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What’s new in Anatomic Pathology Quality Assurance? What’s new in Anatomic Pathology Quality Assurance?

What’s new in Anatomic Pathology Quality Assurance? - PowerPoint Presentation

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What’s new in Anatomic Pathology Quality Assurance? - PPT Presentation

Raouf E Nakhleh MD Mayo Clinic Florida Disclosure Information Raouf E Nakhleh MD I have no financial relationships to disclose Objectives Discuss evidence based guideline development and their impact on the future from a QA perspective ID: 208898

practice validation predictive her2 validation practice her2 predictive evaluation quality guidelines based pathologists cases professional cancer ongoing procedure cap

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Slide1

What’s new in Anatomic Pathology Quality Assurance?

Raouf E. Nakhleh, MD

Mayo Clinic FloridaSlide2

Disclosure InformationRaouf E Nakhleh, MD

I have no financial relationships to discloseSlide3

Objectives

Discuss evidence based guideline development and their impact on the future from a QA perspective

Discuss issues related to immunohistochemistry validation

Discuss ongoing assessment of practicing pathologistsSlide4

Why these topics

Not new

Subject to regulation (USA)

Formalization of issues not previously addressedSlide5

Evidence Based Guidelines

How does one judge good medical practice?

Much easier in retrospect, particularly when there is a negative outcome.

Literature is vast with conflicting knowledge

In the past, informal evolution of practice

Emphasis on local standards

Today national standardsSlide6

Evidence Based Guidelines

In particular situation:

Guidelines provide a road map on how to proceed.

Guidelines help us judge appropriateness of care

From a practitioner’s perspective, easier to know if you are meeting your obligations

From a quality assurance perspective, easier to create measures for comparisonSlide7

Evidence Based Guidelines – Examples

In pathology

Cancer protocols and checklists

Standard set by physicians

Reporting standards

Accreditation by Commission on Cancer

Clinical Laboratory Improvement Act

Standard set by legal decree

Procedural and quality standardsSlide8

Evidence Based Guidelines

Cancer reporting

1980 report

Breast, right, mastectomy:

Infiltrating ductal carcinoma

1 of 20 lymph nodes positive

Margins free Slide9

Evidence Based Guidelines

INVASIVE BREAST CANCER

Macroscopic

1.

Specimen

(partial breast, total breast including nipple and skin, etc)

2.

Procedure

(excision without wire‐guided localization, total mastectomy, etc)

3.

Lymph Node Sampling

(no lymph nodes present, sentinel lymph nodes, etc)

4.

Specimen Integrity

(single intact specimen, multiple designated specimens, etc)

5.

Specimen Size (greatest dimension in cm)6. Specimen Laterality (right, left, not specified)Microscopic7. Tumor Size (size of largest invasive cancer, may also be based on macroscopic)8. Tumor Focality (single focus, multiple foci, etc)9. Skin extent (not present, not involved, invades dermis, etc)*10. Nipple extent (not present, not involved, DICS, Paget’s disease)11. Skeletal muscle extent (not present, present, etc)12. Ductal Carcinoma In Situ (DCIS not present, present, etc)13. Lobular Carcinoma In Situ (LCIS not present, present, etc)14. Histologic Type of Invasive Carcinoma (ductal NOS, mucinous, papillary, etc)

15.

Nottingham Score Overall Grade

(1, 2, 3, not graded)

16.

Tubular Differentiation

(1, 2, 3, not graded)

17.

Nuclear Pleomorphism

(1, 2, 3, not graded)

18.

Mitotic Count

(1, 2, 3, not graded)

19.

Margins

(involved by invasive cancer, involved by DCIS, etc)

20.

Lymph Nodes

‐ total number examined*

21.

Lymph Nodes

‐ number with micrometastases*

22.

Lymph Nodes

‐ number with macrometastases*

23.

Lymph Nodes

0 size of largest metastatic deposit*

24.

Tumor pT Stage

(pTX, pT0, etc)

25.

Regional Lymph Nodes pN Stage

(pNX, pN0, pN1a, etc)

26.

Distant Metastasis M Stage

(not applicable, pM1, etc)

Ancillary Studies

27.

Estrogen Receptor Disposition

(performed, not performed, etc)

28.

Progesterone Receptor Disposition

(performed, not performed, etc)

29.

HER2 Disposition

(performed, not performed, etc)

* If not applicable to the specimen, code as if the element was present in the reportSlide10

Evidence Based Guidelines – Laws

Physician Quality Reporting System

Tax Relief and Health Care Act of 2006

Incentive pay (up to 2% of eligible Part B) for physician who report quality measures (pay-for-reporting)

Voluntary program

2015 becomes mandatory Slide11

Physician Quality Reporting System

Colon Cancer grade and stage (2008)

Breast Cancer grade and stage (2008)

Barrett’s esophagus (2012)

Prostate grade and stage (2012)

HER2 determination in breast cancer (2012)Slide12

Accountable Care Organization (ACO)

Payment of ACO’s rewards quality and efficiency rather than volume

Monitor practice patterns and use performance data to improve the quality of care

CMS establishes performance measures

If met, then eligible for shared savings

Over time - higher standards

Use evidence-based guidelinesSlide13

Overview of Potential Quality System

Evidence based medicine

Practice Guidelines

Addition of standards

Inspection, QA review and PT of an institutions

National or local QA review

Accreditation

Improvement

Clinical studiesSlide14

Evidence Based Guidelines

What’s in our present and future?Slide15

College of American Pathologists Pathology and Laboratory Quality Center

The Center develops evidence-based guidelines and consensus statements related to the practice of pathology and laboratory medicine. Through them, we continually improve the quality of diagnostic medicine and patient outcomes.Slide16

College of American Pathologists Pathology and Laboratory Quality Center

HER2, ER and PR

before official Center creation

CAP/ADASP Consensus Statements on Effective Communication of Urgent Diagnoses and Significant Unexpected Diagnoses in Surgical Pathology and Cytopathology

(published)

Validating Whole Slide Imaging Systems for Diagnostic Purposes in Digital Pathology

(complete, not published)

CAP/ASCCP Lower Anogenital Squamous Terminology (LAST) Standardization Project for HPV-associated Lesions

(complete, not published)

CAP/IASLC/AMP Molecular Testing Guidelines for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

(near completion)Slide17

Guidelines in the works

Immunohistochemistry (IHC) Assay Analytic Validation Principles

CAP/ASH Algorithm for Initial Work-up of Acute Leukemia

ASCP/CAP/AMP/ASCO Molecular Markers for the Evaluation of Colorectal Cancer

CAP-ADASP Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytopathology

Bone Marrow Synoptic Reporting for Hematologic Neoplasms

CAP-NSH Uniform Labeling Requirements for Blocks and Slides in Surgical Pathology

ASCO/CAP Guideline Recommendations for HER2 Testing in Breast Cancer – Update to 2007 Edition

ASCO/CAP Guideline Recommendations for HER2 Testing in Gastric CancerSlide18

Selection Criteria for Center Topics

Patient risk, patient safety and quality; issues that affect patient care and quality outcomes

Performance characteristics of assay and ability to reach consensus. Do problems exist including high false positive/false negative rates and lack of uniformity in practice with significant ability to reach consensus?

Amount of available evidence to predict a clinical response to an agent or change a patient outcome

Guidelines are lacking but regulatory bodies or other professional organizations are trying to preempt specialty development of guidelines or approval/disapproval or show unusual interest

5. Adoption momentum of a particular assay. Consider the number of pathologists affected.

18Slide19

Selection Criteria for Center Topics

6. Feasibility of significantly changing practice of pathology or medicine (e.g., using Ultra Sound Guided FNA to change cytology practice).

7. Ability to collaborate with the right partner(s) in development of a Center product to facilitate development and acceptance, and improve overall probability of success.

8. The public's perception of the issue negatively affects the image of pathologists and the pathologists' role in medicine.

9. Evaluation of existing methods is obsolete or does not bring value in patient care

19Slide20

The Center Process for Developing Guidelines and Consensus StatementsSlide21
Slide22

IHC Antibodies and FDA Classification

Antibodies are medical devices

Classification base on patient safety

Class I

Adjunctive diagnostic information

Class II

Prognostic or predictive data

Separately reported

More stringent quality assurance

Class III

Require FDA premarket approval Slide23

HER2 Guideline

Provide the appropriate HER2 assay validation procedure

Validation with FISH or with another IHC lab

Prescribe appropriate fixation time and documentation: 6 – 48 Hours

Modifies scoring criteria to enhance specificity

Ongoing competency assessment for pathologists

Enroll in HER2 proficiency testing serviceSlide24

HER2

Guideline introduced in late 2006

Mandated in 2008

LAP checklist standards related to HER2 effective in late 2008

CAP sponsored survey to determine how well labs are able to comply (late 2008)

Leads to insight of effectiveness of guideline (2010)Slide25

LAP HER2 Standards

Properly validate HER2 assays

Ensuring appropriate fixation

use the ASCO/CAP scoring criteria

Enforce HER2 proficiency testingSlide26

2008 HER2 Survey

Arch Pathol Lab Med 2010;134: 728-734

HER2 assay validation

Concordance with FISH

81% of Labs achieved 95% concordance for(-)

73% of Labs achieved 95% concordance for(+)

Concordance with another IHC LAB

72% of Labs achieved 95% concordance for(-)

68% of Labs achieved 95% concordance for(+)Slide27

2008 HER2 Survey

Fixation time and documentation

86% made changes to address fixation

60% process specimens on the weekend

Documentation is addressed in reports in 70% of laboratoriesSlide28

2008 HER2 Survey

ASCO/CAP scoring criteria

84% using criteria

Ongoing pathologists competency assessment

91% have a program in placeSlide29

2008 HER2 Survey – Summary

Most labs are meeting HER2 guideline

Gaps still exist, particularly validation

Deficiencies hopefully corrected over time with inspection cycle

Follow up survey conducted at the end of 2011, currently under analysisSlide30

Validation

What about other antibodies?

Gap in understanding of Validation in AP

Few documents address IHC antibody assay validation

Definition

Confirmation through a defined process that a method performs as intendedSlide31

31

Principles of Test Validation

Use manufacturer’s instructions

Use high-quality test materials with known target values

Test materials should be of similar type as patient samples

Complete documentation, including procedure and results

Lab director review/approve resultsSlide32

IHC Validation

For cell markers, (e.g. keratin, actin, Melan A etc.) how many cases should be performed in validation study?

Should you validate with another lab or another technique?

What level of concordance is acceptable?

Are there situations where validation is not necessary?

What about cytology material?Slide33

IHC Validation – Example

New antibody introduction – Prognostic

Example: MIB-1 (Ki-67)

Proliferation marker (estimate of mitotic count)

Antibody needs to work at spectrum of findings (0 – 100%)

Include tissues with various levels of proliferation

Carcinoid tumors of lung (0-10%)

Typical carcinoid (0-3%)

Atypical carcinoid (2-10%)

Small cell carcinoma (25-90%)

Validation cases should cover the spectrum of findingsSlide34

Immunohistochemistry Validation Procedures and Practice: A College of American Pathologists Survey of 727 Laboratories

Lindsay Hardy, MD (Boston, MA)

Raouf Nakhleh, MD (Jacksonville, FL) Jeffrey Goldsmith, MD (Boston, MA)

Patrick Fitzgibbons, MD (Fullerton, CA) Richard Eisen, MD (Greenwich, CT)

Mary Beth Beasley, MD (New York, NY) Rhona Souers, MS (Northfield, IL)Slide35

Methods

September 2010: Questionnaire

1064 surveys distributed with CAP proficiency test mailing (HER-2)

754 returned (Oct. 2010)

27 excluded

727 included

2 major sections

Non-FDA approved, non-predictive

Non-FDA approved, predictive other than HER-2Slide36

Results: Non-predictive

Validation Procedures

 

Percent

Laboratory has a procedure for validation of new antibodies?

68

Procedure specifies the number of cases to be used?

54Slide37

Results: Non-predictive

68% had a written procedure

86% validated the most recently introduced non-predictive marker (despite lack of procedures for some)Slide38

Results: Non-predictive

Validation Procedures

 

10th Pctl

Median

90th Pctl

Minimum

# Cases to validate new antibody:

 

 

 

Positive

2

8

20

Negative

0

5

15

Total Cases

4

13

30

 

 

 

 

 

 

Validation Procedures

 

10th Pctl

Median

90th Pctl

Minimum

# Cases to validate new antibody:

 

 

 

Positive

2

8

20

Negative

0

5

15

Total Cases

4

13

30

Acceptable concordance (%):

 

 

 

Positive

80

95

99

Negative

50

95

99

 

 

 

Validation Procedures

 

10th Pctl

Median

90th Pctl

Minimum

# Cases to validate new antibody:

 

 

 

Positive

2

8

20

Negative

0

5

15

Total Cases

4

13

30

Acceptable concordance (%):

 

 

 

Positive

80

95

99 Negative509599# Cases used in most recent validation:    Positive2720 Negative1515Slide39

Results: Non-predictive

Most recent validation

 

Percent

Weakly or focally positive cases were included

40

Results confirmed by running parallel at another lab (same tissue)

18

Cases were tested on multiple days (between-run precision)

53Slide40

Results: Predictive, excluding HER2

Predictive Markers:

ER

PR

ER/PR

CD117/C-KIT

KI-67

P53

P63

PMS2

EGFR

Other

Validation Procedures

Non-Predictive

 

Percent

Percent

Laboratory has a procedure for validation of new antibodies?

46 

68

Validation Procedures

Non-Predictive

 

Percent

Percent

Laboratory has a procedure for validation of new antibodies?

46 

68

Procedure specifies the number of cases to be used?

65

Validation Procedures

Non-Predictive

 

Percent

Percent

Laboratory has a procedure for validation of new antibodies?

46 

68

Procedure specifies the number of cases to be used?

65

54Slide41

Results: Predictive, excluding HER2

46% had a written procedure

75% validated the most recently introduced predictive marker other than HER-2Slide42

Results: Predictive, excluding HER2

Validation Procedures

 

10

th

Pctl

25

th

Pctl

Median

75

th

Pctl

90

th

Pctl

Minimum

# cases to validate new Ab:

 

 

 

Positive

3

5

11

20

25

Negative

1

5

10

15

25

Total Cases

5

10

25

35

50

Acceptable concordance (%):

 

 

 

Positive

90

90

95

95

99

Negative

50

90

95

95

99

# Cases

used

in most recent validation:

 

 

 

Positive

2

5

10

20

30

Negative

1

3

5

13

20Slide43

Revalidation

Validation Procedures

Non-Predictive

 

Percent

Percent

Procedure specifies repeat validation for:

 

 

New lot of antibody

64

66

Antigen retrieval

80

71

Detection system

81

74 

Instrumentation

74

74

Fixative

78

65

Tissue processor

55

49

Validation Procedures

Non-Predictive

 

Percent

Percent

Procedure specifies repeat validation for:

 

 

New lot of antibody

64

66

Antigen retrieval

80

71

Detection system

81

74 

Instrumentation

74

74

Fixative

78

65

Tissue processor

55

49

Procedure includes specifications for use with cytology?

42

Validation Procedures

Non-Predictive

 

Percent

Percent

Procedure specifies repeat validation for:

 

 

New lot of antibody

64

66

Antigen retrieval

80

71

Detection system

81

74 

Instrumentation

74

74

Fixative

78

65

Tissue processor

55

49

Procedure includes specifications for use with cytology?

42

37Slide44

Summary

IHC validation: 727 labs

Validation was performed at higher rates than the availability of written procedures

Labs are generally following procedures

Most meet designated minimum number of cases

Trend to slightly fewer

Guideline is needed to assist in Predictive and non-predictive IHC

Uncertainty as to the # of cases needed

Uncertainty as to when to revalidate vs. verification

Uncertainty RE validation in cytologySlide45
Slide46

Ongoing assessment of practicing pathologists

Why now?Slide47

American Board of Pathologists

Time limited certification (10 yrs)

The four part MOC process requires diplomates to submit documentation in the following areas:

Part I – Professional Standing

Part II – Lifelong Learning and Self-Assessment

Part III – Cognitive Expertise

Part IV – Practice Performance AssessmentSlide48

Joint Commission Standards

Ms.08.01.01 Monitoring Performance; The organized medical staff defines the circumstances requiring monitoring and evaluation of a practitioner's performance (FPPE)

Ms.08.01.03 Use of Monitoring Information: Ongoing professional practice evaluation information is factored into the decision to maintain existing privileges, to revise existing privileges, or to revoke an existing privilege prior to or at the time of renewalSlide49

Professional Practice Evaluation

Use of objective performance data in the granting and/or maintenance of practice privileges

Ongoing Professional Practice Evaluation – OPPE

On an ongoing basis for privileged practitioners

Focused Professional Practice Evaluation – FPPE

When a practitioner is first privileged

When new privileges are first granted to an already privileged practitioner

When insufficient activity or “performance issues” are identified for a privileged practitionerSlide50

Concepts

Professional competency assessment

Is part of the peer review process (protected)

Is not publicly reported or stored in credentialing files

Is a tool for evaluation, not an adverse action

Produces some data points for assessment

Thresholds are minimum bars, not goalsSlide51

OPPE – Six Core Competencies

Patient care

Medical/Clinical knowledge

Practice-based learning and improvement

Interpersonal and communication skills

Professionalism

Systems-based practiceSlide52

OPPE - Ongoing Professional Practice Evaluation

REQUIREMENTS

Evaluation must be ongoing – More frequently than annually

Process must be clearly defined

What data (“metrics”) will be monitored

Who will be responsible for review of data

How often data will be reviewed

How performance data will be used for decision making

How data will be archived and made availableSlide53

OPPE - Ongoing Professional Practice Evaluation

POSSIBLE OUTCOMES

Privilege being evaluated may be continued, limited, or revoked

POSSIBLE ACTIONS

Continue privilege – no action required

Suspend or revoke privilege because it’s no longer performed or required

Initiate FPPE – Due to insufficient activity or identified “performance issues” with privilegeSlide54

OPPE - Ongoing Professional Practice Evaluation

WHAT METRICS ARE APPROPRIATE FOR PATHOLOGISTS?

Metrics for core vs. delineated privileges

Core privileges – Privileges broadly applicable to the majority of practitioners in a discipline

e.g. anatomic pathologists, clinical pathologists, etc.

Delineated privileges – Privileges specific to a subset of practitioners within a discipline

e.g. surgical pathologists, cytopathologists, hematopathologists, microbiologists, etc,Slide55

OPPE - Ongoing Professional Practice Evaluation

EXAMPLES OF METRICS FOR CORE PRIVILEGES IN AP OR CP

Patient care – Turnaround time for key reports

Medical knowledge – General CME credits, successful MOC

Practice-based learning and improvement – Participation in SAMs

Interpersonal and communication skills – 360° evaluation provided by clinicians, lab staff, etc.

Professionalism – Attendance at medical staff meetings

System-based practice – Membership on hospital or other organizational committeesSlide56

OPPE - Ongoing Professional Practice Evaluation

EXAMPLES OF METRICS FOR DELINIATED PRIVILEGES IN SPECIFIC AREAS

Patient care

Surgical pathology

– Turnaround time for biopsy reports

Number or % amended reports

IOC vs. permanent dx discrepancies

Cytopathology

– FNA success rate

Clinical pathology subspecialties

– timeliness of administrative and clinical reports (transfusion reaction)

All subspecialties

– Peer review of new method validations in relevant lab section(s)

Medical knowledge

Each subspecialty

– CME credits relevant to subspecialtySlide57

FPPE - Focused Professional Practice Evaluation

DIFFERENCES FROM OPPE

More restricted in scope – “focused”

Episodic rather than continuous, with finite endpoint

SIMILARITIES TO OPPE

Basic process must be pre-defined and consistent

Similar monitoring methodologies (review of records, direct observation, monitoring practice techniques, discussion with others involved in care)Slide58

FPPE - Focused Professional Practice Evaluation

CIRCUMSTANCES WHEN NEEDED

When a practitioner is first privileged

When new privileges are first granted to an already privileged practitioner

When insufficient activity or “performance issues” are identified for a privileged practitionerSlide59

Thank You!