McKesson Medical-Surgical Webinar Wednesdays Series

Transcription

1 McKesson Medical-Surgical Webinar Wednesdays Series Moving your Lab from CLIA-Waived to Moderately Complex September 9, 2015 Lynn Glass Vice President of Laboratory Services and Business Development

2 Lynn Glass Vice President of Laboratory Services and Business Development Lynn has more than 30 years experience in the laboratory setting as a generalist, point-of-care coordinator, supervisor and laboratory manager. She formed her own consulting company in 2003 after recognizing a tremendous need in the physician office and independent laboratory for guidance in laboratory setup and continued compliance with state and federal regulations. MedSol Laboratory Consulting now provides this professional service within McKesson to assist our sales team and customers to provide and sustain quality, in-house laboratory testing McKesson Medical-Surgical

3 Topics of Discussion Definition of Waived and Non-Waived Lab Factors to Consider Menu Optimization CLIA Compliance Toolbox for Assistance

4 Waved Laboratory Testing Cleared by FDA (Food and Drug Administration) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible Pose no reasonable risk of harm to the patient if the test is performed incorrectly.

5 Non-Waved Laboratory Testing Categorized by the FDA, tests are rated by: Knowledge Training and experience Reagent and material prep Operational steps Calibration, quality control and proficiency System troubleshooting and maintenance Interpretation and judgment

6 Improving Efficiencies and Quality of Care Faster Results (Saves time) Faster treatment (saves money) Faster Recovery (Saves lives)

7 Should I move from waived to non-waived testing? Factors to Consider: Volume of Testing Ordering Practices and Test Menu Payor Mix and Reimbursement Special Concerns and Specifications Equipment

8 Volume of Testing Obtain reference lab send out report Six month minimum Extrapolate high volume tests Examine waived testing that could be moved to lower cost non-waived test systems

9 Ordering Practices and Test Menu Consider specialties Review current ordering practices Uncover additional tests of interest Maximize your test menu

10 Menu Optimization Am I running tests that are not cost effective? Are there tests available that I am not aware of that I could be performing in house?

11 Low Volume Tests Test Name Mo. Volume Cost/Test Tests/Kit Exp Once Opened True Cost/Test Folate 10 $ months $17.00 Vit B12 15 $ months $17.00 Uric Acid 20 $ month $6.48 CPK 25 $ weeks $12.00

12 Lean Out Your Test Menu Do review of current ordering practices Identify tests with low volume Pinpoint tests with wasted reagent usage Eliminate tests with minimal value

13 Maximize Your Analyzers and Test Menu Keep abreast of new tests with high screening, diagnostic or therapeutic value Determine reimbursement from top insurance providers Discuss with your rep adding tests to menu and test systems

14 Payor Mix and Reimbursement Review insurance contracts Obtain addendums on fee schedules for in house laboratory testing Negotiate contracts when possible to provide for in house testing with reasonable reimbursement Obtain Medicare fee schedule specific to state

15 Spacial Concerns and Specifications Determine available lab space Look at floor space, counter space, what type of equipment will fit within this space Determine additional requirements for electrical, plumbing, HVAC, IT

16 Choose equipment based on: Analyzer Selection Size and throughput Analyzers that have required test menu Available space: floor model vs. benchtop Specialties included and available analyzers

17 Best Practice Evaluation Review monthly test volumes Eliminate low volume tests Discuss with your McKesson Medical-Surgical rep new analyzers and test systems on the market Speak with physicians about in house testing not currently performed Bring in house for added quality testing and increase revenues

18 In the Physician Office Laboratory: CLIA Labs 12,600 labs hold a Certificate of Compliance 5,700 labs hold a Certificate of Accreditation 18,300 total POL labs Largest number of citations in 3 key areas!

19 TOP CLIA Citations Personnel qualifications and responsibilities Proficiency Testing Quality Assurance Plan

20 Personal Qualifications Most notable citations include: No evidence of H.S. diploma for staff in POL No evidence of state license that would provide evidence of proper education Lab Director not qualified under CLIA regs Technical Consultant not qualified under CLIA regs

21 Proficiency Testing Common citations include: One person performing all events Not enrolled for all testing Events run multiple times/run like patients Incomplete records No attestation NO REVIEW AND/OR CORRECTIVE ACTION

22 Additional Concerns Sharing information on results with other laboratories Practices with shared licenses or multiple sites comparing results prior to submission Sending specimens to an outside lab for testing These are actions that may cause the laboratory to lose their license or be given a cease testing order!

23 Quality Assessment Plan The QA plan is an audit of the laboratory processes in the preanalytical, analytical and post-analytical phases of testing. Look proactively at these processes and ensure quality throughout the laboratory. Insanity: doing the same thing over and over again and expecting different results. - Albert Einstein

24 The Surveyor Says: There was no quality assessment plan in place within the laboratory. There was a binder collecting dust on a shelf that had never been opened or utilized. There was a checklist filled out each month that showed no true participation in an actual QC plan.

25 Maximize Quality Have a comprehensive QA plan that includes indicators in the preanalytical, analytical and post-analytical phases of testing.

26 Toolbox for Assistance

27 Tools from MedSol Experts in: Technical Consulting Menu Optimization Clean Up for Troubled Labs Training and Re-training Courses in Basic Lab Operation

28 Solutions for Lab Organizations

29 Technical Consulting Phone Support Remote and On Site Reviews Preparation for Inspection Setup of Labs Addition of New Tests and Analyzers Organization and Layout for Efficiency

30 Lab Training Camp New lab personnel Non-licensed or staff with no prior lab experience Teaches basic QC/QA Basic lab skill sessions Know that your staff is knowledgeable and will provide quality results.

31 Cost Analysis Review of insurance and payor mix Review of current reimbursement Current volume of tests performed Costs by specialty and analyzer Overall net annual revenue generated

32 Solutions for Clean Up

33 Toll Free: McKesson Confidential: For Internal Use Only

34 Thank You! Lynn Glass, Vice President of Laboratory Services and Business Development Toll Free: Unless otherwise noted, the recommendations in this document were obtained from the presenter. Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete information. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information. This webinar has been provided to participants on a complimentary basis. McKesson makes no representations or warranties about, and disclaims all responsibility for, the accuracy or suitability of any information in the webinar and related materials; all such content is provided on an as is basis. MCKESSON FURTHER DISCLAIMS ALL WARRANTIES REGARDING THE CONTENTS OF THESE MATERIALS AND ANY PRODUCTS OR SERVICES DISCUSSED THEREIN, INCLUDING WITHOUT LIMITATION ALL WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE. The content of webinar and related materials should not be construed as legal advice and is intended solely for the use of a competent healthcare professional. Eligibility Requirements For Participating in a McKesson Webinar: This webinar is not open to the general public. Your participation in this webinar cannot be transferred or assigned to anyone for any reason. You do not have to be a current customer of, purchase products from, or be affiliated with, McKesson, in order to participate in the webinars. McKesson, in its sole discretion, may terminate this promotion at any time. Due to certain regulatory restrictions, this promotion cannot be offered to health care providers licensed in Vermont and/or to government employees. All trademarks and registered trademarks are the property of their respective owners. [2015] McKesson Medical Surgical Inc.

35 Please join us next month! Advances in Molecular Diagnostics Paul Barto, BS, MBA, ASCP(MB), ASCP(CG) Category Manager, Moderately & Highly Complex Laboratory, McKesson Medical Surgical October 14, :30pm ET