Chapter 146

146.29 History History: 2009 a. 198.

146.31 146.31 Blood or tissue transfer services.

146.31(1) (1) It is unlawful to operate a blood bank for commercial profit.

146.31(2) (2) The procurement, processing, distribution or use of whole blood, plasma, blood products, blood derivatives and other human tissues such as corneas, bones or organs for the purpose of injecting, transfusing or transplanting any of them into the human body is declared to be, for all purposes except as provided under s. 146.345, the rendition of a service by every person participating therein and, whether or not any remuneration is paid therefor, not to be a sale of the whole blood, plasma, blood products, blood derivatives or other tissues. No person involved in the procurement, processing, distribution or use of whole blood, plasma, blood products or blood derivatives for the purpose of injecting or transfusing any of them into the human body shall be liable for damages resulting from these activities except for his or her own negligence or willful misconduct.

146.31(3) (3) No hospital, nonprofit tissue bank, physician, nurse or other medical personnel acting under the supervision and direction of a physician involved in the procurement, processing, distribution or use of human tissues such as corneas, bones or organs for the purpose of transplanting any of them into the human body shall be liable for damages resulting from those activities except for negligence or willful misconduct by that hospital, nonprofit tissue bank, physician, nurse or other medical personnel.

146.31 History History: 1975 c. 75, 76; 1987 a. 97.

146.31 Annotation Sub. (1) is unconstitutional. It violates the commerce clause, article I, section 8, and the supremacy clause, article VI, of the U.S. Constitution. State v. Interstate Blood Bank, Inc., 65 Wis. 2d 482, 222 N.W.2d 912 (1974).

146.33 146.33 Blood donors. Any person who is 17 years old or older may donate blood in any voluntary and noncompensatory blood program, and any person who is 16 years old may donate blood in such a program if his or her parent or legal guardian consents to the donation.

146.33 History History: 1971 c. 228; 1983 a. 21; 2007 a. 103.

146.34 146.34 Donation of bone marrow by a minor.

146.34(1) (1) Definitions. In this section:

146.34(1)(a) (a) “Bone marrow” means the soft material that fills human bone cavities.

146.34(1)(b) (b) “Bone marrow transplant” means the medical procedure by which transfer of bone marrow is made from the body of a person to the body of another person.

146.34(1)(c) (c) “Donor” means a minor whose bone marrow is transplanted from his or her body to the body of the minor’s brother or sister.

146.34(1)(d) (d) “Guardian” means the person named by the court under ch. 48 or 54 or ch. 880, 2003 stats., having the duty and authority of guardianship.

146.34(1)(e) (e) “Legal custodian” means a person other than a parent or guardian or an agency to whom the legal custody of a minor has been transferred by a court under ch. 48 or 938, but does not include a person who has only physical custody of a minor.

146.34(1)(f) (f) “Parent” means a biological parent, a husband who has consented to the artificial insemination of his wife under s. 891.40 or a parent by adoption. If the minor is a nonmarital child who is not adopted or whose parents do not subsequently intermarry under s. 767.803, “parent” includes a person adjudged in a judicial proceeding under ch. 48 to be the biological father of the minor. “Parent” does not include any person whose parental rights have been terminated.

146.34(1)(g) (g) “Physician” means a person licensed to practice medicine and surgery under ch. 448.

146.34(1)(h) (h) “Psychiatrist” means a physician specializing in psychiatry.

146.34(1)(i) (i) “Psychologist” means a person who is licensed to practice psychology under ch. 455, who is exercising the temporary authorization to practice, as defined in s. 455.50 (2) (o), in this state, or who is practicing under the authority to practice interjurisdictional telepsychology, as defined in s. 455.50 (2) (b).

146.34(1)(j) (j) “Relative” means a parent, grandparent, stepparent, brother, sister, first cousin, nephew or niece; or uncle or aunt within the 3rd degree of kinship as computed under s. 990.001 (16). This relationship may be by blood, marriage or adoption.

146.34(2) (2) Prohibition on donation of bone marrow by a minor. Unless the conditions under sub. (3) or (4) have been met, no minor may be a bone marrow donor in this state.

146.34(3) (3) Consent to donation of bone marrow by a minor under 12 years of age. If the medical condition of a brother or a sister of a minor who is under 12 years of age requires that the brother or sister receive a bone marrow transplant, the minor is deemed to have given consent to be a donor if all of the following conditions are met:

146.34(3)(a) (a) The physician who will remove the bone marrow from the minor has informed the parent, guardian or legal custodian of the minor of all of the following:

146.34(3)(a)1. 1. The nature of the bone marrow transplant.

146.34(3)(a)2. 2. The benefits and risks to the prospective donor and prospective recipient of performance of the bone marrow transplant.

146.34(3)(a)3. 3. The availability of procedures alternative to performance of a bone marrow transplant.

146.34(3)(b) (b) The physician of the brother or sister of the minor has determined all of the following, has confirmed those determinations through consultation with and under recommendation from a physician other than the physician under par. (a) and has provided the determinations to the parent, guardian or legal custodian under par. (e):

146.34(3)(b)1. 1. That the minor is the most acceptable donor who is available.

146.34(3)(b)2. 2. That no medically preferable alternatives to a bone marrow transplant exist for the brother or sister.

146.34(3)(c) (c) A physician other than a physician under par. (a) or (b) has determined the following and has provided the determinations to the parent, guardian or legal custodian under par. (e):

146.34(3)(c)1. 1. The minor is physically able to withstand removal of bone marrow.

146.34(3)(c)2. 2. The medical risks of removing the bone marrow from the minor and the long-term medical risks for the minor are minimal.

146.34(3)(d) (d) A psychiatrist or psychologist has evaluated the psychological status of the minor, has determined that no significant psychological risks to the minor exist if bone marrow is removed from the minor and has provided that determination to the parent, guardian or legal custodian under par. (e).

146.34(3)(e) (e) The parent, guardian or legal custodian, upon receipt of the information and the determinations under pars. (a) to (d), has given written consent to donation by the minor of the bone marrow.

146.34(4) (4) Consent to donation of bone marrow by a minor 12 years of age or over.

146.34(4)(a) (a) A minor who has attained the age of 12 years may, if the medical condition of a brother or sister of the minor requires that the brother or sister receive a bone marrow transplant, give written consent to be a donor if:

146.34(4)(a)1. 1. A psychiatrist or psychologist has evaluated the intellect and psychological status of the minor and has determined that the minor is capable of consenting.

146.34(4)(a)2. 2. The physician who will remove the bone marrow from the minor has first informed the minor of all of the following:

146.34(4)(a)2.a. a. The nature of the bone marrow transplant.

146.34(4)(a)2.b. b. The benefits and risks to the prospective donor and prospective recipient of performance of the bone marrow transplant.

146.34(4)(a)2.c. c. The availability of procedures alternative to performance of a bone marrow transplant.

146.34(4)(b) (b) If the psychiatrist or psychologist has determined under par. (a) that the minor is incapable of consenting, consent to donation of bone marrow must be obtained under the procedures under sub. (3).

146.34(5) (5) Hearing on prohibition of consent or performance.

146.34(5)(a) (a) A relative of the prospective donor or the district attorney or corporation counsel of the county of residence of the prospective donor may file a petition with the court assigned to exercise jurisdiction under chs. 48 and 938 for an order to prohibit either of the following:

146.34(5)(a)1. 1. The giving of consent under sub. (3) or (4) to donation of bone marrow.

146.34(5)(a)2. 2. If consent under sub. (3) or (4) has been given, the performance of the bone marrow transplant for which consent to donate bone marrow has been given.

146.34(5)(am) (am) Any party filing a petition for an order to prohibit performance under par. (a) 2. shall file and serve the petition within 3 days after consent has been given under sub. (3) or (4).

146.34(5)(b) (b) Any party filing a petition under par. (a) shall at the same time file with the court a statement of a physician or psychologist who has recently examined the prospective donor and which avers, if made by a physician, to a reasonable degree of medical certainty or, if made by a psychologist, to a reasonable degree of professional certainty, that the removal of bone marrow presents medical or psychological risks to the prospective donor or to the prospective recipient which outweigh all benefits to the prospective donor or to the prospective recipient.

146.34(5)(c) (c) Any party filing a petition under par. (a) and a statement under par. (b) shall, at the time of filing, provide personal service of notice of the filing and a copy of the statement to the parent, guardian or legal custodian of the prospective donor and, if the prospective donor is a minor who has attained 12 years of age, to the minor.

146.34(5)(d) (d) Following the filing of a petition under par. (a) and a statement under par. (b), the judge shall appoint a guardian ad litem under s. 48.235 for the prospective donor.

146.34(5)(e) (e) If a request for hearing is filed by the prospective donor under sub. (4) or by the parent, guardian or legal custodian within 7 days following the personal service of notice under par. (c), the court shall conduct a hearing to determine whether the giving of consent under par. (a) 1. or performance under par. (a) 2. shall be prohibited and providing the prospective donor under sub. (4) and the parent, guardian or legal custodian opportunity to rebut the statement under par. (b).

146.34(5)(f) (f) If no request for hearing is filed by the prospective donor under sub. (4) or by the parent, guardian or legal custodian within the time limit specified under par. (e), the court may do one of the following:

146.34(5)(f)1. 1. Order prohibition of consent under par. (a) 1. or performance under par. (a) 2.

146.34(5)(f)2. 2. On its own motion conduct a hearing to determine whether the giving of consent under par. (a) 1. or performance under par. (a) 2. shall be prohibited.

146.34(5)(g) (g) If the court on its own motion conducts a hearing under par. (f) 2., the court shall provide personal service of notice of the hearing to all parties and may request submission of relevant evidence.

146.34(5)(h) (h) Any person aggrieved by a final judgment or final order of the court under par. (e) or (f) may appeal within the time period specified in s. 808.04 (3) or (4).

146.34 History History: 1985 a. 50; 1995 a. 77; 1997 a. 188; 1999 a. 32, 162; 2001 a. 38; 2005 a. 387; 2005 a. 443 s. 265; 2021 a. 131.

146.343 146.343 Donation of newborn umbilical cord blood.

146.343(1) (1) In this section, “hospital” has the meaning given in s. 50.33 (2).

146.343(2) (2) Notwithstanding s. 146.33, the principal prenatal health care provider of a woman who is known to be pregnant shall, before the woman’s 35th week of pregnancy, offer her information on options to donate, to an accepting and accredited cord blood bank, blood bank, blood center, or plasma center, blood extracted from the umbilical cord of her newborn child, if the donation may be made without monetary expense for the collection or storage to the woman, to any 3rd-party payor of health care coverage for the woman, or to the hospital in which delivery occurs.

146.343(4) (4) No person may be held civilly liable for failure to comply, or for complying, with sub. (2).

146.343 History History: 2005 a. 56; 2021 a. 239.

146.345 146.345 Sale of human organs prohibited.

146.345(1) (1) In this section:

146.345(1)(a) (a) “Human organ” means a human kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone or skin or any other human organ specified by the department by rule. “Human organ” does not mean human whole blood, blood plasma, a blood product or a blood derivative or human semen.

146.345(1)(b) (b) “Human organ transplantation” means the medical procedure by which transfer of a human organ is made from the body of a person to the body of another person.

146.345(1)(c) (c) “Valuable consideration” does not include reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control or storage of a human organ or an expense of travel, housing or lost wages incurred by a human organ donor in connection with donation of the human organ.

146.345(2) (2) No person may knowingly and for valuable consideration acquire, receive or otherwise transfer any human organ for use in human organ transplantation.

146.345(3) (3) Any person who violates this section is guilty of a Class H felony, except that, notwithstanding the maximum fine specified in s. 939.50 (3) (h), the person may be fined not more than $50,000.

146.345 History History: 1987 a. 97; 1997 a. 283; 2001 a. 109.

146.348 146.348 Reimbursement in cancer clinical trial programs.

146.348(1) (1) In this section:

146.348(1)(a) (a) “Cancer clinical trial” means a research study that tests a new cancer treatment regimen on patients, including chemotherapy and other new treatments.

146.348(1)(b) (b) “Inducement” means paying a person money, including a lump sum or salary payment, to participate in a cancer clinical trial.

146.348(1)(c) (c) “Patient-subject” means a person participating in a cancer clinical trial.

146.348(2) (2) All sponsors of cancer clinical trials shall provide potential patient-subjects at the time of the informed consent process the following information:

146.348(2)(a) (a) Whether reimbursement for travel and ancillary costs may be available to patient-subjects.

146.348(2)(b) (b) That coverage of the travel and ancillary costs is done to eliminate financial barriers to enrollment in order to retain patient-subjects in the cancer clinical trial.

146.348(2)(c) (c) Whether family members, friends, or chaperones who attend the cancer clinical trial treatments to support the patient-subject may be eligible for reimbursement of their travel and ancillary costs.

146.348(3) (3) 

146.348(3)(a) (a) Reimbursement of travel, ancillary costs, and other direct patient-incurred expenses related to cancer clinical trial participation will not be considered an undue inducement to participate in a cancer clinical trial.

146.348(3)(b) (b) Reimbursement for travel and ancillary costs may not be considered coercive or as exerting undue influence to participate in a cancer clinical trial, but rather shall be considered a means to create parity in cancer clinical trial access and remove a barrier to participation for financially burdened patient-subjects.

146.348(3)(c) (c) Government, industry, public charities, private foundations and other nonprofit organizations, associations, corporations and other business entities, individuals, and any other legal or commercial entities may offer financial support to patient-subjects, or the family, friends, or chaperones of patient-subjects, to cover ancillary costs through their support of a reimbursement entity or program.

146.348(4) (4) 

146.348(4)(a) (a) Language informing patient-subjects that reimbursement entities or programs that cover travel, ancillary costs, and other direct patient-incurred expenses may be available must be submitted for review to the relevant federally designated institutional review board in conjunction with the review of a proposed cancer clinical trial and included in the informed consent form approved by the institutional review board.

146.348(4)(b) (b) A reimbursement entity or program must disclose the nature of the ancillary support and general guidelines on financial eligibility to interested patient-subjects and employ a reimbursement process that conforms to federal law and guidance.

146.348 History History: 2019 a. 150.

146.35 146.35 Female genital mutilation prohibited.