FAQs About Office Practices

  • What equipment should I have in my office as a precaution for patient emergencies?

    The possibility of a patient having a medical emergency (such as a cardiopulmonary arrest) in a clinician's office exists in all areas of medical practice. Procedures for handling an emergency should be developed and periodically reviewed with all staff. Appropriate equipment should be available for early intervention. Basic life support equipment (including oxygen, oxygen mask, bag resuscitator, oral airways, IV epinephrine and diphenhydramine) should be available, well-maintained and not locked away. Appropriate equipment for pediatric patients should also be on hand. Since an emergency can occur at any time, several, if not all members of the office staff should be trained (and periodically retrained) in using this equipment. Advanced life support equipment may be appropriate for certain patient populations in practices where staff is trained in its use.

    Clinicians practicing in a hospital setting are best served by calling a code. Those with offices outside the hospital can call 911. But all offices should be able to start interventions with crash carts, bag resuscitators and masks, etc. onsite.

    An inadequate response to a medical emergency may be difficult to defend regardless of the practice specialty or setting. Patients may assume a physician's office is prepared for medical crises, and may well perceive any delay in emergency treatment as negligence.

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  • What am I required to do in order to accommodate patients with sensory disabilities?

    Health care providers need to provide reasonable assistive services and auxiliary aids to patients with disabilities. Blindness and deafness are disabilities covered by the Americans with Disabilities Act (ADA). Providers who cannot demonstrate that the required aids and services impose an "undue burden" could be subject to potential liability for violation of the provisions of the ADA. The nature of the assistive actions needed, the costs to be borne by your medical practice, and your financial resources are considered in any determination by a court of what is reasonable or an undue burden. The failure of a medical practice to make reasonable modifications to ensure that a person known to be disabled is not denied its services is also considered discrimination under the federal law.

    At least one court case has ruled in favor of the plaintiff over the issue of provision of an interpreter for a hearing-impaired patient in a primary care physician's office. Many office settings have evaluated their facilities relative to physical access for the disabled; an assessment of the needs of the practice's patient population to meet any sensory disabilities identified should also be considered.

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  • If the patient can give a current history, should I review prior medical records?

    Yes.

    Reviewing prior medical records as part of a current office visit is good patient care. The patient should be asked to describe not only the current complaint (i.e., "what brings you to the office today?" or "this is your follow-up visit after...") but any concerns that may have led up to the current visit. With one or two skillful questions, you can ascertain what is troubling the patient. With an opportunity to talk (uninterrupted) for several minutes, the patient can relate a significant amount of useful information, and feel that you are listening.

    However, relying only on the patient's memory is risky. For example, a patient may have presented over a period of time, with a series of symptoms that--taken one at a time--have been managed appropriately, but all together may indicate a much more severe condition. Review of the past records is necessary to put those pieces together. In addition, a review of the record can refresh your memory about pending test results, the need for routine screening, results of referrals to specialists, or other matters that should be addressed.

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  • How much notice do I need to give patients if I am closing my practice?

    Send a letter to all current patients approximately 90 days or so before the last date of active practice. Include:

    1. the date the practice will close,
    2. the importance of seeking continued health care,
    3. and notification that the patient's records will be sent to a physician of the patient's choice with the patient's authorization.

    If appropriate, enclose a release form with instructions about its return. The letter should clearly explain that medical records are confidential and cannot be given to anyone without the patient's written authorization. You may wish to send the letter "return receipt requested" to document notification. Include in the letter several well-chosen physicians in the appropriate specialty or refer the patient to the local medical society.

    If you are leaving a group practice, you might refer the patient to an appropriate group member. Patients who are currently ill or hospitalized may need more personal notification. Seeing them in an office visit or on rounds in the hospital may be more appropriate, followed by an official notification letter.

    Obstetricians should be particularly careful to provide care for patients in their last trimester, or for those at high-risk for complications. Personal communication with these patients is essential so that individual treatment plans can be discussed and documented. Make certain that the patient has another physician and the records have been sent.

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  • How should I decide what to disclose in the consent process?

    Determining which risks to discuss within the consent process should be based on the severity of the potential harm, the likelihood of occurrence, and the relevance to the patient. Obviously, even a small chance of death or serious disability is significant. The type and the number of risks to be disclosed should also depend on the significance each patient would attach to such risks in deciding whether to consent to the procedure or treatment. For instance, a remote risk of hearing loss associated with an antibiotic treatment is of major significance to a musician. Alternative treatments, including the risk of no treatment, should always be discussed. Explanations should be tailored to the individual patient's competency, comprehension, need, and desire for detail.

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  • Which are better, general or procedure-specific consent forms?

    Risk-specific consent forms are most helpful in defending an allegation of failure to inform. However, obtaining a patient's signature is an important part of securing consent for treatment and the overall process of sharing risk and benefit information. Personalizing the consent form through the addition of specific issues discussed with the patient is an excellent practice and demonstrates that the form completion was not just a perfunctory task. The form serves as the objective evidence of the informed consent process.

    The discussion should address the most serious risks, less serious risks with a high likelihood of occurring, and any other risks to which the patient attaches significance. The documentation of the discussion of risks can be entered on either the form or in the patient's medical record.

    Documentation of patient-specific and/or procedure-specific risks has been helpful in the successful defense of numerous CRICO/RMF consent-related claims. For example, more than one claim arising from a pregnancy subsequent to a sterilization procedure has been successfully denied when the defense demonstrated that the procedure was correctly performed and the procedure-specific consent form listed "failure of the procedure to prevent pregnancy" as a risk.

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  • What special issues arise in the consent process when the patient is a minor?

    Laws and policies vary depending on your state and health care entity. Generally, a child cannot be given medical or surgical treatment without parental consent. The most common exception is an emergency situation in which the parents cannot be contacted and a delay in treatment would cause harm.

    Minors

    In some states, statutory provisions address circumstances such as pregnancy, venereal disease, and substance abuse, where minors may wish to seek treatment without parental knowledge. Other statutes enable minors to consent to treatment in order to prevent minors from delaying or foregoing crucial treatment in fear of parental involvement. In general, the law respects minors' wishes to keep certain sensitive information from their parents when the minors are mature enough to understand the nature of the procedure and when the procedure does not involve serious risks.

    Mature or Emancipated Minors

    The laws of most states permit a person below the age of majority to give valid consent if the patient has assumed adult responsibilities such as financial independence, marriage, or child rearing. With a mature minor, you should assess and record clearly that the minor is able to understand the risks and benefits of the treatment being considered.

    In these situations, minors are responsible for payment of their own bills; issues regarding their parents' insurance policies can prevent hospital treatment of a minor without the parents' knowledge.

    Additional Information

    Contraceptives: Providing contraceptive services to competent minors is legal if they have given informed consent.

    Pregnancy: Minors can consent to the diagnosis, prevention, and care of pregnancy. Parental notification is not required when pregnancy is diagnosed.

    Abortion: The laws governing abortions for minors vary by state. In general, however, minors have a right to give their medical consent to an abortion without parental consent. A parent may not force an adolescent to have an abortion against her will if she is mature enough to give her consent.

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  • What should I do if a patient refuses to sign a consent form?

    The first issue to be sorted out is whether this refusal relates just to signing the form or to some aspect of care. Further explanations about the treatment plan and the meaning of the form (with the aid of translation services, if necessary) may alleviate the patient's concerns. If the refusal to sign the form is based on concerns about potential medical interventions, more dialogue about the patient's preferences vis-a-vis medical judgment is indicated. This discussion should be documented if proceeding without a signed consent form is necessary.

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  • What should be done if an obstetrical patient refuses to sign a consent form during delivery?

    If concerns about potential medical interventions are leading to the refusal to sign the form, more dialogue about the patient's preferences vis-a-vis medical judgment during labor and delivery is indicated. This discussion should be documented.

    If the patient has issues of trust which cannot be resolved--and is in the early stages of pregnancy--referral to another practitioner may be indicated. Referral to another practitioner during the third trimester is not advised. This could give rise to allegations of abandonment. The obstetrical practitioner, labor and delivery nurses, administration, and the risk manager should develop a coordinated plan to manage the delivery of a patient with unresolved issues of trust.

    In the latter situation, the absence of an institutionally required signed consent form still needs to be addressed. Document in office and hospital medical records the dialogue about the pregnancy and plans for labor and delivery that have occurred during the prenatal period. Note the proposed obstetrical procedures and activities, risks and benefits, including unexpected risks and complications. The patient's verbal consent for continuing obstetrical care and refusal to sign a consent form should also be documented. The institution's printed obstetrical consent form provides an excellent outline for the detailed note. The situation should be discussed with the institutional risk manager who may have additional advice to offer.

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  • What information relating to a patient's HIV status can be shared, and with whom?

    Aside from those health care providers who need to know as part of their direct involvement in a patient's care and treatment, the patient's HIV test results cannot be shared without the patient's written consent. Release of HIV status to third-party payors and/or review organizations cannot be given without the patient's written consent.

    The Massachusetts statute has been designed to encourage voluntary testing while protecting the individual from the disclosure of the fact that they were tested and their test results. A violation of this statute can expose the offender to treble damages under the commonwealth's consumer protection laws.

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  • Can I warn the partner of an HIV-positive patient about the risk?

    By Massachusetts law, a patient's HIV status should never be disclosed to the patient's partner without the patient's written consent. This applies even if the partner is also a patient.

    Carefully explain HIV transmission and risk reduction. Encourage patients to tell their sexual or needle-sharing partners about their HIV status. The Massachusetts Department of Public Health has a partner notification program that patients can use anonymously to inform individuals at risk of HIV infection.

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  • What responsibilities does my office practice have for reporting medical device adverse events?

    The Safe Medical Devices Act (SMDA) requires that any "device user facility" report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes:

    • an ambulatory surgical facility,
    • a nursing home, or
    • an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency).

    The requirements do not apply to a physician's office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients.

    All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.)

    Device user facilities are also required to have written procedures for identifying and evaluating events that might be reportable. These facilities must also comply with documentation requirements, and provide employees with training and education about their obligations under the institution's program. Programs in all settings are subject to FDA auditing for compliance with the mandatory reporting requirements.

    Copies of the mandatory reporting form, instructions, and the coding manual can be obtained from the FDA by calling 1.800.638.2041. Or visit the FDA's website.

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  • What should I do if prescription pads or controlled substances are missing?

    The Massachusetts Board of Pharmacy recommends that any prescription pad theft be reported to local pharmacies, local law enforcement agencies, and the State Police Diversion Unit. Theft of controlled substances also should be reported to local law enforcement agencies and the federal Drug Enforcement Agency which has forms specifically designed for this purpose. Internal investigation into the theft or loss should involve the risk manager along with the other hospital departments affected.

    Prevention

    Prescription slips should never be pre-signed. They should be stored in a locked drawer or safe area and never be left unattended. Pads should be numbered sequentially in order to better identify if any are missing.

    Controlled substances should be locked in the medication room at all times and the keys held by authorized individuals only. Department of Public Health regulations require that Schedule II drugs be double locked. Every step in the system, from ordering to dispensing a controlled substance, should be handled by a different individual to minimize opportunities for theft.

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  • What steps do I need to take if I have an employee protected by a restraining order?

    Once an employer knows of an existing restraining order, he or she must maintain the level of confidentiality desired by the employee. Ask the victim's input in devising a plan in case the batterer appears at work. Options include circulating a photo or description of the subject of a restraining order with an action plan in case he or she shows up at the office or hospital. Alerting security personnel about the situation would also be helpful. Simpler measures could include having the employee escorted to his or her car, bus stop, etc. One common-sense exercise would be for employers to ask themselves what they would want from their workplace if they were victims of domestic violence.

    Case law for determining the extent of liability is scant. Health care facilities and providers might be expected to take "reasonable" measures to protect their workers from unsafe conditions. A facility large enough to have a security staff would be well-advised to provide adequate training in domestic violence response. Having a written plan and adequately disseminating the plan to employees is important. Foreseeability is a component of workplace safety litigation. Batterers are known to commit violent acts against domestic partners at their workplaces. Employers can let all workers know that assistance is available if they are victims of domestic violence, and ensure that their employee assistance plans have a domestic abuse component.

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