Untangling the value of both VOC and VOP during Innovation

Strategic Overview

At the start of the current millennium, a watershed publication by the Institute of Medicine (IOM) entitled To Err is Human: Building a Safer Health System was published [1]. The authors estimated that as many as 98,000 people die in any given year from medical errors that occur in hospitals - more than die from motor vehicle accidents, breast cancer, or AIDS. This publication catalyzed awareness and a warranted focus on patient safety and avenues to reduce the possibilities for human error within the healthcare ecosystem.

Diluent solutions and solutions including pharmaceutical compounds, such as compounded drugs, may be administered to a patient intravenously. A solution to be administered intravenously is typically packaged in an intravenous (IV) container and dispensed to the patient through an IV tubing line engaged with the IV container.

IV containers are typically labeled with information identifying a name of the solution, for example the diluent and/or name of the pharmaceutical compound in the solution. Color-coded labels, color-coded risk indicators, and Tall Man letters [2] are often used to assist healthcare professionals in quickly and accurately identifying the solution dispensed from each of the IV containers.

A patient may be simultaneously treated with multiple intravenously-delivered solutions. Each solution is delivered from an IV container through a dedicated IV tubing line. Line maintenance and tracing under these circumstances is critical – most of us have had the difficult experience of locating, tracing, and untangling wires in our circuit breaker box at home. Decoding multiple IV lines in an Intensive Care Unit (ICU) without any labeling poses a similar challenge.

An improved safety practice is for the IV lines engaged with the IV containers to be tagged with the name of the solution to avoid confusion between lines from different containers, for example when starting a new medication, changing intravenous containers, or inspecting intravenous lines.

However, IV line tags are typically provided separately from the IV container, which could lead to inadvertent mislabeling of the IV line. Additionally, since line tags are very often procured separately, clinicians may also have difficulty locating appropriate pre-printed label supply in a timely fashion. Note: Drug administration practice and IV line management is based on health system or institution protocol or policy.

Line Tag Incorporation onto Compounded IV Containers

A novel approach to enhancing patent safety relating to IV line tags was created by a private equity owned outsourcing compounder [3].

A card containing 3 line tags was affixed through the container hanger hole and draped over the container label (reference Figure 1). The concept was marketed and trademarked as “I.D. Your I.V.” [4]

FIGURE 1: Line Tag Card (marketing material) [3]

This innovation ensured line tags with the premixed drug were supplied to the clinician at the time of IV set-up and drug administration. The three IV line tags provided on the card allowed for marking both the proximal and distal ends of the tubing line.

Feedback is the Breakfast of Champions

As with any new product or solution launch, it’s imperative to garner feedback from both users as well as team members within the organization. Generically, these channels in Lean Six Sigma terminology are typically called the “Voice of Customer” (VOC) and “Voice of Process” (VOP).

VOC is the feedback given to businesses by their customers that gives insight into expectations and experiences surrounding a product or service. VOP is the method in which a process communicates its performance capability to meet the requirements and expectations of the customer.

In this case, VOC was obtained from end users (typically hospital nurses), sales team members, and customer service representatives. VOP was obtained from compounding pharmacists and technicians, labeling/packaging personnel, and the manufacturing/engineering and quality assurance teams.

VOC generated the following key improvement opportunity areas:

·        Smaller tag size - 1”x3” size was seen as too large

·        Card with tags should not obstruct container labeling

·        Confusion on why 3 tags per card (versus 2 for proximal and distal marking)

·        Space on tag to write on (e.g. date, time, clinician initials)

·        Semi-permanent adhesive

·        Patient comfort considerations if the tag come into skin contact - rounded tag edges and softer tag material

·        Minimize visual obstruction of tubing – ability to notice air bubbles, discoloration, blockages, or other abnormalities present in the labeled portion of the IV tubing

·        Main label on both sides of container – increased visibility and identification

VOP generated the following key improvement opportunity areas:

·        Manufacturing Feedback – Very labor intensive and costly to add the label card.

·        Quality Feedback – Production line clearance concerns, given the chance of an incorrect drug name label card could be placed on the container (i.e. tag card and container with different labeling)

Spring boarding off VOC & VOP

With the desire to maintain drug labels on both sides of the container, a design insight and creative opportunity arose. With 2 main labels per container (front and back of the container), a tag incorporated within each main label’s architecture would provide 2 total line tags per container for labeling both the proximal and distal ends of the IV tubing.

Based on both the VOC and VOP feedback, a new design was innovated. This design involved a departure from the card tag carrier concept and incorporated the tags directly within the main container labeling. Additionally, a window section was added to minimize the amount of space the opaque tag might obscure of the transparent IV tubing (reference Figures 2, 3, & 4).

FIGURE 2: Integrated Main Container Label & IV Line Tag Design [5]

The new labeling system provides a label in which the main container label portion and a line tag portion are printed onto a shared backing. The main container label portion is fixed to the shared backing, and the IV line tag portion is removably attached to the shared backing. Thus the entire label combination can be removed from the label carrier sheet and secured to an IV bag as a single unit, but also allows for the subsequent removal of the IV line tag for attachment to either the proximal or distal end of the IV tubing associated with that particular IV container.

FIGURE 3: New Label on IV Container [5]

These changes addressed the actionable VOC customer feature needs that were identified, as well as the VOP opportunities by eliminating the line clearance concern and greatly decreasing both the piece part cost as well as the associated labor cost to attach the tag card carrier separately.

An imperative next step was working with label suppliers to prototype the design and subsequently pilot with several customers for additional VOC and making any necessary final revisions. In parallel, the innovation was protected by filing the novel ideas with the United States Patent and Trademark Office (USPTO) [5].

FIGURE 4: New IV Line Tag applied to IV Tubing [5]

Conclusion

If you don’t continue to innovate and make your own products and services obsolete, then your competition will. Generational enhancements throughout a product’s or service’s life cycle are critical to maintaining market leadership.

Gathering and drawing actionable insights from both external and internal customers (VOC) and your processes (VOP) is a fundamental key to unlocking incremental product and service improvements and also leapfrogging into “new-to-world” design ideas.

Citations:

[1] Kohn KT, Corrington JM, Donaldson MS, eds. Washington DC: Committee on Quality Health Care in America, Institute of Medicine: National Academy Press, 1999.

[2] Institute for Safe Medication Practice (ISMP); U.S. Food and Drug Administration (FDA)

[3] PharMEDium Healthcare Holdings/Compass Services; Clayton, Dubilier & Rice, LLC (private equity); JVC Management, LLC (venture capital); Baxter Healthcare

[4] U.S. Trademark No. 4581505

[5] U.S. Patents 10,373,530 & 10,504,387