QUALITY SYSTEMS AND ANALYTICS
Highlighting Member Experiences with the APHL CLIA Audit Tool
By Tina Su , MPH , manager , Quality Systems and Analytics
In January 2022 , the APHL Clinical Laboratory Improvement Amendments ( CLIA ) workgroup published the APHL Guide for CLIA Internal Audits Related to High Complexity Testing . This guide was developed as a quality improvement tool for internal self-assessments of CLIA laboratory activities . The checklist is divided into applicable sections with the requirements succinctly stated along with examples of compliance .
There are several features of the guide designed to make it user-friendly and comprehensive :
• The State Operations Manual ( SOM )/ Code of Federal Regulations ( CFR ) numbers are hyperlinked within the tables for a full explanation of each requirement .
• The table of contents is clickable , allowing the user to go to that specific section of the guide . There is also a button at the bottom of each page that the user can click to return to the table of contents , eliminating the need for scrolling .
• There is a column designated for user notes .
APHL has received positive feedback on member experiences utilizing the tool in their laboratories :
Lindsay Jolly , MPH , CPH , MLS ( ASCP ) CM Assistant Director , Tennessee Division of Laboratory Services
We have used the guide quite a bit here in Tennessee . I ’ ve used the CLIA position descriptions and competency assessments for supervisors . We have also compared our existing internal audit checklist to the APHL guide and will likely fully transition to the APHL guide within the next year . It has been an extremely helpful tool for us !
Laurie Gregg , MT ( ASCP ) Deputy Laboratory Director , South Dakota Public Health Laboratory
It has been the most thorough and useful tool I have ever used ! South Dakota just had their inspection in early January 2023 . We came through with zero citations ! I can say that much of that had to do with the APHL Guide . The inspectors made several comments to the ease and clarity of our forms . They particularly like the personnel qualifications and delegation forms which I took directly from the APHL guide .
Lydia Mikhail , DrPH , HCLD , MBA , MEL Assistant Laboratory Director , Orange County Public Health Laboratory
I felt it helped me study for my Highcomplexity Clinical Laboratory Director ( HCLD ) exam because I had all the CLIA requirements there in one place . Students who are studying for the exam will find the guide helpful because it lists the information they need to know on what CLIA requires from a public health laboratory . We used the tool in the lab to prepare for our upcoming CLIA audit , by filling out all the sections as a group , including the lab director , assistant lab director and general supervisors . This effort identified gaps , areas we were doing well in and others we needed to address . It was definitely the best and most comprehensive tool to use .
While the checklist was designed for internal self-assessments , it can also be referenced when addressing corrective actions as well as serve as a resource for training new staff . APHL will continue to work with the CLIA workgroup to collect suggestions for improving the guide . If you would like to share your experience using the guide , or have any questions , please contact bertina . su @ aphl . org . g
28 LAB MATTERS Summer 2023
PublicHealthLabs @ APHL APHL . org