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PA Bulletin, Doc. No. 12-52

NOTICES

DEPARTMENT OF HEALTH

Health Care Associated Infection Benchmarking Areas for Hospitals under the Medical Care Availability and Reduction of Error (MCARE) Act

[42 Pa.B. 273]
[Saturday, January 14, 2012]

 The Department of Health (Department), under section 408(8) and (9) of the Medical Care Availability and Reduction of Error (MCARE) Act (MCARE Act) (40 P. S. § 1303.408(8) and (9)), publishes this notice regarding the methods to be used to measure progress of hospitals in reducing the occurrence of health care-associated infections (HAIs) and identify hospitals not meeting benchmark reduction targets.

A. Purpose and Statutory Authority

 Section 408(8) of the MCARE Act requires that the Department develop, in consultation with the Patient Safety Authority and the Pennsylvania Health Care Cost Containment Council, ''reasonable benchmarks to measure the progress [hospitals] make toward reducing health care-associated infections.'' The section further provides, ''Beginning in 2010, all health care facilities shall be measured against these benchmarks.''

 Section 408(9) of the MCARE Act requires that the Department publish a notice in the Pennsylvania Bulletin of the specific benchmarks the Department will use under section 408(8) of the MCARE Act to measure health care facilities. Prior to publishing the final notice, the Department is to seek public comment for at least 30 days on the benchmarks and respond to the comments received during the public comment period.

B. Background

 Since the HAI reporting provisions of Chapter 4 of the MCARE Act (40 P. S. §§ 1303.401—1303.411) took effect in February 2008, the Department has used the following list of HAIs for benchmarking purposes:

 • Central Line Associated Blood Stream Infection (CLABSI)

 • Catheter Associated Urinary Tract Infection (CAUTI)

 • Surgical Site Infection (SSI) for:

  o Coronary artery bypass graft with both chest and donor site incisions

  o Coronary artery bypass graft with chest incision only

  o Cardiac Surgery

  o Hip arthroplasty

  o Knee arthroplasty

  o Abdominal hysterectomy (HYST)

 Data on these benchmark HAIs have been published annually. Currently, data from 2009 is considered to be the baseline year for trend analysis. As published at 41 Pa.B. 6454 (December 3, 2011), beginning January 1, 2012, the Department will also collect data regarding SSIs for colon surgeries for benchmarking purposes in the future.

 Infections associated with surgeries that involve an implant may not develop or be detectable for some time following the surgical procedure. Accordingly, the United States Department of Health and Human Services, Centers for Disease Control and Prevention, National Healthcare Safety Network, requires a full year of patient follow-up for complete identification and reporting of infections associated with procedures that involve an implant. Among the six surgical procedure types selected for benchmark SSI consideration, all but HYSTs may involve an implant. Consequently, annual data on SSIs are published in the year after data on CLABSIs and CAUTIs is published, that is, HAI data published in 2011 includes the CLABSI and CAUTI data for procedures completed in 2010 and the SSI data for procedures completed in 2009. At this time, the 2010 data for SSIs that is required for comparison to the 2009 baseline year are not yet available. However, the 2010 data needed to measure health care facilities against benchmarks are available for CLABSIs and CAUTIs.

C. Benchmark Methodology

 The Department uses two metrics for calculating rates for CAUTIs and CLABSIs. The first metric is the incidence rate of infection. For CAUTIs, this is the number of infections per 1,000 urinary catheter days. For CLABSIs, this is the number of infections per 1,000 central line days. The second metric used by the Department is the standardized infection ratio (SIR). The SIR consists of the number of infections observed (reported) by the hospital divided by the number of infections predicted to be reported by the hospital. The predicted number is a risk-adjusted calculation made by the Department based on Statewide rates of HAIs. The methodology for risk adjustment and calculation of the predicted number of infections can be found in the annual HAI reports prepared by the Department and posted on its web site, http://www.health.state.pa.us. SIRs are produced for each hospital.

 For the initial measurement of hospital progress in reducing HAIs, the Department proposes to rank all hospitals separately by their incidence rates of infection and SIRs for CAUTIs and CLABSIs, in two separate consecutive years, currently 2009 and 2010. Accordingly, hospitals will be ranked for:

 CAUTI Benchmark Targets:

 1) Incidence rate of infection for CAUTIs in year one

 2) SIRs for CAUTIs in year one

 3) Incidence rate of infection for CAUTIs in year two

 4) SIRs for CAUTIs in year two

 CLABSI Benchmark Targets:

 1) Incidence rates of infection for CLABSIs in year one

 2) SIRs for CLABSIs in year one

 3) Incidence rates of infection for CLABSIs in year two

 4) SIRs for CLABSIs in year two

 The Department will then identify the hospitals that fall above the 90th percentile for all Commonwealth hospitals in each of the previously listed rankings. As an example, the 90th percentile for the 2010 CAUTI rate was 3.81 per 1,000 catheter days and the 90th percentile for the 2010 CAUTI SIR was 2.37. Any hospital identified as having both an incidence rate of CAUTIs and an SIR for CAUTIs above the 90th percentile for all Commonwealth hospitals in two consecutive years shall be considered not making progress towards the reduction of CAUTI HAI rates. Similarly, any hospital identified as having both an incidence rate of CLABSIs and an SIR for CLABSIs above the 90th percentile for all Commonwealth hospitals in two consecutive years shall be considered not making progress towards the reduction of CLABSI HAI rates.

 When the 2010 data are available for SSIs, similar procedures will be used to identify the hospitals not making progress towards the reduction of SSI HAI rates for each individual procedure. In subsequent years, the Department will conduct a similar analysis for CAUTIs, CLABSIs and SSIs using the most currently available annual data for two consecutive years.

 Section 408(8) of the MCARE Act also provides minimum requirements relating to actions that must be taken by a hospital and the Department when the hospital is identified as not making progress in reducing HAI rates. At this time, the procedures for implementation of these requirements in section 408(8) of the MCARE Act have not been finalized. The Department will review and consider any comments submitted in response to this notice respective to these requirements.

D. Affected Persons

 All hospitals are currently required to comply with the HAI reporting requirements of the MCARE Act and will be measured for progress in meeting benchmark targets previously set forth. Section 103 of the MCARE Act (40 P.S. § 1303.103) defines a ''hospital'' as ''An entity licensed as a hospital under the act of June 13, 1967 (P. L. 31, No. 21), known as the Public Welfare Code, or the act of July 19, 1979 (P. L. 130, No. 48), known as the Health Care Facilities Act.''

E. Comment Period and Contact Person

 As required under section 408(9) of the MCARE Act, the Department is soliciting public comment for 30 days from the publication date of this notice on the HAI benchmarking areas previously described. Written comments may be submitted to Kimberly Buffington, Director, Health Care-Associated Infection Prevention Section, Department of Health, 8th Floor, Forum Place, 555 Walnut Street, Harrisburg, PA 17101, (717) 425-5422. Comments submitted by facsimile or e-mail will not be accepted.

 Persons with a disability who require an alternative format of this notice or wish to submit questions in alternative formats such as large print, audio tape or Braille should contact Kimberly Buffington at the previously listed address or phone number, or for speech and/or hearing impaired persons V/TT (717) 783-6514, or the Pennsylvania AT&T Relay Service (800) 654-5984 (TT).

ELI N. AVILA, MD, JD, MPH, FCLM, 
Secretary

[Pa.B. Doc. No. 12-52. Filed for public inspection January 13, 2012, 9:00 a.m.]


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