Anatomy of a Successful Value Analysis Project

This project began with a clinical expert in the Infection Control Department (Adina Feldman, MPH, CIC) identifying failures with the hospital’s disposable isolation gowns. The main issue was the poor quality of the neck securement device. The neck securement device was difficult for caregivers to engage and when they did it did not stay secure (opening easily) and often caught the individual’s hair leading to discomfort. However, most of the time the neck was left open, leading to the gown falling off the shoulders, leaving clothing exposed. For some the sleeves were too short, causing skin at the wrist to be uncovered resulting in potential exposure to blood and body fluids on the caregiver’s skin. Other factors, not as dangerous, were also noted. The bedside caregivers reported the gowns as difficult to doff (remove) and not breathable (resulting in the clinician sweating, sometimes profusely, during care). The Infection Control department set about finding an alternative gown. 

In evaluating a different product, an important factor for Adina was to maintain or enhance the product’s quality. The current isolation gowns met the AAMI Level 2 criterion – “Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)."²  More simply, the quality of the trial gown must meet or exceed the current gown, or it would not be considered.

In evaluating Personal Protective Equipment (PPE), the hospital looked to AAMI as the acceptable standard. AAMI, or the Association for the Advancement of Medical Instrumentation, "is a nonprofit organization founded in 1967. It is a diverse community of more than 10,000 professionals united by one important mission—the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.³”

Working with the Value Analysis Department’s Program Manager for Patient Care (Pelumi Hassan, DNP, RN, CCM, CNE, PMP) a formal project was created.  After completion of a Product Evaluation Agreement (a formal, legal document outlining liability for untoward outcomes, terms and conditions for a no-charge evaluation, etc.) a clinical trial was performed. This trial involved bedside clinicians in several inpatient departments. A Likert scale⁴ was used for clinicians to evaluate the trial product on a scale from 1 to 5, when compared to their regular product. 

1 - Much Worse     2 – Worse     3 – Equivalent     4 – Better     5 - Much Better

In a typical Value Analysis project, an average score of 3.0 is deemed clinically acceptable for a product conversion if there is a sufficient financial return on investment (ROI). For a project intending to increase quality / safety, the benchmark is 4.0. More simply, clinically equivalent is good enough to save money, but better is required to improve quality. Another benchmark is the n or the number of participants in a trial. 50 clinicians are a representative sample to achieve a fair impression of a frequently used trial product. Fewer responses are acceptable for products that have limited usage (i.e.  requiring a certain type of patient). 

Additionally, a section of the evaluation tool was left for caregiver comments. Although a score is necessary to provide an objective, measurable metric, comments are much more telling. Here are the data for this trial:

• Baseline metrics
  • Gowns used annually – nearly 2 million “eaches."
  • Annual expense – nearly $2 million.
  • Trial gown pricing – 35% lower
• Participant responses in the clinical trial – 144
• Overall average score – 4.5
• Score detail:  Much Worse (0)     Worse (2)     Equivalent (14)     Better (37)     Much Better (91)

As stated, the comments are often the best part:

• No adhesive to snag on hair. Easy off, so no fear of contaminating when doffing.  Longer arms and thumb holes so no fear of losing protection while stretching and moving arms for patient care like bed cleanups.
• The loops to keep the gown tucked in the gloves are an excellent way to prevent the spread of unwanted bacteria for the patient as well as the employee.
• The neck actually stays secure, not like previous gown. I also like the thumb loop to keep the gown in place under gloves - even with movement.
• I love the thumb loops; I always have to make my own when I wear the current gown. Also, the neck strap is better than our current ones that stick to my hair and always fall apart. Sometimes I just have to cut a hole out of my gown instead of using the sticker in the back.
• Much easier and quicker to put on and take off. I like the newer ones a lot. I feel more protected when I have those gowns on. It’s covers everything.
• With the gown we currently have it takes a while to attach the back side, vs with this one its ties on the side, and it’s stretchy. I also noticed the sleeves are tight at the wrists which help when you are cleaning in bowel movements. 
• Breathable material.

These results were stupendous. The voice of the clinicians was very clear: “Convert to these gowns now!” But what about financials? As stated, the annual expense for the previous gown was nearly $2 million. The “each” pricing was very poor, a holdover from the pandemic, where all PPE pricing increased. The price of the trialed gown was 35% less. Doing the math, that’s savings of nearly $700,000. Financially, it was also a “convert to these gowns now!”   

After a successful trial, there are still several steps before the clinicians will see the new product on their shelves. Contracts with both the “old” and “new” supplier must be considered. GPO and distributor involvement is addressed. The new supplier must ramp up product to meet the needs of their new customer; in this case, it took 8 weeks. The facility may have to “use up” the current product that is on their shelves, in their distributor’s possession, and already in production at the manufacturer. The new products must be loaded into the hospital’s Enterprise Resource Planning (ERP) software to facilitate ordering, billing, etc. A key to a successful value analysis process is to have as many of these steps as possible performed in parallel rather than sequentially. The faster the new product gets to the caregivers, the sooner the ROI is realized, both financially and clinically. 

Lastly, it is important to perform routine follow up to assess the realized impact. A common frequency for financial ROI is to run the usage and expense monthly. With this data, the financial return, or savings in this case, can be calculated. This savings is tabulated monthly for 12 months. After that, it may or may not count as cost avoidance, but it is no longer considered savings. Savings can be deducted from a departmental budget, but avoidance cannot. It is important to perform this step, rather than use the previous data to estimate, because usage can change. If the new product does not perform as expected (seams rip or tear, the fabric allows “bleed-through”, etc.), usage may increase as caregivers end up using more product for each patient interaction than previously. Using more product, even though it’s less expensive, isn’t savings! 

A follow up with the end-users is also paramount. This step can enlighten the value analysis department into concerns that need to be addressed, such as stock-outs during the conversion, unexpected product performance issues, areas that were missed in the conversion, etc. It also creates trust and enhances credibility between the Value Analysis Department and the clinical caregivers. The clinicians understand that the Value Analysis folks are not just out to save money. Monitoring the impact at the bedside is essential to a successful project. In this case, a similar survey with a similar format was facilitated by Pelumi, with the following results:

• Score detail:  Much Worse (2)     Worse (3)     Equivalent (6)     Better (25)     Much Better (53)
• Average score = 4.4

Though not quite as outstanding as the trial results, the scores still easily met the desired standard. Many of the comments were similar to the trial survey comments. 

The success of this project triggers many positive ramifications. As mentioned, the clinician’s confidence in the value analysis process extends to future projects, knowing the value analysis team will evaluate their opinions and take actions to resolve any unexpected difficulties. It also results in a decrease in the departmental budgets for this category, gaining appreciation from the clinical leadership. This project, in particular, truly meets the definition of a “win-win” for all concerned.