Patient Safety

This is a good measure but shouldn’t it have some longitudinal criteria?  It is also a good outpatient measure since pain control is shifting to high dose use of NSAIDs.  This measure also needs stratification by age, race and ethnicity.  Possibly tie in with dose and longevity of use with certain drugs.

NHSN Hospital-Onset Bacteremia & Fungemia

 Thank you for the opportunity to comment regarding the Patient Safety Standing Committee’s recommendation to endorse National Healthcare Safety Network (NHSN) Hospital-Onset Bacteremia and Fungemia Outcome Measure. As one of the largest global medical technology companies in the world, BD is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.  The company develops innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. 

BD is supportive of the endorsement of the measure NHSN Hospital-Onset Bacteremia & Fungemia Outcome Measure. 

The development of the Central Line-associated Bloodstream Infection (CLABSI) metric resulted in considerable improvements in CLABSI rates since its introduction in 2015 and raised awareness of both infection prevention as well as antimicrobial resistance and stewardship, which are now tethered together in the recent CMS CoP ruling on Antimicrobial Stewardship. Improvement in national CLABSI rates are the result of clinicians and researchers identifying high risk practices and implementing infection prevention bundles to significantly reduce infection risks during central line catheter insertion and maintenance.  However, the current focus of surveillance efforts on CLABSI may result in unintended consequences that may not optimize mitigation of Hospital-Onset Bacteremia & Fungemia (HOB) overall. In fact, a narrow focus on CLABSI could result in the placement of a vascular access device which may not be based on the patient’s clinical need and risk factors. A broader measure of bloodstream infection risk to patients, such as the proposed Hospital-Onset Bacteremia & Fungemia Outcome Measure, may further augment infection prevention efforts with risks to patient safety.

Data shows that much of hospital onset bacteremia may be preventable and widening the scope of reportable infections may enhance patient safety efforts.[1]In a 2016 article, non-reportable hospital onset bloodstream infections incurred a 17% incremental mortality and approximately $20,000 additional cost of care compared to propensity matched cases.[2]  S. aureus is a common cause of catheter-related bloodstream infections.[3] While the CDC has reported a 73% reduction in S. aureus CLABSI nationally since the central line bundle was initiated, a recent systematic literature review found that 38% of S. aureus catheter-related bloodstream infections were associated with a peripherally inserted intravenous catheter.^3,[4]   Improved patient outcomes are potentially achievable given S. aureus infections are likely preventable, as indicated in a study evaluating the implementation of a peripheral line care bundle that demonstrated a 63% reduction in S. aureus infections.[5]

In March 2023, the American Hospital Association (AHA) published an e-book “Hospital Onset Bacteremia: Hospital leaders’ attitudes on HOB sources, prevention and treatment”,  which included results from an October 2022 AHA Virtual Thinking Tank and a survey on perceptions of HOB by clinicians and hospital administrators. Insights from 200 executives and subject matter experts indicated a positive perception that the HOB metric would improve patient safety and care. Survey respondents identified best practices they would like included in an HOB bundle, including more granular visibility to the sources of HOB and respective prevention measures. The results of the survey included a perceived ranking of HOB sources with central line catheters ranking first followed by urinary sources (with and without a foley catheter), respiratory sources, and wound/soft tissue/surgical site infection. While the perceptions of source contribution to HOB did not align with perceptions regarding source preventability, sources of HOB were generally thought to be preventable or partially preventable. Given the multiple sources, respondents indicated that best practices for timely pathogen identification, as well as improved definitive HOB therapy should be included in an “HOB bundle”. The survey reported that more standardized prevention workflows are needed not just for nurses and infection preventionists, but due to the multiple sources of HOB, additional focus should include the identification of the pathogen when an HOB does occur, and the time to definitive therapy to mitigate unnecessary antimicrobial use and potentially curb antimicrobial resistance.[6]

 In summary, we believe the proposed risk-adjusted HOB measure will enhance infection prevention and antimicrobial stewardship efforts, promote evidence-based practices, and ultimately may improve patient care and outcomes. In a risk/benefit schematic, the automation of the definition of HOB as outlined by the MAP draft recommendations may help offload frontline data collection time so that infection preventionists can perform rounds in the field and help develop prevention strategies for other sources of hospital onset bacteremia. For most facilities, chart review requirements of HOB would be much less burdensome than the current requirements for CLABSI. While there may be implementation challenges at first—including visibility to the most prevalent sources of bacteremia other than central lines—we believe that an HOB metric will be used to help gage where the high impact sources are, and over time gains can be made in reduction of HOB. 

Sincerely,

Kalvin Yu, MD, FIDSA

Vice President, Medical & Scientific Affairs, North America

BD
 

[1] Dantes RB, Rock C, Milstone AM, Jacob JT, Chernetsky-Tejedor S, Harris AD, Leekha S. Preventability of hospital onset bacteremia and fungemia: A pilot study of a potential healthcare-associated infection outcome measure. Infect Control Hosp Epidemiol. 2019 Mar;40(3):358-361. doi: 10.1017/ice.2018.339. Epub 2019 Feb 18. PMID: 30773166.

[2] Ridgway, et al. “Performance characteristics and associated outcomes for an automated surveillance tool for bloodstream infection.” American Journal of Infection Control. 2016: Volume 44 , Issue 5 , 567 – 571.

[3] Mermel LA. Short-term peripheral venous catheter related bloodstream infections: a systematic review. Clinical Infectious Diseases. 2017: 65 (10): 1757-62

[4] Centers for Disease and Control. Vital Signs: Central Line-Associated Blood Stream Infections. Morbidity and Mortality Weekly Report. 2011; 60 (No. 9): 233-268

[5]Rhodes, et al. “Reducing Staphylococcus Aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of care bundle at a large Australian health service.” The Journal of Hospital Infection. 19(1): 86-9

[6] American Hospital Association. Executive Dialogue on Hospital Onset Bacteremia: Hospital leaders’ attitudes on HOB sources, prevention and treatment. March 2023. https://www.aha.org/sponsored-executive-dialogues/2023-03-13-/hospital-onset-bacteremia?utm_source=newsletter&utm_medium=email&utm_campaign=aha-today&mkt_tok=NzEwLVpMTC02NTEAAAGKqh8jxTVWaEPuiw5-HBJh1pLEcyOlTGYF6VOM0YGlEEI6GN18WmYXjHiumz21LO_V803qkmskRpkXpyyAd_fLzIn5Dv-FN3zuPMLX-ALZiUmEPg

As the developer of measure #3025 Ambulatory Breast Procedure Surgical Site Infection (SSI) Outcome Measure, the Centers for Disease Control and Prevention (CDC) does not agree with the Standing Committee’s vote of ‘consensus not reached’ on the Performance Gap and Usability criteria. Ambulatory Surgical Centers (ASCs) play an important role in the current healthcare delivery system as evidenced in the increased volume and complexity of procedures performed in these facilities.  The importance of standardized definitions and criteria tailored for the unique ASC setting cannot be understated.  The small volume of available scientific literature in this setting is a key reason why tools such as measure #3025 are needed to understand the risks patients may experience post-breast surgery in ASCs.  It is critical that ASCs have access to accurate surveillance resources that empower them to develop strategies that minimize risks of SSIs. 

The intent of measure #3025 is to advance patient safety and ensure quality care for patients in ASCs.  The measure was initially endorsed in 2017 and was launched in the NHSN application in November 2018, shortly before the beginning of the global COVID-19 pandemic.  COVID-19 triggered major disruptions to the care ASCs provided. In response to the pandemic CMS recommended that non-essential (e.g., elective surgeries) procedures performed at these facilities, including breast procedures, be postponed to ensure patient and staff safety.  Due to these recommendations many ASCs limited the number of procedures they performed or temporarily closed their doors.  However, once ASCs were able to perform surgeries again, they were not able to take on abstraction of this measure because they were focused on the backlog of elective surgery cases that were delayed due to COVID-19, managing shortages of PPE, staffing concerns, and infection risk of non-patient visitors (CMS, 2020). Consequently, due to the impact of the COVID-19 pandemic, we were unable to demonstrate a performance gap or an opportunity for improvement for this current measure endorsement cycle. Irrespective of direct measure data supporting a gap in care, evidence shows that SSIs in breast surgeries performed at ASCs, continues to be a quality-of-care issue. 

Surgical procedures classified with a clean wound class have the reported lowest risk of SSI at 3.4% (Pastoriza et al., 2021).  Breast surgeries are classified as clean procedures, however the SSI risk in breast surgery is higher than other clean surgical procedures with rates between 2-38% (The American Society of Breast Surgeons, 2017).  While breast surgeries performed at ASCs are considered low risk and thereby thought to have a lower rate of SSI, standardized surveillance resources to monitor, and identify SSI have not always been available to validate this claim.  The low number of breast SSIs in this setting may be due to lack of opportunity to detect them.  As the volume and complexity of surgical procedures performed at these facilities continue to increase every year the potential risk for SSI also increases.  In addition to increasing volume and complexity, ASCs are unique in that patients have limited encounters making surveillance more challenging because all the monitoring is post-discharge from the ASC.

Prior state level studies have shown lapses in infection prevention practices and higher rates of SSI after breast surgery in ASCs.  In 2008, an audit of ASCs in Maryland, North Carolina, and Oklahoma found that 67.7% (n=68) of the facilities had at least one lapse in infection control practices, with the highest lapses found in equipment reprocessing (28%) and injection safety and medication handling (28%) (Schaefer et al., 2010).   The California Department of Public Health performed surgical site infection surveillance in 49 ASCs from 2016-2018 and found that only 2 ASCs had 100% hand hygiene adherence, 57% had appropriate surgical attire in the OR, and only 56% had high touch surfaces thoroughly cleansed/disinfected after each patient (Keller, 2018).  In 2012, the New Hampshire Department of Health and Human Services began collecting data on SSIs in breast procedures (i.e., excision of lesion or tissue of breast including radical, modified, or quadrant resection, lumpectomy, incisional biopsy, or mammoplasty) at 12 ASCs throughout the state. The state utilized CDC NHSN’s standardized infection ratio (SIR) and found a statewide SIR for breast surgery to be 0.91 (New Hampshire Department of Health and Human Services, 2013).  While the results were not statistically significant and it was determined that the number of breast infections in the state were similar to the number of breast infections seen nationally, it was noted in the study that a few ASCs in the state needed to focus on SSI prevention (New Hampshire Department of Health and Human Services, 2013). The state also tracked SSIs in hernia procedures and open reduction of fracture procedures and no SSIs developed in these cases (SIR 0.00) (New Hampshire Department of Health and Human Services, 2013). 

Outcome measures in the ASC space are also lacking and process measures do not allow ASCs to tie compliance with infection control practices back to improved patient outcomes or reductions in healthcare associated infections.  Outcome measures in the ASC setting have focused on unplanned hospital transfers, acute care visits, and hospital readmissions after surgery (Rajan et al., 2021). Studies have found that unplanned admissions within the 30-days after ambulatory surgery range from 0.9-6.4% (Teja et al., 2020).  Another study using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) found that 2.5% of cases that had surgery in an ambulatory surgery center were admitted to the hospital within 30 days of surgery and age >=70 years was found to be associated with these increased hospital admissions (De Oliveira et al., 2015).  In this study, wound concerns, infections, bleeding, and pain were the most common causes for hospital admission (De Oliveira et al., 2015).  Another recent study in patients who underwent a mastectomy with or without reconstruction, in the outpatient setting, found that 7% of patients had an unplanned return to care (i.e., unplanned reoperation, readmission, or ED visit) for any reason within 7 days of the surgical procedure (Vuong et al., 2021). The most common causes for these unplanned returns to care were wound checks, bleeding and drain concerns (Vuong et al., 2021).  The rates and reasons for unplanned follow-up care after surgery show that there is a performance gap at ASCs that needs to be addressed by implementing an SSI outcome measure. 

The Ambulatory Breast Procedure Surgical Site Infection (SSI) Outcome Measure tracks patients to 90-days following their procedure to determine if an infection developed.  Patients that undergo surgery at an ASC do not return to the ASC post-discharge for follow-up care.  As such, ASCs may be unaware of their SSI rates, because they are not able to track surgical site infections that are developing in their patient populations and have no way of knowing that patients may be experiencing issues related to care provided at the ASC.  The most common postoperative complications that occur after breast surgery are cellulitis, flap necrosis, abscess, dehiscence, and hematoma (Thalji et al., 2023). SSIs are associated with increased morbidity, including reduced quality of life, increased length of stay, poor cosmetic results, and overall increased cost (Pastoriza et al, 2021) with breast surgery SSI estimated to increase costs by $10,000 (The American Society of Breast Surgeons, 2017). To determine SSI events related to breast surgery, ASCs must put in place a post-discharge surveillance process to determine if their patients developed a post-operative SSI.  Like ACS NSQIP, which has been performing 30-day postoperative morbidity surveillance after patient discharge since the early 2000’s, NHSN requires ASCs to perform 90-day post-discharge surveillance to identify SSI occurrences for the Ambulatory Breast Procedure Surgical Site Infection (SSI) Outcome Measure. 

ASCs are encouraged to develop a formal process for investigating and detecting SSIs after breast surgery. CDC NHSN developed a Post-discharge Surveillance Toolkit to assist ASCs in performing 90-day postoperative follow-up on SSIs (CDC, 2020).  The toolkit provides examples of methods ASCs may use to identify SSIs in the postoperative 90-day timeframe, such as contacting their breast surgery patients via letter or phone call, obtaining inter-facility notification of patient encounters or admission, reviewing medical or surgical clinic patient records, or surveying the surgeon’s office directly to determine if a patient developed an SSI.  Any or all these methods may be used by ASCs to identify SSIs; however, the measure requires that the SSI criteria must be met to cite an SSI within the 90-day postoperative period. 

CDC has confidence that the Standing Committee will pass measure #3025 Ambulatory Breast Procedure Surgical Site Infection (SSI) Outcome Measure on performance gap and usability to ensure breast surgery patients undergoing procedures in an ASC receive quality care. 

• American College of Surgeons National Surgical Quality Improvement Program. Quality Programs History. Accessed March 10, 2023, https://www.facs.org/quality-programs/data-and-registries/acs-nsqip/about-acs-nsqip/history/. 
• CDC NHSN. Outpatient Procedure Component Surgical Site Infection. (2020, January). Accessed on March 10, 2023, https://www.cdc.gov/nhsn/pdfs/opc/opc-ssi-post-discharge-toolkit-508.pdf. 
• Centers for Medicare and Medicaid Services, Centers for Medicare and Medicaid Services. CMS Adult Elective Surgery and Procedures Recommendations, 2020, https://www.cms.gov/files/document/covid-elective-surgery-recommendations.pdf
• De Oliveira GS Jr, Holl JL, Lindquist LA, Hackett NJ, Kim JY, McCarthy RJ. Older Adults and Unanticipated Hospital Admission within 30 Days of Ambulatory Surgery: An Analysis of 53,667 Ambulatory Surgical Procedures. J Am Geriatr Soc. 2015 Aug;63(8):1679-85. 
• Keller, V., Nelson, T. (2018, November 7). Surgical Site Infection Surveillance in Ambulatory Surgery Centers [PowerPoint slides]. https://casurgery.org/aws/CASA/asset_manager/get_file/264829?ver=222
• New Hampshire Department of Health and Human Services. (2013, August 15). Healthcare Associated Infection Ambulatory Surgery Center 2012 Report. Accesses March 9, 2023, https://www.dhhs.nh.gov/sites/g/files/ehbemt476/files/documents/2021-11/hai2012asc.pdf. 
• Pastoriza J, McNelis J, Parsikia A, Lewis E, Ward M, Marini CP, Castaldi MT. Predictive Factors for Surgical Site Infections in Patients Undergoing Surgery for Breast Carcinoma. Am Surg. 2021 Jan;87(1):68-76.
• Rajan N, Rosero EB, Joshi GP. Patient Selection for Adult Ambulatory Surgery: A Narrative Review. Anesth Analg. 2021 Dec 1;133(6):1415-1430. 
• Schaefer MK, Jhung M, Dahl M, et al. Infection Control Assessment of Ambulatory Surgical Centers. JAMA. 2010;303(22):2273–2279. 
• Teja B, Raub D, Friedrich S, Rostin P, Patrocínio MD, Schneider JC, Shen C, Brat GA, Houle TT, Yeh RW, Eikermann M. Incidence, Prediction, and Causes of Unplanned 30-Day Hospital Admission After Ambulatory Procedures. Anesth Analg. 2020 Aug;131(2):497-507. 
• Thalji SZ, Cortina CS, Guo MS, Kong AL. Postoperative Complications from Breast and Axillary Surgery. Surg Clin North Am. 2023 Feb;103(1):121-139. 
• The American Society of Breast Surgeons. (2017, June 22). Consensus Guideline on Preoperative Antibiotics and Surgical Site Infection in Breast Surgery. Accessed March 9, 2023 https://www.breastsurgeons.org/docs/statements/Consensus-Guideline-on-Preoperative-Antibiotics-and-Surgical-Site-Infection-in-Breast-Surgery.pdf.
• Vuong B, Dusendang JR, Chang SB, Mentakis MA, Shim VC, Schmittdiel J, Kuehner G. Outpatient Mastectomy: Factors Influencing Patient Selection and Predictors of Return to Care. J Am Coll Surg. 2021 Jan;232(1):35-44.

At the time this measure was developed, the ASC Quality Collaboration and the Colorado Department of Public Health collaborated with CDC in the testing of the measure in an ASC setting.  It fills an important gap in the reporting of healthcare-associated infections occurring in the ASC setting.  The volume of reporting has been low and has limited the accessibility of data for improving patient care.   However, the ASC Quality Collaboration remains in support of the measure because of its relevance to the ASC setting.   

NQF #3498e Hospital Harm-Pressure Injury - Support

The American Geriatrics Society (AGS) believes Hospital Harm-Pressure Injury is an issue that is overlooked despite its importance. While we understand that hospitals caring for higher risk individuals—even if they are providing optimal care—may not be perceived favorably, given the benefits of increasing awareness and attention to this topic, we are supportive of this measure. 

NQF #3713e Hospital Harm-Acute Kidney Injury – Support

The AGS supports Hospital Harm-Acute Kidney Injury (AKI) as the measure is thoughtfully attentive to detecting potentially avoidable AKI and excluding high-risk individuals (e.g., diuresis in congestive heart failure).