Regulatory Aspects of Infection Control

1. Regulatory Aspects of Infection Control State and Federal Requirements for Infection Control in Health Care Facilities

2. Why Regulate Infection Control Practices? • Each year 1.7- 2 million Americans (5-10% of hospitalized patients)acquire at least one infection while hospitalized • 90-100 thousand die of those infections • One third of these are believed preventable • An almost equal number acquire infections while receiving health care in outpatient facilities or nursing care at home • In US nursing care facilities 1.6-3.8 million infections occur each year • Conservatively HAI cost $33 billion eachyear

3. Health Care Associated Infections • Are the eighth leading cause of death in the US • Account for 20% of ICU costs • May persist for years in patients who survive the initial infection • Can be reduced by consistent application of well understood practices • Have multi agency federal and state attention

4. Better: A Surgeon’s Notes on Performance AtulGawande “Stopping the epidemics spreading in our hospitals is not a problem of ignorance-- of not having the know-how about what to do. It is a problem of compliance—a failure of an individual to apply that know-how correctly.”

5. Statute and Regulation Steps in addressing infection control status: • Problem is identified • Experts convened (eg. SHEA, APIC, CDC) • Broad statute enacted • Regulations developed • Survey process adapted • Enforcement initiated

6. Regulations Vary By Setting • The Ambulatory Surgical Center (ASC) • The Residential Care /Long Term Care facility • The Dialysis Center • The Hospital The unifying requirement is establishment of an infection control program with delineated responsibilities and accountability for surveillance and infection reduction strategy implementation

7. Ambulatory Surgical CentersConditions for Coverage The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases • (a) Standard: Sanitary environment The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. PUDDING?

8. Ambulatory Surgical Center • (b) Standard: Infection control program The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines. The program is— • (1) Under the direction of a designated and qualified professional who has training in infection control; • (2) An integral part of the ASC's quality assessment and performance improvement program; and • (3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement. • [73 FR 68813, Nov. 18, 2008]

9. Long Term Care FacilityConditions for Coverage Infection Control regulation constitutes 8 of 548 pages of conditions for coverage: • Influenza and Pneumococcal Immunizations • Infection Control Program: • Investigates, controls , prevents infections • Decides procedures to apply to individual residents • Maintains records of incidents and actions

10. Long term Care Survey Guidance Guidance for Program Evaluation, does it include: • Definition of nosocomial/facility acquired infections and communicable diseases. • Risk assessment of occurrence of communicable diseases for both residents and staff that is reviewed annually, or more frequently if indicated. • Methods for identifying, documenting and investigating nosocomial infections, particularly in high risk patients

11. LTC Program Elements (cont.) • Early detection of residents who have signs and symptoms of TB and a referral protocol to a facility where TB can be evaluated and managed appropriately. • Measures for prevention of infections, especially those associated with intravascular therapy, indwelling urinary catheters, tracheostomy care, stoma care, respiratory care, immunosuppression, pressures sores, bladder and bowel incontinence and any other factors which compromise a resident’s resistance to infections. • Measures for the prevention of communicable disease outbreaks, including tuberculosis, flu, hepatitis, scabies, MRSA.

12. LTC Elements (cont.) • Procedures to inform and involve a local or State epidemiologist, as required • Isolation procedures and requirements for infected and at risk or immunosuppressed nursing home residents. • Use of and inservice education regarding standard precautions, (e.g., universal precautions/body substance isolation). • Handwashing, respiratory protection, linen handling, housekeeping, needle and hazardous waste disposal, as well as other means for limiting the spread of communicable organisms.

13. LTC Elements (cont.) • Measures for the screening of the health care workers for communicable diseases, and for the evaluation of workers exposed to residents with communicable diseases including TB and Blood Borne Pathogens. • Work restriction guidelines for an employee that is infected or ill with a communicable disease. • Measures which address prevention of infection common to nursing home residents (e.g., vaccination for influenza and pneumococcal pneumonia as appropriate) TB screening and testing. • Sanitization of tubs, whirlpools and multiple use equipment to be performed according to manufacturer’s recommendations.

14. LTC Elements (cont.) • Authority, indications, and procedures for obtaining and acting upon microbiological cultures from residents and for isolating residents. • Proper use of disinfectants, antiseptics and germicides in accordance with the manufacturers’ instructions and EPA of FDA label specifications to avoid harm • Orientation of all new facility personnel to the infection control program and periodic updates for all staff.

15. Long Term Care FacilitiesSurveyor tasks • OBSERVE: cleanliness, care, universal precautions with all body fluids and breaks in technique in ANY staff • REVIEW recorded and current infections • DETERMINE patterns , (clusters, high rate, unexplained) monitoring , and action • ASK staff what they do, who they notify if: • Patients are especially vulnerable, communicable, isolated, exposed to infection? • Staff are communicable, violating policy?

16. Dialysis Facility Conditions Condition: Infection control. This Condition incorporates as regulation two documents from the Centers for Disease Control and Prevention (CDC), along with CMS-developed regulations. These infection control requirements apply to both the chronic dialysis facility’s in-center dialysis and any home dialysis program(s).

17. Chronic Dialysis Facilities Survey of this Condition requires: • observations of care delivery, • interviews with staff and patients, • review of medical records, facility logs, policies and procedures and quality assessment and performance improvement (QAPI) documentation. Medical and administrative records should demonstrate recognition of any potential infection and actions taken to decrease the transmission of infection within the dialysis facility. If deficient practices noted in infection control, techniques are multiple, pervasive, or of an extent to present a risk to patient health and safety, Condition level non-compliance should be considered.

18. Chronic Dialysis Conditions • Sanitary Environment: “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients.” (includes procedures and comprehensive program • Hepatitis: “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” (precautions, testing, immunization, isolation, surveillance, response, training

19. Chronic Dialysis Conditions Hand Hygiene, Gloves and PPE: Moving Target • Current guidance is gloves whenever providing patient care or touching a machine surface, and change required both ways in going from one to the other • Medical record, both paper and electronic present PPE challenge • “Holding sites” requires glove(s) for patient or visitor

20. Chronic Dialysis Conditions Additional Specifics: • “splash zone” nothing considered clean in it • Medication prep: no delivery carts, clean prep • Isolation Room or agreement, two station separation for pre-reg facilities • Catheter reduction and Precautions • Water and Dialysate Cultures • Documentation of audits, “breaks” action • QAPI, Medical Director, Board

21. Hospital Conditions 482.42 Condition of Participation: 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. The hospital’s program for prevention, control and investigation of infections and communicable diseases should be conducted in accordance with nationally recognized infection control practices or guidelines

22. Documents Incorporated Into New Jersey IC Requirements • (1) Guideline for Prevention of Catheter-Associated Urinary Tract • Infections (1981); • (2) Guideline for Prevention of Intravascular Device-Related Infections • (Infection Control and Hospital Epidemiology 1996; 17: 438-73 and • American Journal of Infection Control 996; 24: 262-93); • (3) Guidelines for Prevention of Surgical Site Infections (1999) (Infection • Control and Hospital Epidemiology 1999; 20:247-278); • (4) Guideline for Prevention and Control of Nosocomial Pneumonia • (American Journal of Infection Control, August 1994; 22:247-92 and • Infection Control and Hospital Epidemiology, September 1994; 15: 587-627 • and Respiratory Care, December 1994; 39: 1191-1236); • (5) Guideline for Handwashing and Hospital Environmental Control (1985); • (6) Guideline for Infection Control in Hospital Personnel (1998); • (7) Guideline for Isolation Precautions in Hospitals (Infection Control and • Hospital Epidemiology 1996; 17:53-80 and the American Journal of Infection • Control 1996; 24:24-52); • (8) Guidelines for Preventing the Transmission of Mycobacterium • tuberculosis in Health Care Facilities (Morbidity and Mortality Weekly • Report 1994; 43: 11-22); and • (9) HICPAC Recommendations for Preventing the Spread of Vancomycin • Resistance. (Infection Control and Hospital Epidemiology 1995; 16: 105-113)

23. Hospital Conditions The infection prevention and control program must include an active surveillance component that covers both hospital patients and personnel working in the hospital. Surveillance includes infection detection, data collection and analysis, monitoring, and evaluation of preventive interventions

24. Hospital Conditions The infection prevention and control program must include appropriate monitoring of: • housekeeping, • maintenance (including repair, renovation and construction activities), • and other activities to ensure that the hospital maintains a sanitary environment.

25. Hospital Conditions SURVEYORS look for monitoring of: • food storage, preparation, serving and dish rooms, refrigerators, • ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, treatment areas, • labs, waste handling, surgical areas, supply storage, equipment cleaning, etc.

26. Hospitals MULTI-DRUG RESISTANT ORGANISMS (MDROs) And Communicable Disease Outbreaks Require • Close Monitoring, Tracking, Reporting • Prevention of transmission • Identification of infected and Exposed • Particular attention to ambulatory care (eg ER) And have Individual challenges An all-hazards approach can also address bioterrorism

27. Hospital infection ControlSurvey Procedures • Should be coordinated by one surveyor, • All surveyors assess hospital’s compliance • Assure that program is hospital wide * • Determine degree of implementation • Observe Care and Cleanliness • Look for integration into QAPI

28. Hospital 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. • Federal: CDC has defined “infection control professional” as “a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control.” • New Jersey requires board certified physician, board certified in a specialty with additional IC training and a multidisciplinary team

29. Hospital Organization and Policies CMS does not specify either the number of infection control officers to be designated or the number of infection control officer hours that must be devoted to the infection prevention and control programs. However, resources must be adequate to accomplish the tasks required for the infection control program. New Jersey requires a program team and a hospital infection control committee

30. Hospital Organization and Policy Survey Procedures • Determine whether an infection control officer(s) is designated and has the responsibility for the infection prevention and control program. • Review the personnel file of the infection control officer(s) to determine whether he/she is qualified through ongoing education, training, experience, or certification to oversee the infection control program. • Determine whether the infection control officer(s) have developed and implemented hospital infection control policies.

31. Hospital infection Control Plan Program and Team must: • Define roles, accountability and training for all personnel • Identify and monitor potential risks in each hospital area, and object to reduce exposure • Identify and mitigate risks of patients/staff bringing infections into hospital • Monitor compliance, comply with reporting requirements, coordinate with feds, state and locals • Evaluate and revise program annually and as needed • Provide for sanitary environment • Did I mention hand washing and PPE?

32. Mid-Atlantic Renal Coalition & ESRD Network of New England, 5 Diamond Patient Safety Program, Patient Safety in the Dialysis Unit 2008.

33. Incidents and QAPI • Crosses all facility types • Requires a culture of quality • Every person must speak and be heard • Problems must be solved where they live • All teach all learn • Is the court of last resort • Brutal honesty is the only path to survival • May be embarrassing and perhaps costly, but

34. It is not the audit process or the reporting process or the performance improvement or the trip back to the drawing board that is hard: it is the job of saving as many of the 90 thousand+ who lose their lives each year due to infections they acquired in our care.

35. Thank You!

36. Questions?