ANNE C. WALKER, Chief Clerk
AN ACT
Relating to the quality of patient care, with penalty provisions and an effective date for certain sections.
Section 1. 1. Hospitals and ambulatory surgical centers shall establish and implement a written policy relating to the protections for employees who disclose information pursuant to subsection 2 of this section. At a minimum, such policy shall include the following provisions:
(1) No supervisor or individual with authority to hire or fire in a hospital or ambulatory surgical center shall prohibit employees from disclosing information pursuant to subsection 2 of this section; and
(2) No supervisor or individual with authority to hire or fire in a hospital or ambulatory surgical center shall use or threaten to use his or her supervisory authority to knowingly discriminate against, penalize or in any way retaliate against or harass an employee because the employee in good faith reported or disclosed any information pursuant to subsection 2 of this section, or in any way attempt to dissuade, prevent or interfere with an employee who wishes to report or disclose such information.
2. Sections 1 and 2 of this act shall apply to information disclosed or reported in good faith by an employee concerning:
(1) Alleged facility mismanagement or fraudulent activity;
(2) Alleged violations of applicable federal or state laws or administrative rules concerning patient care, patient safety or facility safety; or
(3) The ability of employees to successfully perform their assigned duties.
3. Prior to any disclosure to individuals or agencies other than the department of health, employees wishing to make a disclosure pursuant to the provisions of this section shall first report to the individual or individuals designated by the hospital or ambulatory surgical center pursuant to subsection 3 of this section.
4. Each hospital and ambulatory surgical center shall have a corporate compliance program that meets the reporting of complaint standards established by the Office of Inspector General of the federal Department of Health and Human Services for such programs. Such complaint standards shall include, but not be limited to information reported or disclosed pursuant to subsection 2 of this section. The corporate compliance program adopted by each hospital and ambulatory surgical center shall include a time frame for completion of investigations related to complaints, not to exceed thirty days, and a method for notifying the complainant and the department of health of the disposition of the investigation. All corporate compliance programs shall also identify a designated person responsible for administering the reporting and investigation process and an alternate person should the primary designee be implicated in the report. The department of health shall review such corporate compliance programs to verify their implementation and to verify that they meet the standards set out in this section.
5. Each corporate compliance plan shall allow employees making a report who wish to remain anonymous to do so, and shall include safeguards to protect the confidentiality of the employee making the report, the confidentiality of patients and the integrity of data, information and medical records.
6. Each hospital and ambulatory surgical center shall notify the department of health when an investigation related to a report is initiated and within forty-eight hours of the receipt of a report, shall notify the employee that his or her report has been received and is being reviewed.
Section 2. Any hospital or ambulatory surgical center that violates section 1 of this act may be liable in a civil action for damages, court costs, attorney fees and any equitable relief that the court may order.
Section 3. Hospitals and ambulatory surgical centers shall not assign personnel who lack the appropriate training and education to provide patient care services. Nothing in this section shall be construed to preclude licensed, certified or registered personnel from providing care within the scope of their respective license, certification or registration as authorized by state or federal law or regulation.
Section 4. By July 1, 2001, all hospitals and ambulatory surgical centers shall have established training programs, with measurable minimal training outcomes relating to quality of patient care and patient safety, for all unlicensed staff providing patient care in their facility. Such training may be established by the department of health, the facility or a professional health-related organization, such as a certification entity, and shall be provided to all unlicensed staff providing patient care within ninety days of the beginning date of employment. It shall be a requirement of the licensure required pursuant to chapter 197, RSMo, that all hospitals and ambulatory surgical centers submit documentation to the department of health on the training program used, the minimal training requirements and completion of the required training by unlicensed staff providing patient care. The department of health shall collaborate with the technical advisory committee established pursuant to section 6 of this act to develop recommendations for standardized minimal training requirements for unlicensed staff and report such recommendations to the speaker of the house of representatives and the president pro tem of the senate by December 31, 2002.
Section 5. 1. All hospitals and ambulatory surgical centers shall develop and implement a methodology which ensures adequate nurse staffing that will meet the needs of patients. At a minimum, there shall be on duty at all times a sufficient number of licensed registered nurses to provide patient care requiring the judgment and skills of a licensed registered nurse and to oversee the activities of all nursing personnel.
2. There shall be sufficient licensed and ancillary nursing personnel on duty on each nursing unit to meet the needs of each patient in accordance with accepted standards of nursing practice.
3. By December 31, 2000, all hospitals and ambulatory surgical centers shall report to the department of health regarding the methodology required pursuant to subsection 1 of this section and verify implementation of that methodology.
Section 6. 1. There is hereby established a "Technical Advisory Committee on the Quality of Patient Care and Nursing Practices" within the department of health. The committee shall be comprised of nine members appointed by the governor on or before December 1, 2000, two of whom shall be representatives of the department of health and one of whom shall be a representative of the general public. In addition, the governor shall appoint two members representing licensed registered nurses from a list of recommended appointees provided by the Missouri nurses association, two members from a list of recommended appointees provided by the Missouri hospital association, and one member representing licensed physicians from a list of recommended appointees provided by the Missouri state medical association and one member representing licensed osteopaths from a list of recommended appointees provided by the Missouri association of osteopathic physicians and surgeons.
2. The committee shall work with hospitals, nurses, physicians, state agencies, community groups and academic researchers to develop specific recommendations related to improving the quality of patient care and insuring the safe, efficient and appropriate employment of licensed nurses within hospitals and ambulatory surgical centers.
3. Each year the committee shall select for analysis, either by direction of the general assembly or through committee consensus, at least one issue related to improving the quality of patient care or nursing practices. The committee shall have access to the information collected by the department of health pursuant to section 5 of this act. The committee shall develop recommendations and submit a report based on such recommendations to the governor, the speaker of the house of representatives, the president pro tem of the senate and the department of health no later than December thirty-first of each year, beginning in 2001.
4. The initial issue considered by the committee shall relate to the appropriate licensed nurse staffing levels within hospitals and ambulatory surgical centers that optimize the quality of patient care and efficiency of hospital nursing care and which maximize the professional expertise of licensed nursing staff. During its initial year, the committee shall develop recommendations related to appropriate licensed nurse staffing levels by deriving staffing indicators based on performance and outcome measures reflective of the variations in intensity and acuity of various nursing interventions. The committee's recommendations on the appropriate licensed nurse staffing levels shall take into consideration the patient's care needs, the severity or acuity of the patient's condition, the health care services needed by the patient and the complexity of such services. The committee's initial report shall also include recommendations related to the appropriate staffing patterns of ancillary nursing and nonlicensed personnel employed in a hospital or ambulatory surgical center, the role of physicians and licensed registered nurses in the training and supervision of ancillary nursing and nonlicensed personnel and inclusion of documentation on the recommended staffing patterns with the licensure documentation submitted to the department of health pursuant to section 5 of this act and chapter 197, RSMo. The committee's recommendations shall consider the nursing process elements of assessment, nursing diagnosis, planning, intervention evaluation and, as circumstances require, patient advocacy performed in the planning and delivery of care for patients.
5. The department of health shall provide such support as the committee members require to aid it in the performance of its duties.
6. Committee members shall not be compensated for their services but shall be reimbursed for their actual and necessary expenses incurred in the performance of their duties.
7. The provisions of this section shall expire on December 31, 2006.
Section 7. As used in sections 7 to 9 of this act, the following terms shall mean:
(1) "Medical facility", a hospital, ambulatory surgical center, licensed ambulance service, intermediate care facility, skilled nursing facility, physician office or clinic, hospice or home health agency;
(2) "Needlestick injury", the parenteral introduction into the body of a medical facility employee, including physicians affiliated with the medical facility, of blood or other potentially infectious material by a needle device during the employee's performance of health care duties.
Section 8. 1. By December 31, 2001, medical facilities shall complete a blood-borne pathogen exposure control plan. After December 31, 2001, each plan shall be updated at least annually and made available upon request of the department of health. Each plan shall include an assessment of:
(1) Available needle safety technology;
(2) Work practices in medical facilities which are related to needlestick injuries, including whether length of time worked during a particular shift correlates with the incidence of needlestick injuries and identification of those practices which can reduce the risks of such injuries;
(3) The incidence of injuries to medical facility employees and patients that are collected under the guidelines of the federal occupational health and safety administration governing blood-borne pathogens or needlestick injuries;
(4) The relative risk of disease transmission posed by those injuries; and
(5) The facility's plan to control exposure to blood-borne pathogens.
2. The assessment of available needle safety technology shall allow for the review and assessment of the technology by medical facility employees, including physicians affiliated with the medical facility.
Section 9. 1. By December 31, 2002, medical facilities shall adopt needle safety technology in accordance with the following:
(1) Adoption of needle safety technology shall be implemented in ways that give priority to those cases and devices in which the risk of needlestick injuries is greatest;
(2) Use of a particular needle safety technology shall not be required when the assessment performed pursuant to this section provides evidence that the technology:
(a) Does not enhance employee or patient safety;
(b) Interferes with the quality of patient care;
(c) Interferes with the successful performance of a medical procedure, including but not limited to incompatibility of the needle safety technology with other patient care technology within the medical facility; or
(d) Is not commercially available in sufficient quantities to ensure a stable and adequate supply to meet patient needs;
(3) Until December 31, 2002, sections 7 to 9 of this act shall not be construed to prohibit the use of a prefilled syringe or other prefilled medication delivery device that is approved by the federal Food and Drug Administration.
2. As used in this section, the following terms mean:
(1) "Appropriate state regulatory body":
(a) The department of health for hospitals, ambulatory surgical centers, licensed ambulance services, hospices and home health agencies; and
(b) The division of aging in the department of social services for intermediate care facilities and skilled nursing facilities;
(2) "Medical facility", a hospital, ambulatory surgical center, licensed ambulance service, intermediate care facility, skilled nursing facility, hospice or home health agency.
3. In reviewing policies and actions of medical facilities developed and implemented pursuant to the requirements of this section, the appropriate state regulatory body shall use the standards promulgated by the federal occupational safety and health administration.
Section 10. 1. Each entity offering individual and group health insurance policies providing coverage on an expense-incurred basis, individual and group service or indemnity type contracts issued by a health services corporation, individual and group service contracts issued by a health maintenance organization, all self-insured group arrangements, to the extent not preempted by federal law, and all managed health care delivery entities of any type or description, including the medical assistance program established in chapter 208, RSMo, that are delivered, issued for delivery, continued or renewed in this state on or after January 1, 2001, shall offer coverage for all needlestick safety devices.
2. Health care services required by this section shall not be subject to any greater deductible or co-payment than any other health care service provided by the policy, contract or plan.
3. No entity enumerated in subsection 1 of this section may reduce or eliminate coverage due to the requirements of this section.
Section 11. By February first of each year beginning in 2002, the department of health shall issue an annual report to the governor, the speaker of the house of representatives and the president pro tem of the senate, on the use of needle safety technology as a means of reducing needlestick injuries. The report shall include information on the costs of needle safety technology and the enactment of federal and other state laws requiring the use of needle safety technology. The department of health shall prepare the report on needle safety technology in collaboration with the committee established pursuant to section 6 of this act, during the period of the committee's existence.
Section 12. The department of health shall annually determine the number of hospitals and ambulatory surgical centers with corporate compliance plans and the number of medical facilities as defined pursuant to section 7 of this act with needlestick injury prevention training programs in place.
Section 13. 1. In addition to the powers established in sections 197.070 and 197.220, RSMo, the department of health shall use the following standards for enforcing hospital and ambulatory surgical center licensure regulations promulgated to enforce the provisions of sections 197.010 to 197.120, RSMo, and sections 197.200 to 197.240, RSMo:
(1) Upon notification of a deficiency in meeting regulatory standards, the hospital or ambulatory surgical center shall develop and implement a plan of correction approved by the department which includes, but is 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 or ambulatory surgical center to develop and implement another approved plan of correction pursuant to subdivision (1) of this subsection; or
(b) Require the hospital or ambulatory surgical center 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 or ambulatory surgical center has had an opportunity to correct such deficiency, the department may restrict new inpatient admissions or outpatient entrants to the 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 or ambulatory surgical center has had an opportunity to correct such deficiency, the department may suspend operations in all or part of the service or services affected by such deficiency;
(5) If there is a continuing deficiency after suspension of operations pursuant to subdivision (4) of this subsection, the department may deny, suspend or revoke the hospital's or ambulatory surgical center's license pursuant to section 197.070, RSMo, or section 197.220, RSMo.
2. Notwithstanding the provisions of subsection 1 of this section to the contrary, if a deficiency in meeting licensure standards presents a clear and present danger to the safety of patients served by the hospital or ambulatory surgical center, the department may, based on the scope and severity of the deficiency, restrict access to the service or services affected by the deficiency until the hospital or ambulatory surgical center 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 regulation of the department of health and such decisions shall be approved by the bureau of health facility licensing in 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.
Section 14. 1. A hospital or ambulatory surgical center aggrieved by a decision of the department pursuant to section 13 of this act may appeal such decision to the administrative hearing commission pursuant to section 197.071, RSMo, or section 197.221, RSMo, and seek judicial review pursuant to section 621.145, RSMo. An appeal of an 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. The hospital or ambulatory surgical center may apply to the administrative hearing commission for an order to stay or suspend any such departmental action pending the commission's findings and ruling as authorized by section 621.035, RSMo.
2. If both the department and the hospital or ambulatory surgical center agree to do so, prior to an appeal to the administrative hearing commission pursuant to section 197.071, RSMo, or section 197.221, RSMo, an official action of the department made pursuant to sections 197.010 to 197.120, RSMo, or sections 197.200 to 197.240, RSMo, may be appealed to a departmental hearing officer. The department of health shall promulgate rules specifying 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.
Section 15. 1. The department of health may adopt rules necessary to implement the provisions of sections 1 to 15 of this act.
2. No rule or portion of a rule promulgated pursuant to the authority of sections 1 to 15 of this act shall become effective unless it has been promulgated pursuant to the provisions of chapter 536, RSMo.
Section B. Sections 1 and 2 of this act shall become effective January 1, 2001.
Missouri House of Representatives