| Action | Expanded Requirements for Reporting Healthcare-Associated Infections |
| Stage | Proposed |
| Comment Period | Ended on 4/1/2011 |
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March 17, 2011
The Association for Professionals in Infection Control and Epidemiology, Virginia Chapter (APIC-VA) is a non-profit, multidisciplinary, statewide organization with 176 members whose mission is to improve health and promote safety by reducing risks of infection and adverse outcomes in patients and healthcare personnel. We applaud efforts to improve the quality of patient care, appreciate the opportunity to provide input to state reporting regulation proposals and will continue to assist in these efforts by sharing our expertise in the prevention of healthcare acquired infections (HAI). We all have the same goal – to protect patients from preventable infections.
On January 31, 2011 Diane Woolard, PhD, MPH, Virginia Department of Health’s Director of the Division of Surveillance and Investigation, distributed a letter outlining proposed changes to the Regulations for Disease Reporting and Control. These changes to HAI reporting regulations are published on pages 1134-1142 of the Virginia Register, 1/31/11 edition. http://legis.state.va.us/codecomm/register/vol27/iss11/v27i11.pdf
The proposed changes include reporting of the following three additional healthcare-associated infections:
Acute care hospitals will be required to report three additional measures associated with healthcare-associated infections (pages 1141-1142).
A. Central line-associated bloodstream infections in one adult inpatient medical ward and one adult inpatient surgical ward are to be reported to NHSN. Wards selected should be those with longest length of stay during the previous calendar year, excluding cardiology, obstetrics, hospice, and step-down units. Data shall include the number of central-line days in each population at risk.
B. Clostridium difficile
C. Surgical Care Improvement Project (SCIP) Core Measures pertaining to hip arthroplasty, knee arthroplasty and coronary artery bypass graft procedures are to be reported quarterly to the Virginia Department of Health. Data shall be collected in accordance with the Specification Manual for National Hospital Inpatient Quality Measures and shall include counts of the patient population and the applicable SCIP measures for each of the three surgical procedures.
infection, laboratory-identified events on inpatient units facility-wide - shall include patient days.
Upon review of the proposed changes to the mandatory reporting regulation, APIC VA has identified the following potential revisions to the Regulations for Disease Reporting and Control proposal:
The Regulation states Acute Care hospitals, but during CLABSI validation, VDH surveyed Critical Access facilities. We ask for a list of specific inclusions and exclusions as far as type of facility.
The proposal states, "central line-associated bloodstream infections in one adult inpatient medical ward and one adult inpatient surgical ward. Wards selected should be those with the longest length of stay during the previous calendar year, excluding cardiology, obstetrics, psychiatry, hospice, and step-down units…"
APIC VA recommendations:
a. Revise the statement to include NICUs to coincide with the Centers for Medicare and Medicaid Services (CMS) requirement.
b. Remove the statement: "wards selected should be those with the longest length of stay during the previous calendar year, excluding cardiology, obstetrics, psychiatry, hospice, and step-down units"
c. Add the word "or" to the statement: "Central line-associated bloodstream infections in one adult inpatient medical ward and/or one adult inpatient surgical ward"
d. Clarify "step-down units"
Additional Comments:
All Acute Care Hospitals in Virginia with adult ICUs are now required to report CLABSIs. CMS now requires collecting and entering of data on surgical care improvement process measures pertaining to hip arthroplasty, knee arthroplasty and coronary artery bypass graft surgeries. These reporting proposals add even more areas without any verification that reporting data will make a difference in reducing infections. The Regulation proposal itself, page 1135, states, While the verification of data could be costly, VDH does not plan to conduct data validation on the accuracy of the data reported. In the absence of data validation, it is unclear how the proposed reporting requirements could be effectively enforced. In essence, this regulation is being proposed without any measure to ensure that:
A method to validate data should be considered in any mandatory reporting system to ensure that HAIs are being accurately and completely reported and that rates are comparable among all hospitals reporting. The importance of validation was emphasized by a CDC study of the accuracy of reporting to the NNIS system, which found that although hospitals identified and reported most of the HAIs that occurred, the accuracy varied by infection site (Am J Infect Control 2005;33:217-26.) Additionally, Werner’s article in JAMA, "The unintended Consequences of Publicly Reporting Quality Information" found that publicly reporting rates can be misleading to healthcare consumers and may create pressures for physicians to prematurely discharge patients.
Many IPs are still uncertain as to whether or not their facility has the capability to download denominator data directly to an outside source. As recently as January, 2011, a conference call for currently participating hospitals indicated many are failing in their attempt to accurately download denominator date to the National Healthcare Safety Network (NHSN) at this point. In order to have this type of automation, many facilities will be forced to purchase external data mining resources, at an annual cost of $60,000 and up. As facilities throughout the state vary with their resources dedicated to Infection Prevention and Control, the expectation that a facility will purchase a data mining program is placing an undue hardship on facilities already financially challenged.
3. Clostridium Difficile Infection (CDI):
APIC VA recommendation:
Eliminate this section due to lack of clinical correlation; reporting number of cases does not accurately differentiate between community acquired, hospital acquired or other healthcare associated, i.e. non-acute care faculty.
Rationale:
a. Public reporting of HAIs should promote practices that are epidemiologically sound and evidence based and the information provided on HAIs should be meaningful for both consumers and hospitals. Simply reporting numbers of cases does neither.
b. No accounting for antibiotic-related C-diff.
c. Does not account for patients admitted from a local nursing home or other facility with endemic C-diff. If a C. diff test was collected at the transferring facility, and/or was collected and sent to an external lab, would the hospital inadvertently take ownership of the case?
d. Or, if nursing home did perform C-diff test prior to patient admission to hospital, and another C-diff test is collected by hospital to determine accuracy of therapy – this C-diff could potentially be attributed to the treating hospital.
e. The disease process associated with C. difficile is not being considered. It would be more beneficial to the public if the causes of C. diff were investigated; perhaps perform cultures to determine resistance patterns, rather than simply reporting numbers of cases that are identified after admission.
f. Currently, NHSN is not able to exclude these above-mentioned cases via the suggested laboratory identified module.
g. If C-diff proposal remains, APIC-VA requests clarification of which patient areas will be required to report.
APIC VA recommendations:4. Surgical Care Improvement Project (SCIP):
a. SCIP data is currently publicly reported. This will be a duplicated effort.
b. Table this measure in order to align with the forthcoming Centers for Medicare and Medicaid Services (CMS) indicator.
c. If proposal passes, insert the following: "Surgical site surveillance will be conducted in accordance with CMS guidance. Future reporting opportunities will be aligned/defined with pending CMS regulations requiring SSI reporting. Although specific components of this indicator have not yet been finalized, there should be no duplication and/or conflicting data requirements. Every attempt should be made to streamline reporting of this information."
d. If kept as a measure APIC-VA proposes that Virginia hospitals continue to report SCIP data through their customary channels. The data is available to Virginia Department of Health (VDH) on the Hospital Compare website. VDH should provide the following link to the SCIP data on their website. http://www.hospitalcompare.hhs.gov/hospital-search.aspx?AspxAutoDetectCookieSupport=1
Rationale:
SCIP core measures are currently being reported to a variety of validated sources and are already publicly reported. Why duplicate the effort and require facilities to also report this information again to NHSN/VDH? Since CDC is a long time partner in the sponsorship, development and continued improvement of SCIP, VDH should be able to obtain this information from the already reported sources. Time required to gather and enter this data into NHSN is time best used by an Infection Preventionist for performing tasks directly related to patient safety.
Unfortunately, the proposed regulations have no evidence base to signify they can reduce infections. It is difficult to support a proposal which also states (page 1136 of Regulation), because the proposed requirements do not channel additional resources to existing infection control programs the benefits are expected to be small. In fact, the introduction of the additional measures that must be reported may actually divert resources from infection control activities to reporting activities at the hospitals. In effect, invalidated reporting may have little benefit and will take the very individuals instrumental in advocating improvements even further from the patients we are supposed to protect.
IN CLOSING:
APIC-VA has always been in full support of evidence-based measures proven to reduce infections, as well as researching Virginia facilities which have effectively reduced infections. We strongly support transparency and sharing of information with the public. However, as several studies have concluded, mandatory public reporting has not been linked to improved quality of patient care. The ultimate goal of public reporting of HAIs should be to improve public health and patient safety. The Healthcare Infection Control Practices Advisory Committee (HICPAC), a federal advisory committee providing advice and guidance to the CDC, in 2005 released a document on public reporting of HAIs and concluded that there was insufficient evidence to recommend for or against public reporting of HAIs.
Hospitals currently perform "targeted surveillance" to identify healthcare-associated infections. Rather than collecting data on all infections all of the time, hospitals identify infections and procedures most risky for its patient population and "targets" these for surveillance, prevention and control activities. The Joint Commission requires hospitals to perform an annual risk assessment and to use this risk assessment to prioritize identified risks for acquiring and transmitting infections. Based upon the identified risks, hospitals are to set goals to minimize the possibility of transmitting infections. Requiring hospitals to collect data and report HAI rates not determined by the individual healthcare facility’s risk assessment as being those that pose the greatest risk for that hospital contradicts the Joint Commission’s requirement and diverts the IPs attention to reporting numbers, rather than focusing on strategies to improve the quality of patient care.
Lastly, HAI rates can mislead consumers if inaccurate information is disseminated. Not only will publicly reported HAI data be used by the consumer when making healthcare decisions, but hospital executives will use for marketing, infection prevention personnel will use for improvement programs, third-party payers will use for reimbursement, and lawyers will use when representing a patient/family member. Therefore, in any document revealing HAI information, the limitations of current data collection methodologies, case definitions, and lack of validation should be clearly communicated within the publicly released report.
Respectfully Submitted,
APIC Virginia Chapter 12