}

Regulations

View CMS HAI Reporting Requirements to NHSN

Status of APIC comments on proposed infection prevention and control regulations. 

 Proposed Regulation*

Impact on Infection Prevention 

Committee Action and Status

Which of APIC Strategic Goals does this related to?

CMS: FY 2017 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Payment System (IPPS/LTCH) proposed rule Updates HAI measures and infection-related provisions for acute care hospitals, long-term acute care hospitals, PPS-exempt cancer hospitals, and inpatient psychiatric facilities. Pending
  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: FY 2017 Inpatient Rehabilitation Facility Prospective Payment System Updates HAI measures in the Inpatient Rehabilitation Facility Quality Reporting Program Pending
  • Patient Safety
  • Data Standardization
  • Advocacy
FDA: Ban on powdered gloves Proposal to ban powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove. Pending
  • Patient Safety
  • Advocacy
FDA: Donor screeing recommendations to reduce Zika transmissions Guidance for industry on donor screening recommendations to reduce the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products - released for immediate implementation. Comments submitted 3/25/16
  • Patient Safety
  • Advocacy
FDA: Medical device reprocessing Request for comments concerning the service, maintenance, refurbishment, and alteration of medical devices, including endoscopes, by third-party entities and original equipment manufacturers. Comments submitted 5/9/16
  • Patient Safety
  • Advocacy
FDA: Reclassification of blood lancets Proposal to reclassify single use and single patient blood lancets from class I (requiring general controls) to class II (requiring special controls) Comments submitted 5/24/16
  • Patient Safety
  • Advocacy
OSHA: PPE information collection request Requests extension of current information collection requirements in the Personal Protective Equipment section of the OSHA General Industry Standard. Comments submitted 4/18/16
  • Advocacy
FDA: Fecal Transplantation Draft guidance for industry on enforcement of policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. Comments submitted 4/1/16
  • Patient Safety
  • Implementation Science
CDC/NIOSH: Monitoring and Coordinating PPE in Healthcare to Enhance Domestic Preparedness for Ebola Response Proposal to develop an ongoing hospital surveillance system to evaluate and monitor PPE usage and effectiveness in healthcare workers including Ebola protection. Comments submitted 3/18/16
  • Advocacy
All federal agencies: Revisions to the Common Rule, proposed rule Updates the Federal Policy for the Protection of Human Research Subjects, including quality assurance, quality improvement, and public health surveillance activities. Comments submitted 12/28/15
  • Patient Safety
  • Advocacy
  • Implementation Science
CMS: 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). Comments submitted 12/28/15
  • Patient Safety
  • Advocacy
AHRQ: Draft Technical Brief Critical analysis of evidence for resident safety practices in nursing home settings. Comments submitted 11/20/15
  • Patient Safety

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. Comments submitted 12/17/15
  • Patient Safety

NQF: Patient Safety 2015, draft report for comment

Recommendations from NQF Patient Safety Standing Committee on endorsement or revision of measures, including infection-related measures. Comments submitted 9/3/15
  • Patient Safety
  • Data Standardization
  • Implementation Science

FDA: Draft Guidance for Industry

Premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns intended for use in healthcare settings. Comments submitted 8/28/15
  • Patient Safety
  • Advocacy

CMS: Reform of Requirements of Long-Term Care Facilities

Updates requirements for Long-Term Care Facility participation in Medicare, including infection control provisions Comments submitted 9/10/15
  • Patient Safety
  • Advocacy
CMS: CY 2016 Physician Fee Schedule proposed rule Updates infection-related measures in the Physican Quality Reporting System for Medicare payment determination.

Comments submitted 8/6/2015 

Final rule published 11/16/2015

  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: CY 2016 Home Health Prospective Payment System proposed rule Updates infection-related Home Health Quality Reporting requirements for Medicare payment determination.

Comments submitted 9/3/15

Final rule published 11/5/2015

  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: CY 2016 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center (OPPS/ASC) Payment System proposed rule Updates infection-related measures to the Hospital Outpatient Qualitry Reporting Program and ASC Quality Reporting Program for Medicare payment determination.

Comments submitted 8/10/2015

Final rule published 11/13/2015

  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: CY 2016 End-Stage Renal Disease Prospective Payment System proposed rule Updates infection-related measures to the ESRD Quality Incentives Program for Medicare payment determination. 

Comments submitted 8/24/15

Final rule published 11/6/2015

  • Patient Safety
  • Data Standardization
  • Advocacy
FDA: Healthcare Antiseptics proposed rule Request for additional data from manufacturers on safety and effectiveness of healthcare antiseptic products. Comments submitted 10/26/15
  • Patient Safety
NQF: Data for Systematic Improvement: Summarizing an NQF Meeting on the Data Needed for Sustainably Improving Healthcare Recommendations from NQF meeting of stakeholders to identify opportunities to improve data and make it more useful for systematic improvement. Comments submitted 6/15/15
  • Patient Safety
  • Data Standardization
CMS: FY 2016 Hospital Inpatient Prospective Payment System (IPPS/LTCH) Update Updates HAI measures in Hospital Inpatient Quality Reporting, Hospital Value-Based Purchasing, HAC Reduction Program, LTCH Quality Reporting programs for Medicare payment determination.

Comments submitted 6/10/15 

Final rule published 8/17/15

  

  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: FY 2016 Inpatient Rehabilitation Facility (IRF) Prospective Payment System update Updates the HAI measures in the IRF Quality Reporting Program for Medicare payment determination.

Comments submitted 6/8/15 

Final rule published 8/6/15

 

  • Patient Safety
  • Data Standardization
  • Advocacy
CMS: Meaningful Use Stage 3 The Stage 3 proposed rule streamlines the program by reducing the number of clinical quality measures and aligning EHR measures with measures in other CMS quality reporting programs.

Comments submitted 5/26/15 

Final rule published 10/16/2015

  • Data Standardization
  • Patient Safety
  • Advocacy
HHS: Health IT Certification Criteria Updates and modifies health information technology certification criteria

Comments submitted 5/26/15 

Final rule published 10/16/2015

  • Data Standardization
  • Advocacy
FDA: Reprocessing of Duodenoscopes Request for comments on reprocessing of duodenoscopes and other endoscopes to the Gastroenterology and Urology Devices Panel of the FDA Medical Devices Advisory Committee Comments submitted 4/29/15
  • Patient Safety
  • Advocacy
FDA: Draft Guidance for Industry Mitigating cross-contamination risk from irrigation accessories for flexible gastrointestinal endoscopes Comments submitted 4/16/15
  • Patient Safety
CMS: Medicare Conditions for Coverage (CfCs) for End-Stage Renal Disease (ESRD) facilities APIC sent CMS suggestions for possible revisions to CfCs for ESRD facilities that would incorporate evidence-based infection prevention practice standards into the CfCs. Comments submitted 4/1/2015
  • Patient Safety
HHS: Ethical considerations of Ebola Emergency Response Request for Comments on the ethical considerations and implications of public health emergency response with a focus on the Ebola epidemic. 

Comments submitted 2/5/2015 

Final report published 2/2015

  • Advocacy
  • Patient Safety
  • Implementation Science
HHS: Federal Health IT Strategic Plan 2015-2020 Strategic plan to expand widespread adoption of health IT and increase interoperability among users to improve healthcare.

Comments submitted 2/4/2015 

Final published 9/21/2015

  • Data Standardization

*Federal Agency Abbreviations:
CDC: Centers for Disease Control and Prevention
CMS: Centers for Medicare and Medicaid Services
HICPAC: Healthcare Infection Control Practices Advisory Committee
NIOSH: National Institute for Occupational Safety and Health
OSHA: Occupational Safety and Health Administration
FDA: Food and Drug Administration
NQF: National Quality Forum

 

To access APIC comments organized by agency, click on the appropriate agency page.

 

U.S. government health agencies 

View information about federal agencies with jurisdiction over infection prevention and control.