zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA PS20-2001: - PDF document

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA PS20-2001: Tuberculosis Elimination Cooperative Agreement (CoAg) – Laboratory Component Informational Call Stephanie Johnston, MS Team Lead/Laboratory Capacity Team June 17, 2019 Background  Support for laboratories began in 1992 focused on upgrade of TB methodologies  Change in focus for 2015-2019 project period to laboratory strengthening  Focus for 2020-2024 remains laboratory strengthening Public Health Laboratory Strengthening  Laboratory component consists of 3 elements described beginning on page 23 of the NOFO 1. Ensure availability of high quality and prompt core laboratory services for TB. 2. Promote continual advancement of laboratory efficiency and quality assurance through the use of local data (your laboratory specific data). 3. Collaborate with partners (e.g., healthcare providers, TB programs, and other laboratories) to ensure optimal use of laboratory services and timely flow of information. Definitions  Elements – CDC CoAg goals  Objectives – CoAg awardee goals  Activities – Plans/strategies within the laboratory to achieve objectives  Measure of success – results/outcomes the laboratory wants to achieve  Local data – laboratory specific data  Workload indicators – data to understand volume and complexity of testing  Turnaround time indicators – data to monitor progress in meeting national recommendations

Laboratory Element 1: Availability of High Quality and Prompt Core Laboratory Services Workload Indictors Turnaround Time Indicators   Focused on understanding the volume Used for monitoring progress in and complexity of testing meeting national recommendations   Data should be included for testing Facilitates the identification of effective performed in house or through referral testing practices and algorithms and those possibly needing examination New for 2020-2024 New for 2020-2024  Indicator added to capture volume of  individual patients for whom in-house Indicator added to capture mean and molecular DST performed by PHL range TAT in days for in-house molecular DST o Clinical specimens/sediments o Clinical specimens/sediments o MTBC isolates o MTBC isolates  Indicator added to capture mean number of days between specimen collection and test result for IGRA Volume Considerations for Laboratory Elements 2 and 3  Different level of required activities based on volume o Consideration for differences in level of funding, staff, and capacity to support activities o Description of requirements on page 20 of NOFO New Tiers For Each Element Work Plan Requirement Based on Volume 1. ≤ 1,000 clinical specimens/year Tier 1 ̶ Provide at least one measurable 2. 1,001 – 5,000 clinical specimens/year objective 3. ≥ 5,001 clinical specimens/year Tier 2 ̶ Provide at least two measurable objectives Tier 3 ̶ Provide at least three measurable objectives

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Laboratory Element 2: Promote Continual Advancement of Laboratory Efficiency and Quality Assurance through the Use of Local Data (Your Laboratory-Specific Data)  Different level of required activities based on volume for this element Potential Areas of Focus  Assessment of testing algorithms and workload trends to identify potential sources of delay  Examine or develop written policies to eliminate redundant testing  Examine business practices for process improvements  Conduct laboratory assessments using standard tool Laboratory Element 3: Collaborate with Partners to ensure Optimal Use of Laboratory Services and Timely Flow of Information  Different level of required activities based on volume for this element Potential Areas of Focus  Develop and initiate educational opportunity for TB Program or clinical laboratory partners  Collaborative development of specimen collection guidelines  Promotion of laboratory services to improve test ordering  Collaborative development of nuclei acid amplification testing guidelines for jurisdiction  Incorporate more providers into electronic ordering and reporting systems across the jurisdiction

zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA Application Process  20 page limit for the entire application, due to CDC 9/5/2019  To include (page 44): o Laboratory CoAg Point of Contact (telephone number & email) o Laboratory Organizational Chart o Overview of Testing Algorithms and Methods o Work Plan Spreadsheet (Year 1 only) o Line item budget (true needs not required)  Will not include for Year 1: o Workload volume and performance measure TAT data Contact, Organizational Chart, & Testing Algorithm/Methods  Laboratory CoAg Point of Contact (telephone number & email)  Laboratory Organizational Chart  Overview of Testing Algorithms (visual if possible) and Methods S.ll~h Carey QAQCOffim Nick M:,tluk Dr . KC'll POi e CL IA Tcclmic:,l Supcr.-i~ CLIA LaboratOI)' Director- - Clinic.,! Microbiology $upc1''iwr I N~neyF.llnin Mic-robiologi\t m . TS Supcl'\i\.Of' I I I Eri~Kilhlllll Ro~Bamcn VaCI\J.il Microbiolojht I1 ~·ticrobiolo3l$t I Microbioloii')l I1

~ ¾ ~ zyxwvutsrqponmlkjihgfedcbaZYXWVUTSRQPONMLKJIHGFEDCBA -- ..... . .... 1'0f'.Cfil,l,tt0llto, l,ll'olJIICt,i)I'~ Work Plan  New o Excel document provided on the DTBE NOFO webpage under Sample Work Plans/Laboratory Work Plan - https://www.cdc.gov/tb/education/funding-opportunity-notice.ht m o CDC-RFA-PS20-2001 applicants may use this layout if desired. Alternatively, applicants may choose to format their required work plan in a different manner, as long as it contains all of the required elements for each strategy. o Laboratory objectives for Elements 1, 2, and 3 over 5 years (2020-2024) with activities to achieve the objectives listed Public Hea lt h Labor atory Strengt hen ing W ork Plan Laborato ry E lement 1: E ns ur e ava ll ablll t'/ of hi gh guall t/ and pr ompt co re labora to ry servi ces fo r ru bc rcul os ls (TB ). Wllat i re yo ur ~ borato rv obiectN e; f Of' l:J em e nt 1 du m w:: th i!i fiv e- , ·e..r Cooi,e r .n Ne N; reem errt per fo di> !\ II , & ho t. Id pr ov la bo r .n o rt es , re(;~rdles.s of vo k.: me : de objec1 11. · es r elirtec!to lmprovl nt e Kh of 1hE- n~ lo n al bE ndl mark l u1 11 dll u u 11 d t i,u~ 1~ 1nu 1 ~ 11 d dl io 1~. •.edu :E- t M rnarou"ld tm e;; ! 1 of S P£- C lmi!n :: will be re: e r, ec \l,/lt · 1 n l da· : 0Ue ct 1 :m, we t- op et o 1 mpro· JE t:t- 1 s t o b~ ¾. !'c h1 eve r.11 . 1 of ::rl ! :ie n tl f lG ;t l O"I (I D) drUJ ' ::.L !: : ept l ::> ll ty • : ~ t ing I OS TI wit hin 17 day ;; f:.r ;s ~ :If l· ;;c-lat i! ~. Ji :1. l l l wAi l iwili '"" ll i.11 Y um l 11 lu r..tl 11 1y lii t .Jn V Antici,.nc-d ot» t .xi i:~ to Lht Wh.lt Vo t. r M c~ :. urc ot Succcs:. T o1 r: ct Corna;k: t: on D oltc/l im cl inc W il l llv- t n .\t:. h; M- . ,.. t h ,.. Ahm, .-- Y/il Bc. Sua:css, Obicd iY cs . j" t c O\.. rie· fo • ~ · ~ h ~ : ol le ct 1 :m ,t,J e- ~ end t/h oh : ays. i-' 1l ot u;;e of ov i! rn1 .e:e1 p: w rtr rn one da'{ of ·~olu me ~u bm l tt e•· ;; . Jtcff : Jrn :;, v=r. h cr ea se d n. m bc r of CY.IT rest.lb . ulv 2021 "1 0...c ch=n~ s to OO Twor~ .f l ow ev =i il a blc wi:hin r c- co mm en:k-d TA b ll o \'\' in~ , : at. ::. e na lysi :s . Monit or tor :, T https://www.cdc.gov/tb/education/funding-opportunity-notice.htm