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

A:

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.

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

A:

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.

Q: What are the patient safety implications of reusing disposable medical devices or resterilization services?

A:

Regulations prohibiting resterilization/reuse of disposables have been softened in recent years. Entities such as the Centers for Disease Control (CDC) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) have removed blanket statements against the practice from their recommendations, but it is not without risk.

If the standard of care for a specific procedure would ordinarily be to use "new" equipment/supplies, the institution should be prepared to justify its rationale that reuse/resterilization presents no additional hazard to patient safety or effectiveness.

A facility reusing or resterilizing certain types of equipment should consider how it will handle the issue of informed consent. Arguably, the patient should be apprised of the facility's policy on reuse, and options discussed. From a realistic viewpoint, the occurrence of such discussion may only become an issue if harm comes to an individual based on the facility's reuse/ resterilization decisions.

Q: What are the risk management implications of external service contracts?

A:

If a health care facility leads patients into thinking that a service or provider is an agent of the health care facility, the facility is bound as if it is its own employee or service. The key factors in making this determination are:

  • Does the health care facility control and supervise the treatment?
  • Is the contracting individual subject to the health care facility's rules and regulations?
  • Does the health care facility pay the person's salary directly?
  • Does the hospital put its patients on notice that the person is an independent contractor?

The terms of external service contracts must be consistent with the policies of the health care facility and the liability coverage that protects the staff. The contract process should define the duties and objectives of the facility and the agency. Facilities should obtain a certificate of insurance, review all contracts periodically, and may wish to submit certain contracts to legal counsel for their review. If a contracted employee acts negligently, the health care facility could be held vicariously liable for damages. The contract must specify the party to be responsible for meeting the duties and obligations mandated by law. The delineation of responsibilities assists the health care facility in managing risk that it cannot avoid.

Q: What are the risks of using an FDA-approved drug for a non-approved use?

A:

Approval from the Food and Drug Administration (FDA) does not make any and all uses of that drug approved under federal law. The regulatory approval process requires drug manufacturers to objectively validate the claims submitted. Although a drug manufacturer may not advertise or promote an approved drug for a non-approved use, physicians are not prohibited from making a clinical judgment to prescribe the drug for a so-called “off-label” use by a particular patient. That does not mean that the decision is without risk. The further away the use is from scientific evidence and similar use of the drug by other clinicians, the more likely the use may be viewed as experimental. An informed consent process and documentation of a dialogue regarding the rationale, risks, benefits, and alternatives to the off-label option should be part of the clinician’s and the patient's decision making.

An emerging risk in this area could stem from the FDA’s “expedited development and approval” and “accelerated approval” processes. Both of these programs involve a shortened and potentially less stringent approval process by the FDA. These may increase risk exposure in off-label use of a drug which had undergone an accelerated review that may or may not have demonstrated all potentially significant adverse drug effects.

Q: What are the risk management issues related to using restraints?

A:

Federal regulations require a physician order for the application of restraints in hospitals. When possible, the need for physical or chemical restraints should be discussed with the patient (and family) before they are applied, and the wishes of the patient honored as long as the patient does not pose a danger to him/herself or others. The reasons for using restraints should be documented, and the restrained patient should be monitored at specific intervals by a health care professional. Such monitoring and assessment should be consistent with public health regulations and documented, as should the rationale leading to the discontinuance of restraints.

Q: What can/should I document in the patient medical record about HIV and AIDS?

A:

Before testing anyone for HIV, you must obtain written informed consent. Health care providers are permitted to include HIV test results and the signed consent form in the patient's medical record, even though this means disclosure without specific consent to hospital personnel with a need to know. Medical institutions should take special precautions to ensure that a patient's HIV status is not disclosed except as permitted under the law.

A separate consent form is necessary for transferring medical records containing HIV status information from one health care provider to another. Separate consent is not required for record transfer when the patient is being transferred to a different medical facility for the continuation of care. Under Massachusetts statute, no third-party payor or review organization may be privy to HIV test results without the patient's written informed consent.

An AIDS diagnosis or manifestations that associate a patient with AIDS are not protected by Massachusetts' HIV confidentiality law.

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

A:

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.

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

A:

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.

Q: What information about an adult child's health situation can be shared with parents?

A:

In most cases, none.

All individuals have a right to privacy. For this right to be violated there must be some overriding societal necessity or goal to be realized. Thus, a competent adult has a right, in most instances, to control the release of information about their health status to others, including their spouse and parents. This means that information about an adult child's health situation should not be shared with a spouse or parents (even if the child may be financially dependent), unless the adult child authorizes disclosure, or the individual requesting information has been appointed the legal guardian for an incompetent adult child. The only situations where consent would not be needed would be those limited exceptions to the physician-patient privilege, such as "the duty to warn" under certain conditions.

Q: What patient conditions must I report?

A:

Although there are some variations from state to state, physicians are generally required to report the following conditions to state or local health officials within 24-48 hours of their occurrence:

  • Abuse of children, elders, or disabled persons
  • Births, stillbirths, abortions: all live births, stillbirths of fetuses of 20 weeks gestation or more (or of 350 grams or more), and abortions when the use of an unlawful drug, instrument, or article is suspected
  • Burn injuries: affecting more than five percent of body
  • Cerebral Palsy (initial diagnosis)
  • Childhood vaccine injuries
  • Deaths
  • Diseases dangerous to the public health
  • Dog bites
  • Drug addictions
  • Gunshot wounds
  • Industrial diseases or injuries
  • Knife wounds: if criminal action is suspected
  • Poisoning caused by lead or by controlled substances
  • Sexual assault: omitting the victim's name and address 


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