Scenario. Designing Test Menus for a Majority Population 8/13/2013. Your Faculty

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1 Designing Test Menus for a Majority Population Your Faculty Ruth Cheng, MBA, MT(ASCP) Supervisor, Specimen Processing Area Department Of Pathology Penn State Hershey Medical Center, Hershey, PA Acknowledgements Amy J. Wendel Spiczka, HTL, MB, SCT(ASCP) Manager, Anatomic Pathology Department of Laboratory Medicine and Pathology Mayo Clinic Arizona For her peer review contributions Scenario We may be able to collaborate with local hospitals that use the same methodology. Perhaps we can exchange samples with them semiannually? We have been struggling with the quality of CAP specimens for our herpes simplex virus (by molecular amplification) proficiency tests. When I review the report, there is non consensus with the intended response. Do you have any ideas for improving our standings? 1

2 Designing Test Menus A test menu is a repository of validated assays that are available for clinician and patient consumption. A Strategically, well developed and optimally communicated test menu occurs. best practices for test ordering and triage are followed consistently best patient care and strong outcomes for quality and efficiency Designing Test Menus Designing a test menu involves a periodic review of services offered keeps cost efficiencies in check. New testing can Enhance current testing or be used as a standalone test. Improve Turnaround Time (TAT) Help with staff shortages. Improve safety. 2

3 Designing New Test Menus INTRODUCTION Step 1 Selection of Test Step 2 Test Research Step 3 Interacting with Vendors Step 4 Decision Special Requirements Step 5 & Test Step 6 Documentation Step 7 Training i Validation Learning Objectives INTRODUCTION Upon completion of this course, you should be able to Describe the steps for selection of a new test and design of a new test menu Discuss the importance of test menus in laboratory Discuss special requirements for test menu design Apply best practices for developing test menus 3

4 Collaboration STEP 1: SELECTION A collaborative effort by management and analytical experts including laboratory manager section supervisor technologist medical billing specialist information technology (IT) representative Selection Considerations STEP 1: SELECTION Selection considerations include 1. Test volumes (high vs. low) 2. Perform cost analysis (labor/supplies/expenses) 3. Review Return on Investment (ROI) 4. Proficiency and Quality Control testing 4

5 Published Test Menus STEP 1: SELECTION Components of a Published Test Menu include 1. Available assays 2. Turnaround Time (TAT) 3. Collection and storage requirements 4. Reference Ranges/Critical Values Preparatio n Prior to developing a test menu, analysis of new assays should include a review of ROI volumes equipment validation training compatibility/adaptabilit y 5

6 CAP Considerations College of American Pathologists (CAP) Considerations Intended response (Error rate comparison) Types of errors Need to network with other institutions and establish peer review process instead? Is there a well-communicated test menu that coincides with the activity menu? CAP Considerations Activity Menu Accuracy can be assessed by inquiry of responsible individuals id Inquiry and examination of the laboratory's test requisition(s) computer order screens procedure manuals patient reports 6

7 CAP Considerations Activity Menu All tests performed by the laboratory should be listed Unusual or esoteric tests may be identified as a miscellaneous code Further information may be found with the laboratory's instrumentation list CAP Considerations The specimen collection manual includes instructions for all of the following elements, as applicable Preparation of the patient Type of collection container and amount of specimen to be collected (i.e. nursing stations, clinics, physicians' offices) Need for special timing for collection (i.e. creatinine clearance) Types and amounts of preservatives or anticoagulants Need for special handling between time of collection and time received by the laboratory (i.e. refrigeration, immediate delivery) Proper specimen labeling Need for appropriate clinical data, when indicated Preservation and storage instructions 7

8 Examination of Existing Test Menus Important issues addressed on a particular test include laboratory space available reliability/quality service/support of vendors possibility of batching work costs (including cost per reportable test)/reimbursement/billing codes staffing requirements/training required pre-analytical variables performance (sensitivity and specificity) test complexity Food and Drug Administration (FDA) approval/clearance turnaround time reagents needed/waste produced physical requirements (i.e. temperature, humidity, lighting) Examination of Existing Test Menus What does the customer need? (i.e. accurate name of test, TAT, related requirements in other SOPs) For new test menus, examine related test menus For existing test menus, examine the current test menu and test results Determine test utilization (customer base and consumerism) Develop strategies for access Communication of laboratory tests Specimen collection Submission policies and procedures "Quality in a service or product is not what you put into it. It is what the client or customer gets out of it." Peter Drucker 8

9 Examination of Existing Test Menus How do orders come to the lab? Do all providers have access to the hospital EMR or do they review paper reports Providers do not necessarily know which reference lab will perform these tests. Do the reference lab reports come back to the hospital electronically, or by paper report? How does the paper p report get attached to the patient s medical record? Test Menu Information Test menu information should include the following Test Name Minimum Volume Alternate t Name Specimen Stability Clinical Significance Specimen Transport Patient Preparation Availability Additional Test Stat Availability Information TAT Specimen Type Reference Ranges Collection Critical Value Instructions Specimen Preparation 9

10 SOP Considerations SOPs provide the structural details for the development and maintenance of the test menu Appropriate instrumentation being utilized for the test volume Instrumentation efficiencies (running day shift only, twice a week, etc.) Analyze production data to establish a threshold for analytes. This review should be done annually and should include volume, cost, etc. Cost Analysis Review the following Will the test be performed on an existing platform or use a new methodology Direct costs including instrumentation, QC, calibrations, proficiency testing, disposable supplies, etc. Indirect costs including overhead and labor Pros and cons of performing test in house versus managing costs and reports when sent to a reference lab 10

11 Knowledge Check LEARNING ACTIVITY Test menu design is complex due to A. Clinician vs. Laboratory terminology differences B. Preferred vs. minimum volume requirements C. Transport times between collection and delivery to your facility D. All of the above Scenario Finance is requesting a review of our procedure costs in chemistry. This has not been done in 5 years, and we recently upgraded our instrumentation. What should I look at? <Click here to enter a response> Submit 11

12 Determining ROI STEP 3: WORKING WITH VENDORS How vendors can help to determine ROI of in-house testing Supply a list of labs using a specified product for peer review Labs can provide information about successes and deficiencies Free test kits Equipment Validation panels Training Determining ROI STEP 3: WORKING WITH VENDORS How vendors can help to determine ROI of in-house testing Vendors should be asked to showcase their product They should be interviewed while keeping an open mind Provide a list of goals and a timeline containing target dates Provide your best guesstimate of annual volumes 12

13 Knowledge Check LEARNING ACTIVITY Scenario Alex is considering changing methodologies for his coagulation tests. He has received input from his team about the possible costs involved, but, he is uncertain about what implementing the new instrument might mean. Proper cost analysis requires input from A. Medical director B. Lab supervisor C. Finance D. Clinician E. All of the above Knowledge Check LEARNING ACTIVITY Scenario] Alex is considering changing methodologies for his coagulation tests. Prior to implementation, he will need to A. Research instrumentation available B. Perform validation studies C. Update the test menu D. All of the above 13

14 Scenario STEPS 4 & 5: DECISION- MAKING & SPECIAL REQUIREMENTS That sounds like it is worth checking into. Thank you for being so observant. It is important, however, that we explore the possibility on several levels before making that decision. I have been looking at trends in our facility over the past 3 years Angela, there seems to be an increased patient need for Tacrolimus tests. Do you think we should incorporate them into our test menu? Scenario STEPS 4 & 5: DECISION- MAKING & SPECIAL REQUIREMENTS Yes, we will want to explore if the inquiries are about in house tests, or tests that are normally sent out to other reference labs. I can see if there is a trend on a national level as well. Are there other areas to consider? 14

15 Making the Decision STEP 4: DECISION- MAKING Which particular test or multiple products will best meet the specific needs of the laboratory? Consensus of research team and the laboratory director Allowing examination of contrasting views Laboratory director must be committed; she/he is ultimately responsible for the test s performance Must be approved by medical staff/administration demand cost/benefit analyses literature reviews patient impact FDA Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Is the test FDA-approved or cleared? FDA-approved test a new test or test design that is different from current products for sale that has been approved by the FDA based on data from the manufacturer proving it is safe if used correctly FDA-cleared test a test that is similar to a current product for sale that has been approved by the FDA based on the manufacturer proving it is safe when used correctly 2 15

16 CLIA Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Minimal requirements according to CLIA of 1988 State licensure and certification through CLIA is mandatory for clinical laboratories performing testing Accreditation through a deemed organization is voluntary. Accreditation organizations include College of American Pathologists (CAP), Joint Commission on Accreditation of Healthcare Organizations (JACHO) Commission on Office Laboratory Accreditation (COLA) HHS Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Certificate from Department of Health and Human Services (HHS) Each procedure in the laboratory must be certified under at least of one of the following:³ Certificate of Waiver Certificate of Provider-Performed Microscopy Procedures (PPM) Certificate of Registration Certificate of Compliance Certificate of Accreditation 16

17 Waived and Non-Waived Testing STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION As stated in Harmening s Laboratory Management, the criteria used to determine method complexity are: 4 1. knowledge of personnel 2. training and experience 3. reagent and material preparation 4. characteristics of operational steps 5. calibration, QC and proficiency testing materials 6. test system troubleshooting 7. interpretation and judgment Waived and Non-Waived Testing STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Non-waived Testing CLIA Inspection every two years Analysis of accuracy precision analytical sensitivity analytical specificity reportable range reference range In order to maintain its complexity level, the test can not be altered in any way 17

18 Waived and Non-Waived Testing STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Waived Testing A test that is so uncomplicated erroneous results are negligible More testing that was previously non-waived is available to the laboratory and hospital personnel than ever before Waived tests must follow the manufacturer s instructions for Use QC quality assurance Peer Review Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION precision reportable range accuracy interferences Validation Study reference interval linearity recovery detection limit 18

19 Peer Review Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Proficiency Requirements performed three times a year with five samples per challenge for each test performed by laboratory personnel using proficiency samples from the CAP or other deemed agency testing must be documented for inspections Peer Review Requirements STEP 5: SPECIAL REQUIREMENTS & TEST VALIDATION Proficiency Requirements An approved proficiency program must be implemented on all analytes that are on the regulated analyte list (found in Subpart I). Nonregulated analytes need testing through any proficiency program, or program developed in-house, and must be tested at least once every six months. This could comprise exchanging samples between local laboratories to fulfill the proficiency testing requirement. QC material is not a substitute for proficiency testing material. 19

20 Knowledge Check LEARNING ACTIVITY Which of the following statements is true? A. According to CAP, test menus must be comprehensive and include links to all tests available at your facility B. Test menus must be connected to the hospital information system C. Test menus should include pre-analytical information, including patient preparation and specimen processing requirements Multiple Choice LEARNING ACTIVITY When reviewing CAP proficiency test results, you must consider A. Intended response B. Your facility s response C. Your tech s performance D. Other participants responses E. All of the above 20

21 Scenario STEPS 6 & 7: DOCUMENTATION & TRAINING Thanks for all the work you have done on researching the assays, reviewing the specifications of the new immunohistochemistry tests in histology and preparing validation plans, Ben. The next step in designing our test menu to ensure its success will be documentation and training. My QC team and I will meet to begin working on the development of procedures to ensure the validity of the tests. I will also start work on a training plan and schedule and send it to you for approval soon. Documentation STEP 6 DOCUMENTATION Written policies and procedures including technical procedure QC log quality-assessment manual patient log inventory sheet discrepant results log training log temperature log 21

22 Documentation STEP 6: DOCUMENTATION Quality Assessment Manual responsible staff written procedures verification of results proficiency maintenance of all regulations Performance is monitored internally during staff training at 6 and 12 months (minimal) as required by CAP, and then annually thereafter. Competency is monitored externally through CAP proficiency testing and/or peer review. Staff Training STEP 7: TRAINING Lab Director is responsible for special requirements (i.e. requirements of accreditation agencies such as CLIA and COLA) determining appropriate personnel evaluation for competency proficiency testing oversight 22

23 Knowledge Check LEARNING ACTIVITY Test menu design is complex due to A. Clinician vs. Laboratory terminology differences B. Preferred vs. minimum volume requirements C. Transport times between collection and delivery to your facility D. All of the above Best Practices CONCLUSION Develop an accurate test menu that highlights the requirements needed by clinicians to choose tests wisely Support the development and deployment of a viable test menu through staff training and awareness, accurate SOPs and optimal communication Support the infrastructure test menu with necessary, high-quality, validated assays 23

24 References CONCLUSION 1. Current Population Survey. Outgoing Rotations Unicon Research Corporation. Available at: Accessed on: November 6, Food and Drug Administration. Getting to market with a medical device. Available at: Accessed on: November 15, CLIA Regulations. Sec Available at: wwwn.cdc.gov/clia/regs/toc.aspx. Accessed on: November 6, Harmening, DM. Laboratory Management: Principles and Processes. St. Petersburg, FL: DH Publishing & Consulting; 2007: College of American Pathologists. Proficiency Testing Performance. Available at: Viewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=laborat i t Ptlt{ ti F t tr l b t ory_accreditation%2fptes.html&_state=maximized&_pagelabel=cntvwr. Accessed on: November 6, Completion Requirements CONCLUSION You have successful completed the online learning course: Designing Test Menus for a Majority Population Credit is awarded upon successful completion of the post-test. Access the post-test by exiting the course and returning to the course content page. Click the link Post-Test to take the exam. You must score 80% in three attempts for credit to be awarded. Interested in applying these best practices on the job? You can download LMU Educational Tools and Resources from your Learning Plan in LMU. Please join the discussion in the Lab Management University online communities of practice. The more you participate and share, the more everyone can benefit including you and your team. 24