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