Section 0940-01-03-.02 - PROCEDURES RELATING TO INFORMED CONSENT UNDER RULE 0940-1-1-03(1) A resident's consent for a class of medication may be obtained only by a staff member who has satisfactorily completed the DMHMR course established under rule 0940-1-1-.09(4). A resident's consent may be obtained by such a staff member only after: (a) a clinical professional has determined that the resident does not lack capacity, and(b) a clinical professional who is qualified to obtain consent has discussed the following with the resident: the nature, type dosage, and route of the medication prescribed and the anticipated benefits; the risks, consequences and side effects of the medication; the advantages and risks of alternative treatments; and the prognosis if the medication is not given; and(c) a staff member who is qualified to obtain consent has provided the resident with a consent form and medication fact sheet, discussed the content of the form and sheet, offered to answer questions and advised the resident that the resident may revoke consent at any time.(2) Any member of the developmental center staff may encourage a resident to consent to take medication. A consent is not voluntary if it is given in response to force or the threat of force, discharge, involuntary commitment, transfer to a more restrictive environment, or loss of privileges. Providing information about the benefits of taking medication and adverse consequences of not taking medication is permitted.(3) Consent forms shall be kept in the resident's chart. The medication information fact sheet shall be accessible to the resident upon request.(4) The medication information fact sheet shall include:(a) names of the medication (trade or generic),(b) nature of the medication (e.g. major tranquilizer),(c) dosages, ranges and usual routes of administration,(d) use and usual effects,(e) significant risks, consequences and side effects.(f) measures which might counter side effects, and(g) any other considerations helpful in securing informed consent and promoting optimal effect of the medication.(5) Consent forms shall include notice of:(a) a voluntary resident's right to refuse psychotropic medication except in emergency,(b) an involuntary resident's rights to refuse and to seek review under these rules,(c) a resident's right of access to IDT members to assist if the resident has questions about or wishes to refuse medication,(d) the definition of emergency and the duration of medication allowed in emergency situations, and(e) the right of revocation and procedures and for revocation.(6) The consent form shall state the class of medication prescribed. It shall contain an acknowledgment that the staff member who obtained the consent has fully discussed with the resident the contents of the consent form and medication information fact sheet and offered to answer questions and advised that the consent may be revoked at any time. Such discussion shall include nature, type, dosage, and route of the medication prescribed and the anticipated benefits; the risks, consequences and side effects of the medication; the advantages and risks of alternative treatments; the prognosis if the medication is not given. The form shall include the name of each person who performed the steps required by subsections (1) (a) - (c).(7) The consent form shall be signed and dated by the person consenting and the person who obtained the consent. If a resident or guardian gives oral consent to medication but refuses or is unable to sign the consent form, oral consent shall be noted on the consent form and witnessed by a second staff member.Tenn. Comp. R. & Regs. 0940-01-03-.02
(For Administrative History prior to February, 1985, see page 1.001). New rule filed January 9, 1985; effective February 8, 1985.Authority: T.C.A. §§ 33-1-203 through 33-1-205, 33-3-104 and 33-3-105.