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INTERDISCIPLINARY PRACTICE AND RESEARCH CENTER

INFECTION CONTROL MANUAL

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The Infection Control Manual will be reviewed and revised as necessary by the IPRC Committee every two years.

Version Date IPRC Chair Signature

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Table of Contents Contact Information Authority Statement Commonly Used Acronyms Definitions Clinic Maps Chapter One - General Provisions

1.0 Emergency Response 1.1 Required Training 1.2 Hand Hygiene 1.3 Personal Protective Equipment (PPE) 1.4 The Spaulding Classification System 1.5 Cleaning and Disinfecting Equipment, Devices, and Environment 1.6 Storage of Medical Equipment and Devices 1.7 Laboratory Refrigerators and Freezers 1.8 Food/Beverages

Chapter Two - Bloodborne Pathogen Exposure Control Plan

2.0 General Information 2.1 Biomedical Waste 2.2 Post-Exposure Provisions 2.3 Sharps Safety Devices 2.4 Specimen Collection and Transport 2.5 Spills 2.6 Health Screenings and Vaccinations 2.7 Approved Antiseptics, Disinfectants, Cleaning Agents, and Skin Products

Chapter Three - Precautions

3.0 Standard Precautions 3.1 Contact and Droplet Transmission-Based Precautions 3.2 Droplet Transmission-Based Precautions 3.3 Transmission-Based Precautions: Initiation and Discontinuation

Chapter Four – Infections: Prevention and Control

4.0 Clinical Syndromes or Conditions Warranting Additional Empiric Precautions 4.1 Cystic Fibrosis Disease-based Precautions

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Contact Information

The table below is meant to serve as a quick reference for contact information. For further instructions on contacting campus services, review the full policies given on the pages listed in the last column.

Purpose of Contact Personnel/Service Contact Information See

Emergency situation Office of Public Safety 1-2911 1.0

Bodily spill Environmental Health

and Safety 1-2663 2.5

Laundry Services Steven Hoffa 1-4525

shoffa@gru.edu 2.0

Questions regarding the IPRC or ICM

Jim Hawkins, IPRC Steering

Committee Chair

1-2552 jahawkins@gru.edu

Reserve clinic space or request key access

Nita Sakievich, Admin Assistant

1-2070 NFPG@gru.edu

Call clinic front desk No assigned personnel 1-1195

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Authority Statement Objective To establish the authority for epidemiology regarding infection prevention and control within the Interdisciplinary Practice and Research Center (IPRC). Scope Policies regarding infection prevention and control pertain to operations within the IPRC and must be followed by all healthcare providers, Georgia Regents University (GRU) personnel, contractors, volunteers, and students who may work or enter the IPRC facilities. Policy The IPRC Steering Committee, along with the Principal Investigators (PIs) and their designated clinical and research staff (CRS), the GRU Institutional Biosafety Committee (IBC) and GRU Biosafety Office, and Office of Environmental Health and Safety have the responsibility and authority to implement any infection surveillance, prevention, and control measure or policy to reduce the risk of transmission of healthcare associated infections (HAI). An epidemiologic study may be initiated when there is reason to believe that any patient/subject or personnel may be at risk. The Chair of the IPRC Steering Committee (IPRC Chair) will be the point of contact for users of the facility and will serve as liaison with the Biosafety Office. The IPRC Chair will not be responsible for enforcing infection control policies or decision making: these will be the responsibility of the IPRC Steering Committee as a whole. In the event that GRU policies cannot be implemented or an unusual situation is not covered by such policies, the IPRC Chair must alert the Biosafety Office, who in turn should notify the IBC Chairman for further action. Should the situation appear to be an emergency, the IPRC Chair, the IBC Chair, in consultation with the IBC members, and the Biosafety Officer have the authority to implement measures for up to 36 hours. IPRC PIs and CRS will be involved in this decision process. Any measure extending beyond the 36 hour period requires the concurrence and endorsement of the President and Provost of GRU in consultation with the Vice President for Legal Affairs. Responsibility The IPRC Steering Committee is responsible for this policy and for maintaining current and accurate policies and provisions related to infection prevention and control within the IPRC. The IBC must approve all infection prevention and control policies and provisions

Administrative Policy Objective To establish the authority for policies and provisions regarding infection prevention and control at GRU IPRC. Scope Policies and provisions regarding infection prevention and control pertain to all those that work at the IPRC and must be followed by all healthcare providers, Georgia Regents Health System (GRHS) personnel, GRU personnel, contractors, volunteers and students working in the IPRC.

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Policy 1. The Institutional Biosafety Committee (IBC) approves policy and provisions for infection

prevention, surveillance, and control at the Interdisciplinary Practice and Research Center (IPRC). Changes in the policies and provisions may be initiated by the Biosafety Office, IBC, or IPRC Steering Committee.

2. Established policies and provisions in the IPRC Infection Control Manual (ICM) are available within the IPRC laboratory and maintained by the IPRC Chair or designee. Policies and provisions are developed using current national, state, and local regulations and guidelines, evidence-based research, and/or input from experts in the related field. Examples include but are not limited to APIC, CDC, SHEA, HICPAC, TJC, OSHA, NIOSH, AMMI, and AIA.

3. The IBC approves all infection control policies and provisions on behalf of the Georgia Regents University (GRU).

4. No clinical operations or patients/subjects beyond the scope of those described within the IPRC ICM policies and provisions will be permitted within the IPRC unless the appropriate provision is submitted for review and approval of the IBC.

5. Faculty and clinical and research staff (CRS) working in the IPRC will comply with all standard healthcare practices and standards, including those described in Mosby’s Foundations and Adult Health Nursing, Mosby’s Dictionary of Medicine, Nursing & Health Professionals, and Mosby’s Pediatric Nursing Reference. Similarly, universal precautions will be observed by all personnel. Only appropriately licensed healthcare professionals will be permitted to administer drugs to patients or research subjects or perform healthcare operations, such as phlebotomy.

6. The Bloodborne Pathogen Exposure Control Plan and Tuberculosis Control Plan require annual review. All other policies and provisions will be reviewed every two years. It is the responsibility of the IPRC Chair to submit these to the IBC on the appropriate schedule.

7. Any Principal Investigator (PI) or CRS who witnesses a breach in infection prevention and control policy or provision is responsible for reporting the incident to the IPRC Chair and/or Biosafety Office, who will then report these breaches to the IBC.

8. The IPRC Steering Committee can determine through a meeting or by e-mail to revoke a researcher/clinician’s right to use the IPRC facility, or shut down the facility entirely if the person(s) responsible for a breach in infection control policy cannot be identified. The committee may contact the Biosafety office for direction on whether such action is appropriate.

9. The IPRC Steering Committee will establish training procedures to familiarize the users of the IPRC with the policies and procedures presented in this manual, however the PI will be responsible for ensuring faculty and CRS receive and comply with the training.

10. Faculty and CRS are responsible for providing all supplies necessary to conduct their operations, including Personal Protective Equipment and IBC approved disinfectants.

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Commonly Used Acronyms

CDC Center for Disease Control and Prevention

CRS Clinical and Research Staff

ED Emergency Department

EH&S GRHS Environmental Health and Safety

EVS GRU Environmental Services (housekeeping)

GRHS Georgia Regents Health System

GRU Georgia Regents University

ICM Infection Control Manual

IBC Institutional Biosafety Committee

IPRC Interdisciplinary Practice and Research Center

PI Principal Investigator

PPE Personal Protective Equipment

OSHA Occupational Safety and Health Administration

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Definitions For the purpose of this manual, the following definitions are used: Cleaning: Physically removes organic matter (including dust), lubricants, and visible soils that interfere with microbial inactivation. It is the first step of any sterilization or disinfection process. Decontamination: A physical or chemical process that renders a contaminated inanimate object safe for handling. Disinfection: A process that eliminates many or all microorganisms except spores and is done with liquid chemicals or by pasteurizing objects. High-level disinfection: Can be expected to destroy all microorganisms, with the exception of high numbers of bacterial spores. Intermediate-level disinfection: Eliminates vegetative bacteria, most viruses, and most fungi, but does not necessarily kill bacterial spores Low-level disinfection: The elimination of most pathogenic bacteria. Sterilization: The complete elimination of all forms of microbial life. Wipe: Can be accomplished by using germicidal clothes, the Institutional Biosafety Committee (IBC)-approved germicide and a washcloth. Surfaces must be clean before they can be wiped with germicide. The IBC-approved germicide must never be sprayed directly on plastic or electrical items. Spray on a washcloth and then wipe the surfaces. Clean: All surfaces must be debris free. This must be accomplished using the IBC-approved germicide concentrate mixed in a bucket of water or soap and water. If soap and water are used, the IBC-approved germicide must be wiped on the surfaces after the surfaces are free of debris. Deep clean or Terminal clean: Total cleaning of all horizontal surfaces with a final stage of disinfection for all horizontal surfaces and all items in a room including the floor. Walls are spot cleaned as needed.

Principal Investigator (PI): The term Principal Investigator refers not only to the director of a research study, but any person who is responsible for the conduct of clinical or teaching activities.

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The automatic exterior doors (Door C) for the IPRC remain locked at all times and can only be opened from the outside with specially formatted smart cards. Clean storage (1513), soiled storage (1517), and file storage (1510) are locked at all times.

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Chapter 1 - General Provisions 1.0 Emergency Response Certain emergency situations will require action from the campus Office of Public Safety (Public Safety) while others will require non-campus emergency services (such as the Fire Department). Due to the size and complexity of the GRU campus, Public Safety should be contacted for all emergencies, even if the situation requires alerting an outside response team first. Public Safety will coordinate with outside emergency responders to assist in directing them to the correct location in a timely matter. To ensure an immediate understanding and response from Public Safety, callers should use the keywords “help,” “emergency,” and/or “violence” as appropriate to the event. The automatic exterior doors for the IPRC remain locked at all times and can only be opened from the outside with specially formatted smart cards. Public Safety Officers will be able to unlock these doors, but non-GRU responders will not. The doors can be opened from the inside by pressing the handicapped button beside the doors or by pressing the door control at the receptionist desk. When it is safe to do so (non-fire emergencies) a member of the CRS should be posted by the door to provide access to non-GRU responders. Medical Emergency The Interdisciplinary Practice and Research Center (IPRC) is a facility used for health related research, faculty practice, and education. Therefore, equipment and personnel for medical emergencies are not available on-site. Should a medical emergency occur, the following steps should be followed:

1. Call 911 to dispatch EMS services a. Provide the information to assist EMS services in locating the IPRC clinic:

Georgia Regents University Health Sciences Building 987 Saint Sebastian Way Across from the Stoney Building and the University Cardiovascular Center From Walton Way, Saint Sebastian Way is between 13th and 15th Street From RA Dent Boulevard, Saint Sebastian Way is between Laney Walker Boulevard

and Walton Way The Health Sciences Building is a five story tall brick and glass building The opening to the clinic is on the side of the building opposite of Harper Street and

facing RA Dent Boulevard b. State the emergency c. Give as much pertinent information as possible, such as:

Age and sex Any chronic illnesses the subject may have If the parent/guardian is with the subject (if the subject is a minor) Whether the client is part of a research study and if this is related to the emergency

Is it possible that the subject is experiencing a reaction to study treatment? If so, provide the nature of the study and information related to prior and current treatment(s).

Is the emergency unrelated to the study? What has been done or is being done to address the emergency.

2. Call Public Safety at 1-2911 a. Provide the location the IPRC clinic:

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Health Sciences Building, suite EC-1500, northeast entrance facing the Stoney Building.

b. State the emergency c. Inform Public Safety that 911 has been contacted and request that Public Safety

coordinate with the Emergency Service Dispatcher d. Give as much pertinent information as possible, such as:

Age and sex Any chronic illnesses the subject may have Is the parent/guardian with the subject (if the subject is a minor) Whether the client is part of a research study and if this is related to the emergency

Is it possible that the subject is experiencing a reaction to study treatment? If so, provide the nature of the study and information related to prior and current treatment(s).

Is the emergency unrelated to the study? What has been done or is being done to address the emergency.

3. The clinical and research staff (CRS) responsible for the patient/subject should remain with the person experiencing the medical emergency to assist if possible and to answer any questions the emergency responders may have. The CRS should seek immediate assistance from another staff member(s) to perform the following tasks as quickly as possible:

a. While emergency responders are being called to the scene, the Principal Investigator (PI) responsible for the study should be called and informed of the emergency.

b. A staff member should be sent out of the building to signal and escort the emergency responders to the site of the emergency.

c. A member of the CRS should be posted by the exterior automatic door to provide access to responders who do not have card access to the IPRC.

4. For follow up procedures, see “HAC Adverse Event Follow-up” Fire Emergency The response required for fire emergencies will be determined by the presence or absence of visible flames. In the event of a fire, remain calm. Do not yell “Fire!”

1. In the event of smoke with no visible flames a. Remove personnel and subjects/patients from the area to avoid inhaling smoke, and close

doors to the area affected b. Call Public Safety at 1-2911 c. Provide the location of the IPRC:

Health Sciences Building, suite EC-1500, northeast entrance facing the Stoney Building

d. State the emergency e. Give as much pertinent information as possible, such as:

The absence of visible flames The source/amount/color/smell of smoke

f. Await further instructions from Public Safety. g. For follow up procedures, see “HAC Adverse Event Follow-up”

2. In the event of visible flames a. Remove persons in immediate danger of the fire and close doors to the area affected. b. Activate the nearest fire alarm and call 911 c. Provide the information to assist the Fire Department in locating the IPRC clinic:

Georgia Regents University Health Sciences Building 987 Saint Sebastian Way

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Across from the Stoney Building and the University Cardiovascular Center From Walton Way, Saint Sebastian Way is between 13th and 15th Street From RA Dent Boulevard, Saint Sebastian Way is between Laney Walker Boulevard

and Walton Way The Health Sciences Building is a five story tall brick and glass building The opening to the clinic is on the side of the building opposite of Harper Street and

facing RA Dent Boulevard d. State the emergency e. Give as much pertinent information as possible, such as:

Type of fire (structure, electrical, chemical, etc) Approximate extent of fire If there are known chemicals, gas containers, or other medical/cleaning equipment

that are highly flammable in the affected area If any person cannot be removed from the affected area

f. Call Public Safety at 1-2911 i. Provide the location of the IPRC:

Health Sciences Building, suite EC-1500, northeast entrance facing the Stony Building

ii. State the emergency iii. Inform Public Safety that 911 has been contacted and request that Public Safety

coordinate with the Emergency Service Dispatcher iv. Give as much pertinent information as possible, such as:

Type of fire (structure, electrical, chemical, etc) Approximate extent of fire If there are known chemicals, gas containers, or other medical/cleaning

equipment that is highly flammable in the affected area If any person cannot to be removed from the affected area

g. Calmly notify other personnel in the area h. If it is safe to do so, attempt to extinguish the fire with the proper fire extinguisher

provided in your area i. Evacuate following established fire safety and evacuation procedures for your area (note

that exiting through the IPRC’s exterior doors will require pushing the handicapped button)

j. For follow up procedures, see “HAC Adverse Event Follow-up”

Violent Emergency In the event of violence or the threat of violence, the following steps should be followed:

1. Call Public Safety at 1-2911 2. Provide the location of the IPRC:

Health Sciences Building, suite EC-1500, northeast entrance facing the Stoney Building 3. State the emergency 4. Give as much pertinent information as possible, such as:

Names or descriptions of the persons involved Type of violence The presence or use of a weapon

5. Await further instructions from Public Safety 6. If safe to do so, a member of the CRS should be posted by the exterior automatic door to provide

access to responders who do not have card access to the IPRC 7. If it is necessary to vacate through the IPRC’s exterior doors, the doors must be opened by

pushing the handicapped button.

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8. For follow up procedures, see “HAC Adverse Event Follow-up” HAC Adverse Event Follow-up Once an emergency has been addressed, the following procedures should be followed:

1. The PI must complete the Adverse Event (AE) paperwork as close to the event as possible. 2. All staff and personnel on duty when the emergency occurred need to complete an AE recall

summary prior to completion of the shift. 3. After any emergency event, a debriefing of the event for all participants should be conducted to

ensure procedures were followed and, if not, what prevented compliance with the proper standard operating procedures. Discussion should focus on how to adapt the emergency procedures to improve future adherence and/or operations to facilitate better emergency response.

1.1 Required Training It is the responsibility of the PI to provide training for his/her research/clinical staff (CRS) for safely conducting research/practice in the IPRC. Training should cover:

1. Use of equipment required to perform assigned research/clinical procedures 2. Decontamination, cleaning, and disinfecting procedures (including use of IBC-approved

cleaning/disinfectant products) 3. Disposal procedures 4. Bloodborne Pathogens 5. HIPAA, CITI, and/or any other patient/subject safety and privacy training required for conducting

research/clinical projects When any new IBC-approved cleaning/disinfectant product is introduced, training must be provided to the CRS in its proper use; when any new equipment/device which requires disinfection is introduced, training must be provided to the clinical and research staff (CRS) in its proper cleaning/disinfection. The PI should maintain training documentation for all personnel including:

1. the type of training 2. the name and credentials of the trainer 3. the name of the CRS who completed the training 4. the date training was completed 5. the CRS’s signature affirming that that he/she has understood and will implement the material

presented The PI will provide these records upon request to the Biosafety Office, IBC, or the IPRC Steering Committee.

1.2 Hand Hygiene Hand hygiene is the single most important measure to prevent infections. The IPRC bases its hand hygiene practices on the Center for Disease Control and Prevention (CDC)’s hand hygiene guidelines, which can be viewed at http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf. Hand hygiene is a general term that applies to hand washing, antiseptic handwash, antiseptic hand rub, or surgical hand antisepsis, as appropriate to the operations within the clinic or laboratory. Hand washing is a vigorous, brief (15 seconds) rubbing together of all surfaces of hands lathered with antimicrobial soap (termed “antiseptic handwash”), followed by thorough rinsing under a stream of water. Because these methods rely primarily on the surfactant properties in the detergents in combination with the rubbing to mechanically remove transient microbial flora from hands, washing hands for the

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prescribed time and paying attention to all areas of the hands (including fingernail areas and wrists) is critical for proper hand hygiene. Hand hygiene with alternative agents such as alcohol-based gels or foams (i.e., “hand antisepsis”), is an acceptable alternative under some conditions as described in this provision. To maximize the value of hand hygiene, fingernails should be maintained short (<1/4 inch long), cuticles should be groomed, and nail polish should be in good repair. Wearing artificial nails or extenders, rings with settings, and excessive jewelry should be avoided. Sinks are located in each exam room and the laboratory. Indications for Hand Washing and Hand Antisepsis: When hands are visibly dirty or contaminated with proteinaceious material or are visibly soiled with blood or other bodily fluids, wash hands with antimicrobial soap and water. If hands are not visibly soiled, use of an alcohol-based hand rub or foam, preferably containing emollients to protect from drying effects of the alcohol, is permitted. Hands must be decontaminated at the following times:

1. After entering a clinic room 2. Before putting on gloves 3. Before and after direct contact with patients/subjects 4. Before contact with equipment in the immediate subject care area 5. After contact with a patient’s intact skin (e.g., when taking a pulse or blood pressure, or lifting a

patient) 6. After contact with patient bodily fluids or excretions, mucous membranes, nonintact skin, and

wound dressings. 7. When moving from a contaminated body site (e.g., a wound), or body site more likely to be

contaminated (such as the perineal, inguinal or axillae), to clean-body sites. 8. After contact with inanimate objects (including medical equipment) in the immediate vicinity of

the patient/subject. 9. After removing gloves 10. Before departure from a clinic room 11. Before eating 12. After using a restroom (using antimicrobial soap and water, not an alcohol-based hand rub or

foam). Wearing gloves does not replace the need for hand hygiene. Gloves must be removed prior to hand hygiene procedures; gloves cannot be washed and reused. Do not wear the same pair of gloves for the care of more than one patient. Hand Hygiene Technique

1. When washing hands with anti-microbial soap and water, wet hands with water, apply the amount of product recommended by the soap manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers. Rinse hands with water and dry thoroughly with a disposable towel. Use towel to turn off the faucet. Avoid using hot water, as repeated exposure to hot water may increase the risk of dermatitis.

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2. When decontaminating hands with an alcohol-based hand foam/gel rub, apply the amount of product recommended by the soap manufacturer to palm of one hand and rub hands together, covering all surfaces of hands and fingers, until hands are dry. Do not wipe hands together after application of alcohol-based hand foam/gel rubs.

a. Institutional Biosafety Committee (IBC)-approved alcohol-based gels or foams may be used in the place of hand washing provided that the hands are not visibly soiled and the patient is not suspected to be infected with or colonized by any agents against which alcohol-based disinfectants are not effective (e.g., Clostridium difficile).

b. Alcohol-based gels or foams may be used 8-10 times consecutively before traditional hand washing with anti-microbial soap and water is required.

Approved Agents

1. All hand washing and hand antiseptic agents used in the Interdisciplinary Practice and Research Center (IPRC) will be proposed by the IPRC and must be approved by the IBC before use.

a. Interactions between products used to clean hands, skin care products, and the types of gloves used in the institution should be evaluated during selection (e.g., after use of powdered gloves, certain alcohol hand rubs may interact with the residual powder on hands, resulting in a gritty feeling on the hands; therefore, various alcohol-based hand rubs should be tested).

b. Input from the clinical and research staff (CRS) regarding the feel, fragrance and skin tolerance of any products should be provided to the IPRC Steering Committee. It is the responsibility of the IPRC Steering Committee and Principal Investigators (PIs) who use IPRC facilities to provide products which enhance hand hygiene compliance when possible.

c. Ideally, products should be efficacious and have as low irritancy potential as possible. Products containing emollients should be considered to reduce irritation to skin.

d. Any hand lotions or creams must be approved by the IBC prior to use in IPRC. Manufacturer’s information on any proposed hand lotions or creams must be provided to the IBC for evaluation of the proposed products prior to use. IPRC must ensure that these will not interact with the antimicrobial soaps or the integrity of gloves used within the facility (e.g., petroleum-based hand lotions or creams may adversely affect latex glove integrity).

2. Bar soap is not approved for use in the IPRC. 3. Dispensers for disposable containers of liquid soap, which contains anti-microbial agents, are

required adjacent to sinks in restrooms, laboratories, and clinic rooms. a. The dispenser system should function adequately and deliver an appropriate volume of

product. b. Do not add soap to a partially empty soap disperser. This practice of “topping off”

dispensers can lead to bacterial contamination of soap. 4. Antimicrobial alcohol-based gels or foams containing emollients (to protect skin from the drying

effects of alcohol) will be provided throughout the IPRC facilities. At least one dispenser should be conveniently located in every clinic room. Alcohol-based gel/foam dispensers should not be located near sinks and soap dispensers to reduce confusion with soap dispensers.

a. Because the alcohol-based antiseptic products have reduced effectiveness against some microorganisms—non-lipophilic viruses (e.g., adenovirus, rhinovirus, enterovirus), spore-forming bacteria (e.g., Clostridium difficile and Bacillus spp.), and fungi—the use of alcohol-based gel/foam products after direct contact with patients suspected of carrying these pathogens should be discouraged. Therefore, patients who are suspected of carrying microorganisms resistant to alcohol antiseptics should not be seen in the Interdisciplinary Practice and Research Center (IPRC) facilities.

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b. Alcohol-based hand rubs are flammable and should, therefore, be stored in cabinets or areas approved for flammable materials.

5. Principal Investigators (PIs) are strongly encouraged to make Institutional Biosafety Committee (IBC)-approved hand lotions or creams available to clinical and research staff (CRS) to minimize the occurrence of irritant contact dermatitis associated with hand antisepsis or hand washing in an effort to improve hand hygiene.

Inability of Clinical and Research Staff (CRS) to Wash Hands Hand washing is an essential component of a CRS’s job responsibilities. The CRS must be able to wash his/her hands and forearms appropriately. Adequate washing of hands and forearms can be impeded by prosthetic devices (e.g., casts and braces) that cannot be removed. Therefore, if a CRS is required to wear such devices, he/she is evaluated by the Georgia Regents University (GRU) Occupational Health Office (OHO) on a case by case basis to determine if the employee can participate in direct patient care or laboratory duties. If the OHO determines that the employee cannot perform direct patient duties, it will be the responsibility of the PI to decide whether or not non-patient care/non-laboratory duties can be performed by the employee. Dermatitis CRS with dermatitis related to hand hygiene or glove use are encouraged to report the problem to their supervisor and the OHO. Follow-up will vary with the severity of the dermatitis. A change in the type of hand hygiene agent and/or gloves used by the CRS may be indicated. Additionally, other measure(s) (e.g., work restrictions) may be necessary. Open wounds CRS with open wounds on the hands must ensure wounds have been properly bandaged. Responsibility Employees are responsible for following these hand hygiene procedures. Each PI using IPRC facilities is responsible for ensuring that all CRS members on the project have received and documented proper instruction on hand hygiene. The PIs are responsible for monitoring and documenting hand hygiene compliance within the IPRC. CRS are responsible for instructing patient/research subjects and their families on proper hand hygiene, when applicable. The CRS is responsible for reporting any issues which may impact hand hygiene compliance (for instance, problems with skin irritation with the products selected) to their PI and/or the IPRC Steering Committee for re-evaluation. The IPRC Steering Committee is ultimately responsible for proposing any alterations in IBC-approved hand hygiene products. The IBC is responsible for evaluating and approving any changes in approved hand hygiene products made by the IPRC Steering Committee.

1.3 Personal Protective Equipment (PPE) PIs are responsible for ensuring that the required PPE is available for all CRS in cabinets designated specifically for PPE. PPE includes gloves, gowns, masks, protective eyewear (e.g. goggles, face shields on masks, face shield visors, and prescription glasses with side shields), and shoe/hair covers (these items are necessary only when large volumes of blood or bodily substances are encountered).

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PIs will assess the type and quantity of PPE required for their specific clinical and laboratory activities, and document these on their Biosafety Protocol applications for IBC approval. The appropriate PPE is worn when the risk of contact with blood, bodily substances, or infective material is anticipated, when required based on type of Transmission Based Precautions, or while working in the laboratory with clinical specimens. The clinical and research staff (CRS) health care provider must also evaluate the need for PPE, as well as the type of PPE needed prior to initiating procedures. PPE is not to be worn in public access areas (e.g. hallways, waiting rooms, dining areas, etc.) or as otherwise required by Occupational Safety and Health Administration (OSHA). Gloves Gloving is particularly important for CRS with non-intact skin, (i.e., cuts, abrasions, skin lesions, or chapped hands). Gloves are considered a single patient use item and should be changed in between patients, or when moving from a possibly contaminated body site (e.g., perineal area) to a clean body site (e.g., face), or when glove integrity has been compromised. Hand hygiene should be performed before donning gloves and after removal of gloves. Gloves are worn only when necessary. The use of gloves as a protective substitute for hand hygiene creates a false sense of security for the CRS. This can result in improper hand hygiene and increases the risk of transmission of pathogens. Despite the use of gloves, hands can still become contaminated:

1. The growth of microorganisms already present on the hands is promoted by the warm, moist environment created when wearing gloves.

2. Hands frequently become contaminated when removing gloves. 3. Gloves may have microscopic perforations or may tear during use, allowing some penetration of

microorganisms. 4. The inappropriate and excessive use of gloves contributes to skin problems and allergies related

to glove use. Types of Gloves Permissible

1. Non-sterile latex-free gloves. These can be nitrile or vinyl gloves; however, because nitrile gloves are more durable than vinyl, they are preferable.

2. Specialty gloves, such as the heavy-duty utility gloves for environmental cleaning. Gloves are Required…

1. When there is a reasonable likelihood of contact with blood, bodily substances, secretions, excretions, mucous membranes, or non-intact skin is anticipated or when the human subject requires transmission- or disease-based precautions.

2. During all vascular access procedures, including phlebotomy. 3. When contaminated items or surfaces are handled. 4. For specific Transmission Based Precautions and during outbreak control measures.

Gloves are Not Required…

1. When in contact with intact skin (e.g., when taking a pulse) when the subject does not require transmission- or disease-based precautions.

Gloves Should Not be Worn…

1. When touching non-contaminated items such as telephone receivers, door knobs, or sink handles.

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Glove Usage

1. Gloves are donned immediately before starting a procedure or task and not sooner. This ensures that the gloves do not touch potentially contaminated surfaces before contact with the patient. Hand hygiene is performed prior to donning gloves.

2. Once donned, the outside of the gloves should be treated as if contaminated. 3. Gloves are inspected for holes, cracks or tears before starting a procedure or a task. If/when glove

integrity is compromised, gloves should be immediately changed. 4. Double gloves are used in circumstances when handling sharp instruments or when there is a

reasonable anticipation that glove integrity may be breached. 5. If torn, cut, or punctured, gloves are changed as soon as possible and hand hygiene is performed

before donning new gloves. As applicable, the offending needle or instrument is removed from the sterile field.

6. Gloves are removed immediately after use, before touching non-contaminated surfaces or other patients, and hand hygiene is performed immediately after glove removal.

7. Gloves are changed between patients, or when moving from a contaminated body site to a clean body site.

8. When wearing a gown, the cuffs of the gloves are placed over the gown cuffs. 9. Gloves, regardless of type, do not take the place of hand hygiene.

Proper Removal of Gloves Gloves are typically the final item of Personal Protective Equipment (PPE) removed (in order to protect hands during the process of removal of other soiled PPE). However, care should be taken to not touch the outside of gloves to unprotected areas during other PPE removal.

1. Grasp outside of glove with opposite gloved hand; peel off carefully, turning inside out during removal to reduce aerosolization of microorganisms which may be present on the outside of glove.

2. Hold removed glove in gloved hand. 3. Slide fingers of ungloved hand under remaining glove at wrist. 4. Peel second glove off over first glove, turning the second glove inside out during removal. 5. Discard gloves in appropriate waste container. 6. Perform hand hygiene.

Utility Gloves General purpose utility gloves (e.g., rubber household gloves) are used for housekeeping chores involving potential blood contact, equipment cleaning, and decontamination procedures. The utility gloves are decontaminated with the approved disinfectant after use. If the utility gloves are peeling, cracked, discolored, or if any punctures or tears are present, the gloves are discarded. Gowns Selecting the Appropriate Gown

1. Gowns will be used in the Interdisciplinary Practice and Research Center (IPRC) facilities. Gowns are worn when the risk of being splashed or otherwise contaminated with small amounts of infective material is anticipated (i.e. the splash is unlikely to penetrate through the gown) and as required by Standard and Transmission Based Precautions).

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2. Impervious fluid-resistant gowns are worn to ensure better protection of skin and clothing when the risk of exposure from splashing or spraying or direct contact to large quantities of blood or bodily substances exists or is anticipated (i.e. during trauma, massive gastrointestinal bleed, decontamination of instruments etc.).

3. Lab coats are used in laboratories. Once used in the laboratory, these coats will not be transferred into the clinic area.

Indication for Gown Usage

1. Gowns and protective apparel are used if a high risk of splashing or spraying or contamination by direct contact with blood or bodily substances is anticipated.

2. Gowns are worn if the patient/subject requires transmission- or disease-based precautions and the provision requires gowning.

3. All gowns and aprons are removed promptly (before leaving room or immediate work area) when contaminated with blood or bodily substances and discarded in the appropriate biohazard waste receptacles.

4. Keep the gown off the floor, touch only the inside of the gown while donning, and tie it in back. The clinical and research staff (CRS)’s clothing must be covered completely.

Proper Removal of Gowns

1. The gown should be removed before removing gloves and before leaving the clinic room. 2. Carefully unfasten ties while avoiding unprotected skin, particularly on the neck and/or around

the waist. 3. Pull away gown from neck and shoulders with gloved hands, touching only the outside of gown,

carefully turning the garment inside-out during removal. (Gown front and sleeves are contaminated).

4. Fold or roll into a bundle and discard into appropriate receptacle. 5. Continue de-gowning, and make sure to perform hand hygiene after final removal of gloves.

Masks Selecting the Appropriate Mask

1. Masks are worn to protect mucous membranes of the mouth and nose during activities which may involve aerosol generation or while working with patients who require droplet-based transmission precautions.

2. Surgical masks are available in multiple styles—form fitting cone or pleated face masks, with elastic or ties to hold the face piece in place.

3. It should be very clear that surgical masks differ from respirators. While surgical masks are protective against droplet transmission (particles > 5μm in diameter), respirators provide protection from both droplets and aerosols (particles 0.5-5μm).

a. Use of respirators by clinical and research staff (CRS) would require successful completion of a health clearance procedure through the Occupational Health Office (OHO) to maintain compliance with the Occupational Safety and Health Administration (OSHA) Respiratory Protection Standard; some styles of respirators may also require additional fit-testing.

b. Respirators are classified by their filter types. These are designated with a letter (N-, P- or R-) followed by a number (95, 99 or 100). Please see Section 4.2.1.1.6 of the GRU Biosafety Guide for further information about respirators.

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Indication for Mask Usage

1. Masks are worn during procedures that may cause the splashing or spraying of bodily substances (e.g., respiratory suctioning).

2. Surgical masks are used for Droplet Precautions. 3. Masks are removed and discarded immediately after each use. 4. Put on a mask before donning gloves and press the metal tab on the nose bridge to ensure a secure

fit. Tie in such a way that there is no venting on the sides and chin area. Proper Removal of Mask

1. Mask should be removed before final removal of gloves. 2. If the mask has ties, grasp bottom ties, then top ties or elastics and remove, being careful not to

touch unprotected areas (e.g., the neck) with the contaminated outside of the gloved hands. Once untied, or if elastic bands secure the mask in place, carefully grasp the front outside of the mask with gloved hands and remove from face, being cautious not to have contact with the outside of the mask or gloved hands with face (the front of mask/respirator is considered contaminated- do not touch with ungloved hands).

3. Discard mask in appropriate waste receptacle. 4. Continue de-gowning, and make sure to perform hand hygiene after final removal of gloves.

Protective Eyewear Selecting the Appropriate Eyewear

1. Protective eyewear, safety glasses and mask, a mask and face shield, or a face shield visor alone may be worn depending on the amount of protection required.

2. Goggles and/or masks with a fluid shield extension are permissible for use in Interdisciplinary Practice and Research Center (IPRC) patient/ subject clinic areas and laboratories when indicated.

3. If prescription glasses are used as protective eyewear, glasses with side shields are required or the prescription eyewear must be covered with safety goggles.

4. All protective eyewear must be decontaminated after patient/human subject care within the clinic room and between patients.

5. If eyewear is not being worn for protective purposes during patient/human research subject care (e.g., when prescription glasses are worn for vision correction by the CRS when caring for subjects who do not require transmission- or disease-based precautions or when splashes/sprays of bodily substances into the eyes are not anticipated), then decontamination of eyewear is not required between patients/subjects.

Indication for Protective Eyewear Usage

1. A mask and protective eyewear (e.g. glasses, goggles, or face shield) are indicated when splashing or spraying of bodily substances into eyes is possible and/or can be anticipated.

2. Put on protective eyewear after putting on mask but before donning gloves. 3. Non-disposable goggles and faceshields are removed and cleaned immediately with the

Institutional Biosafety Committee (IBC)-approved disinfectant. If contaminated with visible bodily substances, the goggles or faceshields should be cleaned and disinfected within the clinic room or disposed as biohazardous waste.

4. One-time use protective eyewear are removed and discarded.

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5. If prescription glasses are to serve as Personal Protective Equipment (PPE), the glasses are required to have side-shields.

Proper Removal of Protective Eyewear

1. The front of the protective eyewear should be considered contaminated prior to decontamination. 2. Remove disposable faceshields during mask removal, prior to glove removal. 3. All non-disposable protective eyewear should be removed after replacement of contaminated

gloves with new gloves. Once removed, protective eyewear should be disinfected using an IBC-approved disinfectant.

4. Continue de-gowning/de-gloving as described above and ensure proper hand hygiene is performed after final removal of gloves.

Shoe Covers and Hair Covers Shoe covers and hair covers should be worn if splashing or spraying of blood or bodily substances is anticipated. Shoe/Hair covers should be removed inside the clinic room, prior to the removal of gloves, and not worn into the adjacent hallways. Disposal of Personal Protective Equipment (PPE) PPE is removed upon completion of each patient contact requiring its use. It is not to be saved for reuse unless indicated (non-disposable eye protection gear, for instance). Disposal is performed in a manner that minimizes hand, skin, clothing, and environmental contact with bodily substances on PPE. Disposable PPE is discarded in biohazard waste receptacles lined with red plastic bags; non-disposable linen PPE, if worn, is placed in blue plastic fluid-resistant bags prior to removal from clinic rooms and placed in Soiled Storage (EC-1517). Hands are washed before leaving the room/area where the contact occurred. Perform hand hygiene immediately after removing all PPE and before leaving clinic room.

1.4 The Spaulding Classification System The method of disinfection or sterilization selected should be based on the type of device, how it is used, and the manufacturer’s recommendations. The Spaulding classification for medical and surgical devices outlines three categories based on the potential for the device to transmit infection if microbiologically contaminated.

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This classification system can be used for most items. If an item does not fit into the classification system or if you have any questions, contact the Biosafety Office at 1-2663. Please note, because the Interdisciplinary Practice and Research Center (IPRC) does not have the capability for intermediate or high-level disinfection or sterilization, the only semi-critical or critical medical equipment/devices which can be used in IPRC are commercially-purchased disposable equipment and devices which have documented sterility and are certified as safe for human use.

1.5 Cleaning and Disinfecting Equipment, Devices, and Environment Only non-critical medical devices or equipment (i.e., those which can be properly disinfected within the IPRC) or pre-sterilized disposable medical equipment/devices are permitted for use in the IPRC. Non-disposable equipment with disposable attachments which are designed to prevent infection transmission (such as spirometers equipped with disposable proximal filter mouthpieces to prevent cross-contamination spirometer tubing) are permitted upon approval of the Institutional Biosafety Committee (IBC), and disposable attachments must be changed between subjects. The IPRC does not have the capacity for intermediate or high-level disinfection or sterilization; therefore re-usable medical equipment/devices which require higher levels of disinfection or sterilization are not permitted for use within the facility (ICM 1.4). There is no centralized decontamination area for the IPRC. All equipment and medical devices used with patients/subjects must be capable of being fully cleaned and must be fully cleaned within the IPRC examination rooms or they must be disposed as biohazardous waste. No transport of uncleaned equipment/devices outside of the examination room will be permitted. General Cleaning Policies

1. All cleaning/disinfecting supplies must be kept in the Clean Storage room (EC-1513), which remains locked at all times.

2. Newly purchased cleaning/disinfecting supplies are stored behind items with more recent expiration dates, if applicable (i.e., stock is rotated).

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3. Cleaning agents must be compatible with the material(s) used to construct the equipment, device, or surface being cleaned and all manufacturers’ guidelines for cleaning equipment must be followed. These instructions shall be available in the area where the equipment is cleaned.

4. When soil is visible, it must be washed off using appropriate cleaning solutions (i.e., water, soap, proteolytic) before disinfecting with germicides, or the germicide will not be effective.

5. Appropriate Personal Protective Equipment (PPE) must be worn when cleaning/disinfecting (i.e., gloves, gown, and goggles). Hands must be washed after cleaning/disinfecting and removal of PPE.

6. Those who clean/disinfect cannot then serve food. Equipment Cleaning

1. All equipment must be cleaned between each patient/subject, when visibly soiled, or as specified in the provisions for transmission-based precautions or disease-specific precautions (e.g., cystic fibrosis patients).

2. All equipment leaving a patient/subject room or the Interdisciplinary Practice and Research Center (IPRC) laboratory will be cleaned.

3. Equipment designated for rooms (i.e., IV poles, infusion pumps) are cleaned by the clinical and research staff (CRS) member responsible for that patient/subject’s care in the room at the time of the patient/subject’s departure.

4. CRS will be responsible for cleaning all clinic exam tables and/or stretchers after use. A thorough cleaning should be done at least once a week, after possible contamination of the exam table or stretcher with bodily fluids or as dictated in provisions for transmission-based or disease-specific precautions.

5. All equipment must be free of tape and adhesive matter. Adhesive matter is removed with an adhesive remover. After the adhesive is removed, wipe the equipment with the IBC-approved germicide.

6. An Institutional Biosafety Committee (IBC) -approved germicide shall be used for the disinfecting of all patient care equipment. The solution must remain on the surface (i.e. the surface should be wet) for at least ten (10) minutes prior to wiping off disinfectants.

7. Germicidal wipes/cloths are used on small environmental surfaces not to exceed 3 square feet in size.

8. For areas larger than 3 square feet, a spray bottle of the germicide is used. The germicidal solution shall be sprayed on a clean cloth in an adequate amount to allow full coverage of the item, and the equipment shall be wiped down. Cleaning will begin at the highest level of the equipment working downward and from the least soiled to the most soiled areas.

9. If germicidal solution must be moved to a secondary container, label the bottle with date and time the solution is mixed. Typical germicidal solutions are only good for 24 hours after mixing. Spray bottles must be dated when use is initiated and discarded after 6 months of use. A label with the product name, manufacturer, and hazards associated with the chemical must be displayed on the bottle.

10. A clean unused cloth will be used for each piece of equipment and will be changed on the same piece of equipment when visibly soiled. A cloth used for cleaning visible soil from a piece of equipment will not be used for subsequent disinfection of the same piece of equipment.

11. For large cleaning areas, a mop or multiple cleaning cloths may be used. For all environmental cleaning, the IBC-approved germicide is used. It is preferable to purchase germicides that do not require mixing; if concentrated germicide is used, it should be mixed according to manufacturer’s directions.

12. A clean plastic bag will be placed over the equipment after cleaning if it will not be used again promptly.

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Instrument Disinfection 1. Cleaning is an absolute necessity prior to disinfecting any item. 2. All medical equipment/devices should be disinfected within the exam rooms in which they were

potentially contaminated. Used disposable medical equipment/devices shall be placed in the appropriate biohazardous waste container within the exam room after use on a human subject. If the item is capable of puncturing a bag, it should be placed in the appropriate solid-sided sharps container for disposal. Other devices and disposable Personal Protective Equipment (PPE) shall be placed in biohazardous waste containers equipped with lids in the exam rooms for disposal.

General Disinfection

1. A soiled-to-clean work flow is established. This consistent pattern of work flow separates work areas and prevents cross-contamination of supplies and equipment.

2. The following areas are listed in the order in which the areas exist in the work flow scheme: (1) receiving; (2) decontamination; (3) storage.

Low-Level Disinfection

1. Low-level disinfection is indicated for reusable, noncritical items that ordinarily do not touch the patient/subject, or contact intact skin of patients/subject who do not require contact-based transmission precautions, or do not touch the patient/subject. This includes blood pressure cuffs, stethoscopes, crutches and computers.

2. Cloths used for cleaning and containers used for holding disinfectants are laundered and cleaned, respectively, after each use.

3. Most non-disposable items require disinfection after one time use on a patient/subject or between patients/subjects. Items used for long periods of time are disinfected at least weekly.

4. Open and closed storage cabinet shelves used for patients care supplies are disinfected routinely. 5. Appropriate personal protective equipment (i.e., gown, gloves, mask, and protective eyewear) are

worn when cleaning. Hand hygiene is performed after removal of PPE. Environmental Cleaning Responsibilities The PI must contact EVS for terminal cleaning as soon as he/she becomes aware of any person entering the IPRC with a communicable disease requiring Contact- and Droplet-based Transmission Precautions. Before using the area again, the PI will get confirmation from EVS that the room has been terminally cleaned and is ready to receive patients. GRU Environmental Services (EVS) are capable of performing terminal cleans and carrying out general cleaning duties (including trash disposal, bio-hazardous waste removal, wet-mopping, and bathroom cleaning). However, EVS staff are not available to clean clinical areas immediately after use by patients/subjects, therefore the primary responsibility for cleaning the clinical areas in which patients/subjects are seen, examined, and/or provided treatments falls to the CRS working in the IPRC. If a PI is conducting clinical/research in the IPRC without CRS, the PI must conduct—or make arrangements for—the necessary cleaning procedures. The EVS staff is responsible for ensuring that clinic rooms are cleaned daily with damp mop on floor using appropriate germicidal. The sinks and clear horizontal surfaces are cleaned using IBC germicides. EVS staff will remove trash and biowaste from the clinic areas as needed; the CRS member must contact EVS at x1-2434 if any waste requires removal or if additional biowaste containers are needed.

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The following pages provide examples of the cleaning schedule and checklist to be completed for all clinical spaces used in the course of completing clinical/research activities. Blank copies of the cleaning checklist are available at the receptionist desk. The PI is responsible for ensuring the cleaning schedule is followed and will keep a record of the completed checklists. The PI will make the record available to the IPRC Steering Committee or IBC upon request.

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1.6 Storage of Medical Equipment and Devices The PI is responsible for providing and ensuring correct storage of all disposable medical equipment and devices required for conducting his/her clinical/study in the IPRC. The IPRC has a Clean Storage room (EC-1513), which remains locked at all times, and lockable cabinets in the exam rooms and laboratories, which remain unlocked. PIs whose studies will require that certain cabinets remain locked to protect supplies must request permission from the IPRC Steering Committee prior to locking the cabinets or removing any keys from the rooms. The IPRC Steering Committee will ensure that removing the requested cabinets from general use will not impair other clinicals/studies taking place in the IPRC before approving such requests. Storage of Pre-sterilized Commercial Products Only products which can be documented as sterile from the manufacturer and safe for human use will be permitted for use in the Interdisciplinary Practice and Research Center (IPRC). A product is considered sterile until some event occurs that may compromise the sterility of the product. Storage of sterile products is an event-related process. Any sterile-wrapped product is considered sterile unless:

1. The packaging is worn or damaged. 2. The packaging becomes wet. 3. The product is dropped on a contaminated surface or exposed to a potentially unsafe

environment. 4. The lock/heat seals become loose. 5. A manufacturer’s expiration date has passed.

Storage of Sterile Items

1. Sterile items are stored at least 8 inches from the floor, 18 inches from the ceiling, and 8 inches from outside walls.

2. Storage occurs in a clean, dry, and vermin-free environment with limited access. 3. Any needles and syringes shall be placed in locked cabinets within the clinical areas. 4. Storage of items on floors, window sills, within 3 feet of sinks, and areas other than designated

shelving, carts, or drawers is prohibited. Storage areas should provide protection of sterile items from environments which could compromise the package sterility.

5. Newly purchased sterile items are stored behind items with more recent expiration dates, if applicable (i.e., stock is rotated).

Responsibility for Ensuring Sterility

1. The users of the sterile packaged items assume the responsibility for rejecting items of questionable sterility.

2. Handling of items is kept to a minimum to reduce damage to the integrity of the packages. Storage of Personal Protective Equipment (PPE)

1. PPE (gowns, masks, gloves) which will be used in human subject contact must be stored in its own closed cabinets to protect it. Criteria for rejection of a sterile product should similarly apply to PPE which will used in patient/research subject contact (i.e., the PPE should be in good condition, the package and PPE integrity should be intact (it should not be worn, damaged, wet, or show evidence that it has become wet. PPE exposed to a contaminated surface or environment should never be used).

2. No other equipment/devices may be stored in the same cabinet as the unused PPE which will be used in human subject/patient care.

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1.7 Laboratory Refrigerators and Freezers The refrigerators and freezer located in the IPRC laboratory are reserved for storing medical supplies only. Refrigerator temperature is between 35° to 41° F (i.e., 2° to 5° C), and the temperature for the freezer must be at or below 32° F (-20°C). IPRC users may not adjust the refrigerator or freezer temperatures outside of this range; if a study/clinical will use supplies that must be stored at different temperatures, the PI will make arrangements to store the supplies in an appropriate facility. Supplies should be clearly labeled to show ownership, expiration date, temperature requirements, hazards, and any other pertinent information. Newly purchased supplies are stored behind items with more recent expiration dates, if applicable (i.e., stock is rotated). The PI is responsible for monitoring his/her own supplies. The PI will maintain a log to include daily temperature, variances and contaminations (and actions taken), and adjustments. The log will include signatures from the responsible PI or CRS to verify the information. The PI will retain refrigerator/freezer logs for 6 years.

1.8 Food/Beverages Small finger foods and beverages may be made available in the IPRC waiting area, work station room (EC-1504), and conference room (EC-1507). Food/beverages are not allowed in the exam rooms, laboratory, or any other space reserved for patient/subject care, medical supplies, or specimens. Alcoholic beverages, strong smelling foods, food/beverages that create hard-to-remove stains, and electric kitchen appliances (other than a coffee maker) are not allowed in the IPRC. Food/beverages cannot be stored in the refrigerators or freezer located in the IPRC laboratory. A small fridge for PI/CRS food/beverages is located in EC-1504. All food/beverages stored in the refrigerator must covered or remain in prepackaged containers. The refrigerator must be cleaned regularly or upon indication of contamination (e.g., with mold). There is no cold storage for food/beverages for patients/subjects in the IPRC. Food/beverages that do not require cold storage may be temporarily stored in EC-1504. The expiration dates of prepackaged items will be observed and the items will be disposed of when the expiration date is reached. Once food/beverage is opened and/or removed from commercial packaging, the food must be discarded after 48 hours. If there is any indication that the quality of patient/subject food/beverage may be compromised, the food/beverage should not be provided to the patient/subject. Any area where food/beverages will be served must be disinfected with the appropriate IBC-approved cleaning agent before and after food/beverages are served. The PI/CRS are required to perform hand hygiene before and after serving or consuming food/beverages, and patients/subjects should be encouraged to perform hand hygiene before and after eating/drinking. The PI/CRS will make every effort to ensure patients/subjects are not exposed to food/beverages that may cause an allergic reaction. The CRS providing food/beverages are responsible for disposing of any waste and cleaning any spills. If any suspected outbreak of foodborne illness arises from food/beverages provided to patients/subjects by the CRS, the Biosafety Office must be notified immediately.

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Chapter 2 - Bloodborne Pathogen Exposure Control Plan 2.0 General Information Objective

1. To define policies which minimize the exposure of clinical and research staff (CRS) to infectious agents, while maintaining an uncompromised level of subject care;

2. To define the standards for each procedure involving contact with bodily substances that is written or performed; and

3. The Exposure Control Plan incorporates guidelines recommended by the Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA).

Scope It is prudent to minimize all exposure to bloodborne pathogens. Risk of exposure should never be underestimated. Engineering and work place controls are initiated when possible to eliminate or minimize employee exposure to bloodborne pathogens. This policy is to protect the employee from health hazards associated with bloodborne pathogens and to provide appropriate treatment and counseling should an employee be exposed to a bloodborne pathogen. Provisions Standard Precautions are for routine use (ICM 3.0), unlike Transmission Based Precautions that are implemented when conditions which create a known risk of infection are diagnosed or likely (ICM 6.1). All CRS who have subject or blood/bodily substance/tissue contact are required to implement Standard Precautions during all routine operations. General Information

1. Direct contact, the most frequent means of acquiring an occupational infection, occurs by parenteral inoculation or by contamination of a lesion, mucous membrane, or conjunctiva with a bodily substance(s).

2. Occupational infection is prevented by the routine use of measures that place appropriate barriers between CRS and bodily substances; hence, infectious agents cannot enter the body. Bodily substances include blood, bodily fluids, tissues, secretions, and excretions from a person or animal that may contain infectious agents (i.e., organisms capable of producing infections).

3. Barrier techniques, a combination of the use of impervious physical barriers, Personal Protective Equipment (PPE), proper equipment, appropriate facilities and proper precautions and techniques collectively prevent the spread of infectious agents. These measures range from simple hand washing and "no-touch" techniques to more involved procedures. The number and types of barrier measures used are based on the likelihood that the task being performed will place the CRS in direct physical contact with bodily substances.

4. Invasive, operative, dental, or obstetric procedures where complete sterility is required are not permitted within the IPRC for the protection of both the CRS staff and research subjects/patients.

5. Appropriate personal protective equipment such as gowns, laboratory coats, gloves, masks, and protective eyewear are provided for all CRS who are required to use personal protective equipment as mandated by Standard Precautions and Transmission Based Precautions policies and procedures.

6. The Principal Investigator (PI) is responsible for providing all equipment necessary for the implementation of Standard Precautions and Droplet- and Contact-Based Transmission Precautions to prevent occupational exposures. The IPRC also requires all CRS at potential risk of exposure to blood, bodily substances, or tissues implement adhere to Standard Precautions in

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all situations as well as Transmission- or Disease-based transmission precautions when required as described in these provisions.

Standard Precautions Introduction Since medical history and examination cannot reliably identify all subjects infected with hepatitis B, hepatitis C, HIV, or other bloodborne pathogens, precautionary measures against exposure to blood and bodily substances are used consistently for all subjects. Standard Precautions apply to:

1. Blood 2. All bodily substances, secretions, and excretions (except sweat), regardless of whether or not

these substances contain visible blood 3. Nonintact skin 4. Mucous membranes 5. Unpreserved tissues

Standard Precautions apply to saliva. General infection prevention and control practices already in existence, such as the use of gloves for digital examination of mucous membranes and mask/eye protection for endotracheal suctioning, further minimizes a very minute risk, if any, for salivary transmission of bloodborne pathogens. Preventing Parenteral Exposures Safe handling of needles and sharps is the single most important practice in preventing parenteral exposure of clinical and research staff (CRS) to bloodborne pathogens. All CRS adhere to precautions…

1. to prevent injuries caused by needles, scalpel blades, or other sharp instruments or devices during procedures.

2. when cleaning instruments. 3. during disposal of needles and other sharp items. 4. when handling sharp instruments after performing procedures.

To prevent needlestick injuries, contaminated needles are not recapped, purposely bent or broken by hand, removed from the disposable syringes, or otherwise manipulated. If recapping of needles must be performed (this situation rarely occurs), recapping is accomplished through the use of a mechanical device or a one-handed scoop technique. If a subject requires multiple injections of an anesthetic or other medication from a single syringe, as occurs in dental procedures, unsheathed needles are placed in a neutral zone on a sterile gauze pad or towel between uses to avoid recapping. Furthermore, “needleless” systems should be considered (contact Georgia Regents Health System (GRHS) central supply office). A "drop-system" for disposal of sharps eliminates the dangers of recapping needles and separating sharps from syringes or instruments. After syringes and needles, scalpel blades, and other sharps are used, these items are discarded immediately in the Georgia Regents University (GRU)-provided puncture resistant sharps disposal containers. The containers are either red in color and/or labeled with a biohazard sign. Disposal of sharps in waste receptacles or leaving needles in linen is prohibited. The puncture-resistant sharps containers can be obtained from Environmental Services (EVS, 1-2434). These should be located as close as possible to the point of use, such as in each subject room. In addition, these containers are placed where the containers are readily visible and easily reached. There must be a clear line of sight to the box with no obstructions. National Institute for Occupational Safety and Health (NIOSH) standards

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and recommendations will be followed (see: http://www.cdc.gov/NIOSH/pdfs/97-111.pdf). The puncture-resistant containers used for sharps disposal are maintained upright (i.e., mounted to the wall or contained in a free-standing bracket) and not overfilled. Once 2/3 full (or reaching the “full line” marked on the container), the container is sealed and placed in the Interdisciplinary Practice and Research Center (IPRC) laboratory and EVS is alerted to pick up the container for disposal. If spillage is a possibility, the containers are placed in a second sealable, puncture-resistant container. Containers are not reopened, emptied, or cleaned manually or in any other manner which exposes CRS to the risk of parenteral injuries. Reusable sharps (e.g., re-usable needles, scissors) are not permitted for use within the IPRC as adequate decontamination and sterilization of these items are not feasible within the facility. Any item inadvertently placed in a biohazardous waste receptacle is retrieved by emptying the contents and obtaining the item using intermediary tools (e.g., tongs or forceps) to pick up the item. The item must be immediately decontaminated (ICM 1.5). Preventing Lesion, Mucous Membrane, and Conjunctival Exposures Clinical and Research Staff (CRS) with Non-intact Skin (Skin Lesions): A CRS with a minor, nonexudative, noninfected skin lesion covers the lesion with a moisture-resistant dressing (e.g., Band-Aid) before contact with any bodily substances. No CRS with exudative lesions or weeping dermatitis will be permitted to perform or assist with direct human subject/patient care or laboratory activities. Additionally, the CRS does not handle supplies, instruments, or equipment used for subject care until the condition is evaluated and cleared for these activities by the Occupational Health Office (OHO, x1-3418). The OHO will determine whether the CRS’s skin condition has resolved, and therefore no longer presents a risk for the employee’s or subject exposure, or the OHO is able to determine and counsel the CRS on appropriate barrier measures which would enable the CRS to resume activities without presenting a hazard to themselves or others. OHO clearance documentation must be provided to the CRS’s supervisor before the CRS will be permitted to resume activities. Hazardous Habits of Healthcare Workers: Habits which increase the potential for oral mucous membrane contact with bodily substances are prohibited. These habits include mouth pipetting of any bodily substance, eating, drinking, smoking, applying cosmetics or lip balm, or handling contact lenses in subject care or laboratory areas. Storage of food/drink items and utensils and eating/drinking is permitted only in the designated approved areas outside of the patient/subject care areas and laboratories (ICM 1.8). Strict attention to hand washing is required before touching any item which may be placed in one’s mouth. Other hazardous habits associated with acquisition of hepatitis B includes nail and cuticle biting. Minimizing Aerosols: All procedures and manipulations of bodily substances are performed carefully to minimize the formation of splashes, splatters, sprays, and aerosols. Operations which may be associated with additional risk of aerosols (e.g., bronchoscopy, suctioning of the respiratory tract [if not using in-line suction catheters], endotracheal intubation) in patients who are not suspected of being infected with an agent for which respiratory protection is otherwise recommended (e.g., M. tuberculosis, SARS), wear one of the following in addition to gloves and gown: a face shield that fully cover the front and sides of the face, a mask with attached shield, or a mask and goggles. Centrifuging Equipment and/or Procedures for Ensuring the Containment of Aerosols Tubes are not overfilled and are tightly capped or sealed prior to centrifuging. Safety caps are used on the centrifuge buckets to prevent aerosol exposures. After the centrifuge has completely stopped, the safety caps may be removed, and the tubes removed and moved to a bench top before carefully opening. If a tube has broken, remove the safety-capped bucket. The bucket should not be opened in the IPRC, but transferred to another lab with a Biosafety cabinet before opening. All surfaces and parts of the bucket are

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disinfected (using a freshly prepared 1:10 dilution of household bleach, and rinsed in 70% ethanol) prior to re-use. In addition, microhematocrit and laboratory centrifuges used for specimens are disinfected daily using freshly prepared (<24 hours old) 1:10 dilution of household bleach, followed by 70% ethanol when bodily substances are visible on the centrifuges. Hematocrit tubes must not be glass or must be coated to prevent glass breakage during centrifugation. Surfaces of all equipment within the laboratory or patient/research care areas is routinely decontaminated (whether or not visibly contaminated) prior to servicing or removing from the laboratory. If equipment cannot be decontaminated, a clearly visible label shall be attached to the equipment stating which portion remains contaminated. Routine decontamination of laboratory equipment and immediate decontamination of spills/tube breakages is the responsibility of the CRS who are using the equipment/ materials for their clinical/research project. Environmental Barriers If surfaces are likely to be splashed with bodily substances and are difficult or impossible to disinfect (e.g., electrical equipment), these surfaces are covered with barriers. If these barriers are visibly soiled, the barriers are removed by gloved hands, and the soiled barrier is disposed. Gloves are removed and hands washed as per the Hand Hygiene policy (ICM 1.2). The barrier is replaced on the equipment before re-use. All bins, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or bodily substances are inspected and disinfected on a regularly scheduled basis (at least once per week, unless indicated in a separate IPRC policy). These items are also cleaned and disinfected immediately when known or visible contamination occurs. The CRS using the equipment are responsible for maintaining appropriate barriers, and cleaning/disinfecting the equipment. Hand Hygiene Refer to ICM 1.2 Additional Barrier Apparel or Personal Protective Equipment Refer to ICM 1.3 Appropriate barrier apparel or personal protective equipment (PPE) is used when indicated by the procedure, (e.g., when aerosolization, spraying, or splashing of bodily substances are reasonably expected), or the subject's condition (e.g., the subject has tuberculosis). Improper use and excessive use of PPE are avoided. Gloves Refer to ICM 1.3 Gloves reduce the incidence of blood contamination of hands during phlebotomy, but gloves cannot prevent penetrating injuries caused by needles or other sharp instruments. In Standard Precautions, all blood is assumed to be potentially infective for bloodborne pathogens. Gloves are required…

1. when a reasonable likelihood of contact with blood and bodily substances exists. 2. during all vascular access procedures. 3. when contact with mucous membranes and nonintact skin occurs. 4. when contaminated items or surfaces are handled.

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The PI will ensure gloves are readily available for the CRS. Appropriate "no-touch" barriers (e.g., gauze pads and plastic forceps) are used instead of gloves when feasible. Hand hygiene is performed prior to donning gloves and after removal of gloves. Face Cover Refer to ICM 1.3 A mask and protective eyewear (e.g., glasses, goggles, or faceshield) are required when splashing or spraying of bodily substances into the mouth, nose, or eyes is reasonably expected. Routine Disinfection of Instruments, Equipment, and Work Surfaces Refer to ICM 1.4 and 1.5 Clinical and research staff (CRS) handle, clean, or disinfect instruments, equipment, and work surfaces after these items contact blood or bodily substances, after the completion of a procedure, after any blood or bodily substance spill, and immediately when surfaces have been—or are likely to have been—contaminated. The activity of disinfectants is dependent on the amount of bodily substances present on the surface to be disinfected and the time of contact. Therefore, organic materials should be removed prior to using disinfectants to promote disinfection. Gloves are used as a barrier when hands contact the disinfectants. The manufacturers’ directions for the care of equipment are followed to prevent corrosion. Laundry Soiled linen is handled carefully and with minimal agitation to prevent gross microbial contamination of the air and CRS handling the linen. Soiled linen is handled only while wearing full personal protective equipment (gown, gloves) and is held away from the body to avoid contamination of the CRS’s clothing. Before removing linen from beds or stretchers, the CRS will check for sharp objects, such as needles, accidentally left in the linen. All soiled linen is bagged in fluid-resistant bags that prevent leakage at the point of use. In the event that moisture penetrates the bag, the bag is placed inside another bag before removal from site of origin. The fluid-resistant bags are transported to and kept in laundry hampers in Soiled Storage (EC-1517). The CRS will contact Laundry Services (1-4525) to coordinate linen pick up.

2.1 Biomedical Waste All biomedical waste as defined below will be placed in the proper biomedical waste containers for safe disposal according the Occupational Safety and Health Administration (OSHA) bloodborne pathogen standard and the laws of the State of Georgia. Provisions Biomedical Waste The terms “Biomedical waste,” “Biohazardous Waste,” “Biological Waste,” and “Biowaste” are used interchangeably at IPRC to identify the following:

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Biological Waste: Biological waste is blood and blood products, exudates, secretions, suctionings, and other bodily substances and materials which may have been contaminated with these materials. These materials cannot be directly discarded into the conventional trash or into a municipal sewer system without prior decontamination. Solid biological waste is typically discarded into the biohazard waste containers for subsequent decontamination. Liquid biological wastes must be decontaminated prior to disposal. Sharps: A sharp is any discarded article that causes punctures or cuts. Such waste includes, but is not limited to, needles, syringes, broken glass, scalpel blades, razor blades, and glass Pasteur pipettes. All contaminated sharps materials are to be considered a type of biomedical waste. Pathological Waste: Pathological waste is all recognizable human or animal tissues and body parts, which are removed during surgery, obstetrical procedures, autopsy, or laboratory procedures. Cultures and Stocks of Microbial Agents: Cultures and stocks of microbial agents from research or medical and pathological analyses, wastes from the procedures with biological materials, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures. Chemotherapy Waste: Chemotherapy waste is any disposable material which has contact with cytotoxic/antineoplastic agents (agents toxic to cells) and/or antineoplastic agents (agents that inhibit or prevent growth and spread of tumors or malignant cells) during the preparation, handling, and administration of such agents. Such waste includes, but is not limited to masks, gloves, empty intravenous (IV) tubing, empty bags, empty vials, and other contaminated materials. Chemotherapy wastes must be segregated from the primary biological waste stream for disposal. Bodily Substances that are Potentially Infectious The Occupational Safety and Health Administration (OSHA) and Center for Disease Control and Prevention (CDC) consider the following substances to be potentially infectious for bloodborne pathogens:

1. blood and blood products (serum, plasma) 2. vaginal secretions 3. semen 4. synovial fluid 5. pleural fluid 6. pericardial fluid 7. peritoneal fluid 8. amniotic fluid 9. saliva indental procedures (usually mixed with blood) 10. CSF

If an item is contaminated with the aforementioned substances, treat the item as biomedical waste. Bodily Substances that are Not Usually Infectious OSHA and the CDC consider the following substances to not be a risk for transmitting bloodborne disease, unless visibly contaminated with blood

1. saliva 2. nasal secretions 3. urine 4. sweat 5. feces

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6. tears 7. vomitus

If an item only contains the aforementioned fluids and is not visibly contaminated with blood, treat the item as general waste. Sorting Waste Waste is sorted into general waste, solid biomedical waste, liquid biological waste, pathological waste, or chemotherapy waste at the point of origin. Disposing of Waste

1. Dressings that are contaminated with bodily substances are treated as biomedical waste and discarded in red bagged waste receptacles. If the dressing is soggy, it should be placed an authorized solid-sided sharps containers (e.g., the 7.5 gallon biohazard waste bucket available from EVS) for disposal.

2. Sharps are collected in the Institutional Biosafety Committee (IBC)-approved, puncture-resistant sharps disposal containers. Breakable devices containing bodily substances (e.g., laboratory clot tubes) are treated as sharps.

3. Blood and bodily substances are emptied into a drain/toilet connected to the sanitary sewer system only after disinfection. Household bleach should be added to a final concentration of 10% and allowed to remain in contact with the fluids for 30 minutes prior to disposal into the sanitary sewer system. Receptacles should then be discarded as biomedical waste.

4. Glass receptacles should not be used to contain bodily substances unless absolutely unavoidable. If used, materials inside must be decontaminated by the addition of household bleach to a final concentration of 10% and allowed to remain in contact with the fluids for 30 minutes prior to disposal of the liquids into the sanitary sewer system. The glass container should then be disposed into the Biomedical sharps container. Broken glassware is not picked up directly by hand. An intermediary such as a broom, dust pan, or forceps is used (and then disposed as biomedical waste if the glass is contaminated).

5. Cultures and stocks must be disposed in the biomedical waste containers. 6. Pathological wastes must be disposed separately from the biomedical waste. If pathological waste

is generated, the Interdisciplinary Practice and Research Center (IPRC) clinical and research staff (CRS) should seal it inside a biohazard bag or appropriate sealed solid-sided container and notify the Biosafety Office (1-2633). This waste will need to be transported to the CB building and disposed in the LAS pathological waste containers for incineration.

7. When the biomedical waste receptacles are ¾ full and ready to be picked up by EVS, the CRS should twist the top of the red bag 6-7 times and seal the bag tightly using tape. This will signify that EVS should close the box and dispose of the waste receptacle. The CRS must notify EVS (1-2434) if waste receptacles are not being removed or request immediate removal and/or when waste receptacles need to be emptied and replaced.

Disposal General waste and biomedical waste are disposed of per Georgia Regents University (GRU) policies and procedures by EVS. Waste bags are not dragged on the floor; the bags are picked up and carried. Waste receptacles are inspected and disinfected according to a regular schedule. When visible contamination of containers occurs, the containers are cleaned immediately.

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Filled biohazard waste receptacles should be transported by EVS staff to the Stericycle trailer, which is the GRU central accumulation location. This should be done as soon as possible after filling. Full boxes should remain at their point of origin until transport by EVS staff to the Stericycle trailer. Biomedical waste should not be transported within the IPRC facility and/or stored in a satellite accumulation site within IPRC. Biomedical waste boxes should only be in locations which afford protection from animals, rain and wind, or which do not provide a breeding place or a food source for insects and rodents. Public exposure to the biohazard waste boxes should be minimized. Recycling of Aluminum Cans: Departments that provide patient care are not allowed to recycle aluminum cans. These cans attract insects such as roaches and ants that can serve as vectors for pathogenic microorganisms.

2.2 Post-Exposure Provisions Any employee who has an occupational exposure to human materials (blood, blood products, human cells) or infectious materials must immediately report to the Occupational Health Office (during regular hours) or the Emergency Department (after hours) for management and follow-up. GRU students must report to the Student Health Office (during regular hours) or the Emergency Department (after hours) for management and follow-up. Patients/subjects should be transported to the Emergency Department for management and follow-up. For exposures involving employees, students, or subjects for a research study, the PI should complete Adverse Event procedures for the HAC (see “HAC Adverse Event Follow-up” below). Immediate post-exposure cleaning and procedures Any patients/research subjects or CRS who experiences a parenteral, mucous membrane, or intact skin exposure to blood or bodily substances of another person during the course of work operations at Interdisciplinary Practice and Research Center (IPRC) will receive a prompt medical evaluation and planned prompt post-exposure follow-up. If the exposed person’s intact skin contacts another person’s blood or bodily substances or other human derived materials (e.g., human cells), the exposed area is immediately washed with an Institutional Biosafety Committee (IBC)-approved antiseptic soap and water for 3 to 5 minutes. If patient’s skin is punctured (e.g.,needlestick or cut) by a device contaminated with the blood or bodily substances of another human, the area is immediately squeezed to make the area bleed and the area is washed with an IBC-approved antiseptic soap and water for 15 minutes. The area is made to continue bleeding while washing the area. If an exposed person’s eyes, nose, or mouth is splashed or sprayed with blood or a bodily substance of another person, these areas are rinsed continuously with water or sterile saline for 15 minutes. Likewise, if the exposed person has a large wound exposed, the exposed area is washed or flushed with normal saline for 15 minutes. Patient/Subject Exposure After cleaning/flushing the exposed area, an exposed patient/subject will then be immediately transported to the Georgia Regents Health System (GRHS) Emergency Department (ED) for post-exposure medical follow-up by the supervising clinical and research staff (CRS) or Principal Investigator (PI). If the patient/subject declines medical attention, the CRS or PI should obtain written refusal from the patient/subject to be kept with the patient’s file.

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The exposure incident will be reported to the Biosafety Office, who will transmit this information to the IBC and other appropriate office. The CRS's and patient's privacy will be protected. The PI on the project in which the subject was enrolled is responsible for reporting the incident and ensuring that provisions are made that the recommendations of the healthcare professional treating the subject are followed. If the study PI is unaware of the exposure, it is the responsibility of any staff member who is aware of the incident to inform the PI so that immediate notification can be sent to the Biosafety Office. Employee Exposure If an employee is exposed to human blood or bodily fluids of another or other human-derived materials, after cleaning the wound and notification of their supervisor, they should be immediately taken to the Occupational Health Office (OHO) or, if closed, to the ED, for post-exposure medical follow-up. This will include HIV, hepatitis B and hepatitis C tests and post-test counseling as deemed appropriate by the Healthcare Professional at the OHO or ED. As close to the event as it is safe to do so, the PI should complete the “Employee Report of Accident/Injury” and “Worker’s Compensation Leave Election” forms, and call the Department of Administrative Services (DOAS) at 1-877-656-7475 to report the incident. If the employee declines medical attention, the PI should complete the “Worker’s Compensation Incident Only” form and obtain written refusal from the employee to be kept on file. If an employee who previously declined medical attention would like to obtain it, the PI should complete the “Employee Report of Accident/Injury” and “Worker’s Compensation Leave Election” forms, and call the Department of Administrative Services (DOAS) at 1-877-656-7475 to report the incident. The exposure incident will be reported to the Biosafety Office, who will transmit this information to the IBC and other appropriate offices. The CRS’s privacy will be protected. The supervising PI is responsible for reporting the incident to the Biosafety Office and ensuring that provisions are made that the recommendations of the healthcare professional treating the CRS are followed. Student Exposures Student exposures are handled similarly to employee exposures, except through the Student Health Office (SHO), rather than the OHO. If the SHO is closed, the student should report to the ED for post-exposure medical follow-up. Post-exposure Medical Operations The licensed Healthcare Professional (either the OHO Physician, SHO Physician, Attending Physician in the ED or the Healthcare professional supervised by this physician) should: (1) be notified as soon as possible after the exposure has occurred; (2) counsel the patient about the exposure and HIV testing; (3) obtain and document consent for HIV testing; (3) order initial HIV testing and other serologic testing such as Hbs Ag and HCV as appropriate under the circumstances; (4) provide post-test counseling; and (5) plan medically appropriate follow-up which includes serial testing. HAC Adverse Event Follow-up Once the exposure has been addressed, the following procedures should be followed:

1. The PI must complete the Adverse Event (AE) paperwork as close to the event as possible. 2. All staff and personnel on duty when the emergency occurred need to complete an AE recall

summary prior to completion of the shift.

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3. A debriefing of the event for all participants should be conducted to ensure procedures were followed and, if not, what prevented compliance with the proper standard operating procedures. Discussion should focus on how to adapt the procedures to improve future adherence and/or operations to facilitate better emergency response.

2.3 Sharps Safety Devices The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard and the Needlestick Safety and Prevention Act clarify the need for employers to select safer alternatives to needles and sharp devices whenever possible. No one medical device is appropriate in all circumstances. The Institutional Biosafety Committee (IBC) will review injury/incident reports and based on the trending found, safety devices will be reviewed. Principal Investigators (PIs) should substitute safer sharps alternatives (such as retractable needle devices, needle-free injection technology) for sharps unless the alternatives are not appropriate for the circumstance. Documentation should be provided in the PI’s Biosafety Protocol justifying why a sharp alternative could not be used under particular circumstances. Information on sharps safety devices can be viewed at: http://www.healthsystem.virginia.edu/internet/EPINet/safetydevice.cfm and http://www.gvsafety.com/documents/Safety/NAPPSI%20Sharps%20Education%20&%20Injury%20Prevention.htm

2.4 Specimen Collection and Transport Each bodily substance specimen is placed in an intact, leakproof durable biohazard-labeled specimen container and sealed tightly (i.e., caps completely snapped or screwed into place). If the specimen container is contaminated externally with a bodily substance, the outside of the container is disinfected with a freshly prepared (<24 hours old) 1:10 dilution of household bleach and paper towels. The CRS who performed the collection is responsible for this task. If the specimen container is contaminated externally and the outside of the container cannot be disinfected, place the container in a biohazard-labeled bag and tie the bag for transport. These materials are placed in a sealed, leakproof durable secondary container prior to transport outside of the patient care area or laboratory. Supplies which could potentially become soiled with bodily substances (e.g., tourniquet, vacutainer holder) are disposed. The biohazard-labeled secondary container is used to transport specimens to avoid accidental breakage. Gloves are not worn to transport specimens. Upon delivery of a specimen to the receiving area, hands are washed at the designated laboratory sink. Each CRS who handles the specimen container and requisition form has the right and responsibility to refuse to handle the container if the container is improperly sealed or contaminated externally. The CRS who collected the specimen is responsible for correcting such problems. If a specimen container is leaking, the sample is transferred to a new container if possible or a new specimen is obtained. If these possibilities are not feasible, the specimen container is placed in a well-tied, biohazard-labeled bag to avoid contamination of individuals and the environment. Any specimens (e.g., blood, bodily substances, tissue specimens, infectious waste, etc.) transported outside the Interdisciplinary Practice and Research Center (IPRC) are labeled with a biohazard sign and emergency contact information on the outside of the secondary container. Any specimen testing such as capillary glucose levels, hemocults, gastric pHs, urine dipsticks, etc. are conducted in the exam rooms, or are transported to the IPRC laboratory using containment procedures described, above. Any biological materials (e.g., blood, bodily substances, tissue specimens, infectious waste, etc.) or other potentially hazardous material (e.g., dry ice or liquid nitrogen) as defined by the Department of Transportation (DOT) which will be transported via public roads, extramurally, or shipped, will be done according to

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federal regulations. These operations will be done only by personnel who have received the required training as per federal regulations and Georgia Regents University (GRU) Policies and any required permits for transport/shipping will be the responsibility of the PI to obtain prior to shipping/transporting.

2.5 Spills Biohazardous Spills (potentially infectious) Spills are subdivided into small spills (less than 500 ml) and large spills (greater than or equal to 500 ml). It is the responsibility of the clinical and research staff (CRS) to clean or ensure all spills are cleaned inside the Interdisciplinary Practice and Research Center (IPRC) clinic and laboratory areas. Environmental Health and Safety Services (EH&S) (1-2663) will assist in spill clean-up and it is recommended that they be called to assist in large spill clean-up. Any spill outside of the IPRC laboratory or clinic rooms must be reported immediately to EH&S for clean-up. The appropriate solutions, materials, and equipment used for the cleaning of bodily substances should be easily available as a biohazard spill kit within easy access in the IPRC clinic and laboratory facilities. It is the responsibility of the PIs to ensure that the spill kit has been compiled and maintained, which should contain the following materials:

1. Personal Protection Equipment (PPE) required for handling spills (gloves, disposable lab coat, eye protection, shoe covers, etc.)

2. Mechanical devices for handling objects (forceps, tongs, and/or disposable dustpan/broom) 3. IBC-approved disinfectant (if using bleach, undiluted bleach and water bottle for immediate

dilution is recommended. The undiluted bleach in the spill kit should be replaced routinely—at least annually). A device for application of disinfectant (e.g., spray bottle) should also be considered for inclusion in the spill kit.

4. Absorbent materials (paper towels, diapers, disposable terry shop towels) 5. Biohazard waste bags for disposing used absorbent materials/contaminated materials. 6. Signage to restrict others from walking through potentially contaminated areas.

For spills which occur within IPRC clinic rooms or laboratory:

1. If aerosols are a concern, evacuate all personnel from the room and close the door for 30 minutes to allow aerosols to settle before attempting to clean the spill.

2. The CRS should immediately assess whether any person has been exposed/contaminated by the bodily substances. If this has occurred, the ICM 2.2 Post-Exposure Provisions should be followed.

3. While addressing any health issues, measures should be taken to ensure that personnel are restricted from the area of the spill to prevent tracking of the contamination to other areas. CRS should post spill signs to alert others to avoid contamination.

4. The Principal Investigator (PI) should be notified that a spill has occurred as soon as possible. 5. The CRS should put on appropriate PPE (e.g. disposable face mask and protective eyewear if

splashing of fluids is anticipated). 6. The CRS responsible for cleaning the spill should use the spill kit materials to clean the spill.

They should identify the potentially contaminated area and items that will require disinfection. The area should first be cleaned of organic material, and objects (tubes, needles) which may be in the spill area should be picked up using mechanical devices and disposed as biowaste prior to disinfection. Any object which cannot be adequately surface decontaminated (e.g., cardboard boxes) will be disposed as biohazardous waste.

7. All spills of bodily substances are cleaned/disinfected using the Institutional Biosafety Committee (IBC)-approved detergent with water followed by disinfectant or a 1:10 solution of sodium

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hypochlorite (i.e., household bleach). The sodium hypochlorite solution must be mixed daily or a stabilized bleach alternative (e.g., Bleach-Rite®) must be used prior to its expiration date as indicated by the manufacturer.

8. The CRS then covers the spill with copious absorbent material (e.g. paper towels) to absorb the spill as best as possible. Sufficient IBC-approved disinfectant or freshly diluted bleach is then poured over the contaminated absorbent materials (moving from the outside of the spill toward the center of the spill) to fully saturate the area underneath with disinfectant.

9. Allow for at least 30 minutes contact time of the disinfectant with the spill. Afterwards, remove the absorbent material/paper towels and dispose of them as biohazardous waste.

10. Wash the area with 70% ethanol, or water if bleach was used, to remove disinfectant residues. 11. The CRS is also responsible for removing soiled linen from the patient room and disposing of all

waste (e.g. paper drapes, paper products) as appropriate. When equipment and work surfaces (e.g. DEXA machines and laboratory counters) are involved, the CRS will ensure environmental cleaning of these areas as well.

12. Remove Personal Protection Equipment (PPE) and perform hand hygiene. 13. The PI will keep a report of the spill in his/her records. If any exposures occurred, these must be

reported to the Biosafety Office as per the ICM 2.2 Post-Exposure Provisions. For spills occurring outside the IPRC clinic rooms or laboratory, or a large bodily substance spill (>500ml):

1. If aerosols are a concern, evacuate all personnel from the room and close the door for 30 minutes to allow aerosols to settle before attempting to clean the spill.

2. The CRS should immediately assess whether any person has been exposed/contaminated by the bodily substances. If this has occurred, the ICM 2.2 Post-Exposure Provisions should be followed.

3. While addressing any health issues, measures should be taken to ensure that personnel are restricted from the area of the spill to prevent tracking of the contamination to other areas. CRS should post spill signs to alert others to avoid contamination.

4. The Principal Investigator (PI) should be notified that a spill has occurred as soon as possible. 5. Contact Environmental Health and Safety (EH&S) (1-2663) for assistance in spill clean-up. 6. The CRS should put on appropriate PPE (e.g. disposable face mask and protective eyewear if

splashing of fluids is anticipated). 7. The CRS should cover the spill with copious absorbent material to prevent further spreading of

the liquids which may be present. 8. EH&S staff will direct cleaning the spill. The CRS will remain in the area to assist in these efforts

if necessary. 9. The CRS is also responsible for ensuring for removing soiled linen from the patient room and

disposing of all waste (e.g. paper drapes, paper products) as appropriate. When equipment and work surfaces (e.g. DEXA machines and laboratory counters) are involved, the CRS will ensure environmental cleaning of these areas, as well.

10. Remove Personal Protection Equipment (PPE) and perform hand hygiene. 11. The PI will keep a report of the spill in his/her records. If any exposures occurred, these must be

reported to the Biosafety Office as per the ICM 2.2 Post-Exposure Provisions. Massive Bodily Substance Spills: If a massive bodily substance spill occurs, follow all of the above steps, plus fluid-resistant shoe covers are used when cleaning/disinfecting massive bodily substance spills. Gloves are worn to remove the contaminated shoe covers after completing the task. Hand hygiene is performed after glove removal.

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Chemical Spills EH&S can clean blood/bodily fluid spills, but not chemical spills. In the event of a chemical spill during regular business hours (8:00AM-5:00PM Monday through Friday) the IPRC users should contact Chemical Safety (1-2663), otherwise the IPRC should contact Public Safety (1-2911).

2.6 Health Screenings and Vaccinations It is the responsibility of the PI to provide ensure all CRS and students have completed their annual health screenings and vaccinations as per usual procedure prior to assignment to working where he/she may encounter human materials (blood, blood products, human cells) and infectious material during the course of job duties, at no cost to the CRS or student. Short-Term Infectious Diseases CRS who may carry short-term infectious diseases (e.g., seasonal influenza) are discouraged from patient/research contact during the period in which they may transmit their infections to Interdisciplinary Practice and Research Center (IPRC) subjects. Principal Investigators (PIs) are encouraged to temporarily reassign the ill CRS’s duties which involve patient/ subject contact to another CRS during the infectious periods. Alternatively, strict Contact- and Droplet-based Transmission Precautions should be employed during operations involving potential patient/subject contact to minimize the risks of inadvertent transmission of these illnesses. TB Exposure Prevention Program

1. Any patient/subject with suspected tuberculosis (or other infections transmitted via airborne routes) will be excluded from the IPRC facilities. IPRC has no facilities to permit adherence to Airborne Transmission-based Precautions.

2. Any CRS exhibiting signs and symptoms compatible with tuberculosis are to report to the OHO for prompt evaluation. CRS members do not return to work until tuberculosis is excluded or the CRS is on therapy and is noninfectious, based on the resolution of symptoms and 3 consecutive negative sputum AFB concentrated smears. Consultation with the Biosafety Officer and Human Resources is necessary for the CRS to return to work. The CRS must remain on effective drug therapy for the appropriate time. If the CRS does not continue prescribed therapy, s/he is excluded from work until treatment is resumed and an evaluation for non-infectiousness and consultation with the Occupational Health Office (OHO), the Biosafety Officer and Human Resources has occurred.

3. All clinical and research staff (CRS) members with newly discovered positive PPD test conversion are evaluated by the Occupational Health Nurse and Medical Director of Employee Health and are referred to the Richmond County Health Department for further evaluation and testing.

4. When conversions are identified, other CRS members assigned to the same work area or groups are retested to determine if evidence of excessive transmission exists. Retesting is done no sooner than 10 weeks after the last exposure. If a recent baseline PPD skin test is not available, an initial baseline is done first. Results of the PPD skin test are recorded in the CRS member’s Employee Health record and listed with other CRS results so that periodically an analysis for the risk in areas or groups can be done.

5. The testing for newly discovered positive PPD Tests includes a history and physical to determine if any signs or symptoms of active tuberculosis are present and a chest x-ray. CRS without active tuberculosis are considered for treatment of latent tuberculosis infection with isoniazid. CRS with an active case of tuberculosis are treated according to current CDC and ATS guidelines.

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6. A history of possible exposure to tuberculosis is obtained and the drug susceptibility patterns are used when the source is identified to determine the appropriate preventive therapy. This practice will become more important if/when multidrug-resistant cases of tuberculosis are identified in the community and/or among the subject populations.

7. All CRS receive education about tuberculosis as appropriate to their job duties. This training is the responsibility of the Principal Investigator (PI) supervisors, and documentation of this education should be maintained by the PI.

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2.7 Approved Antiseptics, Disinfectants, Cleaning Agents, and Skin Products

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Chapter 3 – Precautions

3.1 Standard Precautions Interdisciplinary Practice and Research Center (IPRC) personnel will follow Standard Precautions for the care of and handling of specimens from all patients (or human subjects), in which they assume that every person is potentially infected or colonized with an organism that could be transmitted in the healthcare setting, regardless of each patient’s diagnosis or presumed infection status. Standard Precautions apply to (1) blood; (2) all bodily substances, secretions, and excretions (except sweat), regardless of whether or not the substances contain visible blood; (3) nonintact skin; (4) mucous membranes; and (5) unpreserved tissues. These standards also apply to equipment or items in the patient environment likely to have been contaminated with infectious bodily substances. Standard Precautions are designed to reduce the risk of transmitting microorganisms from both recognized and unrecognized sources of infection in hospitals. Further information about Standard Precautions can be found at: http://www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html. (Please note: for the purpose of the IPRC policies and provisions, the terms “patients” and “subjects” may be used interchangeably). Scope This provision applies to all IPRC personnel and all contract services who have contact with human subjects and subject testing equipment. Provisions 1. Hand Hygiene Refer to ICM 1.2 2. Gloves Refer to ICM 1.3 3. Masks, Protective Eyewear, and/or Fluid shields Refer to ICM 1.3 4. Gowns and Coats Refer to ICM 1.3 5. Human Subject Care Equipment soiled with blood, bodily substances, secretions, and excretions is handled in a manner that prevents skin and mucous membrane exposures, contamination of clothing, and the transfer of microorganisms to other patients or the environment. Reusable equipment will not be used on another subject until the equipment has been cleaned and disinfected appropriately (ICM 1.1 and 1.2). Single-use items will be discarded properly and not re-used (ICM 2.1). Equipment will be decontaminated within the patient care room using approved procedures (ICM 1.1 and 1.2) prior to removal from the room. Organic material will be removed from the equipment prior to the use of disinfectants to enable effective disinfection. Personal Protective Equipment (PPE-gloves, gown) will be used when handling and cleaning soiled equipment and the proper degowning and hand hygiene procedures will be followed as described above. 6. Environmental Control: Environmental surfaces, chairs and surfaces in the examination rooms, and other frequently touched surfaces (e.g., doorknobs, computer keyboards, tables in the exam rooms) will be maintained, cleaned, and disinfected at least once per day or after they have become visibly contaminated with blood, bodily substances, secretions, and excretions (ICM 1.1 and 1.2). Examination tables will be cleaned and decontaminated between each patient if there is either a possibility of it having been in contact with the patient’s skin or if it has become contaminated with blood, bodily substances, secretions, and excretions.

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If child play toys are maintained for shared use in the facility, these should be easily cleaned and disinfected (i.e., they should not be made of cloth or other porous or unsealed organic materials). Stuffed furry toys are not permitted for shared use. Large stationary toys (e.g., climbing equipment) should be cleaned and disinfected at least weekly and immediately whenever visibly soiled. If toys are likely to be mouthed, rinse with water after disinfection or, alternatively, wash it in a dishwasher. 7. Linens and other re-usable textiles (e.g., lab coats) (ICM 1.3) 8. Respiratory Hygiene and Cough Etiquette are source control measures to contain respiratory secretions and prevent droplet and fomite transmission of respiratory pathogens, especially during seasonal outbreaks of viral respiratory tract infections. Signs are posted at points of entry in both the ambulatory and laboratory setting to instruct individuals arriving with respiratory symptoms to cover their mouths and noses when coughing and/or sneezing, dispose of tissues after use, and perform hand hygiene after hands have been in contact with respiratory secretions. Tissues in notouch receptacles will be provided at the point of entry along with appropriate means of disposal. Resources and instructions for performing hand hygiene will be readily accessible in the waiting area and patient care/clinical research areas along with conveniently placed dispensers of alcohol based hand products. Soap and paper towels will be available where sinks are located. During times of increased respiratory infections in the community, masks will be offered to all symptomatic (coughing) individuals upon entry into the common waiting area. These individuals should be encouraged to maintain a distance of at least three feet from others while in common waiting areas. 9. Safe injection practices will be followed when using needles, cannulas that replace needles and, where applicable, intravenous delivery systems. Aseptic technique will be used to avoid contamination of sterile injection equipment. Medications will not be administered from a syringe to multiple patients, even if the needle or cannula on the syringe is changed. Needles, cannulae and syringes are sterile, single-use items; they should not be reused for another patient nor to access a medication or solution that might be used for a subsequent patient. Fluid infusion and administration sets (i.e., intravenous bags, tubing and connectors) will be used only for one patient and will be disposed appropriately after use (see IPRC 2.1). A syringe or needle/cannula is considered contaminated once it has been used to enter or connect to a patient’s intravenous infusion bag or administration set. Single-dose vials will be used for parenteral medications whenever possible. Medications from single-dose vials or ampules will not be administered to multiple patients. Leftover contents of single-dose vials will not be combined for later use. The use of multidose vials is highly discouraged, but if used, both the needle or cannula and syringe used to access the multidose vial must be sterile. Multidose vials must not be kept in the immediate patient treatment area and must be stored in accordance with the manufacturer’s recommendations. All medications will be discarded if the sterility is compromised or questionable. Bags or bottles of intravenous solutions will not be used as a common source of supply for multiple patients. All needles and syringes in the IPRC must be kept in locked cabinets or rooms which are inaccessible to the patients/research subjects or guests and the general public. Only authorized clinical and research staff (CRS) are permitted access to needles and syringes. All treatments to be provided to human subjects will be dispensed through the Georgia Regents Health System (GRHS) Research Pharmacy and will be transported to IPRC in a manner to maintain its sterility and integrity. If extra medication(s) remain after administration the patient/research subjects, this must be returned to the GRHS Research in a manner to maintain its integrity.

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Responsibility Principal Investigators (PIs) are responsible for education and will monitor compliance with these standards. The cleaning/disinfection of equipment and environmental surfaces within the patient/subject care areas is the responsibility of the coordinator overseeing that subject. 3.1 Contact and Droplet Transmission-Based Precautions Patients/research subjects who require contact and/or droplet precautions should not be included in IPRC activities. If the PI becomes aware of a patient/subject who requires contact and/or droplet precautions, the subject/patient should be dismissed from the IPRC, and the PI will contact EVS for a terminal cleaning of the areas that had contact with the subject/patient.

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Chapter 4 - Infections: Prevention and Control 4.0 Clinical Syndromes or Conditions Warranting Additional Empiric Precautions

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4.1 Cystic Fibrosis Disease-based Precautions To ensure that proper infection prevention and control measures are in place to minimize the risk of transmission of pathogenic organisms among cystic fibrosis (CF) patients in the Interdisciplinary Practice and Research Center (IPRC) setting, special disease-based transmission precautions are required. Rationale There has been a shift in the delivery of care of cystic fibrosis patients from the inpatient setting to ambulatory care. In addition to this shift in the delivery of care, the life expectancy of cystic fibrosis patients has increased. CF patients receive repeated courses of antimicrobial agents, administered orally, by aerosolization, and intravenously, which may lead to increasing antimicrobial resistance and the emergence of multidrug-resistant organisms among patients with CF. These changes coupled with the fact that the symptoms of cystic fibrosis may be greatly exacerbated by infection some organisms not generally considered pathogenic to healthy patients and increasing patient-to-patient transmission of pathogens among the CF patient population warrant expanded infection control guidelines for preventing infections among this patient population. (These provisions are based on the recommendations of the U.S. CF Foundation for infection control practices as reviewed in Saiman L and Diegel J (2004) Clin, Microbiol. Rev. 17: 57-71). Scope The following guidelines apply to the care of all cystic fibrosis patients in the IPRC setting. A. General Principles 1. Standard precautions, transmission-based precautions, appropriate hand hygiene for clinical and research staff (CRS), CF patients/subjects and their families, and the care of respiratory tract equipment serve as the foundations for infection control and acquisition of potential pathogens by patients with CF. 2. Assume all cystic fibrosis patients may have transmissible pathogens as a Standard Precaution. CRS must recognize that respiratory secretions of all CF patients potentially harbor clinically and epidemiologically important microorganisms, even if they have not yet been detected in cultures from the respiratory tract. Such secretions can transmit infectious agents to other CF patients. Therefore, CRS must use appropriate precautions when working with CF patients to prevent patient-to-patient transmission of pathogens. 3. CRS should recognize the most common clinically and epidemiologically important microorganisms which can infect/colonize CF patients. The CRS should be familiar with their mode of transmission and the transmission-based precautions which must be followed if patients with documented or suspected infection with these highly transmissible or epidemiologically important infectious agents (that may require additional precautions to prevent transmission) are seen in the IPRC. Examples or organisms requiring transmission based precautions are shown in Table 1. 4. CRS should take measures to educate CF patients to avoid risk factors associated with transmission of organisms, including:

Direct contact with infected secretions (e.g., during kissing) Indirect contact with infected secretions (sharing respiratory equipment, drinking from the same

glass as another CF patient, or shaking hand with someone whose hands are contaminated with secretions)

Contact with droplets (inspiration of large infectious particles that are spread by coughing, sneezing, or singing that can be inspired within 3 ft of an infected patient).

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B. STANDARD PRECAUTIONS Standard Precautions (ICM 3.0) should be followed, especially: 1. Hand Hygiene a. Employees: Refer to ICM 1.2 b. Patients: Instruct patients on the importance of performing hand hygiene. Hand hygiene should be performed routinely, before and after airway clearance, when hands are contaminated with respiratory secretions, after toileting, and before donning and upon removal of masks, gloves, and/or gowns. Alcohol foam may be used if hands are not visibly soiled. Instruct patients to wash their hands and wear a mask whenever they leave their room/treatment room. Masks must be changed when they become moist or soiled. Patients three years of age or less who are not capable of keeping on a mask will not be required to wear a mask unless they are on transmission-based precautions. Instruct the patient to cough into tissues and dispose of the tissues in a waste receptacle immediately when performing specimen collection or airway clearance (whether assisted or not). c. Others: Instruct others, e.g., family members and visitors, to perform hand hygiene before coming in to contact with the patient. 2. Personal Protective Equipment (PPE): a. Employees: Refer to ICM 1.3 b. Patients: Wear a mask whenever they leave their room/treatment room. Masks must be changed when they become moist or soiled. Patients three years of age or less who are not capable of keeping on a mask will not be required to wear a mask unless they are on transmission-based precautions. Instruct the patient to cough into tissues and dispose of the tissues in a waste receptacle immediately when performing specimen collection or airway clearance (whether assisted or not). 3. Environmental Controls: Cleaning/disinfection of the facilities and surfaces and maintenance of the facilities within the patient areas is critical, since CF patient conditions may be aggravated by dusts or molds (most commonly, Aspergillus spp.). Dust production and accumulation must be kept minimal and routine facility cleaning must be followed (ICM 1.5). As water leaks may foster mold growth, any water leaks, soiled ceiling tiles or suspected mold accumulation within the CF care facility must be reported immediately to Environmental Health & Safety (EH&S, x1-2663) and to Facilities Management (1-2434)

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for evaluation and immediate repair. Clinical and research staff (CRS) should avoid exposing CF patients to any areas in which mold is suspected until the space is evaluated and mold, if present, is removed and the area fully disinfected (ICM 1.1 and 1.2). 4. Care of Respiratory Equipment: Devices used for respiratory therapy (e.g., nebulizers), diagnostic evaluation (e.g., bronchoscopes or spirometers), or treatment (medication vials) may be reservoirs or vehicles for the transmission of infectious organisms. Transmission may be due to a contaminated device itself or may occur from patient to patient via a contaminated device or from one body site to the respiratory tract of the same patient. Therefore, special care should be taken to avoid such transmission. Because IPRC does not have facilities with which to decontaminate re-usable equipment, subjects requiring nebulizers will bring their own and be responsible for decontamination of the unit as instructed by their health care providers. The only other permissible respiratory equipment permitted in the IPRC facility are those which may be used only by a single patient and disposed afterwards, or have disposable, filtered mouthpieces attachments which prevent contamination of the non-disposable equipment parts (e.g., disposable mouthpieces for flow-gated spirometers which are equipped with HEPA filters to prevent contamination of tubing and metal pneumotacometer parts). Non-disposable parts of these flow-gated spirometers (or similarly protected respiratory devices) should be cleaned and decontaminated between patients/research subjects (ICM 1.1 and 1.2) after use by CF patients/research subjects. C. TRANSMISSION-BASED PRECAUTIONS CF patients/subjects with known transmissible diseases should not be included in IPRC activities. If the PI becomes aware of a patient/subject with a transmissible condition, the subject/patient should be dismissed from the IPRC, and the PI will contact EVS for a terminal cleaning of the areas that had contact with the subject/patient. D. Interdisciplinary Practice and Research Center (IPRC) setting participation management 1. IPRC Area Logistics Patients will be scheduled and managed in an effort to minimize time in common waiting areas. Management will include a staggered clinical schedule to reduce the likelihood that CF patients will need to share the waiting room, and keeping one CF patient in one exam room while the research/clinical team rotates through the rooms. 2. IPRC Subject Waiting Areas a. Patients and family members will be instructed to perform proper hand hygiene upon arrival to the

clinic and throughout their clinic visit. Alcohol foam will be made available to patients and family members.

b. Masks will be provided for all CF patients upon check-in to IPRC, and the CF patient is required to wear the mask when in common areas such as the waiting rooms, hallways, etc. Masks must be changed when they become moist or soiled. Patients three years of age or less who are not capable of keeping on a mask will not be required to wear a mask unless they are on transmission-based precautions.

c. Patients will be asked to follow respiratory etiquette throughout their clinic visit. Respiratory etiquette includes asking individuals to cover their mouths and noses when coughing and/or sneezing, disposing of tissues after use, and then performing hand hygiene. Tissues in no-touch receptacles should be provided at the point of entry along with appropriate means of disposal. Resources and instructions for performing hand hygiene should be readily available.

d. Physical contact among cystic fibrosis patients will be discouraged. e. All respiratory procedures, including pulmonary function tests (PFTs), should be performed with no

other patients present in the patient’s room. f. Respiratory equipment (e.g., nebulizers) which is not disposable or designed to have disposable

protective devices to protect the non-disposable components from contamination (such as disposable

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mouthpieces on flow-gated spirometers equipped with HEPA filters) are not permitted within the IPRC facility, because IPRC is not equipped with sufficient decontamination/disinfection facilities. Patients/research subjects may bring in their own nebulizers for use on projects; however, the clinical and research staff (CRS) should make very clear that this equipment must be properly decontaminated by the patient/research subject following the guidelines provided them by their healthcare provider at home. CRS should not take responsibility for cleaning/decontaminating the patient’s personal respiratory equipment (e.g., nebulizers).

3. Other Infection Prevention and Control Measures for IPRC Subject Areas a. Standard precautions apply to all patients. b. Use Table 1, above, as a quick reference for those most common organisms which require precautions

for CF patients. Refer to Georgia Regents Health System’s (GRHS) Infection Control Manual (ICM) policies, Alphabetical Disease/Organism Listing for Transmission-Based Precautions http://www.hi.GRU.edu/hep/policies/ICM6_1.pdf, for a reference for organisms not listed in Table 1, or contact the Biosafety Office (1-2663) for assistance to determine whether additional Transmission-Based Precautions are warranted.

c. Exam/Testing rooms should be thoroughly cleaned between CF patients. The sheet (paper or linen) covering the exam table should be removed and properly disposed of once a patient has been discharged. All horizontal surfaces, including the exam table, should be cleaned with a freshly prepared (<24 hours) 1:10 dilution of household bleach between patients.

Responsibility CRS caring for cystic fibrosis patients/research subjects must adhere to these provisions.