PURPOSE: This rule establishes procedures for reporting hospital and ambulatory surgical center healthcare-associated infection incidence data to the Department of Health and Senior Services.

1. (1) The following definitions shall be used in the interpretation of this rule:

   1. (A) CDC means the federal Centers for Disease Control and Prevention;
   2. (B) Central line as defined by the CDC;
   3. (C) Central line-associated bloodstream (CLAB) infection as defined by the CDC means central line-related bloodstream infection as referred to in section 192.667.12(3), RSMo;
   4. (D) Department means the Missouri Department of Health and Senior Services;
   5. (E) Healthcare provider means hospitals as defined in section 197.020, RSMo, and ambulatory surgical centers (ASCs) as defined in section 197.200, RSMo;
   6. (F) Intensive care unit (ICU) means coronary, medical, surgical, medical/surgical, pediatric, and neonatal intensive care units (NICU);
   7. (G) National Healthcare Safety Network (NHSN) means the CDC nosocomial infection surveillance system;
   8. (H) Neonatal Intensive Care Unit (NICU) and High Risk Nursery (HRN) are synonymous and mean that the infants in those units are critically ill and receive level III care as defined by the CDC;
   9. (I) Nosocomial infection is defined in section 192.665(6), RSMo and is referred to as healthcare-associated infection (HAI) in this rule;
   10. (J) Risk index means grouping patients who have operations according to the American Society of Anesthesiologists (ASA) score, length of procedure, wound class, and other criteria as defined by the CDC for the purpose of risk adjustment as required in section 192.667.3, RSMo;
   11. (K) Surgical site infection (SSI) as defined by the CDC; and
   12. (L) Ventilator-associated pneumonia (VAP) as defined by the CDC.

2. (2) All hospitals shall submit to the department data to compute HAI infection incidence rates on the following:

   1. (A) CLABs detected in the ICU(s) after June 30, 2005;
   2. (B) SSIs from designated types of surgeries as set forth in section (4) of this rule, performed after December 31, 2005; and
   3. (C) VAPs in the ICU(s) detected after June 30, 2006.
3. (3) All ASCs shall submit to the department data to compute HAI incidence rates on SSIs from designated types of surgeries as set forth in section (5) of this rule, performed after December 31, 2005.
4. (4) Hospitals shall report SSIs by risk index related to a hip prosthesis, to an abdominal hysterectomy, and to a coronary artery bypass graft with both chest and donor site incisions performed after December 31, 2005.
5. (5) ASCs shall report SSIs by risk index related to breast surgery and herniorrhaphy performed after December 31, 2005.

6. (6) In order to be eligible to request a reporting exemption, healthcare providers shall report to the department by March 1, 2005, and every year thereafter the number of central line days and ventilator days in the ICU(s) during the previous calendar year; and the number of surgeries performed as required in sections (4) and (5) during the previous calendar year.

   1. (A) Healthcare providers that had less than fifty (50) central line days in any ICU shall be exempt from reporting CLABs from that ICU for the reporting year starting in July.
   2. (B) Healthcare providers that had less than fifty (50) ventilator days in any ICU shall be exempt from reporting VAPs from that ICU for the reporting year starting in July.
   3. (C) Healthcare providers that had less than twenty (20) surgeries as specified in sections

7. (4) and (5) shall be exempt from reporting the surgery that did not meet the minimum for the reporting year starting in July.

   1. (D) The exemptions shall only apply if the healthcare provider has an infection control program that is in compliance with applicable statutes and regulations of the health facilities regulation unit of the department. The department shall notify the healthcare provider in writing if such provider is exempt from any reporting requirements for the reporting year starting in July.

8. (7) Healthcare providers may meet the HAI reporting requirements if they submit their data to the CDC NHSN or its successor system and if:

   1. (A) All NHSN mandatory data items are submitted to the CDC;
   2. (B) The healthcare provider complies with all NHSN standards and procedures;
   3. (C) The healthcare provider participates in NHSN training provided by the CDC;
   4. (D) The healthcare provider has policies and procedures to ensure that all HAIs as required by this rule are detected and reported. Such policies and procedures shall be consistent with appropriate guidelines of CDC, or the Society for Healthcare Epidemiology of America (SHEA), or the Association for Professionals in Infection Control and Epidemiology (APIC);
   5. (E) The healthcare provider has a process to follow up for SSIs a minimum of thirty

9. (30) days after the procedure was performed, and at a minimum review readmission data to identify potential SSIs. Hospitals shall have a system for reporting identified SSIs to the healthcare provider performing the original surgery;

   1. (F) All data are submitted to the NHSN within sixty (60) days of the end of the month;
   2. (G) The healthcare provider participates in a CDC user group that allows the department access to the data, or a data file is generated by the healthcare provider and submitted to the department; and
   3. (H) The healthcare provider shall maintain records related to the information provided to the department for a minimum of two (2) years.

10. (8) If a healthcare provider chooses to not submit the required data to the CDC NHSN, the healthcare provider may meet the HAI reporting requirements by submitting to the department numerator and denominator data on forms provided by the department, or in a format approved by the department, for each of the infections specified in sections (2), (3), (4), and (5) and if:

    1. (A) The healthcare provider complies with all NHSN standards and procedures;
    2. (B) The healthcare provider participates in NHSN training provided by the CDC;
    3. (C) The healthcare provider has policies and procedures to ensure that all HAIs as required by this rule are detected and reported. Such policies and procedures shall be consistent with appropriate guidelines of CDC, or the SHEA, or the APIC;
    4. (D) The healthcare provider has a process to follow up for SSIs a minimum of thirty

11. (30) days after the procedure was performed, and at a minimum review readmission data to identify potential SSIs. Hospitals shall have a system for reporting identified SSIs to the healthcare provider performing the original surgery;

    1. (E) All data are submitted to the department within sixty (60) days of the end of the month; and
    2. (F) The healthcare provider shall maintain records related to the information provided to the department for a minimum of two (2) years.
12. (9) The healthcare provider chief executive officer or designee shall annually certify in writing to the department, on a form provided by the department, that the healthcare provider has met all conditions specified in this rule.

AUTHORITY: section 192.667, RSMo Supp. 2004.* Original rule filed Feb. 1, 2005, effective July 30, 2005. *Original authority: 192.667, RSMo 1992, amended 1993, 1995, 2004.