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Laboratory as Gatekeeper Fred V. Plapp, MD PhD Saint Luke’s Hospital

Laboratory as Gatekeeper Fred V. Plapp, MD PhD Saint Luke’s Hospital. National Health Expenditures. JAMA 2013;310:1947. Background. Physicians control 80% health care costs Diagnostic testing accounts for 25% of total Lab testing is highest volume medical activity

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Laboratory as Gatekeeper Fred V. Plapp, MD PhD Saint Luke’s Hospital

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  1. Laboratory as GatekeeperFred V. Plapp, MD PhDSaint Luke’s Hospital

  2. National Health Expenditures JAMA 2013;310:1947

  3. Background • Physicians control 80% health care costs • Diagnostic testing accounts for 25% of total • Lab testing is highest volume medical activity • 5B lab tests per year account for 4% HC costs • Direct cost of $60 billion • Genomic & esoteric tests will increase lab cost • Lab test s influence 60-70% medical decisions • Basis for more expensive downstream costs • Rx, imaging, procedures, hospital stay

  4. Quote by David H. Newman, MD “Doctors love tests, perhaps more than they love patients. It is how we are taught. EKGs, X-rays, CAT scans, colonoscopies, stress tests, blood tests, cultures, you name it. We believe in the objectivity, utiliity and veracity of test results”.

  5. Are More Tests Better? • No correlation between number of lab tests per patient & clinical outcomes • Significant geographic variation in lab test usage without differences in outcome • Redundant lab tests waste $5 billion per year

  6. What is an Inappropriate or Unnecessary Laboratory Test? • Any test where the results are not likely to be medically necessary for clinical management of the patient • Overutilization refers to tests that are ordered but not indicated • Underutilization refers to tests that are indicated but not ordered • Inappropriate should NOT be solely defined as any lab test unlikely to be reimbursed • Waste of laboratory resources

  7. Examples of Inappropriate Tests • Legitimate test ordered inappropriately • PSA screen on men 75 years and older • Vitamin D screen of general population • Tests ordered too frequently • HbA1c, FOBT, PAP, lipids, PSA • Tests on inpatients • Thyroid, O&P, D-Dimer, CD4 counts, frequent repeats • Obsolete tests • BT, T3 up, LDH iso, bacterial antigen, HIV-1 WB, MB • Pseudoscience profiles • Oxidative stress, Detoxigenomic profile, Autism

  8. Magnitude of Unnecessary Care • CBO estimates that 5% of GDP spent on tests & procedures that don’t improve outcomes • Institute of Medicine reported that 30% of U.S. health care is duplicative or unnecessary • Lundberg estimated that 30% of tests did not provide new diagnostic information or alter therapy (JAMA 1980;243:2080)

  9. Early Estimate of Lab Test Inappropriateness • Reviewed 49 articles between 1966-1998 contained criteria for inappropriate tests • Test choice, frequency, timing, indications • Subjective criteria included • Mostly inpatients of teaching hospitals • Inappropriateness ranged from 5 – 50% • Highest rates for PT, Ca, VDRL, TDM Van Walraven & Naylor, JAMA 1998;280:550-58

  10. Most Recent Meta-analysis • 42 articles published between 1997-2012 • All addressed appropriateness of lab tests • 1.6 million results of 46 most common tests • 21-45% rate of inappropriate overutilization • 6 fold higher for initial visit than repeat • 3 fold higher for low vs high volume tests • 45% rate of inappropriate underutilization • No improvement over 15 years Zhietal. PLOS ONE 2013;8(11)378962

  11. Variability as Indicator of Over-Utilization Average number of lab tests ordered for same DRG’s by physicians at 3 UPenn hospitals Donald Young, Advance/Laboratory, October 2011

  12. Duplicate Lab Test Audit • Orlando Health tertiary care hospital • Audited 6 tests that should only be ordered once during an admission • Hepatitis panel, ANA, B12, TSH, ferritin, iron • Looked for 2nd order after first result reported • 42,976 tests were ordered • 7-15% of each test were duplicated • Reagent cost for unnecessary test = $33,531 ClinChem 2012;58:1371

  13. Active Surveillance of Tests Repeated Too Frequently • Southern Arizona VA Hospital • 3.5% HbA1c repeated within 21 days • 5% of ferritin repeated within 14 days • 6% lipid panels repeated within 30 days • 16% of hsCRP repeated within 3 months • 10% of HCV genotype repeated • 8% of Factor V Leiden • 1.4% of positive HCV antibody • 17% of send out tests were inappropriate Ron Schiffman, ASCP Teleconference, Feb 28, 2013

  14. PCP Outpt Test Appropriateness • Proportion of PCP visits that included non-recommended care set by Good Stewardship Working Group • Total waste for lab tests was $46 million • 56% visits included inappropriate CBC • 18% visits included inappropriate • 16% visits included inappropriate BMP Arch Intern Med 2011;171:1856

  15. Lack of Follow-up as Indicator of Unnecessary Test Orders • 662,858 labs ordered during 6736 inpatient admissions at 370 bed teaching hospital • 38% admits had at least 1 test not reviewed • 28% admits had unreviewed results at 2 mo • 3.1% tests ordered during admit not reviewed • 1.5% tests not reviewed by 2 mo • 15% unreviewed tests were abnormal • 67% unreviewed, abnormals ordered on DoD • Tests ordered on DoD did not change care Arch Intern Med 2012; 172:1347-49

  16. How do Physicians Contribute to Test Overuse? • Little incentive to order fewer tests • Fee for service; paid to do things • Lab tests perceived to be inexpensive • Physician ownership of lab/pathology • Practice defensive medicine • Tests included in guidelines • Weigh multiple Dx at time of initial order • Order multiple tests for patient convenience • End of life care

  17. How do Medical Students & Residents contribute to test overuse? • Minimal instruction on how to order or interpret lab tests • Taught histology of MI more than troponin • Attendings have little impact on ordering • Don’t need supervise such a low risk activity • Autonomy is necessary for professional development • Don’t appreciate downstream impact of excess testing on patients • Don’t appreciate impact of excess testing on financial health of hospital

  18. Is Repeat Testing Warranted? Warranted Unwarranted • Confirm abnormal • Doubt accuracy or interpretation • Monitor therapy • Result not available • Don’t trust outside result • Don’t take time to look up previous result • Ratchet up likelihood of almost certain diagnosis • Reduce malpractice risk • Increase profitability

  19. Why Duplicate Orders on Same Day or Same Admission? • Patient transferred • More than 1 physician consulted • Too hurried to see if test already ordered • Panels with overlapping tests ordered • CMP, BMP, renal, liver • Panel plus overlapping individual test ordered • Hepatitis profile plus HCV antibody • Standing orders permitted

  20. How Do Patient Expectations Contribute to Test Overuse? • Media hype of medical meetings • Dr Google search • Dr Oz recommendation • Patients expect the best • Patients expect doctor to do something • Tests ordered to reassure family • Tests ordered to buy time

  21. Allure of Health Screening “If your church is endorsing a health fair, it must be good, right?” The Atlantic, October 24, 2012

  22. Screening Contributes to Overuse • Screening guidelines controversial • Belief that better to prevent than treat • Patients overestimate risk reduction associated with screening and & underestimate risk of intervention • Promotes disease, not health • Fastest way to get heart & vascular disease, autism, diabetes, osteoporosis and cancer • Incidentalomas lead to follow-up testing

  23. Labs Contribute to Overuse • Geared to fast TAT without questions • Slow to discontinue obsolete tests • Suboptimal requisition/COE design • Confusing test names w/o indications • All inclusive test menu = shopper’s delight • Confusing chart format & interpretation • Slow turnaround time • Too many lab errors

  24. Ref Labs Contribute to Overuse • Over-bundle test panels • Include tests not needed for a patient at that time • Direct marketing to physicians and patients • Diagnostic utility not yet proven • Physician’s want to be on cutting edge • Patients want latest & greatest • Both may be unaware of indications, limitations, cost or reimbursement

  25. Why Should We Be Concerned? • Increased lab cost • Increased hospital cost per DRG • Increased payment denials & MUE • Increased potential for direct & indirect harm • Inappropriate test ordered • Increased number of abnormal results • Leads to Ulysses Syndrome

  26. Chance of an Abnormal Result If lab performs 5 million tests per year, will report 150,000 falsely abnormal results

  27. Consequences of Abnormal Result • Follow-up increases cost, worry, discomfort, risk • Confirmatory tests • Specialist referrals • Invasive procedures • Unnecessary postponement of procedure • Attention diverted from primary problem • Diagnostic error? • Iatrogenic anemia from repeat testing

  28. Publicizing Overutilization • Choosing Wisely Campaign • American Board Internal Medicine Foundation • Medical specialties plus Consumer Reports • 5 things physicians & patients should question • Mostly low impact items, no major procedures • Most societies named other specialties services as low impact • Payers may use list for coverage & payment

  29. Choosing Wisely Low Value Tests • Chemistry panels & UA for health screening • Annual lipid screen if not being treated • BNP in initial evaluation of CHF • CA-125 to screen for ovarian cancer • PSA screening in men 75 or older • Routine preoperative lab tests for health adults undergoing elective surgery • Lyme tests in early disease or nonspecific symptoms • ANA for nonspecific myalgia & fatigue

  30. Test Utilization Definition Test utilization is defined as a strategy for reducing unnecessary testing and encouraging appropriate testing to improve the quality of care and provide decision support to assist physicians in selecting correct tests from the ever increasing test menu

  31. Strategies for Changing Physician Ordering Behavior • Strategies that do not work by themselves • Physician consensus building • Test guideline dissemination • Traditional education • Utilization audits • Informing physicians of lab charges • Strategies that do work • Environmental interventions • Administrative interventions • Combinations with other strategies Solomon etal JAMA 1998;280:2020-27

  32. Lundberg’s Principles • Know the right thing to do • Confer with respected physician leaders • Implement changes administratively • Educate through writing & conferences • Weather the storm • Remain open to communication • Enjoy the success of a more effective service JAMA 1998;280:2036

  33. Environmental-Requisitions • Test requisition redesign • Restrict lab menu on inpatient order entry • Eliminate esoteric tests on general requisition • Emphasize preferred tests & cascades • Delete outmoded tests or make less obvious • Minimize or eliminate bundles of tests • Review test names & order of appearance • Provide “useful for” information with name • Organize by ordering pattern or disease state

  34. Environmental- CPOE • Limit tests on quick order screen • Provide clinical indications at time of ordering • Warn of overlapping tests (CMP + Liver profile) • Limit test order frequency per admission • Prohibit automatic ordering of daily tests • Notify if test restricted to outpatients • Prohibit reordering of once in lifetime tests • Notify if test only orderable by specialist • Require clinical information • Display cost or relative cost

  35. Environmental-Algorithms • Work best if lab driven • Physicians won’t order sequentially • Coag, thrombophilia, Thyroid, UA, Anemia, Lyme, Celiac, HIV, HCV, ANA • Mayo claims average cost of lab cascade is 1/7th of ala carte ordering • Pathologist driven based on morphology • Flow, bone marrow, cytogenetics, FISH • Genetics counselor driven • Require genetics consult before order • List recommended test for diseases

  36. Pathologist Triage of BM • Flow held for pathologist discretion • FISH & cytogenetics determined by path • Process, grow culture, store 90 days • DNA & RNA extraction for molecular Dx Intermountain (CAP Today, June 2011)

  37. Environmental-Lab Performance • Review lab tests in order sets & guidelines • Rapid turnaround time • Minimize number of laboratory errors • Review reference ranges • Clear, concise, integrated reports with interpretive comments • Immediate & easy access to test results • Merged inpatient and outpatient results

  38. Administrative Interventions • Duplicate checking – 3 half lives • Standing order policy • Reflex testing policy for certain tests • Discontinue obsolete & low volume tests • Limit preoperative tests by specialty • Physician profiling & report cards – credentialing • Test utilization committee • Review test validity & necessity • Ban certain niche laboratories

  39. Administrative-Lab Formulary • University of Rochester (CLN, Jan 2012) • 3 tier system set by lab diagnostic committee • Tier 1 has universal medical necessity • Available to all providers • Tier 2 is restricted to certain specialists • Tier 3 are off formulary & not recommended • Require pathologist or committee review • One time, patient specific appeal • IBD panel, neurogenetics, gene arrays, etc

  40. Administrative-Formulary 2 • University of Michigan (AJCP 2013;139:289) • Formulary committee chaired by internist • Onc, ID, GI, Neuro, Path, DLO, HA • Invite clinical content experts as needed • Vet current or proposed tests • Consider volume, cost, reimbursement, operational issues, utilization patterns • Inpatient versus outpatient availability • Review utilization at 6 months • Review expensive & high volume send outs • UM-CareLink lists ordering availability for each test

  41. Administrative-Send Out Tests • Is esoteric needed for inpt management? • If not, defer to outpatient setting • Require attending to approve order • Have ref lab bill insurance or patient directly • Pathologist approval in real time • Send & hold process for labile specimens • Review send out summaries from all ref labs • Consolidate ref labs

  42. Educational Interventions • One time effort has not effective long term • Continuously available on line & mobile • Laboratory newsletter • Clinical pathways & order sets with pre-approved lab tests • Timely pathology consults • Physician profiling by peer group

  43. Pathologist Role • Pathologist consults • Transfusion, antibiotic stewardship, coagulation • Advantages • Shorten time to diagnosis • Avoid misdiagnosis • Save clinician time • Pathologist test interpretation • EP, coag, tox, endocrine, ID, molecular

  44. Utilization Benchmarks • Consulting services • Chi Solutions & Internek • Professional organizations • CAP & University Health Consortium • Publications • Internal • Trend over time • Physician profiling

  45. Our Approach • Target solvable problems • Analyze your own data • Present to influential physicians • Communicate changes • Remain open to questions • Monitor impact • Persist

  46. Utilization Targets • High volume tests • Low volume, expensive tests • Difficult to perform assays • Questionable medical benefit • Frequently repeated tests • Unusual number of abnormal results • Once in a lifetime tests • Send out tests

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