M any laser users mistakenly believe that laser safety consists of wearing goggles and posting the sign they received with their laser on the treatment room door. Yet, audits around the country have revealed a number of misconceptions, areas of non-compliance with standards, and potential unsafe practices, to say nothing of potential medical-legal problems, should an accident or incident occur and safe practice has to be defended. An ever-evolving universe of laser safety guidance documents, laws, regulations, rules, standards and recommended practices exist in varying forms from state to state. It’s impossible to present a current and accurate listing of these, because of the constant changes, but it’s essential that users contact their state agency (Department of Radiation Safety or Health) for this information. National safety requirements are based on the ANSI Z136.3 Guide to the Safe Use of Lasers in Healthcare Facilities. This document is a benchmark standard, and while it’s not regulatory, it is the basis for OSHA, JCAHO and state laws — and it applies to all healthcare lasers and all practice settings, including non-hospital environments, mobile laser units and private practices. Standards state in section 1.4 “The requirements and principles of safe use of health care laser systems, in these (private practices) settings are no less stringent than when the same systems are used in large institutional settings such as hospitals.” Differentiating “Shoulds” From “Shalls” Laser users need to obtain a copy of the ANSI Z136.3 and abide by all the stated requirements. The terms “should” and “shall” are found throughout the standard. “Shalls” are mandatory for compliance and “shoulds” are good practice, but at your discretion to implement. Laser safety is best addressed through a risk management process that involves three components: 1. risk assessment 2. implementation 3. audit. Since all types of lasers are used in dermatology, it’s essential for the user to understand that risks and hazards, and therefore, control measures, depend on laser-tissue interactions and the characteristics of the system. Risk assessment is based on these principles and is done for each laser and each delivery system. Lasers are classified according to the level of hazard they may present, if used improperly. The lasers are ranked from class 1 through class 4, with 4 being the most hazardous. Almost all medical and surgical lasers, with the exception of a few low-level therapy systems, are class 3b and class 4. Due to this level of classification, all safety precautions and procedures stated in the ANSI Z136.3 must be followed. Top 10 Safety Mistakes 10. Leaving the key in the laser when the machine is not in use. ANSI standards, section 4.3 state “required storage or disabling (removal of keys) of the laser to prevent unauthorized operations in accordance with OSHA.” Discussion: Include a procedure in your practice manual that requires the operator to remove the key after shutting off the laser, and then store it in a designated security spot. This can be a locked desk drawer, the supply cart or any other place that is accessible only to those who are qualified to run the laser. 9. Stepping on the wrong footswitch and firing the laser accidentally. ANSI standards section 4.3.1 state: “. . . the switch which controls the patient exposure shall be guarded . . . . In environments with multiple guarded footswitches, precautions shall be taken to prevent inadvertent activation.” Discussion: The most common occurrence is activating the footswitch of the electrosurgery unit (ESU) generator instead of the laser. Place the laser pedal on one side of the bed or table and all other footpedals on the opposite side, and then clearly indicate to the user which side the laser pedal is on. Users should routinely assure that they are comfortably within reach of the footpedal without having to take their eyes off of the tissue target. 8. Failing to establish a temporary laser controlled area during service. ANSI standards, section 4.5 state: “. . . during service, demonstrations, educational labs, training, maintenance, etc., when accessible laser radiation exceeds the MPE (maximum permissible exposure), a temporary controlled area shall be devised. Safety requirements for all personnel, both within and outside the area, shall be provided. A notice sign shall be posted outside the temporary laser controlled area to warm of the potential hazard.” Discussion: Notice signs are different from the danger signs required during clinical use. Many practices do not have these signs, nor do they follow this SHALL in the standards. If an accident occurs as a result of failure to adequately control the room during hazardous repair or service of lasers, your facility would be held in breach of standards. 7. Not establishing or respecting controlled access areas as required by standards. ANSI states in section 4.4 that: “the Laser Treatment Controlled Area (LTCA) shall be clearly delineated and shall: • be posted with appropriate warning signs at the entry • be supervised by HCP trained in safety • be occupied only by authorized personnel • have protective equipment at the entry • have window covers that reduce transmission to MPE • have rapid egress and entrance entryways.” Discussion: Post the correct signs at each entryway. Either the danger sign or the International Electrotechnical Commission (IEC) yellow and black triangular sign are now acceptable. The sign should be visible only when the laser is in use and removed or covered when the laser is not in use. It should be at eye level and should be posted along with appropriate safety goggles for the laser in use in the room. Staff must be aware that no one is to enter the room without eyewear when the sign is up. 6. Failing to perform and document in writing a formal audit, at least once a year, under the supervision of the laser safely officer (LSO). (Section 4.3.6) An audit is the only way the LSO can ensure compliance with standards. A comprehensive audit requires three components. 1. Interviews with each person on staff will help identify whether or not they know the facility policies and procedures, national standards and the basics of the equipment and applications in which they are involved. 2. Inspection of all laser and accessory equipment, materials and supplies, will identify damage and improper care. 3. Observation of a procedure will identify whether or not staff is actually following the rules and able to maintain a laser patient care environment. Discussion: Document your audit results, as well as follow-up once deficiencies are remedied. This is crucial in case you’re ever in the position of having to support the claim that your practice complied with standards. 5. Leaving education and training to manufacturers, or self-study, and not having fundamental knowledge. The standards state, “Laser safety training shall provide a thorough understanding of all procedures required for establishing and maintaining a safe environment. It shall be provided for LSOs, users, technical support staff, nurses and allied health personnel. All training shall be documented and retained on file.” Table F2 in the standards appendix indicates the core knowledge required for all levels of personnel, including LSOs, doctors, nurses, techs and service personnel. Table F1 outlines all required course topics, including: a. basics of laser technology b. operation of the laser c. intended use d. expected effects e. facility policies and procedures f. knowledge of ANSI standards. Discussion: Education and training should be specific to the wavelengths to be used. It’s also important that they be commercially unbiased. Validation of education can be through written quiz or exam. Competency of skills can be observed by the LSO. 4. Documentation that is incomplete, inaccurate or missing. Documentation must reflect practice. This is the only means for verifying what was done and how it was done, should there ever be a need to do so. Discussion: Your office must maintain proper documentation that specifies safety procedures followed, patient protection monitored, the type of delivery system (indicate spot size), equipment present and used, power parameters used, names and credentials of people present in the room and testing of equipment prior to use. There is no national template for log sheets or operative notes, however, samples are found in the appendix of the ANSI standards. Every practice must develop, maintain and audit appropriate and thorough documentation forms. This includes meeting minutes, audit reports, service and maintenance records, training records, policies and procedures, incident reports with follow-ups and log sheets. 3. Failing to properly capture and manage plume. After eye protection and control of flammability hazards, this is the next major concern for laser users of photothermal devices (CO2, Er:YAG, ESU, excimer, argon, Nd:YAG, KTP, etc.). National and international standards, CDC, NIOSH, OSHA and state regulators, as well as professional organizations, have recognized the hazards of surgical smoke, and have issued recommendations for its control in the clinical setting. Discussion: Particulates down to 0.12 microns, including bacteria, virus (HPV, HIV), carbon, live cellular particles, and more than 80 different gases have been identified in surgical smoke. The odor expressed during hair removal indicates the presence of gases, and should not be excluded. A smoke evacuator having an ULPA filter (0.12 microns) operating at greater than 99.999% efficiency must be used at the site where the smoke is being generated. Due to the presence of potential blood- borne pathogens (see ANSI section 7.4), standard precautions should be required when handling plume, including wearing gloves, masks and goggles when handling the evacuator, filters and tubing. Follow biohazard procedures for proper disposal. Masks and in-line filters, when used properly, can be excellent secondary precautions but should not replace the use of a smoke evacuator at the site to control this well-known and well-documented occupational exposure hazard. 2. Not properly wearing or maintaining protective eyewear to ensure safety. Eye protection is the most important control measure required, and one of the most frequently disregarded — especially in private practice. All laser users must understand the interactions of the beam with the tissues of the eye, as well as the shalls for protection against untoward exposures, as stated in the standards. Discussion: Eyewear must be worn at all times when operating a Class 3b or Class 4 laser. It must cover the entire ocular area, and be permanently labeled (no sticky labels allowed) with appropriate optical density lenses for the laser in use (usually having an optical density above 4.5). Labels should also indicate wavelength in nanometers for the level of protection provided. Do not rely on the color of the goggles or lenses to indicate level of protection. Everyone should learn to read the label information. Glasses must fit comfortably on each person. This may mean that rather than accepting the two to four pairs given by the laser companies at the time of purchase, you will have to assess the needs of each staff person, taking into consideration the facial structure and wearing of prescription glasses. One size does not fit all. Glasses should have safety straps attached, and their use should be required so that the glasses stay snugly on the face during use. Staff must learn to examine glasses for integrity. Scratches, lens damage, color change to the lens or damage to the frame indicate the need to repair or replace the glasses. If there are any problems, the glasses should not be worn. Clean the glasses according to manufacturer’s recommendations, and never with 70% alcohol, which can damage the lenses. Store glasses in their individual covers to prevent mechanical damage. Everyone should examine the glasses before each use to assure safety and integrity. Patient eye protection is based on type and location of the procedure, and anesthesia. Safety goggles that staff use are appropriate if working away from the face; however, if they’re used in the patient’s periorbital area, they must be approved eye protectors (periorbital goggles or corneal shields). Eye protectors must be properly labeled with the wavelength and the optical density. Don’t use unlabeled or untested devices. Ask the manufacturer for written documentation of the testing done on the protectors to ensure it was done at the wavelength and within the anticipated power parameters to be used on the patient. If the company cannot or will not supply this data, don’t use the product, as you’ll be accepting the responsibility for verifying the safety of its performance. 1. Failing to appoint an LSO or failing to authorize the LSO to perform the duties indicated in the standards. The LSO is someone who has the knowledge, authority and responsibility for compliance with standards, safe use, and management of all aspects of the laser safety program. This person can be a doctor, a nurse, an office manager, a technician or anyone who is properly trained and empowered to perform the duties as stated in the standard. Discussion: The LSO must: • evaluate hazards and establish safety in the treatment area. • ensure that proper control measures are in place and are followed. • implement written policies, procedures and documentation tools. • verify that all equipment labels and signs are correct. • approve the installation and maintenance of laser equipment. • ensure that all personnel in the facility have appropriate education and training on laser use and safety. • know and follow all standards, keeping up with changes and additional recommendations and regulations when they occur. Staying Compliant ANSI clearly states that users in private facilities must follow the same standards as those in hospitals. The individual user is responsible for meeting the standards, and may use outside resources if expertise isn’t available in the practice. If you want to contract with a safety expert to assist you, look to your local hospital for this expertise, or contact the American Society for Laser Medicine and Surgery for references. You can easily avoid these and other mistakes if you take some time to learn what ANSI standards require and develop a compliant office safety plan. Safe practice relies on education for all staff, commitment, vigilance, and most of all teamwork. Remember — safety is everyone’s concern.
Laser Safety: Beyond Signs & Goggles
M any laser users mistakenly believe that laser safety consists of wearing goggles and posting the sign they received with their laser on the treatment room door. Yet, audits around the country have revealed a number of misconceptions, areas of non-compliance with standards, and potential unsafe practices, to say nothing of potential medical-legal problems, should an accident or incident occur and safe practice has to be defended. An ever-evolving universe of laser safety guidance documents, laws, regulations, rules, standards and recommended practices exist in varying forms from state to state. It’s impossible to present a current and accurate listing of these, because of the constant changes, but it’s essential that users contact their state agency (Department of Radiation Safety or Health) for this information. National safety requirements are based on the ANSI Z136.3 Guide to the Safe Use of Lasers in Healthcare Facilities. This document is a benchmark standard, and while it’s not regulatory, it is the basis for OSHA, JCAHO and state laws — and it applies to all healthcare lasers and all practice settings, including non-hospital environments, mobile laser units and private practices. Standards state in section 1.4 “The requirements and principles of safe use of health care laser systems, in these (private practices) settings are no less stringent than when the same systems are used in large institutional settings such as hospitals.” Differentiating “Shoulds” From “Shalls” Laser users need to obtain a copy of the ANSI Z136.3 and abide by all the stated requirements. The terms “should” and “shall” are found throughout the standard. “Shalls” are mandatory for compliance and “shoulds” are good practice, but at your discretion to implement. Laser safety is best addressed through a risk management process that involves three components: 1. risk assessment 2. implementation 3. audit. Since all types of lasers are used in dermatology, it’s essential for the user to understand that risks and hazards, and therefore, control measures, depend on laser-tissue interactions and the characteristics of the system. Risk assessment is based on these principles and is done for each laser and each delivery system. Lasers are classified according to the level of hazard they may present, if used improperly. The lasers are ranked from class 1 through class 4, with 4 being the most hazardous. Almost all medical and surgical lasers, with the exception of a few low-level therapy systems, are class 3b and class 4. Due to this level of classification, all safety precautions and procedures stated in the ANSI Z136.3 must be followed. Top 10 Safety Mistakes 10. Leaving the key in the laser when the machine is not in use. ANSI standards, section 4.3 state “required storage or disabling (removal of keys) of the laser to prevent unauthorized operations in accordance with OSHA.” Discussion: Include a procedure in your practice manual that requires the operator to remove the key after shutting off the laser, and then store it in a designated security spot. This can be a locked desk drawer, the supply cart or any other place that is accessible only to those who are qualified to run the laser. 9. Stepping on the wrong footswitch and firing the laser accidentally. ANSI standards section 4.3.1 state: “. . . the switch which controls the patient exposure shall be guarded . . . . In environments with multiple guarded footswitches, precautions shall be taken to prevent inadvertent activation.” Discussion: The most common occurrence is activating the footswitch of the electrosurgery unit (ESU) generator instead of the laser. Place the laser pedal on one side of the bed or table and all other footpedals on the opposite side, and then clearly indicate to the user which side the laser pedal is on. Users should routinely assure that they are comfortably within reach of the footpedal without having to take their eyes off of the tissue target. 8. Failing to establish a temporary laser controlled area during service. ANSI standards, section 4.5 state: “. . . during service, demonstrations, educational labs, training, maintenance, etc., when accessible laser radiation exceeds the MPE (maximum permissible exposure), a temporary controlled area shall be devised. Safety requirements for all personnel, both within and outside the area, shall be provided. A notice sign shall be posted outside the temporary laser controlled area to warm of the potential hazard.” Discussion: Notice signs are different from the danger signs required during clinical use. Many practices do not have these signs, nor do they follow this SHALL in the standards. If an accident occurs as a result of failure to adequately control the room during hazardous repair or service of lasers, your facility would be held in breach of standards. 7. Not establishing or respecting controlled access areas as required by standards. ANSI states in section 4.4 that: “the Laser Treatment Controlled Area (LTCA) shall be clearly delineated and shall: • be posted with appropriate warning signs at the entry • be supervised by HCP trained in safety • be occupied only by authorized personnel • have protective equipment at the entry • have window covers that reduce transmission to MPE • have rapid egress and entrance entryways.” Discussion: Post the correct signs at each entryway. Either the danger sign or the International Electrotechnical Commission (IEC) yellow and black triangular sign are now acceptable. The sign should be visible only when the laser is in use and removed or covered when the laser is not in use. It should be at eye level and should be posted along with appropriate safety goggles for the laser in use in the room. Staff must be aware that no one is to enter the room without eyewear when the sign is up. 6. Failing to perform and document in writing a formal audit, at least once a year, under the supervision of the laser safely officer (LSO). (Section 4.3.6) An audit is the only way the LSO can ensure compliance with standards. A comprehensive audit requires three components. 1. Interviews with each person on staff will help identify whether or not they know the facility policies and procedures, national standards and the basics of the equipment and applications in which they are involved. 2. Inspection of all laser and accessory equipment, materials and supplies, will identify damage and improper care. 3. Observation of a procedure will identify whether or not staff is actually following the rules and able to maintain a laser patient care environment. Discussion: Document your audit results, as well as follow-up once deficiencies are remedied. This is crucial in case you’re ever in the position of having to support the claim that your practice complied with standards. 5. Leaving education and training to manufacturers, or self-study, and not having fundamental knowledge. The standards state, “Laser safety training shall provide a thorough understanding of all procedures required for establishing and maintaining a safe environment. It shall be provided for LSOs, users, technical support staff, nurses and allied health personnel. All training shall be documented and retained on file.” Table F2 in the standards appendix indicates the core knowledge required for all levels of personnel, including LSOs, doctors, nurses, techs and service personnel. Table F1 outlines all required course topics, including: a. basics of laser technology b. operation of the laser c. intended use d. expected effects e. facility policies and procedures f. knowledge of ANSI standards. Discussion: Education and training should be specific to the wavelengths to be used. It’s also important that they be commercially unbiased. Validation of education can be through written quiz or exam. Competency of skills can be observed by the LSO. 4. Documentation that is incomplete, inaccurate or missing. Documentation must reflect practice. This is the only means for verifying what was done and how it was done, should there ever be a need to do so. Discussion: Your office must maintain proper documentation that specifies safety procedures followed, patient protection monitored, the type of delivery system (indicate spot size), equipment present and used, power parameters used, names and credentials of people present in the room and testing of equipment prior to use. There is no national template for log sheets or operative notes, however, samples are found in the appendix of the ANSI standards. Every practice must develop, maintain and audit appropriate and thorough documentation forms. This includes meeting minutes, audit reports, service and maintenance records, training records, policies and procedures, incident reports with follow-ups and log sheets. 3. Failing to properly capture and manage plume. After eye protection and control of flammability hazards, this is the next major concern for laser users of photothermal devices (CO2, Er:YAG, ESU, excimer, argon, Nd:YAG, KTP, etc.). National and international standards, CDC, NIOSH, OSHA and state regulators, as well as professional organizations, have recognized the hazards of surgical smoke, and have issued recommendations for its control in the clinical setting. Discussion: Particulates down to 0.12 microns, including bacteria, virus (HPV, HIV), carbon, live cellular particles, and more than 80 different gases have been identified in surgical smoke. The odor expressed during hair removal indicates the presence of gases, and should not be excluded. A smoke evacuator having an ULPA filter (0.12 microns) operating at greater than 99.999% efficiency must be used at the site where the smoke is being generated. Due to the presence of potential blood- borne pathogens (see ANSI section 7.4), standard precautions should be required when handling plume, including wearing gloves, masks and goggles when handling the evacuator, filters and tubing. Follow biohazard procedures for proper disposal. Masks and in-line filters, when used properly, can be excellent secondary precautions but should not replace the use of a smoke evacuator at the site to control this well-known and well-documented occupational exposure hazard. 2. Not properly wearing or maintaining protective eyewear to ensure safety. Eye protection is the most important control measure required, and one of the most frequently disregarded — especially in private practice. All laser users must understand the interactions of the beam with the tissues of the eye, as well as the shalls for protection against untoward exposures, as stated in the standards. Discussion: Eyewear must be worn at all times when operating a Class 3b or Class 4 laser. It must cover the entire ocular area, and be permanently labeled (no sticky labels allowed) with appropriate optical density lenses for the laser in use (usually having an optical density above 4.5). Labels should also indicate wavelength in nanometers for the level of protection provided. Do not rely on the color of the goggles or lenses to indicate level of protection. Everyone should learn to read the label information. Glasses must fit comfortably on each person. This may mean that rather than accepting the two to four pairs given by the laser companies at the time of purchase, you will have to assess the needs of each staff person, taking into consideration the facial structure and wearing of prescription glasses. One size does not fit all. Glasses should have safety straps attached, and their use should be required so that the glasses stay snugly on the face during use. Staff must learn to examine glasses for integrity. Scratches, lens damage, color change to the lens or damage to the frame indicate the need to repair or replace the glasses. If there are any problems, the glasses should not be worn. Clean the glasses according to manufacturer’s recommendations, and never with 70% alcohol, which can damage the lenses. Store glasses in their individual covers to prevent mechanical damage. Everyone should examine the glasses before each use to assure safety and integrity. Patient eye protection is based on type and location of the procedure, and anesthesia. Safety goggles that staff use are appropriate if working away from the face; however, if they’re used in the patient’s periorbital area, they must be approved eye protectors (periorbital goggles or corneal shields). Eye protectors must be properly labeled with the wavelength and the optical density. Don’t use unlabeled or untested devices. Ask the manufacturer for written documentation of the testing done on the protectors to ensure it was done at the wavelength and within the anticipated power parameters to be used on the patient. If the company cannot or will not supply this data, don’t use the product, as you’ll be accepting the responsibility for verifying the safety of its performance. 1. Failing to appoint an LSO or failing to authorize the LSO to perform the duties indicated in the standards. The LSO is someone who has the knowledge, authority and responsibility for compliance with standards, safe use, and management of all aspects of the laser safety program. This person can be a doctor, a nurse, an office manager, a technician or anyone who is properly trained and empowered to perform the duties as stated in the standard. Discussion: The LSO must: • evaluate hazards and establish safety in the treatment area. • ensure that proper control measures are in place and are followed. • implement written policies, procedures and documentation tools. • verify that all equipment labels and signs are correct. • approve the installation and maintenance of laser equipment. • ensure that all personnel in the facility have appropriate education and training on laser use and safety. • know and follow all standards, keeping up with changes and additional recommendations and regulations when they occur. Staying Compliant ANSI clearly states that users in private facilities must follow the same standards as those in hospitals. The individual user is responsible for meeting the standards, and may use outside resources if expertise isn’t available in the practice. If you want to contract with a safety expert to assist you, look to your local hospital for this expertise, or contact the American Society for Laser Medicine and Surgery for references. You can easily avoid these and other mistakes if you take some time to learn what ANSI standards require and develop a compliant office safety plan. Safe practice relies on education for all staff, commitment, vigilance, and most of all teamwork. Remember — safety is everyone’s concern.
M any laser users mistakenly believe that laser safety consists of wearing goggles and posting the sign they received with their laser on the treatment room door. Yet, audits around the country have revealed a number of misconceptions, areas of non-compliance with standards, and potential unsafe practices, to say nothing of potential medical-legal problems, should an accident or incident occur and safe practice has to be defended. An ever-evolving universe of laser safety guidance documents, laws, regulations, rules, standards and recommended practices exist in varying forms from state to state. It’s impossible to present a current and accurate listing of these, because of the constant changes, but it’s essential that users contact their state agency (Department of Radiation Safety or Health) for this information. National safety requirements are based on the ANSI Z136.3 Guide to the Safe Use of Lasers in Healthcare Facilities. This document is a benchmark standard, and while it’s not regulatory, it is the basis for OSHA, JCAHO and state laws — and it applies to all healthcare lasers and all practice settings, including non-hospital environments, mobile laser units and private practices. Standards state in section 1.4 “The requirements and principles of safe use of health care laser systems, in these (private practices) settings are no less stringent than when the same systems are used in large institutional settings such as hospitals.” Differentiating “Shoulds” From “Shalls” Laser users need to obtain a copy of the ANSI Z136.3 and abide by all the stated requirements. The terms “should” and “shall” are found throughout the standard. “Shalls” are mandatory for compliance and “shoulds” are good practice, but at your discretion to implement. Laser safety is best addressed through a risk management process that involves three components: 1. risk assessment 2. implementation 3. audit. Since all types of lasers are used in dermatology, it’s essential for the user to understand that risks and hazards, and therefore, control measures, depend on laser-tissue interactions and the characteristics of the system. Risk assessment is based on these principles and is done for each laser and each delivery system. Lasers are classified according to the level of hazard they may present, if used improperly. The lasers are ranked from class 1 through class 4, with 4 being the most hazardous. Almost all medical and surgical lasers, with the exception of a few low-level therapy systems, are class 3b and class 4. Due to this level of classification, all safety precautions and procedures stated in the ANSI Z136.3 must be followed. Top 10 Safety Mistakes 10. Leaving the key in the laser when the machine is not in use. ANSI standards, section 4.3 state “required storage or disabling (removal of keys) of the laser to prevent unauthorized operations in accordance with OSHA.” Discussion: Include a procedure in your practice manual that requires the operator to remove the key after shutting off the laser, and then store it in a designated security spot. This can be a locked desk drawer, the supply cart or any other place that is accessible only to those who are qualified to run the laser. 9. Stepping on the wrong footswitch and firing the laser accidentally. ANSI standards section 4.3.1 state: “. . . the switch which controls the patient exposure shall be guarded . . . . In environments with multiple guarded footswitches, precautions shall be taken to prevent inadvertent activation.” Discussion: The most common occurrence is activating the footswitch of the electrosurgery unit (ESU) generator instead of the laser. Place the laser pedal on one side of the bed or table and all other footpedals on the opposite side, and then clearly indicate to the user which side the laser pedal is on. Users should routinely assure that they are comfortably within reach of the footpedal without having to take their eyes off of the tissue target. 8. Failing to establish a temporary laser controlled area during service. ANSI standards, section 4.5 state: “. . . during service, demonstrations, educational labs, training, maintenance, etc., when accessible laser radiation exceeds the MPE (maximum permissible exposure), a temporary controlled area shall be devised. Safety requirements for all personnel, both within and outside the area, shall be provided. A notice sign shall be posted outside the temporary laser controlled area to warm of the potential hazard.” Discussion: Notice signs are different from the danger signs required during clinical use. Many practices do not have these signs, nor do they follow this SHALL in the standards. If an accident occurs as a result of failure to adequately control the room during hazardous repair or service of lasers, your facility would be held in breach of standards. 7. Not establishing or respecting controlled access areas as required by standards. ANSI states in section 4.4 that: “the Laser Treatment Controlled Area (LTCA) shall be clearly delineated and shall: • be posted with appropriate warning signs at the entry • be supervised by HCP trained in safety • be occupied only by authorized personnel • have protective equipment at the entry • have window covers that reduce transmission to MPE • have rapid egress and entrance entryways.” Discussion: Post the correct signs at each entryway. Either the danger sign or the International Electrotechnical Commission (IEC) yellow and black triangular sign are now acceptable. The sign should be visible only when the laser is in use and removed or covered when the laser is not in use. It should be at eye level and should be posted along with appropriate safety goggles for the laser in use in the room. Staff must be aware that no one is to enter the room without eyewear when the sign is up. 6. Failing to perform and document in writing a formal audit, at least once a year, under the supervision of the laser safely officer (LSO). (Section 4.3.6) An audit is the only way the LSO can ensure compliance with standards. A comprehensive audit requires three components. 1. Interviews with each person on staff will help identify whether or not they know the facility policies and procedures, national standards and the basics of the equipment and applications in which they are involved. 2. Inspection of all laser and accessory equipment, materials and supplies, will identify damage and improper care. 3. Observation of a procedure will identify whether or not staff is actually following the rules and able to maintain a laser patient care environment. Discussion: Document your audit results, as well as follow-up once deficiencies are remedied. This is crucial in case you’re ever in the position of having to support the claim that your practice complied with standards. 5. Leaving education and training to manufacturers, or self-study, and not having fundamental knowledge. The standards state, “Laser safety training shall provide a thorough understanding of all procedures required for establishing and maintaining a safe environment. It shall be provided for LSOs, users, technical support staff, nurses and allied health personnel. All training shall be documented and retained on file.” Table F2 in the standards appendix indicates the core knowledge required for all levels of personnel, including LSOs, doctors, nurses, techs and service personnel. Table F1 outlines all required course topics, including: a. basics of laser technology b. operation of the laser c. intended use d. expected effects e. facility policies and procedures f. knowledge of ANSI standards. Discussion: Education and training should be specific to the wavelengths to be used. It’s also important that they be commercially unbiased. Validation of education can be through written quiz or exam. Competency of skills can be observed by the LSO. 4. Documentation that is incomplete, inaccurate or missing. Documentation must reflect practice. This is the only means for verifying what was done and how it was done, should there ever be a need to do so. Discussion: Your office must maintain proper documentation that specifies safety procedures followed, patient protection monitored, the type of delivery system (indicate spot size), equipment present and used, power parameters used, names and credentials of people present in the room and testing of equipment prior to use. There is no national template for log sheets or operative notes, however, samples are found in the appendix of the ANSI standards. Every practice must develop, maintain and audit appropriate and thorough documentation forms. This includes meeting minutes, audit reports, service and maintenance records, training records, policies and procedures, incident reports with follow-ups and log sheets. 3. Failing to properly capture and manage plume. After eye protection and control of flammability hazards, this is the next major concern for laser users of photothermal devices (CO2, Er:YAG, ESU, excimer, argon, Nd:YAG, KTP, etc.). National and international standards, CDC, NIOSH, OSHA and state regulators, as well as professional organizations, have recognized the hazards of surgical smoke, and have issued recommendations for its control in the clinical setting. Discussion: Particulates down to 0.12 microns, including bacteria, virus (HPV, HIV), carbon, live cellular particles, and more than 80 different gases have been identified in surgical smoke. The odor expressed during hair removal indicates the presence of gases, and should not be excluded. A smoke evacuator having an ULPA filter (0.12 microns) operating at greater than 99.999% efficiency must be used at the site where the smoke is being generated. Due to the presence of potential blood- borne pathogens (see ANSI section 7.4), standard precautions should be required when handling plume, including wearing gloves, masks and goggles when handling the evacuator, filters and tubing. Follow biohazard procedures for proper disposal. Masks and in-line filters, when used properly, can be excellent secondary precautions but should not replace the use of a smoke evacuator at the site to control this well-known and well-documented occupational exposure hazard. 2. Not properly wearing or maintaining protective eyewear to ensure safety. Eye protection is the most important control measure required, and one of the most frequently disregarded — especially in private practice. All laser users must understand the interactions of the beam with the tissues of the eye, as well as the shalls for protection against untoward exposures, as stated in the standards. Discussion: Eyewear must be worn at all times when operating a Class 3b or Class 4 laser. It must cover the entire ocular area, and be permanently labeled (no sticky labels allowed) with appropriate optical density lenses for the laser in use (usually having an optical density above 4.5). Labels should also indicate wavelength in nanometers for the level of protection provided. Do not rely on the color of the goggles or lenses to indicate level of protection. Everyone should learn to read the label information. Glasses must fit comfortably on each person. This may mean that rather than accepting the two to four pairs given by the laser companies at the time of purchase, you will have to assess the needs of each staff person, taking into consideration the facial structure and wearing of prescription glasses. One size does not fit all. Glasses should have safety straps attached, and their use should be required so that the glasses stay snugly on the face during use. Staff must learn to examine glasses for integrity. Scratches, lens damage, color change to the lens or damage to the frame indicate the need to repair or replace the glasses. If there are any problems, the glasses should not be worn. Clean the glasses according to manufacturer’s recommendations, and never with 70% alcohol, which can damage the lenses. Store glasses in their individual covers to prevent mechanical damage. Everyone should examine the glasses before each use to assure safety and integrity. Patient eye protection is based on type and location of the procedure, and anesthesia. Safety goggles that staff use are appropriate if working away from the face; however, if they’re used in the patient’s periorbital area, they must be approved eye protectors (periorbital goggles or corneal shields). Eye protectors must be properly labeled with the wavelength and the optical density. Don’t use unlabeled or untested devices. Ask the manufacturer for written documentation of the testing done on the protectors to ensure it was done at the wavelength and within the anticipated power parameters to be used on the patient. If the company cannot or will not supply this data, don’t use the product, as you’ll be accepting the responsibility for verifying the safety of its performance. 1. Failing to appoint an LSO or failing to authorize the LSO to perform the duties indicated in the standards. The LSO is someone who has the knowledge, authority and responsibility for compliance with standards, safe use, and management of all aspects of the laser safety program. This person can be a doctor, a nurse, an office manager, a technician or anyone who is properly trained and empowered to perform the duties as stated in the standard. Discussion: The LSO must: • evaluate hazards and establish safety in the treatment area. • ensure that proper control measures are in place and are followed. • implement written policies, procedures and documentation tools. • verify that all equipment labels and signs are correct. • approve the installation and maintenance of laser equipment. • ensure that all personnel in the facility have appropriate education and training on laser use and safety. • know and follow all standards, keeping up with changes and additional recommendations and regulations when they occur. Staying Compliant ANSI clearly states that users in private facilities must follow the same standards as those in hospitals. The individual user is responsible for meeting the standards, and may use outside resources if expertise isn’t available in the practice. If you want to contract with a safety expert to assist you, look to your local hospital for this expertise, or contact the American Society for Laser Medicine and Surgery for references. You can easily avoid these and other mistakes if you take some time to learn what ANSI standards require and develop a compliant office safety plan. Safe practice relies on education for all staff, commitment, vigilance, and most of all teamwork. Remember — safety is everyone’s concern.
