9/11/2013. Infection Control Training for outpatient healthcare Settings, 2013

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1 Infection Control Training for outpatient healthcare Settings, 2013 Meeting the requirements of 10A NCAC 41A.0206: Infection Prevention healthcare Settings Patients deserve effective infection control wherever they receive healthcare. Adapted from: Jarvis WR Emerg Infect Dis. 2001;7: Macedo de Olivera et al. Annals of Int Med. 2005, 11 Modules Module A - North Carolina Laws Concerning Infection Prevention in Outpatient settings Module B - Complying with OSHAs Bloodborne Pathogen Final Rule Module C - Epidemiology and Risk of Infection in Outpatient Settings Module D - Outbreaks and Safe Injection Practices in Outpatient Settings Module E - Principles and Practices of Asepsis Module F - Principles of Disinfection and Sterilization Module G - Application of Cleaning, Disinfection, and Sterilization Principles to Patient Care Equipment in Outpatient Settings 1

2 Module A NC Laws Concerning Infection Prevention in Outpatient Settings Statewide Program for Infection Control and Epidemiology (SPICE) UNC School of Medicine Module A Objectives: North Carolina infection control laws and regulations Describe pertinent rules for infection prevention Discuss control measures for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C Explain NC communicable disease reporting rules Review medical waste rules Review Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center (ASC) rules Background 1990 CDC becomes aware of a possible transmission of HIV from a dentist to 6 patients (Kimberly Bergalis case) July 1991 CDC publishes Recommendations for Preventing Transmission of HIV and hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures October 1991 Congress passes Public Law , requiring states to adopt CDC Guidelines or equivalent guidelines drafted by the state 2

3 10A NCAC 41A.0207 HIV and hepatitis B Infected HCP All healthcare providers who perform or assist in surgical or obstetrical procedures or dental procedures and who know themselves to be infected with HIV or hepatitis B shall notify the NC State Health Director 10A NCAC 41A.0207 NC State Health Director Responsibilities Investigate practice Reported needle sticks, types of procedures performed, practice during procedures Evaluate clinical condition Viral loads and antigen levels Determine risk of transmission to patients Based on clinical activities, viral burden Convene expert panel Issue isolation order pursuant to findings of the investigation and/or recommendations of the panel Can occur prior to expert panel hearing if there is imminent risk to the public health 10A NCAC 41A.0206 Each healthcare organization in which invasive procedures are performed must Implement a written infection control policy Designate one on-site staff member to direct infection control activities Designated staff member must complete a State approved course in infection control On the job training is not sufficient Must have certificate documenting course completion 3

4 10A NCAC 41A.0206: Infection Prevention in healthcare Settings (1) "healthcare organization" means a hospital; clinic; physician, dentist, podiatrist, optometrist, or chiropractic office; home care agency; nursing home; local health department; community health center; mental health facility; hospice; ambulatory surgical facility; urgent care center; emergency room; Emergency Medical Service (EMS) agency; pharmacies where a health practitioner offers clinical services; or any other organization that provides clinical care. 10A NCAC 41A.0206: Infection Prevention in healthcare Settings (2) "Invasive procedure" means entry into tissues, cavities, or organs or repair of traumatic injuries. The term includes the use of needles to puncture skin, vaginal and cesarean deliveries, surgery, and dental procedures during which bleeding occurs or the potential for bleeding exists. Changes to 10A NCAC 41A Adds safe injection practices to list of topics covered in state-approved courses 2. Explicitly addresses hepatitis C and other bloodborne pathogens in addition to HBV and HIV 3. Requires one designated staff member for each noncontiguous* healthcare facility *non-contiguous defined as two facilities that are not physically connected. 4

5 healthcare provider with Exudative Lesions or Dermatitis on hands/wrists Shall refrain from: Handling patient care equipment Handling devices used for invasive procedures All direct care activities likely to have contact with lesion Infection Control Training of Employees Infection control and OSHA Bloodborne Pathogen (BBP) training can be combined, but must include: Sterilization and disinfection Include sterilizer monitoring and maintenance Sanitation of rooms and equipment Appropriate agents, procedures and frequencies Accessibility of infection control devices and supplies Personal protective equipment (PPE), sharp safety devices, etc. Knowledge Check What constitutes an invasive procedure under.0206? a) Surgery b) Vaginal deliveries c) Dental procedures d) Use of needles to puncture skin e) All of the Above 5

6 Knowledge Check Which of the following is not required by.0206 rule for healthcare organizations that do invasive procedures of any type? a) Have a written infection control policy b) Conduct infection control training for healthcare providers c) Monitor compliance with infection control requirements d) Investigate needlesticks and other exposures to bloodborne pathogens (BBP) e) Update policy as needed to prevent transmission of BBP Module A Objectives: North Carolina infection control laws and regulations Describe pertinent rules for Infection Prevention Discuss control measures for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C 10A NCAC 41A.0202,.0203, and.0214 Explain NC communicable disease reporting rules Review medical waste rules Review Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center (ASC) rules Exposure A needlestick Non-sexual contact that: Exposes non-intact skin or mucous membranes to blood and potentially contaminated body fluids* of a patient, AND Poses a significant risk of transmission of HIV, hepatitis B, or Hepatitis C if source was infected with those viruses *Potentially contaminated body fluids include cerebrospinal, pericardial, joint, peritoneal, pleural, amniotic, vaginal secretions, semen, and any fluid with visible blood. Sweat, tears, saliva, respiratory tract secretions, vomitus, stool, and urine (unless contaminated with blood) are NOT potentially contaminated body fluids. 6

7 Source and Exposed Person Source Person Person who contributes blood or potentially contaminated body fluids to the exposure incident Exposed Person Individual who has needlestick or nonsexual exposure to blood and potentially contaminated body fluids Control Measures HIV, HBV, HCV 10A NCAC 41A.0202,.0203, and Determine if exposure constitutes significant risk Needlesticks For all other exposures must consider Type of body fluid or tissue Volume of body fluid or tissue Concentration of pathogen Infectiousness or virulence of pathogen Route of exposure - percutaneous>mucous membranes>nonintact skin>intact skin Control Measures HIV, HBV, HCV 10A NCAC 41A.0202,.0203, and Required Follow-up Measures Known Source Exposed person s attending physician or occupational healthcare provider must notify source person s attending physician. Source person s physician must test source for HIV, HBV, and HCV and notify exposed person s physician of results. Exposed person s physician offers follow-up in accordance with the rules and CDC guidelines (per OSHA). 7

8 Control Measures HIV, HBV, HCV 10A NCAC 41A.0202,.0203, and Required Follow-up Measures Unknown Source Offer HIV testing to exposed person Determine whether exposed person has been vaccinated for hepatitis B Vaccinate for hepatitis B if indicated Offer hepatitis C testing to exposed person Confidentiality The attending physician of the exposed person shall instruct the exposed person regarding the necessity for protecting confidentiality. Exposed persons are instructed to maintain this confidentiality. Knowledge Check True or False: You have to know or suspect a source person has HIV, hepatitis B or hepatitis C for the control measures rules to apply? False. 8

9 Knowledge Check True or False: A source person must give informed consent before being tested? No. Module A Objectives: North Carolina infection control laws and regulations Describe pertinent rules for Infection Prevention Discuss control measures for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C Explain communicable disease reporting rules Review medical waste rules Review Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center (ASC) rules GS 130A-135 A physician licensed to practice medicine who has reason to suspect that a person about whom the physician has been consulted professionally has a communicable disease or condition declared by the Commission to be reported, shall report information required by the Commission to the local health director 9

10 Mandatory Communicable disease (CD) Reports in NC Routine Physicians, labs & specified others must report CDs designated reportable by NC Commission for Public Health 71diseases/conditions 10A NCAC 41A.0101 Timeframe for report varies (7 days, 24 hours, or immediately) Only if ordered NC State Health Director may issue order requiring HCP to report symptoms, diseases, conditions, trends in use of services, other information needed to investigate a potential outbreak Order must specify who must report what and may not exceed 90 days Diseases and Conditions Reportable in North Carolina What about HIPAA? HIPAA section (a): Can disclose information when required by law Mandatory reporting laws are examples of laws requiring disclosure. HIPAA section (b): Can disclose information to public health authorities that are authorized by law to receive it for purposes including disease control, surveillance, etc. Sometimes have voluntary reporting; covered by this section if public health authority is authorized by law to receive the information GS 130A-142 provides immunity from liability for persons who make reports in good faith. This immunity applies not only to physicians, but to all the other reporters as well 10

11 Confidentiality of records (GS 130A- 143) General rule: Written consent is required to disclose any information that identifies a person who has or may have a reportable communicable disease or condition, including HIV. Exceptions: More limited than HIPAA, but allow for: Disclosures for treatment purposes Disclosures required or allowed by the NC communicable disease laws and rules A few other purposes Communicable Disease Investigation NC law supports access to information as part of an investigation - GS 130A-144(b) Medical facilities, labs, & physicians shall provide access to and copies of medical or other records that pertain to: Diagnosis, treatment, or prevention of a communicable disease for a person known to be, or reasonably suspected of being, infected or exposed Investigation of known or reasonably suspected outbreak Control Measures Public health endeavors geared at controlling communicable disease: Sanitation Immunizations Screening or diagnostic tests Partner notification Treatment regimens Isolation and quarantine Etc. May be population-based or directed to individuals 11

12 Control measures In NC, all persons must comply with communicable disease control measures established by the Commission for Public Health. GS 130A-144(f). Commission adopts rules establishing control measures and publishes them in the NC Administrative Code. 10A NCAC 41A What are the control measures? NC rules specify the control measures for HIV, hepatitis B, hepatitis C, sexually transmitted infections, tuberculosis, smallpox/vaccinia, and SARS For all other communicable diseases, NC rules incorporate control measures specified in: CDC guidelines and recommended guidelines, if available APHA s Control of Communicable Diseases Manual Communicable disease Law Enforcement Two Approaches Civil enforcement: The health director can ask a superior court judge for a court order directing a person to comply with the law. GS 130A-18. A person who refuses to comply with a court order could be held in contempt of court. Criminal enforcement: A person who violates a public health law can be charged with a misdemeanor. GS 130A

13 Where to find Communicable disease Laws and Rules General Statutes are available through NC General Assembly s website: Click on General Statutes Under Look up type in : 130A The NC Administrative Code is found online: Click on Title 10A Click on Chapter 41 Click on.0206,.0207,.0202,.0203,.0214 Knowledge Check True or False: HIPPA prohibits physicians from making Communicable Disease reports? False Knowledge Check True or False: A physician must wait for lab reports confirming the Communicable Disease/Communicable Condition before making the report? False 13

14 Module A Objectives: North Carolina infection control laws and regulations Describe pertinent rules for Infection Prevention Discuss control measures for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C Explain communicable disease reporting rules Review medical waste rules 15A NCAC 13B.1200 Review Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center (ASC) rules There are two types of medical waste! Medical Waste Any solid waste generated in the diagnosis, treatment, or immunization of human beings or animals Cost $0.55/lb to dispose Regulated Medical Waste Any blood or body fluids in individual containers >20ml (about size of test tube) Microbiological waste Pathological waste Must be treated prior to disposal Cost $1.75/lb to dispose of Adapted from Medical Waste Presentation by Bill Patrakis, NC DENR, Division of Solid Waste Management. Blood and Body Fluids Liquid blood, serum, plasma, other blood products, emulsified human tissue, spinal fluids, and pleural and peritoneal fluids Dialysates, urine, and feces are NOT blood or body fluids under this definition Possible methods of treatment dispose of in commode, incineration, steam sterilization. 14

15 Microbiological Waste Cultures and stocks of infectious agents (e.g. Microbiology laboratory) Possible methods of treatment incineration, autoclaved, or chemical disinfectants (bleach 1:5) Pathological Waste Human tissues, organs, and body parts removed during surgery or autopsy Only method of treatment - incineration Disposal of Sharps* Rules do not require treatment before disposal Must be packaged in a container that is rigid, leak-proof when upright, and puncture resistant Can be disposed of with general solid waste Some landfills do not accept sharps * Sharps: Needles, Needles with syringes, Needles with vacationers, blades (scalpels), contaminated broken glassware 15

16 Not Defined as Regulated Medical Waste Dressings and bandages (even blood soaked), sponges, disposable instruments, used gloves, and tubing Disposed of as general solid waste Household waste including injections administered at home is not included in medical waste rules. Occupational Health and safety administration OSHA specifies certain features of the regulated waste containers, including appropriate tagging meant to protect waste industry workers. OSHA rules are intended to minimize employee exposure to bloodborne pathogens. OSHA does not address disposal. OSHA definition of regulated waste may include waste such as bloody gauze, blood saturated dressings, used gloves, or tubing. by Bill Patrakis, NC DENR, Division of Waste Management. 16

17 Knowledge Check Which of the following is NOT classified as Regulated medical waste in the NC Medical Waste Rules? a) Microbiological b) Isolation Precautions room waste c) Pathological d) Blood in quantities of 20 ml per a single unit vessel Knowledge Check What do the NC Medical Waste Rules require for disposal of sharps? a) Container for sharps is rigid, puncture resistant and leak proof when in an upright position. b) Closed sharps container may be disposed of with general solid waste. c) Contained sharps shall not be compacted prior to offsite transportation. d) All of the above Module A Objectives: North Carolina infection control laws and regulations Describe pertinent rules for Infection Prevention 10A NCAC 41A.0206 and.0207 Discuss control measures for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C 10A NCAC 41A.0202,.0203, and.0214 Explain communicable disease reporting rules Review medical waste rules 15A NCAC 13B.1200 Review Centers for Medicare and Medicaid Services (CMS) Ambulatory Surgical Center (ASC) rules 17

18 Background Ambulatory Surgical Centers (ASC) are distinct entities that exclusively provide surgical services to patients who do not require hospitalization and are not expected to need to stay longer than 24 hours. Currently, >5,300 U.S. Medicare-certified ASCs 2007: over 6 million procedures performed in ASCs and paid for by Medicare at a cost of nearly $3 billion Wide variety of procedures including endoscopy, injections to treat chronic pain, and dental surgery Facilities are also varied as to size, staffing, ownership type, chain or hospital affiliation, electronic health records Federal Register CMS Statute 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. (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. Expanded Conditions for coverage for Infection Prevention In 2008, CMS adopted Revised Ambulatory Surgical Center (ASC) Conditions for Coverage (CfC), Interpretive Guidelines and Survey Procedures. (effective 2009): CMS For the first time, the CfC for ASCs specifically addressed the need for infection control programs, including: Maintain an infection control program based upon nationally recognized infection control guidelines. Designate a healthcare professional with training in infection control to direct the infection control program. Integrate the infection control program into the ASC s Quality Assessment and Performance Improvement Program (QAPI) Prevent, identify and manage HAIs through its infection control program activities conducted in accordance with recognized infection control surveillance practices 18

19 CMS INFECTION CONTROL SURVEYOR WORKSHEET FOR ASC A 16-page document listing items that must be assessed during the on-site survey, in order to determine compliance with the infection control Condition for Coverage. Centers for Medicare and medicaid services Infection Control Worksheet Section 1 Ambulatory Surgical Center (ASC) characteristics Type of ASC, scopes of services, organization of its infection control program, training/qualifications, use of nationally recognized standards and/or guidelines, surveillance methods Section 2 Infection Control Practices Assessment Specific practices in five critical areas of infection control: hand hygiene and use of personal protective equipment Injection safety and medication handling equipment reprocessing (e.g., sterilization and high-level disinfection) environmental cleaning handling of point-of-care devices (e.g., blood glucose monitoring equipment) Sample worksheet hand hygiene 19

20 2008 Pilot Survey 68 facilities in North Carolina, Maryland and Oklahoma 68% had at least one lapse in infection control 18% had lapses in 3 of the 5 infection control categories assessed Schaefer et al. Infection Control Assessment of Ambulatory Surgical Centers. JAMA (22): Pilot Survey Schaefer et al. Infection Control Assessment of Ambulatory Surgical Centers. JAMA (22): Questions? 20

21 References Schaefer M. et al. Infection Control Assessment of Ambulatory Surgical Centers. JAMA. 2010;303 (22): Jarvis WR. Infection control and changing health-care delivery systems. Emerg Infect Dis 2001;7: de Oliveira M. et al. An outbreak of hepatitis C virus infections among outpatients at a hematology/oncology clinic. Annals of Internal Medicine, 2005 June 7, 142(11):