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