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Center for Substance Abuse Treatment. Screening for Infectious Diseases Among Substance Abusers. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 1993. (Treatment Improvement Protocol (TIP) Series, No. 6.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Screening for Infectious Diseases Among Substance Abusers.

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Chapter 3 - Legal and Ethical Issues

Screening for infectious diseases among drug treatment populations offers an opportunity to identify infected individuals, provide timely medical care, and halt or slow the progression of disease. The screening process, however, may raise many difficult legal and ethical questions with respect to testing, reporting, and access to care. The implications of testing for human immunodeficiency virus (HIV), in particular, are complex. The privacy rights of patients, treatment needs, and protection of innocent parties are aspects of treatment that are not always comfortably integrated.

The following discussion is intended to provide direction for treatment providers concerning issues of access to treatment, confidentiality and informed consent, confidential and anonymous testing, testing of treatment staff, reporting of infectious diseases, contact tracing and partner notification, recordkeeping, the duty to warn, and environmental safety.

Access to Treatment

Research shows that drug treatment is effective and promotes the development of healthier, more productive members of society. Comprehensive treatment programs, which typically offer or provide referral for medical care, mental health services, social services, and infectious disease screening and treatment, are thought to be the most beneficial. These services should be available to all who need them. The Consensus Panel endorses the concept of comprehensive treatment.

Requiring individuals to be tested for infectious diseases as a condition of admission to treatment, refusing to admit otherwise eligible individuals, or providing differential treatment to such patients are practices that inhibit drug users from seeking treatment, and are actions that are likely to violate Federal and State nondiscrimination laws as well as being unethical. However, to protect the safety and health of the other patients and staff, an individual seeking treatment who is thought to have infectious tuberculosis or any other highly contagious disease such as chicken pox may be denied admission until it has been medically determined if the patient needs treatment prior to being admitted to the program.

Some accommodations by treatment providers may be needed to enable individuals to participate in and benefit from treatment services. Providers are required by Federal nondiscrimination laws to make reasonable accommodations for clients with disabilities, but not to change the basic nature of the services offered or incur undue financial hardship. For example, appointments for treatment services may need to be changed to accommodate a need of a patient with disabilities for more immediate medical care.

Segregating or providing differential treatment to persons with HIV or AIDS under the guise of protecting others from infection are practices that must generally be avoided. Other, nondiscriminatory means are usually available to protect patients and staff, and programs should implement them. Appropriate infection control and prevention measures include education and training for staff about transmission modes for HIV and other communicable diseases and preventive practices such as those detailed by the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration (CDC 1987, 1988; OSHA 1991). Treatment providers must be well trained in and up to date on these precautions and standards.

Confidentiality

The benefits of the therapeutic relationship that is so critical to the recovery of patients in treatment depend, in part, on maintaining strict confidentiality for all patient information and confidences. Patients in treatment rely on this standard of confidentiality when they enter care, and they continue to trust that their medical and personal records will be protected from unwarranted and unwanted disclosure.

The traditions of professional ethics and the desire to keep individuals from harm have protected patients' confidentiality and eventually led to legally protected rights of confidentiality. Federal laws and regulations now protect drug treatment patient records, and some State statutes may equal or exceed these Federal requirements. 1

In addition to the Federal confidentiality laws and regulations, treatment staff need to be familiar with the State confidentiality laws that affect the delivery of services in their particular communities. Similarly, patients in drug treatment programs must be told about the extent of the confidentiality protection provided by law, and when and if this protection does not exist. Discussion of the extent of confidentiality should be part of the initial interview with the patient.

Federal Laws and Regulations on Confidentiality of Drug Treatment Records

The following guidelines explain the Federal laws and regulations concerning the confidentiality of drug referral and treatment information.

General Prohibition of Disclosure

Federal confidentiality regulations prohibit disclosure of patient information as follows:

  • Except under certain limited conditions, Federal confidentiality regulations prohibit the disclosure of records or other information concerning any patient in a Federally assisted drug treatment program. 2
  • The prohibition on unauthorized disclosure applies whether or not the person seeking information already has the information, has other means of obtaining it, enjoys official status, has obtained a subpoena or warrant, or is authorized by State law. 3
  • Federal law supersedes a State law that would permit or require a disclosure prohibited by the Federal confidentiality rules. However, States may have stricter regulations concerning confidentiality than the Federal regulations. 4
  • Redisclosure of patient-identifying information is prohibited unless such disclosure is made in compliance with Federal confidentiality regulations. 5

Exceptions to the General Prohibition of Disclosure

Although the general rule is that patient-identifying information may not be disclosed, the regulations generally permit disclosures to be made with patient consent, and set out a number of circumstances in which disclosures may be made without patient consent. Each of these conditions or circumstances has its own requirements and limitations. In general, permitted disclosures are those made as follows:

  • With the written informed consent of the patient
  • Pursuant to internal program communications
  • Pursuant to a medical emergency
  • In response to a special court order following a court hearing in which disclosure is authorized
  • For the purpose of reporting a crime at the treatment program or against program personnel
  • For research or audit purposes
  • In the course of reporting child abuse or neglect
  • Pursuant to a qualified service organization agreement 6
  • In response to a request for non-patient-identifying information

State Laws on Confidentiality of Drug Treatment Records or Other Medical Information

A variety of State confidentiality laws may affect how services are provided to patients. These laws may control the release of medical records; limit the ability of persons to testify in court based on information obtained when providing professional services (testimonial privilege); or prohibit disclosure of information regarding specific diseases, such as HIV and drug use. Service providers and drug treatment staff should consult with local counsel to determine which State confidentiality laws affect their practices and develop protocols and training programs to help ensure that these laws are followed. Confidentiality is integral to the drug treatment process. Without confidentiality regulations, the patient may be discouraged from even seeking treatment, fearing the invasion of privacy and the exposure of sensitive, personal information.

Infectious Diseases Testing

There is no doubt that testing for infectious diseases can benefit patients in treatment as well as the community at large. Testing for HIV, hepatitis B, tuberculosis, and syphilis and other sexually transmitted diseases is strongly advocated for treatment populations, as it can lead patients to seek appropriate medical care, initiate preventive actions, and interrupt the transmission of disease to others.

Patients generally have the right to be informed of the meaning and implications of a positive test for infectious disease, especially HIV infection. For example, there is currently no cure for AIDS, and a positive HIV test result may be extremely distressing to some patients, even threatening their recovery effort. There is, however, clearly a benefit from treatment of HIV infection.

Historically, there has been some concern in drug treatment programs that the risk involved by testing for HIV - a potential for return to drug use - outweighed any gains, particularly if it was anticipated that the result was going to be positive. Therefore, some drug treatment centers discouraged early testing, believing that the risk of return to drug use far outweighed the benefits of knowing HIV status. This position evolved at a time when very little could be done in the way of prophylactic treatment and maintenance and promotion of health of the HIV-positive individual. Currently, there are a number of effective treatments - prophylactic and otherwise - for people who are HIV positive, and the benefits of knowing HIV status and initiating early treatment far outweigh the risk of return to drug use. Drug treatment providers are encouraged to recommend to their patients that they be tested and identify their status.

Despite the benefits or because of the risk of emotional distress, or for other reasons, some patients may choose not to undergo testing. Treatment providers need to be respectful of these choices. Patients generally have the right to refuse to be tested for infectious diseases and cannot be denied access to or continuation of treatment services based solely on that refusal.

For patients who agree to testing, the Consensus Panel recommends that consent should be obtained before any testing begins. Informed consent is required for HIV testing in many jurisdictions. In some States, minors can give informed consent without parental agreement.

State laws generally govern whether and what form of informed consent is required for medical testing (including infectious disease testing). Drug treatment providers should make sure their consent forms for HIV or other infectious diseases testing comply with applicable State laws.

Informed consent consists of communicating to the patient the risks involved and benefits to be derived from a test in a way that allows the patient to make a decision about whether or not he or she will have the test done. The practitioner involved in securing the patient's informed consent will generally include a note in the patient's record. Written informed consent requires the patient's signature on a document that specifies the above elements in a language that the patient is comfortable with. If written informed consent is required in a particular institution or jurisdiction, the consent should conform with the established guidelines of the institution or jurisdiction. If there is any question about the process, legal counsel should be sought.

Issues Concerning HIV Testing

The circumstances under which testing for HIV infection should occur have been the subject of continuing debate for a decade, although in some States, laws have resolved the issue. Arguments for mandatory versus voluntary and confidential versus anonymous testing are yet to be settled elsewhere. Anonymous testing assigns a unique identifier to each patient, and results are not traceable to an individual. Confidential testing, on the other hand, links the individual by name to test results, and confidentiality safeguards protect the test results.

The Centers for Disease Control and Prevention, the Consensus Panel, and many other professional health care associations represent the public health consensus, which strongly urges voluntary and confidential or anonymous testing for individuals at high risk for HIV.

Under current Federal law, mandatory HIV testing is required on entrance to the military; for donors of blood, organs, and tissue; Federal prisoners; and persons seeking immigration to the United States (Screening for HIV 1989). States may also require mandatory testing of individuals under certain circumstances, such as marriage applicants, mentally ill or mentally retarded patients, injection drug users, and sex offenders (Gostin 1989). In some States, the law requires the reporting of infected individuals to health authorities.

The unfortunate discrimination that persists for many HIV-positive individuals makes it particularly imperative that treatment providers act with great care to inform patients of their legal rights concerning testing. Patients need to receive professional counseling before reaching a decision about HIV testing; in some States, HIV laws mandate pre- and post-test counseling. This counseling should provide patients with important information that may affect their decisionmaking process concerning the transmission of HIV, informed consent, testing procedures, possible results, reporting requirements, and available treatments.

For patients who agree to seek HIV-antibody testing, confidential as well as anonymous procedures are available in many communities and should be discussed as alternatives with patients. In States that require the reporting of HIV-positive individuals by name to health authorities, patients may choose to use anonymous testing sites.

Reporting of Infectious Diseases

Certain infectious diseases are reportable to health authorities under State statutes and regulations. There are many variations among States concerning conditions and diseases to be reported, timeframes for reporting, agencies that should receive reports, persons required to report, conditions under which reports are required, and penalties for not reporting. In most States, local health departments rather than State health departments are the recipients of infectious disease reports. The patient needs to be made aware of these State regulations while at the same time being reassured that this information is confidential and will not be released inappropriately.

Treatment providers should seek information about the requirements of their State and develop protocols and training programs to ensure compliance. Trained health department personnel are able to provide contact tracing and notifications. A summary of general aspects of reporting follows.

Tuberculosis

All cases of active, infectious tuberculosis must be reported immediately to health authorities (CDC 1989). Confidential patient information is usually protected under State law.

Hepatitis

All cases of potentially communicable viral hepatitis must be reported immediately to health authorities (APHA 1990). Confidential patient information is usually protected under State law.

Syphilis

All cases must be reported immediately to health authorities (CDC 1990). Confidential patient information is usually protected under State law.

Other Sexually Transmitted Diseases

Reporting requirements vary significantly by disease and jurisdiction. For example, case reporting of gonorrhea is required by all States, chancroid is reportable in many States, and herpes simplex and chlamydia are reportable in only some States (Benenson 1990). Confidential patient information is usually protected under State law.

HIV and AIDS

All States require the reporting of AIDS cases, as defined by the Centers for Disease Control and Prevention, to health departments. A growing number of States specifically or implicitly require reporting of HIV-positive test results. Some, but not all, of these States require that names of individuals with positive test results be reported. The confidentiality of all reportable information is usually safeguarded by State law. Partner notifications may be conducted by trained health department personnel or health care providers at the request of patients, or by patients themselves.

Contact Tracing and Partner Notification

Many contacts and partners of infected persons are unaware of their risk for disease. The tracing and notification of these individuals gives them the opportunity to receive testing and necessary therapeutic treatment. Preventive risk reduction education and counseling can be provided when appropriate. Furthermore, surveillance data on infection rates, geographic clustering, and other information are available for the development and implementation of successful public policies for disease prevention and infection control.

Public health statutes in States usually authorize or require contact tracing for sexually transmitted diseases. Most States currently do not classify HIV infection as a sexually transmitted disease, although some States have specifically authorized or required such tracing. The informed consent of the patient must be sought for contact tracing and partner notifications in circumstances where statutes are silent. All notifications that are accomplished by persons other than the patient, regardless of the reporting requirement, are performed without revealing the identity of the patient.

While the name of the infected person is not revealed, it may be inferred by the partner in some situations. These notifications may place patients in treatment at risk for negative consequences, such as physical abuse or abandonment. Treatment providers should exercise care to protect patient confidentiality when counseling about, assisting with, or performing partner notifications and contact tracing.

Public health statutes in all States require notification to the Public Health Service of all cases of known or suspected active tuberculosis. In addition, the health department will notify any persons they believe may have been exposed to active tuberculosis. Laws mandate appropriate followup and treatment of anyone who may have acquired tuberculosis from a known exposure to an active case of tuberculosis.

Treatment Program Recordkeeping

Treatment programs have a duty to maintain records about patients in treatment to ensure adequate care. Data from treatment records are useful in monitoring patient progress, case management, seeking funding and reimbursement, and evaluating program effectiveness. Infectious disease test results may be part of the patient's treatment record. Access to records that contain this information must be kept strictly confidential, and the file that contains the information should be locked. Access to the file should be restricted to specified individuals. In States in which there are laws covering disclosure of HIV in health records, drug treatment programs need to comply with restrictions about mentioning HIV diagnosis and treatment in any patient's drug treatment records.

A number of approaches for patient recordkeeping are possible. Treatment providers should ensure that the approach selected meets all Federal- and State-prescribed requirements for confidentiality and management of HIV information where specified. Options may include

  • Maintaining a single, comprehensive record with test results integrated throughout the record and limiting access to medical staff and others authorized to have access to medical information by consent of the patient.
  • Maintaining infectious disease and/or HIV test results separately from the main part of the patient's record and limiting access to medical staff and others authorized to have access to medical information.
  • Maintaining all medical information separately from the main part of the patient's record and limiting access to medical personnel and others authorized to have access to medical information (Legal Action Center 1991).

Disclosures of Infectious Disease Information

Treatment providers need to be prepared to inform patients about any disclosure of confidential information made with their consent. Treatment providers also should have procedures in place concerning the notification of patients when information is permitted to be and is released without their consent. There are times when it may not be in the patient's best interest to sign a consent or when the patient may simply not want to sign a consent. Treatment programs can help the patient determine if signing a consent is in his or her best interest.

The Duty to Warn

In spite of strict ethical codes and legal requirements for the confidentiality of patient information, some treatment providers may find themselves under a "duty to warn" that may require a breach of confidentiality. "Duty to warn" refers to the legal duty of a physician, health care worker, or other professional to protect another individual from harm. Treatment providers may be faced with and should be prepared to resolve the conflicting obligations to protect the patient's right to confidentiality, and the duty to warn a third party. The duty to warn issue is, however, a legal issue that should be addressed through legal channels when necessary.

The legal basis for warning an individual in order to protect that person from severe or deadly harm may be provided by State law. If so, it is most likely that the State statutes allow, but do not require, that a warning be made. The moral duty to warn conflicts with the legal and professional sanctions against unauthorized disclosure of confidential patient information.

Drug treatment providers must keep in mind that, even if State law permits or requires disclosures of patient-identifying information in "duty to warn" situations, they may make such warnings only in ways that are permitted by the Federal drug confidentiality laws and regulations.

Treatment providers should be aware of applicable State laws, have procedures in place that support legally required actions, and understand that a breach of confidentiality is punishable by law.

Sources

  1. American Public Health Association. 1990. Viral hepatitis B.In: Benenson, A.S., ed. Control of Communicable Diseases in Man. 15th ed. Washington, DC: American Public Health Association.
  2. Benenson, A.S. ed. Control of Communicable Diseases in Man. 15th ed. Washington, DC: American Public Health Association, 1990.
  3. Centers for Disease Control. Recommendations for prevention of HIV transmission in health-care settings. Morbidity and Mortality Weekly Report. 1987; 36 (Supplement No.2):1S-18S, Aug. 21 [PubMed: 3112554]
  4. Centers for Disease Control. Update: Universal precautions for prevention of transmission of human immunodeficiency virus, hepatitis B virus, and other bloodborne pathogens in health-care settings. Morbidity and Mortality Weekly Report. 1988; 37(24):377'388, June 24 [PubMed: 2836717]
  5. Centers for Disease Control. Tuberculosis and human immunodeficiency virus infection: Recommendations of the Advisory Committee for the Elimination of Tuberculosis (ACET). Morbidity and Mortality Weekly Report. 1989; 38:236'238, 243'250 [PubMed: 2494425]
  6. Centers for Disease Control. Mandatory reporting of infectious diseases by clinicians and mandatory reporting of occupational disease by clinicians. Morbidity and Mortality Weekly Report. 1990. ; 39(RR-9): 1'28 [PubMed: 2163488]
  7. Gostin, L.O. Public health strategies for confronting AIDS. Journal of the American Medical Association. 1989; 261(11):1621'1630
  8. Legal Action Center of the City of New York, Inc. HIV/AIDS: A Legal, Policy and Practical Guide for Human Service Providers in New York. New York, NY: Legal Action Center. 1991.
  9. Occupational Safety and Health Administration. Occupational Exposure to Bloodborne Pathogens. 56 F.R. 235, 64004-65182, Dec. 6. 1991.
  10. Screening for HIV. In: U.S. Preventive Services Task Force. Guide to Clinical Preventive Services. Baltimore, MD: Williams & Wilkins, eds. 1989.

Footnotes

1

42 USC 290dd-3 and 290ee-3; 42 CFR, Part 2.

2

42 CFR 2.12-2.13(a).

3

42 CFR 2.13(b)-2.20.

4

42 CFR 2.20.

5

42 CFR 2.32.

6

. A qualified service organization agreement allows a drug treatment program to communicate patient-identifying information to another organization that provides the treatment program with a necessary service without a specific consent for each communication. The agreement binds the other party to respect all confidentiality requirements. 42 CFR 2.11 and 2.12 (c)(4).

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