As a member of a VDH/VHHA task force on public reporting I do understand that the public desires (and has a right to access) data on HAIs. As a long time Infection Preventionist I also understand that, to be of value, these rates must be generated via the same process. Additionally, definitions to allow for the generation of these rates must be useful to exclude previously existing conditions. My organization trialed the C difficile lab ID module via NHSN during 2010. This trial allowed us to identify several issues towards generating useful data. This NHSN module does not capture the antibiotic exposure potential for a case of C difficile and does not allow for consideration of symptoms on admission or prior infection at home or at another healthcare facility. As a result, data generated from this NHSN module will not be useful in comparing horizontal transmission of C difficile within a healthcare facility. Each IPs time is valuable towards preventing infections therefore the addition of a non-value added data collection activity will detract from, rather than enhance, an infection prevention program.  I propose that this requirement by eliminated from the regulations.

I support the addition of NICU central line bloodstream infections to the current reporting requirement of adult ICU CLABSIs. This would bring Virginia reporting requirements in line with CMS reporting requirements. If CLABSI reporting outside of the ICU is selected to remain in the requirements I suggest that hospitals be required to report from either one surgical or one medical unit as some smaller facilities do not have both. The IPs dilemma in accurately reporting CLABSIs is in having access to an accurate denominator (central line days). This accuracy is increasingly difficult in a large, non ICU setting. I suggest that it would be advantageous to have accurate data from one non ICU than inaccurate data from multiple non ICUs.

I support the inclusion of the SCIP data for hip arthroplasty, knee arthroplasty and CABG procedures however I would strongly encourage the requirement read that this data be made available from the Hospital Compare website. To report from another source would be a duplication of efforts which always allows for some potential of error.    

Thank you to the opportunity to comment.

Respectfully submitted,

Inova Health System, Infection Prevention & Control Department

Thank you for allowing us to comment .

1.  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.  Recommend removal of  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”.  Recommend 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”.  What is the VDH definition of a step-down unit? Why would you exclude these step-down units, as they are typically the “next step” from an ICU and will have more central lines than other units? ICU’s are already being reported, and this is where the majority of the central lines are used, why would you add another department with no basis for comparison.

2. Clostridium difficile infection, laboratory-identified events on inpatient units facility-wide - shall include patient days. Data analysis does not accurately differentiate between community acquired, hospital acquired or other healthcare associated, i.e. non-acute care faculty.  Rather than simply publicizing the number of cases identified at a facility, VDH should assist hospitals with the development of programs shown to reduce CDI, for example, antibiotic stewardships and public education. The NHSN definitions are ambiguous at best and allows the facilty to determine their perception of where the CDI was originated. NHSN doesn't account for a history or symptoms of previous infection with no testing. What good is this? Does this actually help the patient or hospital with preventing CDI? No! I see no benefit to anyone, even the public, with this proposed regulation.

3. SCIP (Surgical Care Improvement Project) 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. SCIP data is currently publicly reported; reporting to VDH the same data will be a duplicated effort. Surgical site infection reporting should align with the Centers for Medicare and Medicaid Services indicators. The information is already available on the Hospital Compare website.  VDH should provide the Hospital Compare link on the VDH website, rather than require duplication of reporting.

Public reporting diverts the IP's attention from prevention. The State of Virginia needs to move from disease reporting to disease prevention; the proposed changed do not address prevention strategies. Hospitals are already overburdened with reporting requirements and loss of revenue due to budget cuts and reimbursement, these proposed changes will make more work for the IP's who are already at a loss to help keep patient safety the priority.

I do not believe any of these proposed regulations will result in fewer infections and improve patient care, therefore all should be voted against.

Many valid comments have already been made, so I will limit my comments to areas not previously addressed. 

• For each proposed metric, VDH should provide an analysis of:  value added, utility for consumers, validity, potential adverse unintended consequences, and opportunity cost.
• It is unclear to me how having hospitals report CLABSI from 1 surgical and 1 medical ward is of value. Since the goal of public reporting is for consumers to be able to compare hospitals, the variability in types of patients and wards will greatly limit its utility. The proposed regulation asks hospitals to choose the ward with the longest length of stay; however, this may not be the ward with the greatest utilization of central lines. Moreover, without some type of risk adjustment, interhospital comparisions will be fraught with peril.
• C. difficile infection is a problematic metric since it can be difficult to know whether the infections were community- or hospital-acquired. In addition, the testing used by hospitals varies and the tests have different sensitivity. Mandating reporting of C. difficile cases provides hospitals an incentive to employ tests of lower sensitivity, which is not in the best interest of patient care. 
• For every new publicly reported metric proposed, VDH should report its plan for measuring the validity of the metric. The resources devoted to infection prevention, the training and expertise of personnel, and the IT infrastructures vary widely across hospitals in Virginia, all of which have a significant impact on validity.

Reporting of Hospital Associated Infections should be consistent with National Reporting Requirements and be of value to VA citizens.  As hospitals are being tasked to report nationally to the NHSN, I suggest the VDH follow the lead of the national trends.  In 2011 we began reporting CLABSI in ICU's and NICU's and it is forecasted hospitals will be reporting surgical site infections by procedure in 2012 (undetermined type of procedures).  SCIP measures are being reported nationally at this time. 

• not consistent with the current reporting design
• may not be of value to VA citizens.

As an Infection Control Preventionist, I would love to see more benefit for the patient's quality of care from reporting that is done. With that, if the state mandates additional reporting it needs to coincide with current reporting mandates (location of reporting). So that ICP's don't spend too much time doing redundant and manual entry of data. ICP's need more time working on prevention strategies/education that will bring value to the patient's quality of care.

Indicators for Mandatory Reporting should be meaningful, validated and purposeful to improve patient outcomes. I concur with the position taken by APIC-Va. 

In reviewing recommended changes to the State regulations re: HAI reporting, I have concerns  related to indications to further collect data. Regulatory agencies as well as hospitals are more interested in the development of  processes that address data results-simply increasing data collection processes is no longer the quality focus. How does the Department of Health propose to collaborate with hospitals and infection control preventionists related to this data collection process?

Infection control preventionists, as well as other clinical nursing staff should be focusing more on care at the bedside, and collaborating on practices to improve patient safety and quality of care.

As an active member of APIC Virginia I concur with the proposed recommendations posted on this website.  And since these recommendations have been thoroughly discussed by APIC Virginia and others, I will focus my response on a slightly different arena; that of the ultimate goal – infection prevention.

It is inarguable that healthcare acquired infections (HAIs) are a major problem worldwide.  HAIs have moved into the national spotlight and today’s focus is on infection prevention.  The goal of the Virginia Department of Health (VDH) and our legislators is the same as Virginia Infection Preventionists (IPs); to protect patients from preventable infections.  If mandatory public reporting were proven to help us do a better job protecting our patients, this would be a good thing!

However, the question remains; does public reporting actually prevent HAIs?  This query has been debated extensively, yet it is still unknown what impact, if any, public reporting will ultimately have on health care quality.  Reporting data simply for the sake of reporting will divert already slim infection prevention resources away from patient care and infection prevention. 

The Healthcare Infection Control Practices Advisory Committee (HICPAC), a federal advisory committee established in 1991 to provide guidance to the Department of Health and Human Services and CDC, conducted a scientific literature review to evaluate the merits and limitations of HAI reporting systems and found no published information on the effectiveness of public reporting systems in reducing HAIs.

Hospitals are currently required by The Joint Commission (TJC) to conduct annual and as-needed Infection Risk Assessments, utilizing in-house surveillance data to identify potential problem areas and then targeting these areas for performance improvement interventions.  TJC evaluates to determine whether infection control has put plans, processes, procedures and programs in place to address, eliminate or counteract the effects of these risks.

Risk assessments are the cornerstones upon which each hospital’s infection control program is built and help to ensure that data collection is concentrated in populations where HAIs are most frequent and that rates are calculated that are useful for targeting prevention.  IPs should be spending a majority of their time on the floors and units with staff and patients, applying epidemiologic principles to truly prevent infections – not collecting and reporting data that may have no infection relevance to their hospital.

As a non-revenue-producing department, Infection Prevention and Control has a history of being able to generate much with little.  It is common for hospitals with under 250 beds to have an infection preventionist who also serves in other capacities; Employee Health Nurse, Emergency Response, staff nurse, etc.  The proposed regulation forewarns, The disadvantage to the regulated community (hospitals) is increased workload that would be created.  Given the current economic climate in health care, additional staffing to monitor and publicly report HAIs, especially those not on, or pertinent to, a hospital’s Risk Assessment, is not going to happen unless legislated.

The Virginia Department of Planning and Budget Economic Impact Analysis imparts the following:

1. Reporting of three additional measures is expected to demand more administrative resources from VDH.  VDH believes that the current staffing level made possible by the temporary federal stimulus funding would be able to absorb the increased workload in terms of the retrieval of data reported to NHSN and dissemination of the same data to public if requested. 
2. While the verification of data could be costly, VDH does not plan to conduct data validation of the accuracy of the data reported.
3. In the absence of data validation, it is unclear how the proposed reporting requirements could be effectively enforced.  
4. Due to litigation concerns, hospitals already have strong incentives to minimize the number of infections occurring at their facilities. Given already existing strong incentives to minimize infections, it is unclear whether reporting would be an effective way to reduce infections at the margin.  
5. Furthermore, because the proposed requirements do not channel additional resources to existing infection control programs the benefits are expected to be small.
6. In fact, the introduction of the additional measures that must be reported may actually divert staff resources from infection control activities to reporting activities at the hospitals.

The VDH has federal funds to support this effort through December 2011, after which time the requirement could place a financial hardship on the Agency.  IPs will be required to absorb the additional reporting responsibilities on a permanent basis, with no foreseen additional assistance.

A method to validate data is essential in any credible mandatory reporting system in order to ensure that HAIs are being accurately and completely reported and that rates are comparable among all hospitals in the reporting system.  Publicly reported data must convey scientific meaning that is interpretable to a diverse audience and must highlight its potential limitations.  HAI rates could mislead stakeholders if innaccurate or misleading information is disseminated.  The importance of data validation was emphasized by a CDC study of the accuracy of reporting to the NNIS system.  It was determined that, although hospitals identified and reported most of the HAIs that occurred, the accuracy varied by infection site.  

As expressed by many of my fellow colleagues this data is currently reported through CMS, Joint Commission and other payer sources, i.e. QHIP.  For IPs to be required to report this data to NHSN is duplicitous.  If these proposals are approved, this data should be made available to the public through an already reported to entity.

The infection control and epidemiological community in Virginia will continue to work diligently to reduce infection rates.  When health care providers join forces to reduce the risk of infection and improve adherence to infection-prevention protocols, infection rates can be reduced and lives saved.  Success requires collaboration between health care providers, government agencies, legislators, administrators, patients, professional and consumer organizations and payers.  However, I am not convinced that reducing infections will happen simply by publicly reporting HAIs.

Without verification that reporting data will make a difference in reducing actual infections, we should be very careful that we are not reporting simply for “reporting sake” and ultimately creating analysis paralysis for the very people at the forefront of prevention – the Infection Preventionists.

Thank you for the opportunity to comment.

While I appreciate what VDH is trying to achieve, i do not think that the past reporting measures added nor the proposed measures will acheive the real goal.  ICPs value public health and their efforts and wish for their energies and monies be spent making a real impact.

The theory behind publicizing adverse events such as hospital acquired infection (HAI) rates is that by doing so, better prevention strategies will be implemented.  However, reporting via the National Healthcare Safety Network (NHSN) requires data entry of more than just the numbers of a particular infection, device days , and total patient days.  The data entry tasks can be cumbersome, especially without data mining programs.  Manual entry of data diverts the Infection Preventionist from developing and monitoring prevention and control strategies.  Furthermore, other than publicizing the infection rates on the VDH website, nothing is done with that data  once  VDH  receives the information.  The regulation/law does not specify that VDH is to assist hospitals with improvement processes.  This leaves one to question the value of reporting data other than number of cases.  The value of public reporting has even been questioned by the Healthcare Infection Control Practices Advisory Committee (HICPAC) who found that there is insufficient evidence to recommend public reporting of HAIs. 

Questions:

Will reporting numbers and rates in the Healthcare-Associated Infections Report (Virginia Department of Health website) be meaningful to the audience it was intended for – the consumer (is there evidence to demonstrate that the public has benefited from the central line-associated bloodstream infection (CLASBI) data that has been reported since 2009)?

How will reporting such data lead to evidence-based strategies to optimize patient safety and quality?

What tasks will the Infection Preventionist (IP) have to omit in order to fulfill the reporting requirements (most facilities allocate minimal resources to the Infection Control Department)?

Recommendations:

If additional HAI reporting must be required, align the measures/indicators with the Centers for Medicare and Medicaid Services (CMS) so that the Infection Preventionists are not collecting different indicators, for different time spans, and entering data in numerous data bases (for example, CLABSI and SCIP data) .  The State should either (1)obtain access rights to the data submitted to CMS or (2) include the link for CMS on the VDH website.  This will allow the public to obtain the information.  Omit the Clostridium Difficile Infection (CDI) measure.  Since this measure cannot accurately portray a facility specific CDI rate (does not take into account CDI from external facilities such as Long Term Care), rather than requiring time consuming data entry, add to Virginia Reportable Disease List and have it reported similar to Influenza (“report number only”). 

When conducting a business case analysis for a new project or proposal for change, IPs and other leaders are encouraged to consider the effect of such projects on operations, costs, others impacted, and  the ability to improve patient safety and care.  There is no indication in the proposed changes to the Regulations for Disease Reporting and Control of any of these considerations, in fact, the proposal states “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 measure that must be reported may actually divert resources from infection control activities to reporting activities at the hospital level.”

Please consider obtaining the CLABSI and SCIP data from existing sources rather than requiring duplication.  Revisit if and how CDI is to be reported.

Thank you for the opportunity to comment.

As Director of Infection Prevention & Control for the Sentara Healthcare System I appreciate the opportunity that you have provided for the Infection Prevention & Control Community to provide expert input to the current proposed state reporting “Regulations for Disease Reporting and Control”. 

Currently, Sentara facilities are partners with CDC/NHSN in the reporting of healthcare associated infections into a nationally recognized database and perform targeted surveillance based on their facility annual “risk assessment”, targeting those infections for continued surveillance and prevention activities for their patient population.  Additionally, Sentara facilities participate in the state requirement for reporting of CLA-BSIs within the adult intensive care units, and CMS requirement for reporting of surgical care improvement process measures pertaining to specific surgical procedures.  Sentara has a very robust Infection Prevention & Control Team that focuses on the safety of its complete environment inclusive of all patients, visitors, and healthcare providers.

In review of the proposed regulations, I have identified several areas of each component that I would like to focus on:

Measurement #1: “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.”

a)      To reflect the Centers for Medicare and Medicaid Services requirement NICUs should be included in the verbiage;

b)     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”, should be removed as this requirement could be calculated in numerous ways and could lead to non-comparative data;

c)      Change the following statement to reflect the word “or” as many facilities have mixed units or only one type of patient population:  “Central line-associated bloodstream infections in one adult inpatient medical ward and/or one adult inpatient surgical ward”.

d)     Definition of “step-down units” would have to be better defined for specific comparative data.

Measurement #2: “Clostridium difficile infection, laboratory-identified events on inpatient units facility-wide - shall include patient days.”

a)      What epidemiological value or trending can be accomplished with this data program?  Data analysis does not accurately differentiate between community acquired, hospital acquired or other healthcare associated acquisition.  Infection Preventionists would simply be reporting the number of cases identified at a facility.  Perhaps focusing on hospital antibiotic stewardship programs or community education on CDI would serve the public better and addresses actions to reduce the potential for CDI.

Measurement #3: “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.”

a)      SCIP data is already publicly reported through our facility Quality Departments – this would be a duplication of efforts by each facility and therefore would take time away from other prevention measures.  I would recommend the state investigate avenues to work with the Centers for Medicare and Medicaid Services and not have duplicate efforts and double reporting on these indicators.

In closing the proposed regulations do not speak to the validation or verification of data reporting and therefore can not verify standardization or accuracy for comparative value.  The State of Virginia needs to move from disease reporting to disease prevention; the proposed changes do not address prevention strategies and will not result in fewer infections or improve patient care by changing the focus of the Infection Preventionist from prevention to data reporting.  Public reporting of HAIs should promote evidence based practices and report meaningful and accurate data for the consumers and the healthcare industry.

Respectfully Submitted by:

Jacqueline P. Butler, CIC

Director, Infection Prevention & Control

Sentara Healthcare

CLABIs is being reported and validated in ICUs.  It would be very difficult to determine the denominator data on the Medical Surgical units.  Without validation of the accuracy I cannot see this being a benefit. 

CDI public reporting the number of csses does not accurately differentiate between community acquired and other healthcare associated (non-acute care).  Reporting the number of cases will not be a good indicator for the public, it will just be numbers that they cannot understand

Data is currently publicy reported, this would be a duplicate effort.

Not sure I could download my informtaion into NHSN. 

HAI rates can mislead consumers if inaccurate information is disseminated.  There are still too many limitation of current data collection methodolgoies, case definitions, and lack of validation. 

At our state meeting we have has sessions on case studies and identify the HAI, there were lots of different answers. 

I am in full support of evidence based measures to reduce infections but mandatory reporting will only increase the IP workload on data collecting, instead of prevention. 

Comments of the proposed amendments to the state reporting regulations.

Measurement #2: "Central line-associated bloodstream infection in one adult inpatient medical ward and one adult impatient surgical ward are to be reported to NHSN. It would be very difficult to determine the denominator data on the Medical Surgical units. Without validation of the accuracy I cannot see this being a benefit.

Measurement #2 "Clostridium difficile infection", laboratory-identified. Collection of this data is not a benefit to either consumers or hospitals. Reporting of numbers of cases without taking into account local nursing homes or other facility, or when symptoms developed does not give an accurate picture to promote practices.

Measurement #3. "Surgical Care Improvement Project (SCIP) is already publicly reported and would be a duplication of efforts.

A reminder, if whatever the state decides to require, if validation or verification of data reporting is not apart of the State’s plan, then the accuracy of the data is not valid. All the time and effort used to report this invalid data could have been used to prevent them.

Support for the APIC VA Recommendations

 I submit these comments in recognition and support of the comprehensive review submitted by APIC Chapter 12 of Virginia.  The APIC VA review of the proposed additional reporting requirements addresses the general state of hospital acquired infection reporting today. The area that I suggest VDH explore before placing an additional burden on hospital Infection Preventionist is the support our IPs currently receive by their facilities. In the era of increased costs and decreased reimbursement several of our Virginia hospitals have opted to reduce staffing support of their Infection Prevention Departments, even reducing full time positions to part time or eliminating positions.  Reporting requirements have not decreased thus leaving the IP staff reducing time spent in educating front-line staff who actually implement protocols that reduce hospital acquired infections.

 In addition to current published comments, I propose the following considerations.

 1. 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 ... risk.

 Instead of requiring number of wards for reporting of Central line-associated bloodstream infections, why not consider percentages? The current requirement would place all our hospital in-patients except the birthing center into the reporting category, since we have one ICU, one medical, and one surgical unit for a total of approximately 75 beds. Our small hospital does not have a data-mining systems and currently no procedure for identifying central-line days for the surgical and medical units. These responsibilities would be an additional burden with limited resources. In small hospitals such as ours, the step-down unit patients are considered part of the medical floor and identifying the step-down patient to remove them from review of central lines would be difficult and time consuming. Therefore instead of proposing 3 units, consider a range of beds such as 10 to 15%.  The IHI campaign and the CUSP project currently implemented by VHHA propose the five steps to reduce CLABSI: Hand hygiene, Full Barrier Precautions, Chlorhexidine Site Preparation, Appropriate Site (avoid the femoral), and Daily Assessment for removal which we have implemented house-wide. The movement of reporting beyond ICU is a great concept to ensure all our patients receive the same standard of care, but I believe an undue burden on our already over-worked and under-staffed Infection Prevention staff.

2. Clostridium difficile infection, laboratory-identified events on inpatient units facility-wide - shall include patient days.

I fully agree with this INOVA statement: Data analysis does not accurately differentiate between community-acquired, hospital-acquired or other healthcare-associated, i.e. non-acute care faculty. Rather than simply publicizing the number of cases identified at a facility, VDH should assist hospitals with the development of programs shown to reduce CDI, for example, antibiotic stewardships and public education.

 In addition, I propose that this type of reporting to the public may results in physicians not testing for C. diff, but alternately treating without testing. Again as related earlier, the sensitivities of testing methods vary and a patient may test positive on admission to the hospital even though they were appropriately treated prior. To accurately identify prior disease confirmation and treatment requires precious time to review records, make phone calls, talk to patients and etc to assess the course of the disease events. In addition this proposal limits review of healthcare contacts to the reporting hospital and does not include other facilities where colonization may have occurred. With public reporting of antibiotics given on admission to patients diagnosed with pneumonia, we see more patients diagnosed with C diff because even one dose of ceftriaxone stimulates C diff replication in the colonized patient and positive test results. Reporting of this case appears punitive to the hospital that implements the required treatment for pneumonia.

3.       SCIP (Surgical Care Improvement Project) core measures ... reported quarterly to the VDH.

I support the INOVA view: SCIP data is currently publicly reported; reporting to VDH the same data will be a duplicated effort. Surgical site infection reporting should align with the Centers for Medicare and Medicaid Services indicators.

The introduction of infection control programs in healthcare has made a significant impact on patient outcomes, as well as improvements in employee safety. These improvements did not take place with the Infection Preventionist (IP) sitting in an office collecting or reporting data. For a reduction in HAI’s the IP’s need to be visible to patients, visitors, and employees and actively involved in process improvement efforts. The continued availability of the IP is imperative for these improvements which will decrease adverse patient and employee outcomes.

• Consider revising to only one additional inpatient ward as there are acute care facilities in Virginia who do not have separate medical and surgical wards.
• Consider deleting “wards should be those with longest length of stay....excluding cardiology, obstetrics, hospice, and step-down units”. This requirement limits the number of hospitals required to report.
• Why were step-down units excluded? Step-down medical and/or surgical units may in fact be the areas that have the most central lines therefore increasing patients who may be at risk for acquiring a CLABSI.

• Consider removing completely. This requirement does not take into consideration patients who may have received antibiotics in the outpatient setting and not had a previous hospital stay. By not including definitions of healthcare associated C-Diff infection what comparison will be made? Submission of this data without stratification would not provide hospital specific information regarding C.Diff and/or antibiotic stewardship. Where is the scientific evidence that this requirement would lead to prevention and a reduction in the number of C-Diff cases? How will gathering these numbers be used to change practice or prevention efforts?

CJW Medical Center, like most acute care hospitals, identifies healthcare-associated infections through "targeted surveillance" based on an annual risk assessment. This risk assessment is used to prioritize the identified risks for acquiring and transmitting infections within the patient population and community we serve. Infection Preventionists dedicate much of their time and resources to conducting surveillance for reporting measures that impact patient care based on their annual risk assessment. The proposed regulations, as they are written, would not initiate strategies to improve quality or clinical outcomes related to patient care. In addition, “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.” We respectfully request that any proposed regulations provide a method of validation to ensure that HAIs are being accurately and completely reported and that rates are comparable among all hospitals reporting.

In regard to the proposed regulation for central line associated blood stream infections the statement could be revised to include NICUs to coincide with the Centers for Medicare and Medicaid Services (CMS) requirement. 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" in an effort to align with our current reporting requirements. As written, this regulation will be difficult to compare among all hospitals reporting.

Eliminate the proposed regulation for C-difficile lab data, since it does not correlate with our current method of data collection or reporting. The state could provide assistance with the promotion of antibiotic management through a statewide campaign to facilitate antibiotic stewardship in the healthcare setting.

The proposed regulation for reporting SCIP data could be eliminated, since SCIP data is currently available to the public and a link could be added to the VDH website for public access and review.

I agree with comments and concerns shared earlier by APIC VA and Jacqueline Butler, CIC, Director of Sentara Infection Prevention and Control.

As an Infection Preventionist, one of my major concerns is providing meaningful data that can be used to truly promote Infection Prevention in our healthcare facilities.  The proposed measurement for Clostridium difficle infection does not give us meaningful information regarding transmission in healthcare facilities.  A greater effort should focus on community education and awareness.

I also agree that reporting SCIP data through yet another avenue does not add any value to this information and creates a greater burden on facilities who may struggle to meet all other reporting regulations.

Thank you for the opportunity to comment on the proposed regulations,

Sue Felber, CIC  Infection Preventionist  Sentara Bayside Hospital

I do not support public reporting without data validation for accurracy.

Why in today's society are we always adding another report or reporting agency.  The quality should be to the patient.

Re: CLABSI reporting: The physcian management and administration of Doctors Surgery Center strongly propose the recommended changes to CLABSI reporting. First and foremost we do not trust that adding two more areas without proof that the reporting data will absolutely reduce actual infections will be beneficial to our center or to our patients.

In a busy ASC where efficiency is a key component of our success in providing quality surgical care this could be another time consuming step that is implemented without evidence that it will make a difference. The system that is in place currently at our surgery center is outstanding and we have no difficulty in the reporting structure and flow. We do not want nor do we need additional reporting steps that have not been verified to reduce actual infections.

In the for-profit setting we must keep expenses down and profit up. Failure to do this is a failure in our business model. We are certain additional costs would hit our botttom-line and if the return on investing time and money in something that has not been verified to work occurs it will be a huge disappointment to our ownership.  

Re: SCIP reporting to VDH: Why would be asked to duplicate efforts in reporting SCIP core measures when this is already being publically reported. It seems like another bureaucratic requirement that makes us working more efficiently doubly difficult.

Re: Cdiff: We do not have the capabilty to download denominator data directly to an outside source. Forcing our facility to invest thousands of dollars  to purchase external data mining resources to save this type of automation is an expense we can not bear and one our facility owners strongly object to.

Our 14 physician owners and our three administrators strongly vote against these proposed regulations.

It is the goal of the Infection Preventionist to improve the healthcare of the population we serve by implementing evidenced based prevention strategies to reduce infections. This requires surveillance of the infections within your facility and also includes being available to the staff members and patients we serve providing education and being a resource to assist in this effort. While public reporting may provide information regarding your hospitals rate of infection, we also would hope that it would have a positive effect in reducing hospital infection rates by using the data obtained to further prevent hospital acquired infections. Collecting and reporting data that cannot be verified as accurate will not assist in this effort, and it will also pull at the resources of the infection Preventionist with no real benefit or results. The proposed central line associated blood stream infections statement could be revised to include NICU’s to match with the CMS requirement. 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” in an effort to align with our current reporting requirements. As written this regulation will be difficult to compare among all hospitals reporting.   Reporting C-Difficile numbers again will not provide a direct benefit in reducing the number of cases. Better use of resources would be providing education and direction in antimicrobial management that would directly assist in reduction of C-diff cases. SCIPS is already publicly reported and would be a duplication of efforts. Finding a way to link currently reported SCIPS data to public reporting sites would be a better option.  I do not support the currently proposed legislation. mately 3000 words.

 It is the goal of the Infection Preventionist to improve the healthcare of the population we serve by implementing evidenced based prevention strategies to reduce infections. This requires surveillance of the infections within your facility and also includes being available to the staff members and patients we serve providing education and being a resource to assist in this effort. While public reporting may provide information regarding your hospitals rate of infection, we also would hope that it would have a positive effect in reducing hospital infection rates by using the data obtained to further prevent hospital acquired infections. Collecting and reporting data that cannot be verified as accurate will not assist in this effort, and it will also pull at the resources of the infection Preventionist with no real benefit or results. The proposed central line associated blood stream infections statement could be revised to include NICU’s to match with the CMS requirement. 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” in an effort to align with our current reporting requirements. As written this regulation will be difficult to compare among all hospitals reporting.   Reporting C-Difficile numbers again will not provide a direct benefit in reducing the number of cases. Better use of resources would be providing education and direction in antimicrobial management that would directly assist in reduction of C-diff cases. SCIPS is already publicly reported and would be a duplication of efforts. Finding a way to link currently reported SCIPS data to public reporting sites would be a better option.  I do not support the currently proposed legislation.  

The proposed mandatory reporting is partially redundant and without evidence of improving patient outcomes.  The resources required to provide administrative support to the multitude of current reporting requirments are most often at the expense of augmenting resources at the bedside tthat have opportunity to "prevent HAI"   Additionally, it has been my expereience that the benefit of public reporting has a finite end point and beyond only adds additional burden to respond and expalian information that is often very complex, particularly to the public.  It is not in the interest of clinical excellence to keep government agencies in business. Thank yo for the opportunity to respond. 

The proposed amendments for increased mandatory reporting will be labor intensive and redundant in some of the measures on an already stretched budget and limited resources. The opposition is not in the public reporting as we currently participate now, but in the validity or lack thereof in the data coming from a variety of facilities and units. The quality of the return on the investment is very much in question. With everyone's limited resources, we need to focus our efforts on prevention strategies, best practices, and education at the bedside where we can truly make a difference and reduce all HAI'S.

CLABSI: The proposal is for one inpatient medical ward and one inpatient surgical ward. Smaller facilities such as mine have combined units only. If you seperate the two, the numbers may be too small to be statistically significant.

C.Difficile:  Definitely a growing problem that needs to be addressed first through consistent testing methods among facilities, consistent reporting of community vs healthcare or hospital acquired, etc. Numbers without validation serve no purpose in the prevention or reduction of C. difficile.

SCIP: Currently publicly reported.

This comment is in reference to the SCIP Core Measures.  Hospitals are already contracted  with third party vendors for the submission of SCIP data to Joint Commission/CMS.  To submit to VDH would be double the work.  VDH should work with the Joint Commission or CMS to obtain the data with the hospital's approval or authorization.  Also, the schedule for reporting should follow the same schedule as for the reporting to CMS/Joint Commission.

Practicing control and prevention of infections in the acute care setting has been my lot in life for more than 22 years. Public awareness including those in public service is certainly at an all time high. I embrace the interest with an open mind and enthusiastically work toward transparency both within the acute care setting and public sector. I have read the proposed changes to the Regulations for Disease Reporting and Control (12 VAC 5-90). I am grateful for the opportunity to comment on the proposed regulations.  

Excellent points already outline support, weaknesses in the proposed regulations, or recommended alternatives with their comments.  I have one concern or comment not already discussed.

Infection prevention answers to many regulatory agencies. Not all agencies have the same focus or requirements as has already been stated. Collecting accurate data and applying the indicators or definitions accurately is key to any surveillance program. Others have outlined concerns about validation and I definitely share those concerns but from a different angle. Surveillance has to be accurate.

In 1974 the Centers for Disease Control conducted a nationwide project, the Study on the Efficacy of Nosocomial Infection Control (SENIC project). The three main objectives of this study: 1. clarify the scope  and level of effectiveness  the establishment of an infection surveillance and control program had  on decreasing the rate of nosocomial infections; 2.. Describe the current status of the infection control and surveillance program and reported infection rates; and 3. Demonstrate the relationships among characteristics of hospital and patients components of the programs, and changes in the infection rate. That study set the gold standard for infection control departments across the nation. The importance of such a department was outlined as the determination that one Infection Control Practitioner (ICP) for each 250 beds would satisfy the need to conduct surveillance with the goal of reducing infections. But that was in 1974. Since that time the ICP has now become the Infection Preventionist or IP’s. We have moved from data collectors to infection preventionists or interventionists. We have not stop data collection just increased the amount of data collected and are now key leaders in implementing measures to prevent those infections.

Trundle et al. in 2001 showed ICP’s were working at 130 percent, during a normal day. That was 10 years ago.  

Dr. Carol O’Boyle et al., in 2002, published her study on “Staffing requirements for infection control departments in US health care facilities: Delphi project. Surveys were conducted with representation from 20 states. The study concluded: the IC responsibilities have expanded beyond the traditional acute care setting. Staffing recommendations must consider the number of occupied hospital beds, scope of program, the complexity of the health care facility, the characteristics of the patient population, and the unique or urgent needs of the facility and community. The suggested ratio for IP staffing was 1 ICP for each 100 occupied beds. That study significantly moved the ratio from the original 1974 study and today is almost 10 years old.

Stevenson et al. in 2004 reported an average of 1.58 ICP/250 beds, not much of an improvement from 1974.

A recent survey of Virginia IP’s showed implementation of the proposed regulations would add anywhere from a few hours to weeks of time to their more than 40 hour week. Most IP’s reported working 45 to 60 hours per week. .

Countless studies have been published on the impact increased hours worked has on health care workers. Critical thinking and medical decisions are negatively affected by overwork and fatigue for Residents, nursing, and emergency workers. I know the physical workload may not be the same but the critical thinking is definitely involved and impacted by the IP’s stretched workload

I support the use of additional measures, meaningful measures, but would ask for further investigation into proposed mandatory requirements for infection prevention staffing. We are not revenue generators but we have shown positive fiscal impact with decreasing infection rates.  Additional data requires additional hours to manage and analyze. To date, I am not aware of any discussion around this topic. With out additional resources we will not have valid/accurate data. I don’t think this is what the public or government would want. Support the intelligent look at the added indicators; support the need appropriate resources within the IC departments across the state in conjunction with any increased public reporting. Let us be secure in the information we provide to the public, while having time to prevent and implement measures to reduce the infections. Let us follow Dr. O’Boyle’s recommendation of 1 IP for each 100 beds as a minimum then add additional measures.  While we would like to be a trend setter, we would not be the first state to understand this need and follow the direction of our colleagues and make sensible IP requirements with the goal of the most accurate reporting  for selected meaningful measures