No. 30425 (New Rule): R386-705. Health Care Associated Infection

DAR File No.: 30425
Filed: 09/06/2007, 12:33
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This proposed new rule establishes a health care acquired infection surveillance system to monitor state-wide trends, define the scope of the problem in Utah, provide public accountability, and establish baseline rates for improvement activities. Approximately 1 in 10 hospitalized patients will acquire an infection after admission, which will result in substantial economic cost. Each year, more than 2,000,000 Americans contract infections during hospitalization. Health care acquired infections result in an estimated 90,000 deaths each year in the United States and account for at least $4,500,000,000 in excess health care costs annually. Many states (18 to date) are taking some sort of legislative or regulatory action for public reporting. Applying the above incidence rate to the state of Utah, the estimated number of infections based on 2005 hospital discharges (268,652 - most recent data) would indicate that approximately 26,000 patients acquired an infection after admission, 762 (2.84 cases per 1,000 admissions) which may cause mortality/morbidity and for an annual cost of close to $2,000,000 in excess health care costs. The Advisory Committee on Immunization Practices (ACIP) recommends annual influenza immunization of health care workers, that measures be taken to increase health care worker immunization rates, and that those rates be used as a measure of the quality of a patient safety program. Other organizations have made similar recommendations, including the Infectious Disease Society of America and The Joint Commission. This rule establishes reporting requirements for health care associated infections starting with Central Line Associated-Blood Stream Infections (CLA-BSI) and employee influenza immunization rates.

Summary of the rule or change:

This rule establishes the reporting mechanism to begin tracking health care acquired infections. Specifically the rule focuses on (CLA-BSI) and influenza immunization rates of hospital and long-term care employees. The rule defines the facilities and units within those facilities responsible for reporting, the infectious organisms, and the specific classification of blood stream infections. It also defines the reporting periods and mechanisms for reporting immunization information.

State statutory or constitutional authorization for this rule:

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

Anticipated cost or savings to:

the state budget:

Anticipated one time costs of $7,500 - $10,000 will be incurred from existing budget resources for the development of an internet-based reporting tool. This will allow facility reporters to submit their reports on line, to track their reports, and for Department of Health staff to conduct data analysis. Analysis of the data and reporting out will be achieved electronically. The Bureau of Epidemiology staff assigned to this program will conduct periodic statewide analysis of the CLA-BSI as part of its existing duties. The Division of Community and Family Health Services will continue to work with facilities on the immunization reports. 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.

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 are rural. The incidence of these types of events in rural facilities tends to be low due to the low number of hospital days, and in many cases the lack of an Intensive Care Unit (ICU). The impact will be negligible especially after the internet-based reporting system is put into place and the process has been streamlined. Annual local government-owned hospital costs would be $40 for each CLA-BSI and $125 per hospital owned.

small businesses and persons other than businesses:

A facility that is accredited by The Joint Commission already provides essentially the same reports to The Joint Commission. This represents the urban and community hospital or approximately 65% of the hospitals in Utah. Hospitals not accredited by The Joint Commission are the rural hospitals. Rural Utah hospitals owned by major corporations already gather this information if they have an ICU. There are only six rural Utah hospitals that are not owned by major corporations. Aggregate costs for these six rural hospitals would be estimated at approximately $40 per year per hospital or $240 (5 CLA-BSI infections per year X $8). The estimated cost of reporting vaccinations under this rule is $500 per 1,000 employees or approximately 50 cents per 250 employees per 6 hospitals or $750. Patients will not be directly affected by the reporting requirement but should in the future, as state-wide interventions are developed, experience a drop in hospital associated infection rates and consequently improvement in mortality and morbidity and expenses associated with health care associated infections. Projected savings include a decrease in length of stay and improved employee productivity if the spread of infections can be curbed due to state-wide surveillance and intervention. Currently, long-term care facilities voluntarily report employee vaccination rates when they report resident vaccination rates. This rule formalizes the reporting of employee vaccination rates.

Compliance costs for affected persons:

Individual patients will not be directly affected by the reporting requirement but should in the future, as state-wide interventions are developed, experience a drop in rates and consequently improvement in mortality, morbidity, and expenses associated with health care associated infections. Average costs per facility depends on the number of admissions, size of the facility, and whether it currently has an ICU. Because there are so few reportable incidents for all nonaccredited hospitals, it is not possible to estimate the total cost for any one nonaccredited facility. Whether the hospital has an ICU will dictate the number of CLA-BSI infections likely to be reported. An estimate of 20 percent of the 762 estimated Utah infections or 150 infections a year (as estimated by national studies applied to Utah discharges) would be due to CLA-BSI. Industry infection control experts and health care system representatives estimate that the cost will be 10 minutes per report or $8 per report for hospitals accredited by The Joint Commission. Total cost to the health care industry is estimated to be $1,200 a year for CLA-BSI reporting. Vaccination reporting across all hospitals is estimated to be $500 per 1,000 employees. Actual costs will depend on the size of the hospital and the number of employees and turnover rate.

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

Given the serious threat from hospital acquired infection to the public, the fiscal impact this rule will have on business appears to be justified. After public comment, this will be examined again. David N. Sundwall, MD, Executive Director

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

Health
Epidemiology and Laboratory Services, Epidemiology
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231

Direct questions regarding this rule to:

Robert T Rolfs or Iona Thraen at the above address, by phone at 801-538-6191 or 801-538-6471, by FAX at 801-538-9923 or 801-538-7053, or by Internet E-mail at [e-mail] or [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:

10/31/2007

This rule may become effective on:

11/07/2007

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R386. Health, Epidemiology and Laboratory Services, 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) "BSI" means a blood stream infection that meets the criteria in Subsection 22(1).

(2) "Central line" means a vascular access catheter that passes through or has a tip ending at or close to the heart or in one of the great vessels. Great vessels include aorta, pulmonary artery, superior vena cava, inferior vena cava, brachiocephalic vein, internal jugular vein, subclavian vein, external iliac vein, or common femoral 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) "Central line associated blood stream infection" or "CLA-BSI" means a primary blood stream infection that is associated with the presence of a central line that meets the criteria in Subsection 21(3).

(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) "Intensive care unit" or "ICU" 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. An ICU 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.

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

 

R386-705-3. Reports.

(1) All hospitals shall, for all general or specialty care ICU beds, 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.

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

 

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 electronic system approved by the Department. All facilities required to report shall report CLA-BSI quarterly for the January through March quarter by May15, 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.

 

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.

(1) The processes shall include at least one intervention proven by scientifically valid means to be effective in preventing CLA-BSI. 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.

 

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 ICU 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 to arrive at the total 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 that occurs in each patient who is at least one year of age and who was either:

(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) For each case of CLA-BSI, the hospital shall report:

(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.

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.

 

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 not to exceed the sum of $5,000 or be punished for violation of a class B misdemeanor for the first violation and for any subsequent similar violation within two years for violation of a class A misdemeanor as provided in Section 26-23-6.

 

KEY: hospitals, quality improvement, patient safety

Date of Enactment or Last Substantive Amendment: 2007

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