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Laser Safety Manual - University of Arkansas for Medical Sciences

1. Signature Secondary Chairman Date if applicable Signature COMMENTS Date Revised 8 12 04 THE UNIVERSITY HOSPITAL OF ARKANSAS APPLICATION FOR INVESTIGATIONAL LASER PRIVILEGES Name of Applicant Degree Please print Signature of Applicant Date Office Address Office Telephone Investigator must have 1 completed UAMS laser safety training 2 reviewed UAMS laser safety policies and procedures 1 UAMS Laser Safety Course Completed Date 2 UAMS Laser Safety Policy Review Signature APPROVAL Department Chairman Signature Date Laser Committee Date of Approval COMMENTS Laser Safety Infraction Report Date Time Area Name of person in violation __ __ _ Type of Procedure and Laser Infraction Report Completed by Title Any patient or visitor variance associated with this infraction shall be reported according to UAMS policy ML 1 04 Completed Infraction Report should be sent to Scott Ferguson LSO at Mail Slot 543 Do not copy University Of Arkansas for Medical Sciences Area Laser Safety Audit Area_ Standard Operating Procedures Yes No present for each laser Key Secured When Laser Yes No Inactive Proper Warning Signs Posted Yes No During Use Windows Covered Yes No Cover Material Smoke Plume Evacuation Any Burns on walls or Yes No Encl
2. Attendance of a laser training course specific to the laser system the applicant is seeking privileges B Completion of preceptorship as defined by the policy Laser Preceptorship Requirements C Letter attesting to training and competency on the laser system applicant is seeking privileges for from the Department Chairman or Residency Training Director of the Institution where the applicant trained Training must have been completed by 1990 or later pa Applicant must attend a laser safety lecture Policy 12 Laser Privilege Criteria Policy All physicians seeking privileges for use of health care laser system must meet the criteria as outlined by the Laser Committee Purpose e To provide clearly defined requirements for physicians seeking to obtain laser privileges Procedure 1 Applicant must meet and provide documentation for at least one of the following requirements A Attendance of a laser training course specific to the laser system the applicant is seeking privileges B Completion of preceptorship as defined by the policy Laser Preceptorship Requirements C Letter attesting to training and competency on the laser system applicant is seeking privileges for from the Department Chairman or Residency Training Director of the Institution where the applicant trained Training must have been completed by 1990 or later 2 Applicant must attend a laser safety lecture Policy 13 Laser Preceptorship
3. Be under the direct supervision of an Approved Laser Operator or Laser Safety Officer 6 Be so located that access to the area by spectators is limited and requires approval 7 Have any potentially hazardous beam terminated in a beam stop of an appropriate material 8 Employ only diffusely reflective materials in or near the beam path where feasible 9 Ensure all personnel who regularly require entry into a laser treatment controlled area are adequately trained provided with appropriate protective equipment and observe all applicable administrative and procedural controls Mm B amp B WN Policy 4 Laser Treatment Controlled Area cont 10 Have all windows doorways open portals etc either covered or 11 12 13 14 15 restricted in such a manner as to reduce the transmitted laser radiation to levels at or below the appropriate MPE Windows need not be covered for wavelengths where the glazing is opaque Window glass is opaque from 18 to 3 um and from 4 um to 1mm Require storage or disabling removal of the key of the laser system when not in use to prevent unauthorized activation Ensure the laser is placed in stand by when not in use Provide an emergency switch to enable rapid shutdown of equipment Allow both rapid egress and admittance to the laser treatment area under emergency conditions Be equipped with an ABC type fire extinguisher for equipment fire and a bowl of water for any flames involving the
4. Credentialing for Laser Privileges Policy Physicians must obtain laser privileges to use and oversee the use of clinical laser systems Purpose e To maintain the highest standard of safety and competency with the use of lasers Procedure l Applicant must meet all requirements as outlined in the policy Laser Privilege Criteria 2 An application shall be obtained from the UAMS Medical Staff Office One application for each type of laser wavelength the applicant wishes to obtain privileges for 3 Application shall be completed in full by physician 4 Application shall be submitted to department head for signature 5 Completed and signed application shall be returned to the Medical Staff Office 6 Medical Staff Office submits application to Credentialing Committee Executive Committee Hospital Medical Board and then to the Board of Trustees Signature of approval must be made by all committees K An official letter from the Hospital Medical Board will be sent to applicant advising him her of approval Revised 7 13 SLF Policy 12 Laser Privilege Criteria Policy All physicians seeking privileges for use of health care laser system must meet the criteria as outlined by the Laser Committee Purpose e To provide clearly defined requirements for physicians seeking to obtain laser privileges Procedure 1 Applicant must meet and provide documentation for at least one of the following requirements A
5. Policy A preceptorship shall be completed by physicians desiring laser privileges that lack training for the laser system they wish to utilize clinically Purpose e To provide a well defined method of fulfilling the objective of safely training physicians for the use of clinical laser systems Procedure l Physician shall attend Joint Laser Committee sponsored Laser Safety Inservice 2 Physician shall observe a minimum of three cases or more if deemed necessary by the preceptor involving the specific laser the physician is wanting to learn 3 Physician shall perform a minimum of five cases or more if deemed necessary by preceptor under the direct supervision of a credentialed sponsor Policy 14 Quality Assurance Policy Documentation shall be developed and maintained that details laser activity Purpose e To provide a method of tracking laser activities e To provide a record of laser trends to ensure a responsive program To ensure safe practices are being observed Procedure The following forms shall be developed and updated as needed A Laser Procedure Log that includes the following information a Laser used b Physician utilizing laser c Laser Settings d Safety Checklist e Method used to protect patient s eyes Laser Safety Training Attendance Record Approved Laser Operator s Skills Checklist Approved Laser Operator s Competency Test Approved Laser Operator s Certification A
6. laser operation Procedure Approved Research Laser Operator requirements 1 Completion of an annual laser safety course that covers the areas of laser safety laser physics and laser tissue interaction ARLO Duties and Responsibilities include 1 Preoperative setup and testing of the laser and associated equipment 2 Establishing the laser controlled area 3 Operation of the laser system placing in standby when not in use 4 Ensuring laser safety policies are observed during laser use 5 Reporting all safety violations to LSO Authority The approved research laser operator has the authority to place the laser system in the standby position until any safety violation or concern has been rectified Policy 4 Laser Treatment Controlled Area Policy A Laser Treatment Controlled Area LTCA shall be established when a Class 3b or Class 4 laser is to be used Purpose e To clearly define an area where laser hazards exist e To create an isolated environment to address all laser safety issues Procedure A Laser Treatment Controlled Area shall be defined by the limits of the Nominal Hazard Zone the extent of which is clearly designated and shall 1 Shall be considered at minimum the entire room in which the procedure is performed Be posted with the appropriate warning sign s Provide adequate personal protective equipment upon entry Be supervised and only be occupied by authorized personnel
7. laser privileges ILP shall be permitted to conduct research and oversee research associates using Class 3B or Class 4 lasers Clinicians granted privileges in the use of a particular laser will however automatically receive investigational laser privileges by virtue of their clinical privileges Purpose e To ensure safe laser operation within research laboratories and clinical settings Procedure Applicant must successfully complete UAMS laser safety training Applicant must review UAMS Laser Safety Policy Applicant must obtain ILP application from the laser safety officer Application shall be completed in full and submitted to department head for signature 5 Completed and signed application will be returned to the laser safety officer 6 Application will be reviewed by the UAMS Laser Safety Committee The UAMS Laser Safety Committee Chairperson will inform the applicant in writing regarding the determination of the committee 7 Successful applicants will contact the Laser Safety Officer to coordinate a site inspection prior to initiating laser research for any new laser site 8 Successful applicants are required to ensure all personnel working in a laser controlled area receive annual laser safety training 9 Successful applicants are required to ensure their laser research remains in conformance with the safety standards outlined in the ANSI Z136 1 and hospital policy BR WN Re Policy 11 Physician
8. patient Policy 5 Ocular Safety Policy Laser safety eyewear shall be worn by everyone inside a Laser Treatment Controlled Area when the laser system is in operation Patient s eyes shall be protected adequately when the laser is in operation Purpose To prevent ocular injuries to patients and health care personnel working with Class 3b and Class 4 laser systems Procedure _ L Appropriate eyewear will be worn by everyone in the room while the laser is operation Appropriate eyewear consists of glasses or goggles of sufficient optical density to prevent ocular damage at the wavelength in use Exception to this is the operator looking through an attached microscope with a lens that has the appropriate optical density for the laser in use Prior to use the operator and ancillary personnel will be responsible for selecting and examining eyewear for comfort proper fit and presents of labels describing both wavelength and proper optical density If eyewear is damaged it must not be worn and must be reported to the LSO Contact lenses are not acceptable as protective eyewear Prescription lens wearers must use appropriate laser safety eyewear All laser safety eyewear must have side shields to protect from peripheral injury and impact Policy 5 Ocular Safety cont 6 Any articulated arm which is not shuttered must be capped when not connected to the hand piece or the microscope 7 The laser
9. system must be placed in the standby mode when delivery optics are moved away from the target 8 Patients will be fitted with appropriately labeled eyewear or have their eyes covered with wet cloth pads towels When laser treatment is near the eyes corneal eye shields shall be used Policy 6 Annual Eyewear Inspection Policy Laser Safety Eyewear shall be inspected annually by the laser safety officer Purpose e To ensure laser safety eye wear is in good condition and is optically adequate to protect personnel Procedure 1 Laser Safety Officer shall gather and inspect eyewear 2 Damaged eyewear shall be removed from service Since this inspection can be somewhat subjective the following list shall serve as a guide for exclusionary criteria A Lack of mechanical integrity B Scratched severely enough to be a nuisance to personnel C Any scratch that damages protective dye or film D Outdated filter material that has poor luminescent transmission 3 All eye wear inspections shall be documented on the proper Quality Assurance Form 4 Laser Safety Officer shall ensure damaged eyewear is replaced Policy 7 Fire Prevention Policy The physician and approved laser operator for each case shall be responsible for ensuring that all reasonable steps are taken to minimize the risk of fire caused by the laser Purpose e To assign responsibility for insuring all fire safety measures are observed e Ensure adequ
10. Point the laser aperture in a safe direction D Disconnect the laser from the delivery device When acting as an approved laser operator you have the authority and duty to suspend laser operation in the event a hazardous situation is suspected A True B False Test administered by Approved 6 11 12 SLF University of Arkansas for Medical Sciences Laser Safety Committee Awards this Certificate of Completion ohu Smith For Fulfilling the Requirements to Act as an Approved Laser Operator for the__ Clinical Laser System Presented on xx XX XXXX UAMS Laser Safety Officer Page 1 of 2 THE UNIVERSITY HOSPITAL OF ARKANSAS APPLICATION FOR CLINICAL LASER PRIVILEGES 1 Use a separate application form for each laser 2 Copy this application as needed if requesting privileges for more than one laser 3 Attach a log of individual cases with each application upon initial request 4 Applicants requesting these privileges for the first time must complete the entire form Sections A B C and D 5 Applicants requesting renewal of previously approved privileges complete sections A and B only 6 The form will be returned to you unprocessed if it is incomplete or you request more than one laser per form SECTION A Name of Applicant Degree Please print Signature of Applicant Date Specialty Office Telephone SECTION B e I wish to apply for laser privileges for the la
11. University Hospital Laser Safety Policy amp Procedures Manual Policy 1 Joint Laser Committee Policy A Laser Committee shall be formed and maintained Purpose e Develop Institutional Policies and Procedures for the safe use of lasers e Review applications for laser privileges and make recommendations based upon findings e Develop and implement Institutional Quality Assurance plan for laser technology e Review complications associated with laser use e Review institutional laser program to make recommendations for new technology acquisitions e Review and address laser safety violations e Recommend appointments of Laser Safety Officers Procedure 1 Laser Safety Committee members shall include Chairman Secretary to Committee Laser Safety Officers Clinical Resource Management Representative Occupational Health and Safety Representative Medical Staff Representative s Surgical Staff Representative Head Laser Nurses 2 Laser Committee shall meet as required Laser Safety Officer will poll members semiannually to determine necessity 3 Accurate meeting minutes shall be archived by the Laser Safety Officer Revised 11 04 SLF Policy 2 Laser Safety Officer Policy An individual shall be appointed the Laser Safety Officer LSO by the Laser Committee Chairman and approved by the Chancellor The LSO has the authority and responsibility to monitor and enforce the control of laser hazards and to effect t
12. acy of emergency countermeasures Procedure l Avoid combustible ointments or lubricants 2 Avoid combustible preps liquids gels and sprays 3 Have only diffuse reflective materials in or near beam path where feasible 4 Combustible surgical drapes shall not be used 5 Moistened towels shall be placed adjacent to treatment site where feasible 6 A basin of water shall be available to extinguish accidental fires involving the patient T An ABC type fire extinguisher shall be in the room during any procedure utilizing a Class II or Class IV laser system 8 Beware of residual heat from Nd YAG contact tips Policy 8 Laser Plume Policy All personnel in the Laser Treatment Controlled Area shall wear respiratory protection designed specifically for laser plume when laser plume generation is anticipated A smoke evacuator shall be used when smoke plume is anticipated Purpose To protect personnel and patients from hazardous byproducts of vaporized tissue Procedure L A laser smoke evacuator shall be installed and tested in the LTCA prior to laser treatment All personnel inside the LTCA shall wear appropriate masks Plume masks will be placed at entrances to the LTCA During laser treatment the smoke evacuator tubing shall be placed as close to the point of vaporization as possible without interfering with treatment and physician The smoke evacuator s motor shall be adjusted to efficiently capture pl
13. demonstrate the ability to operate and adjust laser system for which the candidate seeks certification 6 Shall demonstrate ability to establish a Laser Treatment Controlled Area 7 Shall attend at least three laser treatment cases with the LSO or certified approved laser operator 8 Shall be assessed annually Policy 3 Approved Laser Operator cont ALO Duties and Responsibilities include 1 2 6 7 Preoperative setup and testing of the laser and associated equipment Establishing the laser treatment controlled area Distributing and ensuring the use of appropriate safety items Operation of the laser system Placing laser in standby when not in use Ensuring laser safety policies are observed during laser procedures Completion of quality assurance documentation Reporting all safety violations to the Laser Safety Officer Authority The approved laser operator has the authority to place the laser system in the standby position until any safety violation or concern has been rectified Policy 3B Approved Research Laser Operator Policy An Approved Research Laser Operator shall be present during all laser studies utilizing a Class 3B or Class 4 laser system The approved research laser operator shall complete an annual laser safety course offered by the Laser Safety Officer Purpose e To ensure laser systems are operated by adequately trained personnel e To ensure safe
14. earch associates using Class 3B or Class 4 lasers Clinicians granted privileges in the use of a particular laser will however automatically receive investigational laser privileges by virtue of their clinical privileges Purpose e To ensure safe laser operation within research laboratories and clinical settings Procedure Applicant must successfully complete UAMS laser safety training Applicant must review UAMS Laser Safety Policy Applicant must obtain ILP application from the laser safety officer Application shall be completed in full and submitted to department head for signature 5 Completed and signed application will be returned to the laser safety officer 6 Application will be reviewed by the UAMS Laser Safety Committee The UAMS Laser Safety Committee Chairperson will inform the applicant in writing regarding the determination of the committee 7 Successful applicants will contact the Laser Safety Officer to coordinate a site inspection prior to initiating laser research for any new laser site 8 Successful applicants are required to ensure all personnel working in a laser controlled area receive annual laser safety training 9 Successful applicants are required to ensure their laser research remains in conformance with the safety standards outlined in the ANSI Z136 1 and hospital policy BR WN Re Policy 10 Investigational Laser Privileges Policy Only individuals granted investigational
15. he knowledgeable evaluation and control of laser hazards The LSO shall report to the Laser Committee and the Hospital Safety Coordinating Committee Purpose e To ensure a safe laser program is maintained at this institution Procedure 1 Classification The LSO shall classify or verify classification of laser systems used under the LSO s jurisdiction 2 Hazard Evaluation The LSO shall be responsible for hazard evaluation of laser treatment areas including the determination of Nominal Hazard Zones 3 Control Measures The LSO shall be responsible for assuring that the prescribed control measures are in effect recommending or approving substitute or alternate control measures when the primary ones are not feasible or practical and periodically confirming the proper functioning of those control measures 4 Procedure Approvals The LSO shall approve standard operating procedures and other procedures that may be part of the requirements for administrative and procedural control measures Policy 2 Laser Safety Officer cont 5 Protective Equipment The LSO shall recommend or approve protective equipment e g eye wear barriers screens as may be required to assure personnel safety The LSO shall assure that protective equipment is inspected periodically to insure proper working order 6 Signs and Labels The LSO shall approve the wording on area signs and equipment labels 7 Facility and Equipment The LSO shal
16. l approve laser systems installation and equipment prior to use and modification of existing facilities or equipment The LSO shall authorize laser technicians for performance of maintenance and service 8 Training The LSO shall assure that adequate safety education and training is provided to laser system area personnel The LSO shall train and certify Approved Laser Operators 9 Medical Surveillance The LSO shall determine the personnel categories for medical surveillance 10 Report to Safety Coordinating Committee Policy 3 Approved Laser Operator Policy An approved laser operator shall be present during all laser cases utilizing a Class IIIb or IV laser system The approved laser operator shall be trained and certified by the laser safety officer The ALO shall have a clear understanding of all ALO duties and responsibilities Purpose e To ensure laser systems are operated by adequately trained personnel e To enforce laser safety policies during procedures e To provide a resource person regarding laser issues Procedure Approved Laser Operator certification requirements 1 Shall attend a laser safety course that covers the areas of laser safety laser physics and laser tissue interaction 2 Shall review laser safety policies 3 Shall pass laser competency examination with a score of 90 or better 4 Shall have at least one hour of hands on training with each laser system to be certified for 5 Shall
17. ment controlled area is required for all Class 3B and Class IV laser procedures A True B False What two items are required at all points of entrance to a laser controlled area A Safety Eyewear and Plume Masks B Safety Eyewear and Laser Warning Sign C Laser Warning Sign and Plume Mask D Laser Manual and Laser Log What are the two most important specifications to consider when choosing appropriate eye wear for laser cases A Lens Color B Frame Style C Wavelength D Optical Density If you re uncertain as to the wavelength of the system to be used where can you find this information A SOP B Laser Warning Labels C Laser User s Manual D All the Above Any staff physician can use clinical laser systems A True B False 10 11 Who should be contacted if the laser system isn t operating properly Physical Plant Clinical Engineering Laser Technician All the Above gomp How do you determine if the requesting physician has privileges for the requested laser A Call the Laser Safety Officer B Call the Medical Staff Office C Consult Previous Logs D Go to http intranet uams edu ProviderPrivileges msldir htm Which of the listed lasers doesn t require additional coverings for window openings A Nd YAG B KTP C CO2 D Argon How do you safeguard against unauthorized users activating clinical lasers A Storing the laser key in a secure location B Removing the co
18. osures Proper Eyewear Available and Yes No Used by Personnel Eyewear Inspection Laser OD Condition Laser Safety Officer o THE UNIVERSITY HOSPITAL OF ARKANSAS APPLICATION FOR INVESTIGATIONAL LASER PRIVILEGES Name of Applicant Degree Please print Signature of Applicant Date Office Address Office Telephone Investigator must have 1 completed UAMS laser safety training 2 reviewed UAMS laser safety policies and procedures 1 UAMS Laser Safety Course Completed Date 2 UAMS Laser Safety Policy Review Signature APPROVAL Department Chairman Signature Date Laser Committee Date of Approval COMMENTS
19. pplication for Clinical Laser Privileges Laser Safety Infraction Report Laser Safety Audit Report Application for Investigational Laser Privileges Pee Gy to University of Arkansas for Medical Sciences Laser Procedure Log w ID Patient Name MRI OPC RADIOLOGY DOB Location MainOR ODS LPR Gender Race Physician Procedure System Information Laser Manufacturer Type Laser Settings Wavelength nm Spot Size mm Fluence J cm CW Watts Pulse Parameters Number of Pulses Total Energy Joules Delivery Mode Micro manipulator Scanner Waveguide Fiber Optic Handpiece Lap Coupler Laser Safety Checklist Follow SOP ___ Window Protection __ S Eye Protection ___ Fire Safety Measures ___ Sign Posted ___ Method Used To Protect Patients Eyes Approved Laser Operator Signature Joint Laser Committee Safety Course Attendance Record Name Approved Laser Operator s Laser Skills Demonstration PROPER LASER SIGNS PLACED AT ALL ENTERANCES PROPER EYEWEAR PLACED OUTSIDE ENTERANCES DELIVERY SYSTEMS CONNECTED PROPERLY PATIENT EYES PROTECTED APPROPRIATELY FIRE MEASURES CONSIDERED SYSTEM ACTIVATION PARAMETER ADJUSTMENT SAFELY TEST FIRE SYSTEM READY STANDBY EMERGENCY SHUTDOWN PROPER DOCUMENTATION DISASSEMBLY AND SECURITY LASER SYSTEM University of Arkansas for Medical Sciences Approved Laser Operator s Competency Test Name Score Pass Date A laser treat
20. rd cap between cases C Moving the lasers to a secure location D Activate password protection When laser energy is directed close to the patient s eyes what type of protection is required A Safety goggles B Safety glasses C Corneal eye shields D Wet patches When laser energy is directed into the airway the following fire safety measures are considered A The use of a laser safe endotracheal tube B Maintaining a FiO2 lt 30 C Keeping a water filled syringe readily available D All the above 12 13 14 15 16 17 18 Laser plume isn t considered a real hazard associated with laser use A True B False Lasers often operate using lethal high voltage A True B False The best protection against laser generated airborne contaminants is a laser mask A True B False The following fire safety measures are to be considered within the laser treatment controlled area A Use of nonflammable drapes and prep solutions B ABC fire extinguisher and a bowl of water readily available C Laser safe endotracheal tube and low FiO2 when working in the airway D All the above The use of reflective instruments increases the risk of inadvertent exposure to laser energy A True B False To safeguard against inadvertent laser activation during an ongoing procedure you should when the laser is not actively being used A Place the laser in standby B Turn off laser C
21. ser e In the last 12 months how many times have you used this laser Available lasers include Argon Dye CO2 Contact Nd YAG Diode Wavelength Er YAG Flash Pump Dye Ho YAG IPL KTP Argon Nd YAG NIR Diode Q switch Nd YAG Ruby STOP HERE IF YOU PRESENTLY HAVE THESE PRIVILEGES AND ARE COMPLETING THESE FORMS AT REAPPOINTMENT SECTION C Criteria Practitioners must have at least one of the following 1 Completed a laser training course 2 Completed a preceptorship Or 3 Provided a letter of support from the Residency Department Chair for the specific laser applicant desires privileges Ineligible if completed before 1990 1 Laser Course Attended Include a copy of course outline and or certificate if possible Sponsoring Institution Length of Course Date of Course 2 Preceptorship Completed Name of Preceptor Approximate of Cases A log of individual cases should be submitted with each form Types of Cases List Procedures 3 Institution Name Title Page 2 of 2 SECTION D Completing the UAMS Laser Safety course is a requirement prior to obtaining privileges To Schedule the course contact Scott Ferguson 686 7578 List ALL Laser Safety Courses attended Location Date Location CME Hours Date Location CME Hours Date Location CME Hours CME Hours APPROVAL Department Chairman
22. ume The smoke evacuators filter shall be replaced as outlined in the standard operating procedures Smoke evacuator tubing and filter media shall be handled as biohazardous materials Policy 9 Equipment Maintenance Policy All Health Care Laser Systems and Delivery Devices shall be inspected and maintained according to manufacturer s recommendations or semi annually whichever is most frequent Purpose e To ensure accurate reliable operation e To ensure system is safe optically and electronically e Verify HCLS meets ANSI CDRH and OSHA standards Procedure l All service and repairs shall be performed by a qualified technician See policy Laser Technician 2 Output power or energy shall be measured and logged with a meter calibrated by procedures traceable to NBS standards 3 Calibration must be accurate to within 20 or manufacturers specification if less than 20 4 All system controls shall be tested to ensure proper function 5 Emergency stop button shall be tested for function 6 Preventive maintenance shall be performed using the manufacturer s recommendations for guidance 7 System shall be inspected for conformity to ANSI CDRH and OSHA standards 8 System shall be tested for conformance to NFPA Code 99 Policy 10 Investigational Laser Privileges Policy Only individuals granted investigational laser privileges ILP shall be permitted to conduct research and oversee res

Laser Safety Manual - University of Arkansas for Medical Sciences

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