Standardisation of the service model in Refractive Surgery

Finland became the first country in the world where the quality standard regarding the operating model for refractive surgery service was formulated and implemented in practice.

The First Clinic (Helsinki, Finland) was the initiator of the standardisation process.

Standardisation of Service Model Enhances Quality in Refractive Surgery Services

Refractive surgery is a medical procedure and a consumer service that targets the functional improvement of a healthy organ.

The objective of standardizing the operating model for refractive surgery was to determine clear and specific requirements in the form of a service standard that optimizes patient safety and the production of the highest possible quality. The standard embodies the guarantee principle for the refractive quality of outcomes.

It is important to note that standardisation of operating model for refractive surgery does not address specific surgical or technical details. Instead, by creating the service standard, it focuses on the non-clinical service characteristics of the operating model of the client-service provider interface.

These characteristics include for example the comprehensiveness of client information, clarity of treatment promises, availability, transparency in pricing, and accountability for the quality of the product.

Addressing the Paradox and the Solution

Refractive surgery is a business enterprise in which the product cannot be returned, and where the formulation of the operating models of service has been naturally driven by commercial interests. Over the years, it has evolved into an effective means to enhance the functioning of one of our essential senses and thus reduce dependence on aids, serving estimatedly 9 milloin clients annually (ISRS, 2023).

However, as a surgical procedure, refractive surgery also inherently carries the risk of adverse effects, ranging from minor adverse effects to very remote but nonetheless existing risk of permanent physical damage and vision impairment.

The operating model of service plays a significant role in determining the likelihood of both minor and major adverse effects and events.

Clients do not possess the expertise to evaluate the quality of operating models offered at refractive surgery market. Transparent and client-understandable criteria for a high-quality operating model in the refractive surgery market have not been formally defined.

Standardizing the operating model fosters a safe service environment that is meticulously designed to prioritize patient well-being, ultimately leading also to the most favorable business outcomes.

A Paradigm Shift in Refractive Surgery

Standardisation of operating model with guarantee principle marks a paradigm shift in refractive surgery.

Typically, patients provide their consent(commitment) to undergo surgery. But in the case of refractive surgery, it is also possible for the service provider to make explicit guarantee commitments regarding the achievable quality of outcome.

In general, this would not be possible in the case of treating diseases or other pathological conditions, but in the case of surgery on healthy structures or organs, it is possible and even desirable from an ethical perspective.

Standardisation of service model with guarantee principle provides clear and easily understandable criteria that enable patients to be conscious decision makers. Standardisation makes the quality criteria transparent. It equips prospective clients considering vision correction surgery with the necessary tools to identify a high-quality refractive surgical operating model and service.

The tenets of a standardized service model with the guarantee principle in refractive surgery embody fairness, equality, and transparency towards clients.

The Key Requirements Defining the Standardized Operating Model with Guarantee Principle

• Clients are provided with a refraction promise regarding the refractive outcome of surgery free-of-charge before committing to the treatment. Since the outcome of refractive surgery can be estimated nowadays quite accurately in advance, the treatment promise can be tailored according to individual situation. This assists clients in making informed decisions about the safety and quality of their planned refractive treatment for their specific case.
• Clients should not have to make any financial commitments before receiving concrete treatment promises specific to their individual case, because it can be considered ethically questionable to require clients to make financial commitments before receiving concrete treatment promises. This means that the preoperative examination process must be provided free of charge until the client receives the refraction promise in written form regarding the expected refractive quality of outcome in their individual case.
• The client is provided with a postoperative guarantee period during which they receive free follow-up care, and the refraction promise is fulfilled. During this time, enhancement operations and their follow-up are provided also for free. According to this operating model all clients pay equal amount for follow-up at the time of the surgery, which ensures equality among clients. Free follow-up increases both the quality of surgery and the quality of follow-up care. Under this policy, customers are not held liable for cost of treatment of complications or side effects. As a result, those who experience adverse effects will not have to bear additional financial burdens for their treatment.
• The client receives a refraction guarantee that includes a full refund for the treatment costs if the refraction promise is not met within the stated guarantee period. This aligns the refraction promise to comply with the client’s individual pre-operative condition, with the performance level of the equipment, and with the competence of the responsible person in using the known equipment in a known specific context.
• The person responsible for the treatment is available to the client before and after the procedure in a manner, that is mutually agreed in advance.
• The client is provided with clear and concise information about all relevant details regarding the treatment in a manner that is easy for the client to comprehend
• Before commitment to surgery, the client is given the opportunity to review all documents requiring their signature
• The client receives all documentation regarding his/her treatment
• The client receives clear and unambiguous pricing that also covers possible events outside of normal treatment, such as the treatment of side effects and enhancement procedures during guarantee time.

The Necessity and Benefits of Standardizing Service Model in Refractive Surgery

This article explores the reasons why standardization is essential, how it contributes to the quality of refractive surgery, and the benefits it offers to patients and service providers.

The starting point for standardisation at 2022 was to determine the operating model of the refractive surgery service that most likely supports the production of the highest quality of outcome.

Standardisation establishes a set of guidelines and requirements of operating model of service, which ensure that there are no obstacles within the service production model itself that could impede the production of the best possible quality.By establishing clear protocols for the operating model, standardisation minimizes complications and reduces the risk of adverse events.

Standardization extends its benefits beyond direct clinical surgical outcomes. Clients gain confidence in refractive surgery knowing that their care adheres to the established standard and and its protocols, fostering trust and a sense of assurance throughout the entire process.

Standardisation enables service providers to market their products transparently and effectively.

Guarantee Principle Gives Means to Assess Individual Risk Level

The challenge lies in the fact that clients, who are considering surgery, lack the ability to assess the quality and safety associated with the offered service model. Neither they are able to estimate the individually varying risk level of the procedure.

Standardisation of service model with guarantee principle provides clients considering surgery with the means to assess their own individual risk level before making decisions, without needing specialized professional expertise.

Standardized Client-Service Provider Interface

Regardless of technological advancements in refractive surgery and the emergence of new surgical techniques, the client-service provider interface will always remain constant in the ever-evolving field of refractive surgery. 

Therefore, the requirements and recommendations made by standardisation of service model will be applicable for identifying high-quality service models in the future as well, regardless of changes in clinical treatment recommendations and the introduction of new surgical techniques and products.

Standardisation as protector of physicians´ role in ensuring high quality care

Physicians have a responsibility to make treatment decisions and provide care with the client’s best interest as the primary consideration. 

However, their autonomy to determine and maintain a safe and high-quality operating model may be questioned in a private sector business environment, where the economic profitability of refraction-altering surgery is quantifiable but clear quality criteria for the service are either lacking or not easily assessable. Standardization of the operating model with a guarantee principle addresses this by establishing clear and visible quality criteria for the service, easily understandable to the client.

Standardization of the refractive surgery service model protects the basic rights of physicians, safeguards their fundamental right and obligation to provide the best possible care and maintain the quality of the operating model, which ensures the fulfillment of their obligation. It also protects both physicians and individuals undergoing surgery from the adverse effects of service models driven solely by commercial interests.

Protecting Patient Interests: Paving the Way for Safe Future Innovations

In general, standardisation of operating model of given medical service with the guarantee principle in can be applied under conditions where the quality criteria of the treatment can be quantifiably measured both before the treatment and as an outcome, and where a pathological process, such as a disease, is not the reason for a treatment, or if so, its impact on the predictability of the treatment outcome is not considered to be remarkable on that extend, that it would prevent giving guarantee promises.

Standardisation of refractive service with guarantee principle can serve as a model for services in the fields of future fields of invasive commercial medicine(like brain&chip), where irreversible volitional procedures may be performed in situations where individuals undergoing the procedure lack the necessary expertise to assess the quality and safety of the operating model of the service, and are unable to estimate the quality of the expected outcome in their individual situation.

In such circumstances, the guarantee principle provides both clients and service providers with a clear framework for assessing the trustworthiness of the expected outcome before undergoing irreversible procedures.

Distinction between medically justified elective surgery and volitional surgery

All surgical procedures involve risks, which can vary greatly. When a disease or pathological condition requires intervention, not performing the procedure typically leads to a worsening of the situation or increases the risks associated with future interventions. For that reason, in surgeries that treat diseases or pathological conditions, it is understandable and justified to take, if necessary, significant risks and accept possible consequences, such as complications and side effects, as a part of the treatment, if an operation is the option that causes the least harm among the available alternatives and the expected benefit of the procedure is considered to be in an acceptable proportion to the associated risks. 

When the timing of such a medically justified procedure can be chosen relatively freely, the procedure is referred to as an elective operation.

Conversely, when surgical methods are employed to enhance the functioning of a feature, organ, or structure without medical necessity, it constitutes a purely voluntary surgery. Here choosing not to undergo a procedure does not lead to the deterioration of the condition, worsen the body’s functionality, or increase a risk level in the future if the procedure is postponed. These surgeries are referred to as volitional operations.

Refractive Surgery as Volitional Procedure Demands Stringent Quality Standard

Refractive surgery procedures fall into the category of volitional operations, because their omission poses no health risk. Consequently, they are considered voluntary procedures that lack a medically justified basis. 

However, the implementation of refractive surgery is justified due to the significant benefits it can provide. By improving the functional performance deficits caused by refractive errors, refractive surgery greatly enhances an individual’s ability to adapt better to their environment.

On the other hand, refractive surgery can potentially result in permanent damage or a condition resembling a disease, leading to a permanent impairment of the crucial sense of sight. 

Given the voluntary nature of refractive surgery, it becomes evident that the responsibility for the quality of the outcome in such procedures must be addressed with greater comprehensiveness compared to surgeries aimed at treating diseases.

Standardising the Guarantee Principle and Refraction Promise in Refractive Surgery

In the context of disease treatment, the presence of the disease or underlying pathological processes can complicate the assessment of the expected outcome’s quality before the procedure, thus limiting the possibilities to assume responsibility for the outcomes accordingly.

In refractive surgery, outcomes are more predictable compared to surgeries aimed at treating diseases. This predictability arises from the absence of underlying disease in the condition being treated and the fact that the parameters being altered can be quantitatively measured. Moreover, there is a vast amount of numerical data accumulated from millions of operations, further contributing to the predictability of outcomes.

In refractive surgery, the operation targets the refraction of the eye, which serves as the primary characteristic defining the quality and functional performance of the initial condition and outcome respectively.

Given the current level of technological development in refractive surgery, the anticipated refractive outcome can already be assessed quite accurately when operating model, surgical equipmentation and the surgeon’s experience are all on sufficient level of quality. Consequently, promises about the outcome can be made.

This enables the provision of the refraction promise, which provides numerical criteria for the quality of the final outcome. The refraction promise, provided prior to the surgery, establishes the guarantee principle as the foundation of the quality standard in refractive surgery.

The guarantee principle in refractive surgery entails, that the surgeon provides the concrete financial guarantee for their treatment promise regarding the quality of the outcome in the form of the refraction promise, before the client decides to undergo the surgery.

The refraction promise is stated as the range of variation of the spherical equivalent (SER D–D) combined with the maximum value of astigmatism (D) as a refractive outcome at the end of a guarantee period.

In order to avoid ambiguity, technical measurement margins must be included in the promise.

Guarantee Period

The guarantee period is the timeframe within which the surgeon commits to fulfill the refraction promise

 It encompasses the follow-up of the primary operation, any potential secondary operation(s) and their subsequent follow-ups, and should be sufficiently lengthy to allow medically justified monitoring and care.

A surgeon determines the length of the guarantee period based on the specific characteristics of the client’s initial condition and the surgeon’s experience in treating similar cases. The sufficient timeframe for any refractive surgical process, even with variations, is typically 2-3 years.

It is important to note that the refraction promise is not a satisfaction promise, as there are many other factors besides refraction that contribute to overall satisfaction. The refraction promise pertains solely to the quality of refraction as the final outcome of the treatment. However, the refraction and its quality as the outcome of the treatment remains the principal criterion for the success of refractive surgery and client´s satisfaction.

The Refraction Guarantee

The refraction guarantee is the commitment made by a surgeon, or a service provider (clinic), or both combined, in a mutually agreed manner, to fully refund the cost paid by the client if the refraction promise is not fulfilled for one or both eyes within the guarantee period. For the refraction guarantee to be valid, the client must accept a possibility of an enhancement procedure(s) during the guarantee period if necessary and feasible, and they must naturally comply with other recommendations and instructions given by the treating surgeon.

The purpose of the refraction promise and refraction guarantee is to provide the client with the realistic assessment of the expected treatment outcome specific to their individual case before committing to refractive surgery. 

The guarantee principle also steers the details of the operating model and fine-tunes the treatment process, ensuring the safest and highest achievable quality of care throughout all its stages – from preoperative planning, through the treatment itself, and until the end of the guarantee period. This comprehensive, guaranteed approach prioritizes the well-being of the patient and ensures that the procedure is conducted with the utmost care and precision. The goal of guarantee principle is this steering effect.

Nevertheless, it is important to acknowledge, that even in situations where a refund is provided based on the refraction guarantee, it does not necessarily indicate that malpractice has occurred, as this will be a refund issued only due to the fact that the refraction promise made prior to the treatment was not fulfilled.

High-Order Aberrations as a Key Factor in Measuring Quality of Refractive Surgery Outcomes

The primary objective of refractive surgery is to modify the level of low-order aberrations in a manner that aligns with the client’s specific needs most effectively. These aberrations—myopia, hyperopia, and astigmatism—must be accurately measurable prior to the procedure if the optical quality of the initial condition can be considered to be normal.

High-order aberrations (HOAs) are higher-frequency distortions in the eye’s ability to focus light accurately on the retina. These aberrations cause blur, glare, and halos, and they can significantly impact the overall quality of vision. HOAs can affect the outcomes of refractive surgery, and they are recognized as a critical factor in measuring the quality of refractive surgery outcomes.

In a normal and successful refractive surgery procedure, the amount of high-order aberrations may decrease, remain unchanged, or only moderately increase in a way that their impact on functional optical performance remains at a tolerable level and they do not interfere remarkably in determinating level of low order aberrations at the end of the guarantee period.

Thus, low-order aberrations must be reliably determinable as the result of the treatment process at the end of the guarantee period, provided that the achieved outcome maintains the same optical quality and level of higher-order aberrations as before the treatment.

If the treatment leads to an increase in high-order aberrations to such an extent that the level of low-order aberrations cannot be reliably determined, it indicates a complicated outcome. In such cases, even spectacle correction cannot fully restore the same level of visual quality that existed prior to the procedure. As a result, vision is permanently impaired, and according to the standard, refund of costs is indicated based on the refraction guarantee.

Free Follow-up During Guarantee Period Increases the Diligence of the Treating Surgeon and Equality of Clients

It should be noted that clients are not held responsible for adverse side effects or complications that might occur during operations. Due to the principle of equality, it is necessary that post-operative care and follow-up visits are provided free-of-charge for everyone during the guarantee period, irrespective of the clinical situation.

The operating model assumes, that the estimated follow-up expence is included in the payment for the operation itself and paid fully together with the primary procedure.

This approach ensures a low barrier for patients during the guarantee period to attend check-ups and enables more effective management of potential side effects, if they occur. It also increases the diligence of the treating surgeon in all their actions and increases the quality of the aftercare. By this way all clients are treated equally, regardless of whether they encounter complications or adverse effects during their treatment process or not. 

Post-Guarantee Follow-up Obligation

Guarantee principle in standardisation also includes a post-guarantee follow-up commitment, whereby the treating surgeon commits to offer free check-ups for the entire duration of their clinical career concerning the medical condition of the structures that were the focus of the procedure and refraction of the eyes, if the treatment promises were not fulfilled during the guarantee period and the money spent on the treatment has been refunded. 

The purpose of the post-guarantee follow-up obligation is to reinforce the concept that the provided refraction promise is realistic for each client’s unique individual case.

Additionally, it serves to prevent the misuse of the standard as a mere marketing tool, where unrealistic refraction promises are made to all clients regardless of their initial condition, solely to attract a large number of clients. 

This obligation ensures that the standard’s protective effect remains in place in all future operating environments, and that it will not be used as a way to attract customers without its original purpose.

The Checklist

The OcuCoach checklist is a checklist that can be used by a customer considering surgery to check whether the offered operating model meets the operating model requirements presented here. The checklist contains about a dozen questions that can be answered with ’yes’ or ’no.’ A ’yes’ response means compliance with the quality standard requirement.

Refractive Surgery Is a Mature Field with Guaranteed Results

In general, it can be said that when a technology is in the research and development phase, its products cannot be guaranteed to have a certain level of quality. The level of medical and technological knowledge in refractive surgery has now reached a point where it is no longer an experimental or developmental field but a mature one, where the quality of its products can be assured. The guarantee principle, included in the standardized operating model, solidifies refractive surgery’s position in the mature development phase to which it already belongs.