2021 order renewal · 1 september 2020 3 • overview of the new 2021 programs • auto-conversions...

© College of American Pathologists.

2021 Order RenewalNew program focus exclusively for CGI

Corrine Cagney, MT (HEW)Senior Technical Marketing Manager

September 2, 2020

© College of American Pathologists. 1 September 2020 2

Confidential

The information presented is property of the College of American Pathologists. It may contain information that is

proprietary and confidential. Any unauthorized review, use, disclosure or distribution is prohibited.


Agenda

1 September 2020 3

• Overview of the new 2021 programs• Auto-conversions

• Top programs

• New program information • Proficiency Tests

• Quality Management Tools

• Additional notifications

• Appendix with 2020 information


Highlights of New Offering

• 24 new proficiency testing and quality improvement programs

• Aligned to meet the changes of cutting-edge laboratory medicineo Proficiency testing programs for SARS-CoV-2

o More microbiology programs to meet the newest instruments and methods

41 September 2020


24 New 2021 Programs, including SARS-CoV-2

1 September 2020 5

Section Number of New Program CodesBacteriology 1Biochemical and Molecular Genetics 1Flow Cytometry 4General IHC 1Hematology 1Histocompatibility 3Immunology 1Microbiology 5Molecular Microbiology 1Quality Management Tools 3Routine Chemistry 3


8 of the 22 will be Auto-ConversionsNew Program

Code New 2020 Program Auto-Converting from* Rationale

BCM Bacterial Blood Culture, Molecular GPBC, GNBC

Combining two programs to one that includes both gram positive and gram negative. Reflects technology improvement that allows for both to

be tested together.

FH16/FH16P

FH 16: Hematology Automated Differential Series

FH16P: Hematology Automated Diff-Blood Cell ID

FH3 Unicell DxH 500 series to FH16

Optimizes technology of Unicell DxH 500 unit (better peer group data)

HCRT High-Sensitivity Cardiac Markers CRT CRT by method

Supports technology advancement and different units of measure and clinically reportable rangesHCRTI High-Sensitivity Cardiac

Markers CRTI CRT by method

HTNT High-Sensitivity Cardiac Markers TNT

TNT2 and TNT5 by method

MXB HLA Crossmatching, Antibody Screen, and Antibody

Identification (Class I/Class II)

MX1B and MX2B Combining two programs to better mimic patient testing and easier for customers currently having to purchase more than one program to fulfill their

PT needs

MXC MX1C and MX2C

MXE MX1E and MX2E1 September

2020 6*Red denotes discontinuing in 2021


Top New 2021 Programs for Growth

1 September 2020 7

New Program Code New Program NameCOV2 SARS-CoV-2 Molecular*COVS SARS-CoV-2 Serology*HCRT High-Sensitivity Cardiac Markers CRTCOVAG SARS-CoV-2 Antigen*COV2Q Quality Cross Check−SARS-CoV-2 Molecular*BCM Bacterial Blood Culture, MolecularHTNT High-Sensitivity Cardiac Markers TNTYBC Yeast Blood Culture, MolecularKI67 Ki-67 Immunohistochemistry MicroarrayHCRTI High-Sensitivity Cardiac Markers CRTIFH16/FH16P Hematology Automated Differential SeriesQP211 Antimicrobial Susceptibility Testing: Monitoring and Trend Analysis*Released mid-year 2020 to help laboratories address COVID-19 pandemic

© College of American Pathologists.© College of American Pathologists.

Microbiology

New Program Information

1 September 2020 8


New Microbiology Programs Address Changing Needs• Most routine testing with wide appeal

• Supports the changing technology and available panels

• Five programso COV2, COV2Q, COVAG and COVS for SARS-CoV-2

o YBC addresses molecular testing before culture

o BCM for complete bacterial blood culture

o IDM5 better aligned to current testing for Meningitis and Encephalitis

o MTR5 gives more challenges

1 September 2020 9


What are the Different Tests for SARS-CoV-2?

1 September 2020 10

Molecular

• Diagnose disease

• Detects activeinfections with SARS-CoV-2

Serology

• Not for diagnosis

• Detects the presence of antibodies against the SARS-CoV-2 virus

Antigen

• Diagnose disease

• Detects the presence of SARS-CoV-2


SARS-CoV-2 Molecular (COV2)

• Launched April 2020

• Whole genome of SARS-CoV-2

• Includes all sequence targets across assay platforms

• Applicable to any laboratory using nucleic acid amplification methods

• Peer group sizes provide significant data for comparison

11


2021 New CAP PT – COV2Microbiology COV2 – SARS-CoV-2 Molecular

Usage Targeting SARS-CoV-2 • agent causing COVID-19• includes CDC and WHO sequence targetsWhole genome of SARS-CoV-2 and includes all sequence targets

across assay platforms for laboratories performing nucleic acid amplification

Benefits Uses non-infectious nucleic acidMeets accreditation requirements for alternative performance

assessmentWho would participate CRO, Molecular/Genetics, Reference/chain/commercial and Hospital

– University, Private and Public/GovernmentLocations focused on population health and molecular SARS-CoV-2

testingOther programs lab may be interested in / currently buying

COVS, ID2, ID3, IDR, IDPN

Mailing Information 3 challenges x 2 mailings1 September

2020 12


Quality Cross Check : SARS-CoV-2 Molecular (COV2Q)• Supply chain issues causing implementation of multiple molecular

testing platforms• Accredited laboratories would benefit

o CAP Accreditation prohibits testing PT samples on multiple instruments during a testing event.o CAP Accreditation requirements, one PT result:

– Per analyte – Per specimen type – Per site

• Quality Cross Checko Risk-free solution for monitoring all the instruments in the laboratoryo Test up to 3 instruments with 3 challenges per mailingo Not PT

13

NEW!Available for order

now & OR 2021


SARS-CoV-2 Serology (COVS)

• Serological testing for antibodies to the SARS-CoV-2 virus that causes COVID-19

• COVS program includes ability to test for total, IgG, IgM and IgA

• Peer group sizes provide significant data for comparison

14


2021 New CAP PT – COVSImmunology COVS – SARS-CoV-2 Serology

Usage Individuals exposed to the SARS-CoV-2 virus and survived will develop antibodies in their bloodstream to fight its infection

Serological testing for antibodies to the SARS-CoV-2 virus that causes COVID-19

Benefits Covers reporting for antibodies including total, IgG, IgM and IgAMeets accreditation requirements for alternative performance

assessmentShould meet needs for many new laboratories adding serological

testing to their test menusWho would participate CRO, Reference/chain/commercial and Hospital – University, Private

and Public/GovernmentAdditional participants would be locations focused on population health and SARS-CoV-2 testing

Other programs lab may be interested in / currently buying

COV2, G, IG, S and S2To a lesser extent, any of the other immunology PT programs.


2020 15


SARS-CoV-2 Antigen (COVAG)

• Evaluates the accuracy of antigen testing –results for qualitative reporting

• Detects potential issues in your antigen testing

• Simulated respiratory specimens that are noninfectious

• Clinically relevant and mimic patient testing

• Meets requirements for assessing the quality of your assay at least twice per year

16

NEW!Available for order

now & OR 2021


How do Cytokines and Procalcitonin Testing Support the COVID-19 Pandemic?

• Infection with SARS-CoV-2 mobilizes a wide variety of biomolecules, mainly immunological in nature

• Cytokines (CTKN)o Hyperproduction of mainly proinflammatory cytokines in severe cases

o IL-1, IL-6, IL-12, IFN-γ, and TNF-α

o Preferentially targeting lung tissue per US NIH

• Procalcitonin (PCT)o Serial measurement may predict a more severe form of the COVID-19 disease

o Procalcitonin from extrathyroidal sources enormously amplified during bacterial infections

o Recently shown in children with viral lower respiratory tract infections per US NIH

17

SARS-CoV-2

Immunological Response

Possibly increased

• Cytokines• Procalcitonin


Yeast Blood Culture (YBC)• For molecular blood culture instruments

• First step in identification before cultureo Followed by identification of positive blood

cultures

• Complements Bacterial Blood Culture, Molecular program (BCM)

• Example instruments o Biofire® FilmArray® Blood Culture Identification

(BCID/BCID2) Panel

o GenMark's ePlex® Blood Culture Identification (BCID) Panel

18


2021 New CAP PT – YBC Microbiology YBC – Yeast Blood Culture, Molecular

Usage Used by molecular blood culture instruments that perform identification of yeast from positive blood culture bottles

Perform identification of yeast by molecular methods first before culture

Benefits Meets the need of molecular users of blood culture yeast identification

Complements the Bacterial Blood Culture Molecular (BCM) program

Who would participate Reference/chain/commercial, Hospital – University, Private and Public/Government, and Molecular/Genetics


Bacterial Blood Culture, molecular program (BCM) Complements YBC for systems that also detect bacteria by

molecular methodsMailing Information 5 challenges x 3 mailings

1 September 2020 19


2021 New CAP PT – BCMBacteriology BCM – Bacterial Blood Culture, Molecular

Usage Molecular blood culture instruments that perform identification of gram-positive and gram-negative bacterial identification and resistance mechanisms from positive blood culture bottles

First step in identification before cultureBenefits Gram-positive and gram-negative bacteria

-No need to buy two separate programs-Decrease overall shipping charges

Who would participate Reference/chain/commercial and Hospital – University, Private and Public/Government


BCS, BCS1 and new YBC (Yeast Blood Culture) complements BCM for systems that also detect yeast by molecular methods

Mailing Information 5 challenges x 3 mailingsGram stain will be provided so that, if applicable, laboratories would know which panel to use

1 September 2020 20

Auto-conversion from GPBC and GNBC


2021 New CAP PT – IDM5 Molecular Microbiology IDM5 – Meningitis/Encephalitis Panel, 5 Challenge

Usage Simulated body fluid designed for BioFire® FilmArray® Meningitis/Encephalitis (ME) panel

May be used with other meningitis/encephalitis testing platformsBenefits Meets needs for customers desiring a 5x3 configuration that

IDME does not currently fill for molecular multiplex panel systems identifying gram negative bacteria, gram positive bacteria, yeast, and viruses

CMS regulatedWho would participate Reference/chain/commercial, Hospital – University, Private and

Public/Government, and Molecular/GeneticsOther programs lab may be interested in / currently buying

ID5, IDME

Mailing Information 5 challenges x 3 mailings

1 September 2020 21


2021 New CAP PT – MTR5 Microbiology MTR5 – Molecular MTB Detection and Resistance,

5 ChallengeUsage Detection of Mycobacterium tuberculosis and the detection of

rifampin resistance in sputum specimensPrimarily designed for the Cepheid GeneXpert® system using the

Xpert® MTB/RIF test kit, at the request of the manufacturerBenefits Includes reporting of rifampin resistance

Material cannot be culturedWho would participate CRO, Reference/chain/commercial, Hospital – University, Private

and Public/Government, and Molecular/GeneticsOther programs lab may be interested in / currently buying

MTBR (3 challenges with 2 mailings) E and E1 for laboratories that perform AFB smears and

identification of MycobacteriumMailing Information 5 challenges x 2 mailings

1 September 2020 22


Routine Chemistry


1 September 2020 23


New Routine Chemistry Programs AddressHigher Sensitivity Troponin Assays• No competitive equivalent

• Three programso HCRT

o HCRTI

o HTNT

1 September 2020 24


High-Sensitivity Troponin Programs (HCRT, HCRTI, HTNT)

• Evaluation of patients with myocardial infarction or injury

• Higher analytical sensitivity than current Troponin I assayso Different reporting units

o Lower limits of reporting

• Limited competition with significant peer group sizes for data comparison

25

Auto-conversion from CRT, CRTI,

TNT and TNT5


2021 New CAP PT – HCRT Routine Chemistry HCRT – High-Sensitivity Cardiac Markers CRT

Usage High-sensitivity Troponin I assays have different reporting units and lower limits of reporting due to their analytical sensitivity compared to contemporary Troponin I assays

Benefits One proficiency testing (PT) program for high-sensitivity Troponin I and CK-MB (immunochemical) plus Myoglobin

Reporting units and target values aligned to the high-sensitivity Troponin I assays

Meets all three: new CLIA proposed rule, CAP’s Accreditation Programs requirements of 5 x 3 for high-sensitivity Troponin I, and CAP’s requirements for CK-MB and Myoglobin

Who would participate CRO, Reference/chain/commercial and Hospital – University, Private and Public/Government


LN25, LN27, QT15, PCARI, PCARM and PCARMX


1 September 2020 26


TNT and TNT5


2021 New CAP PT – HCRTIRoutine Chemistry HCRTI – High-Sensitivity Cardiac Markers CRTI

Usage High-sensitivity Troponin I assays have different reporting units and lower limits of reporting due to their analytical sensitivity compared to contemporary Troponin I assays

Benefits One proficiency testing (PT) program for high-sensitivity Troponin I and CK-MB (immunochemical), CK isoenzymes by electrophoresis, LD isoenzymes by electrophoresis, and Myoglobin

Reporting units and target values aligned to the high-sensitivity Troponin I assays

Meets all three: new CLIA proposed rule, CAP’s Accreditation Programs requirements of 5 x 3 for high-sensitivity Troponin I and CAP’s requirements for CK-MB, CK isoenzyme, LD isoenzyme, and Myoglobin



LN25, LN27, QT15, PCARI, PCARM, PCARMX


2020 27


TNT and TNT5


2021 New CAP PT – HTNT Routine Chemistry HTNT – High-Sensitivity Cardiac Markers TNT

Usage High-sensitivity Troponin T assays have different reporting units and lower limits of reporting due to their analytical sensitivity compared to contemporary Troponin I assays

Benefits Reporting units and target values aligned to the high-sensitivity Troponin T assays

Meets both the new CLIA proposed rule and the CAP’s Accreditation Programs requirements of 5 x 3 for high-sensitivity Troponin T



CRT, CRTI, CRTQ, LN25, LN27, QT15, PCARI, PCARM and PCARMX


1 September 2020 28


TNT and TNT5


Hematology


1 September 2020 29


Hematology Automated Differential Series (FH16/FH16P)• Specifically designed for Beckman Coulter DxH 500 Series

userso Includes nucleated red blood cell parameter (nRBC)

• Opportunity for CE credit

• Auto-converted by instrument to better meet their testing needso FH3 laboratories using the DxH 500 FH16

o FH3P laboratories using the DxH 500 FH16P

30

Auto-conversion from FH3/FH3P by

instrument


2021 New CAP PT – FH16/FH16P Hematology FH16 – Hematology Automated Differential Series

FH16P – Hematology Automated Diff-Blood Cell IDUsage Complete blood count and differential and nucleated red blood cell

parameter (nRBC) on the Coulter Unicel DxH 500 series of hematology analyzers

Benefits Specifically designed for Coulter Unicel DxH 500 seriesIncludes complete blood count and differential, as well as nucleated red

blood cell parameter (nRBC)FH16P also includes online images for blood cell identification.

Opportunity for CE creditWho would participate Coulter Unicel DxH 500 and DxH 520 users

CRO, Reference/chain/commercial and Hospital – University, Private and Public/Government


EHE1, FH3Q, RT3, RT3Q and VPBS

Mailing Information 5 challenges x 3 mailingsFH16P includes ten images

1 September 2020 31

Auto-conversion from FH3/FH3P by

instrument


Flow Cytometry


1 September 2020 32


Helping Laboratories Get the Most Benefitfrom Flow Cytometry• Detect, identify, and count specific cells1

o Can also identify particular components within cells

o Cells from blood, bone marrow, body fluids such as cerebrospinal fluid (CSF), or tumors

• Four new programso FL7 –T-Cell Subsets Analysis o FL8 – Mature B-Cell Leukemia/Lymphomas (2-day stability)o FL9 – Plasma cell myeloma (2-day stability)o RFAV3 – CD30 tumor marker (2-day stability)

1 September 2020 33

1 https://labtestsonline.org/flow-cytometry


2021 New CAP PT – FL7 Flow Cytometry FL7 – Flow Cytometry, T-Cell Subsets Analysis

Usage Determine the percentage and absolute values of specific T-lymphocyte subsets (naive CD4+, naive CD8+, memory CD4, memory CD8 and recent thymic emigrants, TCR CD3+ alpha/beta and TCR CD3+ gamma/delta)

Percentage reporting is appropriate for all flow cytometer platformsAbsolute values should only be reported if the method can directly

perform the count (single platform)Benefits Support for very esoteric field

Percent and absolute value for T-cell subsetsWho would participate CRO, Reference/chain/commercial and Hospital – University, Private

and Public/GovernmentOther programs lab may be interested in / currently buying

B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL8, FL9,PCNEO, PNH, RFAV1, RFAV2 and RFAV3


1 September 2020 34


2021 New CAP PT – FL8 Flow Cytometry FL8 – Flow Cytometry, Mature B-Cell Leukemia/Lymphoma

Minimal Residual DiseaseUsage Detect if minimal residual disease is present for Mature B-Cell

Leukemia/LymphomasGrowing need and demand for quality assurance programs for

flow cytometry laboratories performing minimal residual disease testing

Benefits Supports minimal residual disease testingBenchmark MRD levels against peers



B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL9,PCNEO, PNH,RFAV1, RFAV2, and RFAV3


1 September 2020 35


2021 New CAP PT – FL9Flow Cytometry FL9 – Flow Cytometry, Plasma Cell Myeloma

Minimal Residual DiseaseUsage Detect if minimal residual disease is present for plasma cell

myelomaGrowing need and demand for quality assurance programs for

flow cytometry laboratories performing minimal residual disease testing

Benefits Supports minimal residual disease testingBenchmark MRD levels against peers



B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL8,PCNEO, PNH,RFAV1, RFAV2, and RFAV3


1 September 2020 36


2021 New CAP PT – RFAV3 Flow Cytometry RFAV3 – Rare Flow Antigen Validation, CD30

Usage Test multiple antibody/fluorochrome combinations to ensure reactivity of CD30 (tumor marker) prior to use in patients

Benefits Rare antigen validation program that allows laboratories to help ensure appropriate antigen reactivity

Meets requirements for LAP checklist item FLO.23737Targets all laboratory personnel, including the pathologist and the

laboratory technicians/technologistsWho would participate CRO, Reference/chain/commercial and Hospital – University,

Private and Public/GovernmentOther programs lab may be interested in / currently buying

B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL8, FL9, PCNEO, PNH, RFAV1 and RFAV2

Mailing Information 1 sample x 2 mailings

1 September 2020 37


Advanced Offering


1 September 2020 38


Each Program is Focused • KI67 – Immunohistochemistry Microarrayo Higher Ki67 protein in malignant tissues

o Offers prognostic value in breast cancer cases

• MXB-MXC-MXE – HLA Crossmatching, Antibody Screen, and Antibody Identification (Class I/Class II)o HLA antigens identification and negative/positive crossmatch results

o Organ or bone marrow transplants

• BGL2 – Amino Acid Quantitation for Inherited Metabolic Disorderso Analytical quality of amino acids in plasma

o Inherited metabolic disorders may be serious in newborns

1 September 2020 39


2021 New CAP PT – KI67 General IHC KI67 – Immunohistochemistry Microarray

Usage Ki67 is a nuclear protein expressed higher in malignant tissuesIn breast cancer cases, Ki67 offers prognostic value for therapy outcome Allows laboratories to evaluate their image analysis system for Ki-67 testing

Benefits Composed entirely of cell line materialWill have a definitive number of immunoreactive cells, making it a truly

quantitative surveyProvides formal program for assessment of Ki-67 as a prognostic marker

for cancer and added cumulative data on methodology performance and usage


Additional participants would be cancer treatment centers and those using image analysis


HER2, PM2


1 September 2020 40


Amino Acid Quantitation for Inherited Metabolic Disorders (BGL2)• Diagnosis by analyzing amino acid

concentrations in the body fluidso Monitors the analytical quality of amino acids in plasma

• Inherited metabolic disorders may be serious in newbornso Inability to metabolize amino acids

o Accumulates harmful substances in the body

• Early diagnosis and treatment are critical

41

Graphic source: https://unsplash.com/photos/D66zZdIAXLc


2021 New CAP PT – BGL2Biochemical and

Molecular GeneticsBGL2 – Amino Acid Quantitation for

Inherited Metabolic DisordersUsage Amino acid quantitation monitors the analytical quality of amino acids

in plasmaTesting uses LC-MS/MS, an amino acid analyzer, and/or high/ultra-

performance liquid chromatography (HPLC/UPLC) for screeningBenefits Evaluate the amino acid analytical measurement range

Provide target concentrations seen in pathological states or treated patients of inborn errors of metabolism

24 amino acid analyte targets that expand the analytical measurement range

Who would participate CRO, Reference/chain/commercial, Hospital – University, Private and Public/Government, and Molecular/Genetics

Locations with emphasis on early pediatric medicineOther programs lab may be interested in / currently buying

BGL


2020 42


HLA Crossmatching Antibody Screen/Id and Antibody Identification (Class l and Class ll)• Better mimics patient testing

• Combined program offers shipping and pricing benefits

o MX1B and MX2B MXB

o MX1C and MX2C MXC

o MX1E and MX2E MXE

43

Auto-conversion from MX1B/MX2B, MX1C/MX2C and MX1E/MX2E, correspondingly


2021 New CAP PT – MXB-MXC-MXE

Histocompatibility MXB-MXC-MXE – HLA Crossmatching, Antibody Screen, and Antibody Identification (Class I/Class II)

Usage Identify the presence of HLA antigens and negative/positive crossmatch results for organ or bone marrow transplants

Benefits New configurations more closely resemble actual patient testingShipping costs are reduced due to combined program for both

Class I and Class II antigen reportingWho would participate Hospital – University, Private and Public/GovernmentOther programs lab may be interested in / currently buying

B27, DML, DADR1/DADR2, ME


1 September 2020 44

Auto-conversion from MX1B/MX2B, MX1C/MX2C and MX1E/MX2E, correspondingly


New Quality Programs

1 September 2020 45


What Are Quality Management Tools?Ready-to-use studies to assist laboratories in improving:• Processes• Work efficiencies• Better patient care

Address issues at each phase of testing: • Pre-analytic • Analytic • Post-analytic

Information located in:• 2021 Surveys Catalog • 2021 New Programs Booklet

46


2021 New CAP PT – QP211Quality Management Tools QP211 – Antimicrobial Susceptibility Testing:

Monitoring and Trend AnalysisUsage Laboratories must calculate antimicrobial sensitivity and provide this

information to their pharmacy per CAP MIC.21946 and Joint Commission MM09.01.01

Results of this study can be used to plan their antimicrobial susceptibility reports for the laboratory and antimicrobial stewardship hospital committee, as well as to develop action plans

Benefits Monitor emerging trends in resistance at the local level, to support clinical decision-making, and to evaluate infection control interventions

Informs antimicrobial stewardship efforts and provides benchmarking opportunities

Provides results to optimize required microbiology susceptibility testing and reporting

Guides Pharmacy and Therapeutics Committee formulary decisionsWho would participate University hospitals, county hospitals, large urban center hospitalsOther programs lab may be interested in / currently buying

D, D1, D2, D3, RMC

Mailing Information N/A1 September

2020 47


2021 New CAP PT – QP212Quality Management

ToolsQP212 – Technical Competency Assessment

of Gram StainsUsage Assess the individual technologist's ability to evaluate Gram

stained smears using online, whole slide images for technologists

Benefits Meets applicable CLIA, CAP Laboratory Accreditation, and Joint Commission personnel competency requirements

Fulfills a microbiology requirement for Gram stain reading of morphology by individual for up to ten technologists

Takes this review process off the desk of the manager/supervisorWho would participate Any laboratory with a microbiology sectionOther programs lab may be interested in / currently buying

D, D1, D2, D3, D5, QP211, QT2, QT3, QT4, QT5, QT7, QT8, QT10, QT15, QT16, QT17, RMC and VGS1/2

Mailing Information Online whole slide images

1 September 2020 48


2021 New CAP PT – QP213 Quality Management Tools QP213 – Physician Satisfaction with the Clinical Laboratory

Usage Physician satisfaction survey for the laboratory deployed by the CAP Topics include turnaround time, critical value notification, diagnostic

accuracy, communication, accessibility, responsiveness, and courtesySurvey respondents will also indicate whether they would recommend

the laboratory to another physicianBenefits Meets CAP General Checklist Statements and Joint Commission

Standards and Elements of Performance that require customer satisfaction queries

Online use eliminates supervisor data input - the clinician survey results go right to CAP database

Performance indicators include laboratory recommendation rate (%) and mean satisfaction scores for various categories, helping to find areas of improvement and benchmark against their peers

Who would participate Any labOther programs lab may be interested in / currently buying

AQ, C, D, F, J, IgX, S2/4/5, K, QT1, QT2, QT3, QT4, QT7, QT8, QT10, QT15, QT16, QT17, QP211, QP212

Mailing Information N/A1 September

2020 49


Additional Notifications

1 September 2020 50


2021 Order Renewal Packet Inserts

1 September 2020 51

New Program Flyer Direct Transmission Flyer CVL Flyer


More 2021 Order Renewal Packet Inserts

1 September 2020 52

CAP Laboratory Accreditation Flyer CE Flyer Performance Analytics Dashboard Flyer


Final Two 2021 Order Renewal Packet Inserts

1 September 2020 53

Competency Assessment Program FlyerQuality Management Tools Flyer


2021-2020 New Program Booklet: How to Use It

54


Discontinuing Programs as Part of Customer Service• Annual review

• Evaluation factors includeo Regulatory agencies requirements

o Changing technologies

• Keeping customer needs first

55


Discontinued Programs List for 2021

1 September 2020 56

Program Code Program NameAuto-

conversion needed?

Auto-converted to?

K2 Ligands, Limited Yes K

FH15 Centrifugal Hematology No

GPBC Gram Positive Blood Culture Yes BCM

GNBC Gram Negative Blood Culture Yes BCM

LN43 Lamellar Body Count CVL No

MX1B/MX2B HLA Antibody Screen/ID & Crossmatch Yes MXB

MX1C/MX2C HLA Antibody Screen/ID & Crossmatch Yes MXC

MX1E/MX2E HLA Antibody Screen/ID & Crossmatch Yes MXE

TNT Cardiac Markers Yes HTNT or TNT5


Binder Update

57

• Beginning in 2021 and after:o Single, unifying cover graphic

o Binder spine shows the year

• Improve timeliness while maintaining support for the binder


Improving Customer Experience through Technology• Supporting labs through the COVID-19 pandemic on cap.orgo Educational information

o Podcasts

o Updates

• Performance Analytics Dashboard provideso Comprehensive view of performance

o View/export EQA / PT results

o Complimentary web-based key insight reports

• Complementary Direct Transmission of PT results using Data Innovations

• Accredited laboratories also benefit from:o Streamlined the online application and reapplication process

o Expanded resources and improved access on ELSS

1 September 2020 58


Order Renewal 2021 has Opportunity

• 24 new proficiency testing and quality improvement programs

• New PT to address evolving needso SARS-CoV-2

o High sensitivity troponin

• Comprehensive test program including esoteric tests to support new technologies

• Support for our partners with order renewal materials

1 September 2020 59

Source: https://unsplash.com/photos/OEpC6UQrWQU


Thank you. ありがとうございます.

Questions?

1 September 2020 60


Program Information from Order Renewal 2020

Appendix

1 September 2020 62


Discontinued Programs List for 2020

1 September 2020 63

Program Code Program NameAuto-

conversion needed?

Auto-converted to?

D4 Bacteriology―Limited Yes RMC

D7 Throat/Urine Culture Yes RMC

MC1 Microbiology―Combination w/GC Yes RMC

MC2 Microbiology―Combination Yes RMC

MC5 Throat & Urine Culture/Rapid Strep A AG Detection Yes RMC

FH14/FH14P Hematology Automated Differential No

SW3 Sweat Analysis No


Don’t forget 2020 New Proficiency Tests

1 September 2020 64


New 2020 Programs

1 September 2020 65

Section Number of New Program CodesAnatomic Pathology 4Biochemical/Molecular Genetics 1Histocompatibility 4Immunology and Flow Cytometry 1Microbiology 3Quality Cross Check 1Surgical Pathology 1Virology 1


2020 New CAP PT – AABT, AABT1, AABT2, AABT3Transfusion Medicine AABT, AABT1, AABT2, AABT3 – Antibody Titer-Automated

Usage Detect the reactivity of antibodies present in thepatient's plasmaEach program corresponds to a specific titer:• AABT1 is for Anti-A titer• AABT2 is for Anti-B titer• AABT3 is for Anti-D titer• AABT is for all three

Benefits Program for all antibody titers (Anti-A, Anti-B, and Anti-D)More applicable peer group comparisonsWorks with both automated analyzers and manual processes



ABT, ABT1, ABT2, ABT3

Mailing Information AABT: 2 challenges x 2 mailingsAABT1, AABT2, AABT3: 1 challenges x 2 mailings

1 September 2020 66


2020 New CAP PT – CRTQQuality Cross Check CRTQ – Cardiac Markers Quality Cross Check

Usage Biomarkers measured to evaluate heart function and useful in the early prediction or diagnosis of disease

Benefits Compares the data of up to three instruments in the laboratoryWho would participate Hospital – University, Private and Public/GovernmentOther programs lab may be interested in / currently buying

CRT, CRTI, PCARI, PCARM, PCARMX


1 September 2020 67


2020 New CAP Exercise – CYHIBiochemical/

Molecular GeneticsCYHI – HER2 Gene Amplification by FISH,

Interpretation OnlyUsage HER2 which promotes the growth of cancer cells and tends to be a

more aggressive type of breast cancerFor laboratories that perform interpretation only for HER2 FISH for breast cancerParticipants will provide an interpretation for the data given

Benefits Meet requirements for alternative performance assessmentProvides a method for the Cytopathology Committee to assess the quality of laboratories that interpret only

Who would participate CRO, Reference/chain/commercial, Hospital – University, Private and Public/Government, and Molecular/GeneticsAdditional participants would be locations that perform HER2 (ERBB2) interpretation only (off site hybrid), FISH


CYH, HER2

Mailing Information 3 online x 2 per year

1 September 2020 68


2020 New CAP PT – DPIHCSurgical Pathology DPIHC – Dermatopathology Immunohistochemistry

Usage Dermatopathology laboratories are testing for these analytesAddresses proficiency testing needs for dermatopathology laboratories

Benefits Includes two markers from a list of the most commonly used markers in dermatopathologyOnly program that tests both pre- and post-analytic phases of this IHC testingAdvance the therapeutic usage within dermatopathology labs.

Who would participate Hospital – University, Private and Public/GovernmentAdditional participants would be dermatopathology laboratories


DPATH, DPATH1

Mailing Information 2 cases (6 slides) x 2 mailings

1 September 2020 69


2020 New CAP PT – FL6 Immunology and Flow Cytometry

FL6 ― Flow Cytometry, Post-immunotherapy Analysis

Usage Immunotherapy is increasingly being used but interferes with the detection and/or decreasing the expression of the targeted antigen Familiarize participants with the effects of immunotherapy on flow cytometric analysis – interpretation only

Benefits Removes need to perform alternative assessment for this functionProvides real-life case materials including digital whole slide images and gated dot plots to provide an interpretationOffers learning opportunity through comparison against the actual case interpretationIncreases understanding of the effect of immunotherapy treatment on flow cytometric analysis/interpretation

Who would participate Hospital – University, Private and Public/GovernmentAdditional participants would be laboratories performing flow cytometric analysis on samples from patients treated with CAR T-cell or other immunotherapy that cause immunophenotypic changes to normal and/or neoplastic cells


FL1, FL3, FL5, PCNEO


1 September 2020 70


2020 New CAP PT – HQNEUAnatomic Pathology HQNEU – CAP/NSH HistoQIP Central Nervous System IHC

Usage Gliomas are a type of tumor that starts in the glial cells of the brain or spineIn 2016, the WHO updated classification of tumors with an emphasis on the integration of histology and molecular techniques to diagnose these tumors

Benefits Focuses on hematoxylin and eosin stains and immunostains for the diagnosis and classification of gliomas in histologic preparationsTargets quality of histologic preparations of central nervous system specimens with emphasis on tumor specimensCovers most common gliomas and appropriate immunostains



HQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR, HQWSI, HQISH

Mailing Information 5 challenges x 2 mailingsSubmit up to three IHC and two H&E stained cover slipped glass slides per mailing

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2020 New CAP PT – HQISHAnatomic Pathology HQNEU – CAP/NSH HistoQIP In-Situ Hybridization (Kappa/Lambda)

Usage DNA/RNA in-situ hybridization staining can be adopted on commonly utilized immunohistochemistry instruments and allows for certain interpretation methods in formalin-fixed, paraffin-embedded tissues and bone marrows with a clinical sensitivity similar or superior to flow cytometryFor breast prognostic factor testing (ie, ER, PR, HER-2), preanalytic variables can dramatically affect IHC test performance and interpretation

Benefits Evaluation of preanalytic variables affecting quality of in-house in-situ hybridization techniques (fixation, processing, microtomy, staining) using tissue from the participating laboratory



HQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR, HQWSI, ISH, ISH2

Mailing Information 5 challenges x 2 mailingsSubmit an H&E, positive and negative reagent control slides and kappa and lambda DNA/RNA ISH stained cover slipped glass slides (one from each category) per mailing

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2020 New CAP PT – HQMELAnatomic Pathology HQNEU – CAP/NSH HistoQIP Melanoma IHC

Usage Melanoma arises from mutated skin cellsThe main goal of the program is to assess overall quality of the submitted hematoxylin and eosin (H&E) stains and the three different immunostains performed

Benefits Focus on skin surgical biopsies and resections for melanoma diagnosisOffer H&E and immunohistochemical stain challenges exclusively targeting pathology practices and laboratories with a large or exclusive volume of skin melanoma specimens (ie, skin biopsy and resection specimens)

Who would participate Reference/chain/commercial and Hospital – University, Private and Public/GovernmentAdditional participants would be dermatopathology laboratories


BRAF, BRAFVHQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR, HQWSI, HQISH, HQNEU

Mailing Information 5 challenges x 2 mailingsSubmit up to three IHC and two H&E stained cover slipped glass slides per mailing

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2020 New CAP PT – ID5 Virology ID5 – HSV, VZV, Molecular

Usage Several laboratory diagnostic methods are available for the diagnosis, differentiation, and subtyping of HSV and VZV infections (Herpes Simplex Viruses and Varicella Zoster Virus)

Benefits Test specimens simultaneously for herpes simplex virus (HSV) and varicella zoster virus (VZV) using molecular techniques

Who would participate CRO, Reference/chain/commercial, Hospital – University, Private and Public/Government, and Molecular/GeneticsAdditional participants would be laboratories performing molecular testing for HSV and VZV


ID1, HC2, HC4, IDME, VR1, VR2, VR3


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2020 New CAP PT – IDPN Microbiology IDPN – Infectious Disease, Pneumonia Panel

Usage Pneumonia patients are frequently over-treated with antibiotics because it is difficult to identify the pathogen responsible for their symptoms quicklyThe BioFire® FilmArray® pneumonia panel identifies 33 clinically relevant targets from sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL) samples

Benefits Test the 33 targets of the Biofire FilmArray pneumonia panel which includes bacteria, viruses and resistance mechanismsWill allow for the reporting of bacteria, virus, and resistance mechanismsSemi-quantitative results will be educational, but all reporting combined into one program

Who would participate Reference/chain/commercial, Hospital – University, Private and Public/Government, and Molecular/GeneticsAdditional participants would be molecular multiplex users who want proficiency testing for lower respiratory pneumonia panels such as Biofire


IDR


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2020 New CAP PT – MGENMicrobiology MGEN – Mycoplasma genitalium Molecular

Usage M. genitalium is an STI that has proven more common than previously thought and is often difficult to diagnose and treatHologic’s assay can detect this STI

Benefits Designed for Hologic Aptima® Mycoplasma genitalium assay, thus allowing molecular detection of an important pathogen

Who would participate Hospital – University, Private and Public/Government and Molecular/GeneticsAdditional participants would be laboratories that detect Mycoplasma genitalium by molecular methods such as Hologic's Aptima assay


TVAG, MVP


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2020 New CAP PT – MYCB Anatomic Pathology MYCB – c-Myc/Bcl-2 Immunohistochemistry TMA

Usage MYC and Bcl-2 expression are prognostic in diffuse large B-cell lymphoma and may influence therapy selection

Benefits MYC and Bcl-2 are commonly test in IHC laboratories today and are emerging as predictive for targeted therapies (although at this time there are no such therapies approved on the market)



PM1, PM3, BRAFV, PDL1, CV30, P16, PM5, PM6, maybe HER2/GHER2 and PM2

Mailing Information 2 slides x 2 mailings

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2020 New CAP PT – RMC Microbiology RMC – Routine Microbiology Combination

Usage Basic microbiology testing: urines, throats, genital source for GC, molecular and bacterial antigen testing, gram stains, or urine susceptibility testing

Benefits Comprehensive PT for basic microbiology testing in one programWho would participate CRO, Reference/chain/commercial and Hospital – University,

Private and Public/GovernmentAdditional participants would be laboratories and doctor office laboratories that provide limited Microbiology testing and need a CMS required program


D5 and QP212


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2021 order renewal · 1 september 2020 3 • overview of the new 2021 programs • auto-conversions...

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