IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES...

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COLA’S FALL 2019 www.cola.org IN THIS ISSUE: Letter From the Chair Combating The Opioid Epidemic: $_; vv;mঞ-Ѵ Role of the Laboratory Urine Drug Screens for Monitoring Opioid Therapy Strategic Laboratory Partnership: Team Fight Against the Opioid Epidemic Patient Empowerment Through Patient Education Laboratory Developed Tests and FDA Regulation Education For Your Patients About Their Laboratory Tests

Transcript of IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES...

Page 1: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

COLA’S FALL 2019

www.cola.org

IN THIS ISSUE:Letter From the Chair

Combating The Opioid Epidemic: $_;��vv;mঞ-Ѵ�Role of the Laboratory

Urine Drug Screens for Monitoring Opioid Therapy

Strategic Laboratory Partnership: Team Fight Against the Opioid Epidemic

Patient Empowerment Through Patient Education

Laboratory Developed Tests and FDA Regulation

Education For Your Patients About Their Laboratory Tests

Page 2: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

© COLA 2019ALL RIGHTS RESERVED

COLA INFORMATION RESOURCE CENTER: 800.981.9883

LETTER FROM THE CHAIR

This issue of COLA Insights is devoted to discussing the increasingly central role of the laboratory in addressing the very serious opioid ;rb7;lb1�|_-|�1omঞm�;v�|o��ouv;m�7�;�|o�|_;�bm|uo7�1ঞom�-m7�ruoѴb=;u-ঞom�o=�v�m|_;ঞ1�-m-Ѵo]�;vĺ���ou;�|_-m�ƐƒƏ�r;orѴ;�r;u�7-��-u;�7�bm]�7�;�|o�v�m|_;ঞ1�orbob7�o�;u7ov;vķ�-m7�Ѵ-0ou-|ou��|;vঞm]�_oѴ7v�|_;�h;��|o�;@;1ঞ�;�b7;mঞC1-ঞomķ�|u;-|l;m|ķ�-m7�ru;�;mঞom�strategies.

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COLA’S inSIGHTS FALL 2019

Page 3: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

Combating the Opioid Epidemic: The Essential Role of the Laboratory

INTRODUCTION:

THE NEED TO MONITOR OPIOID DRUG THERAPY

Understanding the Opioid Epidemic

This rise in opioid overdose deaths can be outlined in three distinct waves :

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&ubm;�7u�]�v1u;;mv�Ő&"ő�-u;�o[;m�-�r-u|�o=�|_bv�lomb|oubm]�v|u-|;]�ĺ�$_;�u;v�Ѵ|v�o=�&"�ruo�b7;�;�-Ѵ�-ঞom�o=�1olrѴb-m1;��b|_�|_;�-]u;;7Ŋ�rom�|u;-|l;m|�rѴ-mĺĺ��)_bѴ;�|_;v;�|;v|v�1-m�u-rb7Ѵ��7b-]mov;�u;Ѵ-rv;�ou�7u�]�lbv�v;ķ�|_;�u;v�Ѵ|v�1-m�-Ѵvo�0;��v;7�|o�-7�o1-|;�=ou�|_;�r-ঞ;m|��b|_�|_bu7Ŋr-u|��bm|;u;v|vĺ���$_;�r�urov;�o=�&"�v_o�Ѵ7�0;�;�rѴ-bm;7�|o�|_;�r-ঞ;m|�-|�|_;�bmbঞ-Ѵ�;�-Ѵ�-ঞomĺ�&"�1-m�-Ѵvo�;m_-m1;�|_;�u;Ѵ-ঞomv_br�0;|�;;m�_;-Ѵ|_1-u;�ruo=;vvbom-Ѵv�-m7�r-ঞ;m|v�0��ruo�b7bm]�7o1�l;m|-ঞom�o=�-7_;u;m1;�|o�l�|�-ѴѴ��-]u;;7Ŋ�rom�|u;-|l;m|�rѴ-mv�ĺ

TESTING STRATEGIES Urine Drug Screens: Utilized by Physician Office Laboratories / Point of Care Testing

CONTINUED ON PAGE 4

COLA Technical Assistance 800.981.9883 www.cola.org www.COLAcentral.com

The !rst wave began with increased prescribing of opioids in the 1990s, with overdose deaths involving prescription opioids (natural and semi-synthetic opioids and methadone) increasing since at least 1999.

The second wave began in 2010, with rapid increases in overdose deaths involving heroin.

The third wave began in 2013, with signi!cant increases in overdose deaths involving synthetic opioids, particularly those involving illicitly-manufactured fentanyl (IMF). The IMF market continues to change, and IMF can be foundin combination with heroin, counterfeit pills, and cocaine.

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Page 4: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

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&ubm;�l-��-Ѵvo�1om|-bm�_b]_;u�Ѵ;�;Ѵv�o=�7u�]�l;|-0oѴb|;v�|_-m�0Ѵoo7ķ�ruo�b7bm]�=�u|_;u�;�b7;m1;�o=�7u�]��v;ĸ�

Mass spectrometry Testing (MS): Confirmatory Toxicology laboratories

Point-of-care urine drug screening has several advantages …

CONTINUED ON PAGE 5

COLA’S inSIGHTS FALL 2019

!;Ѵb-m1;�om�-m�bll�mo-vv-��|;v|ķ��_b1_�omѴ��7;|;1|v�1Ѵ-vv;v�o=�7u�]vķ��bѴѴ�Ѵblb|�|_;�m�l0;u�o=�7u�]v�7;|;1|;7ĺ� ou�;�-lrѴ;ķ�vol;�orbob7vķ�v�1_�-v�=;m|-m�Ѵķ�0�ru;mour_bm;ķ�|-r;m|-7oѴķ�-m7�|u-l-7oѴķ�-u;�mo|�uo�ঞm;Ѵ��7;|;1|;7ĸ�

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�-m�ruo7�1;�=-Ѵv;�rovbঞ�;�u;v�Ѵ|v�7�;�|o�1uovvŊu;-1ঞ�b|���b|_�v|u�1|�u-ѴѴ��u;Ѵ-|;7�-m7�o|_;u�1olro�m7v�=uol�ru;v1ubrঞomvķ�_;u0-Ѵ�1olro�m7v�-m7�o�;uŊ|_;Ŋ1o�m|;u�7u�]vķ�ou�=-Ѵv;�m;]-ঞ�;�u;v�Ѵ|v�7�;�|o�Ѵ-1h�o=�u;-1ঞ�b|���b|_�m;�;uķ�;l;u]bm]�mo�;Ѵ�rv�1_o-1ঞ�;�v�0v|-m1;vķ�-ѴѴ�o=��_b1_�1-m�u;v�Ѵ|�bm�roou�r-ঞ;m|�1-u;�-m7�bm1ouu;1|�7-|-�|_-|�vh;��m-ঞom-Ѵ�v|-ঞvঞ1vĺ�

�obm|Ŋo=Ŋ1-u;�|;vঞm]�7o;v�mo|�7;|;1|�|_;�ru;v;m1;�o=�-Ѵ1o_oѴ�ou�b|v�l;|-0oѴb|;v�bm�|_;��ubm;ķ�-m7�vbm1;�lb�bm]�ru;v1ub0;7�l;7b1-ঞomv��b|_�-Ѵ1o_oѴ�bv�om;�o=�|_;�lov|�1ollom�1-�v;v�o=��mbm|;mঞom-Ѵ�o�;u7ov;ķ�|_bv�bm=oul-ঞom�bv��;u��blrou|-m|�|o�|_;�ru;v1ub0;uĺ�

…but there are also significant disadvantages to point-of-care urine drug screen testing :

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Page 5: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

Building Strategic Partnerships

COLA Technical Assistance 800.981.9883 www.cola.org www.COLAcentral.com

LABORATORY LEADERSHIP:

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Alternatively, the more complex MS testing offers the following advantages :

1

Enabling data sharing:-vv;l0Ѵ;�v|-h;_oѴ7;uv�|o��m7;u|-h;�-�=oul-Ѵ�7bv1o�;u��ruo1;vv�|o�7;|;ulbm;�1ou;�;Ѵ;l;m|v�o=�-�7-|-�v_-ubm]�v|u-|;]��|o�bm=oul�r�0Ѵb1�_;-Ѵ|_�-m7�v�u�;bѴѴ-m1;�;@ou|vĸ

2

Fostering collaboration: �;�;u-];�;�bvঞm]�u;Ѵ-ঞomv_brv�-m7�1-|-Ѵ��;�m;��r-u|m;uv_brv�|o�1oѴѴ;1ঞ�;Ѵ��-77u;vv�|_;�-77b1ঞom�-m7�orbob7�;rb7;lb1�-m7�;mv�u;�|_;�bm1Ѵ�vbom�o=�|o�b1oѴo]��Ѵ-0ou-|ou��;�r;u|vĺ

3

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Page 6: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

INTRODUCTION :A11ou7bm]�|o�-m�;�b7;m1;Ŋ0-v;7�-vv;vvl;m|�0��|_;��l;ub1-m�"o1b;|��o=��m|;u�;mঞom-Ѵ��-bm��_�vb1b-mv�Ő�"���őķ�-rruo�bl-|;Ѵ��om;�|_bu7�o=�1_uomb1�r-bm�r-ঞ;m|v�7o�mo|��v;�orbob7v�-v��ru;v1ub0;7�ou�l-��-0�v;�|_;lĺ���ou;o�;uķ�v|�7b;v�_-�;�=o�m7�|_-|�-�v�0v|-mঞ-Ѵ�ruorouঞom�o=�1_uomb1�r-bm�r-ঞ;m|v�bm-11�u-|;Ѵ��u;rou|�momŊ-7_;u;m1;�|o�ru;v1ub0;7�l;7b1-ঞomv�-m7��v;�o=�bѴѴb1b|�7u�]vĺ�

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T_;v;�|;v|v�1-m�0;�r;u=oul;7�;b|_;u�bm�-�Ѵ-0ou-|ou��ou�-|�robm|�o=�v;u�b1;ĺ��ll�mo-vv-��|;v|v�-u;�0-v;7�om�|_;�rubm1brѴ;�o=�1olr;ঞঞ�;�0bm7bm]�-m7��v;�-mঞ0o7b;v�|o�7;|;1|�-�r-uঞ1�Ѵ-u�7u�]ķ�7u�]�1Ѵ-vv�ou�7u�]�l;|-0oѴb|;�bm�-��ubm;�v-lrѴ;ĺ�)b|_�1olr;ঞঞ�;�0bm7bm]ķ�-�C�;7�-lo�m|�o=�-�Ѵ-0;Ѵ;7�7u�]�bv�-77;7�|o�|_;��ubm;�v-lrѴ;ķ�-m7�|_;�7u�]�ou�l;|-0oѴb|;�bm�|_;�v-lrѴ;�1olr;|;v��b|_�|_;�Ѵ-0;Ѵ;7�7u�]�=ou�0bm7bm]�vb|;v�om�|_;�-mঞ0o7�ĺ�$_;�-lo�m|�o=�Ѵ-0;Ѵ;7�-mঞ];m�|_-|�0bm7v��b|_�|_;�-mঞ0o7��bv�bm�;uv;Ѵ��ruorouঞom-Ѵ�|o�|_;�-lo�m|�o=�|_;�7u�]ķ�7u�]�1Ѵ-vv�ou�l;|-0oѴb|;�bm�|_;�v-lrѴ;ĺ

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Immunoassay TestingQualitative Screening

CONTINUED ON PAGE 7

COLA’S inSIGHTS FALL 2019

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Urine Drug Screens:Monitoring Opioid Therapy

Page 7: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

THE POSSIBILITIES OF FALSE NEGATIVE AND FALSE POSITIVE RESULTS :

!-bvbm]�ou�Ѵo�;ubm]�|_;�|_u;v_oѴ7�|_�v�1_-m];v�|_;�ruorouঞom�o=�rovbঞ�;�|;v|vĺ���m;]-ঞ�;�|;v|�bv�bm|;uru;|;7�-v�-�Ѵ;�;Ѵ�0;Ѵo��|_;�|_u;v_oѴ7�-m7�7o;v�mo|�m;1;vv-ubѴ��l;-m�|_-|�|_;�7u�]�ou�l;|-0oѴb|;�bv�-0v;m|ĺ��ll�mo-vv-�v�];m;u-ѴѴ��_-�;�-�u-rb7�|�um-uo�m7�ঞl;ķ��b|_bm�lbm�|;v�=ou�omvb|;�|;v|v�-m7�Ɛ�|o�Ɠ�_o�uv�=ou�Ѵ-0ou-|ou�Ŋ0-v;7�|;v|vĺ�

�$_;u;�-u;��-ubo�v�-rruo-1_;v�|o�bm1ourou-ঞm]�&"�bm|o�r-bm�l-m-];l;m|�-m7�|u;-|l;m|�v;মm]vĺ��ov|�1ollomѴ�ķ�r-ঞ;m|v��m7;u]o�&"�0;=ou;�0;]bmmbm]�|u;-|l;m|�|o��;ub=��|_;�v|-|;�o=�1�uu;m|�7u�]��v;ĺ�"ol;�1Ѵbmb1b-mv�0;Ѵb;�;�|_-|�&"�v_o�Ѵ7�0;�uo�ঞm;Ѵ���v;7�|o�;v|-0Ѵbv_�0-v;Ѵbm;�bm=oul-ঞom�-0o�|�v�0v|-m1;��v;ķ�0�|�|_;�orঞl-Ѵ�=u;t�;m1��-m7�bm|;u�-Ѵ�o=�|;vঞm]�u;l-bmv��m1;u|-bmĺ����mb�;uv-Ѵ�-rruo-1_�|o�v1u;;mbm]�l-���m1o�;u�lou;�bm-rruorub-|;��v;�-m7�l-��u;7�1;�r-ঞ;m|vĽ�v;mv;�|_-|�|;vঞm]�bv�0;bm]�r;u=oul;7�7�;�|o�-�Ѵ-1h�o=�|u�v|ĺ��m�-Ѵ|;um-ঞ�;�-rruo-1_�bv�v;Ѵ;1ঞ�;�|;vঞm]�o=�r-ঞ;m|v��_o�-u;�-|�bm1u;-v;7�ubvh�=ou�7u�]�lbv�v;ĺ�

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Urine Drug ScreensConsiderations of the length of time opioids may be detected in urine :

CONTINUED ON PAGE 8

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Possible reasons for false negative results:

AѴ|_o�]_�bll�mo-vv-�v�-u;��;u��v;mvbঞ�;�|o�|_;�ru;v;m1;�o=�7u�]v�-m7�7u�]�l;|-0oѴb|;vķ�vr;1bC1b|��-m7�-11�u-1���-ub;v�7;r;m7bm]�om�|_;�-vv-���v;7�-m7�|_;�v�0v|-m1;�=ou�7;|;1ঞomĺ�$_bv�Ѵblb|-ঞom�l-��u;v�Ѵ|�bm�=-Ѵv;Ŋrovbঞ�;v�=uol�v�0v|-m1;v�1uovvŊu;-1ঞm]��b|_�|_;�bll�mo-vv-�ĺ��

�-m��ru;v1ubrঞom�-m7�momru;v1ubrঞom�v�0v|-m1;v�_-�;�0;;m�u;rou|;7�|o�1uovvŊu;-1|��b|_�bll�mo-vv-�v�-m7�1-�v;�=-Ѵv;Ŋrovbঞ�;vĺ��ov|�_-�;�omѴ��0;;m�7o1�l;m|;7�bm�1-v;�u;rou|vĺ�$_;�=u;t�;m1��o=�=-Ѵv;Ŋrovbঞ�;v��-ub;vķ�7;r;m7bm]�om�|_;�vr;1bC1b|��o=�bll�mo-vv-���v;7�-m7�|_;�v�0v|-m1;�7;|;1|;7ĺ�

Possible reasons for false positive results:

A�rovbঞ�;�bmbঞ-Ѵ�7u�]�v1u;;mbm]�l;-mv�|_-|�|_;�r;uvom�|;v|;7�_-v�-�v�0v|-m1;�bm�_bv�ou�_;u�0o7��|_-|�=-ѴѴv�bm|o�om;�o=�|_;�7u�]�1Ѵ-vv;v�-m7�bv�-0o�;�|_;�;v|-0Ѵbv_;7�1�|o@�Ѵ;�;Ѵĺ��=�1omCul-|ou��|;vঞm]�ruo�b7;v�-�rovbঞ�;�u;v�Ѵ|ķ�b|�l;-mv�|_-|�|_;�r;uvom�_-v�bm7;;7�|-h;m�|_bv�7u�]ĺ���m�vol;�1-v;vķ�|_bv�u;v�Ѵ|�bm7b1-|;v�-��bm7o��o=�ঞl;�bm��_b1_�|_;�r;uvom�|ooh�|_;�v�0v|-m1;�-m7�b|v�-rruo�bl-|;�t�-mঞ|�ķ�0�|�bm�lov|�1bu1�lv|-m1;vķ�|_-|�bm=oul-ঞom�bv�mo|�m;1;vv-u�ĺ��m|;uru;|-ঞom�o=��_;m�-m7�_o��l�1_�7u�]��-v�1omv�l;7�1-m�0;�1_-ѴѴ;m]bm]�0;1-�v;�|_;�1om1;m|u-ঞom�o=�l-m��7u�]v��-ub;vķ�-v�7o�r;orѴ;ŝv�u-|;v�o=�l;|-0oѴbvlĺ

�=�|;vঞm]�u;�;-Ѵv�mo�7u�]vķ�ou�7u�]v�bm�-lo�m|v�0;Ѵo��|_;�;v|-0Ѵbv_;7�1�|o@vķ�|_;m�|_;�u;v�Ѵ|v�-u;��v�-ѴѴ��u;rou|;7�-v�Şmo|�7;|;1|;7Ş�ou�Şmom;�7;|;1|;7ĺŞ���m;]-ঞ�;�u;v�Ѵ|�7o;v�mo|�m;1;vv-ubѴ��l;-m�|_-|�|_;�r;uvom�7b7�mo|�|-h;�-�7u�]�-|�vol;�robm|ĺ�$_;�7u�]�l-��0;�ru;v;m|�0�|�0;Ѵo��|_;�;v|-0Ѵbv_;7�1�|o@ķ�|_;�7u�]�l-��_-�;�0;;m�-Ѵu;-7��l;|-0oѴb�;7�-m7�;Ѵblbm-|;7�=uol�|_;�0o7�ķ�ou�|_;�|;v|�l;|_o7�7o;v�mo|�7;|;1|�|_;�r-uঞ1�Ѵ-u�7u�]�ru;v;m|�bm�|_;�v-lrѴ;ĺ

�m�v_ou|ķ�|_;�blrou|-m1;�-m7�blr-1|�o=��ubm;�7u�]�v1u;;m�u;v�Ѵ|v�om�|_;�Ѵb=;�o=�|_;�bm7b�b7�-Ѵ�|;v|;7�u;t�bu;v�-�_;b]_|;m;7�-�-u;m;vv�o=�0o|_�|_;�v|u;m]|_v�-m7�Ѵblb|-ঞomv�o=�|_;�l;|_o7oѴo]b;v��v;7ĺ

Reporting the Test Result

Tampering: $;|u-_�7uo�oѴbm;�Ő;�;�7uorvő

�Ѵ;-1_�

(bm;]-u�

"o-r�

�llomb-�

�;lom�f�b1;�

u-bm�1Ѵ;-m;u�

$-0Ѵ;�v-Ѵ|�

Codeine

Heroin (morphine)

Hydromorphone

Methadone

Morphine

Oxycodone

Propoxyphene

48 hours

2 to 4 days

2 to 4 days

3 days

48 to 72 hours

2 to 4 days

6 to 48 hours

OPIATES DETECTION

iv

v

vi

Page 8: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

DEALING WITH UNEXPECTED URINE TOXICOLOGY RESULTS &"�bm�1Ѵbmb1-Ѵ�ru-1ঞ1;�l�v|�0;��v;7�|o�lomb|ou�-m7�blruo�;�r-ঞ;m|�1-u;ĺ�&m=ou|�m-|;Ѵ�ķ�|_;v;�|;v|�u;v�Ѵ|v�l-��1ol;�0-1h��m;�r;1|;7Ѵ��m;]-ঞ�;�=ou�-�ru;v1ub0;7�7u�]�ou�rovbঞ�;�=ou�-m��mru;v1ub0;7�om;ĺ�$_;�Cuv|�v|;r�bm�bm|;uru;ঞm]�|_;v;�u;v�Ѵ|v�bv�|o�1om|-1|�|_;�Ѵ-0�|o�;mv�u;�|_-|�mo�1Ѵ;ub1-Ѵ�;uuouv�_-�;�0;;m�l-7;ĺ��=��m;�r;1|;7�u;v�Ѵ|v�-u;�1omCul;7ķ�|_;u;�l�v|�0;�-�ruo1;vv�bm�rѴ-1;�|_-|�v_o�Ѵ7�bm1Ѵ�7;�7bv1�vvbm]�|_;��m;�r;1|;7�u;v�Ѵ|��b|_�|_;�r-ঞ;m|ĺ

Advantages of Urine Drug Screens �omŊbm�-vb�;�lrѴ;��oѴ�l;u�]v�-m7�7u�]�l;|-0oѴb|;v�=o�m7�bm��ubm;�-u;��v�-ѴѴ��v|-0Ѵ;u�]v�-m7�|_;bu�l;|-0oѴb|;v�-u;�o[;m�ru;v;m|�bm�_b]_;u 1om1;m|u-ঞomv�bm��ubm;�|_-m�bm�o|_;u�0boѴo]b1-Ѵ�l-|;ub-Ѵv;|;1|-0Ѵ;�bm��ubm;�=ou�u;Ѵ-ঞ�;Ѵ��Ѵom]�r;ubo7�o=�ঞl;�u;v;m1;�o=�l;|-0oѴb|;v�Őbm�-77bঞom�|o�r-u;m|�7u�]ő�ruo�b7;v =�u|_;u�;�b7;m1;�o=�7u�]��v;!;-7bѴ��ru;v;u�;7�0��u;=ub];u-ঞom�ou�=u;;�bm]�m-Ѵ�vbv�u;Ѵ-ঞ�;Ѵ��vblrѴ;�0;1-�v;�o=�-0v;m1;�o=�ruo|;bmv�-m7 1;ѴѴ�Ѵ-u�l-|;ub-Ѵ�bm��ubm;)b7;�-�-bѴ-0bѴb|��o=�1oll;u1b-Ѵ�u;-];m|v�-m7�-m-Ѵ�ঞ1-Ѵ�v�v|;lv

Disadvantages of Urine Drug Screens u�]�Ѵ;�;Ѵv�bm��ubm;�7o�mo|�1ouu;Ѵ-|;��;ѴѴ��b|_�Ѵ;�;Ѵv�bm�o|_;u�0o7��Y�b7vu�]�Ѵ;�;Ѵv�l-���-u���b7;Ѵ��7;r;m7bm]�om�Y�b7�bm|-h;ķ��ob7bm]�r-�;umķ�-m7�ঞl;�;Ѵ-rv;7�vbm1;��7u�]�bm|-h;&ubm;�7u�]�;�1u;ঞom�1omঞm�;v�-[;u�r_�vboѴo]b1�;@;1|�o=�|_;�7u�]�1;-v;vķ�u;v�Ѵঞm]�bm�Ѵ-1h�o=�1ouu;Ѵ-ঞom�o=�7u�]�Ѵ;�;Ѵ��b|_�bm|o�b1-ঞom�-��0;�7bL1�Ѵ|�|o�o0|-bm�vr;1bl;m�b=�|;v|�v�0f;1|�1-mmo|��ob7�&ubm;�vr;1bl;mv�-u;�;-vbѴ��v�0vঞ|�|;7ķ�7bѴ�|;7ķ�ou�-7�Ѵ|;u-|;7bu;1|�o0v;u�-ঞom�o=��ubm;�1oѴѴ;1ঞom�l-��0;�-m�bm�-vbom�o=�rub�-1�&ubm;�l-��0;��mv|-0Ѵ;�b=�mo|�ruor;uѴ��_-m7Ѵ;7�-m7�v|ou;7

CONTINUED ON PAGE 9

COLA’S inSIGHTS FALL 2019

!;r;-|�&ubm;�u�]�$;vঞm]�u;]�Ѵ-uѴ�ĸ�

�om7�1|�1omCul-|ou��|;vঞm]�vr;1b=�bm]�|_;�7u�]�o=�bm|;u;v|�(e.g., Oxycodone often missed by immunoassay);

$-h;�-�7;|-bѴ;7�_bv|ou��o=�|_;�r-ঞ;m|Ľv�l;7b1-ঞom��v;�=ou�|_;�ru;1;7bm]�ƕ�7-�v��Ő;ĺ]ĺķ�1o�Ѵ7�Ѵ;-um�|_-|�|_;�r-ঞ;m|�u-m�o�|�v;�;u-Ѵ�7-�v�rubou�|o�|_;�|;v|ĸ�

�vh�r-ঞ;m|�b=�|_;��_-�;�]b�;m�|_;�7u�]�|o�o|_;uvĸ�

�omb|ou�1olrѴb-m1;��b|_�rbѴѴ�1o�m|v

-Ѵv;�m;]-ঞ�;�

�omŊ1olrѴb-m1;�

b�;uvbom

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$;v|�bv�m;]-ঞ�;�=ou�ru;v1ub0;7�orbob7

!;r;-|�&ubm;�u�]�$;vঞm]�u;]�Ѵ-uѴ�ĸ�

�vh�r-ঞ;m|v�b=�|_;��-11;vv;7��rbob7v�=uol�o|_;u�vo�u1;vĸ� �vv;vv�=ou��rbob7�lbv�v;�ņ�-77b1ঞomĸ�

!;�b;��ņ�!;�bv;�$u;-|l;m|��]u;;l;m|

-Ѵv;�rovbঞ�;�

�-ঞ;m|�-1t�bu;7�orbob7v�=uol�o|_;u�vo�u1;v�v�1_�-v�=uol�-mo|_;u�r_�vb1b-m�ou�=uol�-m�bѴѴb1b|�vo�u1;

�bvb7;mঞC1-ঞom�o=�|_;�r-ঞ;m|�ou�vr;1bl;m

$;v|�bv�rovbঞ�;�=oumom�ru;v1ub0;7�orbob7�ou�0;m�o7b-�;rbm;v

!;r;-|�&ubm;�u�]�$;vঞm]�u;]�Ѵ-uѴ�ĸ�

�vv;vv�=ou�-0�v;�ņ�-77b1ঞom�-m7�u;=;u�=ou�-77b1ঞom�|u;-|l;m|�-v�-rruorub-|;

-Ѵv;�rovbঞ�; �-ঞ;m|�bv�o11-vbom-Ѵ��v;u�ou�-77b1|;7�|o�|_;�bѴѴb1b|�7u�]

�-mm-0bv�bv�rovbঞ�;�=ou�r-ঞ;m|v�|-hbm]�1;u|-bm�l;7b1-ঞomv�Ő;ĺ]ĺķ�7uom-0bmoѴő

�bvb7;mঞC1-ঞom�o=�|_;�r-ঞ;m|�or vr;1bl;m

&"�rovbঞ�;�=ou�bѴѴb1b|�7u�]v�Ő;ĺ]ĺķ�1o1-bm;ő

Unexpected Result Possible Explanation Possible Actions for the Physician

ix

vii viii

Page 9: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

CONCLUSION U"�bv�-m�;@;1ঞ�;�|ooѴ�bm�|_;�-vv;vvl;m|�-m7�om]obm]�l-m-];l;m|�o=�r-ঞ;m|v��_o��bѴѴ�0;ķ�ou�-u;�0;bm]ķ�|u;-|;7�=ou�1_uomb1�r-bm��b|_�orbob7�|_;u-r�ĺ��ov|�blrou|-m|Ѵ�ķ�-�_;-Ѵ|_1-u;�ruo=;vvbom-Ѵ�v_o�Ѵ7�_-�;�-�u;Ѵ-ঞomv_br�o=�l�|�-Ѵ�_om;v|��-m7�|u�v|��b|_�|_;�r-ঞ;m|��_;m��vbm]�&"�bm�|_;�1Ѵbmb1-Ѵ�ru-1ঞ1;ķ�-m7�v_o�Ѵ7�l-bm|-bm�or;m�1oll�mb1-ঞom��b|_�|_;�|;vঞm]�Ѵ-0ou-|ou�ĺ����t�-Ѵb|��&"�ruo]u-l�bv�bm|;m7;7�|o�blruo�;�r-ঞ;m|�_;-Ѵ|_�-m7�v-=;|�ķ�-m7�|o�-vvbv|�_;-Ѵ|_1-u;�ruo=;vvbom-Ѵv�-v�|_;��-7�o1-|;�om��0;_-Ѵ=�o=�|_;bu�r-ঞ;m|v�ĺ��

COLA Technical Assistance 800.981.9883 www.cola.org www.COLAcentral.com

��&ubm;�u�]�$;vঞm]�bm��-bm��-m-];l;m|�-m7�"�0v|-m1;��0�v;�$u;-|l;m|ĺ��-1h]uo�m7ĺ��ourou-|;��;7b1-Ѵ��oѴb1�ĺ��Ѵ�;��uovvņ�Ѵ�;�"_b;Ѵ7�o=�(;ulom|ĺ���@;1ঞ�;��1|o0;u�ƑƐķ�ƑƏƐѵĺ��_�rĹņņ���ĺ010v�|ĺ1olņ�rvņ�1lņ1omm;1|ņƖ;0Ѷ--=1ŊƓƔѵƑŊƓƖƐ=ŊƖ0ѵ;Ŋƒ=7Ə70Ɛ1Ɛ0ѵƏņ�7|ŊbmŊr-bmŊl-m-];l;m|Ŋ-m7Ŋorbob7Ŋ-0�v;Ŋ|u;-|l;m|Ŋl;7ŊroѴb1�ŊƑƏƐѵĺr7=ĵlo7Ʒ-fr;u;v

��u�]vĺ1olĺ��u�]�|;vঞm]� � vĺ�_�rĹņņ���ĺ7u�]vĺ1olņ-uঞ1Ѵ;ņ7u�]Ŋ|;vঞm]ĺ_|lѴ

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��&ubm;�u�]�$;vঞm]Ĺ��rruo-1_;v�|o�"1u;;mbm]�-m7��omCul-ঞom�$;vঞm]ĺ���b@ou7���lķ���-m7��-uu����v_Ѵbmķ���ĺ��-0ou-|ou���;7b1bm;ĺ����m;�ƑƏƏƓĺ��oĺѵ�(ĺ�ƒƔĺ�_�rvĹņņ���ĺv;l-mঞ1v1_oѴ-uĺou]ņr-r;uņ&ubm;Ŋu�]Ŋ$;vঞm]ѷƒ�Ŋ�rruo-1_;vŊ|oŊ"1u;;mbm]Ŋ-m7Ŋ��lŊ��v_ѴbmņƓƏƕ7;ѶƖƖ-ƒƐƔƖ11ƕ1Ɛ-0Ɣ-1ƏƓѵѶƒƖѵƒƓ7Ѷ0=ƐѵƔ0

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���_bѴovor_��o=�&ubm;�u�]�$;vঞm]�bm��-bm��-m-];l;m|ĺ��;b|ķ��ķ�-m7��o�uѴ-�ķ�ĺ����u;v1ub0;�!;vromvb0Ѵ�ĺ���Ѵ��Ƒķ�ƑƏƐƔĺ�������_�rvĹņņ���ĺl;7b1-Ѵ7bvrov-0Ѵ;vĺ�vņ�_bѴovor_�Ŋo=Ŋ&ubm;Ŋu�]Ŋ$;vঞm]ŊbmŊ�-bmŊ�-m-];l;m|Ŋ�Ѵbmb1vŊvņƐѶƒƕĺ_|l

Referencesi

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Page 10: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

CONTINUED ON PAGE 10

COLA’S inSIGHTS FALL 2019

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Strategic Laboratory Partnerships: Team Fight Against the Opioid Epidemic

Strategic Partnerships Between Laboratories and Healthcare Providers, Public Health Agencies, and Law Enforcement are Vital in the Fight Against the Synthetic

Opioid Epidemic

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iii

Page 11: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

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LABORATORY TESTING FOR SYNTHETIC OPIOIDS

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The Limitations of Immunoassay Drug Screens

PUBLIC HEALTH AND SAFETY PARTNERSHIPS

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Opioid Surveillance for Monitoring Patterns of Use and Prevalence

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Increased Collaboration

Mass Spectrometry and Laboratory Developed Testing

CONTINUED ON PAGE 12

COLA Technical Assistance 800.981.9883 www.cola.org www.COLAcentral.com

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Page 12: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

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Recommendations by the American Association for Clinical Chemistry (AACC)

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Laboratories and the Healthcare Community

COLA’S inSIGHTS FALL 2019

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Congress & Federal Agencies

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CONCLUSION

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Referencesi

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Page 13: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

Patient Empowerment Through Patient Education

INTRODUCTION:�v�|_;�_;-Ѵ|_1-u;�bm7�v|u��1omঞm�;v�|o�u;Ŋ;m]bm;;u�|_;�7;Ѵb�;u��o=�_;-Ѵ|_1-u;�v;u�b1;v�bm�u;vromv;�|o�u-rb7�|;1_moѴo]b1-Ѵ�1_-m];ķ�m;��]o�;uml;m|�u;]�Ѵ-ঞomvķ�-m7�m;��u;bl0�uv;l;m|�lo7;Ѵvķ�ruo�b7;uv�-u;�u;1o]mb�bm]�|_;�m;;7�=ou�m;��-rruo-1_;v�|o�_;-Ѵ|_1-u;�l-m-];l;m|ķ�-m7�|_;�m;;7�=ou�bm1u;-vbm]�r-ঞ;m|vĽ�;m]-];l;m|�bm�|_;bu�o�m�1-u;ĺ�$_;�Ѵ-0ou-|ou��ruo=;vvbomķ�u;Y;1ঞm]�|_;v;�1_-m];vķ�_-v�0;1ol;�-�1;m|u-Ѵ�robm|�o=�r-ঞ;m|�7-|-�];m;u-ঞomķ�ou]-mb�-ঞomķ�-m7�1oll�mb1-ঞomķ�-vv�lbm]�-m�bm1u;-vbm]Ѵ��blrou|-m|�uoѴ;�bm�_;-Ѵ|_1-u;�7;Ѵb�;u�ĺ�

�m�;vঞl-|;7�ƕŊƐƏ�0bѴѴbom�Ѵ-0ou-|ou��|;v|v�-u;�r;u=oul;7�;-1_��;-u�bm�|_;�&mb|;7�"|-|;vķ�-m7�Ѵ-0ou-|ou��|;v|�u;v�Ѵ|v�bmY�;m1;�l;7b1-Ѵ�7;1bvbomv�ĺ�$_bv�u-rb7Ѵ��bm1u;-vbm]�1-1_;�o=�bm=oul-ঞom�mo|�omѴ��;m-0Ѵ;v�r_�vb1b-mv�-m7�r-ঞ;m|v�|o�b7;mঞ=��7bv;-v;�-m7�0;]bm�|u;-|l;m|�;-uѴb;u�|_-m�;�;u�0;=ou;ķ�0�|�-Ѵvo�-1_b;�;v�|_;�=oѴѴo�bm]Ĺ

IMPACT OF PERSONALIZED MEDICINE

PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT

�;uvom-Ѵb�;7�l;7b1bm;ķ�7;Cm;7�-v�|_;�|-bѴoubm]�o=�l;7b1-Ѵ�|u;-|l;m|�|o�|_;�bm7b�b7�-Ѵ�1_-u-1|;ubvঞ1v�o=�;-1_�r-ঞ;m|ķ�bv�ruo=o�m7Ѵ��blr-1ঞm]�-ѴѴ�-vr;1|v�o=�r-ঞ;m|�1-u;ķ�bm1Ѵ�7bm]�ru;�;mঞomķ�7b-]movbvķ�|u;-|l;m|ķ�-m7�=oѴѴo���rĺ�$_bv�-rruo-1_�u;Ѵb;v�om��m7;uv|-m7bm]�_o��-�r;uvomĽv��mbt�;�loѴ;1�Ѵ-u�-m7�];m;ঞ1�ruoCѴ;�l-h;v�|_;l�v�v1;rঞ0Ѵ;�|o�1;u|-bm�7bv;-v;vĺ�

$_�vķ�b=�-�r;uvomŝv�];molb1�bm=oul-ঞom�bm7b1-|;v�-�_b]_;uŊ|_-mŊ-�;u-];�ubvh�o=�7;�;Ѵorbm]�7b-0;|;v�ou�-�r-uঞ1�Ѵ-u�=oul�o=�1-m1;uķ�|_-|�r;uvom�l-��-7or|�-�Ѵb=;v|�Ѵ;ķ�ou�vol;ঞl;v�0;�ru;v1ub0;7�l;7b1-ঞomvķ�|o�0;�;u�u;]�Ѵ-|;�|_;�-vr;1|v�o=�_;-Ѵ|_�-m7��;ѴѴm;vv�o�;u��_b1_�_;�ou�v_;�_-v�1om|uoѴĺ�"�11;vv=�Ѵ�r-ঞ;m|�l-m-];l;m|�o=�|_;v;�ro|;mঞ-Ѵ�_;-Ѵ|_�bvv�;v�u;t�bu;v�0��Ŋbm�0��|_;�r-ঞ;m|�|o�|_;�m;1;vv-u��u;]bl;mvķ�bm1Ѵ�7bm]�-rruorub-|;�Ѵ-0ou-|ou��|;vঞm]ĺ��7�1-ঞm]�|_;�r-ঞ;m|�om�_o��|_;v;�|;v|v��ouhķ��_-|�|_;�u;v�Ѵ|v�l;-m�bm�|;ulv�o=�ro|;mঞ-Ѵ�=ou�7;�;Ѵorbm]�|_;v;�7bv;-v;vķ�-m7�|_;�u-lbC1-ঞomv�|_-|�1-m�=oѴѴo��-u;��b|-Ѵĺ��

CONTINUED ON PAGE 14

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��v|olb�;�7bv;-v;Ŋru;�;mঞom�v|u-|;]b;vĸ

�u;v1ub0;�lou;�;@;1ঞ�;�7u�]v�-m7�-�ob7�ru;v1ub0bm]�7u�]v��b|_�ru;7b1|-0Ѵ;�vb7;�;@;1|vĸ�-m7

�-�;�-�_b]_;u�ruo0-0bѴb|��o=�7;vbu;7�o�|1ol;v�7�;�|o�0;�;u�|-u];|;7�|_;u-rb;vĺ

Consequently, this has allowed medical providers to :

An empowered, activated patient :�m7;uv|-m7v�|_;bu�_;-Ѵ|_�1om7bঞom�-m7�b|v�;@;1|�om�|_;bu�0o7�

=;;Ѵv�-0Ѵ;�|o�r-uঞ1br-|;�bm�7;1bvbomŊl-hbm]��b|_�|_;bu�_;-Ѵ|_ 1-u;�ruo=;vvbom-Ѵv

=;;Ѵv�-0Ѵ;�|o�l-h;�bm=oul;7�1_ob1;v�-0o�|�|u;-|l;m|

�m7;uv|-m7v�|_;�m;;7�|o�l-h;�m;1;vv-u��1_-m];v�|o�|_;bu�Ѵb=;v|�Ѵ;�=ou�l-m-]bm]�|_;bu�1om7bঞom

bv�-0Ѵ;�|o�1_-ѴѴ;m];�-m7�-vh�t�;vঞomv�o=�|_;�_;-Ѵ|_�1-u;�ruo=;vvbom-Ѵv�ruo�b7bm]�|_;bu�1-u;

|-h;v�u;vromvb0bѴb|��=ou�|_;bu�_;-Ѵ|_�-m7�-1ঞ�;Ѵ��v;;hv�1-u;�omѴ���_;m�m;1;vv-u��-m7

-1ঞ�;Ѵ��v;;hv�o�|ķ�;�-Ѵ�-|;v�-m7�l-h;v��v;�o=�bm=oul-ঞomĺ

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Page 14: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

�7�1-ঞm]�r-ঞ;m|v�-0o�|�|_;�l;-mbm]�o=�|_;bu�Ѵ-0ou-|ou��|;v|v�ruolo|;v�|_;v;�]o-Ѵvĺ��)_;m�|_;�r-ঞ;m|��m7;uv|-m7v�|_;�u;-vomv�vr;1bC1�|;v|v�-u;�ou7;u;7ķ��_-|�|_;�u;v�Ѵ|v�l;-mķ�-m7�_o��|_;��-u;��ঞѴb�;7�bm�|_;�7b-]movbvķ�|u;-|l;m|ķ�-m7�lomb|oubm]�o=�|_;bu�1om7bঞomvķ�b|�bv�lou;�Ѵbh;Ѵ��|_-|�|_;�r-ঞ;m|��bѴѴ�7o��_-|�bv�m;;7;7�|o�-�-bm�-m7�l-bm|-bm�-�_;-Ѵ|_b;u�v|-|;ĺ��

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��uu;m|Ѵ��-Ѵlov|�ƓƏ�v|-|;v�-m7�|_;�bv|ub1|�o=��oѴ�l0b-�r;ulb|�1omv�l;uv�|o�ou7;u�vol;�ou�-ѴѴ�o=�|_;bu�Ѵ-0ou-|ou��|;v|v�7bu;1|Ѵ���b|_o�|�|_;�bm�oѴ�;l;m|�o=�-�r_�vb1b-mĺ�"blbѴ-uѴ�ķ�|_;�=;7;u-Ѵ�]o�;uml;m|�fobm;7�|_bv�|u;m7�0��bvv�bm]�-�u;]�Ѵ-ঞom�7bu;1ঞm]�1Ѵbmb1-Ѵ�Ѵ-0ou-|oub;v�|o�ruo�b7;�bm7b�b7�-Ѵv��b|_�-11;vv�|o�|_;bu�|;v|�7-|-��rom�u;t�;v|ĺ��)b|_�|_;v;�m;��roѴb1b;v�bm�rѴ-1;ķ�1omv�l;uv�-u;�bm1u;-vbm]Ѵ��bm�oѴ�;7�bm�]�b7bm]�|_;�_;-Ѵ|_�7;1bvbomv�|_-|�-@;1|�|_;bu�Ѵb�;vĺ

$_;�]Ѵo0-Ѵ�7bu;1|�|o�1omv�l;u�Ő$�ő�Ѵ-0ou-|ou��|;vঞm]�l-uh;|�|o|-Ѵ;7�ŪƑƏѶ�lbѴѴbom�bm�ƑƏƐѶķ�-11ou7bm]�|o��-Ѵou-l-��m=oul-ঞomĽv�m;��u;rou|ķ�$_;�bu;1|Ŋ$oŊ�omv�l;u�$;vঞm]��-uh;|ĺ� $_;�1Ѵbmb1-Ѵ�7b-]movঞ1v�l-uh;|�u;v;-u1_�Cul�v-b7�7o�0Ѵ;Ŋ7b]b|�]uo�|_�1-m�0;�;�r;1|;7ĺ�"|uom]�]uo�|_�bv�;�r;1|;7�|_uo�]_o�|�|_;�=ou;1-v|�r;ubo7�7�;�|o�;-vbm]�o=�|_;�u;]�Ѵ-|ou��ruo1;vv;v�=ou�$��Ѵ-0ou-|ou��|;v|v�-m7�bm1u;-vbm]�1omv�l;u�7;l-m7�=ou�0o|_�7bu;1|Ŋ|oŊ1omv�l;u�uo�ঞm;�1Ѵbmb1-Ѵ�Ѵ-0ou-|ou��|;v|v�-m7�];m;ঞ1�|;v|vĺ

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�Ѵvoķ�ѶƑĺƔѷ�Őm�Ʒ�ƐѵƔő�ru;=;uu;7�|o�u;1;b�;�0o|_�moul-Ѵ�-m7�-0moul-Ѵ�|;v|�u;v�Ѵ|v�|_bv��-�ĺ�$_;�l-bm�u;-vom�=ou�u;1;b�bm]�u;v�Ѵ|v�omѴbm;��-v�ঞl;�v-�bm]vķ��_b1_��-v�u;rou|;7�0��ƕƕѷ�o=�r-uঞ1br-m|vķ�=oѴѴo�;7�0��Ѵo�;ubm]�|_;�1_-m1;�o=�lbvvbm]�|_;�u;v�Ѵ|v�ŐƒƐѷőĺ��0o�|�ƓƏѷ�o=�r-uঞ1br-m|v�|_o�]_|�;Ŋl-bѴ�moঞC1-ঞom��-v�lou;�v;1�u;�|_-m�-11;vvbm]�|_;�u;v�Ѵ|v�|_uo�]_�-�=-1bѴb|���;0vb|;ĺ�� bm7bm]v�v_o�;7�|_-|�-Ѵ|_o�]_�r-ঞ;m|v��-m|;7�|o�0;m;C|�=uol�omѴbm;�v;u�b1;v�=ou�u;1;b�bm]�|_;bu�|;v|�u;v�Ѵ|vķ�|_;���;u;�1om1;um;7�-0o�|�1omC7;mঞ-Ѵb|��-m7�v;1�ub|�ĺ��;=ou;��vbm]�omѴbm;�|;1_moѴo]b;vķ�v;1�ub|��l;-v�u;v�m;1;vv-u��|o�ruo|;1|�r-ঞ;m|�rub�-1��-m7�|o�]-bm�|_;�|u�v|�o=�r-ঞ;m|v�v_o�Ѵ7�0;�blrѴ;l;m|;7ĺ

�7�1-ঞom�bv�|_;�lo7;um�u;vromv;�|o�;m-0Ѵbm]�r-ঞ;m|�;lro�;ul;m|�bm�|_;�=-1;�o=�-�u-rb7Ѵ��1_-m]bm]�_;-Ѵ|_1-u;�;m�buoml;m|ķ�7ub�;m�0��|_;�u-rb7�r-1;�o=�|;1_moѴo]b1-Ѵ�1_-m];ĺ��-ঞ;m|�;7�1-ঞom�bv��b|-Ѵ�=ou�ruo�b7bm]�|_;�0;v|��-Ѵ�;Ŋ0-v;7�_;-Ѵ|_1-u;ķ�-m7�|o�ruolo|;�Ѵom]Ŋ|;ul�r-u|m;uv_brv�0;|�;;m�r_�vb1b-mv�-m7�|_;bu�r-ঞ;m|vĺ����h;��1olrom;m|�o=�r-ঞ;m|�;lro�;ul;m|��bv�;mv�ubm]�|_-|�r-ঞ;m|v�_-�;�-11;vv�|o�|_;�lov|�1olrѴ;|;�;7�1-ঞom�rovvb0Ѵ;�-0o�|�|_;bu�Ѵ-0ou-|ou��|;v|v�|o�0o|_��m7;uv|-m7�-m7�0;�r-u|m;uv�bm�|_;�o�m�_;-Ѵ|_�1-u;ĺ

COLA’S inSIGHTS FALL 2019

PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT

CONCLUSION

Direct Access aka Direct-To-Consumer Testing (DTC)

Patient’s Preferences for Receiving Laboratory Test Results

Patient education regarding lab testing can be provided in many ways, including through:$_;�r_�vb1b-m�7bu;1|Ѵ�

�-0ou-|ou��v|-@�-m7�o|_;u�-m1bѴѴ-u��_;-Ѵ|_1-u;�ruo�b7;uv��_o�_-�;�|_;�;7�1-ঞom�|o�ruo�b7;�|_bv�bm=oul-ঞomķ�v�1_�-v�m�uv;vķ�-m7��r_-ul-1bv|v

!;=;u;m1;�Ѵ-0ou-|oub;vķ��_;u;�r-ঞ;m|v�1-m��bvb|�7bu;1|Ѵ��ou�u;1;b�;�bm=oul-ঞom��b-�l-bѴ�ou�omѴbm;�

�o�;uml;m|��bm=oul-ঞom�vb|;v�v�1_�-v�|_;� �ķ�-m7�|_;���

�-0ou-|ou��bm=oul-ঞom�vb|;vķ�v�1_�-v��-0�$;v|v��mѴbm;� ĸ�ou� �;-Ѵ|_��;|�ouh��-0ou-|oub;v� ĸ�

�-0ou-|ou��|;vঞm]�bm=oul-ঞom�ruo�b7;7�omѴbm;�0��l-fou�l;7b1-Ѵ�1Ѵbmb1v�-m7�_ovrb|-Ѵv

�;-Ѵ|_�bmv�u-m1;�1olr-mb;v

�-0ou-|ou��ruo=;vvbom�vb|;v�v�1_�-v�|_;��l;ub1-m��vvo1b-ঞom�=ou��Ѵbmb1-Ѵ��_;lbv|u��Ő����őĸ�|_;��l;ub1-m�"o1b;|��=ou��b1uo0boѴo]�Ő�"�őķ�-m7�|_;��l;ub1-m�"o1b;|��=ou��Ѵbmb1-Ѵ��-|_oѴo]�Ő�"��ő�-m7

�-0ou-|ou���11u;7b|-ঞom��ou]-mb�-ঞomvķ�v�1_�-v������ķ��m1ĺķ�|_;��oѴѴ;];�o=��l;ub1-m��-|_oѴo]bv|v�-m7�$_;��obm|��ollbvvbomĺ�

����-�b]-|;�+o�u��-0�$;v|ĺ��Ѵbm�-0�-�b]-|ouĺƑƏƐƖĺ�_�rĹņņ���ĺ1ѴbmѴ-0m-�b]-|ouĺ1olņ1Ѵbmb1-ѴŊѴ-0ou-|ou�Ŋ�ƐƔŊƕƕƓĺ_|lѴ

���u;1bvbom��;7b1bm;Ĺ� uol�"1b;m1;�|o�(-Ѵ�;ĺ��bmv0�u]ķ��ĺ�-m7��_bѴѴbrvķ��ĺ�����ƑƏƐѶ���m�ѵĺ�_�rvĹņņ���ĺm10bĺmѴlĺmb_ĺ]o�ņrl1ņ-uঞ1Ѵ;vņ���ƔƖѶƖƕƐƓņ

���-ঞ;m|v�)-m|�|o��-h;�$_;bu���m��m=oul;7��_ob1;vĺ�);��;;7�|o��;|�$_;lĺ���ѴŊ�]0-ķ��bu-m�"ĺ���;7r-];|o7-�Ľv��;�bm�ĺ1olĺ�";r|ĺ�ƒƏķ�ƑƏƐѵĺ��_�rĹņņ���ĺh;�bml7ĺ1olņ0Ѵo]ņƑƏƐѵņƏƖņr-ঞ;m|vŊ�-m|Ŋl-h;Ŋbm=oul;7Ŋ1_ob1;vŊm;;7ŊѴ;|�ĺ_|lѴ�

���-0�$;v|v��mѴbm;ĺ�ƑƏƐƔ��l;ub1-m��vvo1b-ঞom�=ou��Ѵbmb1-Ѵ��_;lbv|u�ĺ��_�rĹņņѴ-0|;v|vomѴbm;ĺou]

���;-Ѵ|_��;|�ouh��-0ou-|oub;vĺ�ƑƏƐƔĺ�_�rĹņņ����ĺ_;-Ѵ|_m;|�ouhѴ-0vĺ1olņ�-];vņr-ঞ;m|;7�1-ঞomĺ-vr�ĺ

��bu;1|Ŋ$oŊ�omv�l;u��-0ou-|ou��$;vঞm]ĺ��������ovbঞom�"|-|;l;m|ĺ���Ѵ��ƑƏƐƔĺ��_�rvĹņņ���ĺ--11ĺou]ņ_;-Ѵ|_Ŋ-m7Ŋv1b;m1;ŊroѴb1�ņ-7�o1-1�ņrovbঞomŊv|-|;l;m|vņƑƏƐƔņ7bu;1|Ŋ|oŊ1omv�l;uŊѴ-0ou-|ou�Ŋ|;vঞm]

��$���-0ou-|ou��$;vঞm]��-uh;|�$o|-Ѵ;7�ŪƑƏѶ��bѴѴbom�bm�ƑƏƐѶĺ��Ѵo]ņ�-uh;|�!;v;-u1_ĺ���;ѴѴ�ķ��ĺ���bo�m=oul-ঞ1vĺ��-m�-u��ƐѶķ�ƑƏƐƖĺ��_�rvĹņņ0bobm=obm1ĺ1olņ|_;Ŋ7bu;1|Ŋ|oŊ1omv�l;uŊѴ-0ou-|ou�Ŋ|;vঞm]Ŋl-uh;|

���-ঞ;m|Ľv��u;=;u;m1;v�=ou�!;1;b�bm]��-0ou-|ou��$;v|�!;v�Ѵ|vĺ�"-0-_bķ��ĺķ��_l-7b-mķ��ĺķ��bu�-;;ķ��ĺķ�-m7���_-fo�;bķ�!ĺĺ��$_;��l;ub1-m��o�um-Ѵ�o=��-m-];7�1-u;ĺ����rubѴ�ƐƖķ�ƑƏƐƕĺ���_�rĹņņ���ĺ-fl1ĺ1olņfo�um-Ѵvņbvv�;ņƑƏƐƕņƑƏƐƕŊ�oѴƑƒŊmƓņr-ঞ;m|vŊru;=;u;m1;vŊ=ouŊu;1;b�bm]ŊѴ-0ou-|ou�Ŋ|;v|Ŋu;v�Ѵ|v

References

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Page 15: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

COLA Technical Assistance 800.981.9883 www.cola.org www.COLAcentral.com

Laboratory Developed Tests and FDA RegulationBy Brian Reuwer – COLA’s Senior Healthcare Policy Analyst

Current Regulatory Oversight of LDTs

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Recent Changes in Congress

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Page 16: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer
Page 17: IN THIS ISSUE · 2019. 11. 25. · COLA’S inSIGHTS FALL 2019 PATIENT!CENTERED HEALTHCARE REQUIRES PATIENT ENGAGEMENT THROUGH PATIENT EMPOWERMENT CONCLUSION Direct Access aka Direct-To-Consumer

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