Return to Home Page WMI Medical Services GUIDE to Infectious Waste Handling INTRODUCTION Infectious wastes may contain organisms such as Hepatitis B virus, AIDS virus, and other disease causing agents. Infectious agents may be present in the waste from hospitals, clinics, dental offices, doctors’ offices, research facilities (educational and industrial), slaughter houses, veterinary clinics, private residences and other such sources. Generally, these wastes cause little harm to those who have to handle them. However, the recognition of the potential risks of exposure and an understanding of the methods for minimizing that exposure are important in insuring the safe handling and disposal of these materials. It is also important to develop safe working practices and to implement methods for safe spill clean-up as well as for treatment of personnel that may be exposed to infectious wastes. CATEGORIES Infectious waste can be placed into the following categories: 1. Isolation waste 2. Surgical waste 3. Dialysis waste 4. Sharps 5. Cultures and stocks of infectious agents and materials contaminated with them. 6. Blood, blood products and other biological fluids 7. Pathological waste 8. Carcasses of infected animals and contaminated bedding RECOGNITION INFECTIOUS WASTE Infectious waste should always be marked with the universal biohazard symbol. The waste may be in red, orange, clear or translucent bags with the biohazard symbol on them. Bagged infectious waste may also be packaged in rigid containers, marked with the biohazard symbol. Autoclave waste should have “autoclave” tape attached to the outside of the container. When the tape indicates “STERILE”, or shows dark grey to black strips, the container has been decontaminated. Waste from some sources may not be properly packaged or labeled. The major risk from exposure to these wastes is from possible contaminated sharp objects which cause injury to the person handling the waste. HAZARD LEVELS Exposure to infectious waste may result in possible infection of the personnel handling the waste. In order for this to occur, there must be a route of entry. The most common route of entry is through breaks in the skin, however, other routes of entry do exist such s exposure of mucous membranes (eyes, nose, mouth) to aerosolized infectious liquids or dusts. The most hazardous of the categories of infectious waste is SHARPS. These wastes can penetrate containers and cause cuts, punctures, and scratches to personnel, thus establishing a route of entry for the microorganisms. PREVENTION OF INFECTION The major means of protection against infection is to prevent entry of potentially infectious microorganisms through the skin. All cuts and abrasions should be kept covered with bandaids, and when possible, gloves or other protective covering. If unbroken skin is exposed to infectious waste, a thorough washing with soap and water is the most effective method of preventing infection. If cuts or abrasions are present, washing, with soap and water followed by the application of an antiseptic is effective in minimizing the risk of infection. Cuts or puncture wounds caused by handling of infectious sharps may require more extensive treatment and should be referred to medical personnel for evaluation and treatment. HANDLING Infectious waste poses the greatest hazard to personnel when it is released from its container. Infectious waste Page 2 cont’d HANDLING GUIDE to Infectious Waste Handling should always be packaged to prevent exposure to the people who have to treat or dispose of it. Waste may be packaged in double plastic bags, and in rigid containers. Infectious waste containers should never be compacted, or treated in such a way that they may break and release the waste into the environment. Careful handling of all infectious waste to prevent spills will also prevent exposure of personnel to possible infectious agents. Cytotoxic, chemotherapeutic or antineoplastic waste may be generated by the aforementioned facilities. Such waste may be infectious in one or more of the above categories. Additional precautions may be necessary in the presence of residual chemical agents. These precautions must be identified prior to waste collection or disposal. This is waste may be in yellow bags. Other types of wastes may be potentially infectious and must be designated as such by someone within a generating facility. Infectious waste should not be allowed to accumulate unrefrigerated for more than a few hours. If a significant delay in collection or treatment is anticipated, it should be stored under refrigerated conditions. SPILL PROCEDURES Should accidental spills of infectious waste occur, the waste materials should be cleaned up as soon as possible. Clean-up can be done by personnel with appropriate personal protective equipment. If Blood, blood products, tissue or microbiological culture have been spilled, the area should be decontaminated with hypochlorite solution2 (a 1/5 dilution of household bleach in water) for approximately 30 minutes. Following this decontamination process, the waste can be placed in appropriate biohazard containers for disposal. ALWAYS WEAR GLOVES! NEVER HANDLE INFECTIOUS WASTE WITH BARE HANDS! If the spilled waste does not contain blood, tissue, or cultures, it may be picked up, placed in marked containers, and the area cleaned with any good detergent-based disinfectant3. Personnel must wear gloves to protect their hands and should place the spilled material and the clean-up materials into appropriate biohazard containers. DEFINITIONS Antiseptic--Chemical (tincture of iodine, mercurochrome, etc.) used on skin to inactivate infectious agents. Autoclave--Steam sterilizer used to decontaminate waste materials. Disinfectant--Chemicals (bleach, phenol, quarternary ammonium compound) that inactivates infectious agents. (Contact times are dependant upon the type of agent being used.) Infectious Agent--Organism (bacteria, virus, etc.) which causes disease. PROTECTIVE EQUIPMENT Gloves--Neoprene, PVC or latex gloves are recommended for most tasks. Disposable surgical gloves or plastic gloves may also be used. Face masks or respirators--Dust or mist type respirators are suitable for most clean-up operations when there is danger of aerosol formation. Protective clothing--Disposable coveralls and shoe covers are appropriate for clean-up operations. These should be liquid repellent. Paper 2 here HAZARDOUS MATERIALS CLASSIFICATION Fire Hazard (RED) Flash Points Health Hazard (BLUE) 4-Below 73oF 4-Deadly 3-Below 100oF 3-Extreme danger 2-Below 200oF 2-Hazardous 1-Above 200oF 1-Slightly hazardous 0-Will not burn 0-Normal materials (RED) (BLUE) (YELLOW) (WHITE) Special Hazard (White) Reactivity (Yellow) Oxidizer OX 4-May detonate Acid ACID 3-Shock & heat may detonate Alkalai ALK 2-Violent chemical change Corrosive COR 1-Unstable if heated Use NO WATER W 0-Stable Radiation Hazard 1 Betadine, tincture of iodine, mercurochrome, etc. 2 Clorox, Purex bleach 3 Lysol, Pinesol, etc. Paper 3 here INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Isolation waste Bandages, cloth Low Double plastic Collect & place in Avoid contact surgical waste and paper items, biohazard bags’ a plastic biohazard with open Dialysis waste disposable plastic placed in rigid bag. Avoid contact wounds (cuts devices, gloves. containers with with skin. Wear scratches.) the biohazard gloves. Clean Wash hands symbol on them. spill area with thoroughly DO NOT COMPACT! detergent-based following any disinfectant.*** contact. Disinfectant should remain in contact a min. of 5 mins. prior to clean-up. WASH HANDS! Sharps Needles, broken High Should be in rigid Handle with Cuts or glass, broken impermeable extreme puncture plastics, scalpel closed containers, caution! Wear wounds blades. placed in double disposable need plastic biohazard gloves. Use immediate bags’ and rigid tools, such first aid containers with as shovel or treatment**** biohazard symbol scoop to handle Immune on them. Handle sharps. Avoid globulin and with extreme cuts. Contain or Hepatitis caution to prevent spill and vaccine may penetration of the decontaminate be container. with a 1/15 appropriate. DO NOT COMPACT! dilution of Refer to a household Physician. bleach** for 30 mins. Carefully place sharps in rigid container. WASH HANDS! Blood, blood Outdated blood Moderate Handle so as to Spills of Contaminated products and bank blood, (if portal of prevent contact infectious cuts or other biological products, entry through with skin. liquids should wounds need fluids serum, clinical cuts and DO NOT COMPACT! be absorbed immediate laboratory abrasions with an first aid samples. is present) absorbent treatment.**** material (paper Immune towel). Wear globulin and disposable gloves. or Hepatitis A 1/5 dilution vaccine may of bleach** be should be appropriate. poured over Refer to a the absorbed Physician. spill. Let Exposure to stand 30 mins. unbroken page 2 INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Cont’d Place material skin is less in biohazard dangerous. Blood, blood bags. Handwashing products and WASH HANDS! will minimize other biological the risk of fluids. infection. Laboratory Cultures of Low to Untreated Wear two pairs Contaminated wastes infectious Very High laboratory of disposable cuts or wounds agents (Depends waste must gloves. need immediate contaminated upon the be handled Cuts and first aid glass and composition very wounds must treatment. plasticware, of the waste carefully. be covered Wash pipettes, and and on level Decontaminated Place waste thoroughly other lab of prior (autoclaved) in suitable with soap and supplies. treatment. waste is not container water. infectious and (plastic bag). Apply an may be handled Remove gloves antiseptic with and place in such as noninfectious container. Put Betadine or waste when on new gloves. other agent.**** when Decontaminate Medical decontamination area with attention may has been detergent-based be required. properly disinfectant.*** An monitored Place gloves in investigation and the waste biohazard bags. of possible is clearly WASH HANDS! agents labeled. present should DO NOT COMPACT! be made in order to aid in the management of possible infection. Pathological Human tissues, Low These wastes When cleaning See blood and wastes organs, and should be up spills, wear blood products. body parts packaged in disposable sealed opaque gloves. Spilled biohazard contents should bags’ and be placed in a placed in rigid new bag and the container with contaminated area the biohazard treated as with symbol on blood and blood them. Most product spills. states require Following clean-up, incineration or place gloves in interment. Do waste bag and not rupture seal bag. the bag. DO NOT COMPACT! WASH HANDS! page 3 INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Carcasses of Infected animals Low Double plastic Personnel should If possible, infected animals carcasses and to biohazard bag’s wear gloves or determine the and contaminated bedding moderate. placed in rigid a respirator and nature of bedding. contaminated containers with goggles to avoid agents present with infectious the biohazard to avoid exposure in the waste. agents from symbol on them. to airborne Exposure to research contaminated dust. dust may facilities. DO NOT COMPACT!!! Spilled bedding result in should be confined, allergic wet with a SMALL reaction and amount of water and or to control dust respiratory and placed in new infections. bags. Never add Medical bleach directly to evaluation of spilled bedding. of personnel Once spill is with repacked, clean respiratory up with symptoms detergent-based following disinfectant.*** clean-up is WASH HANDS!!! recom- mmended. Exposed cuts and wounds must be washed thoroughly and treated with appropriate antiseptic**** *All infectious waste should be double bagged (each bag a minimum of 2 mil thickness and placed in rigid containers all the generator site. Double bag may be replaced by a single 3 mil bag. **Clorox, Purex ***Lysol, Pinesol, etc ****Betadine, tincture of iodine, mercurochrome *****Disposable protective equipment should be placed in a bag with waste. Non-disposable equipment should be properly disinfected. Paper 4 here DIABETES AND GLANDULAR DISEASE CLINIC LABORATORY CHEMICAL HYGIENE PLAN TABLE OF CONTENTS A. Formal Policy Statement B. Objectives C. Glossary D. Standard Laboratory Operating Procedures/Task Assessment E. Engineering Controls F. Personal Protective Equipment G. Medical Consultation and Examination H. Training I. Contaminated Waste Removal/Disposal J. Chemical Inventory List and MSDS K. Hazard Identification L. Recordkeeping M. Directory of Personnel References Appendix A - Universal Precautions Appendix B - Definition of Contaminated Waste Appendix C - Radiation Monitoring Program Attachment I - 29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928. Hazard Communication, Final Rule 10/92 Revision revised: October 1998 A. FORMAL POLICY STATEMENT Diabetes and Glandular Disease Clinic has made a commitment to provide a safe working environment and believes employees have a right to know about recognized health hazards associated with their work environment. So that employees can make knowledgeable decisions about any personal risks of employment, this Hazard Communications Program/Exposure Control Plan was established to be used in conjunction with existing safety and procedural manuals and to include policies, procedures, and responsibilities designed to develop in employees an awareness of potential hazards of infectious materials in the workplace and to train employees in safe work habits. It is important that employers assure responsibility for clinic workplace safety. All employees will have access to personal protective equipment and to pertinent safety information via the Chemical Hygiene Plan and the Hazard Communications Program/Exposure Control Plan, with supplemental information available through their supervisors. Personnel who work within various areas of the clinic are best able to detect potential problems in either the facility or work procedures. When safety concerns arise, employees are encouraged to contact their supervisor or the safety officer. This program has been designed for the benefit and protection of all employees and will be reviewed and updated annually, or whenever necessary to reflect new or modified tasks and/or procedures that affect occupational exposures or reflect new or revised employee positions with occupational exposures. You will receive the information necessary so that you know what you are working with and how best to handle it. This information will be presented in many forms, including, but not limited to, in-services, hand-outs, memos, etc. ________________________ Clinic Administrator ________________________ Laboratory Director ________________________ Laboratory Manager/Supervisor B. OBJECTIVES Upon completion of the Chemical Hygiene Training Program, the employee will be able to: 1. Locate the potentially hazardous chemicals in the workplace. 2. Recognize the chemical labeling and its meaning. 3. Locate the MSDS book in the workplace. 4. Locate the health hazard, physical hazard, environmental protection, and special protection sections of the MSDS and explain their use. 5. Identify the clinic Chemical Hygiene Officer by name and title. 6. Discuss the major components of the facilities standard labeling system. 7. Identify the appropriate protective clothing for the designated area and demonstrate its use. 8. Demonstrate emergency procedures in case of a hazardous chemical spill. 9. Describe the environmental monitoring protocol. C. GLOSSARY ACUTE: An adverse effect with symptoms of high severity coming quickly to a crisis. CARCINOGEN: A substance capable of causing cancer. CHEMICAL AGENTS: A wide variety of fluids which have a high potential for body entry by various means. Some are more toxic than others and require special measures of control for safety and environmental reasons. CHRONIC: An adverse effect with symptoms which develop slowly over a long period of time or which frequently recur. COMBUSTIBLE: Able catch on fire and burn. DOT: Department of Transportation. EPA: The Environmental Protection Agency. FLAMMABLE: Capable of being easily ignited and of burning with extreme rapidity. INFECTIOUS AGENTS: Sources which cause infections either by inhalation, ingestion, or direct contact with the host materials. LC 50: The concentration of a substance in air that causes death in 50% of the animals exposed by inhalation. A measure of acute toxicity. LD 50: The dose that causes death in 50% of the animals exposed by swallowing a substance. A measure of acute toxicity. MSDS: Material Safety Data Sheets. OSHA: Occupational Safety and Health Administration, the regulatory branch of the Department of labor concerned with employee safety and health. PEL: Permissible exposure limits. This is the legal allowed concentration in the workplace which is considered a safe level of exposure for an eight-hour shift 40 hours per week. Page 2 GLOSSARY pH: A measure of how acid or caustic (basic) a substance is on a scale of 1-14. A pH of 1 indicates that a substance is very acid; and a pH of 14 indicates that a substance is very caustic (basic). PHYSICAL AGENTS: Workplace sources recognized for their potential effects upon the body. Heat exposure or excessive noise levels are examples of this risk group. SENSITIZERS: Agents to repeated exposure over time creating an allergic reaction at some point in time. STERILITY: Changes made in male or female reproductive systems resulting in inability to reproduce. TERATOGENS: Deformity of newborns if a significant exposure exists during pregnancy. TLV: Threshold limit value. The amount of exposure allowable for an employee in an 8 hour day. D. STANDARD OPERATING PROCEDURES Because few laboratory chemicals are without hazards, general precautions for handling all laboratory chemicals should be adopted to include minimizing exposure and assuming any mixture of hazardous chemicals is more toxic than the most toxic component. The following should be used for all laboratory work with chemicals: 1. Accidents and spills a. Eye contact: promptly flush eyes with water for a prolonged period (15 minutes) and seek medical attention. b. Ingestion: encourage the victim to drink large amounts of water. c. Skin contact: promptly flush the affected area with water and remove any contaminated clothing. If symptoms persist after wash, seek medical attention. Clean-up: promptly clean up spills, using appropriate protective apparel and equipment and proper disposal. 2. Avoid unnecessary exposure to chemicals. a. Do not smell or taste chemicals. Vent apparatus which may discharge toxic chemicals. (vacuum pumps, distillation columns, etc.) into local exhaust devices. b. Inspect gloves before use. c. Do not allow release of toxic substances in cold rooms and warm rooms, since these have contained recirculated atmospheres. d. Use only those chemicals for which the quality of the available ventilation system is appropriate. e. Avoid smoking, drinking, eating, gum chewing or application of cosmetics or lip balm, in areas where laboratory chemicals are present. Wash hands before conducting these activities. Page 2 Standard Operating Procedures f. Avoid storage, handling or consumption of food or beverages in storage areas, refrigerators, glassware or utensils which are also used for laboratory operations. g. Handle and store laboratory glassware with care to avoid damage; do not use damaged glassware. Use equipment only for its designated purpose. h. Wash areas of exposed skin well before leaving the laboratory. i. Avoid practical jokes or other behavior which might confuse, startle, or distract another worker. j. Do not use mouth suction for pipetting or starting a siphon. k. Confine long hair and loose clothing. l. Wear shoes at all times in the laboratory but do not wear sandals, perforated shoes, sneakers, or any shoes made of canvas. m. Keep the work area clean and uncluttered, with chemicals and equipment being properly labeled and stored; clean up the work area on completion of an operation or at the end of the each day. n. Assure that appropriate eye protection, where necessary, is worn by all person, including visitors, where chemicals are stored or handled. o. Wear appropriate gloves when the potential for contact with toxic materials exists; inspect the gloves before each use, and replace them periodically. p. Use any other protective and emergency apparel and equipment as appropriate. q. Avoid use of contact lenses in the laboratory unless necessary; if they are used, inform supervisor so special precautions can be taken. Page 3 Standard Operating Procedures r. Remove laboratory coats immediately on significant contamination. s. Seek information and advice about hazards, plan appropriate protective procedures, and plan positioning of equipment before beginning any new operation. t. Leave lights on, place an appropriate sign on the door and provide for containment of toxic substances in the event of failure of a utility service. u. Be alert to unsafe conditions and see that they are corrected when detected. The Laboratory Manager/Supervisor will be responsible for the safe operation of the area. All activities and procedures shall require approval by the Administrator and Medical Director prior to implementation. Assessment of significant risk of all operations will be made by the Laboratory Manager/Supervisor or Chemical Hygiene Officer. Chemical Hygiene and Safety policies have been established for each task performed and engineering controls or personal protective equipment assigned. (See Task Assessment.) TASK ASSESSMENT Assessment of all clinic operations is made by the Safety Officer without regard to the use of personal protective equipment. Safety policies are established for each task performed, and engineering controls and personal protective equipment are assigned. As a minimum, all employees wear a laboratory coat, gloves, and appropriate eyewear when dealing with blood and body fluids. The following list identifies tasks requiring additional protective equipment and engineering controls. Task Protective Equipment Engineering Controls Phlebotomy Lab coats, gloves, face shields Sharps containers Specimen Accessioning Lab coats, gloves Absorbent paper Specimen Processing Lab coats, gloves, face shields Saf DeCaps Specimen Processing: Lab coats, gloves, face shields Absorbent paper 24 hr. urines Specimen Pipetting Lab coats, gloves Saf DeCaps, parafilm Testing Centrifugation Lab coats, gloves Centrifuge lid closed tightly and/or Tubes capped or covered Specimen Storing Lab coats, gloves Appropriately labeled containers Specimen Handling None Closed leakproof Transport container Specimen Shipment Lab coats, gloves, eye protection Closed leakproof Preparation: when working with dry ice container Spill Clean-up Lab coats, gloves, aprons, Leakproof biohazard shoe covers (depending on severity) waste container, Absorbent paper Instrument Cleaning Lab coats, gloves Absorbent paper Instrument Maintenance Lab coats, gloves Absorbent paper Plumbing Repair Aprons, gloves Receptacle to contain waste water (bucket, tub) Page 2 Task Assessment Handling/Disposing Lab coats, gloves Leakproof biohazard of Medical Waste waste container Clean-up Lab coats, gloves, shoe covers, masks Leakproof biohazard Contaminated Area or aprons (depending on severity of waste container, contamination) Absorbent paper Changing of Lab coats, gloves, aprons and Leakproof biohazard Contaminated Linens eye protection (depending on severity waste container Protective Coverings of contamination) Assisting/Performing Lab coats, gloves, eye protection Leakproof biohazard Invasive Procedures waste container, Absorbent paper E. ENGINEERING CONTROLS Eyewash stations shall be inspected every month and records maintained by the laboratory personnel. Fire extinguishers will be inspected annually by Bexar Fire and Safety. All chemicals stockrooms/storerooms must be adequate and well ventilated. Ventilated storage cabinets for chemicals should be provided as needed. F. PERSONAL PROTECTIVE EQUIPMENT * Personal protective equipment is appropriate sizes is readily available to employees. All personal protective equipment is assigned based on the task assessment, which does not allow blood or other potentially infectious materials to pass through to or to otherwise reach the employee’s work clothes (e.g., scrubs), street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the time that the protective equipment is used. * Employees are required to wear disposable, single-use gloves when they have the potential for direct skin contact with blood and infectious materials, mucous membranes, and non-intact skin when touching or handling contaminated items or surfaces. * Employees with rashes, dermatitis, lesions, open wounds, sores, or other exposed lesions shall have medical evaluation before being allowed to perform any duties that may potentially expose them to blood or bloodborne pathogens. Employees with open skin rashes, wounds or erythemas, or other non-intact skin areas, shall not be permitted to work without these areas being adequately protected from exposure. * Gloves are removed inside out aseptically and are replaced when visibly soiled, torn, or punctured or any time their ability to function as a barrier is compromised. They are not washed in disinfectant for reuse. Powderless gloves or hypoallergenic gloves are provided to employees who are allergic to the regularly provided gloves. [Note: Employees with contact dermatitis caused by gloves may find protective skin creams (e.g., DermaShield™) helpful in preventing further irritation.] * Knee-length laboratory coats with long sleeves are to be worn only in the laboratory, processing, phlebotomy, and other areas with potential exposure risk. They are to be closed (e.g., buttoned) to protect clothing. Aprons are worn in addition to the laboratory coat when the laboratory coat cannot provide adequate protection (e.g., during pregnancy) or when fluid contamination is likely. Aprons are not substitutes for laboratory coats but serve as additional protection. LABORATORY COATS ARE WORN ONLY IN THE WORK AREA AND ARE NOT WORN ON MEAL OR REST BREAKS OR IN ANY PUBLIC AREAS (E.G., CAFETERIA, LOBBY, OR PHARMACY). Page 2 PERSONAL PROTECTIVE EQUIPMENT * Soiled laboratory coats are removed immediately after leaving the work area (or as soon as possible) and placed in a designated area for storage or in an appropriate laundry hamper located in the lab storage closet. All coats are laundered by an outside contract service with pick up on Tuesday mornings at 10:00 a.m. at no cost to the employee. Laboratory coats are supplied, repaired, and replaced as needed by the employer at no cost to the employee. Contaminated clothing shall be immediately removed by the employee(s) and placed in a biohazard-marked bag for transport to the laundry service. * Masks and eye protection or chin-length face shields are worn to prevent splashes, sprays, splatter, or droplets of blood or infectious materials if there is a potential for eye, nose, or mouth contamination. This equipment is located in the laboratory and processing areas. * Eyewear is provided by the employer upon employment at no cost to the employee. Replacement and repair caused by normal wear and tear are also the employer’s responsibility. Prescription lenses or replacement because of loss are the responsibility of the employee. Eyewear should be appropriately cleaned before using and whenever splashes or contamination are visible. When not in use, eyewear should be kept decontaminated and stored at an individual’s work station. * Personal protective equipment (e.g., gloves, laboratory coat, or eyewear) is required to be worn by all outside service and maintenance personnel when there is a potential exposure to blood and body fluids. This equipment is provided by the laboratory and located in the lab storage closet. It is the responsibility of the supervisors in the area to alert the outside service or maintenance personnel as to any potential hazard(s) and the use of protective equipment. revised: March 1998 G. MEDICAL CONSULTATION AND EXAMINATION Reporting of incidents and accidents is required by law. Relatively minor incidents without personal injury or only minor injury should be reported to the Safety Officer. The Safety Officer must report serious accidents (fatalities and multiple hospitalization injuries) directly to OSHA. 1. Reportable Incidents Include: A. Every accident (injurious or non-injurious). B. Accidents resulting in damage to instruments or the building. C. Situations or conditions which have the potential for injury, hazard to health, or damage to the property. 2. Serious Accidents Include: A. Fatalities. B. Injuries requiring hospitalization. C. Injuries involving three or more people. D. Property damage exceeding $25,000. 3. Investigation: A. Minor incidents reported to the supervisor must be investigated and a report given to the Safety Officer with an evaluation and any recommendations. B. Major accidents or serious incidents must be investigated by the supervisor and Laboratory Director in conjunction with the Safety Officer. The acute management of skin puncture or surface contamination should be routine first-aid consisting of washing the skin site with soap and water, and then, if appropriate, bandaging the site. Contaminated mucosal and conjunctival sites should be washed with large quantities of water. The incident should be reported to the supervisor and the routine policies of the health-care institution should be followed regarding reporting the incident. The routine practices of the institution regarding HBV/HIV immunoprophylaxis should be followed. During regular clinic hours, all employees needing medical attention as a result of an occupational accident or illness shall be referred to Page 2 MEDICAL CONSULTATION AND EXAMINATION E. DeNoia, M.D. or C. Lerner, M.D. After regular clinic hours, should emergency medical attention be required as a result of an occupational accident or injury, proceed to the Emergency Department at San Antonio Regional Hospital. All medical examinations and consultations necessitated by occupational illness or accident shall be performed by or under the direct supervision of a licensed physician without cost to the employee, without loss of pay and at a reasonable time and place. H. TRAINING Basic lesson plan outlining the expectations of the training program and the time frame for the learning outcome has been completed. The lesson plan(s) include: 1. Objectives 2 Plan of Action a. Scope of subject b. Importance c. Direct benefit to listen 3. Presentation a. Outline guide b. Follow objectives c. Vary methods to keep interest 4. Activity Plan a. List of AV and directions b. What to say c. Time frame 5. Application a. In work area b. Videotapes or slides/tapes c. Questions of/for listeners 6. Summary a. Restate objectives b. Restate main points c. Questions and answers to clear up misunderstandings The body of the training program is outlined below. All employees will be trained at the time of the employee’s initial assignment to a work area where hazardous chemicals are present and prior to assignments involving new exposure situations. Refresher information and retraining will be held periodically and no less than annually. A. The Hazardous Chemicals Laboratory Standard 1. Purpose 2. Objectives B. The Chemical Hygiene Plan 1. Location 2. Content C. PEL For Chemicals Used By Employees D. Signs and Symptoms of Overexposure and Visual Appearances of Chemicals used by Employees E. Location Of MSDS And Their Use F. Environmental Monitoring G. Chemical Labeling H. Physical and Health Hazards of Chemicals in the Workplace I. Work Practices 1. Emergency procedures 2. Personal protective equipment 3. Medical consultation 4. Spill procedures revised: March 1998 I. CONTAMINATED WASTE REMOVAL/DISPOSAL 3CI Medical Services of Texas under contact with the building management for removal and disposal of bio-medical waste by incineration, is responsible for providing leakproof waste containers. These are marked “Infectious Waste-Biohazard”. They are constructed of cardboard with red plastic liners and cardboard lids and are located in all laboratory, phlebotomy and processing area. These containers are to be kept upright throughout use and are routinely checked by the employee(s) assigned to that specific work area and/or the safety officer. They must remain covered when not in use. When full, these containers are to be closed and sealed with packing tape to insure against accidental spilling or protrusion of contents during handling, storage, transport, or shipping. Sharps container, when full, are closed an sealed securely with packing tape. The sealed sharps containers are then placed in a appropriate biohazard waste container for ultimate disposal by 3CI. These container are always located in immediate area of use (e.g., phlebotomy, processing, and diabetes education areas). Scheduled pick up days are Tuesday and Friday. The Waste Management routeman will provide additional containers, lids, and liners, on request. Containers sealed with packing tape and marked with the Suite number are thus identified as containers ready for pick up. Preparation Of Bio-Medical Trash For Pick-Up: Contaminated waste shall be handled using Universal Precautions and appropriate personal protective equipment and clothing to minimize the risk of occupational exposure. 1. Several red bags may be placed in one container. Each bag must be tied and taped and all such bags must be then enclosed in one single red bag. 2. Specimen tubes must be enclosed in a sealed container before placing them in the cardboard container supplied by 3CI. 3. Full containers must be closed and sealed securely with packing tape. Write the appropriate Suite# (420 or 440; 625; 660) on box top to alert routeman of boxes designated for pick up. 4. Use only the red bags supplied by 3CI Medical Services of Texas for the cardboard containers. Page 2 CONTAMINATED WASTE REMOVAL/DISPOSAL 5. Any transporting of red bag trash that has not been enclosed in the 3CI container must be done by the tenant, taking all precautions necessary to prevent a potential accident. If outside contamination of the primary container occurs or potential exists that the contaminated materials could escape the primary container, the primary container must be placed within a second container that prevents leakage during handling, processing, storing, transport, or shipping. The second container shall be labeled “Biohazard.” Should you have any questions or concerns, or require additional supplies or additional pick ups, please contact the Clinic Safety Officer at Ext. 417 or 428. Refer to Appendix B for “Definition of Infectious Waste”. Regular trash includes the remainder of waste in the clinic that poses no health or environmental risk. This trash is disposed of through routine facility waste by the janitorial staff. The janitorial staff have been instructed not to remove “red bag trash” or any regular trash if it contains any form of bio-medical waste. CHEMICAL INVENTORY LIST Revised: March 1998 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor Acetest Ames-2381 1 btl tablet ø ø ø N/A AMES Ammonia #4364 Liquid 2 2 ø N/A Dynarex Mixture Inhalant BacDown 256-494 5 liters Liquid 1 ø ø N/A CMS Detergent BacDown 262-519 5 liters Liquid 1 ø ø N/A CMS Handsoap Barbital N/A N/A N/A 2 ø ø N/A See: Total T4 Test Kit Sodium RIA (DCP) Component Bind-It Bind-it 1 pint Liquid ø ø ø N/A Laboratory Technologies Black D-1710 N/A Powder ø ø ø N/A Toshiba Corp. Minimum Developer RT irritation on exposure to dust Black Toner T-3210 N/A Powder ø ø ø N/A Toshiba Corp. Minimum RT irritation on exposure to dust Black Toner 887401 N/A Powder ø ø ø N/A Ricon Corp. Minimum RT irritation on exposure to dust Boric Acid BAT-250 N/A Tablets 3 ø ø Acid Omni-Tech, Inc. BAT-003 Bromochloro- N/A N/A Liquefied 1 ø ø N/A Ansul Fire Fire difluromethane Compressed Protection Extinguisher Gas Component Carbon N/A N/A Compressed 1 ø ø N/A Ansul Fire Fire Dioxide Gas Protection Extinguisher Component Cavicide N/A Liquid 1 ø ø N/A Micro- Disinfectant aseptic Products Chemstrip 9 417109 N/A N/A ø ø ø N/A Boehringer- Test Strips Mannheim Diagnostics Page 2 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor Chemstrip 00503 N/A N/A ø ø ø N/A Boehringer- BG 50 Mannheim Diagnostics Cidex Plus 2786 N/A Liquid 3 ø ø Aldehyde Johnson and Skin, eye & 28 day Johnson lung Solution/ irritant Activator Citrus II 7752 N/A Liquid 1 2 ø N/A Beaumont Aire Products Freshener Do Not Spray directly on to sensitive skin CON 6 CON 6 6x6 ml Lyophilized 1 ø ø Alkaline DPC Immuno- bottle assay Controls Cytology N/A 1 litter Liquid ø 4 ø Flammable Surgipath Fixative Dermacidol 028 1 gal Liquid ø ø ø N/A Jones Medical Developer 887133 N/A Powder ø ø ø N/A Ricon Corp Minimum RT irritation on exposure to dust Derma 030 500 ml Liquid ø ø ø N/A Jones Medical Scrub Drum OD-2510 1 each Solid ø ø ø N/A Toshiba Corp. (photo OD-4010 Cylinder copier) Ethanol < 5 liters Liquid ø 3 ø N/A Mallinckrody Flammable 95% Fixative: N/A As needed Liquid 2 2 2 Aldehyde Structural Irritant Parke-Davis Research study ONLY Center Page 3 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor Formalin N/A < 6 liter Liquid 2 2 1 N/A Chemtree combustible 10% PO possible Buffer cancer hazard Glucose 671640 4x250 ml Liquid 1 ø ø N/A Beckman Reagent bottles Glucose Included 50 ml Liquid ø ø ø N/A Beckman 150 in glucose bottle mg/dL reagent Standard kits Glucose 3879 100 ml Liquid ø ø ø N/A Sigma Chemicals BUN 100 bottles mg/dL Standard Glucose G3761 100 ml Liquid ø ø ø N/A Sigma Chemicals BUN 300 bottles mg/dL Standard 800 Hydro- N/A 20x10 ml Liquid 3 ø 1 Acid Ricca Chemical Co. chloric vials Acid Hydro- N/A 500 ml Liquid 1 ø 1 Oxidizer Hunt Products For gen bottle Co., Inc. Phlebo- Peroxide tomy use Only Ictotest Ames bottle Solid ø ø ø N/A CMS 2300A Isopropyl N/A 5 pints Liquid 1 4 ø N/A Hunt Products For Alcohol Co., Inc. Phlebo- tomy use Only Liquid N/A 8 bottles Liquid 1 ø ø N/A Gillette Paper Lipid 0369645 2 boxes Lyophilized 1 ø ø N/A Seradyn Control Control Material Page 4 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor LYPHO C-500-3 6 vial/pkg Lyophilized 2 ø 2 N/A Bio-Rad CHECK Anemia Control LYPHO 740 6 vial/pkg Lyophilized 2 ø 2 N/A Bio-Rad CHECK Diabetes Control LYPHO C-370-5 12x5 ml Lyophilized 2 ø ø N/A Bio-Rad CHECK vial/pkg Immuno- assay Control Mercury CAS # 10 Liquid 2 ø 1 Corrosive ERTCO Contained in 7439-96-6 ther- mometers Avoid inhalation - Special Pre- cautions for Spill Clean- up and Disposal Mercury CAS # N/A Liquid 2 ø 1 Corrosive WA Baum Avoid replacement 7439-96-6 Co., Inc. inhalation - for Special sphygmom- Pre- anometer cautions for Spill Clean- up and Disposal Mercury N/A 1 each Granular ø 1 1 N/A Lab Safety Avoid Spill metal Supply, Inc. inhalation - Clean-up Special Kit Pre- cautions for Spill Clean- up and Disposal Parafilm PM 996 Rolls Solid ø 1 1 N/A American “M” Can Co. Quat 256 07301 1 btl Liquid 2 ø 1 Alkaline Sanivac Davis Page 5 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor Sedi- CA-1570 1 btl Liquid 1 ø ø BD Stain Sodium Sx0265 1 jar Anhydrous 1¢ 1 ø N/A EM Science Avoid Acetate inhaling dust Sodium CAS# N/A N/A 3 ø 2 DPC/Bio-Rad Azid 266828-22-8 Excessive buildup or contact with lead can cause explosions Contained within all RIA Test Kits and Diamat Reagent Package Sani Cloth 4386 1 tub N/A ø 2 ø None Profes- Wipes, sional Dis- Disposables infectant Sodium T01-1733 1 gal. Liquid 2 ø ø Strong Chlorox Co. hypo- oxidizer chlorite 1, 1, 1, 022-523 2 cans Gas 2 ø 1 CMS Use with 2-Tetra- adequate fluoro- ventilation thane Thimerosal CAS# N/A N/A 1 ø 2 DPC Contained in 54-64-8 FSH, LH, Prolactin, Total T3 test kit components Tracer BG 00535 12 vials N/A ø ø ø Boehringer- Test Strips Mannheim Diagnostics Vacutainer BD-6455 Case Powder 1 ø ø CMS EDTA tubes Vacutainer BD-6482 Case Powder 1 ø ø CMS Heparin tubes Page 6 Chemical Catalog Quantity Physical Hazard Class Manufacturer Comments Name # Stores State H F R C Distributor Vacutainer BD-6445 Case Powder 1 ø ø CMS Potassium Oxalate/ Sodium Fluoride tubes Vacutainer BD-6510 Case Powder 1 ø ø CMS Serum Separator tubes (SST) WD-40 N/A 1 can Pressurized 1 3 ø WD-40 Co. Propellant considered extremely flammable Next paper here A. POLICY STATEMENT Diabetes and Glandular Disease Clinic has made a commitment to provide a safe working environment and believes employees have a right to know about recognized health hazards associated with their work environment. So that employees can make knowledgeable decisions about any personal risks of employment, this Hazard Communications Program/Exposure Control Plan has been established to be used in conjunction with existing safety and procedural manuals and to include policies, procedures, and responsibilities designed to develop in employees an awareness of potential hazards of infectious materials in the workplace and to train employees in safe work habits. It is important that employers assure responsibility for clinic workplace safety. All employees will have access to personal protective equipment and to pertinent safety information via their departmental copy of the Hazard Communications Program/Exposure Control Plan, with supplemental information through their supervisors. Personnel who work within various areas of the clinic are best able to detect potential problems in either the facility or work procedures. When safety concerns arise, employees are encouraged to contact their supervisor or the safety officer. This program has been designed for the benefit and protection of all employees and will be reviewed and updated annually or whenever necessary to reflect new or modified tasks and /or procedures that affect occupational exposures or reflect new or revised employee positions with occupational exposures. You will receive the information necessary so that you will know what you are working with and how best to handle it. This information will be presented in many forms, including, but not limited to in-service, hand-outs, memos, etc. Any employees who does not follow the safety policies set forth by Diabetes and Glandular Disease Clinic will be subject to remedial training, verbal and/or written counseling, other disciplinary action as deemed appropriate. Physician: Laboratory Director Reviewed: SAFETY OFFICER: Geri R. Becker PHONE EXTENSION: 426, 428, 417 LOCATION: Laboratory; ste. 420 DIABETES AND GLANDULAR DISEASE CLINIC DIABETES AND GLANDULAR DISEASE CLINIC LAB DIABETES AND GLANDULAR DISEASE RESEARCH CENTER (Referred to collectively as “DIABETES AND GLANDULAR”) SAFETY MANUAL 3/98 Revision May 30, 1995 To All Employees of DGDC, We have revised our Safety Policy and will begin distribution of the new manuals soon. I want all Supervisors to play particular attention to the changes. You will find that you are now participating more actively in the Safety Program at DGDC. One of our top priorities at DGDC is to ensure the safety of our employees. Supervisors are the people who know their sections. Our Safety Officer, Geri Becker has other contributions to make to our organization besides administrating the entire Safety Program. Geri will still continue to monitor the Program, but responsibility has been delegated throughout DGDC. Be sure to read the Revised Safety Manual carefully in order to understand your role. I know I can rely on EVERYONE to take a more active role in keeping our organization as safe as possible. Thank you for your continued dedication and support. ____________________ Sherwyn L. Schwartz, MD A. POLICY STATEMENT Diabetes and Glandular Disease Clinic has made a commitment to provide a safe working environment and believes employees have a right to know about recognized health hazards associated with their work environment. So that employees can make knowledgeable decisions about any personal risk of employment, this Hazard Communications Program/Exposure control Plan was established to be used in conjunction with existing safety and procedural manuals and to include policies, procedures, and responsibilities designed to develop in employees an awareness of potential hazards of infectious materials in the workplace and to train employees in safe work habits. It is important that employers assure responsibility for clinic workplace safety. Al employees will have access to personal protective equipment and to pertinent safety information via their personal copy of the Hazard Communications Program/Exposure Control Plan, with supplemental information available through their supervisors. Personnel who work within various areas of the clinic are best able to detect potential problems in either the facility or work procedures. When safety concerns arise, employees are encouraged to contact their supervisor or the safety officer. This program has been designed for the benefit and protection of all employees and will be reviewed and updated annually or whenever necessary to reflect new or modified tasks and/or procedures that affect occupational exposures or reflect new or revised employee positions with occupational exposures. You will receive the information necessary so that you know what you are working with and how best to handle it. This information will be presented in many forms, including, but not limited to, in-service, hand-outs, memos, etc. DIABETES AND GLANDULAR SAFETY MANUAL INTRODUCTION A message to: All Health Care Workers YOU-are a highly trained and valuable resource. We do not want you to be “wasted” by a needless accident. YOU-are the only one who can practice safety procedures for your own protection and that of your fellow workers. YOU-have the responsibility to: BE AWARE OF SAFETY HAZARDS. FOLLOW POLICIES AND PROCEDURES DESIGNED TO HELP YOU. REPORT ALL INCIDENTS OR ACCIDENTS SO THAT STEPS MAY BE TAKEN TO PREVENT RECURRENCE. SUPERVISORS: YOU-have the responsibility for providing as safe working conditions as is possible. YOU-have the responsibility for educating yourself as fully as possible to the potential hazards and of precautionary measures. YOU-have the responsibility of enforcing policies for safe practices and this manual is part of the effort. -SO- BE CAREFUL! THE LABORATORY IS A HAZARDOUS AREA. ___________________ LABORATORY DIRECTOR ___________________ DATE DIABETES AND GLANDULAR SAFETY MANUAL CHEMICAL HAZARDS 1. Introduction: A number of routine procedures in a clinical laboratory involve the use of highly caustic, poisonous, or flammable reagents. These should be appropriately labeled to indicate the hazards. Read labels and observe precautions. Failure to do so is cause for disciplinary action. 2. Classification: Dangerous chemicals may be grouped into the following: A. Caustic or corrosive: Acids and alkalies may cause burns of skin, mouth, or eyes and may also cause damage to equipment and storage areas. B. Poisons: Almost any substance in quantity can be poisonous. For these purposes, a poison will be classified as a substance which may cause death or serious effects if relatively small amounts are inhaled, ingested or contact the skin (such as concentrated phenols). Poisons may be gas, liquid, or solid. C. Carcinogens: Substances designated by OSHA as carcinogenic require special handling. D. Flammable: Such materials that easily ignite, burn, and serve as fuel for a fire. E. Explosive: Materials which may explode under special circumstances. 3. Labeling: All Hazardous Materials shall be labeled to indicate: A. Health hazard (Blue) B. Flammability hazard (Red) C. Reactivity (Yellow) D. Any specific hazard (White) Sample label---- (See “Sample Hazard Classification Labeling Scheme” on pages immediately following this section.) 4. Storage of corrosives: A. Store caustic and corrosive materials near the floor to minimize danger of bottles falling from shelves. B. Separate containers to facilitate handling. Organic acids (acetic acid and acetic anhydride) should be stored separately from strong oxidizing agents (sulfuric, nitric, or perchlorate) to prevent interaction of fumes and corrosion of storage cabinets. C. Acid bottles carries must be used for containers over 1 quart in size. 5. Storage of flammables: A. Quantities of one gallon or over must be stored in a safety can. If a reagent must be stored in a glass for purity, the glass container may be placed in a bottle carrier to lessen the danger of breakage. B. Small quantities (working amounts) may be stored on open shelves, but bulk storage (more than 5 gallons) must be in a safety storage area. C. Do not store ether in a closed area such as a refrigerator. D. Do not store flammables in areas exposed to direct sunlight. 6. Handling caustic materials: A. If quantities of acids or alkalies are being used, use a shield or barrier of some kind or work in a sink so that breaks or spills can be controlled. B. Wear aprons, gloves, and eye protection devices when handling highly corrosive materials. C. DO NOT PIPET BY MOUTH. D. Do not sniff reagents. E. Dilution: Use great care and add reagents SLOWLY. Always add ACID to WATER, never water to acid. Allow acid to run down the side of the container and mix slowly by gentle rotation. Avoid over heating. 7. Accidents and spills: A. Eye contact: promptly flush eyes with water for a prolonged period (15 minutes) and seek medical attention. B. Ingestion: encourage the victim to drink large amounts of water. C. Skin contact: promptly flush the affected area with water and remove any contaminated clothing. If symptoms persist after wash, seek medical attention. D. Clean-up: promptly clean up spills, using appropriate protective apparel and equipment and proper disposal methods. 8. MERCURY A. Avoid or minimize spills or elemental mercury as much as possible. B. CLEAN UP GROSS SPILLS with a pipet or sweeper. Ventilate area well to remove mercury vapors. C. The “No eating or smoking” rule is especially important on benches where mercury is handled. Mercury can be picked up on the tips of cigarettes and easily absorbed by ingestion or inhalation. D. Chronic exposure and absorption of mercury may lead to a metallic taste in the mouth, a “lead line” (grey line) around the gums, and neurological problems (irritability, hyperreflexic, comatose states). E. Do not place elemental mercury waste in drains. MERCURY SPILLS WILL BE HANDLED BY THE SAFETY OFFICER(S) ONLY!!! 9. Disposal of chemicals wastes: the volume of waste disposed of by small laboratories is usually not sufficient to constitute a hazard. A. Liquids should be flushed into the sewer system with copious amounts of water. B. Solid wastes should be placed in a sealed container labeled “chemical wastes- hazardous” before disposal. NOTE: If large quantities of hazardous material are being disposed of, special precautions may be required. Local and regional regulations for environmental protection should be checked for compliance. Consideration should also be given to recovery and reclaiming materials. 10. Material Safety Data Specifications (MSDS) are located in file “MSDS” in the office of the Laboratory Manager. HAZARDOUS MATERIALS CLASSIFICATION Fire Hazard (RED) Flash Points Health Hazard (BLUE) 4-Below 73oF 4-Deadly 3-Below 100oF 3-Extreme danger 2-Below 200oF 2-Hazardous 1-Above 200oF 1-Slightly hazardous 0-Will not burn 0-Normal materials (RED) (BLUE) (YELLOW) (WHITE) Special Hazard (White) Reactivity (Yellow) Oxidizer OX 4-May detonate Acid ACID 3-Shock & heat may detonate Alkalai ALK 2-Violent chemical change Corrosive COR 1-Unstable if heated Use NO WATER W 0-Stable Radiation Hazard Sample Hazard Classification Labeling Scheme Blue Indicates health hazard determination. Red Indicates flammability determination. Yellow Indicates reactivity determination. White Indicates any specific hazard. Identification of the degree of hazard in any given category is indicated by a scale of 0 through 4, with 0 indicating no hazard exists and 4 indicating the highest degree of hazard. Blue (Health Hazard) Red (Fire Hazard) 0 -normal materials; no hazard exists 0-will not burn 1 -slightly hazardous; irritation 1-flash point above 200 degrees F without tissue damage 2-flash point below 200 degrees F 2 -hazardous; continued or intense 3-flash point below 100 degrees F exposure could cause temporary 4-flash point below 73 degrees F or residual damage 3 -extreme danger 4 -deadly; short exposure could cause death or major residual injury. Yellow (Reactivity Hazard) White (Specific hazard) 0 -stable OX Oxidizer 1 -unstable if heated ACID Acid 2 -violent chemical change may occur ALK Alkali 3 -shock and/or heat may lead to COR Corrosive detonation W Use NO Water 4 -material may detonate Radiation Hazard DIABETES AND GLANDULAR SAFETY MANUAL ELECTRICAL SAFETY 1. GROUNDING: All instruments must be grounded including household type appliances, coffee pots, etc. The only exception to the rule are items entirely encased in plastic (such as microscopes). 2. REPORT SHOCKS: All shocks must be reported immediately, including small tingles. Small shocks often precede major shocks and a light tingle may indicate potential trouble. 3. CORRECTIVE ACTION: Shut off the current and/or unplug the instrument. Do not attempt to use an instrument that is causing shocks. Not only is it potentially dangerous, but any results from the instrument would be suspect. 4. REPAIRS: DO NOT work on or attempt to repair any instruments while it is plugged in. In this case, be sure hands are dry, remove all jewelry (watches, rings, etc.) and proceed with caution. 5. Repairs on the electrical system of the building are prohibited. Any work performed on switches, outlets or circuit boxes (fuses, circuit breakers) must be referred to the building maintenance personnel. 6. EXTENSION CORDS: Should be avoided. If used, they must be 3-way type and properly grounded. Gang plugs are prohibited. DIABETES AND GLANDULAR SAFETY MANUAL FIRE PREVENTION AND CONTROL PREVENTION: A. Be aware of ignition sources - open flames, cigarettes, heating elements and spark gaps (motors, light switches, friction and static). SMOKING IS NOT PERMITTED IN ANY AREA OF THE CLINIC. B. Do not use flammable liquids in the presence of ignition sources - and conversely - keep ignition sources away from areas where flammable liquids are used and/or stored. C. Flammable liquids give off vapors which may also burn or explode. Be sure flammable liquids are properly stored. 1. Quantities of one gallon may be stored in the laboratory. 2. Small quantities “in use” should be stored in a well ventilated area. D. DO NOT STORE EITHER IN REFRIGERATORS. E. Do not store any flammable liquids in areas exposed to direct sunlight. F. Festive decorations are restricted to painted decorations on glass. Hanging decorations are prohibited. PRIORITIES IN CASE OF FIRE: A. Sound alarm first to get help and to initiate evacuation of the area or the building. This is essential because small fires can rapidly become conflagrations. Time wasted fighting a fire may only delay effective control and may cost lives. B. Procedure for reporting a fire: 1. Call the Fire Department - 911 - and give them the location of the fire. (Example: “There is a fire at Physician’s Plaza Two, 8042 Wurzbach, Fourth Floor, Suite 420, in the laboratory.) (1) DO NOT HAND UP (2) Check to be sure the message has been received and passed on to the fire department. Page 2 Diabetes and Glandular Safety Manual Fire Prevention and Control 2. Notify everyone in the immediate area of the clinic. C. Evacuation: 1. Evacuate the immediate area of the fire. 2. There will be no general evacuation unless a General Alarm is sounded (i.e., to evacuate the entire building). 3. WALK - DO NOT RUN, to the nearest exit. RESPONSIBILITIES: Supervisor in charge will check to be sure all personnel have have evacuated. CONTROL OF FIRES: A. EVACUATION: 1. Evaluate the type and extent of the fire. If it is going to be large fire, GET OUT! Control measures should only be undertaken for small isolated fires. 2. Evaluate the type of material burning (wood, flammable liquids, electrical or gases). B. SOLID COMBUSTIBLES: 1. Small objects may be handled with asbestos gloves, and extinguished with water or with CO2. 2. Water, CO2, or dry chemical extinguishers may be needed for large fires. C. FLAMMABLE LIQUIDS: 1. Dry chemical extinguishers are usually needed for safe and effective control of burning liquids. CO2 will be effective only on a small fire. DO NOT USE WATER (it enhances the spread of the fire). Page 3 Diabetes and Glandular Safety Manual Fire Prevention and Control 2. If flammable liquids have spilled but not ignited, sand may be used to prevent the spread and reduce the fire hazard. A dry chemical extinguisher should be available in case of fire. D. ELECTRICAL 1. Do not use water unless the circuit has been shut down. (If power is off, water can be used.) 2. Shut down circuit if possible. 3. CO2 is most suitable but dry chemical is safe and effective. E. GAS: 1. Shut off source, if possible. 2. “Blow out” flame with CO2 (possible only when gas has been shut off). 3. Keep other flames away from gas cylinders. FIRE SAFETY EQUIPMENT IN THE LABORATORY: A. Fire extinguishers: They may be used on any type of fire. Unauthorized use (for play or cooling beverages) is strictly prohibited and is grounds for disciplinary action. B. Asbestos gloves: May be used to move or handle a small burning object, or to handle hot vessels, or to turn off hot valves or handles. CAUTION: Asbestos gloves are permeable. Steam or hot liquids can soak through and cause injury. DIABETES AND GLANDULAR SAFETY MANUAL WARNING SIGNS AND LABELS PURPOSE: To provide a uniform policy and procedure for indicating the presence of certain hazards that may not be apparent to the casual observer. POLICIES: A. Area Designations - In this clinic there are no “high risk” areas. The technical work areas will be considered to be “moderate risk” and restricted to authorized personnel. Administrative and clerical areas are considered to be “low risk” areas and are not restricted. B. Labels with appropriate warnings will be affixed to all hazardous reagents in addition to required labels indicating content. C. ALL specimen(s) from patients are treated as being potentially infectious. ALL specimens and subcomponents of specimens will be treated in this manner and disposed of in the biohazard bags. Use extreme caution when handling all specimens. LABELS: A. All reagent kits and materials must be labeled in regard to: Content Concentration (if applicable) Date received (or prepared) Date placed into service Date of expiration Storage requirements B. All hazardous reagents must also be labeled in accordance with the “Hazardous Materials Classification Scheme” adopted for use by the clinic. DIABETES AND GLANDULAR SAFETY MANUAL GENERAL REQUIREMENTS FOR PERSONAL AND LABORATORY SAFETY 1. Smoking is prohibited in the technical work area. Smoke is annoying to some, the burning cigarette is an ignition source to flammable solvents, and the handling of cigarette from bench to mouth is a route of exposure for both bacteria and certain toxic materials such as mercury. 2. Eating and drinking are also prohibited in the technical work areas. It is poor laboratory practice, a source of contamination, and specimens containing a variety of pathogens are handled daily in the technical work area and stored in the lab refrigerators. 3. Food is not permitted in technical refrigerators. 4. Applications of cosmetic in the technical work area is prohibited. 5. Contact lenses, especially the soft ones, will absorb certain solvents and also constitute a hazard in splashes and spills, offer no protection from a splash and may concentrate caustic material against the cornea or prevent tears from washing a caustic away. You are strongly advised not to wear contacts in the lab. 6. Face shields or eye protectors must be worn when handling caustic materials. 7. Hair shall be secured back in such a manner as to prevent it from coming into contact with contaminated materials or surfaces. It is also important to keep hair out of moving machinery such as a centrifuge. 8. Hand washing: Hands should be washed frequently during the day, before leaving the laboratory, and before eating or smoking. 9. Mouth pipetting of specimens is prohibited. There are pipetting aids available for every task. Page 2 DIABETES AND GLANDULAR SAFETY MANUAL GENERAL REQUIREMENTS FOR PERSONAL AND LABORATORY SAFETY 10. Exit and Aisles: A. Must not be obstructed in any way. No equipment, chairs, supplies or trash are permitted in the exit routes or areas. B. Doors to the laboratory should be kept closed, but exit doors must not be blocked, bolted, or obstructed in any way to block egress. 11. Good Housekeeping: A. Rags and/or flammable solvents will be disposed of in self- closing metal containers. B. Do not hang clothing on or near radiators, steam pipes, heating instruments, or open flames. C. Do not allow trash to accumulate in any area. Trash should be disposed of daily. D. Festive decorations will be limited to outside of laboratory work areas. Wax candles are prohibited. Decorations on lights and instruments are prohibited. 12. Glassware: A. Do not use broken or chipped glassware. Discard it and order new. B. Do not leave pipets sticking out of bottles, flasks, or beakers. C. Do not attempt to remove stoppers on glass tubing by forcing. If they are stuck, cut them off. D. Glass blowing and other artistic endeavors are prohibited. E. Decontaminate glass exposed to possible hepatitis- containing samples. Page 3 DIABETES AND GLANDULAR SAFETY MANUAL GENERAL REQUIREMENTS FOR PERSONAL AND LABORATORY SAFETY F. Dispose of broken or discarded pieces in a specially marked separate container. (Disposal of broken glass along with paper and trash is hazard to the custodial staff.) Use the biohazard bags or sharps containers for disposal of broken glass. G. Hot glass - heated containers should be handled with an asbestos glove. 13. Centrifuges: A. Do not operate centrifuge unless the covers are closed. Keep hair, beard, neckties, hair ribbons, necklaces, and other dangling items OUT OF THE WAY. B. Do not operate uncovered tubes of specimens or flammable liquids. Centrifugation creates a vacuum and volatilizes liquids. (Contaminated items become aerosols; flammable liquids become bombs, etc.) USE CAPS OR PARAFILM. DISPOSAL OF BIOHAZARDOUS WASTE Medical Waste Disposal is under contract with DGD for removal and disposal of bio-medical waste, is responsible for providing cardboard waste containers and red plastic liners and for scheduled pick-up and disposal of bio-medical waste. The janitorial staff will not remove “red bag trash” or supply red bag liners for trash containers. They are not authorized to pick up trash in a regular liner it it container bio-medical waste. Scheduled pick up days are Monday, Wednesday and Friday. Pick up days are subject to change based upon the changing needs of DGD. The contracted parties medical disposal routeman will provide additional containers and liners, on request, and must be shown the containers that are to be picked up. Preparation of Bio-Medical trash for pick-up: 1. Several red bags may be placed in one container. Each bag must be tied and taped and all such bags must be then enclosed in one single red bag. 2. Test tubes and sharps must be enclosed in another container before placing them in the Waste Management container. Container must be covered when not in use. 3. Full containers must be closed and sealed securely with packing tape. Write Suite# on box top, if appropriate. 4. There are containers available from the Waste Management vendor. 5. Use only the red bags supplied by our contracted company. 6. Any transporting of red bag trash that has not been enclosed in the container must be done by the tenant. Take all precautions necessary to prevent a potential accident. 7. Additional pick ups may be requested, if necessary. Should you have any questions, or require additional supplies, please contact the Clinic safety officer at Extension 541. Refer to Appendix B for definition of Infectious Waste. RADIATION MONITORING PROGRAM Employees who utilize equipment or materials capable of emitting gamma radiation shall participate in a radiation safety program consisting of the following elements: 1. An employee training and information program including information on the type of risks of the specific radioactive material to which they may be exposed and the methods to control an monitor personal exposure. 2. A personal monitoring program using dosimetry badges. The personal monitoring program shall be capable of determining the accumulated dosage of exposure in “REMS”. Employees shall not be exposed to a radiation dose in excess of the limits specified below: * Whole body, head and trunk, active blood-forming organs, lenses of eyes or gonads; 1-1/4 REMS per calendar quarter * Hands and forearms; feet and ankles: 18-3/4 REMS per calendar quarter * Skin of whole body: 7-/12 REMS per calendar quarter Employees under 18 years of age shall not be exposed to a dose exceeding 10% of the limits specified above. Pre-natal precautions concerning radiation shall be based on the federal regulatory guide 8.13 “Instructions Concerning Pre-Natal Radiation Exposure”, available from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. In case of overexposure to the limits specified herein, the employee must be notified immediately of such condition, and a medical surveillance program be instituted. The record retention period for radiation exposure shall be the length of employment, or as long as is deemed necessary by the Laboratory Director. The records may be annualized for retention purposes and should be available to the employees and their duly authorized representatives upon request. Page 2 RADIATION MONITORING PROGRAM RADIOACTIVE WASTES Radioactive wastes are defined as those wastes that contain substances undergoing radioactive decay. Typical laboratory radioactive waste include: 1. End products of analytical procedures which use radioactive substances. 2. Waste materials such as syringes and paper products which are contaminated during such procedures. STORAGE AND HANDLING OF RADIOACTIVE MATERIALS The radioimmunoassay kits and source materials contain radioactive material and other ingredients which necessitate certain precautions: 1. Handle all components and all patient samples as if capable of transmitting hepatitis and the Acquired Immunodeficiency Syndrome (AIDS). 2. Sodium azide has been added to certain components as a antibacterial agent. To prevent buildup of explosive metal azides in the plumbing, reagents, should be discarded into sewage only when diluted and flushed with large volumes of water. 3. Radioactive materials should be confined to a separate, isolated area with proper labeling and restricted to authorized personnel only. 4. Do not allow radioactive solutions, or blood and other body fluids to come into contact with exposed skin or mucous membranes. 5. Wash hands and other skin surfaces immediately and thoroughly if contaminated with blood or source material. 6. Do not pipet radioactive solutions or specimens by mouth. 7. Do not smoke, eat, drink, or apply cosmetics in areas where radioactive materials and/or specimens are stored or handled. 8. Use disposable labware and disposable absorbent bench covers. 9. Minimize the production of aerosols. 10. Always wear lab coats, film badges, and latex gloves when performing technical duties. 11. Wash hands thoroughly after handling or using radioactive and/or source materials and before leaving the laboratory. 12. Wipe up spills promptly, washing the affected surface with a decontaminant. Page 2 STORAGE AND HANDLING OF RADIOACTIVE MATERIALS 13. Periodically monitor for contamination in areas in which radioactive materials are stored or handled (approximately once a week with swab checks). 14. Maintain complete records of the receipt, use, and disposal of all radioactive materials. 15. Decontaminate all counter tops with disinfectant (10% sodium hypochlorite) when daily bench work is complete. 16. Any transfer of material must be in unopened, labeled shopping containers as received from the supplier. 17. All radioactive material must be stored in the original shipping container or a container which provides equivalent radiation exposure protection. ALL SPILLS, ACCIDENTS, AND EXPOSURES (NO MATTER HOW SMALL) SHOULD BE REPORTED TO THE LABORATORY GENERAL SUPERVISOR AND INVESTIGATED. All persons required to handle radioactive waste materials will be provided with a radiological safety orientation, protective garments, and equipment recommended for the type of material being handled. A radiation monitoring program shall be in effect for all employees exposed to radiological materials. DISPOSAL OF RADIOACTIVE WASTE Radioactive waste will be disposed by the following methods as required by the NRC and the local state agency responsible for environmental regulation: Disposal of low levels of radioactivity (e.g., * 20 microcuries) through biohazardous materials waste or sewage system is authorized under Section 31.11, United States Nuclear Regulatory Commission Regulation. References 1. Centers for Disease Control: Recommendations for protection against viral hepatitis. Morbidity and Mortality Weekly Report 34:313-24, 329-35, 7, June 1985. 2. Centers for Disease Control: Recommendations for prevention of HIV transmission in health-care setting. Morbidity an Mortality Weekly Report Supplement, 36(s):1S-16S, 21 August 1987. 3. Centers for Disease Control: Recommendations for preventing transmission of infection with human T-lymphotrophic virus type III/lymphadenopathy-associated virus in the workplace. Morbidity and Mortality Weekly Report 34:681-86, 691-95, 15 November 1985. 4. Department of Labor/Department of Health and Human Services: Protection against occupational exposure to Hepatitis B virus (HBV) and human immunodeficiency virus (HIV), JOINT ADVISORY NOTICE 19 October 1987. 5. Koop, CE: Surgeon General’s Report on Acquired Immune Deficiency Syndrome, US DHHS, October, 1986, 36 pp. 6. McCray E and the Cooperative Needlestick Surveillance Group. Occupational risk of the acquired immunodeficiency syndrome among health care workers. New England Journal of Medicine 314:1127-32, 1986. 7. National Committee for Clinical Laboratory Standards: Proposed Guideline: Protection of laboratory workers from infectious disease transmitted by blood and tissue. NCCLS Document M29-P, Vol 7 No 9, October 1987. 8. Ronalds CJ, Grint PCA, Kangro HD, Disinfection and inactivation of HTLV-III/LAV (Letter). Journal of Infectious Diseases 153:996, 1986. 9. Weiss SH, Saxinger WC, Richtman D, et al. HTLV-III infection among health care workers: association with needlestick injuries. Journal of the American Medical Association 254:2089-93, 1985. APPENDIX A The Ten Commandments for Clinical Laboratory Personnel 1. TREAT ALL BIOLOGICAL MATERIAL AS POTENTIALLY INFECTIVE!!! 2. DO NOT ATTEMPT TO RECAP, BREAK, OR BEND NEEDLES. Avoid sharp instruments, if possible. Place needles in puncture-resistant containers used solely for disposal. 3. WEAR GLOVES when handling blood and body fluid specimens or performing venipuncture. Change glove after each patient contact. 4. WASH HANDS after removing gloves. WASH HANDS immediately if they become contaminated with blood or body fluids. WASH HANDS after removing laboratory coat. WASH HANDS before leaving the laboratory. WASH YOUR HANDS!!! 5. NO MOUTH PIPETTING!!! NO EATING, SMOKING , OR CHEWING GUM IN THE LABORATORY!!! LEAVE PEN/PENCILS IN THE LABORATORY, DON’T CHEW YOUR PEN/PENCIL, BITE YOUR FINGERNAILS, RUB OR PICK YOUR NOSE! 6. ALWAYS WEAR A LABORATORY COAT OR GOWN, preferably disposable, when working in the clinical laboratory. Remove gowns or uniforms before leaving laboratory. 7. USE A BIOLOGICAL SAFETY CABINET for procedures likely to produce aerosols or droplets; vigorous mixing, sonicating, blending, etc. 8. DECONTAMINATE LABORATORY WORK SURFACES at least DAILY with FRESHLY prepared chemical germicide (e.g., 1-10% sodium hypochlorite) when work activities are completed. 9. ROUTINELY DECONTAMINATE EQUIPMENT which may come in contact with blood or body fluids with an appropriate germicide. 10. IMMEDIATELY DECONTAMINATE LARGE AND SMALL BLOOD AND BODY FLUID SPILLS. APPENDIX B DEFINITION OF INFECTIOUS WASTE Infectious Waste shall include: 1. Sharps, which include any discarded article that may cause punctures or cuts. Examples of such waste are needles, IV tubing with needles attached, scalpel blades, glassware, and syringes. 2. Pathological waste which includes but, it not limited to, all human tissues and anatomical parts which emanate from surgical, obstetrical, autopsy, and laboratory procedures. 3. Biological waste which includes, but is not limited to, blood and blood products, excretions, exudate, secretions, suctioned fluids, wastes emanating from dialysis and plasmapheresis, and any other fluids which cannot be directly discarded into a municipal sewer system. 4. Cultures and stocks of potentially infectious microbiological agents and associated biologics including and without limitation to specimen cultures and stocks, waste from production of biologics, and discarded live and attenuated vaccines. 5. Laboratory waste which has come in contact with potentially pathogenic organisms. Such waste shall include, but is not limited to, petri dishes, materials used to transfer, inoculate, and mix cultures and other materials that have come in contact with specimens or cultures. 6. Waste contaminated with blood or body fluid resulting from the care of treatment of any patient with a known or highly suspected communicable disease that can be spread via blood or body fluids. 7. Surgical waste (materials discarded from surgical procedures) includes, but is not limited to, disposable gowns, soiled dressings, gauze sponges, lavage tubes, drainage sets, underpads, and surgical gloves. APPENDIX C UNIVERSAL BLOOD AND BODY-FLUID PRECAUTIONS BLOOD AND OTHER BODY FLUIDS FROM ALL PATIENTS SHOULD BE CONSIDERED INFECTIVE A. Barrier Precautions 1. WEAR IMPERMEABLE GLOVES for touching blood and body fluids, mucous membranes, or non-intact skin of all patients; for handling items or surfaces soiled with blood or body fluids; and for performing venipuncture and other vascular access procedures. Gloves should be changed and hands washed after each patient contact. 2. WEAR MASKS, PROTECTIVE EYEWEAR, OR FACE SHIELDS during procedures likely to generate droplets of blood or other body fluids to prevent exposure to mucous membranes of the mouth, nose and eyes. 3. WEAR LAB COATS during procedures that are likely to generate splashed of blood or other body fluids. B. Wash hands and other skin surfaces immediately and thoroughly with BacDown hand soap if contaminated with blood or other body fluids. C. Precautions When Using Needles & Other Sharp Instruments 1. Sharp instruments should be considered potentially infectious and should be handled and disposed of with extraordinary care. 2. Needles should not be recapped, purposely bent or broken by hand, removed from disposable syringes, or otherwise manipulated by hand. 3. After use, disposable syringe and needles, scalpel blades, and other sharp items should be placed in puncture-resistant containers for disposal. This container should be located as close as practical to the use area. 4. Large-bore reusable needles should be placed in a puncture-resistant container for transport to the reprocessing area. Page 2 APPENDIX C UNIVERSAL BLOOD AND BODY-FLUID PRECAUTIONS BLOOD AND OTHER BODY FLUIDS FROM ALL PATIENTS SHOULD BE CONSIDERED INFECTIVE D. Mouth-to-Mouth Resuscitation MOUTHPIECES, RESUSCITATIONS DEVICES, OR OTHER VENTILATION DEVICES should be available for use in areas in which the need for resuscitation is predicable to minimize the need for emergency mouth-to-mouth resuscitation. E. Health-care workers who have exudative lesions or weeping dermatitis should refrain from all direct patient care and from handling patient-care equipment until the condition resolves. F. Precautions for Pregnant Health-Care Workers If a health-care worker develops HIV (Human Immunodeficiency Virus) or HBV (Hepatitis-B Virus) infection during pregnancy, the infant is at risk or infection resulting from perinatal transmission. Therefore, pregnant health-care workers should be especially familiar with and strictly adhere to precautions minimizing the risk of HIV and HBV transmission. APPENDIX D GUIDE TO INFECTIOUS WASTE HANDLING INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Isolation waste Bandages, cloth Low Double plastic Collect & place in Avoid contact surgical waste and paper items, biohazard bags’ a plastic biohazard with open Dialysis waste disposable plastic placed in rigid bag. Avoid contact wounds (cuts devices, gloves. containers with with skin. Wear scratches.) the biohazard gloves. Clean Wash hands symbol on them. spill area with thoroughly DO NOT COMPACT! detergent-based following any disinfectant.*** contact. Disinfectant should remain in contact a min. of 5 mins. prior to clean-up. WASH HANDS! Sharps Needles, broken High Should be in rigid Handle with Cuts or glass, broken impermeable extreme puncture plastics, scalpel closed containers, caution! Wear wounds blades. placed in double disposable need plastic biohazard gloves. Use immediate bags’ and rigid tools, such first aid containers with as shovel or treatment**** biohazard symbol scoop to handle Immune on them. Handle sharps. Avoid globulin and with extreme cuts. Contain or Hepatitis caution to prevent spill and vaccine may penetration of the decontaminate be container. with a 1/15 appropriate. DO NOT COMPACT! dilution of Refer to a household Physician. bleach** for 30 mins. Carefully place sharps in rigid container. WASH HANDS! Blood, blood Outdated blood Moderate Handle so as to Spills of Contaminated products and bank blood, (if portal of prevent contact infectious cuts or other biological products, entry through with skin. liquids should wounds need fluids serum, clinical cuts and DO NOT COMPACT! be absorbed immediate laboratory abrasions with an first aid samples. is present) absorbent treatment.**** material (paper Immune towel). Wear globulin and disposable gloves. or Hepatitis A 1/5 dilution vaccine may of bleach** be should be appropriate. poured over Refer to a the absorbed Physician. spill. Let Exposure to stand 30 mins. unbroken page 2 INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Cont’d Place material skin is less in biohazard dangerous. Blood, blood bags. Handwashing products and WASH HANDS! will minimize other biological the risk of fluids. infection. Laboratory Cultures of Low to Untreated Wear two pairs Contaminated wastes infectious Very High laboratory of disposable cuts or wounds agents (Depends waste must gloves. need immediate contaminated upon the be handled Cuts and first aid glass and composition very wounds must treatment. plasticware, of the waste carefully. be covered Wash pipettes, and and on level Decontaminated Place waste thoroughly other lab of prior (autoclaved) in suitable with soap and supplies. treatment. waste is not container water. infectious and (plastic bag). Apply an may be handled Remove gloves antiseptic with and place in such as noninfectious container. Put Betadine or waste when on new gloves. other agent.**** when Decontaminate Medical decontamination area with attention may has been detergent-based be required. properly disinfectant.*** An monitored Place gloves in investigation and the waste biohazard bags. of possible is clearly WASH HANDS! agents labeled. present should DO NOT COMPACT! be made in order to aid in the management of possible infection. Pathological Human tissues, Low These wastes When cleaning See blood and wastes organs, and should be up spills, wear blood products. body parts packaged in disposable sealed opaque gloves. Spilled biohazard contents should bags’ and be placed in a placed in rigid new bag and the container with contaminated area the biohazard treated as with symbol on blood and blood them. Most product spills. states require Following clean-up, incineration or place gloves in interment. Do waste bag and not rupture seal bag. the bag. DO NOT COMPACT! WASH HANDS! page 3 INFECTIOUS WASTE HANDLING PRECAUTIONS CATEGORY COMPOSITION HAZARD SPECIAL SPILL HEALTH (EXAMPLE) LEVEL HANDLING PROCEDURES DATA PROCEDURES ***** Carcasses of Infected animals Low Double plastic Personnel should If possible, infected animals carcasses and to biohazard bag’s wear gloves or determine the and contaminated bedding moderate. placed in rigid a respirator and nature of bedding. contaminated containers with goggles to avoid agents present with infectious the biohazard to avoid exposure in the waste. agents from symbol on them. to airborne Exposure to research contaminated dust. dust may facilities. DO NOT COMPACT!!! Spilled bedding result in should be confined, allergic wet with a SMALL reaction and amount of water and or to control dust respiratory and placed in new infections. bags. Never add Medical bleach directly to evaluation of spilled bedding. of personnel Once spill is with repacked, clean respiratory up with symptoms detergent-based following disinfectant.*** clean-up is WASH HANDS!!! recom- mmended. Exposed cuts and wounds must be washed thoroughly and treated with appropriate antiseptic**** *All infectious waste should be double bagged (each bag a minimum of 2 mil thickness and placed in rigid containers all the generator site. Double bag may be replaced by a single 3 mil bag. **Clorox, Purex ***Lysol, Pinesol, etc ****Betadine, tincture of iodine, mercurochrome *****Disposable protective equipment should be placed in a bag with waste. Non-disposable equipment should be properly disinfected. DIABETES & GLANDULAR DISEASE CLINIC ACCIDENT PREVENTION PROGRAM DATE Diabetes and Glandular Disease Clinic Safety Program Table of Contents STATEMENT OF POLICY SAFETY RESPONSIBILITIES Supervisors Employees QUARTERLY ACCIDENT/INJURY ANALYSIS Quarterly Accident/Injury Analysis Form RECORD KEEPING POLICY Safety Record Keeping Form SAFETY EDUCATION AND TRAINING Safety Meetings Annual Training Ongoing Training New Employee Safety Orientation Safety Reprimand Forms: In-service Attendance Record Safety Meeting Record Basic Safety Rules Office Safety Rules Safety Rules Acknowledgement Form Safety Training Form New Employee Safety Orientation Record Form Safety Reprimand Form Employee Report of Unsafe Conditions Form SAFETY AUDITS/INSPECTIONS General Safety Inspection Form ACCIDENT INVESTIGATION Accident Reporting Procedures Supervisor’s Accident Investigation Training Guide Accident Investigation Form Emergency Information Poster SAFETY PROGRAM REVIEW/REVISION Annual Review Form SPECIFIC/PROGRAMS/INSTRUCTIONS/RULES Hazard Communications Program: “Safety Policy in Biohazardous Materials & Exposure Control Plan” Warning Signs and Labels Chemical Hazards Electrical Safety Fire Prevention and Control General Requirements for Personal & Laboratory Safety Definition of Infectious Waste Disposal of Biohazardous Waste Guide to Infectious Waste Handling Universal Blood & Body Fluid Precautions Radiation Monitoring Program Storage & Handling of Radioactive Materials Ten Commandments For Clinical Laboratory Personnel Manual Lifting Procedure Manual for Specimen Collection & Processing Physicians Plaza II Fire Safety and Emergency Plan Fire and Disaster - Emergency Evacuation (Policy #12) SAFETY RESPONSIBILITIES FOR Diabetes and Glandular Disease Clinic Supervisor’s Safety Responsibilities: Safety is an much as part of the supervisor's responsibility as that of getting the job done efficiently. The most important items, safety, wise, falling the supervisor’s shoulders are: 1. Use simple, easily understood instructions. Follow up to ensure compliance with those instructions. 2. Correct or have corrected all reported hazards. Operating under known hazardous conditions will not be tolerated. 3. Do not permit new or inexperienced employees to work with power tools or complex equipment without proper instruction. 4. Give adequate instructions. Do not assume that an employee knows how to do a job unless you personally have knowledge that the person can perform that task correctly. 5. Ensure that proper tools and/or equipment is available for the job at hand. 6. Ensure that proper personal protective equipment is available and that employees use it when necessary or required. 7. Always set a good example in safety, such as wearing the needed proper safety equipment (eye protection, hand protection, laboratory gowns, etc.) 8. Do not allow the use of unsafe tools or equipment. 9. Rigidly enforce the Company Safety Policies and its rules. 10. Ensure that all employees are provided with a copy of company safety procedures, and that they understand them. 11. Encourage safety suggestions from employees under your supervision. 12. Obtain prompt first aid for injured employees. Employee Safety Responsibilities: All employees bear a certain amount of responsibility in any safety program. You must be aware that your actions, mental state, physical condition, and attitude directly effect the safety of yourself and your fellow employees. All Employees Will: 1. Know your job, follow instructions, and think before you act. 2. Use your protective equipment (eye protection, hand protection, laboratory clothing, etc.), as the job requires. 3. Work according to good safety practices, as posted, instructed, and discussed. 4. Refrain from any unsafe act that might endanger yourself or your fellow workers. 5. Use all safety devices provided for your protection. 6. Report any unsafe situation or act to your supervisor or safety person, immediately. 7. Assume your share of responsibility for thoughtless or deliberate acts that cause injury to yourself or your fellow workers. 8. Follow Company safety rules. 9. Never operate equipment that you are not trained in or equipment that is defective or in need of repair. 10. Report all accidents as soon as they happen to your supervisor. Diabetes & Glandular Disease Clinic Policy FOR QUARTERLY ACCIDENT/INJURY ANALYSIS ( ) will at least quarterly review all injuries, mishaps, near misses, property damage, accident investigation reports, unsafe condition reports, and equipment/facility inspection reports that have occurred over the past quarter to determine if injury or hazard trends are developing. Causes will be determined whenever possible. ( ) will in concert with the Safety Officer, initiate prompt corrective action to reduce hazardous exposures to employees and will follow up on effectiveness of corrective action taken to make sure the hazard has been abated. The attached “Quarterly Accident/Injury Analysis” form shall be used to document this accident/injury analysis. This documentation will be kept on file in the main office for a period of at least five years. Diabetes & Glandular Disease Clinic QUARTERLY ACCIDENT/INJURY ANALYSIS Date:______________________ Year:__________ Quarter__________ Prior 3 quarter’s data shall be reviewed for trends: Analysis (attached additional pages if needed): Accident/Injuries (OSHA recordable and first-aid) Reviewed: Incident/Accident Investigation Reports Reviewed: Unsafe Conditions Reports Reviewed: Inspection Reports Reviewed: Corrective Action (Include responsible party for implementation) Prior quarter’s corrective action status: Review completed by ______________________ ____________________ ___________ Printed Name Signature Date Diabetes & Glandular Disease Clinic SAFETY AUDITS/INSPECTIONS A documented quarterly self inspection of all facilities will be conducted by each respective department supervisor in a effort to detect unsafe conditions and initiate corrective actions as soon as possible. Supervisory personnel are delegated the responsibility to conduct the inspection of facilities each quarter for unsafe conditions and unsafe observed acts of employees. Such information will be documented and provided to management for evaluation and initiation of corrective action. An employee may be requested to assist the supervisor in conducting the inspection. Attached audit/inspection guides will be used and filed in the main office. A biannual documented safety inspection of all facilities will be conducted by the Safety Officer. Employees are responsible for inspecting their work areas for possible hazards on a continuing basis, equipment will be inspected daily to identify any hazardous conditions prior to beginning daily work. Hazards will be reported to supervisory personnel. Diabetes & Glandular Disease Clinic RECORDKEEPING POLICY It is the policy of Diabetes & Glandular Disease Clinic to maintain records of all Health/Safety documents for a minimum of five years (long if required by law), not including the current year. Susie Solis - Assistant Business Administrator will maintain logs and files that include, but are not limited to: INJURY RECORDS: Injuries, per OSHA definitions, will be recorded on an OSHA 200 form or equivalent within 24 hours of being reported. A master injury log will be maintained in the main office for reporting of all injuries, no matter how minor. The summary portion of the OSHA 200 form will be posted in accordance with the current Federal Guidelines-1993 Guidelines require the form to be posted from February 1st to March 1st of each year in a location where employee notices are normally placed. TWCC-1 forms filed with the TWCC shall be kept on file in the main office. Claim/loss information from insurance carriers (all lines of coverage) shall be maintained in files in the main office. INSPECTION REPORTS: A log and file will be maintained in the main office itemizing all inspection reports required in the Safety Program. All equipment and facility inspection reports will be maintained in a file in the main office. Only company approved inspection forms will be used. The departmental supervisor is responsible for turning in monthly inspection reports, with noted correction action taken, to the main office. SAFETY MEETINGS: A log and file of safety meetings held by each area of operation will be maintained in the main office. Only company approved safety meeting forms shall be used. When safety meetings are used as training activities, it should be duly noted on the log. The individual conducting the safety meeting is responsible for turning in a copy of the safety meeting to be main office. Page 2 Recordkeeping Policy SAFETY TRAINING A log and file of all training shall be maintained in the main office. Only company approved safety training forms shall be used. Annual and/or quarterly safety training requirements will be noted on the log and monitored by the main office. All training requirements by OSHA/Regulatory Agencies will be conducted in accordance to regulatory time requirements. Regulatory recordkeeping requirements will be followed. Specialized training concerning specific equipment, hazard communication, radiation safety, bloodborne pathogens etc. will be conducted and documented using company forms in accordance with OSHA/Regulatory guidelines. NEW EMPLOYEE SAFETY ORIENTATION: A log shall be maintained by the main office to insure that new employee safety orientation is conducted with all new employees. Supervisors are responsible for conducting new employee safety orientation using company approved forms. INCIDENT /ACCIDENT INVESTIGATION REPORTS: A log will be maintained by the main office to insure that an accident investigation report is turned in for each reported accident/incident. The main office will maintain a file of all accident investigation reports. Only company approved accident investigation report forms shall be used to document accident investigation data. QUARTERLY ACCIDENT/INJURY ANALYSIS: A file of Quarterly Accident/Injury Analysis reports shall be maintained in the main office. SAFETY EQUIPMENT ORDERED/RECEIVED: A record of safety related equipment ordered and received shall be maintained by the main office. Safety equipment ordered shall be of the specific type/design to address the exposure present. Example: proper type of chemical resistant glove for chemical exposure and physical examinations, sharps containers, protective eye wear, etc. Ms. Geri Becker - Safety Officer will monthly spot check files for inclusion of required safety documentation. SAFETY RECORDKEEPING____________________________ Year Department Jan Feb March April May June Safety Meetings Monthly___________________________________________________________ New Employee Safety Training Safety Inspections Equipment Safety Inspections Vehicle Safety Inspections Safety Training-PPE Safety Training Safety Training Accident Investigation Safety Equipment Ordered/Received *Insert appropriate dates, initials, etc. Page 2 SAFETY RECORDKEEPING__________________________ Year Department July Aug Sept Oct Nov Dec Safety Meetings Monthly____________________________________________________________ New Employee Safety Training Safety Inspections Equipment Safety Inspections Vehicle Safety Inspections Safety Training-PPE Safety Training Safety Training Accident Investigation Safety Equipment Ordered/Received *Insert appropriate dates, initials, etc. DIABETES AND GLANDULAR DISEASE CLINIC SAFETY EDUCATION AND TRAINING Safety Meetings: Safety meetings are an effective way to encourage and inform employees in developing and following safe work practices and will be held on a least a monthly basis. Management will participate in safety meetings. Discussions of new safety rules, possible hazards to be encountered in future job duties, or changes in procedures or equipment are some topics which should be covered on a regular basis. When safety training is provided during safety meetings, it will be documented as to the date, attendance (signature in each employee’s own handwriting) and topic discussed. The attached form for documenting such safety meetings is attached for required use. Annual Training: Annual training will be provided to Diabetes and Glandular Disease Clinic employees in the following area: A. Drug Abuse Policy B. Back Injury Prevention C. Safety Rules/Procedures D. Reporting Unsafe Conditions, Defective Equipment, Unsafe Work Practices E. Safety Equipment F. Personal Protective Equipment G. Equipment Guarding H. Housekeeping I. Fire Extinguishers J. First-Aid Supervisors shall train new employees in the above areas upon hire. Specialized Training: Specialized training listed below will be conducted by the Safety Officer, as applicable, in the following: 1. Bloodborne Pathogens 2. Hazard Communications 3. Emergency Evacuation 4. Radiation page 2 DIABETES AND GLANDULAR DISEASE CLINIC SAFETY EDUCATION AND TRAINING Ongoing Training Management and supervisors will provide ongoing safety training in the following areas as the need arises: A. New Equipment/Material Purchases (Example: new chemicals) B. New or Change in Operations C. Identified Area of Increased Accidents D. Newly Identified Areas of Exposure New Employee Safety Orientation: Documented procedures will be established to make sure that all new employees are informed of the hazards of the job they are bout to perform. This will include a briefing by the supervisor to review the safety rules applicable to that job/equipment. The new employee will be given the opportunity to ask relevant safety questions. The new employee will be required to sign indicating he has been provided safety training in a specific area of operation. Attached is a new employee safety training form that is required to be used. Documentation of Training: All safety training will be documented on the provided form that includes date, topics discussed, trainer, and signature of employees attending training. This documentation will then be placed in the proper Safety Training File in the main office. Reporting Unsafe Conditions: All employees are encouraged and required to report any unsafe conditions they observe. Supervisors are required to promptly respond to all reported unsafe conditions. Safety Reprimands: Should employees be observed not following documented safety rules/procedures, the attached Employee Reprimand form shall be used. Supervisors should make every effort to make sure employees are following safe work practices. Diabetes & Glandular Disease Clinic SAFETY RULES DIABETES & GLANDULAR DISEASE CLINIC BASIC SAFETY RULES 1. In case of sickness, injury, accident or any serious situation, report at ONCE to your immediate superior. 2. Safety devices are for your protection--do not remove or “work around” them. This applies to all types of equipment. 3. Horseplay, throwing things, scuffling, fighting, and/or pranks are all very dangerous and will not be tolerated anywhere at anytime. 4. Never distract the attention of another worker as you might cause him to be injured. 5. Any type of jewelry, rings, bracelets, necklaces, watch chains, wallet chains, key chains and the like shall not be worn when working around moving equipment or machinery. 6. Eye protection, of the type prescribed by the company, must be worn where required. 7. Do not attempt to lift or push objects that may be too heavy for you. Ask for help when you need it. Lift the right way by bending your knees and keeping your body erect, then push upward with your legs. 8. Smoking is forbidden as specified in certain areas. 9. If in doubt about the operations of any machine or equipment, get in touch with your supervisor, get proper instructions first. 10. Keep all work areas clean to reduce trip and fall exposures. 11. Learn the location and proper use of all fire fighting equipment. 12. If you see someone working carelessly, warn and advise them to work carefully. 13. Obey all warning signs and all safety rules. 14. If you don’t know the safe way, stop and find out, use common sense. Page 2 DIABETES & GLANDULAR DISEASE CLINIC BASIC SAFETY RULES 15. The use, possession or distribution on the premises, or in the workplace of any of the following, is STRICTLY PROHIBITED; 1) alcoholic beverages 2) intoxicants and narcotics 3) illegal or unauthorized drugs (this includes marijuana) 4) “look alike” (simulated) drugs 5) related drug paraphernalia 6) firearms and unauthorized explosives are all STRICTLY PROHIBITED, this includes during lunch hour and after work on company property. 17. Employees must not report for duty under the influence of any drug or alcohol. VIOLATION OF SAFETY RULES All employees must obey all safety rules, regulations, and safe work practices as outlined in the Company Safety Policies. Failure to obey safety rules and safe work practices, including the use of appropriate safety equipment, are grounds for disciplinary action, up to and including termination. I acknowledge that I have received a copy of and understand the Basic Safety Rules. I also agree to abide by all departmental safety rules. __________________________ Name of Employee (PLEASE PRINT) __________________________ Signature of Employee Date __________________________ Signature of Witness Date DIABETES & GLANDULAR DISEASE CLINIC OFFICE SAFETY RULES Most people who work in offices feel that they have hazard-free jobs. The facts are in to show that all occupations have serious injuries. The simple office area, which we envision as a hazard-free operation, in fact has serious hazards for unsuspecting employees. Safety can be described as the freedom from dangers of hazards. Dangers and hazards in the office environment may be recognized in a number of ways. One of the largest hazard areas is the sprain/strain injury. Other obstacles lead to the slip, trip and fall injuries. Cuts and punctures cause injuries. Potential electrical hazards exist with electrical operated office equipment. Disarranged office equipment, boxes and materials serve as potential hazards. Floor surfaces often lead to the fall incidents. 1. Keep desk drawers, file drawers and cabinet doors closed when not in use. 2. Use a step ladder or step stool to reach high places. Never stand on boxes, chairs, tables, or desks. 3. Avoid sitting on the edge of chairs. Do not tilt back when sitting in a straight chair. 4. Keep the floor free of tripping hazards such as telephone cord, electric extension cords, and boxes. 5. Keep materials stored on shelves in a manner which will prevent their falling. Heavy objects should be placed on lower shelves. 6. Do not attempt to clean oil or adjust any machine that is running. If the machine is not equipped with a starting switch that can be locked in the “off” position, it should be disconnected from the power source. 7. Unsafe electrical cords, faulty electrical or other equipment, or any hazardous condition should be reported at once. 8. Broken glass and other sharp objects should not be placed loosely in waste paper containers. Items should be wrapped in heavy paper to prevent injury. Page 2 DIABETES & GLANDULAR DISEASE CLINIC OFFICE SAFETY RULES 9. Cigarettes, cigars and other burning materials should not be placed in waste paper containers. 10. Common or sharp-pointed pins should not be used for fastening paper together. Use only approved fasteners such as regular staples, paper clips, etc. 11. Keep floors free of water spills, paper clips, pencils and other slipping hazards. 12. Repair carpeting with holes, rips or tears. Secure carpeting against slipping. 13. Provide well lighted work areas. 14. All employees should walk; not run; and watch their step. Employees, particularly female, are encouraged to wear shoes providing stable footing. 15. Keep outside walks, parking areas and entrances free of ice, holes, obstructions and tripping hazards. 16. Use good judgment and correct lifting posture when it is necessary to move or carry office machines and to get help if necessary. 17. Employees are instructed to use correct lifting methods (back straight, legs bent). 18. Before attempts are made to move heavy items, assess the job first. Determine if you can safely handle the task and use equipment such as carts and dollies if they are available. It is much better to obtain help from a co-worker than to risk the chance of incurring a strain or sprain injury. 19. To avoid strains from improper handling of boxes and bundles of office supplies, ledgers, portable filing cases and office machines. lifting should be done with the back erect by using the more powerful leg muscles. Page 3 DIABETES & GLANDULAR DISEASE CLINIC OFFICE SAFETY RULES 20. Pointed objects, such as pencils, knives or scissors should not be carried with the point exposed in the pockets, attached to the clothing, or through congested aisles or working areas. 21. Gummed strips of envelopes should be moistened with suitable devices, not with tongue. Avoid opening envelopes with finger and sliding hands along edge of paper. 22. Keep fingers away from cutting edge of paper cutters. The cutting knife on hand-operated cutters should never be left raised while unsupported: it shall always be closed when not in use. Machine- operated cutters shall be properly guarded to prevent inadvertent operation or contact with the cutter. 23. Use extreme care in opening file cabinet drawers. Opening of over- loaded upper drawers, particularly more than one at a time, may tip over the cabinet. Where several tiers of cabinets are used at one location, they should be fastened together. 24. Open doors slowly to avoid striking anyone on the other side. DIABETES & GLANDULAR DISEASE CLINIC SAFETY TRAINING Date: _____________________ Trainer: ___________________ Description of Training: Signature of Employees Attending Training: Refresher Training Needed: _________________ *Attach Copy of Training Materials/Handouts Used. Employee Name: _____________________ Date Employed:___________ Occupation: _________________________________________________ NEW EMPLOYMENT SAFETY ORIENTATION RECORD* Date Supervisor’s Employee’s Item Completed Initials Initials Overall Safety Program discussed with employee. General Safety Rules and safety rules specific to job duty discussed with employee. Employee safety responsibilities reviewed with employee: where and when to report unsafe conditions, how/when/where to report injuries, care and use of tools and equipment. General hazards in workplace reviewed. Substance abuse policy discussed with and signed by employee. Safety goggles issued (if needed). Other protective equipment issued: Hazardous chemicals, including MSDS, discussed with employee. Proper lifting and materials handling discussed with employee. Identified past safety problem areas in employees job duty area discussed with employee. Record Keeping system discussed with employee. *To be placed in employee personnel file. DIABETES AND GLANDULAR DISEASE CLINIC EMPLOYEE REPRIMAND DATE: ____________________ REGARDING EMPLOYEE: _________________________________________ EMPLOYEE POSITION: __________________________________________ LOCATION: __________________________________________________ REGARDING: COMPANY POLICY/SAFETY/FOLLOWING INSTRUCTIONS/OTHER DESCRIBE: _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________ _______________________________________ (Employee Signature) (Supervisor’s Signature) EMPLOYEE IS: ___________RETURNED TO DUTY ___________TERMINATED CC: SUPERVISOR EMPLOYEE PERSONNEL FILE *State Company policy or safety rule/procedure violated. EMPLOYEE REPORT OF UNSAFE CONDITIONS WHERE: ____________________________________________________________________________________________________________________ WHEN: ____________________________________________________________________________________________________________________ WHAT: ____________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________ __________________________________________________________ (Signature) (Date) ___________ (Received By) SAFETY ACTIONS INITIATED: ____________________________________________________________________________________________________________________ ____________________________________________________________________________________________________________________ REPLY TO THE ATTENTION OF: ___________________________________ Date Closed: ________________________________ Diabetes and Glandular Disease Clinic SAFETY AUDITS/INSPECTIONS A documented monthly self inspection of all facilities/equipment will be conducted by each respective department supervisor in effort to detect unsafe conditions and initiate corrective action a soon as possible. Supervisory personnel are delegated the responsibility to conduct the inspection of facilities/equipment each month for unsafe conditions and unsafe conditions and unsafe observed acts of employees. Such information will be e documented and provided to management for evaluation and initiation of corrective action. An employee may be requested to assist the supervisor in conducting the inspection. Attached audit/inspection guides will be used and filed in the main office. A quarterly documented safety inspection/audit of all facilities will be conducted by the Safety Officer. Employees are responsible for inspecting their work areas for possible hazards on a continuing basis. Equipment will be inspected daily to identify any hazardous conditions prior to beginning daily work. Hazards will be reported to supervisory personnel. DIABETES AND GLANDULAR DISEASE CLINIC SAFETY PROGRAM REVIEW/REVISION ________________will annually review the entire Safety Program for revisions to meet exposures within current operations. Areas that will be carefully evaluated include: operations added, equipment added/changed, changes in environmental conditions, adequacy of personal protective equipment, etc. Procedures should be reviewed to make sure they are still applicable. Upon changes in the Safety Program, all employees will be informed in writing of these changes and provided proper safety training as needed. This annual review will be documented on the attached form and kept on file in the main office. ANNUAL REVIEW OF SAFETY PROGRAM YES/NO or */X MANAGEMENT COMPONENT ____ Statement of Policy is current? ____ Are copies of the policy provided to new employees? ____ Employee/Supervisor rules and responsibilities are assigned? ____ Employee acknowledgement is current and in use? ____ Accountability has been established? ANALYSIS COMPONENT __ Safety program documentation has been reviewed for completeness? ___ Discrepancies have been corrected? ___ Injury log is current? ___ Insurance loss run information matches in-house records? ___ Safety program continues to address all current company operations and employee activities? RECORDKEEPING COMPONENT ___ Procedures and in place to ensure the following records are kept and organized? a. safety inspections b. safety meeting minutes c. required training d. accident investigations e. injury logs (OSHA 200) f. emergency preparedness drills EDUCATION AND TRAINING COMPONENT ___ All employees have received orientation training? ___ All employees participate in regularly scheduled safety meetings? ___ Management provides resources and participation in employee training? ___ Employees have received and acknowledged required training? a. work area hazards b. personal protective equipment care and use c. emergency action plan d. location and use of emergency equipment e. back injury prevention f. hazard communication g. equipment operation h. other required training ___ Do all employees participate in annual update training? ___ Employees have received instruction to repot unsafe conditions, defective equipment, and unsafe acts? ___ Supervisors have received instruction in accident investigation and hazard abatement? AUDIT/INSPECTION COMPONENT ___ Regularly scheduled inspections are conducted by qualified personnel? ___ Inspections include all facilities, worksite locations, vehicles, equipment, tools, and PPE? ___ Inspection of fire suppression equipment is included in the inspection? ___ Inspection of available first-aid provisions is included the inspection? ___ Are inspection checklists utilized? ___ Are procedures in place to follow-up on inspections to ensure deficiencies are corrected? Page 2 ANNUAL REVIEW OF SAFETY PROGRAM Yes/No or */x ACCIDENT INVESTIGATION COMPONENT ___ Are responsibilities assigned for all phases of the accident investigation process? a. Who completes the TWCC-1? b. Who completes the accident investigation report? c. What forms are used? d. What about vehicular/equipment accidents? e. Who ensures corrective actions are implemented and effective? ___ Have all involved employees received training in accident investigation techniques? PERIODIC REVIEW AND REVISION COMPONENT ___ Is this review conducted at least annually? ___ Are the results of this review shared with management/supervisors/employees? ___ Are professional safety services or other sources utilized in revising or updating the safety program? CORRECTIVE ACTIONS ___ Are deficiencies of this review, proposed correction actions, and commitment dates described in attached documents? Reviewed by:_________________ Last paper here SAFETY RECORD KEEPING Year Department Jan Feb March April May June Safety Meetings Monthly_________________________________________________________ New Employee Safety Training Safety Inspections Equipment Safety Inspections Vehicle Safety Inspections Safety Training-PPE Safety Training Safety Training Accident Investigation Safety Equipment Ordered/Received *Insert appropriate dates, initials, etc. Page 2 SAFETY RECORD KEEPING Year Department July Aug Sept Oct Nov Dec Safety Meetings Monthly_________________________________________________________ New Employee Safety Training Safety Inspections Equipment Safety Inspections Vehicle Safety Inspections Safety Training-PPE Safety Training Safety Training Accident Investigation Safety Equipment Ordered/Received *Insert appropriate dates, initials, etc. This ends Rachels work. Thank you Snuggles Japanese Innovative Strengths and Weaknesses By Paul Herbig* and Laurence Jacobs** Abstract: What are Japan’s innovative strengths and weaknesses? Are they truly innovative and, if so, how? In what areas are they innovative and in what capacities do they lack innovative skills? This manuscript examines these questions, makes conclusions, and offers recommendations on the future of Japan’s innovative efforts. Introduction Many observers of Japan believe the Japanese are exceptional innovators and have taken the technological lead from the United States. For example, the National Science Foundation in its The Science and Technology Resources of Japan: A Comparison with the United States (June 1988) evaluated the relative positions in twelve technological areas in terms of basic research, advanced development, and production and engineering abilities. Japan was judged to be ahead in seven areas whereas the United States was judged to be ahead in only three (the rest were tied). In advanced development, Japan was judged ahead in four areas, even in three, and behind in five others. In basic research, Japan led in three but was behind in the other nine. The study also determined that Japan was not only ahead but was also pulling further away in fiber optics, integrated circuits, mobile radio systems, automated factory assembly, compact disk technology, and computer design. The report indicated that Japan’s major weakness was in basic science and research whereas its greatest strengths were in the production and engineering areas. However, many skeptics question Japan’s innovative abilities. Many observers using the same data derive different conclusions; they believe that Japan is still primarily a “copycat” culture whereas the United States is the world’s technological leader and will continue to be so. Proponents of this view indicate that even the famous Japanese management techniques are adapted and improved versions of North American models. The quality circle (QC) concept was adapted from the Scanlon Plan, which the Japanese observed in the United States and modified for their own usage during the 1950s (Sakach, 1987). Many Japanese say the QC concept is an adaptation of a local ringi (consensus group) and of methods which evolved from rice paddy farming. Statistical quality control was introduced in Japan in the early 1950s by W. Edwards Deming, an American. Almost all Japanese management practices can be described as a Nipponization of something seen in the West. A 1992 McKinsey study says that while Japan has pulled ahead of the United States in several heavy manufacturing industries including cars and machinery, it lags far behind in at least half of its manufacturing base. Even many Japanese believe Japanese “society has become optimized for standardized mass production and Japan is the largest and most competitive producer in an industry only when the given products— transistors, automobiles, calculators, semi-conductors—have entered the state of mass production.” Which side is right? Both or neither? Is Japan a superb innovator or a copycat? The technological behavior of Japanese firms is oriented toward shorter development times, an effective identification and acquisition of external technology, a higher propensity to patent, high manufacturable designs, incremental product and process improvement, competitive matching, an innovation system dominated by large firms, a tendency to combine technologies, interfirm technical cooperation, and a much stronger role of technological planning within corporate strategy. (In the United States, research and development [R&D] organizations tend to be independent of production centers whereas those in Japan are integrated with the manufacturing divisions.) American thinking about the innovation process focuses excessively upon the earliest stages—those kinds of new products or technologies that occasionally emerge out of basic research (sometimes called radical innovation), those creative leaps that sometimes establish entirely new product lines, and the activities of the upstream inventor or scientist rather than the downstream engineer. The emphasis is on major innovations and pioneering efforts rather than sustained effort and small improvements (Rosenberg and Steinmueller, 1988). An example of this is the American invention of the solid-state transistor. In 1953, Western Electric licensed the technology to Sony, whereupon Sony made dramatic improvements on it and launched a host of high-quality consumer electronics products. In 1968, Unimation, an American company, was the pioneer behind robots. It then licensed Kawasaki Heavy Industries to make industrial robots; the American robotics industry never quite got off the ground whereas the Japanese quickly perfected the idea. These are but two of many possible examples over the last thirty years of the Japanese improving and marketing a superior product that was first invented and innovated in the United States. The Japanese literally have concentrated on application to a point at which many of their copies are superior to the American originals (Sakach, 1987). When we look at Japan, we tend to see more application than we do invention. Even the literal Japanese translation of “R&D”—kenkyu kaihatsu—implicitly denotes commercialization. Imitation and application has its advantages. New state-of-the-art technology tends to be like a ladder: climb it and you acquire new knowledge that confers a competitive advantage but only until your competitors learn the new technology; then you have to climb the ladder again. Process-oriented innovation has no beginning and no end; each turn of the wheel improves an existing product and its production methods. The company unveils not-entirely-new products that keep getting better, more reliable, and cheaper, but cumulatively the advantage adds up. In addition, with the soaring cost of doing leading-edge research, the quick-moving follower has certain advantages. For example, the next-generation chipmaking method will use X-rays instead of light to print circuit patterns on silicon. Nearly half a billion dollars will have to be spent by each potential competitor to upgrade to this new technology. The number of entrants decreases in each cycle as the ante keeps climbing (the emergence of international strategic alliances is tacit acceptance that no one company, not even a company the size of Texas Instruments or Siemens, can remain in this game at this level and for these stakes). The pioneers must continue to run even faster just to stay ahead. The follower, in contrast, can watch and wait, seeing which way the wind blows; if the product or technology appears to be a winner, the follower can jump in, having allowed the pioneer to pay all the expenses of market research and development. However, being a follower (even one as good as Japan has been) still implies severe disadvantages and major risks, which could well cause an end or a slowing down of the Japanese miracle: Once a developing country has caught up and reached the technological frontier, no obvious areas exist in which application of large-scale capital can produce certainty of rewards. This is where Japan now stands—at the crossroads between being a capable follower and an inexperienced, unfamiliar, uncertain pioneer. Within the last two decades, the Japanese economic machine has developed into the leading economy in the world on a per capita income basis, second only to the United States in Gross Domestic Product (GDP). (However, the average per capita conceals the fact that Japan’s real purchasing power is reduced by the high costs of food, consumer goods, land, and housing.) Japan has virtually conquered the American consumer electronics, semiconductor, and machine tool marketplace and, except for quotas, would have done the same for the automotive segment. The reasons this has been accomplished are many, and some say it is because of the Japanese ability to listen and serve their customers, to deliver quality merchandise at a lower price, and to be innovators. Yet the question remains: How truly innovative are the Japanese? In what ways do they innovatively prosper and struggle? In this manuscript, we examine Japanese innovative strengths and weaknesses and draw conclusions and implications therein. PATENTS The custom of patents dates back to fifteenth century Europe when in 1460 the Republic of Venice granted two inventors a privilege stating that no one could reproduce their invention without their permission. By the middle of the sixteenth century, this idea had spread throughout much of Europe (Guile and Brooks, 1987). The importance of patents can be seen from the fact that British patent laws date from 1624, whereas those of France date from 1791 and those of other European countries date from the nineteenth century. The original concept of patent protection was that by preventing others from imitating an inventor’s invention or by putting the inventor in a position to license imitators only in exchange for compensation, patents would allow inventors to appropriate the economic benefits of their inventive contributions. The expectation of such rewards is what, theoretically, provides the incentive to invent. Absent patent protection, imitation might occur so swiftly that an inventor would not be able to make a return on the investment and hence would not have an incentive to invent. Patents have been simultaneously praised for providing the economic incentives to innovate and condemned for creating monopolies that stifle competition and raise prices for consumers. Is it only coincidental that the periods of greatest innovation come during strong times of patent protection? The opposing viewpoint states that most companies need innovation for competition’s sake, that patents represent “cream on the pie,” and that patent protection in itself is not the primary incentive to innovate. Patents are far from perfect as a means of appropriating the benefits from the invention; rarely is a patent so strong that a determined effort to circumvent it does not succeed. Mansfield (1989) found that inventing around a patent requires substantially less cost and takes less time than the original invention. Although patents provide strong protection, they may also stimulate overinvestment in R&D as firms duplicate each others’ inventive programs or when competitors attempt extensive R&D aimed at circumventing a patent. Despite the imperfections of the patent system, any other form of protection or incentive has been found to work less well. Economists have determined that inventive activity responds elastically to the demand price of an invention, implying that it is influenced by the correct incentive policy. This should make the private rewards proportional to the potential social value of inventive output, which is precisely what the patent system achieves (Wyatt, 1986). More importantly, the patent system encourages ideas that represent departures from accepted practices, particularly radical innovations. In addition, patents are especially useful in assisting those who pursue unpopular or different ideas. The number of innovations realized per patented invention varies considerably across industries. The relatively high ratios of patents per innovation in the chemical and petroleum sectors and the relatively low ratios in the computer, electrical machinery, lumber, and instruments sectors can be explained by the fact that the value and cost of individual patents vary enormously within and across industries. In some industries, like electronics, considerable speculation exists that the patent system is being bypassed to a greater extent than in the past. Nonetheless, a society that wants to foster invention and innovation must make them worthwhile to the potential inventors and innovators. The patent process, by providing protection to inventors and giving them a monopoly on the rights to their inventions, spurs innovation. The importance given to patents is reflected in the Uruguay round of GATT (General Agreement on Tariffs and Trade). Intellectual property rights protection (of which patents are a part) were a key part of GATT discussions. In addition, the United States aggressively pursued patent protection for American inventors throughout the world during the late 1980s and early 1990s by using the threats implicit in its Super 301 trade clause. These two parallel efforts underscore the attention and importance accorded to patents in the United States. Patents are often viewed as indicative of innovative skills. A review of patents issued by the United States during the 1980s has shown a strong trend upward in the numbers issued to the Japanese. In fact, in 1986 Hitachi ousted General Electric from its top position of receiving the most patents (Yoder and Lachia, 1988). However, numbers are not truly indicative of importance. Patents also vary widely in their significance. A patent in room-temperature superconductivity has greater potential than one that slightly modifies an electronic circuit; and yet both count equally as a statistic. The number of Japanese patents awarded to Japanese residents is greater than the number of U.S. patents awarded to U.S. residents. This is probably due more to the relatively lower costs of Japanese patenting than to any high productivity of Japanese R&D. The rapid increase in Japanese patenting efforts in the United States can be explained by the relatively small amount of technological advance incorporated into each Japanese patent (Pavitt, 1985). In fact, Japanese companies are being pressured by their backlogged government to curtail filings for minor patents. CHI Research Inc. has developed more sophisticated measures that examine patents as indicative of innovation based on earlier patents cited as building blocks for new patents. The Current Impact Index (CII) measures how often a company’s patents are cited relative to those of all other companies. The technological strength is derived by multiplying the impact index by the number of patents. Technology cycle time is the median age in years of patents cited in a company’s new patents; the shorter the cycle time, the faster the company is developing new technology (Business Week, August 3, 1992, p. 68). A review of the data for 1991 shows that eleven of the top twenty-five American patents issued in 1991 were to Japanese companies. However, American companies tended to have higher current impact indices (interestingly, the two German firms in the survey had the lowest indices), thus making up considerable distance. Japanese firms by far have a lower technology cycle time, indicating their emphasis on speed for developing new technologies. In the United States, patents are issued for significantly differentiated items and are secret until issued; in Japan, patents are regularly issued for what in the United States would be considered product line extensions and are public record when applied for. This provides more time to learn about the innovation, decide if it is worth developing, and then replicate, circumvent, or ignore the patent. Competitors can file to delay the patent and then proceed to explore the technology at will. In the United States, strong patent protection is provided to enhance R&D efforts and to provide incentives for a firm to innovate. In Japan, a family philosophy exists. An innovation does not exist merely for the inventing firm but for the benefit of the country as a whole. The entire system is aimed at avoiding conflict and promoting cooperation (cross-licensing) (Melloan, 1988). Japanese patents tend to be narrowly focused on specific improvements to technology. For example, when IBM scientists in Zurich discovered warm temperature superconductors in 1986, Japanese companies duplicated the results and within the year had flooded their patent offices with hundreds of related but minor applications. Another example is the dispute between Mitsubishi Electric and Fusion Systems Corporation. In 1985, Fusion discovered that Mitsubishi had filed more than 160 patents in Japan for products similar to its linear microwave-actuated ultraviolet lamp, which Fusion had been selling in Japan since 1975. Mitsubishi argued in its defense that it did not infringe on Fusion’s patent because the devices were significantly different in design; Fusion countered that Mitsubishi had made only trivial changes to its design. This underscores the real difference between the Japanese and U.S. patent systems. The wide diversity between what a patent is, what it protects, and its primary national objective makes the number of patents issued a questionable usable variable for determining a nation’s innovative capabilities. The Japan honors “first to apply,” whereas the United States honors “first to invent.” American applications must disclose all “prior art” and thus prove that they have something distinctly new and different; in Japan, it is possible to patent a relatively minor change. American patent applications are secret until the patent is issued; whereas in Japan, patent applications are made available to potential challengers at the time of application. Whereas the American system protects individuals, the Japanese system balances individual rights with broader social and industrial interests. As long as it is easier to copy under Japanese law, Japanese companies will continue to do so. Japan has been reluctant to tighten intellectual property laws, especially those concerning patents, believing that the country still needs easy access to the creative ideas of the West, particularly in the computer and entertainment software areas. One of the main problems with the Japanese system from a foreign company’s perspective is the extremely long patent application approval periods (an average of four to six years versus two in the United States); such applications are open to public scrutiny after only eighteen months. Japanese patents offer narrower protection and must be filed in Japanese, and there is a dire shortage of patent attorneys to pursue the interests of foreign companies. If a foreign company has a strategic technology, it should expect to wait a long time in Japan for a patent. Another concern is that domestic companies using patents pending rarely have to pay royalties for periods of use prior to patent award. In rapidly changing markets, the value of the patent protection may have evaporated by the time the patent is issued. In 1960, John Kilby of Texas Instruments applied for a patent on the integrated circuit. The patent was not awarded by the Japanese government until 1989. In the meantime, of course, the technology had far transcended Kilby’s early design. American companies have seen their prime patents stalled on Japanese bureaucrats’ desks as Japanese competitors used the technology to gain new markets. Corning Glass applied for a patent on its optical fiber in the United States in 1974; the patent was granted two years later in the United States. Corning applied in 1975 for a Japanese patent, which was granted in 1985 (Yoder and Lachia, 1988). The Japanese patent process, in comparison with most other industrialized nations, limits the issuance of patents to foreigners. In Japan, only 10 percent of all patents are foreign, versus 48 percent in the United States, 56 percent in Germany, 71 percent in Britain, and 78 percent in France. The enormous rise in Japan’s patent productivity can also be partly attributed to the sustained and steep increases in R&D investment. Real growth rates in Japanese R&D expenditures rose faster than those of any other major industrial state. Other factors may be superior company incentives; greater research continuity made possible by lifetime employment; closer contact and better communications among divisions engaged in research, production, and marketing; fiercer competition among firms; and greater company prestige derived from patenting. International comparisons of patent data tend to overstate Japanese technological accomplishments significantly. Quantitative indicators provide little information about the quality of patents. The Japanese have applied for and registered more patents than others because the knowledge they seek to protect tends to be less significant technologically and of lower quality, and the Japanese have a greater propensity to seek patents for know-how that others would consider too mundane or short lived to bother about. Nearly half the applications made by the Japanese to their own patent office are turned down, compared with less than 20 percent of foreign applicants. Patents provide a skewed and misleading picture of the present Japanese position. Experts indicate that one American patent is worth seven Japanese patents (Heiduk and Yamamura, 1990). Japanese researchers tend to apply for patents for everything as proof of research activity, and as a consequence the majority of Japanese patent applications in Japan are rejected. The turn-down rate of Japanese patent applications is also significantly higher in the United States than for any other nationality. In the United States, the pace of technological change may be so rapid that it makes a lengthy patent approval process an ineffective device for protecting property rights; with public access as patents require, many companies believe that patents will disclose vital information that will help competitors and hence they do not file. Despite the Japanese lead in pure numbers, considerable doubt exists regarding the quality of each patent issued. Patents are sufficiently vague that any inferences regarding innovative strengths and weaknesses are impossible. R&D EXPENDITURES Japan’s R&D expenditures as a percentage of GNP have continued to rise to their current level, which approaches 3 percent and leads the industrialized countries. R&D as a percentage can be misleading: Belgium spends 1.5 percent of its GNP in R&D, a percentage comparable to the United States; however, this factors out to $168 million, roughly 1 to 2 percent of total American non-military R&D spending. In Japan, the salaries of all university and college science teaching personnel are counted as if they were full-time researchers. This leads to a substantial overstatement of Japan’s overall R&D expenditures, a substantial overstatement of the academic sector’s role in Japanese R&D, and a substantial overstatement of the role of basic research. This overstatement can be as much as thirteen times (Okimoto and Saxonhouse, 1987). If percentage of GNP were the only indicator, the former Soviet Union (with R&D spending equivalent to 3.75 percent of its GNP) should have led all nations; but one would hardly qualify Russia, now or then, as a technological leader. R&D expenditures represents inputs, not output. It is important to consider not only the level of R&D spending but also its effectiveness. Capital is a necessary component for innovations but is not in itself sufficient. Not only is the quantity of dollars important but the efficient use of that money. The United States’ level of productivity is as high or higher than that achieved overseas in most industries. The United States puts as much resources in R&D as Japan, Germany, and France combined; twice as much as does Japan. The much feared and publicized Japanese effort to build a fifth-generation supercomputer aided by a government grant of $500 million over ten years (which has little to show for the effort) must be compared to the $3 billion IBM alone spent on R&D in 1984 (Baily and Chakrabarti, 1985). Percentage of GNP also is too elusive and inexact to be used to measure innovation. When it comes to research scientists and engineers relative to the size of the labor force, the United States still has more than any other country. In 1981, only about 4 percent of Japanese R&D dollars were paid to universities or independent institutes for contract work or in support grants (Clark, 1984). In 1981, more than 75,000 engineers graduated from Japanese universities but only 7,000 masters and 1,200 doctorates were awarded in engineering. The United States produced about the same number of engineering graduates but three to four times as many masters and doctorates. American receipts for sales of technological licenses to the rest of the world far exceed those of any other country. Americans write 35 percent of all of the scientific and technical articles published in the world (Thurow, 1987). If one were to compile a list of the most important innovations of the last twenty years—for example, the transistor (Bell Labs), the semiconductors chip (Texas Instruments), the small computer (Apple), and the video recorder (Ampex)—one would see that they were all American ideas. The United States still leads in research efforts, but the lead is smaller than it used to be. Differences in gross spending, numbers of scientists, and GNP percentages tell little. However, dramatic differences between Japanese and American firms in their allocation of R&D resources between process and basic research do exist. American firms devote about two thirds of their R&D expenditure to improved product technology (new products and product changes) and about one third to improved process technology (new processes and process changes). Among the Japanese firms, the proportions are reversed: two thirds are spent for improved process technology and one third goes for improved product technology. In fact during 1987, 54 percent of current Japanese R&D expenditures focused on development, 43.7 percent on applied research, and the remaining minimal expenditures—2.3 percent—were in basic research (Mansfield, 1988a). The Japanese devote a much larger percentage of their R&D dollar to tooling, manufacturing facilities and capital equipment—applied R&D—almost double proportionally than is spent in the United States. The largest proportion of Japanese R&D activity has continuously gone to development research. A study by MITI indicated that from 1960 to 1980 the Japanese came up with only twenty-six technological innovations whereas the United States had 237; however, only two of the Japanese innovations were classified as radical whereas the number of U.S. radical innovations were sixty-five (Harper, 1988). In Chakrabarti, Feinman, and Fuentevilla’s (1978, 1982) studies of 500 industrial innovations introduced in major industrialized countries from 1953 to 1973, the United States was given credit for 257 innovations, of which over half were considered radical; whereas twenty-five of the twenty-seven credited innovations from Japan were of the improvement variety. Their studies noted that over a quarter of the Japanese innovations (a proportion twice as much as found in other countries) were for the innovating firm’s internal use and meant for productivity or quality improvements. Of the U.S. innovations, greater than half of the total of sixty-eight were deemed radical or major technological shifts. Of the Japanese innovations, only 7 percent were radical and the majority were of the improvement variety. According to a 1968 OECD study, Japan has contributed only five major innovations from a list of 139 major innovations which have been invented since the Second World War: the bullet train, the transistor radio, the compact videotape recorder, the electron microscope, and the synthetic fiber Vinylon. Few examples exist to date of Japanese originality in technological development. Nobel prizes are awarded for creative breakthroughs; what do these statistics say? Pure science is a field in which geniuses reign; but geniuses often do not fit standard molds, and nonconformists do not fit well into Japan (Taylor, 1983). Only five Japanese scientists have ever won Nobel prizes (the same number as have been won by Denmark, a country considerably smaller than Japan), and most of the winners did their prize-winning work elsewhere. The 1988 winner in medicine had not lived in Japan since 1963. Leo Ezaki won the Nobel prize in 1973; he left Japan in 1960 to work for IBM in the United States. He bluntly said that Japanese society is not conducive to originality. Tadatsugu Taniguchi who discovered the structure of beta interferon, says that “geniuses get kicked out (of Japan).” He escaped the fate of others by getting his Ph.D. at the University of Zurich and studying in Italy and the United States (Yoder, 1988). The few Japanese Nobel Prize Winners have few kind words to say about Japan. “What should Japanese researchers do if they want to develop into first class scientists? Go overseas. If they’re really interested in science, then that’s what they should do. In Japan, there are no opportunities for young researchers to do independent research. Japan’s science is definitely inferior to America’s in terms of real creativity. It is very clear that Japan is making money by taking and applying the fruits of science that the West creates at great expense.” So spoke Susumu Tonegawa, Japanese Nobel laureate in medicine and physiology (1987). He critiqued the profit-oriented nature of Japanese government research programs, which tend not to pursue fundamental research but only applied research. They are stifled by a rigid hierarchy, archaic rules, inadequate funding, and enormous pressures to conform. That nearly all the Nobel Japanese winners went to the West is an unpleasant reminder of Japan’s continuing failure to produce world-class scientists. Very few mathematicians or scientists who have done significant original work are Japanese. Visiting physicists are typically unimpressed by Japanese research, which is mainly derivative in nature. Western scientists complain that Japanese labs tend to offer too little space, poor equipment, inadequate maintenance, and too few technicians. Japanese scientists rank third behind American and British researchers in contributions to scientific literature each year. Few of their research papers are cited by scientists abroad, and even fewer research papers are co-authored by Japanese and foreign scientists. It appears that the United States excels at basic science whereas the Japanese lag far behind. The vast majority of Japanese effort is not only commercial in orientation but is directed at improving on or advancing existing technology. In contrast, the West, particularly the United States, France, and the United Kingdom are extraordinarily fertile in giving birth to radical breakthrough innovations. Japanese output in this most creative related part of Research and Development is trivial by comparison. Only a small proportion of all Japanese innovation has had the primary end result of using less labor in production. Labor saving and the substitution of capital for labor in production via automation are American traits. Although robots have been utilized in great numbers, the vast bulk of the Japanese economy is made up of small Japanese firms, which account for 70 percent of the total Japanese employment and which employ inexpensive but disciplined Japanese workers. Only the top-tier Japanese companies have been diligent and consistent in automating their factories. A large proportion of Japanese innovation (more than one third) has been oriented toward raw material and energy conservation. This has had a tremendous impact in that these cost savings have been applied to commercial products. A large proportion of Japanese innovations have been oriented to a particularly Japanese problem: space saving and miniaturization. These specific Japanese orientations begin in the Japanese home market in an attempt to meet the special needs of the Japanese people (Franko, 1983). Twenty percent of Japanese R&D is paid for by the Japanese government compared with 54 percent in France, 47 percent in America and 39 percent in Britain. Japanese governmental R&D is almost nonexistent compared to the industrial sector. The Japanese government’s share of R&D expenditures have consistently been near 20 percent, of which expenditures on industrial technology are 13 percent. Thus, the proportion of industrial R&D financed by the Japanese government is less than 3 percent, which is one tenth of that found in most other industrialized countries. The other nations show a balance between the sectors which does not exist in Japan. Whereas universities and government R&D expenditures have remained relatively consistent between 1977 and 1991, industrial R&D has multiplied fivefold. This shift and preoccupation is unique to Japan. Excluding defense-related research, the breakdown in research expenditures among research establishments are similar among all the major industrialized countries (The Economist, September 28, 1991, p. 96). The strength of Japan’s system lies in its capacity to convert breakthroughs swiftly into tangible products on store shelves. Continuous innovation in production technology is pursued at all times by most Japanese companies, almost to the extent of fanaticism, a religious zealotry. Incremental improvements to the innovation drive competition for market attention and more competitive costs. The system is based on consensus building, government industry cooperation, an emphasis on advancing the not glamorous but commercially decisive area of process technology, cost-effective resource allocation, and commercial applications. Japanese firms follow strategies which may be suboptimal to the members of the group in the short run but optimize the group's performance in the long run. Due to the unique aspects of the Japanese labor-management system (lifetime employment and practically no mid-term employment hiring or firing), information is quick to pass among members (divisions of the same company, sister companies within the same keiretsu) but slow to leak outside, to non-associated entities. Innovations are driven by identified commercial markets. Since the Japanese domestic market is highly competitive and demanding, competitive pressures in the private sector drive high R&D investments throughout all the firms in the industry. Japanese managers prefer incremental improvement over radical breakthroughs as a mechanism for growth, dividing risk into smaller elements through short product cycles and quick market response. This is both culturally induced as well as operationally by the Japanese corporate and political environment. This preference for small but constant improvement is matched by a continuing search for emergent technologies outside the firm and industry. If nothing else, the Japanese are extremely vigilant about monitoring and absorbing external technologies. If it is interesting, if it may be usable at some later date, it is picked up, no matter the source. The Japanese have this fascination with technologies, the newer the better. If a competitor has it or is thinking about it, the more adamant it is to get. The primary Japanese vision has been civilian application of technology, which involves improving the methods of production with process innovations usually acquired from abroad. This preoccupation with non-military applications is derived from the American Military Occupation and MacArthur’s insistence that the Japanese energy be diverted into non-military endeavors. That this has become so inbred in Japanese politics and economics has come back to haunt the U.S. Companies have been encouraged by the government to emphasize finding ways to adopt and add to imported technological knowledge and thus to improve efficiency and produce quality. The Japanese view product and process innovation as equally important and originating from the factory engineering staff. IMITATION VERSUS INNOVATION American attitudes toward imitation reflect a cultural bias that copying is less reputable than inventing and imitation is less honorable than innovation. The terms that Americans use for imitators—such as clones, borrowers, pirates, copycats—all reflect this bias (Bolton, 1993). Innovation as implemented by many American firms is a learning-by-doing strategy involving primarily experiential learning within the firm; a firm’s competitive advantage stems from an internal source of competency. In contrast, Japanese companies emphasize the external development of new knowledge, importing ideas and technology across boundaries and “learning by watching.” Japan has no problem with the concept of making exact copies because it studies only the technology, ignoring the philosophical systems of the culture behind it (as a conscious decision to maintain cultural purity). Japan does this by selectively adopting only the desirable features of foreign cultures. It has a national industrial ideology that is oriented toward self-improvement (i.e., greater quality and efficiency), toward a world view in which exports are emphasized, and toward evaluation of performance on the basis of long-term rather than short-term results. Japanese firms achieved unbelievable growth in the 1960s by absorbing and then extending foreign technologies, developing a skilled labor force and advanced manufacturing techniques, exploiting their robust domestic market, and adopting export-oriented strategies. Imitation consists of two essential components: strategic followership and learning-by-watching. Strategic followership occurs when a company purposely delays in adopting a new product or practice—judging when consumer acceptance of a rival’s new product will create an even larger market for a lower priced, less expensive, higher quality product Matsushita’s low-cost strategy is predicated on being a second mover; it deliberately arrives late in the marketplace, competing successfully through an outstanding global distribution system and low-cost, high quality production. Matsushita waits and watches, judging when consumer acceptance of a rival’s new product will create an even larger market for a lower priced, less expensively produced product of equal or better quality (Bolton, 1993). Matsushita’s name in Japanese, maneshita denki, translates as “electronics that have been copied.” Learning-by-watching refers to activities directed toward external knowledge sharing and acquisition, through observation and assimilation of external knowledge. An example of this is benchmarking, wherein a company searches for existing best industry practices to improve performance. This may also take the form of partnerships or strategic alliances. Both types help firms benefit from the experience of pioneers and reduce the uncertainties accompanying innovation. The Japanese perspective focuses on the learning component; the Japanese word manabu ( “to learn”) is extremely close to manebu (“to imitate”). Successful imitation rarely occurs in a vacuum; it requires considerable expertise to transfer a borrowed technology to a different environment. The recipients of borrowed technology must also invest in substantial research and development and related competencies to transfer technology successfully and integrate external knowledge into existing systems and product lines. Expertise acquired during the knowledge-transfer process typically results inmodification or improvement. A pure imitation strategy is seldom effective; it is the rare follower who copies a technology exactly without trying to modify or improve on it. An imitating country must be highly selective and adopt only those practices that fit comfortably into its unique circumstances and culture, a strategy which Japan has mastered for over a century. Japanese businesses fanatically pursue competitive information, conduct widespread technology surveillance, consult foreign specialists, call frequently on suppliers, cull operating manuals, send students to foreign universities, send managers on Western tours, translate technical journals, and attend large numbers of professional meetings. Few firms successfully combine both imitation and innovation strategies; it is difficult to stretch resources across different approaches. Imitators typically will outperform innovators in those industries with weak intellectual property rights protections, in technologically interdependent industries,in industries with high market and technical uncertainty, in industries with rapid technological change, and in industries with rapid information flow. Imitators in industries with extensive information flow can outperform innovators. Innovation in these circumstances has many risks, and companies find it increasingly difficult to realize economic benefits from innovation. State-of-the-art research is different. When Japan was a follower, the research direction was clear: Observe the successes and false starts of the pioneer. Now at the frontier, the paths are not so clear. Setting such technological targets involves greater uncertainties and risks. TECHNOLOGY TRANSFER For the last forty years, the Japanese have been accumulating technologies and patents at an incredible rate. Between 1950 and 1968, Japan entered into some 10,000 contracts with foreign countries and made transfer payments of more than $1.4 billion. This inflow of foreign technology stimulated the modernization of old industries and helped create new ones. This inflow of technology not only matched but exceeded that seen when Meiji Japan decided to modernize after the Meiji Revolution in 1867. Such technical know-how was made available on a relatively inexpensive basis. Technology was purchased in the form of royalties and license fees; seldom was there any direct investment by foreigners. These royalties and license fees were obtained at the best rates obtainable; often times foreign firms were prohibited from doing business in Japan unless they provided to selected Japanese corporations those intellectual property rights deemed most important and vital to Japanese national economic interests. Although not necessarily done at the point of a gun, the technology transfer was conducted on terms and timing most favorable to Japanese interests. This has allowed the Japanese to maintain control over most economic enterprises, an objective deemed particularly important by the Japanese government and policy-makers. Japan is calculated to have spent only about $11 billion dollars between 1950 and 1980, perhaps $25 to $30 billion (in 1980 dollars), for the whole stock of Western technology (Dore, 1989) obtained during the proceeding thirty to thirty-five years. The main pattern in Japanese technological development since the Second World War has been to absorb European and American technology (at bargain store prices) and then to improve and upgrade it. Japanese manufacturers have been finding it increasingly difficult in recent years to import advanced foreign technologies when they have had no technologies in return to offer. This situation can only increase in the coming decade. Nonetheless, Japan’s situation to date has not created a demand or an overwhelming need for creativity. Between 1950 and 1980, a total of 26,804 separate technologies were imported from abroad by Japanese industry. General machinery, electrical machinery, and chemical products manufacturing industries were the major importers (Hirono, 1986) (However, the Japanese were rarely discriminatory, if the technology was usable or easily foreseen to be usable in the future, it was obtained.) Between 1950 and 1967, Japanese industry purchased 4,135 licenses (mainly from the United States), over half in the field of machinery construction and about 20 percent in the field of chemical industries. During the same time, exports of licenses amounted to only about 1 percent of the money spent on imports of patents and licenses. Once imported, foreign technologies have been adapted to specific industrial, commercial, and market requirements in Japan. Product development, including design and packaging, has been tailored to local needs and preferences, as have advertising, sales promotion, and customer services. Imported technologies have frequently been improved on and exported not only to Third World markets but also often back to their own originally exported countries. Japan remains a net importer of technology through license agreements and other purchases of technology. Its basic shortcoming in research stems from its weakness in creativity. Japan’s deficit in technology trade (payment and receipt of money for patents or technical know-how) underlines its weakness in this stage of research. In 1985, Japan’s technology imports surpassed its total exports, as they have every year. The United States has been both giving and receiving technology, whereas Japan is primarily a recipient (Chakrabarti, Feinman, and Fuentevilla, 1978). Five times more Japanese researchers work in the United States than Americans in Japan. Japan exports less technology than most other industrialized countries. At the same time, it is the largest importer of technology in the world. Technology transfer from America to Japan is on the order of three to four times greater than the reverse flow, whereas technology transfer from Europe to Japan is twice as great. The ratio between imports and exports of technology in Japan was .10 in 1965 and rising but was only .26 by 1980. The amount of British technology exports in 1980 amounted to over twice that of Japan. In every category except steel and synthetic fibers, Japan buys more technology than it sells. Japan has also run a sizable deficit in its technological balance of trade, relying heavily on imports of foreign know-how to upgrade its manufacturing capabilities. The majority of Japan’s technological exports are being sold to developing countries (unlike that of the United States in which 85 percent go to advanced countries). Much of the Japanese technological exports are in the category of incremental improvements in production technology for heavy manufacturing sectors (Okimoto and Saxonhouse, 1987). It is clear that Japan is selling off its technology in declining industries while continuing to be a net importer of technology in such key future areas as communications equipment, pharmaceuticals and computer manufacturing. This suggests that for mature technologies, the Japanese export technological advances while importing key portions of new, frontier, state-of-the-art technology from the West (particularly the United States). Contrasting Japanese strengths and weaknesses in different market segments within industry sectors, some patterns become obvious. •Japan exports middle-of-the-lineready-to-wear clothes and textile fabrics. It imports high-fashion items (from the West) and inexpensive garments from the LDCs. •Japan exports massive quantities of inexpensive watches; it remains one of Switzerland's largest markets for fashion and jewelry timepieces. •Despite having the world’s second largest pharmaceutical market, Japanese firms have made a negligible impact on international markets. Japan imports several times as many pharmaceutical products as it exports. •Japan exports massive quantities of basic number-crunching hand-held calculators; it imports advanced complex HP programmable machines. •Japan produces and exports large quantities of standard integrated circuits and RAM memory chips. Yet it imports virtually all its microprocessors and microcomputers. The difference is that the former are hardware, whereas the latter have a majority of their value added in the software (the programs). Most innovations based on external technology are imitative in nature and can be adapted and improved at a relatively low cost. Japan’s greatest technological strength is the speed at which it develops products and processes, improves and cost reduces them. In no other country can production engineers take the very latest technological breakthroughs and quickly build them into inexpensive consumer products which they then mass produce. However, these advantages of time and cost seem to be confined to innovations based on external technology (25 percent less time and 50 percent less money). Many innovations based on external technology are new products that imitate others in important respects. Among innovations based on internal technology, no significant difference in average cost or time between Japan and the United States exists (Mansfield, 1988c). The Japanese have great advantages based on external technology but very little comparative advantage in carrying out innovations based on internal technologies (Mansfield, 1988a). Their ability to absorb and adopt Western technology is well documented, but their ability to create knowledge in return is questionable. Thus, Japan continues to lag behind the West in basic research and number of radical innovations produced (Boisot, 1983). Japan seems to have been more likely than the United States to make significant technical adaptions of the imitated product and to reduce its costs substantially. This reflects, of course, Japan’s emphasis on process engineering and efficient manufacturing facilities. As Mansfield (1988b) concluded, no solid evidence exists that basic research has been fruitful in Japan. Any product advantages are largely confined to applied R&D—particularly R&D concerned with adaption and improvement of existing technology. Japanese firms absorb and then extend foreign technologies; develop a skilled labor force and advanced manufacturing techniques; exploit their own robust domestic market; and then adopt export-oriented strategies (Rosenbloom and Abernathy, 1982). The Japanese have been making the most progress in fields in which incremental improvements on imported technology are possible. The high-technology industries chosen by the Japanese government as key to Japan’s future show two key characteristics: extremely high market growth potential and the ability to link synergistically with technological advances in other industries. The Japanese have developed techniques for cooperative analysis of process quality well beyond anything given them by Deming and Juran, including many techniques for cooperative analysis in quality control. These, however, are largely group process innovations. It appears that Japan excels at evolutionary and (especially at) process innovations but not at radical innovations or basic science. The United States appears to excel at radical innovations and inventions but does poorly (comparatively) at evolutionary and process innovations. Optical computing is a technology of tomorrow. Although Japanese firms are investigating the technology, it will be the Americans who perfect its usage. Most Japanese experts cite their wish to continue the traditional pattern wherein they do better at perfecting a technology than inventing it. Japanese companies develop many systems, but the fundamental motive is commercial. In the United States, the most important thing is the frontier spirit (Hooper and Schlesinger, 1990). Common knowledge supposedly has it that Japanese quality management is superior to that in the United States. Data show this to be a myth. Vendor relationships are often thought to be of longer term duration in Japan than in the United States. The median duration of supply relationships in the air conditioning industry was found to be ten years for Japan and eleven years in the United States (1984). Myth has it that single sourcing is more prevalent in Japan; in reality 80 percent of purchased parts and materials in Japan are derived from, on average, three firms. Another myth is that incoming parts and materials in Japan come directly to fabrication or the assembly line without receiving inspection. In reality, nearly 70 percent of incoming parts and materials were used without inspection. The median number of assembly line inspectors in the air conditioning industry was thirteen for Japan and only nine for the United States. Management Conclusions Japan’s manufacturing processes have an overwhelming advantage over those of the rest of the world; if the index for Japan is 100, the comparative American index is 93, Germany 75, United Kingdom 45. The Japanese are very quick to introduce new machinery. They do not hesitate to dispose of facilities even if they were installed only five or six years ago; if they are obsolete, they are considered out of date no matter how old or young. The time lag between Japanese manufacturing industry R&D and commercialization is estimated at 3.3 years, and the lifetime of the technology is estimated at 10.2 years, superior to any other major industrialized power (Watanbe, 1991). The rapidity of introduction can be seen in the fact that the stock of technological knowledge in the Japanese manufacturing industry in 1987 was seven times as great as that in 1970, equivalent to 9.3 percent of GNP. Even the more rapid exploitation of robotics in Japan appears to be due to the alacrity with which Japanese firms modified and simplified product design to accommodate new robotics technology. It has probably been more sensible to simplify the design of products so that robots could readily assemble them—thus reducing the number of component parts and simplifying the method by which part are attached to one another—than to design robots of more general, and therefore more sophisticated, assembling capabilities. Sendai, the Japanese radio cassette recorder manufacturer, massively automated its factory in 1985. It installed 850 industrial robots; the new assembly line required only sixteen workers compared with 340 before. The chief reason for Japan’s commitment to automation has been a serious labor shortage. Robots were initially deployed in repetitive or dangerous jobs, which relieved workers of unpleasant tasks and promised enhanced productivity that would be reflected in annual bonuses. The use of robots also aided in preserving Japan’s commitment to racial homogeneity instead of importing thousands of guest workers. Several important differences appear in the nature of the innovation policy process, in the policies adopted, and in the types of policy tools employed. In the United States, the policy process is highly political, decentralized and involves a great deal of inter-group negotiation and bargaining; partisanship (strong lobbies) and high visibility appear to be important to policy stability. At the opposite end of the spectrum, policy making in Japan is based on public and private consensus with strong central direction. Throughout Europe, the policy process varies between nations but lies between the two extremes indicated by the United States and Japan (Rothwell and Wissema, 1986). Americans often leave their competitors with a host of opportunities for imitation and modification for improving performance or reducing costs. The Japanese are skilled at rapid adaptation of a new invention for mass production. Many companies give birth to new inventions only to abandon them; and the foster parent Japan picks them up and develops them. The Japanese realize this. In a 1988 survey by the Japan Economic Journal, 80 percent of the technology executives at 100 Japanese manufacturing companies felt that Japan must strengthen its basic research facilities. Japanese success in each of these areas can be traced to the cumulative impact of its great development capabilities. Japanese success in development has often been able to overcome America’s much-heralded innovative capabilities. The more specialized an activity becomes, the greater the importance of efficient information exchanges if inappropriate tradeoffs or inappropriate optimization criteria are to be avoided. For specialists to work well in a large organization, there must be an intimate familiarity with one another’s goals and priorities. A set of shared understandings and concerns must exist. The development efforts of Japanese firms strongly emphasize rotation of personnel among departments in ways that lead to the exchange of useful information and the formation of common goals. In many cases, close communication among functionally separate specialists is strengthened by the awareness of a commonality of interest flowing from stable, long-term employment (and supplier) relationships. Japanese firms appear to make more systematic use of engineering skills. Once the Japanese decide to adopt a product, they tend to do so faster and more thoroughly in an industry than occurs within the United States (especially process innovations). The maximum diffusion rate is higher in Japan than it is typically within the United States. However, the evidence suggests that the hesitation rate (time until first trial) is longer for Japan than for the United States. This patterns generally holds for all three types of innovations (process, evolutionary, and radical). However, diffusion tends to be quicker for the more familiar, less risky type of innovation (i.e., evolutionary or process innovations) and less so for radical innovations. The success of Sony, Matsushita, and JVC as innovators can be ascribed primarily to their strategies and organizational methods, but they also benefited from their location in a mercantile economy such as Japan. In all of their consumer electronics businesses, they served a large protected domestic market that provided the basic bread and butter for cash flow and dramatic market growth. Furthermore, that market was not fragmented; and the leading companies tended to have large shares, giving them a significant scale of operations. American manufacturers had a large and concentrated domestic market also, but they lacked two things the Japanese had from the start—access to an even larger foreign market (the United States used the same technical standards) and protection against import competition. The Japanese approach to the R&D workforce is to have a clearly defined objective, analogous to the dive bomber. The American approach to R&D is akin to carpet bombing: Researchers investigate every possibility, checking out all related technology from every angle: this requires vast amounts of money, a huge research support effort, long periods of R&D, and a certain amount of waste. R&D organizations in the United States are independent of production centers. In Japan, they are incorporated and interwoven into the production center. Japanese R&D workers are not necessarily in R&D because of their speciality or abilities, but often just because of job rotations. They must either cram and acquire enough specialist knowledge or find someone with expert knowledge to work with, gradually learning by watching the expert. Shugyo is the Japanese concept that people who are experts in one speciality can demonstrate the same degree of ability in another. Japanese R&D workers must have this kind of transferred knowledge. One major advantage of the Japanese in their pursuit of process innovation is that Japanese workers welcome technological change. Few try to sabotage productivity improvements. This is not so in America. To the average American factory worker, automation can only result in the exchange of people for machines: Introduce labor-saving machinery into a plant and someone becomes unemployed. Make one worker more productive and someone else loses his or her job. Or install a robot which can work twenty-four hours a day on the assembly line and three workers are no longer needed. In contrast to this fear of unemployment in the United States, many Japanese corporate workers are lifelong employees. They will not be fired except for criminal behavior, insanity, or the company’s bankruptcy. The Japanese worker with lifelong employment does not fear being replaced by machines. If a worker’s duties become automated, the worker will be moved elsewhere. Their company would look after them until they retired, after lifelong service with the same company. Many Japanese companies have also almost completely automated their own blue-collar work, and no one has been dismissed after being replaced by tooling machines. The blue-collar workers whose duties became automated were retrained and transferred to sales, testing, and computer programming; many now program the very machines which automated their work. This is why Japanese employees submit tens of thousands of suggestions per year without any significant monetary reward. Group unity and loyalty help stimulate suggestions and a spirit of participation (Alston, 1986). Increased productivity results in higher pay and other benefits. Higher profitability is translated into higher pay in the form of semi-annual bonuses, often worth four to six months’ wages. In Japan, increased profits go to the workers in the form of bonuses, not to the managers in terms of executive bonuses or to the stockholders in the form of dividends, as is often the case in the United States. 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