Letters to the Editor should not be used to determine HER2 status.’’4 We certainly think the utility of trastuzumab in patients with IHCnegative, FISH-positive tumors is worthy of additional study, but we believe it is too early to deny these patients therapy based on a retrospective analysis that did not reach statistical significance in a study that was not designed to assess outcome based on IHC result. Additionally, we would argue that the FDA has also cautioned about using a single testing modality to deem a patient ineligible for trastuzumab; we therefore believe statements advocating the use of IHC alone to exclude patients with gastric cancer from receiving trastuzumab is tenuous at best. It is the policy at our institution to perform FISH on all nonpositive IHC, and if the patient is found to be IHC-negative, FISH-positive, then the patient should be considered to be eligible for HER2targeted therapy with trastuzumab. CHRISTA WHITNEY-MILLER, MD DAVID G. HICKS, MD University of Rochester Medical Center Rochester, NY 14642 1. Bartley AN, Christ J, Fitzgibbons PL, et al. Template for reporting results of HER2 (ERBB2) biomarker testing of specimens from patients with adenocarcinoma of the stomach or esophagogastric junction.ArchPathol Lab Med. 2014; 139(5):618–620. 2. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for the treatment of HER2-positive advanced gastric or gastro-oesophageal cancer (ToGA): a phase 3, open-label, randomized controlled trial. Lancet. 2010;376(9742):687–697. 3. Herceptin [package insert]. South San Francisco, CA: Genentech, Inc; 2010. 4. United States Food and Drug Administration. Medical devices: companion diagnostic devices: in vitro and imaging tools. http://www.fda.gov/ MedicalDevices/ProductsandMedicalProcedures/ InVitroDiagnostics/ucm301431.htm. Accessed July 22, 2014.
Dr Hicks is a paid speaker for Genentech BioOncology, South San Francisco, California. Dr Whitney-Miller received grant support from Genentech, Inc, South San Francisco, California. The authors have no other relevant financial interest in the products or companies described in this article. Published as an Early Online Release October 8, 2014
doi: 10.5858/arpa.2014-0352-LE 710 Arch Pathol Lab Med—Vol 139, June 2015
In Reply.—We appreciate the comments regarding the now-published ‘‘Template for Reporting Results of HER2 (ERBB2) Biomarker Testing of Specimens From Patients with Adenocarcinoma of the Stomach or Esophagogastric Junction.’’ As stated at the beginning of this and each biomarker reporting template, our intent is to assist pathologists in providing clinically useful and relevant information when reporting results of biomarker testing. Data elements should be reported only if a specific test has been done and the result is available to the pathologist. Markers are included in the templates for reporting purposes only and are not intended to suggest a mandate for specific testing for individual patients. The intent of this template is not to make recommendations for HER2 testing in patients with adenocarcinoma of the stomach or esophagogastric junction, nor to make recommendations on specific laboratory testing algorithms or policies for these patients. The explanatory notes are simply informational to supplement the template and to present data on scientific literature applicable to the template, and include the National Comprehensive Cancer Network recommendations for HER2 testing in gastric cancer. The statement about the Food and Drug Administration (FDA) is only to report that in the United States, the FDA has approved trastuzumab in association with chemotherapy for metastatic gastric cancer using the eligibility criteria of the trastuzumab in gastric adenocarcinoma (ToGA) trial. Of interest, a multi-organizational group is now being formed that will include representatives of the College of American Pathologists, the American Society of Clinical Pathologists, and clinical organizations with the intent to construct guidelines for HER2 testing in gastric and esophageal cancer. Such guidelines may include recommendations on specific testing modalities or algorithms, but that is not the intent of the reporting template. ANGELA N. BARTLEY, MD Department of Pathology and Laboratory Medicine St. Joseph Mercy Hospital Ann Arbor, MI 48108
PATRICK L. FITZGIBBONS, MD Department of Pathology St Jude Medical Center Fullerton, CA 92835 Dr Bartley and Dr Fitzgibbons (chair) are members of the College of American Pathologists (CAP) Cancer Biomarker Reporting Committee; Dr Bartley is also a member of the CAP Molecular Oncology Committee. The authors have no relevant financial interest in the products or companies described in this article. Published as an Early Online Release October 8, 2014.
doi: 10.5858/arpa.2014-0438-LE
The College of American Pathologists House of Delegates Redefined To the Editor.—Readers of John Milam and James Carson’s1 comprehensive yet concise history of the College of American Pathologists (CAP) House of Delegates (HOD) might conclude, as did we, that for most of the HOD’s existence, its relationship with the CAP has been ill defined and adversarial. We describe the HOD’s recent 4-year journey (2010–2014) to repair that relationship and to integrate the HOD into the organizational fiber of the CAP. THE HOD The CAP HOD is an elected body of CAP fellows who represent to the leadership of the CAP the views and needs of its 18 000-plus members.2 Delegates serve 3-year terms, elected by CAP fellows residing in their home states, apportioned 1 delegate per 50 CAP fellows. To manage the affairs of the HOD, delegates elect a steering committee (HODSC) comprising the speaker, vice speaker, secretary, 2 sergeants-at-arms, and 2 membersat-large.3 Twice yearly, the HOD convenes for 1-day meetings, one of which is held in conjunction with the CAP annual meeting and other of which is held in the spring. ORIGINS OF THE HOD: A WELL-INTENTIONED IDEA EXECUTED POORLY The CAP is a baby boomer, founded 12 days before Christmas, 1947. InLetters to the Editor
Letters to the Editor councils, and committees—work cooperatively as a single unit. EXECUTING THE MISSION: HOD STRATEGY In order to achieve its mission, the HODSC designed a strategy to accomplish 3 objectives: 1. Remove the unworkable notion of the HOD as ‘‘the legislative body’’ of the college (or for that matter the wisdom of having an organization with more than one policymaking arm). 2. Engage delegates in the operation of the HOD. 3. Engage the BOG in partnering with the HOD.
Figure 1. House of Delegates membership.
corporated under the laws of the state of Illinois, CAP bylaws placed the responsibility for establishing and executing CAP policy in the hands of its Board of Governors (BOG).2 It did not take long before the rank and file of CAP fellows articulated their desire to share in CAP policy making.1 The dialogue dragged on for 23 years, culminating in the passage of CAP bylaws establishing the HOD as the ‘‘legislative body’’ of the CAP, and hence a vehicle by which non-BOG members could have a hand in crafting CAP policy.2 This assignment of the HOD as a legislative body turned out to be one in name only, having perhaps political but certainly not functional purpose, as there exist nowhere in CAP bylaws provisions requiring anyone to enact or implement any ‘‘legislation’’ that might emanate from the HOD. For the better part of half a century, this disconnect appears to have been the root of mutual frustration and irritation among members of the HOD and BOG.1 Delegates seemed to have had only vague notions about their roles, the HOD’s role, and the purpose of HOD meetings, if indeed they attended those meetings at all. Prior to 2011, HOD meeting registration had dropped to its lowest levels (Figure 1). House leadership and delegates’ engagement in the HOD seemed to be limited to a relatively small number of delegates, perhaps regarded by some as ‘‘insiders.’’ In 2010, the HODSC (Table 1) set out to repair this fractured relationship, revive pride in and the purpose of the HOD, and forge a cooperative working relationship with the rest of Arch Pathol Lab Med—Vol 139, June 2015
the CAP. Driving this determination was the HODSC’s opinion that the HOD was the only body within the CAP available to and capable of coalescing and representing to the CAP leadership the collective views of CAP’s membership. ESTABLISHING OUR MISSION, VISION, AND STRATEGY Speculating that delegates lacked a unified sense of mission and vision for the HOD, the HODSC offered definitions for both. They interpreted the mission of the HOD, namely the voice of the membership, as articulating to the BOG the needs of the CAP membership and apprising the BOG on the success with which delegates believed the BOG addressed those needs. They defined a vision for the HOD as One College, the intention that the HOD and the rest of the college—the BOG,
The HODSC replaced the HOD’s fabricated legislative role with one that established the HOD as the ‘‘customer,’’ apprising the board as to how well HOD delegates believe college activities and policies meet the needs of the CAP’s 18 000-plus members. To legitimize this role, HOD delegates voted to remove from their HOD rules (2011), and to have the BOG request that the CAP membership remove from the college bylaws (2014), verbiage that designated the HOD as a legislative body. To engage their fellow delegates, HOD members wrote job descriptions for all HOD positions. To hold delegates accountable for performing those jobs, HOD leadership posted on the HOD Web site delegates’ performance compliance statistics.4 House leadership created opportunities for delegates to involve themselves in HOD operations by initiating a series of projects, all designed to build the infrastructure necessary to
Table 1. College of American Pathologists (CAP) House of Delegates Steering Committee Members Serving Between October 2010 and September 2014 CAP fellows
CAP resident members CAP staff
2010–2011
2011–2014
Alfred Campbell, MD Bharti Jhavari, MD Rebecca Johnson, MD Nancy Kois, MD Kathy Knight, MD Rudy Laucirica, MD Arthur McTighe, MD John Newby, MD David A. Novis, MD Ricardo Mendoza, MD, MS
Alfred Campbell, MD Kathy Knight, MD Rudy Laucirica, MD Arthur McTighe, MD John Newby, MD David A. Novis, MD James E. Richard, DO
Sandra B. Grear Geoffrey Jaroch Mike Troubh Marci Zerante
Erin Consamus, MD Sara Jiang, MD Sandra B. Grear Melissa Norwick Mike Troubh Marci Zerante Letters to the Editor 711
Letters to the Editor Table 2.
2013 House of Delegates Report Card Summarya
House Delegates’ Rating of Issues and Their Importanceb
House Delegates Who Believe the CAP’s Efforts in Informing Them and Preparing Them to Deal With Important Issues Are Only Somewhat or Not Effectivec Not Prepared, %d
Mean Category Reimbursement issues/billing challenges Compliance EMR/electronic health record Practice operational efficiencies Sustainable growth rate Competition for specimens from other practices Informatics Workforce manpower General practice management issues (HR, operations, finance) Point-of-care testing Accountable care organizations/ coordinated care Subspecialization Digital pathology/whole slide imaging Sales/marketing Molecular diagnostics Genomics In-office ancillary services exception Telepathology Practice consolidation In vivo microscopy Survey response rate, %
2012 2013 2014 (N ¼ 120) (N ¼ 190) (N ¼ 203)
Not Informed, %e
2012
2013
2014
2012
2013
2014
NA NA 3.67 NA NA
NA NA 4.18 NA NA
4.63 4.35 4.17 4.12 4.12
NA NA 64 NA NA
NA NA 59 NA NA
36 32 53 59 43
NA NA 57 NA NA
NA NA 55 NA NA
32 33 50 57 39
NA NA NA
3.86 3.99 3.82
4.11 4.02 3.98
NA NA NA
72 51 62
65 54 57
NA NA NA
70 50 58
64 51 51
NA 3.54
NA 3.89
3.96 3.49
NA 44
NA 41
55 42
NA 42
NA 38
57 32
3.90 3.59
3.77 3.72
3.86 3.72
55 65
51 46
57 43
51 61
49 43
55 41
3.56 NA 4.42 3.92
3.16 NA 4.51 3.88
3.10 3.41 NA NA
50 NA 34 54
57 NA 34 49
62 69 NA NA
33 NA 27 42
42 NA 29 44
42 69 NA NA
3.77 NA 3.16 2.84 41
3.55 3.07 3.02 2.13 61
62 NA 74 75
59 62 73 79
NA NA NA NA
51 NA 69 73
54 56 74 75
NA NA NA NA
NA NA NA NA 61
Abbreviations: CAP, College of American Pathologists; EMR, electronic medical record; HR, human resources; NA, not applicable (not surveyed that year). a Modified from College of American Pathologists Web site6 with permission from College of American Pathologists. b Delegates were asked, ‘‘Please rate the following topics in terms of how important they are to you.’’ c For these questions, delegates were asked to respond on a 5-point scale where 5 ¼ very effective, 4 ¼ effective, 3 ¼ somewhat effective, 2 ¼ only slightly effective, and 1 ¼ not at all effective. Percentages shown are the percentages of delegates responding 1 through 3. d Delegates were asked, ‘‘How effective do you feel the college is at preparing you to deal with the following topics?’’ e Delegates were asked, ‘‘How effective do you feel the college is at providing information on the following topics?’’
execute the HOD’s mission, achieve its vision, and provide value to the CAP. Each project was performed by an HOD action group (AG), chaired and staffed by rank and file delegates. House leadership assigned to each AG a charge, deliverables, and deadlines by which to complete their projects. House leadership reconstituted with new members those AGs that were unable to complete their assignments within their deadlines. House leadership created a platform upon which delegates could articulate their voices. Once yearly, the HODSC presents to the BOG essential membership needs as brought forward by delegate chairs. CAP governors then describe what they are doing to address those issues. The HODSC places governors’ responses on the HOD Web site in a location dedicated specifically for that purpose, and 712 Arch Pathol Lab Med—Vol 139, June 2015
where delegates may debate those responses.5 House leadership created a second platform that allows delegates to express their assessments of how well they believe the BOG addresses essential membership needs. Once yearly, delegates complete a survey evaluating BOG performance. The results are tallied onto a BOG report card and posted on the HOD Web site (Table 2).6 Revising HOD strategy included revising the format of biannual HOD meetings. Rather than present, as they did formerly, topics that HOD leadership believed might interest delegates, HOD leadership now arranges presentations that address issues according to preferences that delegates rank on yearly surveys. At spring HOD meetings, candidates for CAP governor and officer positions no longer present, as they have done in the past,
their bios and campaign speeches, but instead spend the entire session answering unedited questions put to them by delegates.7 ACHIEVING THE VISION The HODSC reasoned that in order to realize the vision of One College, the HOD would have to provide the CAP with tangible value. In considering what that value might be, the HODSC alit upon the notion of linking this value to activities that they believed embodied the motivation that drove fellows to become delegates in the first place, namely to have voices in shaping CAP policy, to become CAP leaders, and to be involved in CAP activities. Delegates influence CAP policy by voicing to the BOG the needs of their constituents. For most issues, we believe the grades that delegates give to governors on yearly BOG Letters to the Editor
Letters to the Editor One College Yearly, the HODSC surveys delegates and governors to determine their assessment of the HOD’s effectiveness, including its abilities to influence CAP policy and articulate the voice of the membership. The perception of effectiveness among both delegates and governors has increased steadily since 2010 (Figure 4).10 RECOMMENDATIONS FOR THE FUTURE
Figure 2. House of Delegates fall and spring meeting registration. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists.
report cards suggest that college governors are listening to that voice and incorporating its message into the policies that they create and implement. The HOD has always provided delegates a portal by which to enter positions of leadership throughout the CAP. Historically, about a third of the CAP’s presidents and two-thirds of its governors have initiated their leadership careers in the HOD. Currently, two-thirds of HOD delegates serve on CAP councils and committees. To provide additional opportunities for delegates to engage in leadership roles, the HODSC assembled AGs to serve as think tanks or customer research arms for the CAP. In the past 2 years, these AGs have produced 9 topics for future CAP practice guidelines, identified 67 conversation leaders for the CAP Peer2Peer program, characterized the composition of 234 pathology practices, profiled specific attributes and talents of 253 delegates, and advised the Council on Education on ways to improve its new learning management system.8,9 These activities provide value by assisting college leaders in their selection of qualified people to serve on CAP councils and committees and by ensuring that CAP programs meet the needs of its members. MEASURING SUCCESS Prior to launching its initiatives, the HODSC established outcome metrics by which to gauge its successes or failures. The former have outweighed the latter. Arch Pathol Lab Med—Vol 139, June 2015
Engaging Delegates Since September 2010 HOD membership has increased by 37% (Figure 1), the number of filled delegate positions by 26%, annual HOD meeting registration by 159% (Figure 2), and delegates’ satisfaction with those meetings by 40% (Figure 3). The HOD archives do not include metrics by which to assess delegates’ involvement in HOD activities prior to 2010; however, since 2010 the HODSC has provided 169 engagement opportunities for delegates.
By removing the incongruities in its charter, serving the needs of its delegates, and creating value for the CAP, the HOD has finally come to terms with its mission. To continue growing, provide value to the CAP, and realize its vision of One College, HOD leadership must capitalize on this momentum. In order to sustain the value that the HOD brings to the CAP, we suggest that future HODSCs consider the following recommendations. Get a Job The HOD needs to perform some task that the CAP views as being essential to function. The CAP must hold the HOD, and the HOD must hold its delegates, responsible and accountable for some function that creates mutual dependence and inexorably integrates the HOD into the infrastructure and operation of the CAP.
Figure 3. House of Delegates’ (HOD) satisfaction with meeting format. Scores are mean scores of delegates’ responses to the following survey questions: (1) joint session with residents effective; (2) format allows HOD input to College of American Pathologists leadership; (3) format was appropriate and encouraged participation; (4) meeting met stated objectives. 5.0 ¼ strongly agree, 4.0 ¼ agree, 3.0 ¼ neither agree nor disagree, 2.0 ¼ disagree, 1.0 ¼ strongly disagree. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists. Letters to the Editor 713
Letters to the Editor HOD meets its responsibilities to the BOG and the CAP membership. The HOD has gained much ground in the last 4 years. Unless the HOD continues to provide value to the CAP and its members, the HOD could revert to its former uncomfortable but familiar role as CAP antagonist. In their vision of One College, delegates have embraced their partnership with their physician and staff peers who make up the CAP. In order to sustain the value that the HOD provides the CAP, the HOD must now demand that the CAP embrace a partnership with the HOD. DAVID A. NOVIS, MD Novis Consulting, LLC Lee, NH 03861 MARCI ZERANTE, BA Member Engagement College of American Pathologists Northfield, IL 60093
Figure 4. House of Delegates’ (HOD) and Board of Governors’ (BOG) perceptions of HOD effectiveness. Scores are mean scores of delegates’ and governors’ responses to the following survey questions: (1) ample opportunities for delegates to participate; (2) College of American Pathologists leadership is receptive to HOD opinions; (3) HOD is an effective body and meets its obligations; (4) HOD input instrumental in influencing policy; (5) HOD functions well in articulating voice of membership. 5.0 ¼ strongly agree, 4.0 ¼ agree, 3.0 ¼ neither agree nor disagree, 2.0 ¼ disagree, 1.0 ¼ strongly disagree. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists.
Broaden Our Network The HOD must develop a communication network in which delegates can connect with their constituents, CAP leadership, and their peers in state pathology societies. The greater those bonds, the louder and more productive will be the HOD’s voice. Elevate the Stature We believe that it is in the CAP’s best interests to establish HOD leadership as a goal to which fellows aspire, just as fellows aspire to leadership roles in councils, committees, and the BOG. Perhaps providing the speaker a masthead in some CAP publication, similar to that occupied by the CAP president in CAP Today, might be the nidus about which to generate such enthusiasm. Reverse the Direction For the past 4 years, the HOD has engaged in activities designed to embrace the college. Now, the col714 Arch Pathol Lab Med—Vol 139, June 2015
lege needs to embrace the HOD. The BOG and its councils and committees, as a routine matter of business, must engage the HOD’s assistance with and assessment of their activities. We suggest that CAP councils and committees begin by adding as a line item to their meeting agendas the consideration of partnering activities with the HOD. Demand a Metric Delegates must hold HOD and CAP leaderships accountable not for what they’ve done, but for what they’ve accomplished. They must require that their leaders provide measurable outcomes and mileposts for ventures and projects before they commit resources to initiate them. In the same manner in which the HOD evaluates and reports the effectiveness with which the BOG meets its responsibilities to the HOD and the CAP membership, so must the BOG evaluate and report on the effectiveness with which the
1. Milam JD, Carson JG. A brief history of the formation and transformation of the College of American Pathologists House of Delegates. Arch Pathol Lab Med. 2008;132:1926–1939. 2. College of American Pathologists Constitution and Bylaws. Bylaws Article II House of Delegates, Section 1 Purpose. Adopted December 13, 1946. Last amended March 17, 2012. http://www.cap.org/ apps / docs / about _ college / cap_constitution_and _bylaws.pdf. Accessed July 28, 2014. 3. College of American Pathologists House of Delegates. Rules of the House of Delegates. Article II Membership, Article III Officers and Steering Committee. Last revised November 29, 2011. College of American Pathologists Web site. http://w ww. cap.or g/apps/docs/ house_of_delegates/HDPDF/hod_rules.pdf . Accessed July 28, 2014. 4. College of American Pathologists. HOD attendance report card 2013. http://www.cap.org/apps/ docs/house_of_delegates/HDPDF/hod-attendancereport-card.pdf Accessed July 28. 2014. 5. College of American Pathologists. Committee collaboration: House of Delegates: discussion forum: delegate questions/issues % CAP Responses. http://www.cap.org/collaboration/groups/HOD/ 2013-delegate-issues/view. Accessed July 28, 2014. 6. College of American Pathologists. 2013 CAPHOD report card. http://www.cap.org/apps/docs/ house_of_delegates/HDPDF/survey_results_2013. pdf. Accessed July 29, 2014. 7. College of American Pathologists. Meeting presentations & recordings. http://www.cap.org/ apps/cap.portal?_nfpb¼true&cntvwrPtlt_action Override¼%2Fportlets%2FcontentViewer%2Fshow &_windowLabel¼cntvwrPtlt&cntvwrPtlt{action Form.contentReference}¼house_of_delegates% 2Fhod_see_listen.html&_state¼maximized&_page Label¼cntvwr. Accessed July 28, 2014. 8. College of American Pathologists. AG on the Council of Membership and Professional Development. In: House of Delegates Spring ’14 Meeting. Northfield, IL: College of American Pathologists; 2014:25–26. http://www.cap.org/apps/docs/ house_of_delegates/HDPDF/hod-spring-2014agenda-book.pdf. Accessed July 29, 2014. 9. College of American Pathologists. Fall 2014 agenda book. In press. 10. College of American Pathologists. CAP HOD baseline metric: HOD as a whole. http://www.cap. org/apps/cap.portal?_nfpb¼true&cntvwrPtlt_action
Letters to the Editor
Letters to the Editor Override¼%2Fportlets%2FcontentViewer%2Fshow &_windowLabel¼cntvwrPtlt&cntvwrPtlt{action Form.contentReference}¼house_of_delegates% 2Fhod_dashboard.html&_state¼maximized&_ pageLabel¼cntvwr. Accessed July 29, 2014.
The authors have no relevant financial interest in the products or companies described in this article.
doi: 10.5858/arpa.2014-0422-LE
Limiting Specimen Rejection To the Editor.— I read the article by Drs Donald Karcher and Christopher Lehman titled ‘‘Clinical Consequences of Specimen Rejection’’ 1 with nostalgic interest. Years ago we had a substantial problem in a specific area of a
Arch Pathol Lab Med—Vol 139, June 2015
hospital with specimen rejection and laboratory result turnaround time dissatisfaction. We knew that personnel who were not well trained in phlebotomy and laboratory specimen requirements were more likely to obtain specimens that would have to be rejected for a variety of reasons. We simply instituted a policy that all specimens collected in that department and all bedside laboratory testing in the same department were to be done only by laboratory-trained personnel. By having a trained person in the department at all times, we were able to decrease the incidence of specimen rejection, decrease laboratory result turnaround time, and improve bedside testing. In addition, by obtaining a select set of collection tubes from all patients on initial phlebotomy, we were able to quickly
respond to the majority of requests for additional laboratory tests without repeat phlebotomy. In order to implement such a policy, one may have to justify the possible increased expenses in materials and personnel as well as deal with other issues. Once the policy was instituted, and everyone adapted to working as a multidepartment team, it was a success and well accepted. FERNANDO GOMEZ, MD Department of Specialty Medicine Rocky Vista University Parker, CO 80134 1. Karcher DS, Lehman CM. Clinical consequences of specimen rejection: a College of American Pathologists Q-Probes analysis of 78 clinical laboratories. Arch Pathol Lab Med. 2014; 138(8):1003–1008.
doi: 10.5858/arpa.2014-0435-LE
Letters to the Editor 715
Copyright of Archives of Pathology & Laboratory Medicine is the property of College of American Pathologists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Dr Hicks is a paid speaker for Genentech BioOncology, South San Francisco, California. Dr Whitney-Miller received grant support from Genentech, Inc, South San Francisco, California. The authors have no other relevant financial interest in the products or companies described in this article. Published as an Early Online Release October 8, 2014
doi: 10.5858/arpa.2014-0352-LE 710 Arch Pathol Lab Med—Vol 139, June 2015
In Reply.—We appreciate the comments regarding the now-published ‘‘Template for Reporting Results of HER2 (ERBB2) Biomarker Testing of Specimens From Patients with Adenocarcinoma of the Stomach or Esophagogastric Junction.’’ As stated at the beginning of this and each biomarker reporting template, our intent is to assist pathologists in providing clinically useful and relevant information when reporting results of biomarker testing. Data elements should be reported only if a specific test has been done and the result is available to the pathologist. Markers are included in the templates for reporting purposes only and are not intended to suggest a mandate for specific testing for individual patients. The intent of this template is not to make recommendations for HER2 testing in patients with adenocarcinoma of the stomach or esophagogastric junction, nor to make recommendations on specific laboratory testing algorithms or policies for these patients. The explanatory notes are simply informational to supplement the template and to present data on scientific literature applicable to the template, and include the National Comprehensive Cancer Network recommendations for HER2 testing in gastric cancer. The statement about the Food and Drug Administration (FDA) is only to report that in the United States, the FDA has approved trastuzumab in association with chemotherapy for metastatic gastric cancer using the eligibility criteria of the trastuzumab in gastric adenocarcinoma (ToGA) trial. Of interest, a multi-organizational group is now being formed that will include representatives of the College of American Pathologists, the American Society of Clinical Pathologists, and clinical organizations with the intent to construct guidelines for HER2 testing in gastric and esophageal cancer. Such guidelines may include recommendations on specific testing modalities or algorithms, but that is not the intent of the reporting template. ANGELA N. BARTLEY, MD Department of Pathology and Laboratory Medicine St. Joseph Mercy Hospital Ann Arbor, MI 48108
PATRICK L. FITZGIBBONS, MD Department of Pathology St Jude Medical Center Fullerton, CA 92835 Dr Bartley and Dr Fitzgibbons (chair) are members of the College of American Pathologists (CAP) Cancer Biomarker Reporting Committee; Dr Bartley is also a member of the CAP Molecular Oncology Committee. The authors have no relevant financial interest in the products or companies described in this article. Published as an Early Online Release October 8, 2014.
doi: 10.5858/arpa.2014-0438-LE
The College of American Pathologists House of Delegates Redefined To the Editor.—Readers of John Milam and James Carson’s1 comprehensive yet concise history of the College of American Pathologists (CAP) House of Delegates (HOD) might conclude, as did we, that for most of the HOD’s existence, its relationship with the CAP has been ill defined and adversarial. We describe the HOD’s recent 4-year journey (2010–2014) to repair that relationship and to integrate the HOD into the organizational fiber of the CAP. THE HOD The CAP HOD is an elected body of CAP fellows who represent to the leadership of the CAP the views and needs of its 18 000-plus members.2 Delegates serve 3-year terms, elected by CAP fellows residing in their home states, apportioned 1 delegate per 50 CAP fellows. To manage the affairs of the HOD, delegates elect a steering committee (HODSC) comprising the speaker, vice speaker, secretary, 2 sergeants-at-arms, and 2 membersat-large.3 Twice yearly, the HOD convenes for 1-day meetings, one of which is held in conjunction with the CAP annual meeting and other of which is held in the spring. ORIGINS OF THE HOD: A WELL-INTENTIONED IDEA EXECUTED POORLY The CAP is a baby boomer, founded 12 days before Christmas, 1947. InLetters to the Editor
Letters to the Editor councils, and committees—work cooperatively as a single unit. EXECUTING THE MISSION: HOD STRATEGY In order to achieve its mission, the HODSC designed a strategy to accomplish 3 objectives: 1. Remove the unworkable notion of the HOD as ‘‘the legislative body’’ of the college (or for that matter the wisdom of having an organization with more than one policymaking arm). 2. Engage delegates in the operation of the HOD. 3. Engage the BOG in partnering with the HOD.
Figure 1. House of Delegates membership.
corporated under the laws of the state of Illinois, CAP bylaws placed the responsibility for establishing and executing CAP policy in the hands of its Board of Governors (BOG).2 It did not take long before the rank and file of CAP fellows articulated their desire to share in CAP policy making.1 The dialogue dragged on for 23 years, culminating in the passage of CAP bylaws establishing the HOD as the ‘‘legislative body’’ of the CAP, and hence a vehicle by which non-BOG members could have a hand in crafting CAP policy.2 This assignment of the HOD as a legislative body turned out to be one in name only, having perhaps political but certainly not functional purpose, as there exist nowhere in CAP bylaws provisions requiring anyone to enact or implement any ‘‘legislation’’ that might emanate from the HOD. For the better part of half a century, this disconnect appears to have been the root of mutual frustration and irritation among members of the HOD and BOG.1 Delegates seemed to have had only vague notions about their roles, the HOD’s role, and the purpose of HOD meetings, if indeed they attended those meetings at all. Prior to 2011, HOD meeting registration had dropped to its lowest levels (Figure 1). House leadership and delegates’ engagement in the HOD seemed to be limited to a relatively small number of delegates, perhaps regarded by some as ‘‘insiders.’’ In 2010, the HODSC (Table 1) set out to repair this fractured relationship, revive pride in and the purpose of the HOD, and forge a cooperative working relationship with the rest of Arch Pathol Lab Med—Vol 139, June 2015
the CAP. Driving this determination was the HODSC’s opinion that the HOD was the only body within the CAP available to and capable of coalescing and representing to the CAP leadership the collective views of CAP’s membership. ESTABLISHING OUR MISSION, VISION, AND STRATEGY Speculating that delegates lacked a unified sense of mission and vision for the HOD, the HODSC offered definitions for both. They interpreted the mission of the HOD, namely the voice of the membership, as articulating to the BOG the needs of the CAP membership and apprising the BOG on the success with which delegates believed the BOG addressed those needs. They defined a vision for the HOD as One College, the intention that the HOD and the rest of the college—the BOG,
The HODSC replaced the HOD’s fabricated legislative role with one that established the HOD as the ‘‘customer,’’ apprising the board as to how well HOD delegates believe college activities and policies meet the needs of the CAP’s 18 000-plus members. To legitimize this role, HOD delegates voted to remove from their HOD rules (2011), and to have the BOG request that the CAP membership remove from the college bylaws (2014), verbiage that designated the HOD as a legislative body. To engage their fellow delegates, HOD members wrote job descriptions for all HOD positions. To hold delegates accountable for performing those jobs, HOD leadership posted on the HOD Web site delegates’ performance compliance statistics.4 House leadership created opportunities for delegates to involve themselves in HOD operations by initiating a series of projects, all designed to build the infrastructure necessary to
Table 1. College of American Pathologists (CAP) House of Delegates Steering Committee Members Serving Between October 2010 and September 2014 CAP fellows
CAP resident members CAP staff
2010–2011
2011–2014
Alfred Campbell, MD Bharti Jhavari, MD Rebecca Johnson, MD Nancy Kois, MD Kathy Knight, MD Rudy Laucirica, MD Arthur McTighe, MD John Newby, MD David A. Novis, MD Ricardo Mendoza, MD, MS
Alfred Campbell, MD Kathy Knight, MD Rudy Laucirica, MD Arthur McTighe, MD John Newby, MD David A. Novis, MD James E. Richard, DO
Sandra B. Grear Geoffrey Jaroch Mike Troubh Marci Zerante
Erin Consamus, MD Sara Jiang, MD Sandra B. Grear Melissa Norwick Mike Troubh Marci Zerante Letters to the Editor 711
Letters to the Editor Table 2.
2013 House of Delegates Report Card Summarya
House Delegates’ Rating of Issues and Their Importanceb
House Delegates Who Believe the CAP’s Efforts in Informing Them and Preparing Them to Deal With Important Issues Are Only Somewhat or Not Effectivec Not Prepared, %d
Mean Category Reimbursement issues/billing challenges Compliance EMR/electronic health record Practice operational efficiencies Sustainable growth rate Competition for specimens from other practices Informatics Workforce manpower General practice management issues (HR, operations, finance) Point-of-care testing Accountable care organizations/ coordinated care Subspecialization Digital pathology/whole slide imaging Sales/marketing Molecular diagnostics Genomics In-office ancillary services exception Telepathology Practice consolidation In vivo microscopy Survey response rate, %
2012 2013 2014 (N ¼ 120) (N ¼ 190) (N ¼ 203)
Not Informed, %e
2012
2013
2014
2012
2013
2014
NA NA 3.67 NA NA
NA NA 4.18 NA NA
4.63 4.35 4.17 4.12 4.12
NA NA 64 NA NA
NA NA 59 NA NA
36 32 53 59 43
NA NA 57 NA NA
NA NA 55 NA NA
32 33 50 57 39
NA NA NA
3.86 3.99 3.82
4.11 4.02 3.98
NA NA NA
72 51 62
65 54 57
NA NA NA
70 50 58
64 51 51
NA 3.54
NA 3.89
3.96 3.49
NA 44
NA 41
55 42
NA 42
NA 38
57 32
3.90 3.59
3.77 3.72
3.86 3.72
55 65
51 46
57 43
51 61
49 43
55 41
3.56 NA 4.42 3.92
3.16 NA 4.51 3.88
3.10 3.41 NA NA
50 NA 34 54
57 NA 34 49
62 69 NA NA
33 NA 27 42
42 NA 29 44
42 69 NA NA
3.77 NA 3.16 2.84 41
3.55 3.07 3.02 2.13 61
62 NA 74 75
59 62 73 79
NA NA NA NA
51 NA 69 73
54 56 74 75
NA NA NA NA
NA NA NA NA 61
Abbreviations: CAP, College of American Pathologists; EMR, electronic medical record; HR, human resources; NA, not applicable (not surveyed that year). a Modified from College of American Pathologists Web site6 with permission from College of American Pathologists. b Delegates were asked, ‘‘Please rate the following topics in terms of how important they are to you.’’ c For these questions, delegates were asked to respond on a 5-point scale where 5 ¼ very effective, 4 ¼ effective, 3 ¼ somewhat effective, 2 ¼ only slightly effective, and 1 ¼ not at all effective. Percentages shown are the percentages of delegates responding 1 through 3. d Delegates were asked, ‘‘How effective do you feel the college is at preparing you to deal with the following topics?’’ e Delegates were asked, ‘‘How effective do you feel the college is at providing information on the following topics?’’
execute the HOD’s mission, achieve its vision, and provide value to the CAP. Each project was performed by an HOD action group (AG), chaired and staffed by rank and file delegates. House leadership assigned to each AG a charge, deliverables, and deadlines by which to complete their projects. House leadership reconstituted with new members those AGs that were unable to complete their assignments within their deadlines. House leadership created a platform upon which delegates could articulate their voices. Once yearly, the HODSC presents to the BOG essential membership needs as brought forward by delegate chairs. CAP governors then describe what they are doing to address those issues. The HODSC places governors’ responses on the HOD Web site in a location dedicated specifically for that purpose, and 712 Arch Pathol Lab Med—Vol 139, June 2015
where delegates may debate those responses.5 House leadership created a second platform that allows delegates to express their assessments of how well they believe the BOG addresses essential membership needs. Once yearly, delegates complete a survey evaluating BOG performance. The results are tallied onto a BOG report card and posted on the HOD Web site (Table 2).6 Revising HOD strategy included revising the format of biannual HOD meetings. Rather than present, as they did formerly, topics that HOD leadership believed might interest delegates, HOD leadership now arranges presentations that address issues according to preferences that delegates rank on yearly surveys. At spring HOD meetings, candidates for CAP governor and officer positions no longer present, as they have done in the past,
their bios and campaign speeches, but instead spend the entire session answering unedited questions put to them by delegates.7 ACHIEVING THE VISION The HODSC reasoned that in order to realize the vision of One College, the HOD would have to provide the CAP with tangible value. In considering what that value might be, the HODSC alit upon the notion of linking this value to activities that they believed embodied the motivation that drove fellows to become delegates in the first place, namely to have voices in shaping CAP policy, to become CAP leaders, and to be involved in CAP activities. Delegates influence CAP policy by voicing to the BOG the needs of their constituents. For most issues, we believe the grades that delegates give to governors on yearly BOG Letters to the Editor
Letters to the Editor One College Yearly, the HODSC surveys delegates and governors to determine their assessment of the HOD’s effectiveness, including its abilities to influence CAP policy and articulate the voice of the membership. The perception of effectiveness among both delegates and governors has increased steadily since 2010 (Figure 4).10 RECOMMENDATIONS FOR THE FUTURE
Figure 2. House of Delegates fall and spring meeting registration. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists.
report cards suggest that college governors are listening to that voice and incorporating its message into the policies that they create and implement. The HOD has always provided delegates a portal by which to enter positions of leadership throughout the CAP. Historically, about a third of the CAP’s presidents and two-thirds of its governors have initiated their leadership careers in the HOD. Currently, two-thirds of HOD delegates serve on CAP councils and committees. To provide additional opportunities for delegates to engage in leadership roles, the HODSC assembled AGs to serve as think tanks or customer research arms for the CAP. In the past 2 years, these AGs have produced 9 topics for future CAP practice guidelines, identified 67 conversation leaders for the CAP Peer2Peer program, characterized the composition of 234 pathology practices, profiled specific attributes and talents of 253 delegates, and advised the Council on Education on ways to improve its new learning management system.8,9 These activities provide value by assisting college leaders in their selection of qualified people to serve on CAP councils and committees and by ensuring that CAP programs meet the needs of its members. MEASURING SUCCESS Prior to launching its initiatives, the HODSC established outcome metrics by which to gauge its successes or failures. The former have outweighed the latter. Arch Pathol Lab Med—Vol 139, June 2015
Engaging Delegates Since September 2010 HOD membership has increased by 37% (Figure 1), the number of filled delegate positions by 26%, annual HOD meeting registration by 159% (Figure 2), and delegates’ satisfaction with those meetings by 40% (Figure 3). The HOD archives do not include metrics by which to assess delegates’ involvement in HOD activities prior to 2010; however, since 2010 the HODSC has provided 169 engagement opportunities for delegates.
By removing the incongruities in its charter, serving the needs of its delegates, and creating value for the CAP, the HOD has finally come to terms with its mission. To continue growing, provide value to the CAP, and realize its vision of One College, HOD leadership must capitalize on this momentum. In order to sustain the value that the HOD brings to the CAP, we suggest that future HODSCs consider the following recommendations. Get a Job The HOD needs to perform some task that the CAP views as being essential to function. The CAP must hold the HOD, and the HOD must hold its delegates, responsible and accountable for some function that creates mutual dependence and inexorably integrates the HOD into the infrastructure and operation of the CAP.
Figure 3. House of Delegates’ (HOD) satisfaction with meeting format. Scores are mean scores of delegates’ responses to the following survey questions: (1) joint session with residents effective; (2) format allows HOD input to College of American Pathologists leadership; (3) format was appropriate and encouraged participation; (4) meeting met stated objectives. 5.0 ¼ strongly agree, 4.0 ¼ agree, 3.0 ¼ neither agree nor disagree, 2.0 ¼ disagree, 1.0 ¼ strongly disagree. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists. Letters to the Editor 713
Letters to the Editor HOD meets its responsibilities to the BOG and the CAP membership. The HOD has gained much ground in the last 4 years. Unless the HOD continues to provide value to the CAP and its members, the HOD could revert to its former uncomfortable but familiar role as CAP antagonist. In their vision of One College, delegates have embraced their partnership with their physician and staff peers who make up the CAP. In order to sustain the value that the HOD provides the CAP, the HOD must now demand that the CAP embrace a partnership with the HOD. DAVID A. NOVIS, MD Novis Consulting, LLC Lee, NH 03861 MARCI ZERANTE, BA Member Engagement College of American Pathologists Northfield, IL 60093
Figure 4. House of Delegates’ (HOD) and Board of Governors’ (BOG) perceptions of HOD effectiveness. Scores are mean scores of delegates’ and governors’ responses to the following survey questions: (1) ample opportunities for delegates to participate; (2) College of American Pathologists leadership is receptive to HOD opinions; (3) HOD is an effective body and meets its obligations; (4) HOD input instrumental in influencing policy; (5) HOD functions well in articulating voice of membership. 5.0 ¼ strongly agree, 4.0 ¼ agree, 3.0 ¼ neither agree nor disagree, 2.0 ¼ disagree, 1.0 ¼ strongly disagree. Reprinted from College of American Pathologists Web site10 with permission from College of American Pathologists.
Broaden Our Network The HOD must develop a communication network in which delegates can connect with their constituents, CAP leadership, and their peers in state pathology societies. The greater those bonds, the louder and more productive will be the HOD’s voice. Elevate the Stature We believe that it is in the CAP’s best interests to establish HOD leadership as a goal to which fellows aspire, just as fellows aspire to leadership roles in councils, committees, and the BOG. Perhaps providing the speaker a masthead in some CAP publication, similar to that occupied by the CAP president in CAP Today, might be the nidus about which to generate such enthusiasm. Reverse the Direction For the past 4 years, the HOD has engaged in activities designed to embrace the college. Now, the col714 Arch Pathol Lab Med—Vol 139, June 2015
lege needs to embrace the HOD. The BOG and its councils and committees, as a routine matter of business, must engage the HOD’s assistance with and assessment of their activities. We suggest that CAP councils and committees begin by adding as a line item to their meeting agendas the consideration of partnering activities with the HOD. Demand a Metric Delegates must hold HOD and CAP leaderships accountable not for what they’ve done, but for what they’ve accomplished. They must require that their leaders provide measurable outcomes and mileposts for ventures and projects before they commit resources to initiate them. In the same manner in which the HOD evaluates and reports the effectiveness with which the BOG meets its responsibilities to the HOD and the CAP membership, so must the BOG evaluate and report on the effectiveness with which the
1. Milam JD, Carson JG. A brief history of the formation and transformation of the College of American Pathologists House of Delegates. Arch Pathol Lab Med. 2008;132:1926–1939. 2. College of American Pathologists Constitution and Bylaws. Bylaws Article II House of Delegates, Section 1 Purpose. Adopted December 13, 1946. Last amended March 17, 2012. http://www.cap.org/ apps / docs / about _ college / cap_constitution_and _bylaws.pdf. Accessed July 28, 2014. 3. College of American Pathologists House of Delegates. Rules of the House of Delegates. Article II Membership, Article III Officers and Steering Committee. Last revised November 29, 2011. College of American Pathologists Web site. http://w ww. cap.or g/apps/docs/ house_of_delegates/HDPDF/hod_rules.pdf . Accessed July 28, 2014. 4. College of American Pathologists. HOD attendance report card 2013. http://www.cap.org/apps/ docs/house_of_delegates/HDPDF/hod-attendancereport-card.pdf Accessed July 28. 2014. 5. College of American Pathologists. Committee collaboration: House of Delegates: discussion forum: delegate questions/issues % CAP Responses. http://www.cap.org/collaboration/groups/HOD/ 2013-delegate-issues/view. Accessed July 28, 2014. 6. College of American Pathologists. 2013 CAPHOD report card. http://www.cap.org/apps/docs/ house_of_delegates/HDPDF/survey_results_2013. pdf. Accessed July 29, 2014. 7. College of American Pathologists. Meeting presentations & recordings. http://www.cap.org/ apps/cap.portal?_nfpb¼true&cntvwrPtlt_action Override¼%2Fportlets%2FcontentViewer%2Fshow &_windowLabel¼cntvwrPtlt&cntvwrPtlt{action Form.contentReference}¼house_of_delegates% 2Fhod_see_listen.html&_state¼maximized&_page Label¼cntvwr. Accessed July 28, 2014. 8. College of American Pathologists. AG on the Council of Membership and Professional Development. In: House of Delegates Spring ’14 Meeting. Northfield, IL: College of American Pathologists; 2014:25–26. http://www.cap.org/apps/docs/ house_of_delegates/HDPDF/hod-spring-2014agenda-book.pdf. Accessed July 29, 2014. 9. College of American Pathologists. Fall 2014 agenda book. In press. 10. College of American Pathologists. CAP HOD baseline metric: HOD as a whole. http://www.cap. org/apps/cap.portal?_nfpb¼true&cntvwrPtlt_action
Letters to the Editor
Letters to the Editor Override¼%2Fportlets%2FcontentViewer%2Fshow &_windowLabel¼cntvwrPtlt&cntvwrPtlt{action Form.contentReference}¼house_of_delegates% 2Fhod_dashboard.html&_state¼maximized&_ pageLabel¼cntvwr. Accessed July 29, 2014.
The authors have no relevant financial interest in the products or companies described in this article.
doi: 10.5858/arpa.2014-0422-LE
Limiting Specimen Rejection To the Editor.— I read the article by Drs Donald Karcher and Christopher Lehman titled ‘‘Clinical Consequences of Specimen Rejection’’ 1 with nostalgic interest. Years ago we had a substantial problem in a specific area of a
Arch Pathol Lab Med—Vol 139, June 2015
hospital with specimen rejection and laboratory result turnaround time dissatisfaction. We knew that personnel who were not well trained in phlebotomy and laboratory specimen requirements were more likely to obtain specimens that would have to be rejected for a variety of reasons. We simply instituted a policy that all specimens collected in that department and all bedside laboratory testing in the same department were to be done only by laboratory-trained personnel. By having a trained person in the department at all times, we were able to decrease the incidence of specimen rejection, decrease laboratory result turnaround time, and improve bedside testing. In addition, by obtaining a select set of collection tubes from all patients on initial phlebotomy, we were able to quickly
respond to the majority of requests for additional laboratory tests without repeat phlebotomy. In order to implement such a policy, one may have to justify the possible increased expenses in materials and personnel as well as deal with other issues. Once the policy was instituted, and everyone adapted to working as a multidepartment team, it was a success and well accepted. FERNANDO GOMEZ, MD Department of Specialty Medicine Rocky Vista University Parker, CO 80134 1. Karcher DS, Lehman CM. Clinical consequences of specimen rejection: a College of American Pathologists Q-Probes analysis of 78 clinical laboratories. Arch Pathol Lab Med. 2014; 138(8):1003–1008.
doi: 10.5858/arpa.2014-0435-LE
Letters to the Editor 715
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