James S. Hernandez

Leadership and management training for residents and fellows: a curriculum for future medical directors.

CONTEXT Management of laboratories and pathology practices is increasingly complex. Residents and fellows in laboratory medicine and pathology need more structured curricula in leadership and management (L&M) training to function as medical and laboratory directors. OBJECTIVE To define a curriculum that provides basic competency in L&M for residents and fellows in pathology. DESIGN A year-long formal L&M course included didactic lectures, interactive sessions, case scenarios, team-building exercises, formal team presentations (capstone project), and precourse and postcourse assessment of L&M knowledge. The curriculum meets requirements of American College of Graduate Medical Education and supports goals for leadership training of the College of American Pathologists. Participants evaluated (5-point scale) the content and speakers of all sessions. Trainees were evaluated after considering postcourse examination results, quality of the capstone presentation, and a global assessment. RESULTS The 5 non-capstone sessions received evaluation scores ranging from 4.4 (informatics) to 5 (L&M basics). Postcourse test scores showed significant improvement when compared with the pretest scores for the 2003-2004 and 2004-2005 trainee cohorts. CONCLUSIONS Short-term results indicate that the course described improves trainee knowledge of L&M issues.

Cost-effectiveness of laboratory testing.

OBJECTIVE To illustrate how laboratorians and pathologists must demonstrate accountability for efficiency (how well something is done), effectiveness (what is done), and cost-effectiveness (a proxy for value, in which value equals quality per cost). DATA SOURCES A literature search was conducted, including documents in the National Library of Medicine. STUDY SELECTION The literature on cost-effectiveness of laboratory testing was reviewed. CONCLUSIONS The demand for proving the value of newer and more expensive medical technologies, including newer medical tests, will increase substantially. Payers, including Medicare, commercial insurers, and employers, will demand accountability and elimination of the abuse and misuse of ineffective testing strategies. Pathologists and laboratorians play a key role in guiding the most cost-effective use of testing strategies, including the judicious use of algorithms.

Neutralizing blood-borne polyphosphate in vivo provides safe thromboprotection

Polyphosphate is an inorganic procoagulant polymer. Here we develop specific inhibitors of polyphosphate and show that this strategy confers thromboprotection in a factor XII-dependent manner. Recombinant Escherichia coli exopolyphosphatase (PPX) specifically degrades polyphosphate, while a PPX variant lacking domains 1 and 2 (PPX_Δ12) binds to the polymer without degrading it. Both PPX and PPX_Δ12 interfere with polyphosphate- but not tissue factor- or nucleic acid-driven thrombin formation. Targeting polyphosphate abolishes procoagulant platelet activity in a factor XII-dependent manner, reduces fibrin accumulation and impedes thrombus formation in blood under flow. PPX and PPX_Δ12 infusions in wild-type mice interfere with arterial thrombosis and protect animals from activated platelet-induced venous thromboembolism without increasing bleeding from injury sites. In contrast, targeting polyphosphate does not provide additional protection from thrombosis in factor XII-deficient animals. Our data provide a proof-of-concept approach for combating thrombotic diseases without increased bleeding risk, indicating that polyphosphate drives thrombosis via factor XII.

Hemoglobin A1c testing alone does not sufficiently identify patients with prediabetes.

Whether hemoglobin A(1c) (HbA(1c)) values are suitable for diagnosing diabetes has been debated. We sought to assess the prevalence of elevated HbA(1c) levels in a prediabetes patient population. Oral glucose tolerance tests and HbA(1c) levels were analyzed for patients entering a diabetes prevention program between January 1, 2007, and September 13, 2009. We calculated the percentage of patients with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) who had HbA(1c) values in the 6.0% to 6.4% range or in the 5.7% to 6.4% range. The mean age of the 242 patients was 62 years; 64.0% were women, and 88.0% were white. Isolated IFG was detected in about 56.2% of patients and combined IFG and IGT in about 37.2%. Only 28.5% of patients had HbA(1c) values in the 6.0% to 6.4% range, whereas 65.3% had values in the 5.7% to 6.4% range. Our data suggest that reliance on HbA(1c) testing alone to identify candidates for a diabetes prevention program would miss a substantial number of eligible patients.

Management structure: establishing a laboratory utilization program and tools for utilization management.

As laboratories are challenged to do more with fewer resources, the pathologist and laboratory director will play a greater role in improving the effectiveness of the laboratory, as well as addressing the overuse, misuse and underuse of laboratory testing. We describe the necessary characteristics for pathologists and laboratory directors to successfully lead utilization efforts, as well as key leadership tools and essential steps in creating a utilization management program. When we established a laboratory test utilization program de novo, it became clear how important the laboratory director was in guiding those initiatives by working with stakeholders outside of the laboratory, particularly clinicians, nurses and administrators.

Challenges and Opportunities for Medical Directors in Pathology and Laboratory Medicine

Because the practice of pathology and laboratory medicine evolves rapidly, laboratory medical directors must constantly introduce new tests and services and continue to provide consistent, reliable results for existing tests. Innovations in laboratory medicine are frequently introduced, and the number of commercial vendors of test kits and reagents increases yearly. These innovations, however, may pose barriers to standardization and integration of laboratories and to interpretation of results generated by different laboratories. We propose a practical framework for medical directors to address the seemingly contradictory challenges of standardizing and integrating while simultaneously providing the flexibility to introduce innovations. We recommend initiating standardization first, then integration, while maintaining flexibility for innovation. As organizations strive to create effective processes to enhance value, the role of the laboratory medical director will become critical in resolving the natural tension between standardization/integration and innovation in laboratory medicine and pathology.

“No Pay, No Play”: The End of Professional Ethics in Pathology?

As part of efforts to improve the leadership and management training of pathologists, the College of American Pathologists (CAP) formed a Laboratory Medical Director Working Group in 2010 to guide the establishment of educational modules for pathologists who have, or will have, responsibilities as laboratory medical directors. This is in concert with the CAP’s transformation efforts. One of those modules concerns communications, specifically, improved direct communications between pathologists and patients. Upon hearing of such a module, at least one pathologist remarked, ‘‘No pay, no play.’’ In essence, unless there is direct payment for speaking to patients, there would be no effort by that pathologist to interact with patients. Similar remarks have been made in the past about clinical pathology. The CAP has no data to know how many pathologists share that perspective, or what percentage of pathologists will never, under any circumstances, speak to patients. Certainly, pathologists must work with the patient’s primary physician. Many of us remember the phrase, ‘‘the doctor’s doctor.’’ For many of us, it is a joy and not a burden to consult with colleagues in other specialties, sharing our in-depth knowledge and understanding of the pathophysiology of disease. During my nearly 3 decades as a practicing pathologist in both community hospital and academic medical center settings, I considered it a high honor to be asked to ‘‘Please go upstairs, examine the patient, and tell me what you think.’’ Hematopathology, dermatopathology, and hepatic pathology are 3 areas in particular that require a profound knowledge of clinical medicine as well as anatomic and clinical pathology. In a study from Wake Forest University of Medicine (Winston-Salem, North Carolina) by Anderson, Barbara, and Feldman, the researchers sought to find the key qualities that affected patients’ satisfaction with primary care. Their study showed that patients value access to the physician, communication, personality and demeanor of the provider, quality of medical care processes, care continuity, quality of the health care facilities, and office staff as reasons for rating the physicians as excellent. Patients desire empathy, value the doctor-patient relationship, and crave communication with physicians. We are physicians first, part of a health care team. We have a long history of professional ethics and medical decorum. Alpha Omega Alpha (AVA), founded in 1902, is the national medical honor society. Its mission statement declares: ‘‘Alpha Omega Alpha—dedicated to the belief that in the profession of medicine we will improve care for all by

Legal Aspects of Laboratory Medicine and Pathology for Residents and Fellows: A Curriculum for Pathology Training Programs

CONTEXT Preparing residents and fellows to manage laboratories and pathology practices increasingly requires awareness of the law and a framework within which to manage legal risk in dealing with compliance, malpractice, and human resources issues. OBJECTIVES To describe a curriculum for pathology and laboratory medicine residents and fellows that highlights activities most likely to result in adverse legal outcomes and to help trainees understand when the services of an attorney may be required. DESIGN The 3-hour course evolved as part of a comprehensive leadership and management curriculum designed to help meet systems-based practice and professionalism requirements. Didactic lectures and interactive case scenarios were presented, and participants then evaluated the course content and speakers on a 5-point scale (5 = high). Short-term knowledge accumulation was assessed by comparison of performance on the laboratory administration section of the Resident In-Service Examination between junior residents who had not taken the course and senior residents who did take the course. RESULTS The course was evaluated by 72 trainees during a 5-year period (2004-2008); the mean overall rating was 4.6 (range, 3.5-5.0). Senior residents (n = 37) had a mean (SD) score on the Resident In-Service Examination laboratory administration section of 521 (67) for 2004 through 2008. Junior residents (n = 51), who had not yet completed the course, scored 470 (70) (P < .001) for the same period. CONCLUSIONS This curriculum met the needs of professionals entering careers in laboratory medicine and pathology and can be modified for other pathology and laboratory medicine training programs.

Challenges and opportunities for medical directors in pathology and laboratory medicine: standardization, integration, and innovation.

Because the practice of pathology and laboratory medicine evolves rapidly, laboratory medical directors must constantly introduce new tests and services and continue to provide consistent, reliable results for existing tests. Innovations in laboratory medicine are frequently introduced, and the number of commercial vendors of test kits and reagents increases yearly. These innovations, however, may pose barriers to standardization and integration of laboratories and to interpretation of results generated by different laboratories. We propose a practical framework for medical directors to address the seemingly contradictory challenges of standardizing and integrating while simultaneously providing the flexibility to introduce innovations. We recommend initiating standardization first, then integration, while maintaining flexibility for innovation. As organizations strive to create effective processes to enhance value, the role of the laboratory medical director will become critical in resolving the natural tension between standardization/integration and innovation in laboratory medicine and pathology. The practice of pathology and laboratory medicine has evolved substantially in the past decade. Laboratory medical directors are faced with the dual challenges of introducing new tests and services while simultaneously providing consistent, reliable results for existing tests. Point-of-care testing, noninvasive testing, automation, genetic testing, and telepathology are just a few of the many innovations that have changed the practice of laboratory medicine and pathology. This burgeoning growth includes a similar increase in the number of commercial vendors of test kits and reagents. Although greater purchasing options may offer financial savings, lack of standardization across vendors and practices impedes integration of laboratories and often presents problems for physicians who

A flow cytometry-based assay for procoagulant platelet polyphosphate

Platelet polyphosphate is an inorganic procoagulant polymer of orthophosphate units that is stored in dense granules and is released upon platelet activation. Here, we describe an assay to measure polyphosphate on the surface of procoagulant human platelets.