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The 3 Rs in the Clinical Laboratory
REACH TO TEACHRoxanne Alter, M.S.MLS(ASCP)cm Nebraska State Biosafety Officerralter@unmc.edu
OBJECTIVES• Describe The 3 Rs affecting the Clinical Laboratory.
• Examine the current environment for biosafety training.
• Evaluate strategies for training and risk assessment.
ReimbursementHow the laboratory gets paid for the tests that they perform.
RegulatoryFDA - Federal drug administrationCMS -Center for Medicaid and Medicare ServicesCLIA – Clinical Laboratory Improvement AmendmentsCAP College of American PathologyJCAHO- Joint commission on the accreditation of Healthcare organizations
ResourcesLaboratory personnelBOC (board of certification)certified through ASCP(American Society of Clinical Pathology)
medical laboratory scientists -MLSmedical laboratory technicians-MLTPhlebotomy CytotechnologistBiology degree HistotechnologistPublic Health degree
Approximately 14 Billion Laboratory tests are performed every year. The
single highest medical activity.It is estimated that 70% of the medical decisions on any one patient are influenced by laboratory test data.
When evaluating access to medical information or electronic health records laboratory information is accesses 8 times more than any other hospital data.
Rodney Forsman (Past President of CLMA) provided another fact about Mayo to reinforce his point about the essential role that laboratory test data plays within the clinical continuum. At the Mayo Clinic each day, 60,000 laboratory test results are added to the Mayo EMR. This lab test data is in high demand, as Mayo tracks, on average, 200,000 daily retrievals of lab test data from the system by caregivers within the Mayo Clinic.
WHICH OF THE THREE Rs DO YOU
CONSIDER MOST IMPORTANT?
A. ReimbursementB. RegulatoryC. Resources
A. REIMBUSEMENT - 22.5%
B. REGULATION - 34.2%
C. RESOURCES - 43.2%
9
REIMBURSEMENTGOVERNMENTINSURANCE
FEE FOR SERVICECAPITATIONBUNDLINGVALUE-BASED PAYMENTS
CLFS –Clinical Laboratory Fee SchedulePAMA – Protecting Access to Medicare ACT
Fee For Service
• Each Test/procedure reimbursed separately.• Simple accounting for the laboratory
• No “gatekeeper’ incentive• Potential overutilization (too many tests)• Third party payers (insurance or Medicare/Medicaid) assume
overutilization.Limits patient access as an unintended consequence
11
CAPITATION• Tests not reimbursed separately• Linked to individual patient• Linked to a care event• Encourages gatekeeping and lab
efficiency• Lab bears the financial risk• Limits patient access as unintended
consequence
BUNDLING
• Tests are grouped
• Same reimbursement for all tests in group tests
• Simplified accounting for payers
• Risk of assignment to incorrect group
• Lab financial risk varies with test mix
• Limit patient access as unintended
consequences. CABG coronary artery bypass graft
VALUE BASED PAYMENTSPortion of the payment rates tied to Clinical OutcomesPatient Satisfaction
General Eric Shinseki former chief of staff US ARMY
“IF YOU DISLIKE CHANGE, YOU’RE GOING TO DISLIKE IRRELEVANCE
EVEN MORE.”
CLFS and PAMAMedicare currently pays $7 billion dollars annually for clinical diagnostic laboratory testing under the CLFS.This is 1.6% of the Medicare spending.
CLFS was first adopted in 1984Promised of annual consumer price index (CPI) Frozen prices and cuts reduced to a third of what was legislated.
June 23, 2016 CLFS Final Rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System” (CMS-1621-F) was published creating a new market base.Implementation of rule 216(a) of the Protecting Access to Medicare Act (PAMA) passed in April 2014.
PAMA requiresLaboratories performing clinical diagnostic laboratory test to collect and report to CMS the amounts paid by private insurers for tests. CLFS will be calculated on the weighted median of private insurance payments to applicable laboratories.
Does not figure in cost differences between Nebraska and California; or cost differences between Omaha and Imperial, NE.
CMS predicts that the new rule will lead to cost savings of almost $5 billion over the course of 10 years.
Applicable Labs ??? HAVE A CLIA NUMBER Bill UNDER THEIR OWN NPI (NATIONAL PROVIDER IDENTIFIER) Have more than 12,000 in Medicare revenues form CLSF Receive more than 50% revenues from lab and or Physician services
during a collection period. *** does not include 95% not reporting including most hospital laboratories
and physicians labs because they report under the Hospitals NPI or Physician's NPI.
Report each test for which final payment is receivedvolume of tests paid at private payor rateHCPSC code associated with test
COLLECTION PERIOD Registration open Oct 2016 Data entry January to March 31 2017. collect, review and verify $10,000 fine per day for failure to report.
NEW RATES WILL BE SET BY CMS NATIONALLY NOT GEOGRAPHICAL
LABORATORY BUSINESS DECISIONS
THREE KEY QUESTIONS
1. Should we outsource or sell part or all of our laboratory services?
2. Does a partnership or joint venture with a commercial laboratory make more sense economically?
3. Do we maintain ownership and control of our laboratory services?
Publically Traded Commercial laboratories• MUST GROW BY ACQUISITION TO MAINTAIN
HEALTH PROFIT MARGINS
• MUST SATISFY STOCKHOLDERS
• HOSPITAL LABORATORIES REPRESENT 70% OF THE TOTAL LABORATORY INDUSTRY
Healthcare EnvironmentPopulation Growth 85 million over 65 in 2020.Longer LifespanIncrease intensity of care
Type 2 Diabetes CancerTypes of testing – molecular, proteomicsTypes of care: biologics, cell therapy, wound care
DELIVER MORE CARE BUT KEEP COSTS DOWN
Which of these would be the most effective
countermeasure for falling reimbursement?
A. Decrease labor expenditureB. Decrease consumables expenditureC. Not applicable –neither labor or
consumables expenditure can be decreased.
A. 40%
B. 32.5%
C. 27.5%Those that picked C may already be maximized or a pessimist.
Chemistry Tests
The AU5800 series is the newest addition to Beckman Coulter’s AU chemistry portfolio, representing the highest throughput and fastest chemistry analyzers in the AU family. With true random access capabilities and a throughput ranging from approximately 2,000 tests up to an impressive 9,800 tests per hour, the AU5800 is available in four different scalable models, positioned for the high-volume core hospital laboratory to the ultra-high-test volume commercial laboratory market segments.
Hematology
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS
1988
1988 Law based on AmendmentsMINIMUM requirements for operation of
every laboratory testing facility performing Human tests.
FDA(Federal Drug Administration)Regulates the manufacturers and devices. Defines LDTs(Laboratory
Developed Tests)
CLIA 88 is a Facility Licensure
Mandated that every laboratory must have a CLIA license
or often referred to as a CLIA Number.
This License is applied for at the STATE level which
enforces the Federal Amendments. This License is
based on the Complexity Model and is granted to the
facility based
1) The complexity level of testing.
2) The volume of testing that is performed
under each category
WAIVED TESTING
So simple that if there is a mistake there is no risk to the
patient.
The test is so simple/ minimum steps in the testing method
that there is no risk for error or for making a mistake.
NO PROFICIENCY TESTING REQUIRED BUT YOU
MUST FOLLOW MANUFATURERS GUIDELINES
MODERATE COMPLEX
1. Never a walk away process
2. Control Levels at High, Low and Normal.
3. Documentation of results
4. Procedures
5. NEVER Walk away
6. Requires Judgement and specimen processing
7. Proficiency Testing on all tests from all
laboratorians that are performing tests
HIGH COMPLEXITY
1. Laboratory Developed Testing
2. OFF SCRIPT testing of the Waived Category
3. Proficiency testing
4. All of requirements for Moderate complexity but
increase educational requirements.
IQCP
Individualized Quality Control Plan (IQCP) - Centers for Medicare
Replaces Equivalent Quality Control “Westgard Rules” which was an attempt to simplify quality control.
CAP College of American Pathology
In order to receive CAP accreditationThe laboratory must demonstrate that it operates with the highest standards of quality, accuracy, precision and consistency.
The CAP inspection process investigates several components of the laboratory: 2. assay validation data3. quality management program4. sample tracking procedures5. lab personnel qualifications6. Facilities and safety7. lab is compliant and ready for inspection. 8. The CAP Laboratory Accreditation Process is an internationally recognized
program designed to help clinical labs achieve excellence beyond that which is required for regulatory compliance.
9. Because of its comprehensive nature, the Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority to inspect and accredit clinical laboratories.
Resources Labor most valuable asset Manual versus intellectual effort Manual steps are error-prone Repetitive motion injury “Opportunity cost “What could you be
doing if you weren’t pipetting
ASCP Policy Statement: The Medical Laboratory Personnel Shortage”Highly skilled workers difficult to recruit and retain
Aging labor pool: “Laboratory personnel labor force is aging at a 78 percent faster rate than the entire U.S. Labor Market.
Labor Reagent Equipment mix1991
Equipment and reagents labor
“Laboratory Automation; Trajectory, Technology and Tactics” Markin, RS and Whalen SA Clinical Chemistry 2000;46:764‐771.
1999
equipment and reagents labor
ASCP Vacancy Survey 2015• 525,000 hold BOC certification former
BOR• 16,661 responded to surveyDemographics• 81% Female 19% Male• 75% Caucasian 10% African American 15% otherEducation• 60% BS degree with 60% trained NAACLS program• 10% have Masters• 20% Associate DegreeExperience13.5 years 9.3 years at current title position
Vacancy RateHematology 7%Chemistry 10%Microbiology 8%Blood Bank 12%
EducationMASTERY
Based LearningMINDSET
Grit and perseverance
STATE MEETINGSASCLS-NECLMA- Greater Nebraska ChapterRegional Meetings
Limited CEUs
Flipped Classroom
EVALUATION to measure outcomes
Coaching Reading USA is
ranked #15SCIENCE in USA is
#23Math in USA is #32
HANDS ON EXPERIENCES
Minopro camera and tripod
SPARKS EDUCATIONINTERACTIVE VIDEOS.
EVALUATION OF SITUATION THAT SHOWS LAPSE IN BIOSAFETY.
CRITICAL AND CREATIVE THINKING.
IN DEPTH DISSCUSSION.
SOLVE REAL WORLD PROBLEMS.
SOLVE REAL LABORTORY SAFETY SITUATIONS.
What if don’t have Biosafety Cabinet
AEROSOLS
Questions to ask What is one thing I can do better?
If you were me and had unlimited resources how would I get staff to want to wear gloves?
Affective Domain
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