SENATE BILL No. 807 October 14, 1999, Introduced by Senator SCHWARZ and referred to the Committee on Health Policy. A bill to amend 1978 PA 368, entitled "Public health code," by amending section 5431 (MCL 333.5431), as amended by 1998 PA 88. THE PEOPLE OF THE STATE OF MICHIGAN ENACT: 1 Sec. 5431. (1) A health professional in charge of the care 2 of a newborn infant or, if none, the health professional in 3 charge at the birth of an infant shall administer or cause to be 4 administered to the infant a test for each of the following: 5 (a) Phenylketonuria. 6 (b) Galactosemia. 7 (c) Hypothyroidism. 8 (d) Maple syrup urine disease. 9 (e) Biotinidase deficiency. 04095'99 * CPD 2 1 (f) Sickle cell anemia. 2 (g) Congenital adrenal hyperplasia. 3 (h) Other treatable but otherwise disabling conditions as 4 designated by the department. 5 (2) THE INFORMED CONSENT REQUIREMENTS OF SECTIONS 17020 AND 6 17520 DO NOT APPLY TO THE TESTS REQUIRED UNDER SUBSECTION (1). 7 ThetestTESTS required under subsection (1) shall be adminis- 8 tered and reported within a time and under conditions prescribed 9 by the department. The department may require that thetest10 TESTS be performed by the department. 11 (3) If the results of a test administered under subsection 12 (1) are positive, the results shall be reported to the infant's 13 parents, guardian, or person in loco parentis. A person is in 14 compliance with this subsection if the person makes a good faith 15 effort to report the positive test results to the infant's par- 16 ents, guardian, or person in loco parentis. The department shall 17 promulgate rules that define a good faith effort to report posi- 18 tive test results for purposes of this subsection. 19 (4)IfSUBJECT TO THE ANNUAL ADJUSTMENT REQUIRED UNDER 20 THIS SUBSECTION AND SUBJECT TO SUBSECTION (6), IF the department 21 performsa test1 OR MORE OF THE TESTS required under 22 subsection (1), the department may charge a fee for thetest23 TESTS of not more than$25.00$39.00. The DEPARTMENT SHALL 24 ADJUST THE amountstated inPRESCRIBED BY this subsection 25shall be adjustedannually by an amount determined by the state 26 treasurer to reflect the cumulative annual percentage change in 27 the Detroit consumer price index. As used in this subsection, 04095'99 * 3 1 "Detroit consumer price index" means the most comprehensive index 2 of consumer prices available for the Detroit area from the bureau 3 of labor statistics of the United States department of labor. 4 (5) A person who violates this section or a rule promulgated 5 under this part is guilty of a misdemeanor. 6 (6) The department shall provide for a hardship waiver of 7 the fee authorized under subsection (4) under circumstances found 8 appropriate by the department. 9 (7) THE DEPARTMENT SHALL DO ALL OF THE FOLLOWING IN REGARD 10 TO THE BLOOD SPECIMENS TAKEN FOR PURPOSES OF CONDUCTING THE TESTS 11 REQUIRED UNDER SUBSECTION (1): 12 (A) BY APRIL 1, 2000, DEVELOP A SCHEDULE FOR THE RETENTION 13 AND DISPOSAL OF THE BLOOD SPECIMENS USED FOR THE TESTS AFTER THE 14 TESTS ARE COMPLETED. THE SCHEDULE SHALL MEET AT LEAST ALL OF THE 15 FOLLOWING REQUIREMENTS: 16 (i) BE CONSISTENT WITH NATIONALLY RECOGNIZED STANDARDS FOR 17 LABORATORY ACCREDITATION AND FEDERAL LAW. 18 (ii) REQUIRE THAT THE DISPOSAL BE CONDUCTED IN COMPLIANCE 19 WITH SECTION 13811. 20 (iii) REQUIRE THAT THE DISPOSAL BE CONDUCTED IN THE PRESENCE 21 OF A WITNESS. FOR PURPOSES OF THIS SUBPARAGRAPH, THE WITNESS MAY 22 BE AN INDIVIDUAL INVOLVED IN THE DISPOSAL OR ANY OTHER 23 INDIVIDUAL. 24 (iv) REQUIRE THAT A WRITTEN RECORD OF THE DISPOSAL BE MADE 25 AND KEPT, AND THAT THE WITNESS REQUIRED UNDER SUBPARAGRAPH (iii) 26 SIGNS THE RECORD. 04095'99 * 4 1 (B) ALLOW THE BLOOD SPECIMENS TO BE USED FOR MEDICAL 2 RESEARCH DURING THE RETENTION PERIOD ESTABLISHED UNDER 3 SUBDIVISION (A), AS LONG AS THE MEDICAL RESEARCH IS CONDUCTED IN 4 A MANNER THAT PRESERVES THE CONFIDENTIALITY OF THE TEST SUBJECTS 5 AND IS CONSISTENT TO PROTECT HUMAN SUBJECTS FROM RESEARCH RISKS 6 UNDER SUBPART A OF PART 46 OF SUBCHAPTER A OF TITLE 45 OF THE 7 CODE OF FEDERAL REGULATIONS. 8 (8) THE DEPARTMENT SHALL REWRITE ITS PAMPHLET EXPLAINING THE 9 REQUIREMENTS OF THIS SECTION WHEN THE SUPPLY OF PAMPHLETS IN 10 EXISTENCE ON THE EFFECTIVE DATE OF THE AMENDATORY ACT THAT ADDED 11 THIS SUBSECTION IS EXHAUSTED. WHEN THE DEPARTMENT REWRITES THE 12 EXPLANATORY PAMPHLET, IT SHALL INCLUDE AT LEAST ALL OF THE FOL- 13 LOWING INFORMATION IN THE PAMPHLET: 14 (A) THE NATURE AND PURPOSE OF THE TESTING PROGRAM REQUIRED 15 UNDER THIS SECTION, INCLUDING, BUT NOT LIMITED TO, A BRIEF 16 DESCRIPTION OF EACH CONDITION OR DISORDER LISTED IN SUBSECTION 17 (1). 18 (B) THE PURPOSE AND VALUE OF THE INFANT'S PARENT, GUARDIAN, 19 OR PERSON IN LOCO PARENTIS RETAINING A BLOOD SPECIMEN OBTAINED 20 UNDER SUBSECTION (9) IN A SAFE PLACE. 21 (C) THE DEPARTMENT'S SCHEDULE FOR RETAINING AND DISPOSING OF 22 BLOOD SPECIMENS DEVELOPED UNDER SUBSECTION (7)(A). 23 (D) THAT THE BLOOD SPECIMENS TAKEN FOR PURPOSES OF CONDUCT- 24 ING THE TESTS REQUIRED UNDER SUBSECTION (1) MAY BE USED FOR MEDI- 25 CAL RESEARCH PURSUANT TO SUBSECTION (7)(B). 26 (9) IN ADDITION TO THE REQUIREMENTS OF SUBSECTION (1), THE 27 HEALTH PROFESSIONAL DESCRIBED IN SUBSECTION (1) OR THE HOSPITAL 04095'99 * 5 1 OR OTHER FACILITY IN WHICH THE BIRTH OF AN INFANT TAKES PLACE, OR 2 BOTH, MAY OFFER TO DRAW AN ADDITIONAL BLOOD SPECIMEN FROM THE 3 INFANT. IF SUCH AN OFFER IS MADE, IT SHALL BE MADE TO THE 4 INFANT'S PARENT, GUARDIAN, OR PERSON IN LOCO PARENTIS AT THE TIME 5 THE BLOOD SPECIMENS ARE DRAWN FOR PURPOSES OF SUBSECTION (1). IF 6 THE INFANT'S PARENT, GUARDIAN, OR PERSON IN LOCO PARENTIS ACCEPTS 7 THE OFFER OF AN ADDITIONAL BLOOD SPECIMEN, THE BLOOD SPECIMEN 8 SHALL BE PRESERVED IN A MANNER THAT DOES NOT REQUIRE SPECIAL 9 STORAGE CONDITIONS OR TECHNIQUES, INCLUDING, BUT NOT LIMITED TO, 10 LAMINATION. THE HEALTH PROFESSIONAL OR HOSPITAL OR OTHER FACIL- 11 ITY EMPLOYEE MAKING THE OFFER SHALL EXPLAIN TO THE PARENT, GUARD- 12 IAN, OR PERSON IN LOCO PARENTIS AT THE TIME THE OFFER IS MADE 13 THAT THE ADDITIONAL BLOOD SPECIMEN CAN BE USED FOR FUTURE IDENTI- 14 FICATION PURPOSES AND SHOULD BE KEPT IN A SAFE PLACE. THE HEALTH 15 PROFESSIONAL OR HOSPITAL OR OTHER FACILITY MAKING THE OFFER MAY 16 CHARGE A FEE THAT IS NOT MORE THAN THE ACTUAL COST OF OBTAINING 17 AND PRESERVING THE ADDITIONAL BLOOD SPECIMEN. 04095'99 * Final page. CPD