2021 Order Renewal New program focus exclusively for CGI - September 2, 2020
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2021 Order Renewal
New program focus
exclusively for CGI
Corrine Cagney, MT (HEW) September 2, 2020
Senior Technical Marketing Manager
© College of American Pathologists.
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.
1 September
© College of American Pathologists. 2
2020
Agenda
• Overview of the new 2021 programs
• Auto-conversions
• Top programs
• New program information
• Proficiency Tests
• Quality Management Tools
• Additional notifications
• Appendix with 2020 information
1 September
© College of American Pathologists. 3
2020
Highlights of New Offering
• 24 new proficiency testing and quality
improvement programs
• Aligned to meet the changes of
cutting-edge laboratory medicine
o Proficiency testing programs for SARS-CoV-2
o More microbiology programs to meet the newest
instruments and methods
1 September
© College of American Pathologists. 4
2020
24 New 2021 Programs, including SARS-CoV-2
Section Number of New Program Codes
Bacteriology 1
Biochemical and Molecular Genetics 1
Flow Cytometry 4
General IHC 1
Hematology 1
Histocompatibility 3
Immunology 1
Microbiology 5
Molecular Microbiology 1
Quality Management Tools 3
Routine Chemistry 3
1 September
© College of American Pathologists. 5
2020
8 of the 22 will be Auto-Conversions
New Program Auto-Converting
New 2020 Program Rationale
Code from*
Combining two programs to one that includes
Bacterial Blood Culture, both gram positive and gram negative. Reflects
BCM GPBC, GNBC
Molecular technology improvement that allows for both to
be tested together.
FH 16: Hematology Automated
FH16/ Differential Series FH3 Unicell DxH Optimizes technology of Unicell DxH 500 unit
FH16P FH16P: Hematology Automated 500 series to FH16 (better peer group data)
Diff-Blood Cell ID
High-Sensitivity Cardiac
HCRT CRT by method
Markers CRT
High-Sensitivity Cardiac Supports technology advancement and different
HCRTI CRT by method
Markers CRTI units of measure and clinically reportable ranges
High-Sensitivity Cardiac TNT2 and TNT5
HTNT
Markers TNT by method
MXB MX1B and MX2B Combining two programs to better mimic patient
HLA Crossmatching, Antibody
testing and easier for customers currently having
MXC Screen, and Antibody MX1C and MX2C
to purchase more than one program to fulfill their
Identification (Class I/Class II)
MXE MX1E and MX2E PT needs
1 September
© College of American Pathologists. *Red denotes discontinuing in 2021 2020
6
Top New 2021 Programs for Growth
New Program Code New Program Name
COV2 SARS-CoV-2 Molecular*
COVS SARS-CoV-2 Serology*
HCRT High-Sensitivity Cardiac Markers CRT
COVAG SARS-CoV-2 Antigen*
COV2Q Quality Cross Check−SARS-CoV-2 Molecular*
BCM Bacterial Blood Culture, Molecular
HTNT High-Sensitivity Cardiac Markers TNT
YBC Yeast Blood Culture, Molecular
KI67 Ki-67 Immunohistochemistry Microarray
HCRTI High-Sensitivity Cardiac Markers CRTI
FH16/FH16P Hematology Automated Differential Series
QP211 Antimicrobial Susceptibility Testing: Monitoring and Trend Analysis
*Released mid-year 2020 to help laboratories address COVID-19 pandemic
1 September
© College of American Pathologists. 7
2020
New Program Information
Microbiology
© College of American Pathologists.
1 September
© College of American Pathologists. 8
2020
New Microbiology Programs Address
Changing Needs
• Most routine testing with wide appeal
• Supports the changing technology and available panels
• Five programs
o 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
© College of American Pathologists. 9
2020
What are the Different Tests for SARS-CoV-2?
Molecular Serology Antigen
• Diagnose • Not for • Diagnose
disease diagnosis disease
• Detects active • Detects the • Detects the
infections with presence of presence of
SARS-CoV-2 antibodies SARS-CoV-2
against the
SARS-CoV-2
virus
1 September
© College of American Pathologists. 10
2020SARS-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
© College of American Pathologists. 112021 New CAP PT – COV2
Microbiology COV2 – SARS-CoV-2 Molecular
Usage Targeting SARS-CoV-2
• agent causing COVID-19
• includes CDC and WHO sequence targets
Whole genome of SARS-CoV-2 and includes all sequence targets
across assay platforms for laboratories performing nucleic acid
amplification
Benefits Uses non-infectious nucleic acid
Meets accreditation requirements for alternative performance
assessment
Who would participate CRO, Molecular/Genetics, Reference/chain/commercial and Hospital
– University, Private and Public/Government
Locations focused on population health and molecular SARS-CoV-2
testing
Other programs lab may be COVS, ID2, ID3, IDR, IDPN
interested in / currently buying
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 12
2020Quality Cross Check : NEW!
Available for order
SARS-CoV-2 Molecular (COV2Q) now & OR 2021
• 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 Check
o Risk-free solution for monitoring all the instruments in the laboratory
o Test up to 3 instruments with 3 challenges per mailing
o Not PT
© College of American Pathologists. 13SARS-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
© College of American Pathologists. 142021 New CAP PT – COVS
Immunology 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 IgA
Meets accreditation requirements for alternative performance
assessment
Should meet needs for many new laboratories adding serological
testing to their test menus
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private
and Public/Government
Additional participants would be locations focused on population health
and SARS-CoV-2 testing
Other programs lab may be COV2, G, IG,
interested in / currently buying S and S2
To a lesser extent, any of the other immunology PT programs.
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 15
2020NEW!
SARS-CoV-2 Antigen (COVAG) Available for order
now & OR 2021
• 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
© College of American Pathologists. 16How do Cytokines and Procalcitonin Testing
Support the COVID-19 Pandemic?
• Infection with SARS-CoV-2 mobilizes a wide variety of biomolecules,
SARS-CoV-2
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
Immunological
Response o Preferentially targeting lung tissue per US NIH
• Procalcitonin (PCT)
o Serial measurement may predict a more severe form of the COVID-19 disease
Possibly o Procalcitonin from extrathyroidal sources enormously amplified during bacterial
increased infections
• Cytokines
o Recently shown in children with viral lower respiratory tract infections per US
• Procalcitonin
NIH
© College of American Pathologists. 17Yeast Blood Culture (YBC)
• For molecular blood culture instruments
• First step in identification before culture
o 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
© College of American Pathologists. 182021 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
Other programs lab may be Bacterial Blood Culture, molecular program (BCM)
interested in / currently Complements YBC for systems that also detect bacteria by
buying molecular methods
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 19
2020Auto-conversion from
2021 New CAP PT – BCM GPBC and GNBC
Bacteriology 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 culture
Benefits 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
Other programs lab may be BCS, BCS1 and new YBC (Yeast Blood Culture) complements
interested in / currently BCM for systems that also detect yeast by molecular methods
buying
Mailing Information 5 challenges x 3 mailings
Gram stain will be provided so that, if applicable, laboratories
would know which panel to use
1 September
© College of American Pathologists. 20
20202021 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 platforms
Benefits 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 regulated
Who would participate Reference/chain/commercial, Hospital – University, Private and
Public/Government, and Molecular/Genetics
Other programs lab may be ID5, IDME
interested in / currently
buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 21
20202021 New CAP PT – MTR5
MTR5 – Molecular MTB Detection and Resistance,
Microbiology
5 Challenge
Usage Detection of Mycobacterium tuberculosis and the detection of
rifampin resistance in sputum specimens
Primarily designed for the Cepheid GeneXpert® system using the
Xpert® MTB/RIF test kit, at the request of the manufacturer
Benefits Includes reporting of rifampin resistance
Material cannot be cultured
Who would participate CRO, Reference/chain/commercial, Hospital – University, Private
and Public/Government, and Molecular/Genetics
Other programs lab may be MTBR (3 challenges with 2 mailings)
interested in / currently E and E1 for laboratories that perform AFB smears and
buying identification of Mycobacterium
Mailing Information 5 challenges x 2 mailings
1 September
© College of American Pathologists. 22
2020New Program Information
Routine Chemistry
© College of American Pathologists.
1 September
© College of American Pathologists. 23
2020New Routine Chemistry Programs Address
Higher Sensitivity Troponin Assays
• No competitive equivalent
• Three programs
o HCRT
o HCRTI
o HTNT
1 September
© College of American Pathologists. 24
2020High-Sensitivity Troponin Programs Auto-conversion from
CRT, CRTI,
TNT and TNT5
(HCRT, HCRTI, HTNT)
• Evaluation of patients with myocardial infarction or
injury
• Higher analytical sensitivity than current
Troponin I assays
o Different reporting units
o Lower limits of reporting
• Limited competition with significant peer group
sizes for data comparison
© College of American Pathologists. 25Auto-conversion from
CRT, CRTI,
2021 New CAP PT – HCRT TNT and TNT5
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
Other programs lab may be LN25, LN27, QT15, PCARI, PCARM and PCARMX
interested in / currently buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 26
2020Auto-conversion from
CRT, CRTI,
2021 New CAP PT – HCRTI TNT and TNT5
Routine 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
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private
and Public/Government
Other programs lab may be LN25, LN27, QT15, PCARI, PCARM, PCARMX
interested in / currently buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 27
2020Auto-conversion from
CRT, CRTI,
2021 New CAP PT – HTNT TNT and TNT5
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
Who would participate CRO, Reference/chain/commercial and Hospital – University,
Private and Public/Government
Other programs lab may be CRT, CRTI, CRTQ, LN25, LN27, QT15,
interested in / currently PCARI, PCARM and PCARMX
buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 28
2020New Program Information
Hematology
© College of American Pathologists.
1 September
© College of American Pathologists. 29
2020Hematology Automated Differential Auto-conversion from
FH3/FH3P by
instrument
Series (FH16/FH16P)
• Specifically designed for Beckman Coulter DxH 500 Series
users
o Includes nucleated red blood cell parameter (nRBC)
• Opportunity for CE credit
• Auto-converted by instrument to better meet their testing
needs
o FH3 laboratories using the DxH 500 FH16
o FH3P laboratories using the DxH 500 FH16P
© College of American Pathologists. 30Auto-conversion from
FH3/FH3P by
2021 New CAP PT – FH16/FH16P instrument
FH16 – Hematology Automated Differential Series
Hematology
FH16P – Hematology Automated Diff-Blood Cell ID
Usage 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 series
Includes 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 credit
Who would participate Coulter Unicel DxH 500 and DxH 520 users
CRO, Reference/chain/commercial and Hospital – University, Private
and Public/Government
Other programs lab may be EHE1, FH3Q, RT3, RT3Q and VPBS
interested in / currently buying
Mailing Information 5 challenges x 3 mailings
FH16P includes ten images
1 September
© College of American Pathologists. 31
2020New Program Information
Flow Cytometry
© College of American Pathologists.
1 September
© College of American Pathologists. 32
2020Helping Laboratories Get the Most Benefit
from 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 programs
o 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 https://labtestsonline.org/flow-cytometry
1 September
© College of American Pathologists. 33
20202021 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 platforms
Absolute 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 subsets
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private
and Public/Government
Other programs lab may be B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL8, FL9,
interested in / currently buying PCNEO, PNH,
RFAV1, RFAV2 and RFAV3
Mailing Information 2 challenges x 2 mailings
1 September
© College of American Pathologists. 34
20202021 New CAP PT – FL8
FL8 – Flow Cytometry, Mature B-Cell Leukemia/Lymphoma
Flow Cytometry
Minimal Residual Disease
Usage Detect if minimal residual disease is present for Mature B-Cell
Leukemia/Lymphomas
Growing need and demand for quality assurance programs for
flow cytometry laboratories performing minimal residual disease
testing
Benefits Supports minimal residual disease testing
Benchmark MRD levels against peers
Who would participate CRO, Reference/chain/commercial and Hospital – University,
Private and Public/Government
Other programs lab may be B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL9,
interested in / currently PCNEO, PNH,
buying RFAV1, RFAV2, and RFAV3
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 35
20202021 New CAP PT – FL9
FL9 – Flow Cytometry, Plasma Cell Myeloma
Flow Cytometry
Minimal Residual Disease
Usage Detect if minimal residual disease is present for plasma cell
myeloma
Growing need and demand for quality assurance programs for
flow cytometry laboratories performing minimal residual disease
testing
Benefits Supports minimal residual disease testing
Benchmark MRD levels against peers
Who would participate CRO, Reference/chain/commercial and Hospital – University,
Private and Public/Government
Other programs lab may be B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL8,
interested in / currently PCNEO, PNH,
buying RFAV1, RFAV2, and RFAV3
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 36
20202021 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.23737
Targets all laboratory personnel, including the pathologist and the
laboratory technicians/technologists
Who would participate CRO, Reference/chain/commercial and Hospital – University,
Private and Public/Government
Other programs lab may be B-ALL, FL, FL2, FL3, FL4, FL5, FL6, FL7, FL8, FL9, PCNEO,
interested in / currently PNH, RFAV1 and RFAV2
buying
Mailing Information 1 sample x 2 mailings
1 September
© College of American Pathologists. 37
2020New Program Information
Advanced Offering
© College of American Pathologists.
1 September
© College of American Pathologists. 38
2020Each Program is Focused
• KI67 – Immunohistochemistry Microarray
o 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 Disorders
o Analytical quality of amino acids in plasma
o Inherited metabolic disorders may be serious in newborns
1 September
© College of American Pathologists. 39
20202021 New CAP PT – KI67
General IHC KI67 – Immunohistochemistry Microarray
Usage Ki67 is a nuclear protein expressed higher in malignant tissues
In 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 material
Will have a definitive number of immunoreactive cells, making it a truly
quantitative survey
Provides formal program for assessment of Ki-67 as a prognostic marker
for cancer and added cumulative data on methodology performance and
usage
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private and
Public/Government
Additional participants would be cancer treatment centers and those using
image analysis
Other programs lab may be HER2, PM2
interested in / currently buying
Mailing Information 10 challenges x 2 mailings
1 September
© College of American Pathologists. 40
2020Amino Acid Quantitation for Inherited Metabolic
Disorders (BGL2)
• Diagnosis by analyzing amino acid
concentrations in the body fluids
o Monitors the analytical quality of amino acids in plasma
• Inherited metabolic disorders may be serious
in newborns
o Inability to metabolize amino acids Graphic source: https://unsplash.com/photos/D66zZdIAXLc
o Accumulates harmful substances in the body
• Early diagnosis and treatment are critical
© College of American Pathologists. 412021 New CAP PT – BGL2
Biochemical and BGL2 – Amino Acid Quantitation for
Molecular Genetics Inherited Metabolic Disorders
Usage Amino acid quantitation monitors the analytical quality of amino acids
in plasma
Testing uses LC-MS/MS, an amino acid analyzer, and/or high/ultra-
performance liquid chromatography (HPLC/UPLC) for screening
Benefits 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 medicine
Other programs lab may be BGL
interested in / currently buying
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 42
2020HLA Crossmatching Antibody Auto-conversion from
MX1B/MX2B, MX1C/MX2C and
Screen/Id and Antibody MX1E/MX2E, correspondingly
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
© College of American Pathologists. 43Auto-conversion from
2021 New CAP PT – MXB-MXC-MXE MX1B/MX2B, MX1C/MX2C and
MX1E/MX2E, correspondingly
MXB-MXC-MXE – HLA Crossmatching, Antibody Screen, and
Histocompatibility
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 testing
Shipping costs are reduced due to combined program for both
Class I and Class II antigen reporting
Who would participate Hospital – University, Private and Public/Government
Other programs lab may be B27, DML, DADR1/DADR2, ME
interested in / currently
buying
Mailing Information 4 challenges x 3 mailings
1 September
© College of American Pathologists. 44
2020New Quality Programs
© College of American Pathologists.
1 September
© College of American Pathologists. 45
2020What 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
© College of American Pathologists. 462021 New CAP PT – QP211
QP211 – Antimicrobial Susceptibility Testing:
Quality Management Tools
Monitoring and Trend Analysis
Usage 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 decisions
Who would participate University hospitals, county hospitals, large urban center hospitals
Other programs lab may be D, D1, D2, D3, RMC
interested in / currently buying
Mailing Information N/A
1 September
© College of American Pathologists. 47
20202021 New CAP PT – QP212
Quality Management QP212 – Technical Competency Assessment
Tools of Gram Stains
Usage 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/supervisor
Who would participate Any laboratory with a microbiology section
Other programs lab may be D, D1, D2, D3, D5, QP211, QT2, QT3, QT4, QT5, QT7, QT8,
interested in / currently QT10, QT15, QT16, QT17, RMC and VGS1/2
buying
Mailing Information Online whole slide images
1 September
© College of American Pathologists. 48
20202021 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 courtesy
Survey respondents will also indicate whether they would recommend
the laboratory to another physician
Benefits 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 lab
Other programs lab may be AQ, C, D, F, J, IgX, S2/4/5, K, QT1, QT2, QT3, QT4, QT7, QT8, QT10,
interested in / currently buying QT15, QT16, QT17, QP211, QP212
Mailing Information N/A
1 September
© College of American Pathologists. 49
2020Additional Notifications
© College of American Pathologists.
1 September
© College of American Pathologists. 50
20202021 Order Renewal Packet Inserts
New Program Flyer Direct Transmission Flyer CVL Flyer
1 September
© College of American Pathologists. 51
2020More 2021 Order Renewal Packet Inserts
CAP Laboratory Accreditation Flyer CE Flyer Performance Analytics Dashboard Flyer
1 September
© College of American Pathologists. 52
2020Final Two 2021 Order Renewal Packet Inserts
Quality Management Tools Flyer Competency Assessment Program Flyer
1 September
© College of American Pathologists. 53
20202021-2020 New Program Booklet: How to Use It © College of American Pathologists. 54
Discontinuing Programs as Part of Customer Service • Annual review • Evaluation factors include o Regulatory agencies requirements o Changing technologies • Keeping customer needs first © College of American Pathologists. 55
Discontinued Programs List for 2021
Auto-
Auto-converted
Program Code Program Name conversion
to?
needed?
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
1 September
© College of American Pathologists. 56
2020Binder Update
• Beginning in 2021 and after:
o Single, unifying cover graphic
o Binder spine shows the year
• Improve timeliness while maintaining
support for the binder
© College of American Pathologists. 57Improving Customer Experience through Technology
• Supporting labs through the COVID-19 pandemic on cap.org
o Educational information
o Podcasts
o Updates
• Performance Analytics Dashboard provides
o 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
© College of American Pathologists. 58
2020Order Renewal 2021 has Opportunity
• 24 new proficiency testing and quality
improvement programs
• New PT to address evolving needs
o 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
Source: https://unsplash.com/photos/OEpC6UQrWQU
1 September
© College of American Pathologists. 59
2020Questions?
Thank you. ありがとうございます.
© College of American Pathologists.
1 September
© College of American Pathologists. 60
2020© College of American Pathologists.
Appendix
Program Information from Order Renewal 2020
© College of American Pathologists.
1 September
© College of American Pathologists. 62
2020Discontinued Programs List for 2020
Auto-
Auto-converted
Program Code Program Name conversion
to?
needed?
D4 Bacteriology―Limited Yes RMC
D7 Throat/Urine Culture Yes RMC
MC1 Microbiology―Combination w/GC Yes RMC
MC2 Microbiology―Combination Yes RMC
Throat & Urine Culture/Rapid Strep A AG
MC5 Yes RMC
Detection
FH14/FH14P Hematology Automated Differential No
SW3 Sweat Analysis No
1 September
© College of American Pathologists. 63
2020Don’t forget 2020 New Proficiency Tests
© College of American Pathologists.
1 September
© College of American Pathologists. 64
2020New 2020 Programs
Section Number of New Program Codes
Anatomic Pathology 4
Biochemical/Molecular Genetics 1
Histocompatibility 4
Immunology and Flow Cytometry 1
Microbiology 3
Quality Cross Check 1
Surgical Pathology 1
Virology 1
1 September
© College of American Pathologists. 65
20202020 New CAP PT – AABT, AABT1, AABT2, AABT3
Transfusion Medicine AABT, AABT1, AABT2, AABT3 – Antibody Titer-Automated
Usage Detect the reactivity of antibodies present in the
patient's plasma
Each 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 comparisons
Works with both automated analyzers and manual processes
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private
and Public/Government
Other programs lab may be ABT, ABT1, ABT2, ABT3
interested in / currently buying
Mailing Information AABT: 2 challenges x 2 mailings
AABT1, AABT2, AABT3: 1 challenges x 2 mailings
1 September
© College of American Pathologists. 66
20202020 New CAP PT – CRTQ
Quality 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 laboratory
Who would participate Hospital – University, Private and Public/Government
Other programs lab may be CRT, CRTI, PCARI, PCARM, PCARMX
interested in / currently
buying
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 67
20202020 New CAP Exercise – CYHI
Biochemical/ CYHI – HER2 Gene Amplification by FISH,
Molecular Genetics Interpretation Only
Usage HER2 which promotes the growth of cancer cells and tends to be a
more aggressive type of breast cancer
For laboratories that perform interpretation only for HER2 FISH for
breast cancer
Participants will provide an interpretation for the data given
Benefits Meet requirements for alternative performance assessment
Provides 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/Genetics
Additional participants would be locations that perform HER2 (ERBB2)
interpretation only (off site hybrid), FISH
Other programs lab may be CYH, HER2
interested in / currently buying
Mailing Information 3 online x 2 per year
1 September
© College of American Pathologists. 68
20202020 New CAP PT – DPIHC
Surgical Pathology DPIHC – Dermatopathology Immunohistochemistry
Usage Dermatopathology laboratories are testing for these analytes
Addresses proficiency testing needs for dermatopathology
laboratories
Benefits Includes two markers from a list of the most commonly used
markers in dermatopathology
Only program that tests both pre- and post-analytic phases of this
IHC testing
Advance the therapeutic usage within dermatopathology labs.
Who would participate Hospital – University, Private and Public/Government
Additional participants would be dermatopathology laboratories
Other programs lab may be DPATH, DPATH1
interested in / currently
buying
Mailing Information 2 cases (6 slides) x 2 mailings
1 September
© College of American Pathologists. 69
20202020 New CAP PT – FL6
Immunology and FL6 ― Flow Cytometry,
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 function
Provides real-life case materials including digital whole slide images and gated dot
plots to provide an interpretation
Offers learning opportunity through comparison against the actual case
interpretation
Increases understanding of the effect of immunotherapy treatment on flow
cytometric analysis/interpretation
Who would participate Hospital – University, Private and Public/Government
Additional 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
Other programs lab may be FL1, FL3, FL5, PCNEO
interested in / currently buying
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 70
20202020 New CAP PT – HQNEU
Anatomic 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
spine
In 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 preparations
Targets quality of histologic preparations of central nervous system
specimens with emphasis on tumor specimens
Covers most common gliomas and appropriate immunostains
Who would participate Reference/chain/commercial and Hospital – University, Private and
Public/Government
Other programs lab may be HQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR,
interested in / currently buying HQWSI, HQISH
Mailing Information 5 challenges x 2 mailings
Submit up to three IHC and two H&E stained cover slipped glass slides
per mailing
1 September
© College of American Pathologists. 71
20202020 New CAP PT – HQISH
Anatomic 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 cytometry
For 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
Who would participate CRO, Reference/chain/commercial and Hospital – University, Private and
Public/Government
Other programs lab may be HQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR,
interested in / currently buying HQWSI, ISH, ISH2
Mailing Information 5 challenges x 2 mailings
Submit 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
1 September
© College of American Pathologists. 72
20202020 New CAP PT – HQMEL
Anatomic Pathology HQNEU – CAP/NSH HistoQIP Melanoma IHC
Usage Melanoma arises from mutated skin cells
The 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 diagnosis
Offer 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/Government
Additional participants would be dermatopathology laboratories
Other programs lab may BRAF, BRAFV
be interested in / currently HQIP, HQIPBX, HQBX1, HQBX2, HQBX3, HQBX4, HQNSC, HQMMR,
buying HQWSI, HQISH, HQNEU
Mailing Information 5 challenges x 2 mailings
Submit up to three IHC and two H&E stained cover slipped glass slides per
mailing 1 September
© College of American Pathologists. 73
20202020 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/Genetics
Additional participants would be laboratories performing
molecular testing for HSV and VZV
Other programs lab may be ID1, HC2, HC4, IDME, VR1, VR2, VR3
interested in / currently
buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 74
20202020 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 quickly
The 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 mechanisms
Will allow for the reporting of bacteria, virus, and resistance mechanisms
Semi-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/Genetics
Additional participants would be molecular multiplex users who want
proficiency testing for lower respiratory pneumonia panels such as Biofire
Other programs lab may be IDR
interested in / currently buying
Mailing Information 5 challenges x 3 mailings
1 September
© College of American Pathologists. 75
20202020 New CAP PT – MGEN
Microbiology 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 treat
Hologic’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/Genetics
Additional participants would be laboratories that detect
Mycoplasma genitalium by molecular methods such as Hologic's
Aptima assay
Other programs lab may be TVAG, MVP
interested in / currently
buying
Mailing Information 3 challenges x 2 mailings
1 September
© College of American Pathologists. 76
20202020 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)
Who would participate Reference/chain/commercial and Hospital – University,
Private and Public/Government
Other programs lab may be PM1, PM3, BRAFV, PDL1, CV30, P16, PM5, PM6, maybe
interested in / currently HER2/GHER2 and PM2
buying
Mailing Information 2 slides x 2 mailings
1 September
© College of American Pathologists. 77
20202020 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 program
Who would participate CRO, Reference/chain/commercial and Hospital – University,
Private and Public/Government
Additional participants would be laboratories and doctor office
laboratories that provide limited Microbiology testing and need a
CMS required program
Other programs lab may be D5 and QP212
interested in / currently
buying
Mailing Information 9 challenges x 3 mailings
1 September
© College of American Pathologists. 78
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