Compliance with CMS Infection Control Standards in Healthcare

“Compliance with CMS Infection Control Standards in Healthcare Settings” Karen Hoffmann RN BSN MS CIC FSHEA Infection Preventionist, Clinical Instructor University of North Carolina School of Medicine

Disclosures I have a financial relationship with the following : � AMA Foundation - consultant

Disclaimer � The views and opinions expressed in this lecture are those of the speaker and do not reflect the official policy or position of any agency of the U. S. government.

Objectives Attendees will be able to explain: 1. CMS Infection Control regulations and authority at (federal, regional, state) levels. 2. Federal Infection Control Initiatives 3. Survey and Certification Group - Survey strategies - Hospital Infection Control worksheets - ASC Infection Control survey tool

CMS covers 100 million people. . . through Medicare, Medicaid, the Children's Health Insurance Program, and the Health Insurance Marketplace. � 1 of every 3 Americans; 105 million beneficiaries; paying out $1. 5 billion in benefits

CMS Agency overview Formed 1977 (1977 -MM) Preceding Agency Health Care Financing Administration (1977 -2001) Headquarters Woodlawn, Baltimore County Maryland Agency executive Marilyn Tavenner Website www. cms. gov

CMS Regional and State Agencies CMS has 10 regional offices located throughout the United States: Region IV – Atlanta, Georgia Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South. Carolina, and Tennessee. State Agencies - conduct inspections to certify medical, mental health and adult care facilities, emergency medical services, and local jails for Medicare and Medicaid compliance. They also investigate and validate complaints made by individuals. � SC Dept. of Health & Environmental Control (DHEC) � www. scdhec. gov/

Fewer People Are Getting Infections In Hospitals, But Many Still Die CDC (Epi-centers)– point prevalence study of 183 hospitals (in 10 states) nationwide in 2011, emphasizing smaller community hospitals, and all HAI infections. Results: - 1 out of every 8 inpatients nationally suffered an HAI - 4 percent of people hospitalized picked up an infection, and of those, about 11 percent died. - today and every day, more than 200 Americans with an HAI will die during their hospital stay. ~70, 000 deaths a year caused by hospital infections. - most common HAIs: pneumonia (21. 8%), SSI (21. 8%), GI (17. 1%), C. difficile (12. 1%) N Engl J Med 2014; 370: 1198 -1208; March 27, 2014

Infections Waning But Not Meeting Federal Targets � Medicare to penalize about 750 hospitals with highest rates of infections and patient injuries. Sanctions estimated to total $330 million over a year, will kick in at a time when most infections and accidents in hospitals are on the decline, but still too common. � A quarter of the nation's hospitals — those with the worst rates — will lose 1 percent of every Medicare payment for a year. � When all ACA (IPPS, VBP) programs are in place this fall, hospitals will be at risk of losing up to 5. 4 percent of their Medicare payments.

Hospital Inpatient Quality Reporting Program (HIQRP) � CDC database- National Healthcare Safety Network (NHSN) � CMS currently requires hospitals to report: ü ü ü CLABSI (2011) CAUTI (2012) SSI (2012) MRSA, C Diff, HCW Influenza Vaccination (2013) NEW, In Jan 2015, CLABSI and CAUTI on Adult & Pediatric Medical, Surgical, & Medical/Surgical Wards

Long Term (Acute) Care Hospital Quality Reporting (LTCHQR) Program and the Inpatient Rehabilitation Facility - IPPS FY 2015 Two new quality measures will require data submission beginning with admissions and discharges occurring on or after January 1, 2015: � (1) Facility-Wide Inpatient Hospital-Onset Methicillin. Resistant Staphylococcus aureus (MRSA) Bacteremia Outcome Measure (NQF 1716); and � (2) Facility-Wide Inpatient Hospital-Onset Clostridium difficile Infection (CDI) Outcome Measure (NQF 1717).

Healthcare Personnel Influenza Vaccination HAI Reporting Requirements to CMS In October 2014 � Inpatient Rehabilitation Facility Quality Reporting Program � Long Term (Acute) Care Hospital Quality Reporting (LTCHQR) Program � Ambulatory Surgery Centers Quality Reporting Program � Hospital Outpatient Quality Reporting (OQR) Program

CMS Inpatient Psychiatric Facilities Quality Reporting (IPFQR) FY 2015 Influenza immunization rates for inpatients age 6 months and older: - collected through chart abstraction - FY 2017 payment determination Influenza Vaccination coverage among HCP (NQF supported): - Data collected through NHSN; beginning October 1, 2015 to March 31, 2016 - FY 2017 payment determination Mandatory HCP influenza as a condition of employment. Note: CMS has revised the reporting requirement for this measure to allow facilities to collect and report a single vaccination count by facility CMS certification number (CCN).

CMS Conditions of Participation (Co. Ps) Conditions for Coverage (Cf. Cs) CMS develops Co. Ps - (hospitals) Cf. Cs - (ESRD, LTC/NH, ASCs) � minimum health and safety standards that providers and suppliers must meet in order to be Medicare and Medicaid certified and receive reimbursement. � Health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs. � Department of Health and Human Services

CMS Deemed Status and national accreditation organizations (AOs) � AOs (e. g. TJC, ) are approved by CMS for enforcing standards that meet the CMS Co. Ps/Cf. Cs. � CMS grants AO "deeming" authority and "deem" each accredited HCO as meeting the CMS certification requirements…Result HCO not subject to routine Medicare survey and certification process. � However, CMS still conducts random validation surveys and complaint investigations of HCO with deemed status. � In addition, the AOs are obliged to provide CMS with a listing of documentation for HCO receiving conditional accreditation, preliminary , and non-accreditation. � The AO also provide CMS with accreditation decision reports for HCO involved in CMS validation surveys and any other survey report CMS requests.

CMS Conditions of Participation (Co. Ps) and Interpretive Guidelines (IGs) CMS provides the conditions of participation (Co. P) or standards for each healthcare setting, � Title 42 CFR 42 Public Health- all 23 Hospital Conditions of Participation � Hospital Co. P- Infection control : Standard 42 CFR 482. 42 Infection Control The CMS State Operations Manual (SOM) - provides the "interpretive guideline" (IG) for each standard within each healthcare setting. � cms. gov

42 CFR 482. 42 Co. P: Infection Control The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. (a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases. (1) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. (b) Standard: Responsibilities of chief executive officer, medical staff, and director of nursing services. The chief executive officer, the medical staff, and the director of nursing services must (1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and (2)Be responsible for the implementation of successful corrective action plans in affected problem areas. � CMS. gov

Infection Control – COPs Overview System of seven subsystems includes: � Surveys/investigations � Patient population � Employee population � Environmental � Program evaluation and corrective action � Re-evaluation & revisions

Surveyor Role As integral parts of determining compliance with the Co. P, the surveyor will: � Verify an active and effective surveillance program � Evaluate if the program is meeting the needs of patients and staff throughout the complex � Verify a sanitary environment � Verify comprehensive educational outreach � Validate the program has been evaluated or revised if needed

Co. P: Infection Control – 482. 42 � The hospital must provide a sanitary environment to avoid sources & transmission of infection & communicable diseases � There must be an active program for the prevention, control and investigation of infections & communicable diseases. � Not limited to HAIs � Includes communicable diseases

Survey Methods – Records Review � Organizational chart � Infection control Manual � Policies and Procedures (as needed) � Committee minutes (as needed) � Surveillance plan � Personnel files

Survey Methods - Interviews Done to verify staff knowledge of policies � Infection Control Officer � Unit staff- throughout the facility � Patients/families

Survey Methods - Observations � Strongest source of evidence � Observations confirmed with knowledgeable person � Parallel observations with team members � Will follow pertinent observations with interviews � Observe throughout survey/ all location - hand hygiene

Survey Method IC Program Tag 047 Active and include specific measures of : � Prevention � Early detection � Control � Education � Investigation Must be evaluated/reviewed/revised Must be inclusive of nationally recognized guidelines � Must follow your own policies and procedures

Infection Control in Ambulatory Care � Policies and procedures meeting patient needs � Special Problems includes ER with congestion/traffic in common areas. � Physical plan adaptions- prevention and transmission methods for airborne or droplet routes � Environmental sanitation – rapid turnover of patients may compromise cleaning routines. � Screening for potentially infected may be delayed. � Does space allow for physical separation if needed. P&P for what to do with infectious patients

Infection Control Co. P � Condition has 2 standards 1. 2. 482. 42(a) Organization and policies 482. 42(b) Responsibilities of CEO, medical staff & Director of Nurses Note; the Infection Control Log is no longer required.

Standard: Organization & Policies 42 CFR 482. 42(a) � Person/persons must be designated as the infection control officer (IP) � Delegation of authority is to be in writing � Must have documentation of qualifications � Must develop and implement policies related to control of infections and communicable diseases. � ICO (IP) must develop a system for identifying, reporting, investigating and controlling infections and communicable diseases- for patients, HCP, and visitors. � Must incorporate CDC outbreaks and bioterrorism

Survey Methods � Verify the ICO/s (IP/s) have the authorization via (personnel files & interviews) � Coordinate with other team members covering administrative issues. � Verify policies that been developed are implemented correctly (observations/interviews/policies) � Verify IC program is integrated with QAPI - QAPI on IC committee IP on QAPI committee?

Surveillance � Must be hospital-wide � All departments/ all locations � All data fed into one location for analysis � Does not imply “total hospital surveillance” But does mean that hospital must have reliable sampling or other methods in place to permit monitoring all locations to identify infection and infection control issues.

Surveillance – Survey Questions Policies to address: � Definitions of HAIs and CD � Procedures to prevent HAIs � Mechanisms to identify, investigate, and report HAI/CDs � Surveillance plan � Infection reports from individuals/departments � How would these be investigated � Consistent with CDC or other nationally recognized guidelines

Sanitary Environment - observations � Methods to maintain safe air handling in specialty areas. � Appropriate use of facility and medical equipment - HEPA filters or UV lights � Isolation rooms – techniques and use of precautions � Waste disposal � Pest control measures � Hand hygiene technique – how monitored? � Protocols for disinfection and sterilization � Food sanitation

NEW IUSS Sterilization S&C memo (released 8/29/14) Change in Terminology and Update of Survey and Certification (S&C) Memorandum 09 -55 Regarding Immediate Use Steam Sterilization (IUSS) in Surgical Settings Key memo points: Based current recommendations from nationally recognized organizations (AORN, AAMI, CDC) with expertise in infection prevention and control and other professional organizations � Abandons use of “flash” terminology and replaces it with IUSS. � Clarifies that routine or exclusive use for one instrument type is out of compliance. Ref: S&C: 14 -44 -Hospital/CAH/ASC

During general observations Patient #1 was observed at 2: 00 PM on 09/15/2014 to be on Contact Precautions. At 2: 15 PM a female was observed visiting the patient while seated in the chair next to the patient’s bedside. The female was observed not to wearing any PPE. Medical record review indicated the visitor was the patient’s wife who refused to follow the CP protocol. Interview with the social service director and unit nurse at 4: 15 PM on 09/15/2014 indicated the family had been counseled several times but felt the use of gowns and gloves was a dignity issue and was upsetting the patient. Review of the medical record and care plan with both the social service director and unit nurse confirmed that there was no evidence of counseling, education, or intervention related to the failure to comply with CP protocols. Based upon team discussions with these preliminary findings the team should: A. B. C. D. Cite Infection Control 482. 42 at the Standard level Cite under Nursing Service related to care plan Delete the findings – wife is exercising her right to choose Cite both Infection Control and Nursing at the Condition level

Occupational Health/Communicable Diseases Interviews/Document review � IC must develop and implement measures for all HCP - applies to all staff, contractors, , all departments, full or part-time; permanent or float staff � How is staff evaluated for immunization status? � What is the screening process for infections likely to cause significant adverse outcomes? � What system will identify and assess patients at risk of communicable diseases…early identification of those needing isolation following CDC/PHD? � What is staff knowledge of PPE? (N 95 v. surgical masks)

Survey Interview/Document Review HCP IC Training � What is the IC orientation program covering? � Who conducts the training/how is it evaluated? � Are competency checks completed? � How are patients educated? � Program is hospital wide.

Standard: Responsibilities of CEO, Medical Staff & DON � 42 CFR 482. 42(b) � Must ensure a hospital-wide QAPI and training program to address problems identified by IP � Are responsible for implementation of successful corrective actions.

Summary: Hospital Cop-Infection Control For compliance, infection control services must: � Be provided by qualified staff � Have policies & procedures to meet patient needs � Be provided via an active program � Be incorporated into the hospital-wide QAPI

Hospital Infection Control Worksheet � Patient Safety Initiative (PSI) is a stand-alone CMS SCG quality initiative. � Developed Infection Control Worksheet (ICW) with CDC input and assistance. � SCG developed surveyor tools to better assess Co. Ps for: - Infection Control, - Quality Assessment and Performance Improvement (QAPI), - Discharge Planning 39

Infection Control Worksheet Timeline � FY 2011 Tool developed and received Feedback and changes (pre-test of 20 surveys)– Comments from surveyors, AOs, and professional organizations during revisions. � FY 2012 All-States - - Pilot Phase: Every SA tested each worksheet (i. e. IC, discharge planning, QAPI) � FY 2013: Each State used all three survey tools in a single survey. Non-punitive (no citations) promoted educational aspects. Data collected. � FY 2014 � FY – Last revision of ICW completed. 2015 - ? ? ?

Hospital IC Surveyor Tool � What’s in it � Interviews, Elements, Patient Tracers, � Questions with no regulatory language (ASP) = “no citation” � What’s out and why � Feedback and changes � Relationship to QAPI � Use as self assessment tool

Infection Control/Prevention Program (Interviews) � Program and resources � Hospital QAPI systems related to infection control � MDRO prevention, antimicrobial stewardship, surveillance � Education and training of personnel

General Infection Control Elements (to be applied to every location) � Hand hygiene � Standard precautions/personal protective equipment � Injection practices/sharps safety � Environmental services � Device reprocessing

What’s Out and Why � Locations - Kitchens – - Pharmacy – - Laboratory – � Processes - Wound care

§ 482. 21 Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI) � The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.

Elements of QAPI � Design and scope � Feedback, Data systems, and Monitoring � Performance Improvement Projects � Systemic Improvement � Governance and Leadership

Vision of Infection Control Survey Tool for Hospitals �Ultimate goal: a tool that promotes HAI prevention and patient safety in hospitals �Consistency in survey process �Address minimum health and safety standards for hospitals to meet the CMS Co. P for Infection Control �Tool will be freely accessible on-line for hospitals �Best practices self-assessment �Proactive self-assessment in advance of a survey

Summary � Well received in IP community � Transparent expectation for CMS compliance � Flexible � Could be used as a performance improvement process tool � You can try the final version soon!

Worksheet S&C memos � G: S&C Policy Memos to State SAs1. Final. Issued. S&CPolicy. LettersS&C-13 lettersSC 1303. 03 PSI Pilot Hospital Infection Control Worksheet 2013. pdf � G: S&C Policy Memos to State SAs1. Final. Issued. S&CPolicy. LettersS&C-13 lettersSC 1303. 02 PSI Pilot Hospital QAPI Worksheet 2013. pdf � G: S&C Policy Memos to State SAs1. Final. Issued. S&CPolicy. LettersS&C-13 lettersSC 1303. 04 PSI Pilot Hospital Discharge Planning Worksheet 2013. pdf � G: S&C Policy Memos to State SAs1. Final. Issued. S&CPolicy. LettersS&C-13 lettersSC 1303. 01 PSI FY 2013 Pilot Phase- Revised Draft Surveyor Worksheets. pdf

Thank you… Enjoy your next survey!