With relatively little fanfare, Massachusetts Governor Deval Patrick signed S.2158, into law on April 27, 2012, making HIV testing possible with simply verbal consent, as opposed to written consent. The legislation amends Mass. Gen. L. ch. 111, section 70F; its aim is to increase screening for HIV and I believe it will have that effect.
Will the change in the law have an impact on health information management? I believe it will. If there are more HIV tests, there will be more HIV records. And if there are more HIV tests, there will be more requests for HIV records.
The Massachusetts Department of Public Health has published some FAQs that are worth reviewing in this regard:
Q. Does the consent signed by the patient have to be lengthy in order to meet the “written informed consent” requirement?
A. No. The law is silent on the issue of what the consent must look like. A simple statement indicating that the patient understands what s/he is being tested for and agrees to be tested is sufficient. (See attached model consent form.)
Q. Does 70F require a pre‐test counseling session before an HIV test is administered?
A. No. Section 70F does not mention counseling.
Q. Does the law specify that the signed consent must “follow” the patient through the health care facility (e.g., from the ordering physician to the laboratory to follow‐up care)?
A. No. As long as the patient has been informed about the test and has signed a consent, the consent itself need not be held or viewed by other staff involved in the testing or follow‐up process. The signature of the ordering physician on the test request form will serve as notice that the patient has provided written informed consent.
Q. Does the law specify who may obtain consent from a patient or who may conduct specimen procurement, interpretation of results, or delivery of results to patients?
A. No. The law is silent on this point. Anyone who is authorized by the state to conduct HIV testing, including rapid testing and collection of oral mucosal samples, may obtain consent and participate in all other ways in the testing and follow‐up procedures. Authorized individuals may include HIV testing counselors, physicians, nurses, nurse practitioners, physician assistants, and other health care professionals.
Q. May an HIV test consent be included among other consents and legal documents at intake? For instance, may the consent for HIV testing be part of a general consent to care developed by individual sites?
A. Yes. The consent may be part of a general consent to care form as long as the language pertaining to the HIV test is distinct from the rest of the consent. Provided that the person consenting to the HIV test is informed about the test and understands what it is, there is nothing in 70F that prohibits health care providers from including the consent with other materials and from obtaining the consent at intake. If the consent to HIV testing is temporally separate from the test itself, the provider should let the individual know when the test is actually performed.
Q. Does the law specify how the signed consent needs to be stored?
A. No. Section 70F does not mention storage of consent forms. Existing rules and regulations regarding confidential storage of medical records apply to consent forms for HIV testing.
Q. Does the law require a time‐limit on the consent?
A. No, the law does not. The MDPH recommends that consent expire after no more than one year.