Health, Disease Control and Prevention, Epidemiology

Rule R386-705

Epidemiology, Health Care Associated Infection

Notice of Proposed Rule

(Amendment)

DAR File No.: 36853
Filed: 09/24/2012 02:34:56 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), and the passage of H.B. 55, Health Care Associated Infections, 2012 General Session, the Utah Department of Health proposes to amend the Healthcare Associated Infection (HAI) rule to replace reporting requirements related to health care associated infections with data sharing requirements for health care associated infection data reported by facilities to the National Healthcare and Safety Network (NHSN). The revised rule also enables facilities that will be required to report healthcare worker (HCW) influenza vaccination data to NHSN to share data with UDOH in order to meet the reporting requirement for HCW influenza vaccination data already in place in the rule. In addition, the rule amendment modifies the definition of HCW to be consistent with the Centers for Disease Control and Prevention (CDC) definition.

Summary of the rule or change:

The rule change: 1) replaces healthcare associated infection reporting requirements with data sharing requirements for healthcare associated infection data reported by facilities to NHSN; 2) enables facilities that report HCW influenza vaccination data to NHSN to share that data with the UDOH in order to meet the HCW influenza vaccination reporting requirement; and 3) updates the definition of HCW to be consistent with the CDC definition.

State statutory or constitutional authorization for this rule:

• Section 26-6-3
• Subsection 26-1-30(2)
• Section 26-6-31
• Section 26-6-7

Anticipated cost or savings to:

the state budget:

Bureau of Epidemiology staff assigned to this program conduct periodic statewide analyses of Central Line Associated Blood Stream Infection (CLABSI) and HCW data as part of existing duties. UDOH has received $100,000 for H.B. 55 mandated activities, including annual reporting and validation of mandated CMS healthcare associated infections. Efforts to improve rates of HAI (once baseline rates have been established) will in the long run benefit all Utah patients, including Medicaid recipients, and reduce the costs associated with excess healthcare 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 $200 for printing materials, excluding personnel time.

local governments:

If a local government owns a healthcare 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 hospitals, type of patient care provided, and patient days. Costs are expected to be minimal for facilities owned by local governments to authorize UDOH to access data entered into NHSN; costs will be related to personnel time for facilities to access the NHSN system and accept a template for reporting different data elements that UDOH provides for data sharing. There may be some initial costs for facility staff to learn NHSN's reporting system and requirements if they are just beginning to report to NHSN. It is expected there may be savings as compared to current Rule requirements for HAIs since facilities will be sharing data already reported to NHSN; however, costs of data sharing and validation related to new UDOH requirements are anticipated to be about the same as reporting costs related to the current rule.

small businesses:

Costs are expected to be minimal for facilities to authorize UDOH to access data entered into NHSN; costs will be related to personnel time for facilities to access the NHSN system and accept a template for reporting different data elements that UDOH provides for data sharing. There may be some initial costs for facility staff to learn NHSN's reporting system and requirements if they are just beginning to report to NHSN. It is expected there may be savings as compared to current rule requirements for health care associated infections since facilities will be sharing data already reported to NHSN; however, costs of data sharing and validation related to new UDOH requirements are anticipated to be about the same as reporting costs related to the current rule. Two licensed hospitals in Utah that are required to report HCW influenza vaccination rates have less than 50 employees on their payroll. While more employee types may be included in the revised HCW definition, expected costs to small business continue to be approximately seven minutes to report data into the state reporting system (Utah Facility Online Reporting System or UFORS), or $2.45 (7 minutes x $35 hour) per year, per report. Expected costs for gathering HCW influenza vaccination data are difficult to determine since each facility gathers data differently over different time frames; additional costs related to the HCW definition change are expected to be minimal, but are difficult to approximate. Expected costs for facilities to report HCW influenza vaccination data by sharing data through NHSN with UDOH are difficult to determine as reporting HCW influenza vaccination data will not be a requirement for facilities until January 2013, but are expected to be minimal and similar to costs associated with sharing data through NHSN for a HAI.

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

Costs are expected to be minimal for facilities to authorize UDOH to access data entered into NHSN; costs will be related to personnel time for facilities to access the NHSN system and accept a template for reporting different data elements that UDOH provides for data sharing. There may be some initial costs for facility staff to learn NHSN's reporting system and requirements if they are just beginning to report to NHSN. It is expected there may be savings as compared to current rule requirements for health care associated infections since facilities will be sharing data already reported to NHSN; however, costs of data sharing and validation related to new UDOH requirements are anticipated to be about the same as reporting costs related to the current rule. There are 60 licensed hospitals in Utah required to report HCW influenza vaccination data. While more employee types may be included in the revised HCW definition, expected costs to for facilities continue to be approximately seven minutes to report data into the state reporting system (Utah Facility Online Reporting System or UFORS), or $2.45 (7 minutes x $35 hour) per year, per report. Expected costs for gathering HCW influenza vaccination data are difficult to determine since each facility gathers data differently over different time frames; additional costs related to the HCW definition change are expected to be minimal, but are difficult to approximate. Expected costs for facilities to report HCW influenza vaccination data by sharing data through NHSN with UDOH are difficult to determine as reporting HCW influenza vaccination data will not be a requirement for facilities until January 2013, but are expected to be minimal and similar to costs associated with sharing data through NHSN for a healthcare associated infection. 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 healthcare associated infection rates, improvements in patient safety, reduction in mortality and morbidity, and reduction in expenses associated with HAIs will be achieved. Projected savings include a decrease in length of stay and improved employee productivity as infections are reduced due to statewide surveillance and implementation of science-based interventions.

Compliance costs for affected persons:

As noted above, compliance costs are expected to be minimal for facilities to authorize UDOH to access data entered into NHSN; costs will be related to personnel time for facilities to access the NHSN system and accept a template for reporting different data elements that UDOH provides for data sharing. It is expected there may be savings as compared to current rule requirements for HAIs since facilities will be sharing data already reported to NHSN; however, costs of data sharing and validation related to new UDOH requirements are anticipated to be about the same as reporting costs related to the current rule. Reporting HCW influenza vaccination data to UFORS is estimated to take seven minutes per report, or $2.45 per annual report. It is not possible to approximate costs of gathering HCW influenza vaccination data for a single facility since there is a range of methods used by different facilities. Expected costs for a facility to report HCW influenza vaccination data by sharing data through NHSN with UDOH are difficult to determine as reporting HCW influenza vaccination data will not be a requirement until January 2013; costs of establishing data sharing with UDOH are expected to be minimal and similar to costs associated with sharing data through NHSN for a HAI.

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

The current rule on HAI with local reporting requirements will change. The proposal is to allow facilities to comply by granting to health department personnel access to national data that facilities are required to report by federal rules. Overall this should be a savings to facilities and a reduction in regulatory impact.

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 [email protected]

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:

11/14/2012

This rule may become effective on:

11/21/2012

Authorized by:

David Patton, Executive Director

R386. Health, Disease Control and Prevention, Epidemiology.

R386-705. Epidemiology, Health Care Associated Infection.

R386-705-1. Authority and Purpose.

This rule establishes [reporting]data sharing requirements for health care associated infections and for influenza vaccination of health care workers. It is authorized by Utah Code S[ubs]ections 26-1-30(2)[(a), (b), (d), (e), and (g)], 26-6-3, [and] 26-6-7, and 26-6-31.

 

R386-705-2. Definitions.

For purposes of this rule:

(1) "Ambulatory surgical center" or "ASC" is as defined in Utah Code Section 26-21-2.

[(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.

](2) "Department" means the Utah Department of Health.

(3) "End stage renal disease facility" is as defined in Utah Code Section 26-21-2.

(4) "General acute hospital" is s defined in Utah Code Section 26-21-2.

(5) "Health care facility" is as defined in Utah Code Section 26-21-2[means a facility or agency licensed pursuant to Utah Code Title 26, Chapter 21].

(6) "Health care worker s" or "HCW"s [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 , but are not limited to, personnel such as physicians, nurses, nursing assistants, therapists, technicians, [emergency medical service personnel,] 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[dietary, housekeeping, and maintenance personnel].

(7) "Specialty hospital" is as defined in Utah Code Section 26-21-2.

[ (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. Health Care Associated Infections Reporting.

(1) Pursuant to Utah Code Section 26-6-31, facilities required to report data on the incidence and rate of health care associated infections as mandated by the Center for Medicare and Medicaid Services (CMS) to the National Healthcare Safety Network (NHSN) in the Centers for Disease Control and Prevention (CDC) shall:

(a) Share data with the Department by joining the Department NHSN Group, UDOH HAI (ID# 17686), and confer rights to the Department in NHSN. All data shared with the Department under this rule shall exclude patient identifiers unless necessary for reporting requirements and data validation.

(b) Follow CMS rules and NHSN protocols for defining terms and criteria for reporting infection data.

(2) Facilities required to share data submitted to NHSN with the Department include:

(a) Ambulatory surgical facilities;

(b) General acute hospitals;

(c) Specialty hospitals;

(d) End stage renal disease facilities; and

(e) Any other facilities as required by CMS.

(3) Facilities required to report data to NHSN shall confer rights to the Department for all reported data elements, except for patient identifiers unless necessary for reporting requirements, including for data validation, for the following conditions:

(a) Central line associated bloodstream infections (CLABSI);

(b) Catheter associated urinary tract infections;

(c) Surgical site infections from procedures on the colon and abdominal hysterectomy;

(d) Methicillin-resistant Staphylococcus aureus bacteremia;

(e) Clostridium difficile infection of the colon; and

(f) Any other health care associated infections reported to NHSN as required by CMS.

 

R386-705-4. Influenza Vaccination Rate Reporting.

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

(2) Reports of influenza vaccination rates shall include the total number of HCWs and the number of those workers who are documented to have received an influenza vaccine for the current influenza season.

(a) Licensed hospitals that report HCW influenza vaccination data to NHSN may confer rights to the Department to HCW influenza vaccination data (excluding any patient identifiers) to fulfill this reporting requirement.

(b) Licensed hospitals that do not confer rights to the Department for HCW influenza vaccination data through NHSN shall report HCW influenza vaccination data online to the Department through the Utah Facility Online Reporting System (UFORS). Facilities may contact the Bureau of Epidemiology at (801) 538-6191 with questions about UFORS, to report a problem, or to obtain instructions for using the system.

(c) Influenza vaccination rates reported to UFORS shall be measured using complete enumeration of all HCWs in the facility during the season and the number of them who were vaccinated during that season.

(d) Licensed long term care facilities shall report HCW influenza vaccination data according to requirements in Utah Administrative Code R432-40, the Long-Term Care Facility Immunizations Rule.

 

[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]5. Health Care Associated Infection Prevention.

Each facility required to [report]share data with the Department as described in R386-705-3 [under Subsection 3(1)] shall implement processes to prevent [central line associated blood stream infections]the incidence of health care associated infections.

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

(2) The facility shall have a system to monitor [that program]these processes and shall make information about them [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]6. Attestation Required.

Each facility required to [report]share data with the Department as described in R386-705-3 and R386-705-4[under Subsection 3(1),] shall attest to the implementation and effectiveness of its health care infection prevention program, as described in R386-705-5, and its systems for reporting, as required by this rule, once every three years.

 

R386-705-[101]7. 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 Utah Code Section 26-23-6.

 

KEY: [hospitals, ]quality improvement, patient safety, health care, infection controls

Date of Enactment or Last Substantive Amendment: [March 15, 2010]2012

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; 26-6-31