Radiation, Lab, and Drug Hazards

Ionizing radiation occurs naturally from the decay of radioactive materials or by the operation of x-ray emitting devices� A radioactive element spontaneously changes to a lower energy state and emits particles and gamma rays from its nucleus� X-rays result when highly energized electrons strike the nuclei of a targeted material� The electrons deflected from their path release energy as electromagnetic radiation or x-rays� Ionizing radiation occurs anytime an electron dislodges from its parent atom or molecule� Ionizing radiation’s ability to penetrate the body depends on the wavelength, frequency, and energy of the material� Alpha particles do not penetrate the skin� An alpha particle cannot penetrate a thin layer of paper or clothing� Highly energized beta particles require shielding using some type of low-density material such as plastic, wood, water, or acrylic glass� Beta particles can travel a few centimeters into living tissue� Beta contaminants that remain on the skin for a prolonged period can cause injury� Beta emitting contaminants can also cause harm if deposited internally� Gamma and x-rays can penetrate human tissue� Radioactive materials that emit gamma radiation constitute both an external and internal hazard to humans� Gamma radiation frequently accompanies the emission of alpha and beta radiation� X-rays also possess longer wavelengths, lower frequencies, and lower energies than alpha or beta particles� The international community measures radiation using the International System of Units (SI)� The United States uses a conventional system of measurement depending on what aspect of radiation requires measurement�

BOX 8.1 RADIATION MEASUREMENT TERMS

• Absorbed dose is the amount of radiation that is absorbed by the body� • Curie (Ci) is a unit of measurement of radioactivity where 1 Ci = 3�7 × 1010 decays

per second� • Exposure is the amount of radiation to which the body is exposed� • Radiation absorbed dose (RAD) is a measure of the absorbed dose of ionizing

radiation� • RAD = 100 ergs per gram = 0�01 gray (Gy)� • Radioactive half-life is the time required for isotope radioactivity to decrease by

50 percent� • Roentgen equivalent man (Rem) is the dosage of any ionizing radiation that will

cause biological injury to human tissue equal to the injury caused by one roentgen of x-ray or gamma ray dosage with one rem equivalent to 0�01 Sievert (Sv)

• Roentgen is the unit of measure for the quantity of radiation produced by gamma or x-rays�

The Occupational Safety and Health Administration (OSHA) standard covers X-ray equipment, accelerators, accelerator-produced materials, electron microscopes, and naturally occurring radioactive materials such as radium� OSHA exposure standards for whole body radiation should never exceed three rem/quarter (year)� Lifetime or cumulative exposure should not exceed five (N-18) rem� OSHA regulates exposure to all ionizing radiation for sources not under Nuclear Regulatory Commission (NRC) jurisdiction� OSHA and NRC signed a Memorandum Agreement in 1989 that outlined the compliance authority of both agencies� This coordinated interagency effort helps prevent gaps in protecting workers and avoids duplication of effort�

The degree of human exposure depends on the amount of radiation, duration of exposure, distance from the source, and the type of shielding used� OSHA recommends workers wear a badge or device to support long-term exposure monitoring efforts� OSHA recommends a passive dosimeter for personnel working with x-ray equipment, radioactive patients, or radioactive materials� Depending on the work situation, body badges may be worn at the collar, chest, or waist level� Personnel working in high-dose fluoroscopy settings need to wear two badges for monitoring purposes� Personnel exposed to beta and gamma doses should wear ring devices on the hand nearest the radiation source� Lead aprons and gloves offer some protection for employees and patients exposed to a direct x-ray field� Assign a specific person to ensure proper maintenance of all portable x-ray machines� For preventive and corrective maintenance information for x-ray machines, refer to 21 CFR 1000, Radiological Health� For information about exposure limits, refer to the OSHA Ionizing Radiation standard found in 29 CFR 1910�1096� Employers must supply appropriate personnel monitoring equipment such as film badges, pocket chambers, pocket dosimeters, or film rings�

OSHA requires the designation of restricted areas to protect individuals from radiation exposure� The term “unrestricted area” refers to any area where access is not controlled by the employer for purposes of protection of individuals from exposure to radiation� No employer can possess, use, or transport radioactive material within a restricted area that causes individuals to experience airborne radioactive material exposure in excess of limits specified in Table 1, Appendix B to 10 CFR 20� When monitoring exposure, make no allowance for the use of protective clothing or equipment, or particle size�

A survey is an evaluation of the radiation hazards incident to the production, use, release, disposal, or presence of radioactive materials or other sources of radiation under a specific set of conditions� When appropriate, such evaluation includes a physical survey of the location of materials and equipment, and measurements of levels of radiation or concentrations of radioactive material present� Every employer should supply appropriate personnel monitoring devices such as film badges, pocket chambers, pocket dosimeters, or film rings for use by exposed employees� Personnel monitoring equipment refers to devices designed to be worn or carried by an individual for the purpose of measuring the dose received�

A “radiation area” refers to any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in any one hour a dose in excess of five millirem, or in any five consecutive days a dose in excess of 100 millirem� “High radiation area” means any area accessible to personnel in which there exists radiation at such levels that a major portion of the body could receive in any one hour a dose in excess of 100 millirem�

Caution signs, labels, signals, and symbols should use the conventional radiation caution colors of magenta or purple on yellow background� The radiation symbol contains a three-bladed design with the words “Radiation Area�” Each area with radiation should be conspicuously posted with a sign or signs bearing the radiation caution symbol� Each high radiation area should be conspicuously posted with a sign or signs bearing the radiation caution symbol and appropriate wording�

Airborne radiation can appear in any room, enclosure, or operating area in which radioactive materials exist in concentrations in excess of the amounts specified in Table 1 of Appendix B to 10 CFR 20� Post a sign or signs bearing the radiation caution symbol and the word CAUTION in areas where exposure could occur�

Each area containing radioactive material exceeding 10 times the quantity of such material as specified in Appendix C to 10 CFR 20 must post conspicuous signs bearing the radiation caution symbol and the word CAUTION� Secure radioactive materials stored in nonradiation areas to prevent unauthorized removal from the place of storage� Employers must never dispose of radioactive material in an improper or illegal manner� They can transfer materials to an authorized recipient�

Facilities should protect radiology personnel from tuberculosis (TB) exposures during x-ray procedures� Exposures to TB can occur if radiology rooms do not contain proper ventilation� Hospitals should develop written procedures for the safe handling of TB patients in all radiology areas� TB patients should wear masks and stay in radiology suites the shortest time possible� Healthcare facilities serving populations with a high prevalence of TB may need to supplement general ventilation and use additional engineering approaches�

Radiology staff can experience work-related musculoskeletal disorders (MSDs) from constant lifting and reaching during x-ray procedures and patient transfers� Employers should assess the radiology area for ergonomic stressors� Train employees in proper lifting techniques� Avoid awkward postures and working above shoulder height� Use lift mechanical aids and ensure sufficient staffing� Provide instructions to patients on ways to help facilitate the lift or transfer procedure�

Potential exists for slips and falls in the radiology area� Ensure floors don’t contain slip hazards such as water, blood, vomit, or excreta� Keep aisles and passageways clear and in good repair with no obstruction across or in the aisles� Provide floor plugs for equipment to prevent the need for placing cords across pathways� Report and clean all spills immediately� Correctly maintain floors by using nonskid waxes�

Use gloves, masks, and gowns if blood or fluid exposure exists� Use appropriate engineering and work practice controls to limit exposure� Wear gloves to protect hands coming into contact with

blood, mucous membranes, or nonintact skin� Follow proper work practices when performing vascular access procedures or when handling contaminated items or surfaces�

Properly calibrate radiation measurement instruments before each use� Train personnel handling and exposed to radiation wastes� Each department that generates radioactive wastes should develop written procedures that cover handling, transportation, and disposal� Properly secure and store all waste materials and designate controlled areas� Dispense or draw materials only behind a protective barrier� Label refrigerators that contain stored materials� Notify the radiation control officer when receiving a contaminated shipment�

A radionuclide refers to any type of radioactive material including elements and isotopes of elements� Most radioactive materials used in nuclear medicine consist of isotopes since individual medical treatment may require an isotope with specific radioactive properties� Radioisotopes show how the disease process alters the normal function of an organ� A patient swallows, inhales, or receives an injection of a tiny amount of a radioisotope� Cameras then reveal where the isotope accumulates in the body� Laboratory tests use radioisotopes to measure important substances in the body including thyroid hormones� Some facilities use isotopes to sterilize hospital items such as sutures, syringes, catheters, and hospital clothing otherwise destroyed by heat sterilization� Sterilization using radioisotopes can prove valuable because the process permits the items to remain in their sealed packages� NRC rules outline minimum safety requirements for workers and patients�

The effectiveness of shielding material relates to its cross section for scattering and absorbing radiation� The radiation that manages to get through falls exponentially with the thickness of the shield� Practical radiation protection depends on juggling the three factors to identify the most cost-effective solution� Different types of ionizing radiation can behave in different ways� This results in the use of different shielding techniques� Particle radiation consists of a stream of charged or neutral particles, charged ions, and subatomic elementary particles� This includes solar wind, cosmic radiation, and neutron flux in nuclear reactors�

ALARP stands for “as low as reasonably practicable�” An equivalent term, ALARA, “as low as reasonably achievable,” is also commonly used� The application of radiation can aid the patient by providing doctors and other healthcare professionals with a medical diagnosis� However, keeping exposure reasonably low will reduce the probability of cancers or sarcomas and eliminate skin reddening or cataracts� Any radiation exposure, no matter how small, can increase the chance of negative biological effects such as cancer� The probability of the occurrence of negative effects of radiation exposure increases with cumulative lifetime dosage�

Nuclear medicine uses small amounts of radioactive material to diagnose or treat a variety of diseases, including cancer and heart disease� Nuclear medicine or radionuclide imaging procedures help physicians diagnose medical conditions� Depending on the type of nuclear medicine, a radiotracer is injected into a vein, swallowed, or inhaled as a gas� It eventually accumulates in the organ

or area of your body being examined, where it gives off energy in the form of gamma rays� This energy can then be detected by a device called a gamma camera, a positron emission tomography (PET) scanner, and/or a probe� These devices work together with a computer to measure the amount of radiotracer absorbed by the body� The devices also work to produce special pictures detailing the structure and function of organs and tissues� Nuclear medicine images superimposed by computed tomography (CT) or magnetic resonance imaging (MRI) produce special views� This practice is known as imaging fusion or co-registration� These views allow the information from two different studies to become correlated and interpreted as one image, which results in a more precise diagnosis� Manufacturers now make single photon emission computed tomography (SPECT)/CT and PET/CT units that perform both imaging studies at the same time� Iodine therapy uses radioactive material to treat cancer and other medical conditions affecting the thyroid gland� Most nuclear medicine procedures use a gamma camera, a specialized camera encased in metal that is capable of detecting radiation and taking pictures from different angles� It may be suspended over the examination table or beneath the table� New technologies make the diagnosis, management, and treatment of illnesses more sensitive, more specific, more accurate, and ultimately safer for both the patient and the technologist�

CT, MRI, and “ultrasound scans” do not involve radioactive materials� Most patients receive radioactive iodine-131 (I-131)� I-131 has a half-life of eight days and emits both beta particles and gamma rays� The beta particles are responsible for killing the tumor cells� They have such a short “range” in tissue that they do not leave the patient’s body, and so present no external hazard� However, if any I-131 is unintentionally ingested, the beta particles can present an internal hazard� Because I-131 is excreted in the patient’s urine, saliva, and perspiration, small amounts of radioactivity may be present on surfaces in the patient’s room� This “contamination” can be ingested by “surface-to-hand-to-mouth” contact� The gamma rays have properties like x-rays� They pass out of the patient’s body, and therefore present a potential external hazard to bystanders� To reduce this hazard, some patients may be housed in special lead-lined rooms� Work safely by using a few simple techniques:

1� Put on shoe covers and protective gloves before entering the patient’s room� 2� Work quickly, but effectively and courteously� Minimize your time in the room� 3� Maintain the greatest distance possible from the patient consistent with effective care�

Radiation exposure drops off drastically with increasing distance� 4� Observe Universal Precautions while handling blood and other body fluids, especially urine� 5� Leave all trash, linens, and food trays in the room� Upon leaving the room, remove gloves

and shoe covers and place them in the trash box inside the room� 6� After leaving the room, wash your hands� 7� In the event of a medical emergency involving the patient, the patient’s well-being is the

primary consideration� All initial measures necessary to sustain the patient should be undertaken, regardless of radiation considerations�

It may be possible to further reduce the external hazard by using portable shields� In general, lead aprons are minimally effective and their routine use during ordinary caregiving is not recommended� However, during prolonged procedures at close proximity to the patient, they can reduce exposure by about 15 percent� A few patients are treated with pure beta emitters such as phosphorus-32 (P-32), strontium-89 (Sr-89), yttrium-90 (Y-90), and samarium-153 (Sm-153)� These patients usually do not require hospitalization for radiation protection purposes, since there is no external hazard� Use Universal Precautions when caring for these patients if they are hospitalized�

In cases where their tumors are close to accessible body cavities, oncology patients may undergo a procedure called brachytherapy, or “implant” therapy� Implant therapy is effective in some cases

of uterine, prostate, and lung cancer� In implant therapy, a sealed source of radioactive material, usually a gamma emitter such as cesium-137 or iridium-192, is placed in a body cavity close to the tumor and left in place for a prescribed period of time� During the time the implant is in place, staff entering the room is exposed to gamma rays and must take precautions� Once the treatment is completed and the implant is removed, the patient is no longer radioactive and presents no hazard� Work safely with implant therapy patients by following these techniques:

1� Put on protective gloves before entering the patient’s room� Although breakage of a sealed source is an unlikely occurrence, ingestion of radioactivity is easily prevented by wearing gloves�

2� Work quickly, but effectively and courteously� Minimize your time in the room� 3� Maintain the greatest distance possible from the patient consistent with effective care�

Radiation exposure drops off drastically with increasing distance� 4� Leave all trash, linens, and food trays in the room� Upon leaving the room, remove gloves

and place them in the trash receptacles inside the room� The radiation safety department surveys all materials before they leave the room�

5� After leaving the room, wash your hands�

In the event a source becomes dislodged, notify the radiation oncology resident on call immediately� Do not permit others to enter the room until the source is secured� Do not attempt to handle a dislodged implant or applicator, unless you are specially trained to do so�

The potential adverse health effects of ionizing radiation have been evident since the end of the 19th century, with the discovery of x-rays and the isolation of radium� Many of the early radiologists and scientists who worked with radiation personally experienced its detrimental effects, which included leukemia, skin cancer, and bone sarcomas� Controlled studies with bacteria, plants, and animals showed exposure to high doses of radiation to be carcinogenic (capable of inducing cancer), teratogenic (capable of causing birth defects), and mutagenic (capable of producing genetic mutations)� Studies of people exposed to radiation during atomic bombings demonstrated the ability of ionizing radiation to produce profound medical effects on the gastrointestinal and hematopoietic systems� Over the past half-century, thousands of additional medical, scientific, and epidemiological investigations have further increased our understanding of the biological and medical effects of ionizing radiation, and at what radiation doses these effects can be expected to occur� For this reason, we have been able to establish with some certainty the levels of exposure that can be sustained without significantly increasing the risk of harm to an individual, or his or her offspring�

The NRC, established by the Energy Reorganization Act of 1974, ensures civilian uses of nuclear substances meet safety, environmental, and security laws� The NRC accomplishes its mission through standards setting, rulemaking, inspections, and enforcement actions� The commission also conducts technical reviews, studies, and public hearings� The NRC issues authorizations, permits, and licenses to ensure nuclear safety� The NRC issues five-year licenses to healthcare organizations that adhere to prescribed safety standards� To apply for a license, organizations should identify authorized users, designate a radiation safety officer (RSO), and identify the address or location of radioactive materials� Any changes require the organization to file for a license amendment� Some vendors must verify that facilities receiving radioactive materials possess a license� Some radionuclide licenses apply to generators of infectious and medical wastes� A general license is issued to medical practices, clinical laboratories, and healthcare facilities� A specific use license is required

for physicians in private practice� Medical use pertains to human administration of radioactive substances or radiation� A broad scope license can be issued to facilities that provide patient care and conduct research using radioactive materials�

Some NRC regulations contain detailed procedures and others leave procedural details to the licensee� Approval of the license remains contingent on NRC evaluation of the proposal submitted with the application� Report all occurrences of therapeutic or diagnostic misadministration to the NRC Regional Office within 24 hours� The NRC requires that organizations meet all radiation protection standards as outlined in 10 CFR 20� Persons working or frequenting areas with radioactive materials must understand the basic right to know information contained in 10 CFR 19, Notices, Instructions, and Reports to Workers: Inspections and Investigations� “Agreement states” refer to states with a formal agreement with the NRC pursuant to Section 274 of the Atomic Energy Act� Under this agreement, the NRC relinquishes regulatory control over certain byproducts, sources, and special nuclear materials used within each state� NRC periodically assesses compatibility and adequacy of the agreement state enforcement efforts�

Each NRC licensee should maintain a written management plan that requires the participation of all users, organizational administrators, and RSOs� Develop procedures to inform workers about the types and amounts of materials used, dosing information, safety precautions, recurring training, and continuing education� Develop guidelines to keep doses as low as reasonably achievable� The RSO should develop and implement written procedures to cover the purchase, storage, use, and disposal of radioactive byproducts� Develop procedures to investigate all incidents, mishaps, accidents, or other deviations from prescribed procedures�

The Radiation Safety Committee must approve or disapprove use of radioactive material within the licensed institution� Decisions must consider the radiological health and safety of patients and staff� Other committee duties include prescribing special conditions for the proposed use of radioactive materials including bioassay requirements, physical examinations, and the minimum level of training required� The committee should address topics such as film badge return rates, exposure guidelines, safety, quality, and regulatory compliance� The committee should review records and reports submitted by the RSO� The committee recommends actions to take for ensuring the safe use of radioisotopes� The committee must maintain a written record of all actions taken and members must demonstrate their competency or expertise in radiation safety� Committee membership should include expertise in the areas of diagnostic radiology, clinical pathology, and nuclear medicine� Committees should meet at least quarterly�

The RSO must qualify to serve based on education, training and experience� The RSO should advise others on safety matters pertaining to ionizing radiation and supervise radiation safety efforts� The officer implements the policies established by the Radiation Safety Committee and supervises all aspects of radiation measurement and protection activities� Duties include monitoring activities, maintenance of exposure records, survey methods, waste disposal, and radiological safety practices� The RSO should monitor the education of all users of ionizing radiation� The RSO function must also maintain an inventory of all radioisotopes and ionizing radiation producing devices, and must

ensure documentation of radiation surveys and exposures of personnel� He or she should promptly report to the committee all radiation hazards, serious infractions of rules, or other items relevant to radiation safety� Organizations must maintain the radioisotope inventory, all receipt and disposition logs, radiation survey records, and any NRC documentation required by 10 CFR 20�401�

Contact with radionuclide patients should never result in adverse health effects� However, healthcare organizations must comply with state and federal regulations regarding the possession and use of radioactive materials� Operations at hospitals should never pose a risk to the public� Procedures should keep exposures less than one hundred millirems in one year� While some patient treatments can meet these criteria, others require extra shielding� Similarly, the special collection of urine and trash can create environmental concerns� Hospitals should promote the concepts of ALARA� The current U�S� mandated annual occupational dose limit is 5000 millirem (5 rem)� Dozens of epidemiological studies fail to demonstrate any adverse effects on health, fertility, or genetic viability at or below the occupational dose limit� However, attempt to keep exposures below 500 millirem per year, wherever feasible�

This group, created by Congress, collects, analyzes, develops, and disseminates information and recommendations on radiation quantities, measurements, and units� The National Council on Radiation Protection (NCRP) publishes maximum permissible levels of external and internal radiation� The major handbook is entitled, Maximum Permissible Body Burdens and Maximum Permissible Concentrations of Radionuclides in Air and Water for Occupational Exposure and Review of the Current State of Radiation Protection Philosophy� The NCRP suggests an annual permissible whole body dose of 5 rem per year, with 3 rem permitted within a 13-week period�

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) ensures that the public and professionals remain informed of the risks posed by different types of radiation emissions and radiation-emitting products� CDRH also seeks to ensure that each patient receives the appropriate radiation dose using the appropriate, medically necessary imaging exam at the appropriate time� These efforts recognize the role everyone has in promoting radiation safety� Manufacturers should design safe products� Users should know how to appropriately use radiation-emitting electronic products and understand radiation safety and protection principles� Patients and consumers should know basic radiation risk and protection concepts� Regulators must collect and disseminate appropriate information and take action on this information as necessary� The FDA continues to take efforts to reduce the risks associated with medical uses of ionizing radiation, in order to maximize their benefits� The FDA Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging describes actions that support the benefits of medical imaging while minimizing the risks� The FDA is also

BOX 8.2 WAYS TO REDUCE HUMAN RADIATION EXPOSURE

• Shielding: Use proper barriers to block or reduce the penetration of ionizing radiation • Time: Spend less time in radiation fields • Distance: Increase the distance between radioactive sources and workers or

population • Amount: Reduce the quantity of radioactive material for a practice

exploring steps to improve patient safety in radiation therapy� CDRH collaborates with the Conference of Radiation Control Program Directors (CRCPD) in a unique federal-state partnership to characterize the radiation doses patients receive and to document the state of the practice of diagnostic radiology� Each year the Nationwide Evaluation of X-ray Trends (NEXT) survey selects a particular radiological examination for study and captures radiation exposure data from a nationally representative sample of U�S� clinical facilities� CDRH staff compiles, analyzes, and publishes survey results on population exposure, radiographic and fluoroscopic technique factors, diagnostic image quality, and film processing quality� Surveys should be repeated periodically to track trends as technology and clinical practices change� Since 1973, NEXT has been conducting surveys on examinations related to the adult chest, abdomen, lumbosacral (LS) spine, upper gastrointestinal fluoroscopy, mammography, CT of the head, dental radiography, and pediatric chest radiography�

The Radiological Society of North America (RSNA), an association of more than 40,000 radiologists, radiation oncologists, medical physicists, and related scientists, promotes excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care� The society seeks to provide radiologists and allied health scientists with educational sessions and materials of the highest quality, and to constantly improve the content and value of these educational activities� The Society also seeks to promote research in all aspects of radiology and related sciences, including basic clinical research in the promotion of quality healthcare�

The American College of Radiology (ACR) members strive to improve quality patient care and remain committed to the advancement of the science of radiology� ACR has established guidelines, standards, and accreditations to provide the foundation for achieving quality patient care� ACR accreditation offers radiologists and other providers the opportunity for peer review of their facility’s staff qualifications, equipment, quality control, and resultant image quality� The ACR actively promotes the causes and issues of radiology professionals and their patients at both the federal and state levels and offers a selection of highly respected continuing education materials as well as the opportunity for physicians to learn the latest, cutting-edge imaging techniques and image-guided procedures at the one-of-a-kind ACR Education Center�

Radioactive waste exists in solid, liquid, or gas forms� Solid waste can include rags and papers from cleanup operations, solid chemicals, contaminated equipment, experimental animal carcasses, or human or experimental animal fecal matter� Consider and evaluate properties of waste when determining the method of disposal� Specific disposal methods vary according to the material involved and licensing authority of users� Radioactive waste typically remains onsite until its half-life is spent and it is no longer considered hazardous� Segregate low-level radioactive waste and properly label it, considering the isotope, form, volume, laboratory origin, activity, and chemical composition� Proper labeling and handling are legally required and make waste management decisions easier� Never mix radioactive and other hazardous waste� Retain suppliers that accept return of isotope containers�

Develop a plan to ensure disposal of radioactive waste meets government guidelines and regulations� The plan should contain procedures for waste containing radioactive materials as defined by the NRC� Develop an emergency plan to use in response to a radiation accident or incident� Keep radioactive waste segregated, centrally processed, and properly labeled� Secure radioactive waste storage areas and identify with a radioactive hazard symbol� Consider using sensors to detect

radioactive levels in trash and medical waste prior to its leaving the facility� Return all isotope containers to the appropriate distributor�

This form of radiation lacks the energy of ionizing radiation and causes damage by vibrating the atoms or molecules causing heating by friction� Examples of nonionizing radiation include lasers, microwave (MW)/radio-frequency (RF)-generating devices, ultraviolet lamps, MRI machines, cell phones, and other electrical devices that produce electromagnetic fields� Health effects include retinal and skin damage� Electromagnetic radiation has different effects on humans depending on the wavelength and type of radiation involved� Low-frequency radiation such as that generated by broadcast radio and shortwave radio has generally been considered as not dangerous� Some new information suggests that exposure to electric power frequencies could pose an adverse impact on human health� Exposure to MW radiation can occur in healthcare facilities� Some exposure risks include microwave ovens, cancer therapy procedures, thawing organs for transplantation, sterilizing ampoules, and enzyme activation in research animals� The greatest hazard associated with exposure to MW radiation is thermal heating� The exposure limit for MW energy is expressed in voluntary language and has been ruled unenforceable by OSHA� The OSHA Construction Standard does specify the design of an RF warning sign and 29 CFR 1926�54 limits worker exposure�

Ultraviolet (UV) radiation can emit from germicidal lamps, during some dermatology treatments, from nursery incubators, and even from some hospital air filters� Overexposure can result in skin burns and serious eye damage� Long-term exposure can contribute to accelerated skin aging and increased risk of skin cancer� The National Institute for Occupational Safety and Health (NIOSH) recommendations for UV exposure range from 200 to 400 nanometers, depending on length of exposure� All UV sources capable of causing eye or skin burns should be interlocked so that direct viewing or bodily exposure is not possible� The total intensity of UV light from lamps and reflecting surfaces should not exceed the levels specified in the latest edition of the American Conference of Governmental Industrial Hygienists (ACGIH) reference “Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices�”

Consider RF and MW as nonionizing radiation sources with insufficient energy to ionize atoms� The primary health effect of RF/MW energy comes as a result of heating� The absorption of RF/ MW energy varies with frequency� MW radiation is absorbed near the skin, whereas RF radiation may absorb in deep body organs� Exposure standards of Western countries are based on preventing thermal problems; however, research continues on possible nonthermal effects� Use of RF/ MW radiation includes radios, cellular phones, heat sealers, vinyl welders, high-frequency welders, induction heaters, communications transmitters, radar transmitters, ion implant equipment, MW drying equipment, sputtering equipment, and glue curing� The warning symbol for RF hazards should consist of a red isosceles triangle above an inverted black isosceles triangle, separated and outlined by an aluminum colored border� The upper triangle should contain the following wording: WARNING RADIO-FREQUENCY RADIATION HAZARD�

Wireless medical telemetry helps monitor patient physiological parameters over a distance via RF communications between a transmitter worn by the patient and a central monitoring station� These

devices give the advantage of allowing patient movement without tethering the patient to a bedside hard-wired connection� The Wireless Medical Telemetry Service (WMTS) report and order sets aside the frequencies of 608 to 614 MHz, 1395 to 1400 MHz, and 1429 to 1432 MHz for primary or co-primary use by wireless medical telemetry users� A key feature of the WMTS is the provision for establishment of a Frequency Coordinator to maintain a database of user and equipment information to facilitate sharing of the spectrum and to help prevent interference among users of the WMTS� The Federal Communications Commission (FCC) order also provides a definition for wireless medical telemetry that is consistent with the recommendations made in 1999 by the American Hospital Association (AHA) Task Group on Wireless Medical Telemetry� The FCC defines wireless medical telemetry as “the measurement and recording of physiological parameters and other patient-related information via radiated bi-or unidirectional electromagnetic signals�” The FCC order also describes the requirements for users of the new WMTS� Eligible WMTS users are limited to authorized healthcare providers, which includes licensed physicians, healthcare facilities, and certain trained and supervised technicians� The healthcare facilities eligible for the WMTS include those that offer services for use beyond 24 hours, including hospitals and other medical providers� Do not include ambulances and other moving vehicles within this definition�

CDRH receives many inquiries from healthcare organizations, medical device manufacturers, clinicians, and the public seeking information about experiences with and prevention of electromagnetic interference (EMI) with medical devices� The following information is intended to help minimize the risks associated with medical device EMI and promote electromagnetic compatibility (EMC) in healthcare facilities� Some recommendations for healthcare facilities to follow include

• Making use of available resources such as EMC professionals and publications and Internet web pages on the subject of medical device EMC

• Assessing the electromagnetic environment of the facility and identifying critical medical device use areas

• Managing the electromagnetic environment, RF transmitters, and all electrical and electronic equipment, including medical devices, to reduce the risk of medical device EMI and achieve EMC

• Coordinating the purchase, installation, service, and management of all electrical and electronic equipment used in the facility to achieve EMC

• Educating healthcare facility staff, contractors, visitors, and patients about EMC and EMI and how they can recognize medical device EMI and help minimize EMI risks

• Establishing and implementing written policies and procedures that document the intentions and methods of the healthcare institution for reducing the risk of medical device EMI and achieving EMC

The American National Standards Institute (ANSI) publishes consensus standards on RF exposures and measurements� The Institute of Electrical and Electronics Engineers (IEEE) Standards Coordinating Committee 28 is the secretariat for ANSI for developing RF standards� It is also the parent organization for the IEEE Committee on Man and Radiation (COMAR), which publishes position papers on human exposure to electromagnetic fields� ANSI C95�1-1992 (Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields [200 kHz – 100 GHz]) includes different exposure limits for controlled and uncontrolled sites� FCC OET Bulletin #65 (August 1997) Appendix A provides a table and figure of RF exposure limits adopted by the FCC� The FCC received concurrence for these limits from other government

agencies, including OSHA and NIOSH, with the reservation that induced current limits be added to the FCC standard�

• IEC 60601-1-21, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2�1 [Edition 2:2001 consolidated with Amendment 1:2004])

• AAMI/ANSI/IEC 60601-1-22, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

• ANSI/RESNA WC/Vol� 2-19983, Section 21, Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters

• ANSI C63:19:20014, Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids

Light amplification by stimulated emissions of radiation or laser can pose a risk to healthcare workers and patients� A laser emits electromagnetic radiation in the visible spectrum� Laser use is increasing at a very fast pace in the healthcare environment� Lasers used in radiology departments help align patients for treatment� Eye safety is the number one concern for anyone working with or near a laser� Though rare, laser eye injuries become permanent� The nature of eye damage depends on the type, power, and duration of the laser exposure� The most common type of injury results when a light beam heats the retina and causes loss of vision in a point of a person’s field of vision� A beam from a pulse laser can cause an explosion in the retina and result in severe damage� A laser with enough energy can cause retina cell death� Any damage is permanent but not as severe as thermal or acoustic damage� Lasers striking the skin can result in erythematic, blistering, and charring� The extent of the damage depends on wavelength, power, and length of exposure� Lasers also use high voltage and pose electrical risks� The FDA Bureau of Radiological Health under 21 CFR 1040 regulates laser performance� Lasers receive calibration by the manufacturer, but always check the laser system before each procedure and during extended procedures� Classifications of lasers should coincide with actual measurement of output� Only personnel trained in laser technology should make measurements� Engineering controls, such as protective housings, remote controls, or enclosed laser beam paths, ensure protection for laser operators except when the operator needs to set up, adjust, or maintain the beam� These technicians experience the highest risk for serious injury� The Laser Safety Officer (LSO) must take actions to ensure monitoring and enforcing the control of laser hazards� These controls apply to operation, maintenance, and service� Lasers and laser systems are classified on the basis of the level of the laser radiation accessible during intended use�

The primary responsibility of a perioperative nurse during a laser procedure is keeping the patient safe� Safety hazards are inherent with laser usage, but adherence to proper procedures lowers injury risks� When perioperative nurses receive education in laser science and safety, they can recognize potential hazards and help ensure adherence to safety parameters� Class 3b and 4 laser exposures usually occur from unintentional operation or when users fail to follow proper controls� The high electrical energy used to generate the beam is a potential shock hazard� Direct beam exposure can cause burns to skin and eyes possibly resulting in blindness� Electric shock and fire also pose potential hazards when using lasers� Primary worker protection measures include using effective

eye protection and properly shielding high-energy beams� Ensure availability of an approved fire extinguisher� Identify laser use areas and post warning signs� Personnel should prevent laser beams from coming into contact with combustible, flammable, and reflective materials� Ensure personnel using or exposed to lasers become part of the eye health medical surveillance system�

Appoint an LSO when personnel use Class 3 or 4 lasers� Ensure the LSO possesses the authority to monitor and enforce the laser safety requirements� The LSO administers the overall laser safety plan, including confirming the classification of lasers and assuring the use of proper control measures� The LSO also approves substitute controls and standard operating procedures (SOPs)� The LSO recommends and/or approves eyewear and other protective equipment, specifies appropriate signs and labels, provides proper laser safety training, and conducts medical surveillance� The LSO should receive detailed training on laser fundamentals, laser bio-effects, exposure limits, and classifications, as well as control measures including area controls, eyewear, barriers, and medical surveillance requirements�

No federal requirements exist for safety during laser procedures� Hospital operating rooms, surgery centers, and physician practice-based surgery suites should comply with the recommended consensus safety standards� The General Duty Clause permits OSHA to cite employers for not providing a place of employment free from recognized hazards� NIOSH believes that potential hazards exist from smoke generated by lasers� Studies indicate formaldehyde, hydrogen cyanide, and benzene can occur in surgical smoke emitted from lasers� NIOSH has issued suggestions for the use of smoke evacuation units, preferably vented to the outside, as well as protective equipment to be worn by personnel servicing or changing filters on smoke evacuation devices� The FDA’s CDRH regulates lasers approved for the market� These agencies also regulate which procedures lasers can perform and the ancillary supplies, including fibers and hand pieces, authorized for sale� Laser injury incidents fall under the Safe Medical Device Act reporting requirements� The key safety standards for laser use are ANSI Z136�1-1993: American National Standard for the Safe Use of Lasers and ANSI Z136�3-1996: American National Standard for the Safe Use of Lasers in the Healthcare Environment. OSHA regulates work exposures by using the “general duty clause” and CFR 1910�132, which addresses face and eye protection� ACGIH publishes recommendations about how to reduce occupational exposures� NIOSH recommends that organizations appoint an LSO in facilities where laser use warrants extra precautions� The Laser Institute of America also publishes information on safely using lasers and is the source organization for the ANSI standards� The Association of periOperative Registered Nurses (AORN) addresses laser safety in its Recommended Practices for Laser Safety in Practice Settings. ANSI Standard Z136�3 remains the recognized national standard for laser safety in healthcare organizations� However, AORN standards function as the optimal standards of perioperative nursing practice� For the most part, both sets of standards communicate the same information regarding laser safety and strongly promote laser safety education and training for all individuals present during a laser procedure� Individuals must complete this training before being assigned to work with lasers� Yearly reinforcement of the information and recredentialing should also take place�

New classes-1m, 2m, and 3r-will further delineate the danger potential of medical and industrial lasers� Laser energy is light energy� Consider all Class 3 and Class 4 lasers as nonionizing, which indicates that laser energy does not cause molecular changes to tissue of the operator or others in

close proximity� A pregnant staff member or physician need not fear that laser energy will cause harm to her fetus� Beam-related safety hazards include eye injuries, fire and thermal injuries, and smoke plume� Consider any electrical hazards as nonbeam related� Refer to the IEC 60825-1 standard for requirements of the classification system� Classes 2 and higher must contain the triangular warning label� Lasers may require other labels in specific cases indicating laser emission, laser apertures, skin hazards, and invisible wavelengths�

1. Class 1 Laser A Class 1 laser is safe under all conditions of normal use� Never exceed the maximum permissible exposure (MPE) limit� This class includes high-power lasers within an enclosure that prevents exposure to the radiation and that cannot be opened without shutting down the laser� For example, a continuous laser at 600 nm can emit up to 0�39 mW, but for shorter wavelengths, the maximum emission is lower because of the potential of those wavelengths to generate photochemical damage� The maximum emission is also related to the pulse duration in the case of pulsed lasers and the degree of spatial coherence�

2. Class 1M Laser A Class 1M laser is safe for all conditions of use except when passed through magnifying optics such as microscopes and telescopes� Class 1M lasers produce large-diameter beams, or beams possess divergent capabilities� Never exceed the MPE for a Class 1M laser unless using focusing or imaging optics to narrow the beam� Classify a laser as Class 1M if the total output power remains below Class 3B� Lasers with the power that can pass through the pupil of the eye stays within Class 1�

3. Class 2 Laser A Class 2 laser is safe because the blink reflex will limit the exposure to no more than 0�25 seconds� It only applies to visible-light lasers (400-700 nm)� Limit Class 2 lasers to 1 mW continuous wave or more if the emission time remains less than 0�25 seconds or if the light does not perform as spatially coherent� Intentional suppression of the blink reflex could lead to eye injury�

4. Class 2M Laser A Class 2M laser is safe because of the blink reflex if not viewed through optical instruments� As with Class 1M, this applies to laser beams with a large diameter or large divergence, for which the amount of light passing through the pupil cannot exceed the limits for Class 2�

5. Class 3R Laser A Class 3R laser is considered safe if handled carefully, with restricted beam viewing� With a Class 3R laser, the MPE can be exceeded but with a low risk of injury� Visible continuous lasers in Class 3R must be limited to 5 mW� For other wavelengths and for pulsed lasers, other limits apply�

6. Class 3B Laser A Class 3B laser poses hazards when eyes receive direct exposures� Diffuse reflections such as from paper or other matte surfaces are not harmful� Continuous lasers in the wavelength range from 315 nm to far infrared must be limited to 0�5 W� For pulsed lasers between 400 and 700 nm, the limit is 30 mJ� Other limits apply to other wavelengths and to ultra-short pulsed lasers� Protective eyewear is typically required where direct viewing of a class 3B laser beam may occur� Class 3B lasers must be equipped with a key switch and a safety interlock�

7. Class 4 Laser Class 4 lasers include all lasers with beam power greater than Class 3B� By definition, a Class 4 laser can burn the skin, in addition to potentially devastating and permanent eye damage as a result

of direct or diffuse beam viewing� These lasers may ignite combustible materials, and thus may represent a fire risk� Class 4 lasers must be equipped with a key switch and a safety interlock� Most entertainment, industrial, scientific, military, and medical lasers are in this category�

During surgical procedures that use a laser or electrosurgical unit, the thermal destruction of tissue creates a smoke byproduct� An estimated 500,000 workers (surgeons, nurses, anesthesiologists, and surgical technologists) are exposed to laser or electrosurgical smoke each year� NIOSH research studies have confirmed that this smoke plume can contain toxic gases and vapors such as benzene, hydrogen cyanide, formaldehyde, bio-aerosols, cellular material including blood fragments, and viruses� At high concentrations, the smoke causes ocular and upper respiratory tract irritation in healthcare personnel, and creates visual problems for the surgeon� The smoke produces an unpleasant odor and may possess mutagenic potential� Surgical smoke may possess potential for generating infectious viral fragments� Use portable smoke evacuation devices and room suction systems� Keep the smoke evacuation devices or room suction hose nozzle inlet within two inches of the surgical site to effectively capture airborne contaminants� Keep smoke evacuation devices activated at all times when airborne particles are produced during all surgical or other procedures� Consider all tubing, filter, and absorbers as infectious waste and dispose of them appropriately� Install new filters and tubing before each procedure� Inspect smoke evacuation systems regularly to prevent possible leaks� Use Universal Precautions as required by the OSHA Bloodborne Pathogens Standard� For additional information refer to Control of Smoke from Laser/Electric Surgical Procedures: DHHS (NIOSH) Publication No� 96-128�

If a potential exists for skin exposure to ultraviolet lasers (200-400 nm), use skin covers and/or sunscreen� Most gloves will provide some protection against laser radiation� Tightly woven fabrics and opaque gloves provide the best protection� A laboratory jacket or coat can provide protection for the arms� For Class 4 lasers, give consideration to using flame-resistant materials� Use protective clothing when exposed to levels of radiation that exceed exposure limits for the skin�

Place the laser in standby mode whenever it is not in active use� Activate the laser only when the tip is under the surgeon’s direct vision� Allow only the person using the laser to activate it� Deactivate the laser and place it in standby mode before removing it from the site� When performing laser surgery through an endoscope, pass the laser fiber through the endoscope before introducing the scope into the patient� This will minimize the risk of damaging the fiber� Before inserting the scope in the patient, verify the fiber’s functionality� During lower airway surgery, keep the laser fiber tip in view and make sure it is clear of the end of the bronchoscope or tracheal tube before laser emission� Use appropriate laser resistant tracheal tubes during upper airway surgery� Follow the directions in the product literature and on the labels, which typically include information regarding the tube’s laser resistance, use of dyes in the cuff to indicate a puncture, use of a saline fill to prevent cuff ignition, and immediate replacement of the tube if the cuff becomes punctured�

MRIs provide detailed images of organs and tissues throughout the body without the need for x-rays� Instead, an MRI uses a powerful magnetic field, radio waves, a rapidly changing magnetic field, and a computer to create images that show whether or not there is an injury or some disease process present� For this procedure, the patient is placed within the MRI scanner� The magnetic

field aligns atomic particles called protons that exist in most of the body’s tissues� Radio waves then cause these particles to produce signals received within the MR scanner� The signals become specially characterized by using a changing magnetic field, and a computer processor creates very sharp images of tissues as “slices” that can be viewed in any orientation� An MRI exam causes no pain, and the magnetic fields produce no known tissue damage of any kind� The MR scanner may make loud tapping or knocking noises at times during the exam; using earplugs prevents problems that may occur with this noise� Key safety concerns involve the use of strong magnetic fields, RF energy, time-varying magnetic fields, cryogenic liquids, and magnetic field gradients� Magnetic fields from large bore magnets can literally pick up and pull large ferromagnetic items into the bore of the magnet� Take caution to keep all ferromagnetic items away from the magnet� The kinetic energy of such an object being sucked into a magnet can smash an RF imaging coil� Similar forces work on ferromagnetic metal implants or foreign matter in those being imaged� These forces can pull on these objects, cutting and compressing healthy tissue� For these reasons individuals with foreign metal objects such as shrapnel or older ferromagnetic implants are not imaged� There exist additional concerns regarding the effect of magnetic fields on electronic circuitry, specifically pacemakers� An individual with a pacemaker walking through a strong magnetic field can induce currents in the pacemaker circuitry, which will cause it to fail and possibly cause death� Magnetic fields will also erase credit cards and magnetic storage media�

The guidelines state that field strengths not exceeding 2�0 Tesla may be routinely used� People with pacemakers should never enter magnetic fields greater than 5 gauss� A 50 gauss magnetic field will erase magnetic storage media� The RF energy from an imaging sequence can cause heating of the tissues of the body� The FDA recommends limited exposure to RF energy� The specific absorption rate (SAR) serves as the limiting measure� The formula for this is SAR = joules of RF/second/kg of body weight = watts/kg� The recommended SAR limitations depend on the anatomy being imaged� The SAR for the whole body should be less than 0�4 W/kg� It should be less than 3�2 W/kg averaged over the head� Any pulse sequence should not raise the temperature by more than 1 degree Celsius (C) and no greater than 38 degrees C in the head, 39 degrees C in the trunk, and 40 degrees C in the extremities� Some RF coils, such as surface coils, contain failure modes that can cause burns to the patient� Take care to keep these coils in proper operating order� The FDA recommendations for the rate of change of a magnetic field state that the dB/dt for the system should be less than that required to produce peripheral nerve stimulation� Imaging gradients do produce high acoustic noise levels�

The ACR has made safety recommendations for the use of MRI machines� The new recommendations include restricting access to MRI rooms, appointing a special director of hospital MRI

BOX 8.3 MRI SAFETY AND COMPATIBILITY STANDARDS

• ASTM F2052-00 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment

• ASTM F2119-01 Standard Test Method for Evaluation of MRI Artifacts From Passive Implants

• IEC 601-2-33 - Medical Electrical Equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis

facilities, and educating those working near or in an MRI department about safety� Consider patients with certain implanted devices, such as many types of intra-cranial aneurysm clips, as contraindicated from MRI imaging since the torque and displacement forces produced on the device can result in the tearing of soft tissues� Other implants, such as certain cardiac pacemakers, can function erratically even in relatively weak magnetic fields� In device labeling for pacemakers, MRI is listed as a contraindication� Prohibit individuals with implanted pacemakers from entering the MRI procedures room or coming within the five gauss line around the scanner� With regard to medical devices, electrical currents may occur due to conductive metal implants, such as skull plates, and hip prostheses�

When using conductive patient leads during MRI scanning, ensure that the leads do not form loops� Looped patient leads or devices such as the halo device used for spinal immobilization can pick up RF energy resulting in induced currents, heating of the material, and as a result, potentially severe patient burns� To reduce the possibility of burns, thermally insulate electrically conductive material in the bore of the magnet from the patient using blankets or sheets� Other steps to prevent burns include the following:

• Ensure conductive cables are not looped and that cables do not cross each other • Place sensors-such as those for pulse oximetry-as far as possible from the RF coils • Use manufacturer-supplied padding, rather than blankets or sheets, to prevent patients

from contacting the magnet bore • Regularly check all sensors, cables, and MR accessories such as RF coils and cables for

any breaks in insulation • Regularly inspect items provided for patient comfort, such as headphones and video gog-

gles, for signs of damage

Even when steps such as these are taken, heating can occur during an MRI scan, so MRI technicians must ask patients to signal if they feel undue heat during the scan�

CT is fast, reliable, and convenient, but its comparatively high x-ray dose has only just begun to attract attention� In the United States, it has been estimated that CT could be responsible for about 6,000 additional cancers a year, roughly half of them fatal (ECRI Institute, 2008)�

To ensure patients are not unnecessarily exposed to high dose levels, consider the following:

• The expected benefits of a CT need to outweigh the radiation risks and CT referral guidelines should be regularly reviewed, particularly where children are concerned�

• Scanning protocols should be optimized to minimize doses� • Those performing CT exams should be specifically trained for CT and maintain their

training� • Monitoring CT use and dose should be part of normal quality control and equipment main-

tenance efforts� • Referring clinicians should have easy access to information regarding the dose and the

cancer risk associated with CT�

Fiber-optic light sources-used in devices such as endoscopes, retractors, and headlamps-are often referred to as “cold” light sources� This can be misleading� There are two main sources of burns from fiber-optic lights:

• The light itself: This is usually caused when a clinician places the endoscope or the distal end of the fiber-optic cable on the patient without shutting off the light source�

• Heated cable connections: This is typically caused when the diameter of the light cable is too large for the light post on the connected device� The light then contacts the metal portion of the light post, rather than the fibers within, heating the connection� If the connection contacts skin, a burn may result�

To reduce the risk of burns, consider the following:

• Never place the endoscope or the end of the light cable on a patient or on flammable objects� • Turn off the light source or place it in standby mode before removing the cable from the

light source or the instrument from the cable� • Use only the minimum output needed to perform the procedure� • Only use light sources that incorporate safety features, such as those that power up in

standby mode or at very low output settings�

As sonographers work with ultrasound equipment they may incur a risk for developing workrelated MSDs� Sonographers with heavy workloads and those with experience in the profession can incur risks� According to the Society of Diagnostic Medical Sonography (SDMS), sonographers on average experience pain or other disorders within five years of entering the profession� Sonographers can experience a variety of ergonomics-related risks when they performing specific tasks such as

• Transporting patients and equipment • Positioning patients and equipment • Using and orientating ultrasound equipment

Engineering, administrative, and work practice controls such as room layout and equipment placement, scheduling, staffing, patient assessment, training, and work practices may also need consideration to reduce the risk of developing an injury�

Hospitals operate in a variety of clinical laboratory functions� The size and scope of these lab functions will vary depending on the size and type of organization or facility� Many outside clinical laboratories also serve a variety of medical organizations and practices�

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the United States through the Clinical Laboratory Improvement Amendments (CLIA)� In total, CLIA covers approximately 200,000 laboratory entities� The

Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO), has the responsibility for implementing the CLIA Program� The objective of the CLIA is to ensure quality laboratory testing� Although all clinical laboratories should be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid responsibilities�

Since 1979, the Joint Commission has been accrediting hospital laboratory services� It has been accrediting independent laboratories since 1995� The Joint Commission accredits approximately 3,000 clinical laboratories� CMS officially recognizes the Joint Commission Laboratory Accreditation Program as meeting the requirements of CLIA ‘88� CLIA regulations require that all laboratories be surveyed on a two-year cycle� Joint Commission standards and CLIA regulations require that laboratories use CMS-approved proficiency testing for all regulated tests conducted by the lab� CLIA requires that a laboratory’s proficiency testing results be monitored on an ongoing basis� Achieving accreditation sends a strong statement about a lab’s commitment to provide services of the highest quality� The Joint Commission uses a tracer methodology that reviews the entire scope of the laboratory testing process, including pre-and post-analytical processes that occur outside the laboratory� The tracer system follows results to the bedside� Joint Commission lab surveys also evaluate other areas such as environment of care management, emergency management, infection control, and adherence to National Patient Safety Goals�

The College of American Pathologists (CAP) Laboratory Accreditation is an internationally recognized program and the only one of its kind that utilizes teams of practicing laboratory professionals to serve as inspectors� Designed to go well beyond regulatory compliance, accreditation helps laboratories achieve the highest standards of excellence to positively impact patient care� Accreditation standards focus on detailed checklist requirements� The checklists provide a quality blueprint for laboratories to follow� CAP Laboratory Accreditation meets the needs of a variety of laboratory settings from complex university medical centers to physician office-based laboratories� Because of its comprehensive nature, CAP accreditation can help achieve a consistently high level of service throughout an institution or healthcare system� CMS grants CAP Laboratory Accreditation deeming authority� The Joint Commission recognizes CAP and accreditation helps organizations meet state certification requirements� CAP also provides laboratory accreditation to forensic urine drug testing and reproductive laboratories, cosponsored with the American Society for Reproductive

BOX 8.4 CLINICAL LAB FUNCTIONS IN SOME HOSPITAL SETTINGS

• Pathology: Processes and tests tissue removed during surgical procedures • Cytology: Processes specimens to determine abnormalities in cell structure • Chemistry: Analyzes body fluids to determine glucose, protein, enzyme, and hor-

mone levels • Serology: Analyzes body fluids for antigens and antibodies • Hematology: Analyzes blood to determine info relating to red cells, white cells, and

platelets • Microscopy: Analyzes urine and body fluids • Microbiology: Analyzes specimens to determine causes of infection

Medicine (ASRM)� The goal of CAP Laboratory Accreditation focuses on improving patient safety by advancing the quality of pathology and laboratory services� Upon successful completion of the inspection process, the laboratory receives CAP accreditation to become part of an exclusive group meeting the highest standards of excellence�

This accreditation program seeks to improve patient safety and reduce laboratory-related risks� The accreditation conforms to ISO 15189:2007 requirements� Laboratories accredited to the ISO standard are well positioned to rapidly respond to the changing healthcare environment and demonstrate measurable quality to their customers� CAP serves as a medical society serving more than 17,000 physician members and the laboratory community throughout the world� It is the world’s largest association composed exclusively of board-certified pathologists and pathologists-in-training and is widely considered the leader in laboratory quality assurance� CAP is an advocate for high quality and cost-effective medical care� ISO promotes standardization facilitating the international exchange of goods and services, and developing cooperation in the spheres of intellectual, scientific, technological and economic activity�

The Commission on Office Laboratory Accreditation (COLA) was founded in 1988 as a private alternative to help laboratories stay in compliance with the new CLIA regulations� In 1993, CMS granted COLA deeming authority under CLIA, and in 1997 the Joint Commission recognized COLA’s laboratory accreditation program� After 35,000 surveys in which COLA’s practical, educational accreditation methods helped physician office laboratories stay in compliance with CLIA, COLA has expanded its program offerings to include hospital and independent laboratories� COLA is approved by CMS to accredit laboratories in the following specialties: (1) chemistry, (2) hematology, (3) microbiology, (4) immunology, (5) immune-hematology and transfusion services, and (6) pathology (cytology, histopathology, and oral pathology)�

The OSHA standard requires labs to produce a Chemical Hygiene Plan that addresses the specific hazards found in its location, and its approach to them� The standard emphasizes the use of safe work practices and appropriate worker protection as required by the laboratory environment� The standard covers all chemicals that meet the definition of a health hazard as defined in the Hazard Communication Standard published in 29 CFR 1910�1200� The standard does not specify work practices necessary to protect employees from potential hazards associated with chemical use but does require that physical hazards be addressed in the employer’s training program� The OSHA Lab Standard requires continued compliance with all published permissible exposure limits (PELs) and with the employer’s written chemical hygiene plan� The standard requires that special consideration be given for particularly hazardous substances including some selected carcinogens, reproductive toxins, and substances containing a high degree of acute toxicity� The laboratory standard 29 CFR 1910�1450 can apply to clinical hospital laboratories because of the use of hazardous chemicals� Laboratory use of hazardous chemicals means handling or use of such chemicals in which all of the following conditions are met: (1) chemical manipulations carried out on a laboratory scale, (2) multiple chemical procedures or chemicals used, (3) procedures involved not part of a production process, and (4) protective laboratory practices and equipment used to minimize employee exposures� Please note that according to an OSHA interpretation, the standard does not apply to a pharmacy operation mixing cytotoxic drugs�

BOX 8.5 KEY REQUIREMENTS OF THE OSHA LAB STANDARD

• Conduct employee exposure monitoring (under certain conditions) • Develop SOPs • Emphasize requirements of the HAZCOM Standard for employee training • Arrange for medical consultations and examinations • Develop a Chemical Hygiene Plan and appoint a Chemical Hygiene Officer • Provide hazard identification information such as Safety Data Sheets (SDSs) and

labeling requirements • Ensure chemical fume hood performance certifications

BOX 8.6 RELEVANT OSHA STANDARDS FOR LABORATORIES

• Personal Protective Equipment (29 CFR 1910 Subpart I) • General PPE Requirements (29 CFR 1910�132) • Respiratory Protection (29 CFR 1910�134) • Toxic and Hazardous Substances (29 CFR 1910 Subpart Z) • Hazard Communication (29 CFR 1910�1200) • Bloodborne Pathogens (29 CFR 1910�1030) • Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910�1450)

BOX 8.7 OTHER RELEVANT LAB STANDARDS & RESOURCES

• ANSI Z358�1-2004, Emergency Eyewash and Shower Equipment, contains provisions regarding the design, performance, installation, use, and maintenance of various types of emergency equipment� In addition to these provisions, some general considerations apply to all emergency equipment�

• ANSI Z9�5-2003, Laboratory Ventilation, is intended for use by employers, architects, occupational and environmental health and safety professionals, and others concerned with the control of exposure to airborne contaminants� The book includes new chapters on performance tests, air cleaning, preventative maintenance, and work practices� It also highlights the standard’s requirements and offers good practices for laboratories to follow� The book also offers referenced standards and publications, guidance on selecting laboratory stack designs, an audit form for ANSI Z9�5, and a sample table of contents for a laboratory ventilation management plan�

• ANSI/ASHRAE 110-1995, Method of Testing the Performance of Laboratory Hoods, specifies a quantitative test procedure for evaluation of a laboratory fume hood� A tracer gas is released at prescribed rates and positions in the hood and monitored in the breathing zone of a mannequin at the face of the hood� Based on the release rate of the tracer gas and average exposure to the mannequin, a performance rating is achieved�

• NFPA 45, Standard on Fire Protection for Laboratories Using Chemicals, 2004 Edition, applies to laboratories that handle hazardous chemicals�

• NIOSH Pocket Guide to Chemical Hazards (NPG) provides a source of general industrial hygiene information on several hundred chemicals and classes for workers, employers, and occupational health professionals�

• NIOSH Master Index of Occupational Health Guidelines for Chemical Hazards summarizes pertinent information about the properties and hazards of many chemicals found in laboratories�

(Continued)

Supervisors must prohibit mouth pipetting or suctioning of blood related materials� Restrict eating, drinking, smoking, applying cosmetics or lip balm, or handling contact lenses in areas with a reasonable likelihood of occupational exposure to bloodborne pathogens� Never store food or drink in refrigerators, freezers, shelves, cabinets, or on countertops or bench tops where blood or other potentially infectious materials exist� Use splatter guards to prevent splashing from reaching employees� Use hands-free sensor-controlled automatic sinks with foot, knee, or elbow controls� Other safety suggestions include using centrifuge tubes with caps, working in appropriate biological safety cabinets (BSCs), checking daily for proper air exchange and air flow, and maintaining records of ventilation systems and other equipment� Workers should never stand on chairs, lab stools, boxes, or drums to reach high shelves or the ceiling area� Use stepladders or step stools specially designed for such purposes� Wash hands and arms several times during the course of the day to remove bits of irritating chemicals, animal dander, or biohazards� Maintain adequate ventilation at all times� Check hood drafts regularly, and direct questions about the proper functioning of the hood to the maintenance department or the chemical hygiene officer� Stay aware that static electricity can develop when transferring poor conductor liquids from one container to another� Watch for electrical charges that could develop when compressed gases release rapidly from a cylinder� These charges can jump air gaps and form sparks, which may ignite flammable vapors or gases� Ensure the proper grounding of cylinders by connecting the container and receiver by a ground wire� Electrical charges may also build up on personnel wearing shoes with rubber or plastic soles� Report sluggish drains to the maintenance department immediately� Never pour chemicals down a drain that could interact with the pipe material or cause a chemical reaction� Never pour any flammable materials down a drain� Refer to NFPA 45, Fire Protection Standard for Laboratories Using Chemicals, for information on construction, ventilation, and fire protection requirements�

Cover all centrifuges during operation� Centrifuge tubes should fit the metal buckets and should never contain defects or cracks� Cushions at the bottom of the cups should be in good condition� Implement an inspection and maintenance schedule for centrifuges and associated equipment installed in the laboratory� Equip all electrical heating equipment with over-temperature shutoff controls� Make thermal gloves, beaker and crucible tongs, and test tube holders available for handling hot items�

Take appropriate actions to prevent exposure of laboratory employees to bloodborne pathogens while handling contaminated lab samples such as blood or other body fluids� OSHA sets additional

BOX 8.7 OTHER RELEVANT LAB STANDARDS & RESOURCES (Continued)

• The AIHA Laboratory Health & Safety Committee provides resources to aid in prevention, identification, and control of potential exposures to chemical, biological, ergonomic, ionizing and nonionizing radiation, and physical hazards in laboratories�

• The Hazardous Substances Data Bank (HSDB), National Library of Medicine (NLM), provides a toxicology data file that focuses on the toxicology of potentially hazardous chemicals� It is enhanced with information on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas�

• Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, provides guidance for implementing safety and hazard control practices in research labs�

requirements for biomedical research labs and facilities� Exposure of laboratory employees to bloodborne pathogens can occur while handling contaminated lab samples such as blood or other body fluids� Require workers to wear appropriate personal protective equipment (PPE) as required by the OSHA standard� The type and amount of PPE depends on the anticipated exposure� Post a hazard warning sign incorporating the universal biohazard symbol on all access doors when potentially infectious materials, including infected animals, remain present in the work area� The hazard warning sign must meet OSHA 29 CFR 1910�1030 requirements� Conduct all activities involving other potentially infectious materials using a BSC or other physical containment device within the containment module� Prohibit work with other potentially infectious materials on open benches� Use only certified BSCs or other appropriate combinations of personal protection or physical containment devices� Detail any requirements for special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals to prevent exposures to droplets, splashes, spills, or aerosols� Recommend that sinks permit foot, elbow, or automatic operation and locate sinks near an exit door in the work area� Each laboratory must provide a handwashing and eyewash facility that is readily available within the work area� Establish controls to prevent employee exposure from needle stick injuries or cuts from sharp objects when working with specimens, centrifuge tubes, or overfilled sharps containers� Use engineering controls such as safer needle devices and work practice controls include altering the way a task is performed to reduce the chance of injury� OSHA, FDA and NIOSH now recommend not using glass capillary tubes due to exposure risks during breakage� Human immunodeficiency virus (HIV) and hepatitis B virus (HBV) research laboratories must only use hypodermic needles and syringes for parenteral injection and aspiration of fluids from laboratory animals and/or diaphragm bottles� Research facilities must only use needle locking syringes or disposable syringe needle units for the injection or aspiration of other potentially infectious materials�

Require the use of appropriate controls such as limiting access, sealing windows, providing directional airflow, preventing recirculation of laboratory exhaust air, and filtering exhaust air� Use BCSs whenever working with infectious materials that could aerosolize� Processes that can expose employees to aerosolized materials include (1) pouring liquid cultures, (2) using fixed volume automatic pipetting devices, (3) mixing liquid cultures with a pipette, (4) preparing specimens and culture smears, and (5) dropping and spilling tubes containing suspensions of bacilli�

Employee exposures include biological risks from infectious diseases and agents such as staph, strep, and HBV� Formaldehyde exposures from contact with cadavers pose a real hazard� Use appropriate PPE� Additional protections may apply during autopsies� Ensure the operation of appropriately designed ventilation systems� Locate local vacuum systems for power saws in the morgue� Provide appropriate ventilation systems such as downdraft tables that capture the air around the cadaver� Use splatter guards to prevent splashes from reaching employees� Require the use of surgical caps or hoods and shoe covers or boots when anticipating high contamination�

Laboratory workers can experience routine exposure to hazardous chemicals such as acetone, carbon monoxide, formaldehyde, hydrogen sulfide, mercury, nitric acid, and xylene� Many exposures occur annually in laboratories, resulting in chemical-related illnesses such as dermatitis, eye irritation, and even fatal pulmonary edema� Employers must include information on additional protective measures for work that involves carcinogens, reproductive toxins, and acutely toxic substances�

Establish a designated area with appropriate warning signs of the hazards present� Provide information on safe and proper use of a fume hood or equivalent containment device� Develop procedures for decontaminating the designated area, including the safe removal of contaminated waste and biohazards� Employers must ensure that hazardous chemical container labels are not removed or defaced� SDSs must accompany incoming shipments of chemicals and employers must make them made available to exposed employees� Develop plans and conduct drills to prepare for emergencies such as fire, explosion, accidental poisoning, chemical spill, vapor release, electric shock, bleeding, and personal contamination� Employers must provide appropriate safety equipment and first aid kits� Safety equipment may include fire extinguishers, fire blankets, automated external defibrillators (AEDs), safety showers, eyewash fountains, spill control materials, and fume exhaust hoods� Test or check safety equipment on a monthly basis�

Determine exposure outcomes by considering the following issues: (1) route of exposure, (2) physical properties of the chemical, and (3) individual susceptibility to the chemical� Report all exposure incidents to the laboratory manager or supervisor, or principal investigator, regardless of severity� When decontaminating skin, immediately flush with water for at least 15 minutes� Use shower and eyewash stations as appropriate� Check the SDS to determine if any delayed effects should be expected� Discard contaminated clothing or launder them separately from other clothing� Consider formaldehyde as a suspected carcinogen� When any possibility exists that employee’s eyes may be splashed with solutions containing 0�1 percent or greater formaldehyde, the employer must provide acceptable eyewash facilities within the immediate work area for emergency use�

Develop SOPs relevant to safety and health considerations to be followed when laboratory work involves the use of hazardous chemicals� This is especially the case if your lab operations include the routine use of select carcinogens, reproductive toxins, and substances of acute toxicity� SOPs can function as standalone documents or supplemental information included as part of research notebooks, experiment documentation, or research proposals� The key idea with laboratories having SOPs is to ensure a process is in place so that an experiment is well thought out and includes and addresses relevant health and safety issues�

Laboratory equipment may include refrigerators, centrifuges, microscopes, glassware, vacuum systems, stirring and mixing devices, heating devices, and autoclaves� Laboratory workers should understand all potential equipment hazards, and should follow cleaning, maintenance, and calibration schedules� Electrically powered equipment such as hot plates, stirrers, vacuum pumps, electrophoresis apparatus, lasers, heating mantles, ultrasonic devices, power supplies, and microwave ovens can pose significant hazards when mishandled or not maintained� Require grounded plugs on all electrical equipment and ground fault interrupters (GFIs) at needed locations� Compressed gases can pose toxic, flammable, oxidizing, corrosive, inert, or a combination of hazards� Use appropriate care when handling and storing compressed gas cylinders�

Modern microtomes are precision instruments designed to cut uniformly thin sections of a variety of materials for detailed microscopic examination� For light microscopy, the thickness of a section can vary between 1 and 10 microns� All microtomes consist of a base or the microtome body, knife

attachment and knife, and the material or tissue holder� With most microtomes a section is cut by advancing the material holder towards the knife while the knife is held rigidly in place� The cutting action can occur in either in a vertical or horizontal plane� Microtome knives constitute one of the ever-present and continuing hazards faced by medical laboratory personnel in the production of quality sections for diagnosis� Sharp microtome knives pose cutting hazards to users� However, injuries need not occur if workers take precautions and handle microtome knives with care and respect at all times� Always use knife guards on microtomes and carry a solid microtome knife in its box� Attach a handle before removing the knife from the box and never attempt to catch a dropped knife� Take extra care when tightening the screws used for holding disposable blades firmly in blade holders� Recommend workers take tetanus boosters every 5 to 10 years� Glass knives, prepared on knife-making machines by breaking hardened glass under pressure, pose an extra hazard� Splintering may occur when making new glass knives and safety glasses should be worn to prevent eye damage�

Working with hazardous chemicals at high or low pressures requires planning and special precautions� Implement procedures to protect against explosion or implosion through appropriate equipment selection and the use of safety shields� Take care when selecting glass apparatus and ensure that selected models can safely withstand designated pressure extremes� Always provide guards on all vacuum pumps� Vacuum work can result in an implosion and the possible hazards of flying glass, splattering chemicals, and fire� Correctly install all vacuum operations and know the potential risks�

A well-designed chemical fume hood, when properly installed and maintained, offers a large degree of protection to the user� A fume hood functions as a ventilated enclosure that contains gases, vapors, and fumes to prevent their release in the laboratory� Hoods can also limit the effects of a spill by partially enclosing the work area and drawing air into the enclosure by means of an exhaust fan� An exhaust fan situated on the top of the laboratory building pulls air and airborne contaminants into the hood through ductwork and exhausts them to the atmosphere� In a well-designed, properly functioning fume hood, only about 0�0001 to 0�001 percent of the material released within the hood actually escapes from the hood and enters the laboratory� Base the necessity of a fume hood by conducting a hazard analysis� The analysis should include a review of the quantity and toxicity of the materials used and the experiment conducted� Also consider volatility of the materials present, potential for their release, the number and sophistication of manipulations, and the skill of the lab person performing the work� Many laboratories use equipment and apparatus that can generate airborne contaminants that cannot be controlled by a fume hood� Examples include gas chromatographs, ovens, and vacuum pumps�

Employers must provide training on safe lab work practices� Topics should include issues such as hazard awareness, handling of chemicals, procedures, and PELs� Provide workers with information on health and hygiene, physical hazards, electrical safety, emergency procedures, PPE, working alone in the laboratory, security, and handling visitors� Conduct worker training prior to initial assignment and whenever new exposure situations occur� Training must include location of the facility hygiene plan and the requirements of the OSHA Laboratory Standard� Provide information about OSHA PELs and recommended exposure limits (RELs) if no regulatory standard applies� Educate workers on the procedures for handling, storing, and disposing of hazardous chemicals� Review the elements of the chemical hygiene plan� Review specific employer procedures, engineering controls,

work practices, and PPE� Ensure employees understand detection methods, observation guidelines, and monitoring procedures� Training should emphasize visual appearances and presence of odors that can help detect the presence of hazardous chemicals� Consider conducting regular departmental safety meetings to discuss the results of inspections and aspects of laboratory safety�

The OSHA Laboratory Standard does not mandate medical surveillance for all laboratory workers� The employer must provide workers an opportunity for medical attention� This includes follow-up examinations and treatment recommended by an examining physician when an employee exhibits signs or symptoms associated with exposure to a hazardous chemical or the worker is routinely exposed above the action level or PEL for a regulated substance� Offer medical consultation to any employee potentially exposed through a spill, leak, or explosion of a hazardous chemical or substance� Employers must provide information about the hazardous chemical, conditions under which the exposure occurred, and a description of symptoms experienced by the worker� They must also obtain from a treating physician any written opinion requiring follow-up examinations or medical tests�

Supervisors must ensure that employees know, understand, and follow the chemical hygiene plan and related SOPs� Supervisors must ensure availability of proper PPE and train employees in its proper use� Perform quarterly chemical hygiene and housekeeping inspections� Perform semiannual chemical inventories of all laboratories and storage areas� Determine PPE for the procedures and chemicals in use in the area� Supervisors must conduct self-inspections to assure that healthful working conditions are regulatory compliant�

Safety personnel can help lab safety by providing training, resources, and consultation for a variety of laboratory safety issues, including chemical safety, biological safety, electrical safety, laser safety, radiation safety, and other topics� They can also review the chemical hygiene plan, help develop and maintain laboratory safety manuals, conduct exposure monitoring, inspect fume hoods, and perform safety audits�

Lab personnel must plan and conduct each laboratory operation in accordance with the chemical hygiene plan� Employees must also keep lab work areas in good order� Employers must educate personnel on how to correctly select and use required PPE� Provide employees with a system to report exposures, injuries, or problems to supervisors or the chemical hygiene officer�

Use care when handling animals to avoid being bitten or scratched� Use proper restraining or protective devices whenever possible� Wear protective gloves when dissecting or conducting necropsy� Use first-aid procedures to treat animal bites and scratches and report all incidents immediately� Immediately report allergic reactions to animals or to the drugs used in treating animals� When using animals to study the progress of disease, it is the responsibility of the supervisor to explain methods of protection to all workers� Thoroughly disinfect the living area of infected animals� Render all animal carcasses noninfectious by autoclaving or incineration� Animal Biosafety Levels  1, 2, 3, and 4 provide increasing levels of protection to personnel and the environment�

One additional biosafety level designated BSL-3-Agriculture addresses activities involving large or loose-housed animals and/or studies involving agents designated as High Consequence Pathogens by the United States Department of Agriculture (USDA)�

Lab workers must know waste characteristics, proper packaging standards, labeling requirements, and waste collection or containment policies� Labs should maintain chemical inventory to avoid purchasing unnecessary quantities of chemicals and develop a program for dating stored chemicals� Other helpful information needed to ensure proper disposal includes the following: (1) procedures for drain disposal of chemical waste, (2) policies on disposing of empty chemical containers, and (3) knowledge of federal, state, and local regulations for proper disposal� Determine procedures for special types of waste including batteries, mercury-containing items, used oil, and recycling chemicals�

Autoclaves provide steam sterilization using a combination of temperature and pressure for a set time� A common autoclave cycle is 121 degrees Celsius at 15 psi for 20 minutes; however, settings on individual autoclave machines can vary slightly� While autoclaving does sterilize products, it does not clean the product, so take measures to clean labware to remove any soil or debris� Use a manual cleaner, ultrasonic cleaner, or laboratory washer� Because of the high temperature required for autoclaving, some plastics cannot survive autoclaving due to heat requirements� These would include polyethylene, polystyrene, or polyurethane� It is important for anyone using high-temperature sterilization processes to determine if their lab ware can tolerate high heat applications�

To maintain a good clinical laboratory practices (GCLP) environment for clinical trials, labs must implement all key GCLP practices� These elements include (1) developing effective organization and personnel management, (2) designing testing facilities, (3) appropriately validating assays, (4) using relevant positive and negative controls for the assays, and (5) creating a system for recording, reporting, and archiving data� Conducting audits helps ensure compliance with GCLP guidance� GCLP compliance will help laboratories ensure production of accurate, precise, and reproducible data to support sponsor confidence and withstand regulatory agency review� GCLP embraces both research and clinical labs� GCLP standards encompass applicable portions of 21 CFR Parts 58 (GLP) and 42 CFR part 493 (Clinical Laboratory Improvement Amendments -CLIA)� Due to the ambiguity of some parts of the CFR regulations, the GCLP standards are described by merging guidance from regulatory authorities as well as other organizations and accrediting bodies, such as the CAP and the ISO� The GCLP standards provide a single, unified document to guide the conduct of laboratory testing for human clinical trials� The intent of GCLP guidance is to help laboratories ensure the quality and integrity of data� The guidelines also encourage accurate reconstruction of experiments, monitoring of data quality, and comparing of test results�

Provide an environment in which laboratory testing does not compromise the safety of the staff, or the quality of the pre-analytical, analytical, and post-analytical processes� Design the laboratory to assure proper equipment placement, adequate ventilation, and sufficient storage areas� Ensure lab design supports archiving of data in a secure fireproof, fire-resistant, or fire-protected environment� Provide access to authorized personnel only� Laboratory designs must provide sufficient

work areas to support worker effectiveness and safety� Maintain the laboratory’s ambient temperature and humidity to ensure equipment and testing remains in tolerance limits established by the manufacturer� Use ambient temperature logs to document the acceptable temperature range, record actual temperatures, and provide documentation of corrective action taken to maintain acceptable temperature ranges� Clean and maintain all floors, walls, ceilings, and bench tops in the laboratory�

Because of the complexity of medications, including specific indications, effectiveness of treatment regimens, medication safety, and patient compliance issues, many pharmacists practicing in hospitals gain more education and training after pharmacy school through a pharmacy practice residency, which is sometimes followed by another residency in a specific area� Those pharmacists, often referred to as clinical pharmacists, specialize in various disciplines of pharmacy� For example, pharmacists can specialize in hematology/oncology, HIV/AIDS, infectious disease, critical care, emergency medicine, toxicology, nuclear pharmacy, pain management, psychiatry, anti-coagulation clinics, herbal medicine, neurology/epilepsy management, pediatrics, neonatal pharmacists, and more�

Hospital pharmacies usually stock a larger range of medications, including more specialized medications, than would be feasible in the community setting� Most hospitals dispense medications as a unit dose, or a single dose of medicine� Hospital pharmacists and trained pharmacy technicians compound sterile products for patients including total parenteral nutrition (TPN), and other medications given intravenously� This is a complex process that requires adequate training of personnel, quality assurance of products, and adequate facilities� Some hospital pharmacies outsource highrisk preparations and some other compounding functions to companies who specialize in compounding� The high cost of medications and drug-related technology, combined with the potential impact of medications and pharmacy services on patient safety make it imperative that hospital pharmacies perform at the highest level possible�

Clinical pharmacists provide direct patient care services that optimize the use of medication and promote health, wellness, and disease prevention� Clinical pharmacists care for patients in all healthcare settings, but the clinical pharmacy movement initially began inside hospitals and clinics� They often collaborate with physicians and other healthcare professionals to improve pharmaceutical care, and now serve as an integral part of the interdisciplinary approach to patient care� They work collaboratively with physicians, nurses, and other healthcare personnel in various medical and surgical areas, and often participate in patient care rounds and drug product selection� In most hospitals in the United States, potentially dangerous drugs that require close monitoring are dosed and managed by clinical pharmacists� Pharmacies must comply with Joint Commission, American Osteopathic Association, or other Medicare accreditation/certification standards� OSHA regulates worker safety in pharmacies, including exposure to hazardous materials and drugs� In hospital settings, the pharmacy plays a key role in providing quality care� The pharmacy serves other functions including directing special drug programs, providing services to satellite locations, and managing drug information systems� The pharmacy department also plays a key role in preventing medication errors� The onsite licensed pharmacists prepare pharmacy compounds and mix all sterile medications, intravenous admixtures, or other drugs, except in emergency situations�

Use safety materials and equipment while preparing hazardous medications� Avoid contamination by using clean or sterile techniques as appropriate� Maintain clean, uncluttered, and functionally separate areas for product preparation� Visually inspect the integrity of the medications� Workers

not aware of proper work practices and controls may be exposed to hazardous drugs through the skin, mouth, or by inhalation� The OSHA Technical Manual and new NIOSH Guidelines provide guidance regarding the safety, use, administration, storage, and disposal of hazardous drugs�

The American Society of Healthcare System Pharmacists recommends that pharmacies develop and implement a safety management program� Pharmacy representation on the safety committee is important not only to the department, but also to the effectiveness of the safety committee� Concern over safe handling of medication, errors, and hazardous drug safety has increased the pharmacy’s presence on the committee� The pharmacy director must ensure that the department conducts an effective orientation and on-the-job training program to address

• The importance of practicing safety on the job • The department’s disaster planning and emergency response roles • Hazards found in specific jobs or processes • Organizational/departmental safety policies and procedures

Pharmacy personnel must be familiar with the organization’s emergency management plan, and must be trained in the department’s responsibilities in supporting the plan� The department should develop a plan for obtaining and distributing drugs during emergency situations� Pharmacy staff members should know

• Fire identification and reporting procedures • The classes and hazards of fire • How to activate the fire alarm and notify others • How to select and use the proper fire extinguisher • Techniques for controlling smoke and fire • Evacuation routes and egress responsibilities

OSHA requires a written plan that contains information related to worker training, warning labels, and access to SDSs� Employees must understand the requirements of the Hazard Communication Standard, including operations or procedures with hazard exposures� The Hazard Communication Standard applies to drugs and pharmaceuticals that the manufacturer has determined to be hazardous� It could also apply to hazardous substances known to be present in the workplace that employees may be exposed to under normal conditions or in a foreseeable emergency� The exemptions to the standard include

• Drugs that are in solid, final form for direct administration to the patient (final form exemption would also apply to tablets or pills that are occasionally crushed, if the pill or tablet is not designed to be dissolved or crushed prior to administration)

• Consumer products subjected to the labeling requirements of the terms as defined in the Consumer Product Safety Act and the Federal Hazardous Substances Act

Pharmacy personnel may develop MSDs such as carpel tunnel syndrome or tendonitis from activities that involve repetitive tasks, forceful exertions, awkward postures, or contact stress� Use assistive devices if possible� Modify pharmacy tasks to decrease incidence of work-related MSDs� Redesign

the process to incorporate variation into the task� Ergonomically comfortable workstations should include wrist pads, adjustable padded chairs, keyboard trays, and monitors that are at a comfortable height�

Pharmacists may be exposed to workplace violence due to the availability of drugs and money in the pharmacy area� OSHA recommends that employers establish and maintain a violence prevention program� Install Plexiglas® in the payment window in the pharmacy area� Provide better visibility and lighting in the pharmacy area� Conduct training for staff in recognizing and managing hostile and assaultive behavior� Implement security devices such as panic buttons, beepers, surveillance cameras, alarm systems, two-way mirrors, card-key access systems, and security guards�

Standardize labeling to meet organization policy, applicable law, or practice standards� Properly label all medication when prepared if not administered immediately� Appropriately label any container, including plastic bags, syringes, bottles, or boxes, that can be labeled and secured� Label with the drug name, strength, and amount, if not apparent from the container� Include expiration date when not used within 24 hours� Label compounded IV admixtures and nutrition solutions with the date prepared and the diluents� When preparing medications for multiple patients or if the preparing person will not administer the medication, include the patient name and location on the label�

Develop a process for providing medications to meet patient needs when the pharmacy is closed� Store the medications in a night cabinet, automated storage and distribution device, or a selected section of the pharmacy� Only permit trained designated prescribing professionals or nurses to access medications� Establish quality control procedures such as a second check by another individual or a secondary verification such as bar coding to prevent medication retrieval errors� Arrange for a qualified pharmacist to stay available on call or at another location to answer questions or provide for medications beyond those accessible to nonpharmacy staff� Implement changes as needed to reduce the amount of times nonpharmacist healthcare professionals obtain medications after the pharmacy is closed�

When the organization has been informed of a medication recall or discontinuation by the manufacturer or the FDA for safety reasons, retrieve the medications within the organization and handle per organization policy, law, or regulation� Recalls generally occur by lot number� An organization may retrieve all lots of a recalled medication instead of recording and identifying medications by their lot number� When the organization has been informed of a medication recall or discontinuation by the manufacturer or the FDA for safety reasons, notify everyone that orders, dispenses, and administers of the recalled or discontinued medications�

Refer to lists of high-risk or high-alert drugs available from the Institute for Safe Medication Practices (ISMP) or the United States Pharmacopeia (USP)� The organization should develop a list of high-risk or high-alert drugs based on its utilization patterns, administered drugs, and internal data about medication errors� High-risk drugs may include investigational drugs, controlled

medications, drugs not approved by the FDA, medications with a narrow therapeutic range, psychotherapeutic medications, and look-or soundalike medications� As appropriate to the services provided, the organization should develop processes for procuring, storing, ordering, transcribing, preparing, dispensing, administering, and monitoring high-risk or high-alert medications�

The organization protects the safety of patients participating in investigational or medication studies by ensuring adequate control and support� The organization should show sensitivity to the use of particular populations for experimentation and research, and review all investigational medications to evaluate safety� Develop a written process for reviewing, approving, supervising, and monitoring investigational medication use� Review and accommodate, as appropriate, the patient’s continued participation in the protocol� Specify that the pharmacy controls the storage, dispensing, labeling, and distribution of the investigational medications�

Evaluate the medication management system for risk points and identify areas to improve safety� Routinely evaluate literature for new technologies or successful practices demonstrated to enhance safety for improving the medication management system� Review internally generated reports to identify trends or issues within the system� When the organization receives a medication recall or discontinuation notice for safety reasons, identify all patients who received the medication� Return any medications when allowed under law, by regulation, and organization policy� Control and account for previously dispensed but unused, expired, or returned medications� The pharmacy remains responsible for controlling and accounting for all unused medications returned to the pharmacy�

The American Society of Healthcare System Pharmacists (ASHP) sets guidelines on drug quality and specifications� Pharmacy procedures should require that all drugs and medications meet the standards of the U�S� Pharmacopeia/National Formulary (USP/NF)� Drugs not included in the USP/ NF should be approved by the FDA� Obtain drugs from known sources that meet identity, purity, and potency requirements� Drugs should comply with FDA current manufacturing practices� Store drugs for external use separately from medications taken internally� Never keep respiratory care drugs and those used to prepare irrigation solutions with other injectable drugs� Never store large quantities of acids or other hazardous materials close to floor level� Never store large or heavy drug containers in lower shelves� Identify hazardous storage areas and post appropriate caution or warning signs� Never store drugs in a refrigerator that contains food or drink� Consider the following factors when assessing sources of drugs and medications:

• Data on sterility and analytical controls • Bioavailability and bioequivalence information • Information about raw materials and finished products • Miscellaneous information on the quality of the drug or medication

NIOSH released new hazardous drug guidelines in 2004 for healthcare organizations� OSHA currently enforces safety issues using the general duty clause and existing standards dealing with hazard communication and PPE� Consider all drugs with toxic, irritating, sensitizing, or organ-targeting

characteristics as hazardous� Both clinical and nonclinical workers may experience exposures to hazardous drugs when they create aerosols, generate dust, clean up spills, or touch contaminated surfaces during the preparation, administration, or disposal of hazardous drugs� Risks and hazard exist when reconstituting powdered or lyophilized drugs and further diluting either the reconstituted powder or concentrated liquid forms of hazardous drugs� Exposures to hazardous drugs may occur through inhalation, skin contact, skin absorption, ingestion, or injection� Inhalation and skin contact/absorption remain the most likely routes of exposure, but unintentional ingestion from handto-mouth contact and unintentional injection through a needle stick or sharps injury can also occur� In most cases, the percentage of air samples containing measurable airborne concentrations of hazardous drugs has been low� Recently, several studies examined environmental contamination of hazardous drug preparation and administration areas� Factors that affect worker exposures include the following:

• Drug handling circumstances (preparation, administration, or disposal) • Amount of drug prepared • Frequency and duration of drug handling • Potential for absorption • Use of ventilated cabinets

No NIOSH RELs, OSHA PELs, or ACGIH threshold limit values (TLVs) exist for hazardous drugs� PELs, RELs, and TLVs exist for inorganic arsenic compounds, which include the antineoplastic drug arsenic trioxide� Some pharmaceutical manufacturers develop risk-based occupational exposure limits (OELs) for use in their own manufacturing setting� Look for this information on available SDSs or request it from the manufacturer� Resource Conservation and Recovery Act (RCRA) regulations require that hazardous waste be managed by following a strict set of regulatory requirements� The RCRA list of hazardous wastes includes only about 30 pharmaceuticals, nine of which classify as antineoplastic drugs� Recent evidence indicates that a number of drug formulations exhibit hazardous waste characteristics� Dispose of hazardous drug waste in a manner similar to that required for RCRA-listed hazardous waste� Hazardous drug waste includes partially filled vials, undispensed products, unused IVs, needles and syringes, gloves, gowns, underpads, contaminated materials from spill cleanups, and containers such as IV bags or drug vials that contain more than trace amounts of hazardous drugs and are not contaminated by blood or other potentially infectious waste�

The 1990 ASHP definition of hazardous drugs was revised by the NIOSH Working Group on Hazardous Drugs in 2004� Drugs considered hazardous include those that exhibit one or more of the following characteristics in humans or animals:

• Carcinogenicity • Teratogenicity or other developmental toxicity • Reproductive toxicity • Organ toxicity at low doses • Genotoxicity

Compliance with the OSHA Hazard Communication Standard (HCS) entails (1) evaluating whether these drugs meet one or more of the criteria for defining hazardous drugs and (2) posting a list of the hazardous drugs to ensure worker safety� Organizations may access the NIOSH website to refer

to the NIOSH listing of hazardous drugs� Hazardous drug evaluation remains a continual process� Local hazard communication plans should provide for assessment of new drugs as they enter the marketplace� Toxicological data is often nonexistent for investigational drugs� However, if the mechanism of action suggests that there may be a concern, it is prudent to handle them as hazardous drugs until adequate information becomes available to exclude them� Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation� However, they may pose a risk if solid drug formulations become altered, such as by crushing tablets or making solutions from them outside a ventilated cabinet�

Pharmacy or nursing departments often develop lists of hazardous drugs� These comprehensive lists should include all hazardous medications routinely used or likely used by a local practice� Some of the resources that employers can use to evaluate the hazard potential of a drug include the following:

• Material SDSs • Product labeling approved by the FDA and packaging inserts • Special health warnings from drug manufacturers, the FDA, and other professional groups • Reports and case studies published in medical and other healthcare profession journals • Evidence-based recommendations from other facilities that meet the criteria for defining

hazardous drugs

The NIOSH website Hazardous Drug Listing was compiled from information provided by (1) four institutions that generated lists of hazardous drugs for their respective facilities, (2) the American Hospital Formulary Service Drug Information (AHFS DI) monographs, and (3) several other sources� Institutions may want to adopt this list or compare theirs with the list on the NIOSH website�

NIOSH has published an update to their 2004 Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings� This latest update adds 21 drugs to Appendix A, the list of drugs considered hazardous� The update added the following nine chemotherapy drugs to the previous list published in the 2004 alert� These chemotherapy drugs include

• Bortizomib • Clofarabine • Dasatinib • Decitibine • Nelarabin • Pemetrexed • Sorafenib • Sunitinib malate • Vorinostat

Accomplish a workplace analysis of all hazardous drug areas� Develop, implement, maintain, and review annually the written hazardous drug safety plan designed to protect those who handle or are exposed to hazardous medications� NIOSH and OSHA provide guidance in the development of a drug safety and health plan� Nursing stations on floors where hazardous drugs will be administered

should provide spill and emergency skin and eye decontamination kits� Maintain copies of relevant SDSs for guidance� Plan contents should include the following:

• Labeling, storage, spill control, and response actions • Detailed procedures for preparation and administration • Use and maintenance of equipment used to reduce exposures such as ventilated cabinets,

closed system drug transfer devices, needleless systems, and PPE • Work practices covering manipulation techniques • General hygiene practices, including no eating or drinking in drug handling areas such as

the pharmacy or clinical areas • Provide both general and specific safety training in handling hazardous drugs • Training about location and proper use of spill kits • Ensure training meets all relevant OSHA requirements • Procedures for cleaning and decontamination of the work areas and for proper waste han-

dling and disposal of all contaminated materials including patient wastes

During the preparation of hazardous drugs, use a ventilated cabinet to reduce the potential for occupational exposure� Performance test methods and criteria for BSCs may be found in Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, 2nd Edition, CDC/NIH, 2000� A current field certification label should be prominently displayed on the ventilated cabinet per NSF/ANSI 49�

Protocols should specify that unventilated areas such as storage closets not be used for drug storage or any tasks involving hazardous drugs� Hazardous drugs should also be stored and transported in closed containers that minimize the risk of breakage� The storage area should contain sufficient general exhaust ventilation to dilute and remove any airborne contaminants� Depending upon the physical nature and quantity of the stored drugs, consideration should be given to installing a dedicated emergency exhaust fan sufficient in size to quickly purge to the outdoors any airborne contaminants within the storage room and to prevent airborne contamination in adjacent areas in the event of a spill� Limit access to areas where personnel prepare, receive, or store hazardous drugs� Place signs to restrict entry� Design bins or shelves for storing hazardous drugs to prevent breakage and to limit risk of falling� Apply warning labels to all hazardous drug containers, shelves, and bins� Recommend hazardous drugs requiring refrigeration be stored separately from nonhazardous drugs� The most significant risk for exposure during

BOX 8.8 OTHER HAZARDOUS DRUGS LISTED IN THE 2010 UPDATE

• Alefacept • Bosentan • Entecavir • Lenalidomide • Medroxyprogesterone acetate • Palifermin • Paroxetine HCl • Pentetate calcium trisodium • Rasagiline mesylate • Risperidone • Sirolimus • Zonisamide

distribution and transport is from spills, resulting from damaged containers� PPE is generally not required when packaging is intact during routine activities� Any person opening a container to unpack the drugs should wear chemotherapy gloves, protective clothing, and eye protection� Wear chemotherapy gloves when transporting the vial of syringe to the work area due to possible contamination�

Transfers from primary packaging such as vials to dosing equipment such as infusion bags, bottles, or pumps should be carried out using closed systems whenever possible� Devices that contain the product within a closed system during drug transfers limit the potential for aerosol generation, as well as exposure to sharps� Evidence has documented a decrease in drug contaminants present within a Class II BSC when a closed system transfer device was used� However, a closed system transfer device is not an acceptable substitute for a ventilated cabinet and should only be used in conjunction with a ventilated cabinet�

Exposure can occur in personnel handling patient linens and excreta from patients receiving hazardous drugs within the last 48 hours� In some cases, take precautions for up to seven days� Wear two pairs of appropriate gloves and a disposable gown� Wear face shields if a potential exists for splashing� Wash hands with soap and water after removal of gloves�

Ribavirin, a synthetic nucleoside with antiviral activity, can be effective against respiratory syncytial virus� It is reconstituted from a lyophilized powder for aerosol administration� Ribavirin is usually administered in the aerosolized form via mask or oxygen tent for 12-18 hours per day for three to seven days� A small particle aerosol generator creates respirable particles of 1�3-micrometer median diameter� Under current practice, excess drug is exhausted into the patient’s room, causing additional exposures� Studies show that Ribavirin is a reproductive risk in rodents and rabbits� Human studies on nurses who administer the drug by oxygen tent absorbed a dose that exceeded the safety factor of the short-term daily dose level� Minor pulmonary function abnormalities did occur in healthy adult volunteers in clinical studies� When administering aerosolized drugs, additional precautions should be observed:

• Use of NIOSH-approved respirators • If possible, administer in booths with local exhaust or isolation rooms with high efficiency

particulate air (HEPA)-filtered systems • Permit only trained personnel to administer hazardous drugs • Require caregivers to wear disposable gloves and gowns • Work at waist level if possible and avoid working above the head • Warn pregnant staff or women breast-feeding to avoid contact with these drugs

Aerosolized pentamidine is FDA approved for the treatment and prophylaxis of some types of pneumonia� Pentamidine administered as an aerosol must be reconstituted from a lyophilized powder� No studies exist to evaluate the potential carcinogenic, mutagenic, or reproductive effects of pentamidine� Studies among healthcare workers reveal uptake by those personnel who administer the drug� Side effects include coughing, sneezing, mucous membrane irritation, headache, and bronchospasms�

OSHA covers bags containing materials contaminated with hazardous drugs under the Hazard Communication Standard� Recommend the use of thick, leak-proof plastic bags, colored differently from other hospital bags� Use these bags for routine collection of discarded gloves, gowns, and other disposable materials� Label these bags as hazardous drug-related wastes� The OSHA Technical Manual suggests keeping waste bags inside a covered waste container clearly labeled “Hazardous Drug WASTE ONLY�” At least one such receptacle should be located in every area preparing or administering hazardous drugs� Never move waste from one area to another� Seal bags when filled and tape covered waste containers� Label needle containers and breakable items of hazardous waste as “Hazardous Drug WASTE ONLY�” The Bloodborne Pathogens Standard requires the use of properly labeled, sealed, and covered disposal containers for waste containing blood or other potentially infectious materials� Hazardous drug-related wastes should be disposed of according to the Environmental Protection Agency (EPA), state, and local regulations for hazardous waste� This disposal can occur at either an EPA-compliant incinerator or a licensed sanitary landfill for toxic wastes� Commercial waste disposal must be performed by a licensed company� While awaiting removal, maintain waste in a secure area in covered, labeled drums with plastic liners�

Spills should be managed according to workplace hazardous drug spill policies and procedures� The size of the spill might determine both who can conduct the cleanup and the decontamination� Make spill kits and other cleanup materials available in areas handling hazardous drugs� However, OSHA requires that persons who wear respirators such as those contained in some spill kits follow a complete respiratory protection program including fit testing� The written program should address the protective equipment required for differing amounts spilled, the possible spreading of material, restricted access to hazardous drug spills, and signs to be posted� Dispose of all cleanup materials in a hazardous chemical waste container in accordance with RCRA regulations�

In addition to preventing exposure to hazardous drugs and careful monitoring of the environment, medical surveillance is an important part of a safe handling program� NIOSH recommends employees handling hazardous drugs participate in medical surveillance efforts provided at their workplace� The OSHA Technical Manual recommends that workers handling hazardous drugs receive monitoring as part of the medical surveillance program that includes the taking of a medical and exposure history, physical examination, and some laboratory measures� Professional organizations also recommend medical surveillance as the recognized standard of occupational health practice for hazardous drug handlers�

Conduct all tasks related to mixing, preparing, or manipulating hazardous drugs within a ventilated cabinet designed specifically to prevent hazardous drugs from being released into the surrounding environment� Follow aseptic requirements established by state boards of pharmacy� Recommend the use of ventilated cabinets when concerned about hazardous drug containment and aseptic processing� Use a Class I BSC or an isolator for containment when not required to process with asepsis� In some applications, a containment isolator may suffice� For mixing requiring an aseptic technique, use the Class II, Type B2 BSC� If possible, use Class III cabinets as isolators intended for asepsis and containment� Equip all ventilated cabinets with a continuous monitoring device to confirm adequate airflow prior to each use� Filter exhaust from these controls with a HEPA filter�

Exhaust 100 percent to the outside if feasible� Install an outside exhaust system to prevent entrainment by the building envelope or heating, ventilation, and air conditioning systems (HVAC)� Place the fan downstream of the HEPA filter to ensure contaminated ducts remain under negative pressure� Never use a ventilated cabinet with air recirculation unless the hazardous drug in use will not volatilize during process manipulation or after capture by the HEPA filter� Use the information on volatilization provided by the drug manufacturer or determined from air sampling data� Refer to NSF/ANSI 49 for additional information regarding placement of the cabinet, exhaust system, and stack design� Never consider additional engineering or process controls, such as needleless systems, glove bags, and closed system drug transfer devices, as substitutions for ventilated cabinets� Clean the cabinet according to the manufacturer’s instructions� Some manufacturers recommend weekly decontamination, as well as whenever spills occur, or when the cabinet requires moving, service, or certification� Decontamination should consist of surface cleaning with water and detergent followed by thorough rinsing� The use of detergent is recommended because there is no single accepted method of chemical deactivation for all agents involved� Avoid quaternary ammonium cleaners due to the possibility of vapor buildup in recirculated air� Use ethyl alcohol or 70 percent isopropyl alcohol if the contamination is soluble only in alcohol� Alcohol vapor buildup has also been a concern, so the use of alcohol should be avoided in BSCs where air is recirculated� Avoid spray cleaners due to the risk of spraying the HEPA filter� Never use ordinary decontamination procedures, which include fumigation with a germicidal agent, when handling dangerous drug waste�

Maintain any workplace exposure records created in connection with hazard drug handling for at least 30 years� Maintain medical records for the duration of employment plus 30 years in accordance with the Access to Employee Exposure and Medical Records Standard (29 CFR 1910�1020)� In addition, sound practice dictates that training records should include the following information:

• Dates of the training sessions • Contents or a summary of the training sessions • Names and qualifications of the persons conducting the training • Names and job titles of all persons attending the training sessions

Maintain training records for three years from the date on which the training occurred�

The proposed rule encourages generators to dispose of nonhazardous pharmaceutical waste as universal waste, thereby removing this unregulated waste from wastewater treatment plants and municipal solid waste landfills� The addition of hazardous pharmaceutical waste to the Universal Waste Rule will facilitate the collection of personal medications from the public at various facilities so that they can be more properly managed� This proposed rule applies to hazardous pharmaceutical wastes generated by the following types of facilities: pharmacies, hospitals, physicians’ offices, dentists’ offices, other healthcare practitioners, outpatient care centers, ambulatory healthcare services, residential care facilities, veterinary clinics, and reverse distributors� This rule does not apply to pharmaceutical manufacturing or production facilities� The EPA believes that hazardous pharmaceutical wastes meet the factors considered when determining if waste is appropriate for inclusion in the Universal Waste Rule� Specifically, most hazardous pharmaceutical waste presents a relatively low risk during accumulation and transport due to their form and packaging, which is typically in small, individually packaged dosages, such as pills or capsules�

Under current RCRA requirements, any facility that generates RCRA hazardous pharmaceutical waste falls under RCRA generator regulations� Under the universal waste program, generators of hazardous pharmaceutical waste may opt to manage this waste as universal waste� If a facility opts to manage its hazardous pharmaceutical waste under the universal waste option, then that facility will become a handler of pharmaceutical universal waste, rather than a generator of hazardous pharmaceutical waste� Compared to a generator of hazardous pharmaceutical waste, a handler of pharmaceutical universal waste can note the following benefits: (1) an increased accumulation threshold; (2) an increased onsite accumulation limit; (3) an increased storage time limit; (4) no manifest requirement; and (5) basic training requirements�

Approximately 31 commercial chemical products listed on RCRA’s P and U lists have pharmaceutical uses� The EPA bases their P and U lists on chemical designations; this number does not completely represent the total number of brand-name pharmaceuticals that may actually be listed as hazardous waste� In addition, waste pharmaceuticals may also pose hazards because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity, and toxicity� Characteristic pharmaceutical wastes include those that exhibit the ignitability characteristic, such as solutions containing more than 24 percent alcohol� An example of a pharmaceutical that may exhibit the reactivity characteristic is nitroglycerine� Pharmaceuticals exhibiting a corrosive characteristic generally apply to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide� Depending on the concentration in different preparations, pharmaceuticals may also exhibit the toxicity characteristic because of some contaminants such as arsenic, barium, cadmium, chromium, selenium, and silver�

The Food and Drug Administration Modernization Act of 1997 (FDAMA) included a section on pharmacy compounding� The law introduced limits on pharmacy compounding and attempted to protect patients from unnecessary use of compounded drugs� The power of regulation granted to the FDA by the FDAMA was ruled unconstitutional by the Supreme Court in 2001� The new USP Chapter 797, Pharmaceutical Compounding-Sterile Preparations became enforceable by regulatory agencies on January 1, 2004� The provisions and requirements of USP 797 are designed to achieve compounding accuracy and sterility to ensure the safety of patients� USP 797 combines process and preparation quality controls with formal staff training and competency assessment guidelines� USP 797 addresses the responsibilities of compounding personnel, how to determine risk levels, and maintaining quality after a medication leaves the pharmacy� The development of USP 797 came after decades of increasing safety and quality consciousness�

Compounding medications continues as a high-risk and labor-intensive process� The implementation of USP 797 ensured that pharmacies would not overlook problems or evade compliance with necessary provisions� Pharmacies must comply with the USP 797 sterile compounding requirements during inspections, enforcement actions, and accreditation surveys� The ASHP Accreditation Services Division requires that a pharmacy comply with all federal, state, and local regulations concerning pharmacy practice�

The 2008 revision shifted emphasis to human factors and diminished mandates for primary engineering controls� New technological advances can supersede the written requirements of Chapter 797, if such advances can be shown to produce equivalent, or better, results than the ideas in Chapter 797� The revision added a new risk level category of “immediate use” to the previous categories of low, medium and high risk� An immediate-use compounded sterile product (CSP) is defined as a compound prepared with no more than three sterile, commercially supplied nonhazardous drugs; using

commercial, sterile devices; for an infusion that will start within one hour of preparation and be completed within 12 hours� It should be emphasized here that this does not include any chemotherapeutic or other hazardous drug preparations� The revision also specified that this immediate-use classification is NOT intended to circumvent USP 797 intent� Never store immediate-use compounds for later use� Eliminating the requirement for an ISO 7 buffer basically eliminated the engineering control mandates that caused so much concern� The revision also increased beyond-use dating for medium risk compounding to a maximum of nine days refrigerated instead of seven� This allows alternatesite pharmacies to have a week’s worth of in-date IVs, such as TPN and antibiotics� Multi-dose vials (MDVs) now contain specific maximum beyond-use dates of 28 days� Single-dose vials (SDVs) contain new guidelines that restrict beyond-use dating� Never store ampoules for any period of time� CSPs must develop adequate controls from preparation until the time of the administration to meet USP 797 requirements� The revision addressed radiopharmaceuticals, and also addressed clean rooms and environmental sampling� Air sampling is now required only monthly for low-and medium-risk certified compounding areas and weekly for high-risk areas� The revision addressed protective garb requirements and isopropyl alcohol glove washing� Under the revision, garbing order is more clearly defined to focus on moving from dirtiest to cleanest in the process� When dressing to work in clean areas begin with a hair net, beard mask, gown and finish with a gown, gloves, shoe covers and finish with a 70 percent isopropyl alcohol (IA) glove washing�

1� Describe the origin and characteristics of the following forms of ionizing radiation: a� Alpha particles b� Beta particles c� Gamma rays d� X-rays

2� Define the following radiation-related terms: a� Absorbed dose b� Ci c� RAD d� Radioactive half-life e� Rem f� ALARP

3� Describe the concept of radiation shielding� 4� What role does the NRC play in healthcare radiation safety? 5� Describe the key duties of a radiation safety committee� 6� What is the mission of the NCRP? 7� What is the key goal of the FDA CDRH in relation to radiation safety? 8� Define “nonionizing radiation” and provide several examples of generating devices� 9� List at least three safety concerns involving the use of MRI devices� 10� List and define at least five types of healthcare laboratories� 11� What was the purpose of the CLIA? 12� List at least five mandates of the OSHA Laboratory Standard� 13� What is formaldehyde and how do OSHA safety standards relate to worker exposures? 14� List and describe the four biosafety levels� 15� Describe investigational medications� 16� What nongovernmental organization sets guidelines on drug quality and specifications? 17� List the occupational exposure routes for hazardous medications� 18� List the five characteristics as defined by NIOSH that would classify a drug as hazardous� 19� What was the purpose for the development of the USP 797?