COMMITTEE ON LEGISLATIVE RESEARCH

OVERSIGHT DIVISION



FISCAL NOTE



L.R. No.: 4608-07

Bill No.: Truly Agreed to and Finally Passed HCS for SS for SCS for SB 1279

Subject: Health Care; Health Care Professionals; Health Department; Hospitals; Health, Public; Vital Statistics

Type: Original

Date: June 7, 2004




FISCAL SUMMARY



ESTIMATED NET EFFECT ON GENERAL REVENUE FUND
FUND AFFECTED FY 2005 FY 2006 FY 2007
General Revenue ($490,739) ($536,824) ($550,587)
Total Estimated

Net Effect on

General Revenue

Fund

($490,739) ($536,824) ($550,587)



ESTIMATED NET EFFECT ON OTHER STATE FUNDS
FUND AFFECTED FY 2005 FY 2006 FY 2007
Infection Control Advisory Panel Fund $0 to Unknown $0 to Unknown $0 to Unknown
Total Estimated

Net Effect on All

State Funds

$0 to Unknown $0 to Unknown $0 to Unknown



Numbers within parentheses: ( ) indicate costs or losses.

This fiscal note contains 10 pages.











ESTIMATED NET EFFECT ON FEDERAL FUNDS
FUND AFFECTED FY 2005 FY 2006 FY 2007
Total Estimated

Net Effect on All

Federal Funds

$0 $0 $0



ESTIMATED NET EFFECT ON LOCAL FUNDS
FUND AFFECTED FY 2005 FY 2006 FY 2007
Local Government (Unknown) (Unknown) (Unknown)


FISCAL ANALYSIS



ASSUMPTION



Officials from the Department of Health and Senior Services (DOH) state the proposal requires DOH to collect and analyze data on nosomocial infection data from health care providers including hospitals, produce a consumer guide on findings and trends, and implement prevention and control strategies. DOH states 125 hospitals will be required to submit data on nosocomial infections in their respective hospitals. There are approximately 725,000 Missouri patients annually. DOH assumes that 7% of the patients in Missouri hospitals have a nosocomial infection, or 725,000 x .07 = 50,750 cases per year. The proposal requires that the DOH collect sufficient information to risk adjust the data. DOH estimates that a minimum of 20 data elements per record or 50,750 x 20 = 1,015,000 data items per year would have to be collected.



DOH states it would need to revise hospital and ambulatory surgical center regulations to reflect the proposal's infection control provisions. The statutory and regulatory changes will result in: (1) Additional infection control complaints that will require investigation, (2) Increased inspection time due to need to evaluate compliance with additional statutory and regulatory requirements, and (3) Increased inspection/investigation time due to identification of infection control problems stemming from receipt and analysis of infection data from facilities.





ASSUMPTION (continued)



DOH states it is required to implement surveillance, educational, and control activities as part of the legislation.



Staffing:

Division of Environmental Health Care and Communicable Disease Prevention



Health Educator III - This position is responsible for planning and directing prevention and control strategies in collaboration with providers, developing and using various educational materials and methods, working with health care providers, medical associations and consumers to implement activities, and coordinating the publication of a consumer guide.



Epidemiology Specialist - This position is responsible for the collection and review and analysis of nosocomial infection data, preparation of reports on findings and trends in antibiotic resistance, and developing data for presentation in publications including articles.



Center for Health Information Management and Evaluation

Three Research Analyst IIIs and 1 Senior Office Support Assistant will be needed to:

· Determine what data elements are needed to conduct the required analysis.

· Publish rules.

· Create data reporting requirements.

· Prepare correspondence with hospitals on the reporting requirements.

· Create computer edits to ensure clean data.

· Correspond with hospitals on edit reports.

· Create management controls to ensure hospitals are reporting according to the rules.

· Correspond with hospitals that are not responding as required.

· Create a database for analysis.

· Conduct a later review on appropriate risk adjustment techniques.

· Develop a risk adjustment technique suitable for the data.

· Create reports on hospitals.

· Publish reports on a quarterly basis.

· Correspond with hospital concerning complaints about the reports.

· Respond to consumers and media inquiries about the report.



DOH reports in federal fiscal year 2003, 16 complaints were received alleging infection control issues in regulated health care facilities. As of March 11, 2004 of federal fiscal year 2004, 9 such complaints have been received. If this rate continues through the remainder of federal fiscal year 2004, approximately 22 infection control complaints will be received. Assuming a doubling of the rate of complaints due to the increased visibility and patient education resulting from this ASSUMPTION (continued)



legislation, an additional 22 complaints would need to be investigated each year. Infection control complaints are some of the most time consuming to investigate because they involve extensive observation in multiple areas of the hospital. DOH estimates a typical infection control complaint investigation following the statutory and regulatory changes would require 56 hours for investigation, write-up, and follow-up. This results in the need for an additional 1,232 hours of employee time (22 additional investigations x 56 hrs./investigation).



DOH estimates that statutory and regulatory changes would result in adding an additional 8 hours of inspection time for each of the 150 hospitals and an additional 6 hours of inspection time for each of the 62 ambulatory surgical centers licensed each year. This additional time for inspections includes write-up, and follow-up time in addition to the additional time at the facility. These changes will result in the need for an additional 1,572 hours of employee time [(150 facilities x 8 hours) + (62 facilities x 6 hours)].



The number of additional inspections/investigations that might be necessitated by concerns resulting from receipt and analysis of infection data is unknown at this time.



Total estimated hours of additional employee time:

Increased complaint investigations 1,232 hours

Increased inspection time 1,572 hours

Inspections/Investigations due to concerns

identified by data Unknown

Total 2,804 hours plus



Two FTE full-time Health Facility Nursing Consultants would be needed to assume the additional duties involved above. It would be necessary to hire inspectors that have extensive knowledge and experience in infection control; therefore, DOH has used an annual salary rate of $53,484 instead of the market rate of $49,140 annually (4 steps above market).



DOH estimated panel expenses in a similar fiscal note. Oversight has presented these panel expenses in the Infection Control Advisory Panel Fund.



Officials from the Office of State Treasurer assume this proposal would not fiscally impact their agency.



Officials from the Office of the Secretary of State (SOS) state this proposal creates the

Missouri Hospital Infection Control Act of 2004. Based on experience with other divisions, the

rules, regulations and forms issued by the DOH could require as many as 50 pages in the Code of ASSUMPTION (continued)



State Regulations. For any given rule, roughly one-half again as many pages are published in the Missouri Register as are published in the Code because cost statements, fiscal notes and notices are not published in the Code. The estimated cost of a page in the Missouri Register is $23.00. The estimated cost of a page in the Code of State Regulations is $27.00. The actual costs could be more or less than the numbers given. The fiscal impact of this legislation in future years is unknown and depends upon the frequency and length of rules filed, amended, rescinded and withdrawn. The SOS estimates the cost of this legislation to be $1,925 in FY 05.



Oversight assumes the SOS could absorb the costs of printing and distributing regulations related to this proposal. If multiple bills pass which require the printing and distribution of regulations at substantial costs, the SOS could request funding through the appropriation process.

Any decisions to raise fees to defray costs would likely be made in subsequent fiscal years.



Officials from the Office of Attorney General (AGO) assume that this proposal may create additional costs, as it permits the DOH to terminate certain practices and procedures in hospitals as well as suspend state payments to hospitals that do not provide information that is being sought. AGO assumes it would be required to review subpoenas, move in court to enforce subpoenas and represent the DOH in proceedings if hospitals are permitted to appeal the termination of practices and suspension of payments. AGO further assumes any potential costs

arising from this proposal would be minimal and could be absorbed with existing resources.



Officials from Barton Co Memorial Hospital, Bates County Memorial Hospital, Cedar County Memorial Hospital, and Washington County Memorial Hospital did not respond to our fiscal note request. Oversight assumes there will be an unknown cost to county hospitals for the necessary database systems to track infections.



FISCAL IMPACT - State Government FY 2005

(10 Mo.)

FY 2006 FY 2007
GENERAL REVENUE
Costs - Department of Health and Senior Services
Personal Services (8 FTE) ($269,216) ($331,136) ($339,414)
Fringe Benefits ($111,455) ($137,090) ($140,517)
Expense and Equipment ($110,068) ($68,598) ($70,656)
ESTIMATED NET EFFECT ON GENERAL REVENUE



($490,739)


($536,824)


($550,587)
INFECTION CONTROL ADVISORY PANEL FUND
Income-Department of Health and Senior Services private donations
Private donations $0 to Unknown $0 to Unknown $0 to Unknown
Costs - Department of Health and Senior Services
Panel expenses* ($15,930) to $0 ($10,620) to $0 ($10,620)
ESTIMATED NET EFFECT ON INFECTION CONTROL ADVISORY PANEL FUND*



$0 to Unknown




$0 to Unknown




$0 to Unknown
*If insufficient private donations are received, there will not be panel expenses.


FISCAL IMPACT - Local Government FY 2005

(10 Mo.)

FY 2006 FY 2007
LOCAL FUNDS
Costs - County Hospitals
Expense and equipment (Unknown) (Unknown) (Unknown)
ESTIMATED NET EFFECT ON LOCAL FUNDS



(Unknown)


(Unknown)


(Unknown)





FISCAL IMPACT - Small Business



This proposal would have potential costs to small hospitals, ambulatory surgical centers, and other health facilities that the DOH may designate related to the collection, analysis, and reporting of nosocomial infection data. They may also incur costs associated with improving their infection control programs in accordance with the proposal's requirements and the requirements in revised regulations. Labs would incur cost to submit information to the DOH.







DESCRIPTION



This proposal creates the "Missouri Nosocomial Infection Control Act of 2004" to encourage health care facilities to take appropriate actions to decrease the risk of infection.



SECTION 192.020 - The Department of Health and Senior Services (DOH) shall include MRSA and VRE in its list of communicable diseases.



SECTION 192.067 - The DOH shall have the authority to collect, analyze, and disclose nosocomial infection data from patient records.



SECTION 192.131(1)-(2) - This section provides definitions for "advisory panel", "antibiogram", and "antimicrobial". Every laboratory performing culture and sensitivity testing on humans in Missouri shall submit data on health care associated infections to the DOH. The data to be reported shall be defined by the DOH. By July 1, 2005, the data must include the number of patients or isolates by hospital, ambulatory surgical center, and other facility who are infected with MRSA and VRE.



SECTION 192.131(3)-(5) - All information collected pursuant to this section shall be confidential. However, this information shall be available to the appropriate facility or professional licensing authorities. The Advisory Panel shall develop a plan, using the collected data, to create a system that enhances the ability of health care providers to track preventable infections and that monitors trends relating to antibiotic-resistant microbes. The Advisory Panel and the DOH must conform to standards adopted by the Centers for Disease Control and Prevention.



SECTION 192.665 - This section adds new definitions for "nosocomial infection", "nosocomial infection incidence rate", and "other facility".



SECTION 192.667(1)-(11) - The DOH must collect data on nosocomial infection incidence rates from hospitals, ambulatory surgical centers, and other appropriate facilities. By July 1, 2005, the DOH must promulgate rules regarding the standards and procedures for the collection and

reporting of nosocomial infection incidence rates and these rules shall be based upon the methodologies established by the Centers for Disease Control and Prevention National Nosocomial Infection Surveillance System and the recommendations of the Infection Control Advisory Panel.



The Infection Control Advisory Panel shall make a recommendation, based on certain factors, to the DOH regarding the implementation of nosocomial infection data collection, analysis, and reporting. If the DOH chooses the requirements of the Centers for Disease Control Prevention's DESCRIPTION (continued)



National Nosocomial Infection Surveillance System instead of the requirements listed in this section, then hospitals and ambulatory surgical centers that opt to participate in the federal program must provide the necessary data as a condition for licensure. Any hospital or ambulatory surgical center which does not voluntarily participate in the federal program shall be required to abide by the requirements enumerated in subsections 2,3, and 6 through 12 of this section.



SECTION 192.667(11)-(14) - Physician's offices shall be exempt from the reporting and disclosure of infection incidence rates. In consultation with the Advisory Panel, the DOH must disseminate reports to the public, based on data compiled over a twelve-month period and updated quarterly thereafter, that show for each hospital, ambulatory surgical center, and other facility a risk-adjusted nosocomial infection incidence rate for class I surgical site infections, ventilator-associated pneumonia, central line-related bloodstream infections, and other infections defined by rule by the Department. By December 31, 2006, these reports shall also be published on the DOH's website and shall be annually distributed to the Governor and the General Assembly.



SECTION 192.667(15)-(17) - If the Hospital Industry Data Institute fails by July 31, 2008 and annually thereafter to publish a report of Missouri's compliance with the quality of care measures established by the Centers for Medicare and Medicaid Services, the DOH shall have the authority to collect and publish this information. This information shall also be available to the DOH for the licensing of hospitals and ambulatory surgical centers pursuant to Chapter 197, RSMo.



SECTION 197.150 - Hospitals, ambulatory surgical centers, and other facilities must have procedures for monitoring compliance with infection control regulations and standards. These procedures must be coordinated with administrative and personnel staff. The infection control program shall include the surveillance of personnel, with a portion of the surveillance done without the staff's knowledge. However, this unobserved surveillance requirement cannot be considered grounds for licensure enforcement actions until the DOH establishes criteria for determining compliance.



SECTION 197.152 - Infection control officers and other employees shall be protected from retaliation from any hospitals, ambulatory surgical centers, or other facilities. Any interference in the duties of an infection control officer shall be reported to the hospital and ambulatory surgical center supervisors. Infection control officers have the authority to order the termination of any practice that falls outside the standard of care in infection control. The hospital or ambulatory surgical center infection control committee must convene as soon as possible to review any termination action. Employees who report infection control concerns in good faith shall not be DESCRIPTION (continued)



subject to retaliation or discrimination.



SECTION 197.154 - By July 1, 2005, the DOH must promulgate rules establishing certain standards for the infection control programs, which shall based upon nationally recognized standards.



SECTION 197.156 - "Nosocomial infection outbreaks" are defined by the Centers for Disease Control and Prevention within a defined time period. The DOH shall define the time period based upon the number of infected patients in a facility.



SECTION 197.158 - Beginning June 1, 2006, all hospitals and ambulatory surgical centers shall provide each patient an opportunity to submit complaints, comments, or suggestions.



SECTION 197.160 - The DOH shall have access to all information compiled by hospitals, ambulatory surgical centers, and other facilities related to infection control practices, rates, and treatments. The failure to provide access to this information shall be grounds for a full or partial licensure suspension or revocation. If a hospital, ambulatory surgical center, or other facility willfully impedes access to this information, then the DOH has the authority to direct any state agency to suspend all or a portion of state payments until the DOH receives the information.



SECTION 197.162 - For the licensing of hospitals and ambulatory surgical centers, the DOH shall give special attention to infection control practices and shall direct these facilities to set quantifiable measures of performance for reducing nosocomial infections. The DOH must annually prepare a report on infection control standards and compliance. The report shall be distributed to the General Assembly and the Governor.



SECTION 197.165 - The DOH must appoint an "Infection Control Advisory Panel", which shall consist of fifteen members. Any reasonable expenses of the Panel shall be paid from private donations made specifically to the "Infection Control Advisory Panel Fund", which is created in the State Treasury. If donations are not received, there will not be an advisory pane..



SECTION 197.294 - No information disclosed by the DOH to the public pursuant to this act shall be used to establish a standard of care in a civil action.



This legislation is not federally mandated, would not duplicate any other program and would not require additional capital improvements or rental space.





SOURCES OF INFORMATION



Secretary of State

Office of Attorney General

State Treasurer's Office

Department of Health and Senior Services



NOT RESPONDING: Barton Co Memorial Hospital, Bates County Memorial Hospital, Cedar County Memorial Hospital, and Washington County Memorial Hospital



















Mickey Wilson, CPA

Director

June 7, 2004