BLOODBORNE EXPOSURE CONTROL PLAN

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Subject: BLOODBORNE EXPOSURE CONTROL PLAN Recommended: Section: Infection Control Application: System Wide Contact Person: Infection Control Approved: Policy Number: Page: 1 of 14 Date of Issue: May 2009 Supersedes: May 2008 Signed Original on File Chairman, Infection Control Committee Signed Original on File President, Professional Staff Signed Original on File Linda S. Chappell Senior Vice President, Quality Management Source of Policy: Regulatory Occupational Safety and Health Administration (OSHA) Signed Original on File Rick W. Merrill President and Chief Executive Officer Review: Initial/Date POLICY It is the policy of Cook Children's Health Care System (CCHCS) to comply with "OSHA's Final Standard on Occupational Exposure to Bloodborne Pathogens," as published by the Occupational Safety and Health Administration (OSHA) in the Federal Register. This policy will be reviewed annually. As part of the annual review, the attachment will be updated to reflect changes in technology, and to document consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure. SCOPE This policy applies to all CCHCS employees, medical/dental staff, contract employees, or volunteers who have occupational exposure to blood or other potentially infectious material. PURPOSE To prevent occupational exposure to bloodborne pathogens. DEFINITIONS Blood - Human blood, human blood components, and products made from human blood. Bloodborne Pathogens - Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Clinical Laboratory - A workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.

Bloodborne Pathogen Exposure Control Plan Page 2 of 14 Contaminated - The presence or the reasonably anticipated presence of blood or other potentially infectious materials. Contaminated Laundry - Laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. Contaminated Sharps - Any contaminated object that can penetrate the skin including, but not limited to needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. Decontaminated - The use of physical or chemical means to remove, inactivate, or destroy Bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use or disposal. Engineering Controls - Controls (e.g., sharps containers, etc.) that isolate or remove the bloodborne pathogen hazard from the workplace. Examples: safer medical devices, such as sharps with engineered sharps injury protection and needleless systems. This also includes blunt suture needles, plastic, or mylar wrapped capillary tubes. Exposure Incident - An exposure incident is defined as a specific eye, mouth, or other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious material that results from the performance of an employee's duties. Exposure Prone - Any procedure or task that would by its nature have a probability of endangering a health care worker by blood or other potentially infectious material. Hand Washing Facility - A facility providing an adequate supply of running potable water, soap, and single use towels or hot air drying machines. HBV - Hepatitis B virus. HCV - Hepatitis C virus. HIV - Human immunodeficiency virus. Needleless Systems - A device that does not use needles for: A. The collection of fluids or withdrawal of body fluids after initial venous or arterial access is established; B. The administration of medication or fluids; or C. Any other procedure involving the potential of occupational exposure to bloodborne pathogens due to percutaneous injuries for contaminated sharps. Occupational Exposure - Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Parenteral - Piercing mucous membranes or the skin barrier through such events as needle sticks, human bites, cuts, and abrasions. Personal Protective Equipment (PPE) - Specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts, or blouses) are not intended to function as protection against a hazard and are not considered to be personal protective equipment.

Bloodborne Pathogen Exposure Control Plan Page 3 of 14 Potentially Infectious Materials A. Includes blood and human body fluids including semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and any and all bloody fluids in situations where it is difficult or impossible to differentiate between body fluids. B. Any unfixed tissue or organ (other than intact skin) from a human (living or dead). Regulated Waste - Liquid or semi-liquid blood or other potentially infectious materials, contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed, items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling, contaminated sharps, and pathological and microbiological wastes containing blood or other potentially infectious materials. Liquid waste which has been treated with a solidifier is not considered regulated waste. Sharps with Engineered Sharps Injury Protections - A non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medication or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. This includes syringes with a sliding sheath that shields the attached needle after use; needles that retract into a syringe after use. Source Individual - Any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Sterilize - The use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. Universal/Standard Precautions - A concept that all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens. Work Practice Controls - Controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping needles by a two-handed technique). PROCEDURE A. Exposure Determination - A list of job categories within each department or division of all employees who have a reasonable likelihood of occupational exposure during the performance of their assigned duties without regard to the use of personal protective equipment will be compiled and maintained by the Human Resources department. B. Engineering and Safe Work Practices will be used to eliminate or minimize employee exposure. 1. Universal/Standard Precautions are used throughout CCHCS to prevent contact with blood and other potentially infectious materials to reduce the risk of occupational exposure (refer to CCHCS policy IC 500 Universal Standard Precautions). 2. Hand washing facilities are available to all employees. a. An approved alcohol hand gel or approved hand soap may be used, based on the level of contamination and/or on the procedure/task to be performed. b. Employees are to perform hand hygiene immediately after removal of gloves. c. Hands are to be washed with soap and water immediately following contact with blood and/or body substances. Hand hygiene is to occur before and after every patient contact.

Bloodborne Exposure Control Plan Page 4 of 14 d. In areas where running water is not available, a substitute hand cleaner is provided. Refer to CCHH policy INF 102 or CCMC policy IN 15- Hand Hygiene for additional information. C. Work Area Guidelines 1. Eating or drinking are only permitted in designated areas, which will be maintained separate from contaminated areas. 2. Food and drink are not to be kept in refrigerators, freezers, shelves, and cabinets or on countertops or bench tops where blood or body substances are present. 3. Applying cosmetics or lip balm and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. D. Handling of Contaminated Sharps 1. Sharps will be disposed of in sharps containers that are readily recognized, accessible in every work area, are closable, puncture-resistant and leak proof on the sides and bottom and labeled with a biohazard label. 2. The following procedures are PROHIBITED: a. Removal of contaminated needles from syringes by hand. b. Bending, shearing, or breaking of contaminated needles. c. Recapping of contaminated needles using a two-handed technique. d. When situations or procedures occur where recapping is unavoidable, a mechanical recapping device or a safe one-handed recapping technique will be used, such as: i. Recapping of contaminated needles using a one-handed technique. ii. iii. iv. On the Psychiatric unit where sharps containers are not readily available because of the patient safety issue. Some blood gas sampling equipment and vacutainers necessitate recapping of the needle. Administration of incremental doses of medication to the same patient. v. Safety devices are used to reduce risk of injury in areas where sharps containers are not readily available. 3. Needleless devices and systems will be evaluated, selected, and implemented when appropriate, effective, and are commercially available Non-managerial staff will be involved in the evaluation and selection of these devices. Selection and evaluation of devices will be accomplished by written evaluation forms and maintained by Cook Children s Home Health (CCHH), Cook Children s Medical Center (CCMC) Value Analysis Committee, and Cook Children s Physician Network (CCPN), as appropriate. Training and education will be provided for employees whenever safer devices are implemented.

Bloodborne Pathogen Exposure Control Plan Page 5 of 14 4. Management of Used Sharps Containers a. Nursing personnel for CCMC, CCHH, or the safety officer for CCPN clinics will check the sharps containers in their patient care areas at the beginning of their shift and replace those that are 2/3 full. b. After closing the lid, nursing personnel will place the used sharps container in a biohazard labeled bag and leave it in the Housekeeping closet for disposal. Housekeeping will transport the 2/3 filled, closed container in an upright position to the contaminated waste disposal area in the medical center. c. CCPN and CCHH staff will place the full sharps container in the designated medical waste location and dispose in the designated biohazard receptacle. The contracted waste management company for CCPN and CCHH will dispose of this waste in accordance with state and federal law. 5. Vacutainer holders are to be disposed into the sharps container after each use. Under no circumstances is the needle to be removed from holder. 6. Reusable Sharps a. Reusable sharps that are contaminated with blood or other potentially infectious materials will not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. b. Contaminated reusable sharps will be placed in a container until properly reprocessed. The container will be puncture resistant, labeled or color coded, and leak proof on sides and bottom. 7. Mechanical means, such as tongs or a dustpan and brush, will be used to clean up broken glassware or other items capable of puncturing the skin. Broken glass will not be picked up by hand. E. Handling of Specimen 1. Mouth pipetting/suctioning of blood or body substances is prohibited. 2. All procedures involving blood or other potentially infectious materials will be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. 3. Specimens of blood and body substances are to be placed in a container to prevent leakage during collection, handling, processing, storage, transport, or shipping. 4. All specimens are handled as potentially infectious material. 5. Use of Secondary Containers (e.g., Plastic Bag) - All specimen containers will be placed into a plastic bag labeled with the appropriate biohazard warnings before being taken or sent to the laboratory. 6. Laboratory specimens transported outside the facility will be packaged to prevent leakage during transport, handling, processing, and storage and will be labeled appropriately with a biohazard sign (refer to State of Texas Hazard Waste Act, 1991).

Bloodborne Pathogen Exposure Control Plan Page 6 of 14 F. Equipment 1. Equipment which may become contaminated with blood or other potentially infectious materials will be examined prior to servicing or shipping and will be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. 2. A readily observable biohazard label will be attached to the equipment stating which portions remain contaminated. 3. The originating department will provide this information to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. G. Personal Protective Equipment (PPE) 1. Employees will be provided with appropriate barriers such as gloves, gowns, face shields, overlay barriers, masks, lab coats, plastic aprons, protective eyewear, and resuscitation devices. 2. Refer to CCHCS policy IC 500 - Universal/Standard Precautions for specific instructions on use of protective barriers. 3. Employees will be trained on the proper mandated use, selection, and indications for PPE as well as the procedures for disposal or reprocessing of PPE per departmental/division policies. 4. Surgical caps or hoods and/or shoe covers or boots will be worn in instances when gross contamination can reasonably be anticipated (e.g., autopsies, orthopedic surgery). 5. Compliance for wearing PPE will be monitored within the employee's performance appraisal and standards of performance. 6. Employees must use PPE unless a rare and extraordinary circumstance occurs in which the employee believes the use of PPE would prevent the delivery of health care or create risk to the worker or a co-worker (e.g., a cardiac arrest in the hallway and there is a short delay in obtaining the crash cart). a. Decisions not to use protective barriers in those rare and extraordinary circumstances will not be applied to a particular work area or a recurring task. b. All such instances must be documented and investigated to determine whether prevention of similar occurrences in the future is possible. 7. Should the employee's personal clothing, uniform, or hospital supplied scrub suit become contaminated with blood or other potentially infectious material the following steps will be taken: a. Notify supervisor of the occurrence. b. A disposable scrub suit will be obtained from the Materials Management department by the house supervisor (a general stores requisition will be needed for this item). CCHH staff have disposable scrub suits available to them as part of the Employee Protection Kit (refer to CCHH policy INF 103 - Personal Protective Equipment). c. The contaminated clothing will be removed in a manner to prevent further risk of exposure to the health care worker and replaced with the clean, disposable scrub suit, or clean clothing by CCPN staff.

Bloodborne Exposure Control Plan Page 7 of 14 H. Housekeeping d. The contaminated clothing will be placed into a biohazard labeled plastic bag to be laundered. The employee's name will be written on the tag of the clothing or marked in someway to identify the owner. e. The cleaned clothing will be picked up by the employee from the housekeeping department or supervisor as directed. There is no charge to the employee. 1. The work area will be maintained in a clean and sanitary condition. An appropriately written schedule for cleaning and method of decontamination will be maintained based on the location, type of surface to be cleaned, type of soil and tasks or procedures performed in the area. 2. All contaminated work surfaces must be decontaminated: a. After completion of each procedure, except in situations where procedures are performed on a continual basis throughout the shift, such as blood analysis. b. Immediately or as soon as possible when surfaces are overtly contaminated. c. After any spill of blood or other potentially infectious materials. d. At the end of the work shift if the surface may have been contaminated since the last cleaning. 3. Cleaning supplies are available for employees to use when housekeeping staff is not available. Employees are trained within their department in the appropriate procedure for cleaning up blood spills. 4. Trash containers with plastic liners which are used for contaminated items must be routinely inspected and decontaminated on a regular schedule or when visibly contaminated. I. Laundry 1. All laundry is considered contaminated and is handled in accordance with linen collection policy where applicable. 2. Contaminated laundry will be handled as little as possible with a minimum of agitation. 3. Contaminated laundry will be bagged in a leak proof Biohazard labeled bag at the location where it was used and will not be sorted or rinsed on site. 4. Employees who have contact with contaminated laundry will wear appropriate PPE as per departmental policy. J. Other Regulated Waste 1. Regulated waste will be placed in containers which are reclosable, constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping, biohazard labeled, closed prior to removal to prevent spillage or protrusion of contents during handling storage, transport, or shipping. 2. If outside contamination of the regulated waste container occurs, it will be placed in a second container that meets the above criteria. 3. Disposal of all regulated waste will be in accordance with applicable regulations of each state, the United States, and its territories, and political subdivisions of its states and territories.

Bloodborne Pathogen Exposure Control Plan Page 8 of 14 K. Compliance Monitoring 1. Compliance with Universal/Standard Precautions is considered to be a standard of performance and is included in the annual performance evaluation. 2. Compliance will be monitored by the supervisors, medical staff, and infection control. L. Hepatitis B Vaccine - Reference CCHCS policy HR 800 - Employee Comprehensive Immunization Plan. M. Post Exposure Evaluation and Follow-up Procedures - Refer to CCHCS policy HR 840 - Guidelines for Bloodborne Pathogen Exposure Follow-up for requirements of sharps injury log. N. Employee Medical Records - Reference CCHCS policy HR 840 - Guidelines for Bloodborne Pathogen Exposure Follow-up. O. Hazard Communication - Labels and Signs 1. Warning labels will be affixed to containers of regulated waste, refrigerators, and freezers containing blood or other potentially infectious materials and other containers used to store, transport, or ship blood or other potentially infectious materials (exception: blood, blood components, or blood products released for transfusions or other clinical use). 2. Labels must contain the Biohazard symbol ( ) which must be fluorescent orange or orange red, with letters, or symbols in a contrasting color. 3. Labels may be attached to the container with string, wire, adhesive or other methods that prevent the loss or unintentional removal. 4. Red bags or red containers can be substituted for labels. 5. Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment, or disposal are exempted from the labeling requirement. 6. All used equipment is considered to be contaminated and will be handled in accordance with departmental policies. 7. All employees will be trained to recognize the method of identification of hazards and any alternative labeling or color-coding. P. Employee Training - All employees with potential for occupational exposure will be trained. The training will be conducted as follows: 1. At the time of initial assignment and annually thereafter. 2. Additional training will be provided with modification or institution of new tasks or procedures which may affect occupational exposure. 3. Appropriate training records will be kept by the Human Resources department for three years and will include: a. Dates of the training session; b. Contents or a summary of the training; c. Names and qualifications of the persons conducting the training session; and d. Names and job titles of all persons attending.

Bloodborne Pathogen Exposure Control Plan Page 9 of 14 4. The training program will contain at a minimum the following elements: a. An accessible copy of the regulatory text of 29 CFR Part 1910.1030 and an explanation of its contents; b. A general explanation of the epidemiology and symptoms of bloodborne diseases; c. An explanation of the modes of transmission of bloodborne pathogens. d. An explanation of the employer's exposure control plan and the means by which the employee can obtain a copy of the written plan; e. An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials; f. An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment; g. Information on the types, proper use, location, removal, handling, decontamination, and disposal of personal protective equipment; h. An explanation of the basis for selection of personal protective equipment; i. Information on the Hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge; j. Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials; k. An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available; l. Information on the post-exposure evaluation and follow-up that the employer is required to provide for the employee following an exposure incident; m. An explanation of the signs and labels and/or color-coding required by the standard; and n. An opportunity for interactive questions and answers with the person conducting the training session. 5. The person conducting the training will be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address.

Bloodborne Pathogen Exposure Control Plan Page 10 of 14 REFERENCES CCHCS policy Employee Comprehensive Immunization Plan (HR 800) CCHCS policy Guidelines for Bloodborne Pathogen Exposure Follow-Up (HR 840) CCHCS policy Universal/Standard Precautions (IC 500) CCHH policy Hand Hygiene (INF 102) CCHH policy Personal Protective Equipment (INF 103) CCHH policy Cleaning and Disinfection of Equipment and Toys (IFN 110) CCMC policy Blood and Body Fluid Post Exposure Evaluation and Follow-up (MC 255) CCPN policy Hand Washing (DR 800) CCPN policy Equipment Cleaning (DR 812) Infection Control policy Hand Hygiene (IN 15) Sterile Processing policy Loading of the Sterilizer (SP 106) Occupational Safety and Health Administration (OSHA) End of Policy 9/28/2009 1:34 PM m:\system policies\ic\ic 100 bloodborne pathogen exposure control plan 04-09.docx

Bloodborne Pathogen Exposure Control Plan Page 11 of 14 Attachment A 2009 Evaluation and Implementation of Safe Sharp Devices Cook Children's Medical Center (CCMC), Cook Children s Physician Network (CCPN), and Cook Children s Home Health (CCHH) have processes in place to review appropriate, commercially available safety devices and implement those that prove to be effective at eliminating or minimizing worker exposures and injuries. The Infection Control Committee reviews the sharps injury analysis report presented by the Occupational Health department, and makes a recommendation for the selection of safety product evaluation to the Value Analysis Committee and CCPN Technology Assessment Committee. The Value Analysis Committee is responsible for the evaluation and implementation process of safety devices for the Medical Center. The committee includes representation from various clinical settings. Recommendations of this committee are forwarded to the Patient Care Council. If a device shows promise it is evaluated through pilot testing at multiple clinical areas including CCHH. Based on the outcome of a product evaluation the Value Analysis Committee may make a determination on product standardization for the medical center and Home Health and facilitate the training and implementation of a safer device. A. Current Sharp Safety Products Used By CCMC Include: 1. Lancets: BD and Accucheck brands; 2. Safety butterfly needles: BD brand; 3. Safety Glide needles: BD brand; 4. Smart Site needleless system; 5. Braun Introcan IV catheter; 6. J&J ProtectIV IV catheter; 7. BD brand mylar wrapped capillary tubes; 8. Radiometer brand mylar wrapped clinic tubes 9. BD brand plastic blood collection tubes; 10. Derma Bond skin sealant; and 11. Stat Lock 12. SHPI Mini Loc huber style needles 13. Kendall sharps containers 14. Medisystems fistula needles with safety shields 15. Therasence Freestyle Unistick safety lancets 16. Wing Eater Safety AV fistula needle set 17. BD Brand blood transfer devices 18. Radiometer/Copenhagen Safe Clinitubes

Bloodborne Exposure Control Plan Page 12 of 14 Attachment A (continued) Upon review of 2008 injury data, analysis revealed that needlestick injuries were 1.7 per 100 FTE s; this is unchanged from the previous year. Injuries were related to insulin and other micro fine needles. Safety devices were implemented for insulin injections. There are currently no alternative safety devices for suture needles.. B. Current Sharp Safety Products Utilized At CCHH Include: 1. Clave needleless system; 2. Clave vial adapters; 3. Interlink needleless system; 4. J&J ProtectIV catheters; 5. BD brand safety lock blood collection set; 6. BD brand blunt plastic cannula and blunt needles; 7. Safety Glide needles, BD brand; 8. Kendall angel wing blood transfer device; and 9. BD brand Safety Glide needles. 10. SHPI Mini Loc huber style needles Upon review of the 2008 injury report, analysis revealed 0 needlesticks for the year. No trends were noted. Home Health will continue to look for vented filter needles, and needleless devices for TPN bag/vial additives. C. Current Sharps Safety Products Utilized throughout CCPN include: Retractable Technologies, Inc. (RTI) Vanish Point retractable syringe with needle remains the product of choice for all locations; The Becton-Dickinson (BD) SafetyGlide needles and syringes; BD Genie Lancets (orange, pink, green, and blue); Microtainer Brand Quik Heel Lancets; Tenderlett (ITC) 1.75 depth lancets; Vacutainer Safety-Loc BD Push Button Blood Collection Set CCPN locations continue to use the products listed above. There has not been a product that has appeared on the market that meets the caliber of the RTI syringes to date. CCPN s needlestick rate per 100 FTEs was 1.0 for 2008, with 7 contaminated sticks reported: 2 contaminated sticks, caused by child moving during injection; 4 contaminated sticks while activating the safety device; and one from an RTI syringe, which failed to activate. While an increase over 2007,. numbers remain exceptionally low in consideration of a volume of more than 500,000 injections. The overall contaminated needlestick rate for CCPN, based on annual volume alone, is 0.000014.

Bloodborne Pathogen Exposure Control Plan Page 13 of 14 D. Documentation is maintained in the Occupational Health department for specific areas and circumstances where the safety devices are not medically safe for the patients. In these instances a non-safe needle device may be used as approved by the Medical Director for the Occupational Health department.

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