Educational Resources to Improve Waived Testing Practices

(1)

Heat her St ang, MS, MT

Health Scientist

The Division of Laboratory Programs, Standards, and

Services (DLPSS-proposed)

CLIAC

August 21, 2013

The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Educat ional Resources to Improve

Waived Test ing Pract ices

Office of Public Health Scientific Services (OPHSS – proposed)

(2)

Out line



Laboratory Demographics



Educat ional Product Dist ribut ion

(3)

(4)

Number of CLIA Cert ified Laboratories

by Cert ificate Type – 1993-2013

0 50 100 150 200 250 300 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 2012 2013 N u m b e r ( in t h o u s a n d s ) Year

Certificate of Accreditation/Certificate of Compliance Provider performed Microscopy Procedures Certificate Certificate of Waiver

*Data obtained from CMS OSCAR database (08/06/2013)

Numbers include laboratories in CLIA-exempt states of NY and WA.

14.6% 15.9%

(5)

Waived Testing

Measurement Parameter 1993 1998 2003 2008 2011 2013

No. of analytes for which waived test systems are available

9 40 74 84 87 88

No. of waived test

systems* 203 608 1,495 3,228 4,369 6,811

No. of laboratories with a

Certificate of Waiver** 67,294 78,825 102,123 129,219 153,702 166,472 Percentage of laboratories

with a Certificate of Waiver 44% 50% 57% 64% 67% 70%

*Numbers reflect multiple names under which individual tests are marketed and might include waived tests no longer sold. **Numbers include laboratories in CLIA-exempt states of NY and WA.

Source: CDC and FDA CLIA Test categorization databases and CMS On-line Survey, Certification, and Reporting database.

(6)

U.S. Laboratory Demographics, 2013

Laboratory t ypes, all CLIA-Cert ified Laboratories

1

0 20000 40000 60000 80000 100000 120000 Physician Office Laboratory Skilled Nursing/Nursing Facility Hospital and Independent Home Health Agency Outpatient Clinics* Public Health Laboratories Other** 117903 14931 14925 14658 8880 680 67647 Total=239,624

Additional Laboratory Demographics:

333,000 laboratory personnel2

>13 billion tests/year1

>$52 billion/year in laboratory revenues3

1_{Data obtained from CMS OSCAR database, 08/06/2013. OSCAR data are self-reported.}_{Numbers include laboratories in CLIA-exempt states of NY and WA.} 2_{Data obtained from US Department of Labor Bureau of Labor Statistics Occupational Employment Statistics (OES) at}_{http://www.bls.gov/oes/#tables} 3_{Data obtained from}_{http://www.kaloramainformation.com/Clinical-Laboratory-Services-2565239/}

*Community clinic, rural health clinic

**Insurance, pharmacy, tissue bank/repositories, blood banks, ambulance and mobile units, industrial, health fair, ancillary test sites, school/student health service, other not specified.

(7)

Percent age of Test s in Each Category

August 2013

Waived 11% Moderate 71% High 18% 7

(8)

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9

CONTENTS

Introduction……….1

Background………..2

Surveys of Waived Testing Sites………4

Recommended Good Laboratory Practices………..8

Conclusions………19

Acknowledgments………19

References……….19

Terms and Abbreviations Used in this Report………..22 Continuing Education Activity……….CE-1

(10)

To Test

or

Not to Test?

Considerat ions for Test ing



Describes considerations

when beginning to test or

adding a test to your menu



Intended to assist those

who want to initiate or

direct CLIA-waived testing



Contains helpful

information for all

physician offices or

point-of-care settings

(11)

Ready?

Set?

Test!

Assuring t he Qualit y of Test s Performed



Describes recommended

practices for physicians,

nurses, medical assistants,

pharmacists, and others

who perform patient testing

under a CLIA Certificate of

Waiver



Contains tips, reminders,

and resources along with

forms and examples for use

in the testing site

(12)

Ready?

Set?

Test!

Assuring t he Qualit y of Test s Performed

Poster and Postcard

Waived Testing Educational Products Fact Sheet

(13)

Waived Test ing Good Laboratory Pract ice

Product Dist ribut ion

Total Posters Distributed = 4,167 Total Ready? Set? Test! Booklets Distributed = 12,050 Total Postcards Distributed = 17,937 Total To Test or Not To Test? Booklets Distributed = 4,462

0 1000 2000 3000 4000 5000 6000 7000 8000 9000 2010 2011 2012 2013 N um be r of B ook le ts

Posters Postcards Ready? Set? Test! booklet To Test or Not To Test? booklet

(14)

(15)

(16)

Course Overview



Course Goal



To promote reliable, high quality testing and enhance patient

safey by explaining steps of the waived testing process and to

provide the learner with additional resources to assist on the job



Course Object ives:



Ready?

• Identify the basic requirements for performing waived testing.

• Identify at least three good laboratory practices for preparing the laboratory or testing site to produce high quality test results.



Set?

• Select at least two good laboratory practices that assure the right sample type is obtained from the correct patient.

• Identify patient samples that are labeled correctly.



Test?

• Identify at least two good laboratory practices for testing.

• Identify at least two good laboratory practices for recording and reporting results.

(17)

Course Overview



Target Audience:



Nurses, (LPN, RN, NP, Midwife)



Medical Assistants, (MA)



Physicians, (MD, DO, DPM, DDS)



High school graduates or individuals with GED



Emergency Medical Technicians (EMT), paramedics



Clinical Nursing Assistants (CNA) Certified Nursing Assistant (CNA),

Patient Care Assistant (PCA), State Tested Nurse Aid (STNA) or

Nursing Assistant-Registered (NA/R)



Pharmacists



Physician Assistants, (PA)



Phlebotomists or others



CE Credit



CME and CNE offers 1.0



CEU, CE and CPE offers 0.1

(18)

Course Feat ures



Knowledge check quest ions t hroughout t he course to

reinforce learning



Templates, checklist s, resources to save/download

(19)

http://wwwn.cdc.gov/clia/Resources/WaivedTests/

Ready? Set? Test! Online Course Participation

(Nov 2011—July 2013)

Ready? Set? Test! Credit Type(s) Awarded: 0.1 CEU/CE; 1 CME; 1 CNE Contact Hours; 0.1 Pharmacist Contact Hours

Tot al Registered 1843

Completed 1604 In Progress 222

Withdrawn 17

Credit Type Tot al Hours Awarded

CEU/CE 79.2

CME 84

CNE Contact Hours 288 Pharmacists Contact Hours 1.6

(20)

Course Evaluat ion

0% 20% 40% 60% 80%

The content and learning materials addressed a need or gap in my knowledge or skills

The difficulty level was appropriate The length and pace of the activity was appropriate Feedback I received during the activity was helpful The content experts demonstrated expertise in the

subject matter

The delivery method used helped me learn the content The instructional strategies helped me learn the

content

The learning environment was conducive to learning This activity effectively met my educational needs

(21)

Course Evaluat ion

0% 10% 20% 30% 40% 50% 60% 70% If given an opportunity, I can apply the knowledge gained

as a result of this activity

I can identify the basic requirements for performing waived testing

I can identify three or more good laboratory practices to prepare my laboratory or testing site to produce high

quality test results

I can identify at least two good laboratory practices to ensure the right sample type is obtained from the correct

patient

I can identify properly labeled patient samples I can identify at least two good laboratory practices for

testing

I can identify at least two good laboratory practices for recording and reporting results

The content was relevant to the learning objectives

(22)

Comment s from Part icipant s

 It is really helful and very organized. I liked t he met hod used to give us

t he necessary tools and t he websites to clearly underst and t he content.

 Much more educat ional t han I expected. I will direct st aff nurses to t his

website in t he fut ure.

 The material was excellent. It helped me underst and why we did all t he document at ion of lot numbers, expirat ion dates, etc. I realize t he

import ance of all of our procedures now.

 Wonderful refresher for me. I could not explain QC,waived test ing any

bet ter!

 I am going to make t his a mandatory course for all of my st aff who perform CLIA waived test s.

 I believe t he course has helped me ident ify areas in t he performance of Waived Test ing procedures t hat I should emphasize in t raining st aff.

 Content was simply explained and feedback kept my interest.  Excellent course will require all Medical Assit ant s to t ake t his test.  I took t his course to evaluate it s potent ial use in t raining st aff at my

(23)

Summary



Part icipant s achieved course object ives



The educat ional value was appreciated by t he high

number of posit ive comment s



Suggest ions for improving course:



Allow for the ability to bookmark the course and return at a later

time to complete (updated course to include the bookmark

feature on June 2012)



Improve course navigation especially pop-up boxes



Increase CE credit

(24)

Acknowledgement s



Clinical Laboratory Improvement Advisory Commit tee



Waived Test ing Workgroup



Centers for Medicare & Medicaid Services



Division of Laboratory Services



Food and Drug Administ rat ion



Office of In-Vit ro Diagnost ic Device Evaluat ion and Safet y



Centers for Disease Cont rol and Prevent ion

(25)

Office of Public Health Scientific Services (OPHSS – proposed)

Center for Surveillance, Epidemiology and Laboratory Services (CSELS – proposed)

Waived Testing materials:

ht t p://wwwn.cdc.gov/clia/Resources/WaivedTest s/

For questions, comments, or to obtain free copies of waived testing materials,

contact us: email - [email protected]

phone - 404-498-2290

Contact information: Heather Stang 404-498-2769

[email protected]