The Medical Laser Safety Program Audit: NO FEAR!

In the first quarter of 2009, we find ourselves in a business environment that seems to be encouraging businesses that desire to survive and thrive in the next decade to reflect back to the basics and fundamentals of operating a business; treating clients and business associates fairly, fiscal responsibility, as well as performing and implementing a plan based on due diligence of what is expected of a business to enable it to grow as expected with as few unexpected obstacles as possible that might derail success along the business growth path. There are many resources available that will help you with issues to plan and prepare your medical spa business such as; choosing the appropriate equipment and operational training, choosing your location, hiring and training practices, marketing your facility, and how to impart excellent customer service. One area I believe we have done poorly in is providing the appropriate training and services to prepare these facilities to meet expectations from both a federal and state perspective on the basics of establishing, documenting, and implementing a proper laser safety program. As the cosmetic laser technologies move faster, the continued misconceptions and misunderstandings abound in the medical spa community about what it means to operate a safe and compliant laser facility. Issues in this area are common in those medical spas with experienced physician medical directors as well as those facilities with little or no physician guidance. New medical spa facilities as well as more mature facilities can be equally lacking in a fundamentally sound laser safety program.

What is involved in an Office Laser Safety Program?

Components of a complete medical laser safety program for the medical spa setting will include practices to deal with the responsibilities and training of the facility MLSO (Medical Laser Safety Officer), beam hazards, non beam hazards, equipment repair and maintenance, OSHA laser safety training, operator training, documentation practices, clinical parameters documentation, state specific delegation of authority issues, state specific registration requirements, quality improvement programs, as well as methods to ensure a method to monitor the status of the laser safety program.

Southwest Innovative Solutions, Inc. provides the training and education for office MLSOs (Medical Laser Safety Officers) as well as the documentation framework and training on the use of the framework to help medical spa facilities to put into place programs to document a functioning and dynamic laser safety compliance program based on the needs of the individual facility and Federal guidelines, with variations of the program and specific emphasis on state specific issues associated with existing state legislation as well as local medical board guidelines. Southwest Innovative Solutions, Inc. also continues to monitor each state for continuing activity associated with medical laser safety regulations and guidelines.

Meeting the Needs of New and Existing Medical Spa Facilities

The issues associated with laser safety guidelines and state requirements have changed significantly in the past few years. Generally, our organization will be called to work with more mature medical spa facilities when either new equipment is purchased and the manufacturer or distributor offers this service or portions of this service to that purchaser as part of the purchase agreement. SIS, Inc. has also been called into mature medical spas as issues arise that require an outside auditing body to compel the medical spa to offer evidence that the facility is fully compliant with varying regulations or guidelines. A number of existing successful medical spa facilities have been working under the same framework for many years without incident. However; it is when that incident occurs that our work becomes an emergent need. The facility may have been under the illusion that their safety program was properly documented; however, the pieces were never put in place to maintain a dynamic working safety program.

Our work with new medical spas is early in the medical spa building process. These new facilities may know to prepare for these issues as a result of due diligence, or because they may be working with a consultant group or well versed distributor or manufacturer that has the client's best interest and long term success in mind. These facilities tend to be very easy facilities to work with, and they are new to the information, and do not have pre set beliefs that may challenge their current practices and documentation processes in terms of meeting the needs of current federal recommendations and state requirements.

The challenging issue is that medical spa owners may not be familiar with the federal guidelines, the possible existence of specific state laser safety regulations, or state related medical board issues associated with delegation of authority and training and documentation. Some state legislatures also involve themselves in specific training requirements as well as regulations associated with laser safety. Even if the state is not involved, many medical spa practices to not realize that in the absence of these specific state regulation and state medical board involvement, all facilities should be developing their laser safety program based on the existing federal guidelines developed for any facility utilizing these lasers in the area of health care or operating the devices on human beings. If a state is involved in legislative practices associated with medical laser safety, generally these rules are based on the federal medical laser safety guidelines.

Unfortunately, a common method of establishing and documenting the process of an office laser safety program is based on limited information and existing behaviors and belief systems. It is also common for a facility to rely on the group or organization that sold the equipment to tell them what they need to know. Another contributor to the lack of understanding of how to establish a complete office laser safety program is the misunderstanding that a 30 minute safety talk included with a comprehensive laser applications and marketing program will provide the information necessary to establish an office laser safety program. These training programs are most often designed to simply introduce the basics of laser safety. These safety introductions are not intended to fulfill the education and training requirement of the individual responsible for working with the medical director on developing the safety program. These short safety talks will do little to help establish documentation of the safety program, training staff on the safety protocols, and working with the medical director to develop the internal credentialing process for laser operators, and providing a continuous audit process to ensure that the laser safety program that continues to meet the needs of the facility, staff, and patients.

The most common issue with facilities, again, is the belief system that staff is doing the right thing, with no documentation or fundamental guide to show what that process is or proof that the process exists and is followed. There is so much more to a laser safety program that putting signs on the door and wearing laser safety eyewear. It is imperative that the facility trained MLSO understand some basic fundamental about laser physics and safety, so that the facility staff are not at the mercy of well intentioned laser device distributors, sales personnel, and even practicing physicians. Many injuries reported today, both patient and staff can be directly related to laser safety practices or device operational techniques and parameters based on assumptions provided by well meaning individuals that are passing the information from one facility to another or one staff member to another. A lack of understanding of laser physics and safety by many device sales forces has contributed to many misconceptions and poor safety practices in medical spas and hospitals today.

If an office laser facility has a program loosely based on these assumptions without the basic understanding of how the practice is developed and documented, there may never be an issue until something occurs out of the ordinary. That one unusual issue may result in serious injury and a follow up of intense scrutiny. Each medical spa is independently responsible for their own safety practices to protect themselves and their patients.

The informed cosmetic laser office should have the program and training in place to be able to differentiate information as to true or false, and should be able to make educated judgment calls on situations that may arise out of the ordinary based on accurate information.

Possible Triggers of External Laser Safety Audits:

A variety of issues or situations can bring attention to an existing cosmetic laser program. Once the attention is on the facility, a facility audit from an external entity may be necessary. Some of these audit triggers are listed below:

  • Patient injury or complaint of unexpected outcome may lead to Medical Board Investigation
  • Competition Spa reports (directly or indirectly) your facility to the state or Medical Board
  • State Department of Radiation makes routine inspection of neighboring ionizing radiation facility, happens to notice that there are non ionizing devices (your lasers) also at the facility
  • Employee contacts OSHA for any unrelated reason
  • Accident occurs with laser device requiring treatment
  • Operator injured due to wearing eyewear from manufacturer sold with the laser equipment, but eyewear did not meet specifications of the device's current wavelength and energy output
  • Use of mobile laser company does not alleviate the hosting facility of taking responsibility of ensuring the proper maintenance of the device and the proper operational training of the laser operator. Facility is responsible for the credentials of that operator, the current status of that laser device, and any injuries that might occur due to the operation or malfunction of a device that has not been properly maintained or an operator without proper training credentials.
  • Some states may audit medical laser facilities without a trigger

Although unexpected outcomes and possible injuries may occur with the best safety practices in place and monitored, they are much less likely to happen to facilities with actively monitored laser safety programs. During an involuntary outside facility audit, it will be evident as to whether the facility was even capable of making the effort to provide and document a safe environment for both patients and staff. Those facilities unable to show an established and compliant laser safety program, can be at great exposure for fines, sanctions, and possible law suits. In severe cases involving lack of medical supervision in some states, criminal charges have been filed.

It may be helpful to point out that it is not unusual for states that have laser safety regulations to work closely with the state medical boards on issues that may arise. So if your facility is flagged for some reason associated with state regulatory questions, the state medical board may also get involved for issues associated with delegation or authority or lack of training documentation issues.

The Role of the MLSO in the Cosmetic Laser Office

All facilities that use Class 4 lasers (most all cosmetic and surgical lasers) are required to have a MLSO or Medical Laser Safety Officer on staff. The individual taking on the responsibilities of a facility Medical Laser Safety Officer at a medical spa facility should have a fundamental understanding of laser physics, biophysics, and safety associated with each of these potentially dangerous devices represented in the facility. In addition, patients and staff must be protected by non beam hazards associated with these lasers. After the facility determines what will be required of an individual in order to be allowed to treat patients, the MLSO must ensure those individuals meet those requirements and those accomplishments can be documented (including the Medical Director and other laser operators). According to OSHA, each individual working within the laser facility has the right to know (annually) what these devices are, what type of danger may be associated with them, and what protective mechanisms are in place to protect them from these potential dangers. That is also the responsibility of the MLSO to ensure this level of training is provided and documented.

Unless the facility had a large number of lasers and locations, the MLSO duties is usually a list of duties and responsibilities added to an existing job description. Although the initial laser safety program set up requires some time and dedication of services, once the program is established, the program maintenance requires only maintenance and oversight. Involving a medical laser safety specialist in the initial training of your assigned facility MLSO (and delegate) and in assistance to help plan your laser safety program framework and priority list will significantly limit the initial time and resources that will be required to establish your program.

The facility, and the assigned MLSO, is ultimately responsible the safety for the patients and staff of the facility. This requires the facility to have the right information to be able to establish safety protocols, and to adjust those protocols with reason and science when the situation requires this flexibility.

Who should be the Medical Laser Safety Officer?

The role of the MLSO of a cosmetic office facility is not required to have any specific educational level requirement. Although they should be trained on basic fundamentals for the MLSO as well as the duties and responsibilities, this role may be the Medical Director or any other individual that will work well with the Medical Director and works regularly with the equipment and operators. This responsibility should be in the hands of an individual that is involved, interested, and willing to learn and implement the basic fundamentals required to build and drive such a support program. The MLSO should work closely with the Medical Director to ensure that the support needed to build a successful and compliant safety program is readily available. If possible, a MLSO delegate should also be involved in the training program and the program implementation to ensure coverage in the absence of the primary MLSO.

Understanding a Laser Safety Audit:

There are two types of audit processes involved in the laser safety program facilities: The Internal Voluntary Audit Process and the External Involuntary Audit Process. The most important is the "internal voluntary audit" process. The internal audit process is developed and utilized by each individual facility to help ensure that the safety program is working as expected. This audit process is designed to be performed by the MLSO or MLSO delegate in the laser facility, and can be used concurrently as a very effective as a Quality Assurance program. This audit process analyzes the policies, procedures, patient documentation, equipment maintenance, and training and credentialing documentation, OSHA training, operating protocols, accident reporting, etc. The audit transforms into a tool to be used by the facility to look for opportunities to improve the safety program or make it more efficient. This improvement process becomes a quality improvement measurement that can be documented. Many states require a documented laser safety quality improvement program to be in place. The intent of this program is two fold: first to ensure the safety of the patients and staff, second to fulfill the federal guidelines or state regulations of a laser safety audit program and QI program. The internal audit process allows the Medical Director and MLSO to feel confident that their program represents current practices and will hold up as comprehensive evidence to any questioning entity as to the safety practices of their facility.

What is a Medical Office Laser Safety Audit?

A medical laser safety audit is a general term to define the process of analyzing aspects of the laser safety program associated with a medical facility. This audit should include physical laser equipment maintenance report inspections, evaluations during procedures with multiple operators, policy and procedure updates, laser operator credentialing files, OSHA training updates, patient documentation spot checks, as well as any quality assurance programs in place. According to the federal government and many state regulations, audits should be performed annually for each Class 4 laser device.

The Voluntary Audit Process

The voluntary audit process is the recommended method for overseeing the effectiveness and efficiency of the office laser safety program. This audit process is recommended by the federal government, and required by many state laser regulations. This process is an excellent way to "umbrella" the entire laser safety program and track the effectiveness of the process in place. .

I think it is important to note here, that this internal audit may also be performed by an outside company or entity. Although this is a valuable practice for large hospital systems with multiple locations and over one hundred different laser and medical/surgical services to cover, in the medical spa community, this may not be an efficient use of funds. If the program is small and compact, it would be in the best interest of the medical spa facility to have the facility MLSO perform this function. When performed inside the facility, the properly trained MLSO or delegate can most easily control the process and meet the needs of the facility. Anytime it is possible and reasonable for the facility MLSO to perform this internal audit, it becomes a valuable learning opportunity and resource for the facility.

The Involuntary Audit Process

The second type of audit practice would be an external audit process brought about by complaints, community concerns, or injuries. This type of audit will be based on any existing state requirements or regulations. Official inquires are also common from State Medical Board representatives responding to specific patient complaints, concerns, or "well meaning" concerned citizens. This type of audit can cost the facility time, money, resources, and a considerable amount of stress. In most cases, should the audit expose issues with the laser safety program and documentation framework, the auditing body will simply request that the facility begin the process of establishing the laser safety program and begin the documentation framework. The auditing body may then request regular updates or request some proof of that progress within a few weeks. The facility may be on notice for another planned audit as follow up. If the state requires devices or facilities to be registered, this audit process may delay that registration process. If the state medical board is involved, this body will often want to continue follow up to ensure that the medical practice is following established delegation and training guidelines.

Even if a laser facility has a well established and documented program based on federal guidelines and state regulations, it is still possible to have to endure the rigors of an external audit. However, when such a facility has a well functioning laser safety program in place and can show they have been performing their own external audits by a trained MLSO and can show the framework that the internal audit covers, often the external auditing body will be quickly defused. They may even ask for examples to show other facilities!

A word about Intense Pulse Light Devices

Although the federal government currently does not address intense pulse light devices specifically, some states do address these devices. State laser safety regulations as well as state Medical Boards may incorporate intense pulse light devices with regulations or guidelines associated with medical lasers. It is suggested, that the medical spa treat training documentation and maintenance procedures address these IPL devices as well as lasers.

Conclusion

In closing, if you are involved with an existing medical spa currently using Class 3b or Class 4 lasers, take a critical look at your existing laser safety program and the documentation in place to support that program. Remember the wise reflection of, "If it is not documented, it did not happen". If your office program does not conduct annual laser safety program audits and provide follow up for concerns that should always exposed, question if your program really meets the safety standards you have for your facility.

If you are purchasing equipment or in the beginning stages of the medical spa build out, seek out services that can make this a quick and relatively painless process. Have confidence in your safety program and look forward to your first opportunity for your own internal audit and be prepared to address the follow up opportunities for improvement.

If an external audit comes your way, know you have made every effort to make your medical spa a safe environment, and know that you have proper documentation to show your intent and efforts. That will make a major difference in the outcome of the external audit. Be Safe!

Leslie J. Pollard, BSMT LEOT CMLSO
Southwest Innovative Solutions, Inc.
Specialists in Medical Laser Applications and Safety
Dallas, Texas
www.siselearn.com
214-850-3302