No. 35376 (Amendment): Rule R386-705. Epidemiology, Health Care Associated Infection

(Amendment)

DAR File No.: 35376
Filed: 10/26/2011 02:34:22 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

Due to a new regulatory requirement from the Centers for Medicaid and Medicare Services (CMS), the Utah Department of Health (UDOH) proposes to amend the Healthcare Associated Infection (HAI) rule to allow hospitals to meet both UDOH and CMS requirements by reporting Central Line Associated Blood Stream Infections (CLABSI) to the National Healthcare and Safety Network (NHSN). The revised rule also defines new CLABSI required reporting elements. In addition, changes to the rule include the addition of a new reporting requirement to the current HAI rule. The revised rule adds laboratory identified Clostridium. difficile infection (CDI) events as a reportable condition, as well as requiring reporting facilities to report C. difficile events to NHSN. The rule defines the required reporting elements for C. difficile and establishes standardized definitions of reporting elements that replicate NHSN requirements and definitions. In addition, changes to the rule standardize definitions of "health care worker" to meet those of CDC.

Summary of the rule or change:

The rule change would establish the reporting mechanisms to begin tracking laboratory identified C. difficile infections, and allow reporting facilities to report CLABSI and C. difficile to NHSN. Changes in the rule also define reporting elements and update reporting definitions.

State statutory or constitutional authorization for this rule:

• Subsections 26-1-30(2)(a), (b), (d), (e) and (g)
• Section 26-6-3
• Section 26-6-7

Anticipated cost or savings to:

the state budget:

Bureau of Epidemiology staff assigned to this program will conduct periodic statewide analysis of CLABSI and CDI data as part of existing duties. Efforts to improve rates of health care acquired infections (once baseline rates have been established) will in the long run benefit all Utah patients including Medicaid recipients and the costs associated with excess health care expenditures. Analysis of the data will be achieved electronically. Reports sent to facilities will be a combination of electronic and printed materials. Printed materials are expected to cost about $100 for printing materials, excluding personnel time.

local governments:

If a local government owns a health care facility, this may have an indirect impact on the subsidy they are providing to that facility. Currently there are only a few that fall in this category, and these are rural. The incidence of these types of events in rural facilities tends to be low due to the low number of hospital and patient days, and in many cases the lack of an Intensive Care Unit (ICU). The impact will be negligible for facilities with electronic laboratory reporting of CDIs, internet-based reporting, and a streamlined process. Costs will be higher in facilities where infection control preventionists will need to collect data manually. There will be an initial personnel time cost for facility staff to learn NHSN's reporting system and requirements.

small businesses:

There is no anticipated cost or savings to this type of business as all reporting facilities will have 50 or more employees.

persons other than small businesses, businesses, or local governmental entities:

A facility that is accredited by The Joint Commission should currently be providing similar reports to The Joint Commission. Those facilities represent urban and community hospitals, or the majority of hospitals in Utah. Hospitals not accredited by The Joint Commission include rural hospitals. Rural Utah hospitals owned by major corporations already gather this information if the hospital has an ICU. There are only seven rural Utah hospitals that are not owned by a major corporation. Aggregate reporting costs for seven rural hospitals are estimated at approximately $24 per year per hospital or $168 (3 CLA-BSI infections per year x $8). Industry infection control experts and health care system representatives estimate that the reporting cost will be ten minutes per report, or $8 per report for The Joint Commission accredited hospitals. Patients will not initially be affected by the reporting requirement, but should benefit from the reporting implementation. As statewide interventions are in place, benefits from reductions in hospital-associated infection rates, improvements in patient safety, reduction in mortality and morbidity, and reduction in expenses associated with healthcare associated infections will be achieved. Projected savings include a decrease in length of stay and improved employee productivity as the infections are reduced due to statewide surveillance and implementation of science-based interventions.

Compliance costs for affected persons:

Patients will not initially be affected by the reporting requirement, but should benefit from the reporting implementation. As statewide interventions are in place, benefits from reductions in hospital-associated infection rates, improvements in patient safety, reduction in mortality and morbidity, and reduction in expenses associated with health care-associated infections will be achieved. Average cost per facility will depend on the number of admissions, number of patient days, size of the facility, and whether it currently has an ICU. Because there are so few reportable incidents for all non-accredited hospitals, it is not possible to estimate the total cost for any one non-accredited facility. Whether the hospital has an ICU will dictate the number of CLABSIs likely to be reported. Based on 2008 and 2009 CLABSI reports from hospitals with an ICU, there were an average of 90 infections reported in Utah per year (as estimated from the total of actual hospital reports for 2008 and 2009 divided by 2) due to CLABSIs. Industry infection control experts and health care system representatives estimate that the cost will be 10 minutes per report, or $8 per report for The Joint Commission accredited hospitals. Total cost to the health care industry is estimated to be $720 per year for CLABSI reporting. Based on 2008 and 2009 hospital discharge data, there are an average of 1,100 CDIs in Utah each year. National prevalence studies by the Association for Professionals in Infection Control indicate that 73% of CDIs are health care associated. Based on that information, Utah would expect to see approximately 800 health care associated CDIs per year. Applying the above industry costs, the estimated cost to comply with the revised rule and report CDIs will be 10 minutes, or $8 per report for The Joint Commission accredited hospitals, resulting in total cost to the healthcare industry of approximately $6,400 a year for C. difficile reporting.

Comments by the department head on the fiscal impact the rule may have on businesses:

This proposed rule change was developed in close collaboration with the affected hospital providers and reflects their input. By adopting the federal standards for reporting required by CDC, duplication of effort is minimized and costs reduced. Patients will benefit from this reporting and monitoring.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Disease Control and Prevention, Epidemiology
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Melissa Stevens Dimond at the above address, by phone at 801-538-6810, by FAX at 801-538-9923, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/15/2011

This rule may become effective on:

12/22/2011

Authorized by:

David Patton, Executive Director

RULE TEXT

R386. Health, Disease Control and Prevention, Epidemiology.

R386-705. Epidemiology, Health Care Associated Infection.

R386-705-1. Authority and Purpose.

This rule establishes reporting requirements for health care associated infections and for influenza vaccination of health care workers. It is authorized by Utah Code Subsections 26-1-30(2)(a), (b), (d), (e), and (g), 26-6-3, and 26-6-7.

 

R386-705-2. Definitions.

For purposes of this rule:

(1) "Admissions" means the total number of inpatient admissions to the facility per month, with the exception of neonatal and well baby nursery admissions.

[(1)](2) "BSI" means [a]primary blood stream infection that meets the criteria [in Subsection 22(1)]in the Centers for Disease Control and Prevention National Healthcare Safety Network Patient Safety Component Manual, Chapter 4 - Central Line Associated Bloodstream Infection Event, June 2011.

(3) "CDI Laboratory-Identified Event" or "LabID Event" refers to all non-duplicate CDI positive laboratory assays collected from inpatients, including specimens collected during an emergency department visit if collected same day as the inpatient admission.

(4) "CDI positive laboratory assay" refers to stool specimens with a positive laboratory result for Clostridium difficile toxin A and/or B, or with a C. difficile organism cultured and confirmed to be toxin producing through other laboratory testing.

(5) "Centers for Disease Control and Prevention (CDC)" is an agency of the United States Department of Health and Human Services.

[(2)](6) "Central line" means a n intravascular venous[vascular access] catheter that terminates at[passes through] or [has a tip ending at or] close to the heart or in one of the great vessels which is used for infusion, withdrawal of blood, or hemodynamic monitoring. [Great vessels include]The following are considered great vessels for the purpose of reporting central-line associated BSIs and counting central-line days: aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic vein s, internal jugular vein s, subclavian vein s, external iliac vein s, common iliac veins,[or common] femoral vein s and in neonates, the umbilical artery/vein.[ The following vascular access catheters are central lines: subclavian vein catheter, internal jugular vein catheter, PICC (peripherally inserted central catheter), Swan-Ganz catheter, Cook, Shiley, Port-a-Cath, Broviac, Groshong, Hickman, or dialysis catheter. The following catheters are not central lines for purposes of this rule: arterial catheters inserted into an artery, midline PICC, and pacemaker wires.]

[(3)](7) "Central line associated blood stream infection" or "[CLA-BSI]CLABSI" [means]is a primary BSI [blood stream infection that is associated with the presence of] in a patient that had a central line [that meets the criteria in Subsection 21 (3)]or umbilical catheter in place at the time of onset of the BSI and that is not related to an infection at another site.

(8) "Central Line Days" means a daily count at the same time each day of the number of patients with a central line in place.

(9) "Clostridium difficile" or "C. difficile" is a species of an anaerobic, gram-positive, spore-forming- bacillus that when toxin producing may cause diarrhea and other intestinal diseases when the normal flora of the intestinal tract is disrupted (for example, from the use of antibiotics). In the case of toxin producing C. difficile, C. difficile attaches to the mucosa of the colon and sets the stage for toxin production with resultant mucosal disease.

(10) "Clostridium difficile infection" or "CDI" is an infection that meets the required reporting criteria in the Centers for Disease Control and Prevention. National Healthcare Safety Network Patient Safety Component Manual, Chapter 12 - Multidrug-Resistant Organism and Clostridium difficile Infection (MDRO/CDI) Module Protocol, June 2011.

[ (4) "Common skin commensal" means microorganisms that are commonly found on the skin and often indicate contamination of the blood culture media rather than identification of a pathogenic organism when identified in blood culture tests, and include coagulase negative staphylococci, propionibacterium species, corynebacterium species, diphtheroids, bacillus species, and micrococcus species.

(5) "Health care facility" means a facility or agency licensed pursuant to Utah Code Title 26, Chapter 21.

(6) "Health care worker" means any person employed by a health care facility and who in the usual course of work either enters patient rooms or provides direct patient care. Health care workers may include personnel such as physicians, nurses, nursing assistants, therapists, technicians, emergency medical service personnel, dental personnel, pharmacists, laboratory personnel, dietary, housekeeping, and maintenance personnel.

] [(7)](11) " Critical[Intensive] care unit[" or "ICU"] (CCU)" means any general or specialty unit that provides intensive observation, diagnosis, and therapeutic procedures for patients who are critically ill[who are 1 year of age or older]. A CCU excludes nursing areas that provide step-down, intermediate care or telemetry only. An [ICU]adult CCU includes [coronary care units, medical intensive care units, medical/surgical intensive care units, surgical intensive care units, trauma intensive care units, neurosurgical intensive care units, burn trauma intensive care units, and pediatric intensive care units that provide care for at least some patients]burn, medical cardiac, medical, medical/surgical, neurologic, neurosurgical, prenatal, respiratory, surgical cardiothoracic, surgical and trauma critical care units. A pediatric CCU includes burn, cardiothoracic, medical, medical/surgical, neurology, neurosurgical, respiratory, surgical, and trauma critical care units. A neonatal CCU includes infants in NICU level II/III and III.[

(8) "Pathogenic organism" means a microorganism that is not a common skin commensal.]

(12) "Health care facility" means a facility or agency licensed pursuant to Utah Code Title 26, Chapter 21.

(13) "Health care worker" or "HCW", includes (but are not limited to) physicians, nurses, nursing assistants, therapists, technicians, dental personnel, pharmacists, laboratory personnel, autopsy personnel, contractual staff not employed by the health-care facility, and persons (e.g., clerical, dietary, housekeeping, maintenance, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that can be transmitted to and from employees of a healthcare facility.

(14) "Inpatient" is defined as a patient whose date of admission to the healthcare facility and the date of discharge are different calendar days. Observation patients are to be counted as inpatient if date of discharge is different from admission.

(15) "National Healthcare Safety Network" or "NHSN" is a secure internet-based surveillance system managed by CDC's Division of Healthcare Quality Promotion (DHQP).

(16) "Patient days" means the total daily count of the number of patients in the patient care location during a time period.

(17) "Patient ID" refers to a unique patient identifier assigned by the hospital and may consist of any combination of numbers and/or letters. This should be an ID that remains the same for the patient across all visits and admissions. This may be the patient's medical record number, but could be any identifier the facility creates to identify the patient. This is needed for CDI reporting to capture recurrent cases, but is also used for CLABSI reporting.

 

R386-705-3. Reports.

(1) All hospitals shall, for [all]each general or specialty care [I]CCU[ beds], not including[except] bone marrow transplant units[, newborn or neonatal intensive care units,] or nursing areas that provide step-down, intermediate care, or telemetry monitoring only, report:

(a) the number of central line patient days; and

(b) each case of [CLA-BSI]CLABSI.

(2) Each hospital and each long term care facility shall report its influenza vaccination rates for its healthcare workers.

(3) All facilities shall, for all inpatients facility wide, except patients in neonatal intensive care units and well baby nurseries, report:

(a) all non-duplicate CDI-positive laboratory assays

(b) the number of facility-wide admissions

(c) the number of facility-wide patient days.

 

R386-705-4. Health Care Associated Infection Report Methodology.

The information required by this rule shall be reported to the Utah Department of Health, Bureau of Epidemiology using [a form or]an electronic system approved by the Department. All facilities required to report shall report [CLA-BSI]CLABSI and CDI data at least quarterly for the January through March quarter by May 15, for the April through June quarter by August 15, for the July through September quarter by November 15, and for the October through December quarter by February 15. Facilities are required to report to the NHSN reporting site for CLABSI and CDI and the Utah Facility On-line Reporting System (UFORS) for HCW influenza data. Facilities reporting via NHSN must share data with the Utah Department of Health through conference of rights functionality in NHSN through joining the UDOH HAI group in NHSN. Data shared with the Utah Department of Health under this rule shall exclude patient identifiers, unless necessary for reporting requirements. The Utah Department of Health shall evaluate the case definitions and reporting algorithm at least annually with input from the users group and make any needed clarifications or changes.

 

R386-705-10. Health Care Associated Infection Prevention.

Each facility required to report under Subsection 3(1) shall implement processes to prevent [central line associated blood stream infections]CLABSI.

(1) The processes shall include at least one intervention proven by scientifically valid means to be effective in preventing [CLA-BSI]CLABSI. Interventions that have been recommended by an accepted health authority, including the Centers for Disease Control and Prevention, or the federal Hospital Infection Control Practices Advisory Committee, meet this requirement.

(2) The facility shall have a system to monitor that program and shall make information about the program available upon request from the Utah Department of Health.

 

R386-705-20. Central Line Days.

(1) Each facility required to report under this rule shall report central line patient days.

(a) The facility shall count the number of patients [who were at least one year of age and] with a central line in place and resident in the [I]CCU at the time of the count.

(b) The count shall be performed at the same time each day, within 1 hour before or after the target time, during the reporting period.

(c) A patient with two or more central lines in place at the time of the count is counted as one patient with a central line on that day.

(d) The facility shall calculate the sum of the individual daily counts for each day in the reporting period for each CCU to arrive at the total central line days for each CCU for the reporting period.

(2) The number of central line days may be estimated based on a valid sampling method.

 

R386-705-21. Blood Stream Infection Reports.

(1) Each facility required to report under this rule shall report each case of [CLA-BSI]CLABSI that occurs in each patient [who is at least one year of age and who was either:]in a CCU or NICU. Facilities shall follow the current definition for CLABSI as defined in the National Healthcare Safety Network Patient Safety Component Manual, Chapter 4 - Central Line Associated Bloodstream Infection Event, June 2011.[

(a) in an ICU at the time the CLA-BSI was identified and had been in the ICU for at least 2 days prior to that time; or

(b) had been in an ICU within 2 days prior to the time the CLA-BSI was identified;

(2) The time the CLA-BSI is identified is the time that the first positive blood culture result used to identify the CLA-BSI was collected from the patient.

(3) A case of CLA-BSI is reportable if meets the criteria in Subsections 22(1), (4), and (5) and does not meet the criteria in Subsection 22(3).]

[(4)](2) For each case of [CLA-BSI]CLABSI, the hospital shall report[:] current required NHSN reporting elements as defined in Section 705-2(2)and 705-21.

(3) For each CLABSI, the hospital will confer rights to the Utah Department of Health through NHSN without patient identifiers, unless necessary for reporting requirements.

[ (a) the date the CLA-BSI was identified;

(b) the type of ICU in which the case occurred, i.e., the ICU in which the patient resided at identification of the CLA-BSI if in ICU at the time, or the ICU from which patient was most recently discharged if not in ICU at the time;

(c) the organism or organisms isolated from blood cultures associated with the CLA-BSI episode; and

(d) whether the CLA-BSI was considered a mixed BSI episode based on meeting the criteria in Subsections 22(2).

(5) The Utah Department of Health shall evaluate the case definitions and reporting algorithm at least annually with input from the users group and make any needed clarifications or changes.

]

R386-705-22. [Classification Criteria for Central Line Associated Bloodstream Infections.]Facility Wide Admissions.

[ Definitions of bloodstream infections established in this rule are not to be construed as technical medical definitions of bloodstream infections, but only as definitions necessary to establish a reporting requirement. In reporting CLA-BSI under this rule, facilities shall apply the following criteria as required by Section R386-705-21:

(1) Criteria 1-BSI:

(a) at least one blood culture result includes a pathogenic organism;

(b) at least two blood culture results from specimens obtained at different times or from specimens drawn at different phlebotomy sites, e.g., left arm and right arm, within a 2 day period include the same type of common skin commensal organism; or

(c) at least one blood culture result includes a common skin commensal organism and antibiotic treatment effective against that organism was started on the day that the culture was collected and was continued for greater than three days.

(2) Criteria 2-Mixed BSI:

A BSI is a mixed BSI episode if more than one type of organism is identified in blood culture results obtained within a 5 day period.

(3) Criteria 3-Secondary BSI:

(a) A BSI is a secondary BSI if the organism is a pathogenic organism and is detected in a culture from a source other than blood that:

(i) was obtained from the patient within the 3 days before or 7 days after the positive blood culture;

(ii) is not a surveillance culture, i.e., a culture obtained routinely to detect carriage of an organism and not to diagnose an infection that is suspected based on clinical findings;

(iii) is not a culture of a catheter tip; and

(iv) is not a yeast obtained in a culture from respiratory source.

(b) A mixed BSI episode is secondary if any one of the organisms detected in blood cultures during the current episode meets the criteria for a secondary BSI.

(4) Criteria 4-New Episode:

A primary BSI is a new episode of BSI if:

(a) it is the first BSI in the patient during the patient's current hospitalization;

(b) it is the first time this organism is detected in the patient and no other BSI was detected in the patient in the previous 5 days; or

(c) the organism was detected in a previous blood culture from this patient and that blood culture was collected more than 30 days before the blood culture indicating the current BSI episode.

(5) Criteria 5-Central Line:

A BSI is a CLA-BSI if a central line was in place for at least two days before the first blood culture identifying the BSI was collected.

] (1) Each facility required to report CDI-positive laboratory assays under this rule shall report overall facility wide admissions.

(a) The facility shall count the number of overall facility admissions.

(b) The count shall be performed at the same time each day, within 1 hour before or after the target time, during the reporting period.

(c) A patient is considered admitted to the facility if the date of discharge is different from the date of admit.

(d) The facility shall calculate the sum of the individual daily counts for each day in the reporting period to arrive at the total for the reporting period.

(e) Counts for NICUs and well-baby nurseries should be excluded from the daily counts.

(2) The number of facility wide admissions may be estimated based on a valid sampling method.

 

R386-705-23. Patient Days Report.

(1) Each facility required to report CDI-positive laboratory assays under this rule shall report patient days.

(a) The facility shall count the total daily number of inpatients in the facility at the time of the count and record the number of inpatients.

(b) The count shall be performed at the same time each day, within 1 hour before or after the target time, during the reporting period.

(c) The facility shall calculate the sum of the individual daily counts for each day in the reporting period to arrive at the total for the reporting period.

(d) Counts for NICUs and well-baby nurseries should be excluded from the counts.

(2) The number of facility wide admissions may be estimated based on a valid sampling method.

 

R386-705-24. Clostridium Difficile LabID Event Reports.

(1) Facilities shall report for each CDI LabID Event that occurs in each inpatient consistent with the current NHSN definition for CDI positive laboratory assays. Facilities must report to NHSN.

(2) Facilities reporting CDI LabID Events to NHSN are required to report current required NHSN reporting elements that meet the criteria in Section 705-2(10).

(3) For each CDI LabID Event reported to NHSN, the facility will confer rights to the Utah Department of Health through NHSN without patient identifiers, unless necessary for reporting requirements.

 

R386-705-25. Influenza Vaccination Rate Reporting.

(1) Reports of influenza vaccination rates shall include the number of health care workers and the number of those workers who are documented to have received an influenza vaccine for the current influenza season. Influenza vaccination rates may be measured by complete enumeration of all health care workers in the facility during the season and the number of them who were vaccinated during that season or may be estimated by a cross-sectional assessment.

(2) Each hospital and licensed long term care facility shall report its influenza vaccination rates for the current influenza season by January 31.

 

R386-705-100. Attestation Required.

Each facility required to report under Subsection 3(1)[,] shall attest to the implementation and effectiveness of its health care infection prevention program and its systems for reporting[,] as required by this rule, once every three years.

 

R386-705-101. Penalties.

As required by Section 63-46a-3(5): An entity that violates any provision of this rule may be assessed a civil money penalty as provided in Section 26-23-6.

 

KEY: [hospitals, ]quality improvement, patient safety, healthcare, infection control

Date of Enactment or Last Substantive Amendment: March 15, 2010

Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(a); 26-1-30(2)(b); 26-1-30(2)(d); 26-1-30(2)(e); 26-1-30(2)(g); 26-6-3; 26-6-7

 

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