A project developed through the Clinical and Laboratory Standards Institute (CLSI) consensus process begins with a proposal. Anyone may submit a project proposal to CLSI: members, volunteers, delegates, and people who have never before been involved in CLSI activities. Anyone who perceives a need for a standard or guideline in the patient-testing field is encouraged to submit a project proposal form to the CLSI offices.

The elements of a project proposal include:
• complete, accurate contact information of the individual submitting the proposal;
• recommended title for the proposed project;
• description of the type of product being proposed;
• project description; and
• proposed subcommittee membership.

Jennifer K. McGeary, MT(ASCP), MSHA, Senior Director, Standards and Quality, CLSI, says, “Many long-term volunteers submit project proposals. In addition, many project ideas are generated during area committee meetings. However, we have seen an upswing in proposals from new volunteers. It is exciting to see how CLSI documents provide an answer to a specific need identified from professionals in the health care community.”

Volunteers who recently submitted proposals weighed in on the CLSI project proposal submission process.

Julie Miller, Program Manager, Newborn Screening & Genetics, Nebraska Department of Health & Human Services, recently submitted her first project proposal titled Newborn Screening Guidelines for Premature and/or Sick Newborns (I/LA31). Miller explains how the need for this project was identified, “Working in newborn screening over the last 12 years, certain troubling trends were becoming apparent to me. An increasing number of premature, sick, and low birth weight babies were surviving, but requiring very specialized care. This was having significant implications for obtaining reliable newborn screening results, and disparate policies amongst programs creating some uncertainty as to how to follow up with these babies.” After identifying a need for standardization, Miller contacted CLSI and requested the proposal form. Miller says, “CLSI made the form available quite easily, and I worked with CLSI volunteer, Judi Tuerck, RN, MSN, to draft the proposal.” When asked about the benefits of volunteering with CLSI, Miller comments, “By volunteering, I can bring to the table issues I see on a day-to-day basis working in newborn screening. Not only do I get to help form policy, my program directly benefits from the shared expertise of all the volunteers working for a common goal, which is always improved quality, no matter what the project.”

A recent proposal on Disaster Preparedness and Disaster Recovery in the Laboratory was submitted by Richard Seaberg, MT(ASCP), Senior Administrative Director, North Shore University Hospital. Seaberg describes the background that led to the submission of his first project proposal, “Considering the disaster from Hurricane Katrina and the events of 9/11 (supplies coming into and out of the New York area), it became apparent that the clinical laboratory needed to have some type of contingency plan to ensure patient services. Such a plan should consider many different aspects, ie, termination of services and subsequent “reactivation” of services (all inclusive) when the event has been mitigated; how to “partner/support” other facilities to ensure services in the event of a biological/chemical event, etc. This plan needs to consider all of the different support areas of the facility and how they work together to handle such an event. The ongoing disaster preparedness in the Gulf states and the issues we experienced during 9/11 when we had problems getting critical supplies over the bridges demonstrated that no facility is immune. We need to develop plans on how best to deal with such an unexpected event so we can continue to meet our missions and the needs of the communities we serve.”

On the project proposal submission process, Seaberg says, “I worked with my CLSI area committee liaison, David Sterry, MT(ASCP), Director, Standards, who sent me examples I could follow to help me develop the plan.” Seaberg says volunteering in CLSI provides many benefits. He comments, “It allows me to stay engaged in the many different aspects of this complex industry and allows me to determine/develop best practices with which to enhance the services my facility provides. It also enables me to be on the ‘cutting edge’ and impact this industry when such guidelines/standards are completed. They provide a ‘roadmap’ that can be used to enhance the services provided by hospitals and reference centers while standardizing practices or providing guidelines for laboratories.”

Charles D. Hawker, PhD, MBA, FACB, Scientific Director, Automation and Special Projects, ARUP Laboratories, recently submitted a proposal titled Standard for Specimen Labels: Content and Location, Fonts, Label Orientation. Dr. Hawker was already familiar with the project proposal process, since he wrote a proposal several years ago for the now approved-level document Autoverification of Clinical Laboratory Test Results (AUTO10). Dr. Hawker says, “The [autoverification] project was completed more than a year ago and is very successful based on customer acceptance and purchases of the document.” Currently, Dr. Hawker is trying to develop a new technology in which cameras can read a patient name on a label and determine if that name matches the name on a second label applied to the specimen at a subsequent part of the chain. Hawker explains, “I realized that all labels are different—different in fonts, font sizes, colors, and location of the patient name, among other things. At an automation conference in October, I was describing the general concept of automated systems for quality inspection to the audience and described this particular project.” Hawker says the audience at the conference was very supportive of proposing a project to CLSI for standardizing the location of patient names on labels and standardizing fonts, etc. Dr. Hawker proceeded with the proposal, which will be presented at the next CLSI Area Committee on Automation and Informatics meeting. Hawker comments, “Making progress toward uniform labels will facilitate automated quality inspections—everybody benefits by seeing the name in a consistently readable font in a consistent location. It could result in the reduction of patient errors.” Regarding the project proposal submission process, Dr. Hawker says, “A project always requires a champion.” He feels the benefits of volunteering in CLSI are twofold. “First, I get to meet and work with great people. In this business, relationships are very valuable. Second, there is satisfaction in getting a standard in place that contributes to patient safety and improved health care.”

Once a project proposal is submitted, project assessment/authorization requires a series of steps including:

• preliminary review and evaluation by the CLSI staff and the appropriate area committee to ensure that a proposed project is consistent with the mission and goals of CLSI, and that there is a perceived need for the project; and
• start of volunteer recruitment process.

The CLSI staff present the completed project proposal to the CLSI Chairholders Council for approval, rejection, or, in limited situations, delayed start.

If approved, the consensus process for document development begins. The expected timeline for the entire process from authorization to approved-level consensus status is 22 months.

CLSI serves medical professionals around the world by providing consensus documents that are the gold standard for best practices across the health care disciplines. By communicating with members of the health care community who identify areas of need, CLSI can respond accordingly with the development of a document through the highly regarded consensus process.

Miller concludes, “CLSI documents bring improved consistency, improved quality, and improved efficiencies to the health care community.” Seaberg feels that the “CLSI process and documents aid facilities in providing the guidance to meet both testing and regulatory requirements.”

CLSI welcomes questions, comments, and suggestions about the project proposal process: e-mail customerservice@clsi.org or call +610.688.0100. To submit a new project proposal, use the project proposal form.
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