ANNE C. WALKER, Chief Clerk
AN ACT
To amend chapters 192 and 197, RSMo, by adding thereto four new sections relating to department of health, division of health standards and licensure.
Section A. Chapters 192 and 197, RSMo, are amended by adding thereto four new sections, to be known as sections 192.950, 197.075, 197.076 and 197.132, to read as follows:
192.950. 1. As used in this section, the following terms mean:
(1) "Assistive reproductive technology" or "ART", all clinical treatments and laboratory procedures which include the handling of human oocytes and sperm, or embryos with the intent of establishing a pregnancy. Assistive reproductive technology includes, but is not limited to, in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, embryo cryopreservation, oocyte or embryo donation, and gestational surrogacy;
(2) "Department", the department of health;
(3) "Embryo", the normal fertilized egg that has undergone one or more divisions;
(4) "Embryo laboratory", a facility in which human oocytes and sperm, or embryos are subject to ART laboratory procedures;
(5) "Oocyte", the female reproductive cell, also called an egg.
2. In order to provide accurate consumer information on fertility resources practices and procedures, the department of health shall establish a registration program for embryo laboratories. Beginning January 1, 2001, registration shall be required for all laboratories that provide ART laboratory procedures for the treatment of infertility in order to operate in the state of Missouri. Such registration shall include the following information:
(1) Ownership data, including the name and address of the owner of the laboratory;
(2) Laboratory data, including the location and mailing address of the laboratory;
(3) The number and qualifications of employees of the laboratory; and
(4) Any quality assurance measures implemented by the laboratory.
3. Every embryo lab that registers with the department shall:
(1) Provide the department with all registration information and information relating to success rates;
(2) Provide each client with the department of health's information on ART labs and the department's telephone number for information and complaints.
4. The department of health shall:
(1) Keep a record of consumer complaints relating to embryo laboratories;
(2) Provide an information and compliant telephone number to consumers. Such number may be an existing department telephone line;
(3) Provide information to consumers on ART labs;
(4) Collect success rate and registration data;
(5) Act as an intermediary between a complainant and an ART lab;
(6) By January 1, 2003, prepare a report for the speaker of the house of representatives, the president pro tem of the senate and the chairs of the house and senate public health committees containing success rate and registration information and possible recommendations for further regulation of or implementation of a certification process for embryo labs in this state.
5. The department may, by rule, establish a fee to cover the costs associated with the registration process required in this section.
6. The department shall promulgate rules and regulations to implement the provisions of this section. No rule or portion of a rule shall become effective unless it has been promulgated pursuant to the provisions of chapter 536, RSMo.
197.075. 1. In addition to the powers established in section 197.070, the department of health shall use the following standards for enforcing hospital licensure regulations promulgated to enforce the provisions of sections 197.010 to 197.120:
(1) Upon notification of a deficiency in meeting regulatory standards, the hospital shall develop and implement a plan of correction approved by the department which includes, but not limited to, the specific type of corrective action to be taken and an estimated time to complete such action;
(2) If the plan as implemented does not correct the deficiency, the department may either:
(a) Direct the hospital to develop and implement another approved plan of correction pursuant to subdivision (1) of this subsection; or
(b) Require the hospital to implement an approved plan of correction developed by the department;
(3) If there is a continuing deficiency after a departmental order pursuant to subdivision (2) of this subsection and the hospital has had an opportunity to correct such deficiency, the department may restrict new inpatient admissions or outpatient entrants to the hospital service or services affected by such deficiency;
(4) If there is a continuing deficiency after the department restricts new admissions pursuant to subdivision (3) of this subsection and the hospital has had an opportunity to correct such deficiency, the department may suspend operations in all or part of the hospital service or services affected by such deficiency;
(5) If there is a continuing deficiency after suspension of hospital operations pursuant to subdivision (4) of this subsection, the department may deny, suspend or revoke the hospital's license pursuant to section 197.070.
2. Notwithstanding the provisions of subsection 1 of this section to the contrary, if a deficiency in meeting hospital licensure standards presents a clear and present danger to the safety of patients served by the hospital, the department may, based on the scope and severity of the deficiency, restrict access to the hospital service or services affected by the deficiency until the hospital has developed and implemented an approved plan of correction. Decisions as to whether a deficiency constitutes a clear and present danger shall be made in accordance with guidelines established pursuant to regulations of the department of health. Such decisions shall be approved by the director of the bureau of health facility licensing within the department of health, or its successor agency, or by a person authorized by the guidelines to approve such decisions in the absence of the director.
197.076. 1. A hospital aggrieved by a decision of the department pursuant to section 197.075 may appeal such decision to the administrative hearing commission pursuant to section 197.071 and seek judicial review pursuant to section 621.145, RSMo. An appeal of the departmental action to restrict new inpatient admissions or outpatient entrants, suspend operations or revoke a license shall be heard on an expedited basis by the administrative hearing commission.
2. If both the department and the hospital agree to do so, prior to an appeal to the administrative hearing commission pursuant to section 197.071, an official action of the department made pursuant to section 197.010 to 197.120 may be appealed to a departmental hearing officer. The department of health shall promulgate regulations to specify the qualifications of such a hearing officer, establish procedures to ensure impartial decisions and provide for comparable appeal remedies when a departmental hearing officer is unavailable.
197.132. The department of health and licensed hospitals may jointly design and implement a pilot project to develop and assess an alternative model for enforcing hospital licensure standards. The pilot project may apply the alternative model in hospitals or multihospital systems that choose to participate. The pilot project shall:
(1) Provide for regular submission of data to the department by participating hospitals to verify compliance with patient safety and regulatory accountability standards;
(2) Provide a mechanism for the department to verify the accuracy and completeness of the data submitted by the participating hospitals and compliance with patient safety standards;
(3) Permit fewer or less comprehensive hospital inspections by the department if the data submitted to the department provides satisfactory evidence of positive patient outcomes and that there are no indicators of regulatory deficiencies which may adversely affect patient safety or quality of care;
(4) Provide for inspections, including but not limited to unannounced inspections or any other verification measures necessary to assure equivalent or greater patient safety than provided for under the traditional hospital licensure process;
(5) Be designed to allow the department and participating hospitals to focus their resources on quality assurance and improvement in areas of services identified by the data submitted. Nothing in this subdivision shall be interpreted to preclude an investigation based on a report to the elder abuse and neglect hot line;
(6) Allow the department and hospitals to collaborate in establishing benchmarks for assessing hospital performance and identifying trends in hospital operations; and
(7) Provide the following protections for confidentiality of patient care data submitted by the participating hospitals to the department of health or nationally recognized private accreditation agencies for hospitals:
(a) Copies of original documents and data on quality of patient care which are provided to the department pursuant to the pilot project shall be confidential and shall not be further disclosed by the department. Such documents and data shall be considered a closed record for purposes of chapter 610, RSMo, and shall not be subject to subpoena or subpoena duces tecum in any civil or criminal action;
(b) In reviewing the documents and data provided to the department pursuant to the pilot project, the department
shall be deemed an organization formed pursuant to state law to exercise the responsibilities of a peer review
committee and shall be subject to the provisions of section 537.035, RSMo. In addition, such committee acting
under the auspices of a nationally recognized hospital accrediting organization, including the joint commission on
accreditation of health organizations and the American Osteopathic Association, shall be deemed an organization
formed pursuant to state law to exercise the responsibilities of a peer review committee and shall be subject to the
provisions of section 537.035, RSMo.
Missouri House of Representatives