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NOTICES

Health Care Associated Infection Benchmarking Areas = for=20 Hospitals under the Medical Care Availability and Reduction of Error = (MCARE)=20 Act; Final Notice

[42 Pa.B. 2543]
[Saturday, May 12, = 2012]

 Section 408(9) of the Medical Care Availability and = Reduction of Error=20 (MCARE) Act (MCARE Act) (40 P. S. =A7 1303.408(9)) = requires that the Department=20 of Health (Department) publish a notice in the Pennsylvania = Bulletin of=20 the specific benchmarks the Department will use under section 408(8) = to=20 measure the progress health care facilities are making to reduce the = incidence=20 of healthcare associated infections (HAI). Before publishing a final = notice on=20 the benchmarks, the Department is to seek public comment and respond = to any=20 comments received during the public comment period.

 The public notice was published at 42 Pa.B. 273 (January 14, = 2012). The=20 Department proposed to use catheter-associated urinary tract = infections=20 (CAUTI), central line-associated bloodstream infections and selected = surgical=20 site infections (SSI) as benchmarking conditions. For these HAI = infection=20 types, the Department proposed to define hospitals that are not = meeting=20 reduction targets as those that, for each of the two most recent years = of=20 analyzed data, had both standardized infection ratios (SIR) and = infection=20 rates that were above the 90th percentile when compared to other = Commonwealth=20 hospitals.

 During the 30-day comment period, the Department received a = total of four=20 submissions. These comments were generally supportive of the approach = proposed=20 by the Department but raised concerns about the inherent difficulty of = assessing performance across the range of hospitals found in this=20 Commonwealth. Specific comments are summarized as follows along with = the=20 Department's response. Some respondents raised multiple concerns. = Therefore=20 the total number of items exceeds the number of submissions. The = number of=20 respondents who raised each concern is included.

 1. Two respondents indicated the data used for = analysis should be as=20 accurate as possible. They felt that until the data used for analysis = had been=20 validated through auditing, it is possible that conclusions based on = the=20 current data set will be inaccurate and potentially biased.

 The Department concurs that audits of data quality are = important to assure=20 the accuracy of reporting by Commonwealth hospitals and the validity = of=20 analyses of the data performed by the Department. The Commonwealth = uses a=20 number of auditing methods to accomplish these goals. All data = submitted to=20 the National Healthcare Safety Network (NHSN) by Commonwealth = hospitals are=20 assessed for potential errors and hospitals receive a quarterly data = integrity=20 validation (DIV) report and are asked to investigate and (if = necessary)=20 correct any errors. Since the DIV report has been in operation as a = feedback=20 mechanism, the number of identified errors has declined substantially. = In=20 addition, Department representatives routinely visit hospitals to = determine=20 whether HAI reporting requirements and data collection methods are = being=20 followed. Finally, the Department has conducted onsite chart audits of = both=20 2009 and 2010 HAI data in a selected sample of hospitals. Findings of = these=20 audits were provided to the audited hospitals and seminars were = conducted for=20 all hospitals to review the overall results to identify common issues = and=20 improve reporting accuracy. The Department agrees that more extensive = onsite=20 chart audits would be beneficial. However, conducting onsite audits of = all=20 Commonwealth hospitals before the data are analyzed would result in=20 substantial delays in producing any reports. In addition, the findings = of the=20 chart audits performed to date do not suggest that error rates are = high enough=20 (either over- or under-reporting) to invalidate the data analyses = published to=20 date by the Department. Therefore, the Department does not believe the = published benchmarking methods require modification based on this = comment.

 2. Two respondents noted there are important = differences between=20 different types and groups of hospitals that cannot be easily = accounted for=20 through the use of an overall SIR. These respondents felt it was not=20 appropriate to aggregate all Commonwealth hospitals to generate SIRs = for the=20 proposed ranking as described in the Notice.

 The Department concurs that there are differences between = hospitals=20 (individually and by group). Each hospital differs by location, by = size, by=20 population served and by the level and type of care. The Department = accounts=20 for these differences through indirect adjustment of the predicted = number of=20 infections (which in turn determines the SIR) based on the ward types = present=20 in each hospital, by hospital size, medical school affiliation and = hospital=20 geographic location. These are factors commonly recognized as possibly = confounding HAI rates. For SSIs, direct adjustment using patient-level = data is=20 performed. However, there are no adjustment methods that can perfectly = account=20 for differences between hospitals. Sub-stratification of hospitals for = the=20 purposes of generating SIRs based on hospital type or other factors = would be=20 problematic because the number of facilities in some categories would = be small=20 and would make generation of meaningful SIRs nearly impossible. The = Department=20 believes the use of an overall SIR for benchmarking purposes is a = reasonable=20 approach and therefore does not believe the proposed analytic method = requires=20 modification based on this comment.

 3. Two respondents suggested that additional = strategies are needed to=20 standardize data from hospitals that provide care to children, as the = risk=20 factors for infection in children are different from the risk factors = in=20 adults. The respondents felt the adjustments used by the Department to = generate SIRs are insufficient to account for these risk = factors.

 The Department concurs that risk factors for infection in = children may=20 differ from those in adults. This is why the Department calculates = Statewide=20 ward-specific rates (including rates for pediatric ward types) and=20 incorporates these rates into its risk adjustment calculations by = adjusting=20 for the ward types present in each hospital. This Commonwealth has a = small=20 number of exclusively pediatric hospitals, but the number of general = hospitals=20 that have pediatric wards (including neonatal intensive care units) is = much=20 larger. Therefore it would be inappropriate to separately display or=20 separately calculate SIRs for pediatric-only facilities with the = knowledge=20 that a large proportion of pediatric care occurs in other hospital = types. The=20 Department welcomes feedback that might improve current risk = adjustment=20 methods. But this feedback would not produce any alteration in the = proposed=20 approach to identifying hospitals not meeting benchmark reduction = targets. It=20 would only alter which hospitals would be identified by the proposed = method.=20 Therefore no changes need to be made in the methods based on this = comment.

 4. One respondent indicated that the approach to = identifying hospitals=20 not making progress towards the reduction of HAIs should be amended, = as there=20 may be organizations identified as not making progress that have = actually=20 decreased their rates of infection, but the decreases are not as large = as=20 those that have occurred in other organizations. In addition, it may = be=20 difficult to identify reductions for organizations that have = successfully=20 reduced utilization of devices such as urinary catheters and central = lines as=20 an HAI prevention method.

 The Department concurs that a hospital's annual SIR may = paradoxically=20 increase if the rates of HAI reductions occurring in most other = hospitals are=20 greater than the ones that have occurred at the hospital in question. = This is=20 because the predicted number of infections at each hospital is based = on=20 overall Statewide rates. This is the reason the Department has chosen = to=20 assess both the SIR and the actual HAI rate for each hospital, and to = only=20 cite hospitals that have both SIRs and rates that are above the 90th=20 percentile. This approach identifies hospitals not performing as well = as its=20 peers, and does not penalize hospitals with very low HAI rates even = though the=20 rate may slightly increase from one year to the next. The Department = considers=20 its approach to be a broad one that fulfills the obligation to = identify less=20 well performing hospitals without citing hospitals that are = sufficiently=20 addressing HAI prevention.

 5. One respondent suggested that organizations may = be repeatedly=20 identified as not meeting benchmark reduction targets.

 The respondent is correct that the same hospital may be = repeatedly=20 identified as not meeting benchmark reduction targets. If certain = hospitals=20 are not making sufficient progress in comparison to other hospitals or = have=20 sustained high SIRs and rates, the Department's methods will continue = to=20 identify these institutions. Hopefully, this will allow the hospital = to=20 identify approaches that will reduce their HAI incidence in future = years. The=20 Department does not believe that citing a facility for one 2-year = period=20 should remove it from being cited again if the rates or SIRs remain = high.

 6. One respondent noted that the methodology = appears to be biased=20 against larger organizations that care for more complex = patients.

 The Department has performed and published analyses of HAI = data for the=20 last half of 2008, for 2009 and for 2010. The findings indicate that = larger=20 hospitals tend to have SIRs that are significantly higher or lower = than=20 predicted when compared to smaller hospitals. This is because the = larger=20 number of HAIs, device days and patient days allows more reliable = estimates of=20 actual rates to be calculated. This can be seen in the much narrower=20 confidence intervals for larger hospitals than smaller hospitals. = However, the=20 proposed methodology for identifying hospitals with high SIRs or rates = considers only the actual SIR and rate, not their significance. This = approach=20 would therefore not penalize larger hospitals, and no changes are = needed based=20 on this comment.

 7. One respondent noted that the proposed approach = does not use the=20 most currently available information. Hospitals that are identified as = not=20 meeting benchmark targets may have actually made progress since the = time=20 period used for the calculations. The proposed methodology should be = used as a=20 screening tool only and a correction plan should only be required if = there is=20 no evidence of subsequent improvement with more recent data.

 The Department produces an annual report on HAIs. This = report is targeted=20 for publication approximately 6 months after the close of the = reporting period=20 because data submission, DIV and data cleaning follow a 4-month cycle. = In=20 addition, implant-associated surgical procedures must be followed to = see if an=20 HAI develops for a full 12 months post-procedure. Therefore, SSI data = has a=20 1-year lag period for reporting. The Department does not believe it is = appropriate to use more recent (which would be partial year, = provisional data)=20 data to determine whether a hospital should be cited for the previous = 2 years=20 of high SIRs and rates. The goal of notifying the hospitals of this = finding is=20 to alert them to the problem and assist them in identifying and = correcting the=20 conditions that result in HAIs. If the hospital has been following the = Department's published reports, it may already have noted its = performance=20 relative to other facilities and taken appropriate steps. In this = situation,=20 no further actions or interventions would be needed unless the = interventions=20 are unsuccessful. Since this comment does not suggest any changes in = the=20 proposed benchmark methods, the Department does not believe the = proposed=20 approach needs modification based on the comment.

 

Therefore, the final approach to benchmarking hospitals and = identifying=20 those not making sufficient progress in reducing HAIs is as = follows:

 The Department, under section 408(8) and (9) of the MCARE = Act, publishes=20 this notice regarding the methods to be used to measure progress of = hospitals=20 in reducing the occurrence of HAIs and identify hospitals not meeting=20 benchmark reduction targets.

A. Purpose and Statutory Authority

 Section 408(8) of the MCARE Act requires that the Department = develop, in=20 consultation with the Patient Safety Authority and the Pennsylvania = Health=20 Care Cost Containment Council, ''reasonable benchmarks to measure the = progress=20 [hospitals] make toward reducing health care-associated infections.'' = The=20 section further provides, ''Beginning in 2010, all health care = facilities=20 shall be measured against these benchmarks.''

 Section 408(9) of the MCARE Act requires that the Department = publish a=20 notice in the Pennsylvania Bulletin of the specific benchmarks = the=20 Department will use under section 408(8) of the MCARE Act to measure = health=20 care facilities. Section 408(9) of the MCARE Act requires that prior = to=20 publishing the final notice, the Department is to seek public comment = for at=20 least 30 days on the benchmarks and respond to the comments received = during=20 the public comment period. The Department published a notice at 42 = Pa.B. 273=20 announcing these benchmarks and requesting public comment. The = Department's=20 responses to these comments are included in the present notice.

B. Background

 Since the HAI reporting provisions of Chapter 4 of the MCARE = Act (40 P. S.=20 =A7=A7 1303.401=971303.411) took effect in February 2008, the = Department has used=20 the following list of HAIs for benchmarking purposes:

 =95 Central Line Associated Blood Stream Infection = (CLABSI)

 =95 CAUTI

 =95 SSI for:

 o Coronary artery bypass graft with both chest and = donor site=20 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=20 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=20 Department will also collect data regarding SSIs for colon surgeries = for=20 benchmarking purposes in the future.

 Infections associated with surgeries that involve an implant = may not=20 develop or be detectable for some time following the surgical = procedure.=20 Accordingly, the United States Department of Health and Human = Services,=20 Centers for Disease Control and Prevention, NHSN, requires a full year = of=20 patient follow-up for complete identification and reporting of = infections=20 associated with procedures that involve an implant. Among the six = surgical=20 procedure types selected for benchmark SSI consideration, all but = abdominal=20 HYSTs may involve an implant. Consequently, annual data on SSIs are = published=20 in the year after data on CLABSIs and CAUTIs is published, that is, = HAI data=20 published in 2011 includes the CLABSI and CAUTI data for procedures = completed=20 in 2010 and the SSI data for procedures completed in 2009. At this = time, the=20 2010 data for SSIs that is required for comparison to the 2009 = baseline year=20 is not available yet. However, the 2010 data needed to measure health = care=20 facilities against benchmarks are available for CLABSIs and = CAUTIs.

C. Benchmark Methodology

 The Department uses two metrics for calculating rates for = CAUTIs and=20 CLABSIs. The first metric is the incidence rate of infection. For = CAUTIs, this=20 is the number of infections per 1,000 urinary catheter days. For = CLABSIs, this=20 is the number of infections per 1,000 central line days. The second = metric=20 used by the Department is the SIR. The SIR consists of the number of=20 infections observed (reported) by the health care facility divided by = the=20 number of infections predicted to be reported by the health care = facility. The=20 predicted number is a risk-adjusted calculation made by the Department = based=20 on Statewide rates of HAIs. The methodology for risk adjustment and=20 calculation of the predicted number of infections can be found in the=20 published annual HAI reports prepared by the Department and posted on = its web=20 site, http://www.health.state.pa.us. SIRs are produced for each = hospital.

 For the initial measurement of hospital progress in reducing = HAIs, the=20 Department proposes to rank all hospitals separately by their = incidence rates=20 of infection and SIRs for CAUTIs and CLABSIs, in two separate = consecutive=20 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=20 percentile for all Commonwealth hospitals in each of the previously = listed=20 rankings. As an example, the 90th percentile for the 2010 CAUTI rate = was 3.81=20 per 1,000 catheter days and the 90th percentile for the 2010 CAUTI SIR = was=20 2.37. Any hospital identified as having both an incidence rate of = CAUTIs and=20 an SIR for CAUTIs above the 90th percentile for all Commonwealth = hospitals in=20 2 consecutive years shall be considered not making progress towards = the=20 reduction of CAUTI HAI rates. Similarly, any hospital identified as = having=20 both an incidence rate of CLABSIs and an SIR for CLABSIs above the = 90th=20 percentile for all Commonwealth hospitals in 2 consecutive years shall = be=20 considered not making progress towards the reduction of CLABSI HAI = rates.

 When the 2010 data are available for SSIs, similar = procedures will be used=20 to identify the hospitals not making progress towards meeting the SSI=20 benchmark targets for each individual procedure. In subsequent years, = the=20 Department will conduct a similar analysis for CAUTIs, CLABSIs and = SSIs using=20 the most currently available annual data for 2 consecutive years.

D. Affected Persons

 All hospitals are currently required to comply with the HAI = reporting=20 requirements of the MCARE Act and will be measured for progress in = meeting=20 benchmark targets set forth. Section 103 of the MCARE Act (40 = P. S.=20 =A7 1303.103) defines a ''hospital'' as ''An entity licensed as = a hospital under=20 the act of June 13, 1967 (P. L. 31, No. 21), known as the Public = Welfare Code,=20 or the act of July 19, 1979 (P. L. 130, No. 48), known as the = Health Care=20 Facilities Act.''

 For additional information, or for persons with a disability = who require=20 an alternative format of this notice (for example, large print, = audiotape,=20 Braille), contact the Office of Healthcare Associated Infection = Prevention,=20 555 Walnut Street, 8th Floor Forum Place, Harrisburg, PA 17101, or for = speech=20 and/or hearing impaired persons V/TT (717) 783-6514, or the = Pennsylvania=20 AT&T Relay Service at (800) 654-5984.

ELI N. AVILA, MD, JD, MH, = FCLM, 
Secretary

[Pa.B. Doc. No. 12-856. Filed for public inspection May 11, = 2012, 9:00=20 a.m.]


No part of the information on this site may be reproduced for = profit or=20 sold for profit.=20

This material has been drawn directly from the official = Pennsylvania=20 Bulletin full text database. Due to the limitations of HTML or = differences=20 in display capabilities of different browsers, this version may differ = slightly from the official printed version.

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