it should be written so that any other doctor who has a reason to pick up the record knows exactly what has been done for the patient, when it has been done, and why.
- How do I appropriately document the medical record
Entries in the medical record must be contemporaneous with treatment and should be written legibly in ink or transcribed. Be sure to use a consistent style for your entries. If your records are ever challenged in court, consistency will impart credibility to your records and will demonstrate your professionalism in maintaining them. You must accurately record both positive and negative findings, and enter the time and date of all entries, signing each one. All entries should follow sequentially; do not leave any spaces between them. If you make an incorrect entry, cross it out by drawing a single line through it, writing the word error, and initialing and dating the correction. Do not, under any circumstances, use white-out or erase an entry. Both techniques suggest you have something to hide. Each correction should be made as it happens with an explanation for the correction to preserve the record’s integrity. Be sure to record missed appointments and any failure by the patient to accept or follow instructions. This type of information will be helpful in defending a future court action. Always be sure to record your observations in an objective and dispassionate manner. The medical record is not the place to settle disputes, assign blame, or write derogatory remarks. Such superfluous entries seem to communicate a lack of professionalism and may raise doubts about the record’s overall credibility.
Retention and Release of Medical Records
- How long must I retain medical records?
Medical records of non-obstetrical adult patients and mammograms should be retained for 10 years from the date of submission of the last claim for payment. Records of minors, that is persons under the age of 18, must be retained for at least 10 years from the date of submission of the last claim for payment, or when the minor reaches the age of 20-1/2, whichever is longer. Medical records of obstetrical patients must be retained for the same period as minors. If the birth was viable, but the child did not survive, the records must be retained for 10 years from the date of submission of the last claim for payment. These time periods are recommended in view of state and federal statutes and regulations, pertaining to malpractice and healthcare offenses.
- What documents do I need to release medical records to someone other than a patient?
You must have an authorization or release form signed by the patient or by an individual legally authorized to request healthcare information. The authorization must be dated and must designate the name of the party who is releasing the record and to whom the records are to be released. A release that states “to bearer” is not acceptable. The authorization or release form must state the reason for the authorization (“at my request” is sufficient) and must specify the medical information to be released (e.g., “all my records”). Each authorization form must contain an expiration date or event. In addition, the Health Insurance Portability and Accountability Act (HIPAA) requires that certain statements be included in each authorization form. Thus, you must insure that the authorization form is HIPAA compliant and that it contains all of the required elements. Although notarization is not mandated by law, you may as a policy decision require that the signature on the authorization be notarized. We recommend comparing the patient’s signature on the release form to his/her signature in the chart. If the patient is not the person who signed the authorization, then a copy of a legal document permitting the designee to sign the authorization must be also obtained. These may include, for example, healthcare proxy documents or court papers appointing the person as the administrator or executor of a deceased patient’s estate. In unusual circumstances, such as those concerning custody or divorce, patient incompetence, or death, you should contact your attorney to discuss how to proceed.
- What type of information requires specific or special authorizations to release the medical record?
Any medical records containing HIV-related information, the records from an alcohol or drug treatment program, and/or psychiatric or mental health facility records require a specific and special authorization. The New York State Department of Health HIPAA compliant HIV authorization is available on the DOH website. Psychotherapy notes that receive heightened protection are defined by HIPAA as notes recorded by a mental health professional documenting or analyzing the contents of a conversation during a counseling session. They are particularly protected under HIPAA only if maintained separately from the record. Release without authorization is limited to situations defined under the law, i.e. patient treatment by the originator of the notes, for mental health training in programs at the covered entity and for defense by the covered entity in a legal proceeding brought by the individual, government investigations or lawful activities by a medical examiner. Patients are not entitled to access to psychotherapy notes and may be denied the opportunity for review of this decision. Notes not deemed to be psychotherapy notes include medical prescriptions and monitoring, session times, modalities and frequency of treatment, summaries of diagnosis, functional status, treatment plan, symptoms, prognosis and progress to date. However, if a physician merely writes a note in the office record about the patient’s history of mental illness, the use of psychotropic medications, or the addiction to or abuse of alcohol or illegal drugs, a special consent to release records is not required.
- If a patient advises me that he/she has risk factors and/or has been tested for HIV, may I include that in my progress notes or the history and physical notes?
Yes, if the patient relays this information as part of his/her history, or it is medically relevant to his/her present care and treatment, it may and, in fact, should be documented. However, that chart then becomes a protected chart under Article 27F of the Public Health Law, which governs the confidentiality of HIV-related information.
- May I release records containing HIV information when I receive a subpoena, particularly if it is a judicial subpoena?
The HIV law clearly requires the release of records only with a special HIV consent form or a court order, issued only after a hearing, at which time the patient has had an opportunity to contest the release. A subpoena is not sufficient.
- Does even a negative HIV test result require specific protection of the chart?
Yes, the fact that an HIV test has been done, regardless of the result, raises the possibility that the patient has risk factors for HIV. The patient may sustain harm if this information is released inappropriately.
- If a patient tells me in the Emergency Department (ED) or prior to surgery that he/she is HIV positive, may I inform the ED or the operating room staff who will be involved in the patient’s care?
You may not tell the staff if the sole purpose of informing them is infection control or having them take extra precautions. You may only tell the staff if the disclosure is necessary for the patient’s care and treatment.
The "Good Samaritan" & "Do Not Resuscitate (DNR)" Laws
- Does the Good Samaritan Law protect me from being sued?
No, the Good Samaritan Law does not protect you from being sued if you are in your office or a hospital. It provides that any licensed physician who voluntarily, without expectations of receiving monetary compensation, renders first aid or emergency treatment at the scene of an accident or other emergency which occurs in a location other than the doctor’s office, a hospital, or other healthcare facility, to a person who is unconscious, ill, or injured shall not be liable for damages. This protection from liability, however, does not apply if the doctor is grossly negligent.
- If a patient has a DNR order, must I write another order saying “Do not intubate?”
A DNR order can specify what resuscitative efforts a patient wants. For example, the patient may desire CPR and certain medications but does not want to be intubated. It is very important to carefully discuss with the patient, family, surrogate, or proxy agent exactly what a DNR order means and what the patient wants. The competent patient and/or family should be advised that if a DNR order is issued, the following actions will not be taken if the patient suffers a cardiac or respiratory arrest. They include:
- mouth-to-mouth resuscitation
- external chest compression
- electric shock
- insertion of a tube to open the patient’s airway
- injection of medication into the heart, or
- open chest heart message.
The National Practitioner Data Bank
- I am a co-defendant in a malpractice lawsuit. If my insurer pays money to satisfy a settlement or judgment on behalf of my co-defendants, but does not make a payment on my behalf, will I still be reported to the Data Bank?
No, the National Practitioner Data Bank only requires your insurer to report indemnity payments made on your behalf as a result of a written claim.
- Is an incorporated solo practitioner considered to be an entity for purposes of reporting to the Data Bank a payment he/she made?
No, regardless of the form under which you practice as a solo practitioner (for example, you may be operating as a P.C.), individual practitioners are no longer required to report to the Data Bank payments they make on their own behalf personally out of pocket.
- Must I permit HMOs, other insurers, and hospitals to query the National Practitioner Data Bank?
HMOs and group medical practices qualifying as entities under the Data Bank plan because of their professional and formal peer review activity may query the Data Bank. Hospitals must query the Data Bank when a physician, dentist, or other qualified healthcare practitioner applies for a position on the medical staff or applies for a change in clinical privileges. Hospitals must also query the Data Bank when re-credentialing members of its medical staff. The initial inquiry must be done no later than two years after the opening of the Data Bank and every two years thereafter. An insurance carrier cannot request information from the Data Bank.
- Will I be notified by the Data Bank if an inquiry about me is made?
Practitioners can receive copies of their complete file at any time, free of charge, by submitting a Request for Information Form to the Data Bank. Healthcare practitioners are not automatically notified when a report is released on them in response to an inquiry, but may periodically obtain this information by requesting a copy of their Data Bank file. Practitioners are only notified when they are the subject of a report received by the Data Bank.
- Is there a minimum threshold of loss payment that does not require a report by my carrier for a settle- ment made in my behalf?
No. All payments made after September 1990 on behalf of a practitioner are reportable to the Data Bank.
Diagnostic Test Follow-Up
- What is my responsibility or liability if a patient fails to have a laboratory or radiological test performed or to keep an appointment with a specialist?
There is a duty imposed upon the attending doctor to follow up on all tests and consultations he/she has ordered. The failure to do so could lead to a delay in diagnosis or misdiagnosis of a serious disease. The physician should follow-up first by telephoning the patient or the consultant’s office, and then by writing a letter to the patient. These efforts should be documented in the chart.
The Healthcare Proxy Law
- If an incompetent patient has a living will and a designated proxy agent, and the agent appears to be making decisions that are in contravention of the patient’s stated wishes, who prevails?
If you feel the proxy agent is not acting in the patient’s best interest, you may request that a court remove the agent and/or override the agent’s decisions which were made in bad faith. You should first attempt to meet with the proxy agent, either alone or with the hospital’s ethics committee, to discuss the matter and attempt to resolve any disputes, prior to going to court.
Handling Requests from Attorneys
- If a patient signs an authorization solely for release of his/her records, am I at liberty to speak to his/her attorney or to the defense counsel?
One area of concern for physicians and their attorneys involves requests from patients’ attorneys for records, especially when the reason for the request is not made clear. On occasion you may receive a call from an attorney requesting an appointment to discuss your care of a patient, or to have you interpret your notes in the patient’s medical record, which the attorney already has in his possession. Even if the attorney assures you that you will not be sued, or that your conversation is off the record, exercise caution and immediately contact your own attorney before agreeing to speak with him/her. Frequently these statements are simply not true. Further, it should be noted that an authorization to release records requires only that you release the patient’s records. It does not sanction discussion with any attorney. If an attorney wishes to question you about a patient’s care, the appropriate place to do so is at an Examination Before Trial (EBT) or deposition, where you may have counsel present for your protection. If you have been retained to be an expert witness for a plaintiff ’s attorney, you should request a specific and HIPAA compliant release from the patient, which will permit you to discuss all aspects of his/her care, treatment, diagnosis, and prognosis with that attorney.
- If a patient’s attorney asks me to provide a narrative summary of my care or sends me written questions for my response, must I agree to do so?
No. The best way to handle such a request is to obtain from the patient a properly signed and dated authorization allowing the attorney making the request to obtain access to the patient’s medical information. You should advise the attorney that your records speak for themselves. In addition, you are not obligated to be an expert witness for a patient you have not treated.