Chapter Legislative Representatives Government Affairs Update

2. Chapter Legislative Representatives Government Affairs Update December 2015

3. CDC/CMS Joint Reminder In response to anecdotal reports of intentional non-reporting of HAI events, CDC and CMS issued a joint reminder of the importance of complete and accurate data for purposes of quality of care measurement and improvement. APIC released talking points for members to help educate colleagues on the importance of adhering to CDC infection definitions.

4. Federal funding of infection prevention programs Voice your support for federal antibiotic resistance and HAI programs The Congressional process for allocating federal funding is long but APIC members must be there every step of the way advocating for infection prevention and antibiotic resistance resources. NHSN funding supports: • Training and system support for NHSN, including updates • Expanded access to NHSN for over 17,000 facilities • Surveillance of antibiotic use and trends Use this link to send a letter: http://cqrcengage.com/apic/app/onestep-write-a-letter?5&engagementId=100215

5. Coalition Efforts APIC has joined allied organizations in supporting: • Additional federal funding for antibiotic resistance programs • Approval of the nomination of Karen DeSalvo for Assistant Secretary for Health at the U.S. Department of Health and Human Services • Release of antibiotic development and diagnostics economic incentives report from a working group established by the National Action Plan to Combat Antibiotic Resistant Bacteria • Criteria by which on farm antibiotic use should be collected and evaluated

6. Recent Public Policy Committee regulatory activities • AHRQ Draft Technical Brief • Critical analysis of evidence for resident safety practices in nursing home settings. Status: Submitted comments to AHRQ • Revisions to Discharge Planning Requirements for Hospitals, Critical Access Hospitals and Home Health Agencies proposed rule • Updates discharge planning requirement for Medicare and Medicaid participation to comply with the "Improving Medicare Post-Acute Care Transformation Act of 2014" (IMPACT Act). Status: Public Policy Committee drafting comments to CMS • FDA Draft Guidance for Industry • Selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in multiple-dose, single-dose, and single-patient-use containers for human use. Status: Public Policy Committee drafting comments to FDA • Proposed revisions to the Common Rule • Updates the Federal Policy for the Protection of Human Research Subjects, including quality assurance, quality improvement, and public health surveillance activities. Status: Public Policy Committee is currently drafting comments

7. FDA Safety Communications FDA recommends transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods • FDA ordered Custom Ultrasonics to recall all of its AERs from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and a previous settlement agreement related to violations. FDA orders duodenoscope surveillance • FDA ordered three manufacturers of duodenoscopes marketed in the U.S. to conduct post-market surveillance studies on the effectiveness of current reprocessing instructions and practices http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM472605 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

8. NTM infections and heater-cooler devices Background: Between January 2010 and August 2015, the FDA received 32 Medical Device Reports (MDRs) of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. CDC recommendations for healthcare facilities: • Remove contaminated heater-coolers from operating rooms • Ensure that facilities use the most current manufacturer’s instructions and follow FDA’s recommendations for maintenance, cleaning, disinfection and monitoring of heater-cooler devices • If a heater-cooler device in your facility tests positive for NTM or if there is concern for patient infections related to the heater-cooler device, review your facility’s microbiology laboratory database and records of surgical procedures to identify any patients that have had NTM-positive cultures within four years following a cardiac surgery procedure. • If a heater-cooler device is suspected to have led to patient infections or if a heater-cooler device has tested positive for NTM, promptly notify your local health department, submit a report to FDA via MedWatch, and assess the need for notifying exposed patients in coordination with public health authorities.

9. November HICPAC Meeting Notes • The November HICPAC meeting featured information on: • Development of an antibiotic stewardship “playbook” to help expand implementation efforts • Renewed efforts to address training and competence in infection prevention for healthcare personnel • Ongoing workgroup examining the human factors impacting endoscope reprocessing • Update on outbreaks of NTM infections associated with Heater Cooler Devices

10. Targeted Assessment for Prevention (TAP) Strategy • TARGET: Use TAP report function in NHSN to identify and engage facilities/units that may need additional infection prevention interventions and support. • ASSESS: Measure perceptions and practices in targeted facilities/units to assess potential infection prevention gaps. • PREVENT: Utilize TAP report and assessment feedback data to implement strategies to addressed identified gaps and evaluate for improvement. http://www.cdc.gov/HAI/prevent/tap.html

11. Additional Resources CDC/CMS Joint Reminder http://www.cdc.gov/nhsn/pdfs/cms/nhsn-reporting-signed.pdf APIC Joint Reminder Question and Answer http://www.apic.org/Resource_/TinyMceFileManager/APIC_Q_and_A_CDC_CMS_communique_10_7_15.pdf APIC Regulations Page http://www.apic.org/Advocacy/Regulations FDA Safety Communication Nontuberculous Mycobacterium (NTM) Infections Associated with Heater-Cooler Devices http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm CDC NTM Infections and Heater-Cooler Devices Interim Practical Guidance http://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf CDC Targeted Assessment for Prevention (TAP) Strategy http://www.cdc.gov/HAI/prevent/tap.html