Lab Matters Fall 2020 - Page 54

Quality Systems analytical testing procedure where multiple , nonessential steps extended the amount of time it took for results to be compiled and released . These redundancies were removed , and the process was automated to streamline and decrease the amount of time spent in this phase . Implementing these changes allowed for additional and unexpected improvements including adding a second day of testing which reduced batch sizes and improved turnaround time . Adoption of a quality improvement methodology has been proven to increase efficiency while empowering laboratory staff to seek opportunities for improvement , evaluate the present process , and make changes .
Presenter : Julie Miranda , Texas Department of State Health Services Laboratory , Austin , TX , yuli _ mir @ hotmail . com
Innovative Approach to Laboratory Risk Assessments S . York , Centers for Disease Control and Prevention , Atlanta , GA
Many laboratories use a lengthy , standardized form as the basis of their risk assessments . A new approach using a risk assessment tool utilized on construction sites would prompt laboratory scientists to incorporate the act of assessing risk present in day to day lab activities and keep those identified hazards in mind as they are working .
At first glance , a laboratory and a construction site do not have much in common . A construction site is loud , exposed to the elements , and dirty . Laboratories are clean , climate-controlled spaces with tightly controlled access . However , when you look closer , there is a great deal in common with these two work environments . Both work environments demand the use of personal protective equipment , use large instruments and equipment , and require an understanding of the hazards present to work safely . These industries both try to mitigate the hazards by performing risk assessments .
Many laboratories perform risk assessments by utilizing a form that attempts to outline a proposed laboratory activity and assign an overall assessment of the activity ’ s risk . A risk matrix is utilized to quantify the severity and probability of a non-conforming event occurring in order to determine the overall risk of the activity or procedure . Risk assessments in laboratories are typically performed when a new assay or activity is planned and are reviewed annually for changes .
The risk assessment utilized at a local construction site is formatted differently but could be easily adapted to laboratory work . The construction site risk assessment tool asked three very simple questions to encourage workers to think about the activities being performed and what risks were associated with those activities . These questions included “ What tasks are we doing today ?”, “ How could we get hurt ?”, and “ How can we keep from getting hurt ?”. A simple , three step risk assessment like the one used at the construction site could encourage laboratory scientists to think about the risk associated with their daily activities . This approach may be more useful for day to day laboratory activities and help laboratory scientists incorporate risk assessment into their daily routine .
Presenter : Shannon York , Centers for Disease Control and Prevention , Atlanta , GA , phy3 @ cdc . gov
Resolution of Intermittent Calibrator Control Fails of a 4th Generation HIV-1 / 2 Ag / Ab Combo Immunoassay at a Paper-based Laboratory
D . Silva , E . Aroh , R . Watkins , H . Guililat , H . Kidane , J . Stringer and E . Bannister , Dallas County Health and Human Services , Dallas , TX
Continuous monitoring of quality control is an important part of quality assurance ( QA ). However in the absence of an electronic laboratory information system ( LIS ) or sufficient personnel , this QA practice is often difficult to maintain . The Public Health Laboratory at Dallas County Health and Human Services ( DCHHS ) is a 25-person laboratory that processes HIV tests using the CDC recommended algorithm , starting with a 4th generation HIV-1 / 2 Ag / Ab Combo immunoassay ( HIV Combo ). Here we present a case study of a QA investigation at DCHHS . The investigation was triggered several months after increased but intermittent calibrator control fails of two subsequent lots of HIV Combo kit with fail rates of 5 % and 10 %, as compared with the 0 % fail rate at baseline . The increased calibrator control fails led to unexpected spending of $ 26,937 in the re-running of failed plates . More common causes of assay fails such as faulty instrument , improper reagent storage , operator error were ruled out . To identify the potential cause of the fails , quality control , calibrator , operator and other data from 7 months of testing , representing over 185 runs , were manually inputted into the statistical software JMP SAS from instrument print-outs of each HIV Combo run . Statistical tests identified the HIV Combo lot , Wash buffer lot , and Stop solution lot as having significant statistical correlation with the failed runs . As a corrective action , we directed the use of new lots of both the current HIV Combo and Wash buffer lots which reduced the calibrator control fail rate from 10 % to 1.8 %. We also changed the Stop solution lot but observed no additional decrease in calibrator control fail rates . Measurements of turn-around time between Test Order and Test Result increased from 1.4 days at baseline , to 1.6 days and 2.4 days with the defective HIV Combo kits , to 1.7 days during the corrective action . Thus while maintaining patient testing , we were able to conclude that the HIV Combo Lot or the Wash buffer lot , together or individually , contributed to the increases in failed runs and our corrective action reversed negative trends observed during testing . Lastly , the data generated from this investigation enabled us to obtain a $ 26,937 refund from the manufacturer . Thus this case study highlights the critical importance of continuous monitoring of quality control for quality assurance of laboratory services . Paper – based laboratories should strive to allocate resources to maintain an effective quality assurance program by reallocating duties of existing personnel to include quality assurance , seeking additional funding for new personnel , or implementation of an electronic LIS to reduce waste and improve the quality of laboratory services .
Presenter : David Silva , Dallas County Health and Human Services , Dallas , TX , david . silva @ dallascounty . org
Measuring Success in Response to Outbreaks
M . Pentella 1 , L . Liu 2 , J . Barnett 2 , W . Aldous 1 ; 1 State Hygienic Laboratory at the University of Iowa , Iowa City , IA , 2 University of Iowa , Iowa City , IA
The frequency of outbreaks of novel infectious diseases continues to increase . The recent Ebola and Zika virus outbreaks demonstrated variable preparedness of many public health systems with delayed identification and confirmation of infected patients