Lab Matters Summer 2018 | Page 89

APHL 2018 Annual Meeting Poster Abstracts

four elements of validation for FDA approved tests to be verified, there are often different approaches to meet the requirements. For non-FDA approved tests, there are additional requirements for limit of detection, interferences and sample stability for example. To this end, at the South Carolina DHEC Public Health Laboratory, we have established a validation protocol to guide method validations. In this poster, we will outline the key requirements and provide examples of how to meet the requirements. The backbone of our validation protocol is to establish a validation plan. Many times, a plan is already developed in the mind of the laboratory supervisor. By documenting the elements of the validation testing, it allows for a complete validation to be performed without having to“ start over.” The key elements to address are 1. Accuracy, 2. Precision, 3. Reportable Range, 4. Reference Range / Interval, 5. Sensitivity and 6. Specificity. The overall process may be more streamlined by having a concise validation plan agreed upon by the laboratory director, division director, QA office, laboratory supervisor and testing personnel. Establishing the validation plan up front allows for the validation studies to be conducted more efficiently in terms of instrumentation, time, assay reagents and personnel resources. In addition, we have revised our validation summary format to be more prescriptive and descriptive of the validation study. The standard operating procedure and competency assessment are elements we capture on a validation checklist. A final validation checklist helps to ensure all items have been completed and documented prior to patient testing. Our going forward approach is training of the updated validation SOP. We will integrate feedback from our staff on the validation process in continuous quality improvement. As we move forward, we will evaluate the efficiency and robustness of the process.

Presenter: Robert Dixon, PhD, HCLD( ABB), FAACC, South Carolina Public Health Laboratory, Columbia, SC, Phone: 803.896.0965, Email: dixonrb @ dhec. sc. gov

Reducing Time to Treatment by Tracking Specimens H. MacIntosh, STACS DNA, Ottawa, ON, Canada

Specimens that are transported to the laboratory by courier occasionally get delayed or lost. This delays testing, diagnosis and treatment, not to mention the inconvenience and possible pain and anxiety for a patient— as well as cost to the medical system— if a replacement specimen must be collected. The ability to track samples from the time they are collected through transport, delivery and storage produces a complete audit trail for a public health program. It alerts the laboratory and submitters of delays so that action, such as locating the specimen or recollecting, can be taken sooner. It documents the performance of submitters for greater transparency, accountability and the identification of improvement measures. Documenting that specimens were received at the lab meets submitter regulatory requirements. The laboratory gets a global view of all specimens that are in transit to the lab; this allows lab staff to anticipate workloads and capture performance metrics. In addition, tracking storage assists laboratories to retrieve specimens. Finally, everyone benefits from smoother audits. Here are two examples where specimen tracking is making an impact:

Newborn screening( NBS): Specimens must be tested within 48 hours of collection to identify babies who are at risk of serious disease. Delays in diagnosis and treatment can result in delay in development, lifelong serious disease or premature death. Yet samples do go astray. Track-Kit specimen tracking is used by

Newborn Screening Ontario. When fully implemented, Track-Kit will track 150,000 NBS specimens a year, submitted from 200 hospitals and midwives across Ontario and sent by courier to their laboratory in Ottawa, Ontario.

Sexual assault kits( SAK): Many states now have laws specifying that rape kits must be sent to the lab and processed within a certain timeframe; some enforce that survivors must be able to access their testing results. Track-Kit is being implemented in Washington State, Arizona and Michigan to track SAKs from the time they are collected at the hospital, in the custody of law enforcement and delivered to the DNA lab. Survivors can access the location and status of their SAK and the testing results via a confidential survivor portal. States are able to maintain a global view of all SAKs to meet their legislative and reporting requirements.

Presenter: Heather MacIntosh, STACS DNA, Ottawa, ON, Canada, Phone: 613.274.7822, Email: heather. macintosh @ stacsdna. com

Clinical Laboratory Tests of Public Health Significance: What Is Really Necessary?

W. Aldous, State Hygienic Laboratory at the University of Iowa, Coralville, IA

One of the core functions of public health laboratories is disease prevention, control and surveillance. Each state laboratory performs mandated disease testing( tests of public health significance) according to their respective state requirements. In Iowa, these are found in the Iowa Administrative Code 641( Public Health) Chapter 1.18. While no state lab is alike, there are certain core tests offered by all labs. A thorough review of all state laboratory clinical test menus shows a broad range of tests offered. Many are provided due to geographical endemicity of disease within their respective state and are often associated with specific testing or surveillance programs. Over time, state menus added some new tests as recommended by CDC( Ebola, Zika), but overall many laboratories dropped numerous tests or service testing areas due to funding limitations. Of note, many tests offered by state labs can be performed in most hospital laboratories due to affordable technological advances and requirements. This decreases test volumes which will conversely affect lab testing costs. This trend is expected to continue and will impact all state’ s abilities to provide appropriate testing per individual state requirements.

Presenter: Wade Aldous, PhD D( ABMM), State Hygienic Laboratory at the University of Iowa, Coralville, IA, Phone: 319.335.4765, Email: wade-aldous @ uiowa. edu

Strengthening Clinical and Veterinary Laboratory Systems and Capacity in Cambodia Through Mentoring and Training

( complete abstract in Global Health, p. 62)

Quality Systems