By, Deirdre H. Elder, DABHP, CMLSO

Who uses medical lasers in your institution? How do you know the provider is qualified? These are questions that should be asked in every medical facility that uses Class 3B and Class 4 lasers.

The Challenge

There is currently a lot of variation in the specificity of laser privileges and the requirements for them to be granted, even within an institution. In a non-scientific survey conducted by the author, twelve academic medical centers, six community hospitals and one military hospital responded to questions regarding the laser privileging process. Three of the nineteen facilities grant core privileges for “use of lasers” or “laser surgery” to all physicians within a specialty. Four facilities have privileges based on the laser type and wavelength [e.g. CO₂ laser (10,600 nm) or Nd:YAG laser (1064 nm)]. Three have very specific privileges that indicate the type of laser and the procedure for which it can be used. For example, Ophthalmology may have privileges for Nd:YAG laser capsulotomy and ArF Excimer photorefractive keratectomy, while Cardiology may have a privilege for XeCl Excimer laser atherectomy. Nine of the facilities had a mixture of laser privileges that differed by specialty.

There is also variation in the requirements for physicians to be granted a laser privilege. Only 63% of the facilities required providers to complete laser safety training and 68% required documentation of training and experience.

Once laser privileges are granted initially, 53% automatically grant them at each reappointment. Only 47% require documentation of a minimum number of cases with each laser, with good outcomes, to renew the privileges.

Image of CO2 laser.

Standards, Guidelines and Regulations

What is the best process to ensure patient safety and to protect the provider and facility? Let’s begin with a review of the requirements in the American National Standard for Safe Use of Lasers in Health Care (ANSI Z136.3-2018). In section 5.2.1, laser safety training is required for health care personnel including laser users and laser operators and 5.2.2 indicates, “Retraining programs should be provided […] not less frequently than every five years for laser users, laser operators” and other personnel. Section 5.2.3 states that “All certification and credentialing processes at the facility […] shall require training in the safe use of lasers, as well as the maintenance of a safe environment […].”

The Association of periOperative Registered Nurses (AORN) also provides guidance regarding the safe use of surgical lasers. AORN indicates that the laser safety committee responsibilities should include “establishing requirements for credentialing” and “verifying that any physician who operates a laser has completed the health care organization’s required education on the operation and safety precautions and course work in basic laser physics, laser-tissue interaction, and clinical applications for the specific laser for which privileges are sought.” (AORN 2017)

The Joint Commission (TJC) defines credentialing as “the collection, verification, and assessment of information regarding three critical parameters; current licensure; education and relevant training; and experience, ability, and current competence to perform the requested privilege(s).” TJC indicates that “core/bundled privileges must clearly and accurately define the specific activities/procedures/privileges to be included the core/bundle and reflect only activities/procedures/privileges performed at the organization from which privileges have been requested.” The Centers for Medicare & Medicaid Services (CMS) requires that “the hospital’s Governing Body must ensure that all practitioners who provide a medical level of care and/or conduct surgical procedures in the hospital are individually evaluated by its Medical Staff and that those practitioners possess current qualifications and demonstrated competencies for the privileges granted.”

Image of greenlight laser.

Recommendations

To comply with ANSI Z136.3-2018, AORN guidelines, TJC standards, and CMS regulations, healthcare facilities need to ensure that providers who use lasers have documented training and experience with the lasers they will use before granting laser privileges. Privileges should be specific to the laser(s) to be used, and the facility needs to have a process for ensuring retraining in laser safety at intervals not to exceed 5 years and evaluation of continued competency.

Ideally, provider privileges would be very specific as to the laser used and the procedure that is performed with the laser (e.g. Nd:YAG laser capsulotomy or Ho:YAG laser lithotripsy). However, the list of specific laser privileges could be quite long. For this reason, many facilities grant privileges for procedures and laser use separately. Physicians may have core privileges to perform typical procedures and then special privileges for the use of specific laser(s). At my facility, providers can request privileges from a list that includes 13 different lasers from the ArF Excimer laser with a wavelength of 193 nm to the CO­₂ laser with a wavelength of 10,600 nm. There are separate privileges for each wavelength of diode laser.

Physicians should be required to submit documentation of training and experience with each laser for which privileges are requested. The facilities in which I work require 2 cases during the previous two years, but some facilities require up to 5 cases and/or allow up to 5 years.

Training in laser safety and maintaining a safe environment should be required at initial credentialing and periodically. While ANSI Z136.3 allows up to 5 years, our credentialing committee decided to require retraining at each reappointment (every 2 years) to renew laser privileges. We have four different laser safety training modules available through our computer-based learning system so providers complete training that is relevant to the setting in which they work and the types of lasers they are likely to use.

If your facility currently has very generic laser privileges and/or does not require any documentation of training and experience, I recommend that you start a conversation with physicians who use lasers, medical credentialing staff and facility administration to discuss the gaps in the current program and best practices that can be implemented. I recruited physician champions and worked with them and medical staff office personnel to develop the policy for laser privileges. We then presented it to the credentials committee and then the medical board.

References

American National Standards Institute (2018). American National Standard for Safe Use of Lasers in Health Care Z136.3-2018. Laser Institute of America. Orlando, FL

American Society for Laser Medicine and Surgery (2012). Standards Of Training For Physicians For The Use Of Lasers In Medicine And Surgery. Available at https://www.aslms.org/for-professionals/professional-resources/standards-of-practice/standards-of-training-for-physicians-for-the-use-of-lasers-in-medicine-and-surgery

Association of PeriOperative Registered Nurses (2016). Guideline Summary: Energy Generating Devices, Part 2 – Lasers. AORN Journal (105) 4, (pp. 402-406)

Centers for Medicare & Medicaid Services (2004). Centers for Medicare & Medicaid Services (CMS) Requirements for Hospital Medical Staff Privileging. Ref: S&C-05-04. Available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCletter05-04.pdf

The Joint Commission (2020). Standards FAQs: Privileging Process – Core or Bundled Privileging Model. Available at https://www.jointcommission.org/standards/standard-faqs/hospital-and-hospital-clinics/medical-staff-ms/000001472/

About the Author

Deirdre Elder is a Certified Health Physicist and Certified Medical Laser Safety Officer with twelve years of experience.  She is the Radiation Safety Manager for UCHealth and serves as the Radiation Safety Officer and Laser Safety Officer for University of Colorado Hospital and other facilities within the system.

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By, Bobbi Childers, BSN,RN,CNOR,CMLSO

Respecting Laser Light

Over the years, lasers have become an important part of medical practices. The light produced by lasers is amplified by the stimulated emission of radiation. This light can be invisible, or it can be a bright visible color such as green or red. A laser system can be as small as a microchip or as immense as a ten-story building (National Facility & Photon Science, nd). Since the light starts as a low-energy pulse and is amplified a quadrillion times, it creates a beam that is both useful and potentially hazardous. Lasers can be dangerous if not used properly, leaving the patient and staff in a vulnerable situation. This is why it is vital for medical facilities with class 3B or class 4 lasers to have a laser safety program.

Red laser beam light

Green laser beam light

Responsibilities of the LSO

Each organization should have a designated LSO who has the responsibility for the oversight and the control of laser hazards(American National Standard Institute 136.3, 2018). AORN Recommended Guidelines recommends that all health care facilities performing laser procedures establish a laser safety program. As the Laser Safety Officer (LSO), I determined that the level one trauma center where I worked did not have a laser safety program. Therefore, there was no consistent standard of practice established for laser procedures, and we were out of compliance with standards and regulations concerning the safe use of lasers.

Getting Approval

Once I discovered our hospital was lacking a laser safety program, I started researching the standardized practice for the use of lasers in health care facilities.  Guidelines from the American National Standard for Safe Use of Lasers in Health Care, AORN’s Guidelines for Perioperative Practice, and the State of Texas regulation were vital resources. This research provides guidelines to help the staff meet the expectations of the hospital and myself.

At this time, I was already a Certified Medical Laser Safety Officer, but I still needed more insight on our particular laser systems, so in November 2015, I attended Laser Institute of America’s  (LIA) Medical Laser Safety Officer Training. The training provided the confidence I needed to get my laser safety program off the ground. Later, I met with my Operating Room Director and the Vice President of Nursing Services to give my recommendation for this project. At first, they were reluctant about creating a new program and were not sure it was necessary. Then I shared with them my vision of a laser safety committee, that evidence-based practice of laser safety by interdisciplinary teams could help ensure safe, efficient, and effective patient care, and they soon agreed.

The Laser Safety Committee

I had the approval of the administration, and I created my plan of action. I composed a letter explaining the purpose and importance of an LSC. The message went to the hospital’s interdisciplinary teams which consisted of: a surgeon who uses lasers, Anesthesia, Credentialing, Nursing Administration, Performance Improvement, Biomed, the Administrator of Surgical Services, and the educators of each department that houses a laser. On July 11, 2016, we had our first laser safety committee meeting. The meeting’s goal was to provide information on the importance of laser safety, to standardize safe patient care, and to submit information to the LSC on the regulations and guidelines for various medical laser systems. Standardizing nursing language for documentation was critical for direct patient care and it has helped promote laser safety by communicating why it is essential, what is involved, and the desired outcomes of laser safety.

The importance of policies concerning laser safety was explained to the LSC. The only existing policies in the hospital were in the surgical department. Each department wrote a plan specifically for their department, and the committee began writing a house-wide policy with the laser safety requirements. Following the completion of the policies and procedures, the education process began. Education was a big challenge, because the other departments, (Cath lab, Gastroenterology, Physical Therapy, and the Cancer Center) had no formal training in laser safety. To remedy this, laser safety in-services were given to each department and now continues annually. Education for the staff members on laser safety is now the responsibility of the Clinical Instructors.

Facing the Challenges of Change

Change always brings some challenges along the way. Educating the staff was not a big issue; it was their acceptance of the new policies and practices related to the use of the lasers; they had been using these laser systems for several years already. The biggest obstacle was wearing laser protective eyewear (LPE) during endoscopic procedures. The argument was that the laser fiber wire was inside the body when the laser fired; therefore, the staff did not need to wear LPE. According to ANSI Z136.3-2018 (C1.6.1), “it should be emphasized that using endoscopes, microscopes, or video monitors does not preclude the laser beam’s emission from a break in the optical fiber” (p.65-66). The LSO can determine if the LPE is required (p.66). The staff wears LPE on all laser procedures in compliance with our policy. The decision to use the LPE for all cases ensures the team remembers to wear the LPE when the fiber is not inside the body. We found this made it simpler.

Team members are wearing laser protective eyewear during the laser procedure.

Another obstacle was related to the laser procedures done in the Pediatric Intensive Care Unit. The ophthalmologist was doing procedures in the PICU with no window coverings. Uncovered windows were a problem that had to be solved immediately. The solution was to take the patient to the obstetrical department and use one of the procedure rooms. The window to this area has a laser window covering. This solution worked well once the physician understood that this was safest option for the patients and the staff.

Conclusion

Lasers are changing the lives of people every day, however there are hazards associated with the use of these machines. Safety during laser procedures is never an option and neither is the safety of the patient. The LSO and the LSC are instrumental in training and educating the staff, making lasers safer for everyone involved in the procedures. A successful laser program takes a dedicated LSO, supportive LSC and a cooperative interdisciplinary team. Before I started my mission on creating the laser safety program, I knew I had to do my research on lasers, study the  recommendations on the safe use of lasers and determine who to contact with any questions that might arise.  LIA, AORN, ANSI Standards for Safe Laser Use, and the Texas Department of Radiation were my resources in building a successful program. Always keep in mind that a team working together can be more successful than working alone.

About the Author

I am Bobbi Childers, BSN,RN,CNOR,CMLSO of University Medical Center in Lubbock, Texas which is a level 1 trauma center. I have been a nurse for 36 years and the past 19 years worked in the operating room at UMC. I received my Laser Safety Officer certification 6 years ago and since then I have expanded my knowledge on the importance of laser safety and the value of a laser safety program.

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By, Casey Branham, MBA/CMLSO

There is a wide range of practices in how hospitals receive healthcare laser system (HCLS) disposables and accessories at their facility. As someone who works for a third-party provider that does this over 90,000 times a year, I’ve seen them all.

In some hospitals, the surgeon may ask for the instructions for use (IFU), or biomed may ask for the UL mark. In others, supply chain may just ask about the cost. There are very few exchanges where we see a Medical Laser Safety Officer (LSO) or Surgical Director present to review HCLS accessories and disposables – which is now a requirement under the latest Z136 guidelines.

Updated American National Standards Tackle Third-Party Provider Risk

ANSI Z136.3 (Sections 1.3.2.8 & 4.3.2) requires that a Medical Laser Safety Officer approve each HCLS and equipment prior to use. This includes any disposables and accessories for use in laser cases. This is necessary to ensure the correct combinations of items are used for each case.

For example, there is difference between an FDA approved item and an FDA approved system. The difference is that a disposable and an accessory can each be FDA approved, yet that specific combination may not be FDA approved based on the OEM and the IFUs for each.

When a facility owns its lasers and purchases fibers directly from the OEM, there isn’t much risk of running into that issue. However, most hospitals do not have a process – or the appropriately certified laser safety professionals – in place to ensure items brought in by third-party providers are also approved (1.4.2).

The result? Hospital staff may be unknowingly introducing risk into their OR that could impact patient outcomes.

The LSO community has an opportunity to educate healthcare professionals on a thorough intake procedure needed to control what enters the OR and what combination of HCLS accessories and disposables can be used without limiting the surgeon’s access to cutting edge technology.

A Good Place to Start: OEM vs. Non-OEM Fibers

My co-worker Richard Gama, CMLSO, presented a dynamic risk assessment tool at the International Laser Safety Conference last year to help LSOs take a closer look at the risk around non-OEM disposables used on different OEM devices. The concept is that risk is not binary or static – it is dynamic. Adding items to a procedure or using different non-OEM combinations may increase the risk that an unsafe event occurs in a laser case.

For example, the risk profile is very different between flexible fiber CO₂ versus Holmium laser disposables. In the case of Holmium laser disposables, the fiber optic transmits laser energy. In the case of flexible fiber CO₂, the CO₂ fibers are made of different materials entirely (Silica hollow core or OmniGuide Polymer). The differences in materials create more aspects that require risk evaluation.

Holmium lasers emit 2100 nm wavelength energy, and the Holmium fibers transmit this energy. This relationship limits risk to the integrity of the fiber and the dexterity of the cladding. The IFUs for the Holmium fibers are validated for use on many different manufacturers’ Holmium lasers. However, the LSO should review and approve and the laser settings prior to use.

There are several well-established third-party Holmium fiber manufacturers that exist today with proven track records. The established track record combined with the simple make up of Holmium fibers makes a good argument for this being a low risk pairing.

The CO₂ flexible fiber is a comparatively recent invention. OmniGuide claims to have produced the first hollow core polymer CO₂ laser fiber in 1998. The OmniGuide fiber (known as a flexible instrument) carries 10,600 nm laser energy as well as helium gas at a predefined PSI based on the inner lumen of the flexible instrument.

The addition of this pressurized gas dramatically changes the risk profile. Due to this, the challenges around third-party silica fibers on OmniGuide equipment are many. The challenges for CO₂ flexible fiber systems manufactured for use with silica fibers are not as dynamic because the material of the fiber is the same as the one intended for use on the HCLS.

Approving silica fibers for use on the OmniGuide laser creates several potential issues. The correct PSI setting for the pressurized gas is first and foremost, as no one wants to see an unanticipated tissue interaction or an airway fire. Once that risk is properly evaluated, the next risk is the durability of the silica fiber.

The OmniGuide polymer fiber is ideal for CO₂ energy for a few reasons. The OmniGuide selling point is that it fails safely. Compared to a hollow core silica fiber, this is true. OmniGuide claims 23,000 surgeries without a single instance of a fiber breaking. The Maude database shows that a few hollow core silica-based CO₂ fibers have broken inside patients or on the surgical field. CO₂ laser energy does not diffuse at the same rate as Holmium energy; therefore, the risk of burns is high if the silica fiber breaks. In 2019, OmniGuide posted a product safety alert around the use of third-party silica fibers on their HCLS.

Approving silica CO₂ laser fibers for use with systems designed to transmit CO₂ energy through a silica fiber are much simpler to evaluate. The major issue there is identifying whether the IFU has a conversion chart for the PSI setting based on the CO₂ silica laser fiber inner lumen diameter. The type of gas recommended for use with the HCLS OEM fibers and the one on the IFU for the non-OEM fiber also needs evaluation.

Imagining a Better Process to Reduce Risk

In order to mitigate the risk described above, hospitals should implement a defined process that involves LSO review of the IFU for HCLS, accessories and disposables. There should also be a follow-up evaluation to determine whether the combined products suggested for use fits that of the IFU for the laser, accessory and the disposable.

After the LSO approves each item use and their combined use, the process moves to the value analysis committee in the same way a facility evaluates a new purchase. Facilities that follow the value analysis process may slow down how quickly an item is available for use, but they ensure the item has been properly reviewed. I often see this process used for new HCLS entering facilities, but I rarely see it when disposables or accessories are involved.

In summary, any process that allows a laser disposable into the facility OR without review from the LSO and a subsequent trip to value analysis increases facility risk. Third-party providers should be required to add any disposable to their contract, and any item should go through the value analysis committee prior to the disposable being placed on contract or entering the OR.

This reduces the risk that disposables enter a facility without proper review of the related IFUs. If your facility has not followed this process in the past, requesting all related IFUs for all contracted items from your third-party partner is a quick way to evaluate the risk you have today. Adopting a more rigorous disposable entry path policy is a proven way to limit risk in the future.

About the Author

Casey Branham is the Operations Director at Agiliti where he works with OEMs to select new technology offerings and partners with large Health Systems around their laser program needs, including the service and delivery of over 330 surgical cases per day. Casey has over 7 years of experience as a certified laser operator and has over 6 years of experience managing multiple ambulatory surgery centers across the Eastern United States that provided laser treatments. He has also been a Board-certified medical laser safety officer for over 2 years

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