GREEN, BARTELSMEYER (Co-sponsors), WAGNER, O'CONNOR, FOLEY, LUETKENHAUS, MURRAY,
GEORGE, KELLY (27), FARNEN, KREIDER, McKENNA, MONACO, BONNER, NAEGER,
SCHEVE AND LADD STOKAN.
Read 1st time January 26, 2000, and 1000 copies ordered printed.
ANNE C. WALKER, Chief Clerk
AN ACT
Relating to the quality of patient care, with penalty provisions and an effective date for a certain section.
Section 1. 1. Hospitals and ambulatory surgical centers shall establish and implement a written policy relating to the reporting by employees of facility mismanagement or violations of applicable laws or rules, including but not limited to the quality of care of patients, patient safety, facility safety, fraudulent activity, and the ability of employees to successfully perform their assigned duties. 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 related to applicable laws or rules or which the employee reasonably believes evidences mismanagement or violations of applicable laws or rules; 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 information related to suspected mismanagement or a violation of applicable laws or rules, or in any way attempt to dissuade, prevent or interfere with an employee who wishes to report or disclose suspected mismanagement or violations of applicable laws or rules.
2. 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 section 1 or 2 of this act shall first report to the individual or individuals designated by the hospital or ambulatory surgical center pursuant to subsection 3 of section 2 of this act.
3. The provisions of this section shall not be construed to:
(1) Authorize an employee to leave his or her assigned work areas during normal work hours without following applicable rules and policies pertaining to leave, unless the employee is requested by the department of health to officially meet with department representatives;
(2) Authorize an employee to represent the employee's personal opinions as the opinions of his or her employer;
(3) Preclude the hospital or ambulatory surgical center from taking appropriate disciplinary actions against an employee, as long as the disciplinary actions are not related to an employee's good faith disclosure of information or the reporting of mismanagement or suspected violations of applicable laws or rules, including but not limited to the quality of care of patients, patient safety, facility safety, fraudulent activity, and the ability of employees to successfully perform their assigned duties;
(4) Permit an employee to disclose information that violates state or federal laws or regulations governing the confidentiality of patient records, or which impairs or diminishes the patient's rights of confidentiality of communication pursuant to state or federal law;
(5) Preclude an employee from making an independent report concerning suspected mismanagement or violations of applicable laws or rules to the department of health or to any appropriate private accreditation, public, state or federal agency;
(6) Limit the free speech rights guaranteed by the first amendment to the Constitution of the United States; or
(7) Sanction the filing of a report or disclosing information by an employee in bad faith or for purposes unrelated to a reasonable belief that mismanagement or a violation of an applicable law or rule has occurred.
Section 2. 1. Each hospital and ambulatory surgical center shall establish a process for reporting mismanagement or suspected violations of applicable laws or rules, pursuant to section 1 of this act.
2. The process shall:
(1) Be publicized through the conspicuous display of notices regarding the process in each hospital and ambulatory surgical center, and through written informational documents and training sessions provided to all employees. Employees hired after the effective date of sections 1 to 18 of this act shall receive the written documents and training within three months of beginning employment with the hospital or ambulatory surgical center. Employees hired prior to the effective date of sections 1 to 18 of this act shall receive the written documents and training within six months of the effective date of sections 1 to 18 of this act. The process shall also establish a schedule for providing ongoing education about the process for employees who have already received the written documentation and initial training;
(2) Designate a single person who is responsible for administering the reporting process who is directly responsible to the chief executive officer of the hospital or ambulatory surgical center, or the governing board if the chief executive officer is implicated in the report. The process shall also designate an alternate person for administering the reporting process should the primary designee be implicated in the report;
(3) Allow and encourage employees to freely and directly communicate, in writing or orally, with the person designated to receive reports, or the alternate person should the primary designee be implicated in the report, and shall allow employees making a report who wish to remain anonymous to do so;
(4) Within forty-eight hours of the receipt of a report, provide for notification to the employee that his or her report has been received and is being reviewed. Such notification requirement shall not apply in situations involving anonymous reports;
(5) Stipulate the maximum time period for completion of any investigations related to an employee report, not to exceed thirty days from the date the report was made;
(6) Require that the department of health be notified by the hospital or ambulatory surgical center when an investigation related to a report is initiated, and of the disposition of the investigation related to a report. Information submitted by hospitals or ambulatory surgical centers to the department of health as required in this subdivision shall be compiled and reported by the department of health in such a format that the identities of the parties remain confidential;
(7) Provide that the findings of an investigation be communicated to the employee submitting the report and who requests a response to the report;
(8) 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.
Section 3. Copies of the policy and process required pursuant to sections 1 and 2 of this act shall be included in the hospital's or ambulatory surgical center's licensure documentation submitted to the department of health pursuant to chapter 197, RSMo.
Section 4. It shall be a rebuttable presumption that a hospital or ambulatory surgical center is in compliance with the requirements of sections 1, 2 and 3 of this act if it has 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 the reporting of issues related to patient care, patient safety, facility safety, fraudulent activity and the ability of employees to successfully perform their assigned duties. The department of health shall review such corporate compliance programs to verify their implementation and to verify they meet the standards set out in this section.
Section 5. Any hospital or ambulatory surgical center that violates section 1 of this act shall be subject to a civil penalty of up to ten thousand dollars for each violation, court costs and attorney fees of the plaintiff and any other relief the court may order.
Section 6. All personnel providing patient care in hospitals or ambulatory surgical centers must demonstrate competence to perform their assigned duties and tasks. Such facilities shall not assign personnel who lack the appropriate training and education to perform professional nursing functions pursuant to section 335.016, RSMo, in lieu of a licensed registered nurse.
Section 7. 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, 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 9 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 8. 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, the department of health shall have access to information regarding the methodology required pursuant to subsection 1 of this section and documentation that verifies implementation of that methodology.
Section 9. 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 within sixty days of the effective date of sections 1 to 18 of this act, 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 two members representing licensed physicians from a list of recommended appointees provided by the Missouri state medical association.
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 professional 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 8 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 8 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 10. As used in sections 10 to 12 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) "Appropriate state regulatory body":
(a) The department of health for hospitals, ambulatory surgical centers, hospices and home health agencies;
(b) The division of aging in the department of social services for intermediate care facilities and skilled nursing facilities; and
(c) The state board of registration for the healing arts for physician offices and clinics;
(3) "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 11. 1. By December 31, 2001, medical facilities shall complete a blood-borne pathogen exposure control plan. After December 31, 2001, the plan shall be reviewed by the department of health and updated at least annually. The 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; and
(4) The relative risk of disease transmission posed by those injuries.
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 12. 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;
(d) Is not commercially available in sufficient quantities to ensure a stable and adequate supply to meet patient needs; or
(e) Is not recommended by medical facility employees, including physicians affiliated with the medical facility.
2. In reviewing policies and actions of medical facilities developed and implemented pursuant to the requirement of sections 10 to 12 of this act, the appropriate state regulatory body shall use the standards promulgated by the federal occupational safety and health administration.
Section 13. Insurers, health maintenance organizations, domestic health services corporations and the medical assistance program established pursuant to chapter 208, RSMo, shall provide in their contracts of coverage that devices for needlestick safety are a medically necessary and covered expense. The provisions of this section shall apply to policies or contracts of coverage issued or renewed on or after January 1, 2001.
Section 14. 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 8 of this act, during the period of the committee's existence.
Section 15. 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 10 of this act with needlestick injury prevention training programs in place.
Section 16. 1. In addition to the powers established in section 197.070, RSMo, 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, RSMo:
(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 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 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, RSMo.
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.
Section 17. 1. A hospital aggrieved by a decision of the department pursuant to section 16 of this act may appeal such decision to the administrative hearing commission pursuant to section 197.071, RSMo, and seek judicial review pursuant to section 621.145, RSMo.
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, RSMo, an official action of the department made pursuant to section 197.010 to 197.120, RSMo, may be appealed to a departmental hearing officer.
Section 18. 1. The department of health may adopt rules necessary to implement the provisions of sections 1 to 18 of this act.
2. No rule or portion of a rule promulgated pursuant to the authority of sections 1 to 18 of this act shall become
effective unless it has been promulgated pursuant to the provisions of chapter 536, RSMo.
Missouri House of Representatives