Clinical Chemistry 52: 917-949, 2006.
First published March 28, 2006; 10.1373/clinchem.2005.066076
(Clinical Chemistry. 2006;52:917-949.)
© 2006 American Association for Clinical Chemistry, Inc.
Curriculum Content and Evaluation of Resident Competency in Clinical Pathology (Laboratory Medicine): A Proposal
Brian R. Smith1,a,
Alan Wells2,
C. Bruce Alexander3,
Edwin Bovill4,
Sheldon Campbell1,
Amitava Dasgupta5,
Mark Fung4,
Barbara Haller6,
John G. Howe1,
Curtis Parvin7,
Ellinor Peerschke8,
Henry Rinder1,
Steven Spitalnik9,
Ronald Weiss10,
Mark Wener11 for the Academy of Clinical Laboratory Physicians and Scientists
1 Yale University, New Haven, CT.
2 University of Pittsburgh, Pittsburgh, PA.
3 Univeristy of Alabama at Birmingham, Birmingham, AL.
4 Univeristy of Vermont, Burlington, VT.
5 University of Texas at Houston, Houston, TX.
6 University of California at San Francisco, San Francisco, CA.
7 Washington University, St. Louis, MO.
8 Weill Cornell School of Medicine, New York, NY.
9 Columbia University, New York, NY.
10 University of Utah, Salt Lake City, UT.
11 University of Washington, Seattle, WA.
aAddress correspondence to this author at: Department of Laboratory Medicine, Yale University School of Medicine, 333 Cedar St., PO Box 208035, New Haven, CT 06520-8035.
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Abstract
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Ten years have passed since the Graylyn Conference Report on Laboratory Medicine/Clinical Pathology training was issued. Over that time period, the Accreditation Council for Graduate Medical Education (ACGME) substantially revised the requirements for training programs, the American Board of Pathology (ABP) amended both the requirements and the time periods needed for certification, and the discipline itself, along with the broader discipline of pathology, evolved significantly. Recently, a curriculum proposal in anatomic pathology was published as a potential template to be used by training programs to help meet these new and evolving needs. Toward the same end, the Academy of Clinical Laboratory Physicians and Scientists has now developed a template for a curriculum in clinical pathology (laboratory medicine), taking into account newly designated and revised areas of residency core competency, the alterations in training requirements promulgated by the ACGME and ABP, and the rapidly developing nature of the discipline itself. The proposed clinical pathology curriculum defines goals and objectives for training, provides guidelines for instructional methods, and gives examples of how outcomes can be assessed. This curriculum is presented as a potentially helpful outline for use by pathology residency training programs.
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Introduction
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Clinical pathology (CP),
1
also referred to as laboratory medicine, is an expansive discipline that is anchored in the clinical laboratory and encompasses a fund of knowledge, reasoning, and skills in pathophysiology, diagnostics, and therapeutics. The appropriate constituents of training in this field and the best means for evaluating adequacy of that training are topics of continuous evolution, as they are in all fields of medical practice. In the case of CP, several different training traditions exist. In the United States, a highly academic venue with a focus on translating research laboratory technologies into clinical practice ("Laboratory Medicine") has combined with a community practice–based tradition emphasizing clinical consultation and resource management ("Clinical Pathology") to produce training programs that integrate all the diverse subdisciplines of CP and which are centered under the broader aegis of pathology. This cohesive training, research, and service environment distinguishes the discipline in the United States; in contrast, in much of the rest of the world training in the subdisciplines more frequently remains discrete and/or embedded within other medical specialties. As such, training in the United States, and in those other countries which share this approach, must not only convey subdiscipline-specific information but also enshrine the common approaches, competencies, and world view shared by these pathology subdisciplines.
Ten years ago, 4 major pathology organizations [Association of Pathology Chairs, College of American Pathologists (CAP), Academy of Clinical Laboratory Physicians and Scientists (ACLPS), and American Society for Clinical Pathology] formed a conjoint committee to examine issues related to optimal CP training, which culminated in publication of the Graylyn Conference Report (1). The major conclusions from that conference are summarized in Table 1
. Since then, however, several major shifts in clinical practice and in the philosophy behind residency education and evaluation have occurred. In particular, the Accreditation Council for Graduate Medical Education (ACGME) has mandated the development of a defined educational program (i.e., curriculum) for trainees in all medical specialties, focused on 6 main areas of competency: patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice(2). A second major change was the reduction in the total time period required by the American Board of Pathology for pathology training by 12 months, from 5 years to 4 years in the case of combined anatomic pathology (AP)/CP certification qualification and from 4 years to 3 years for qualification in AP alone or CP alone. In response to these changes, the Association of Directors of Anatomic and Surgical Pathology recently published a proposal for an "idealized" curriculum for AP training(3)(4)(5). In a parallel fashion, ACLPS has now formulated a similar document for CP training, which forms the basis of this report. To accomplish this goal, the ad hoc committee of ACLPS (a) reviewed subdiscipline CP curricula that were previously published, especially in the areas of transfusion medicine(6), molecular diagnostics(7), laboratory management(8), and informatics(9), as well as broader curriculum documents in the field(10)(11); (b) reviewed the CP curriculum in use at 11 institutions that volunteered to supply their programmatic documentation (Stony Brook University Hospital, University of Alabama at Birmingham, University of Minnesota, University of Southern California, University of Texas at San Antonio, University of Utah, University of Vermont, University of Virginia, Weill Medical College of Cornell University, William Beaumont Hospital, and Yale University); and (c) produced a draft proposal that was subsequently reviewed by an additional coterie of members and nonmembers drawn from academic, community, and commercial practice as well as by current residents in 4 programs and by the full membership of ACLPS at the 2005 annual meeting.
The Residency Review Committee for Pathology has had the opportunity to independently review this curriculum. The Committee found the document to be comprehensive and "of great value to anyone who is responsible for the design, evaluation, and improvement of CP education at any level. As such, the Committee encourages its dissemination to program directors, faculty and others who are involved in the education of pathology residents and/or fellows." In particular, the Residency Review Committee for Pathology believes that this curriculum "should be especially valuable to residency directors as they respond to the ACGME’s General Competency initiatives" (Steven P. Nestler, PhD, Executive Director, Residency Review Committee for Pathology, August 2005).
It is important to recognize the diversity of pathology training programs themselves as well as the fundamental need to train individuals for potentially diverse career paths in CP, the latter including pathways that emphasize full-time clinical practice as well as those that concentrate on investigative work in addition to clinical practice. Moreover, careers in CP, as for all of medicine, may take place in a variety of settings that themselves emphasize different aspects of the discipline, including academic, community, public health, and industry environments. Thus, this proposed curriculum is viewed as a document that can and should be appropriately modified by individual programs to best meet their own unique programmatic goals, in keeping with both their available resources and their ability to provide appropriate levels of training for all, or for a subset, of these career paths in CP. The current document is deliberately phrased in broad terms in many areas. The hope of the ad hoc committee is that this publication will represent the first step in an evolutionary process, which will be followed by the articulation and publication of more detailed subspecialty curricula, created with input from subspecialty organizations as well as from the general pathology associations and community.
The outline below is designed to meet the didactic criteria articulated by the ACGME, specifically: "Education in clinical pathology must include microbiology (including bacteriology, mycology, parasitology and virology), immunopathology, blood banking/transfusion medicine, chemical pathology, cytogenetics, hematology, coagulation, toxicology, medical microscopy (including urinalysis), molecular biologic techniques, aspiration techniques, and other advanced diagnostic techniques as they become available" (12). It is also designed to presage and incorporate the emerging fields of complex multiparameter diagnostic systems, new biological approaches to diagnostics, including proteomics, cellular therapeutics, and pathology informatics, that are now becoming more routinely incorporated into medical delivery systems and will play an increasingly important role for the clinical pathologist of the future. Finally, the areas of overlap between AP and CP training are taken into account, and hence there are some portions of this CP curriculum that are appropriately also included in an AP curriculum, such as that proposed by Association of Directors of Anatomic and Surgical Pathology(3)(4). The goal of the current document is to be as reasonably comprehensive and inclusive as possible while simultaneously recognizing the need for creative exploration of new educational strategies by diverse programs.
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Overall Goals of the Laboratory Medicine Curriculum
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The overall goals of a training program in CP should be to develop a pathologist with the following characteristics (Table 2
): - A pathologist capable of communicating as a medical consultant to other clinicians and to patients, as well as being capable of optimally directing the management of the clinical laboratory enterprise. The pathologist understands the science and technology of the clinical laboratory and assures the quality, clinical appropriateness, and usefulness of the data produced by that laboratory. The pathologist is a clinician first and foremost.
- A pathologist who understands and consults on methods of diagnostic test development, test utilization in the context of both generally applicable and patient-specific clinical settings, and assay interpretation in the acute and chronic clinical management of patients. These activities include the pathologist’s role in the development and implementation of integrated medical informatics that optimize patient care. The specific level of technical expertise attained in training will vary with career goals/roles and with the emphasis of the training program itself.
- A pathologist who understands methods and implementation of clinical laboratory–based therapeutics, including minimally manipulated and engineered cellular therapy. The specific level of technical expertise attained in training will vary with career goals/roles of the trainee and with the emphasis of the training program.
- A pathologist who has the skills to consult in these areas at the broader systems level, and in the various extant healthcare delivery models.
- A pathologist who understands the role of research, in its broadest definition, in clinical decision-making, test development, knowledge generation, and continuing education.
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Competencies Common to All Rotations
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Competencies that are common to all rotations are outlined here. Competencies that are specific to individual rotations are included with each subdiscipline. Means of assessing competency in laboratory medicine are discussed in a separate section toward the end of the document.
Patient Care
- Gather essential and accurate information about patients using all relevant available modalities.
- Act as a skilled consultant to other clinicians to develop a diagnostic plan based on specific clinical questions and relevant clinical and pathologic information. This should be accomplished both in the patient-specific setting and the broader context of developing appropriate clinical pathway algorithms for diagnosis.
- Consult as part of a multidisciplinary healthcare team in developing a therapeutic plan that includes laboratory monitoring of efficacy and toxicity. Where clinically appropriate, consult on the use of laboratory-based therapeutics such as blood transfusion and other forms of cellular therapy.
- Provide expert consultation on the interpretation and follow-up of unusual or unexpected test results.
- Consult as a clinical expert in laboratory medicine at multidisciplinary conferences.
Medical Knowledge
- Be able to use all relevant information resources to acquire and evaluate evidence-based information. Demonstrate proficiency in evaluating and presenting findings from appropriate peer-reviewed journals.
- Develop and maintain a knowledge base in the basic and clinical sciences necessary for effective consultation in laboratory medicine.
- Demonstrate sufficient knowledge to determine clinically optimal yet cost-effective testing and laboratory-based therapeutic strategies, including issues of turnaround time, test menu construction, and in-house vs referral diagnostic testing.
- Employ mathematics and statistics as appropriate to laboratory testing; understand and implement quality control (QC) and quality assurance procedures as required.
- Recognize the unique aspects of laboratory medicine practice as modified by patient age and other patient population characteristics, especially aspects of pediatric and geriatric practice.
- Demonstrate awareness and understanding of general and test-specific standards for method development and evaluation, such as those promulgated by the Clinical Laboratory Standards Institute (CLSI; formerly NCCLS), CAP, and similar organizations.
- Demonstrate awareness and understanding of proficiency programs, such as those provided by CAP and similar organizations.
- Demonstrate knowledge of the principles of clinical research design, implementation, and interpretation. Understand the various levels of evidence in medicine and their translation into evidence-based practice.
- Be able to design a study that can be used to validate methodologies and parameters of clinical utility for the implementation and continuing use of new evidence-based analytes in the local setting.
Practice-Based Learning and Improvement
- Demonstrate the ability to critically assess the scientific literature.
- Demonstrate knowledge of evidence-based medicine and apply its principles in practice.
- Use multiple sources, including information technology, to optimize lifelong learning and support patient care decisions.
- Develop personally effective strategies for the identification and remediation of gaps in medical knowledge needed for effective practice.
- Use laboratory problems and clinical inquiries to identify process improvements to increase patient safety.
- Demonstrate knowledge of how to establish continuing competency assessment for pathologists as well as for laboratory personnel.
- Use proficiency programs to improve laboratory practices.
Interpersonal and Communication Skills
- Demonstrate the ability to write an articulate, legible, and comprehensive yet concise consultation note. Provide a clear and informative report, including a precise diagnosis whenever possible, a differential diagnosis when appropriate, and recommended follow-up or additional studies as appropriate.
- Demonstrate the ability to provide direct communication to the referring physician or appropriate clinical personnel when interpretation of a laboratory assay reveals an urgent, critical, or unexpected finding and document this communication in an appropriate fashion.
- Conduct both individual consultations and presentations at multidisciplinary conferences that are focused, clear, and concise.
- Demonstrate the ability to communicate the vision of the CP service role to other clinicians as well as to other healthcare personnel and administrators to develop clinically advantageous and cost-effective strategies.
- Choose effective modes of communication (listening, nonverbal, explanatory, questioning) and mechanisms of communication (face-to-face, telephone, e-mail, written), as appropriate.
- Demonstrate skills in obtaining informed consent, including effective communication to patients about procedures, alternative approaches, and possible complications of laboratory-based patient care diagnostic and therapeutic activities, such as those related to transfusion medicine.
- Demonstrate skills in educating colleagues and other healthcare professionals: (1) demonstrate the ability to help other residents obtain proficiency in laboratory medicine; (2) demonstrate the ability to work well with medical technologists and to present laboratory medicine concepts to them effectively in continuing education settings and in the day-to-day laboratory environment; (3) demonstrate the ability to educate nonpathology clinicians and other healthcare workers, including pharmacists, nurses, residents, medical students, and others, about topics such as the fundamental principles of pathophysiology underlying test design/interpretation and the approach to choosing and interpreting laboratory tests; (4) demonstrate an understanding of the principles one must follow when educating other practicing pathologists through publications or seminars on new testing and therapeutic strategies, research discoveries, and other cutting-edge professional knowledge.
Professionalism
- Demonstrate compassion: be understanding and respectful of patients, their families, and the staff and physicians caring for them.
- Interact with others without discriminating on the basis of religious, ethnic, sexual, or educational differences.
- Demonstrate positive work habits, including punctuality, dependability, and professional appearance.
- Demonstrate a responsiveness to the needs of patients and society that supersedes self-interest.
- Demonstrate principles of confidentiality with all information transmitted both during and outside of a patient encounter.
- Demonstrate knowledge of regulatory issues pertaining to the use of human subjects in research.
- Demonstrate a commitment to excellence and ongoing professional development.
- Demonstrate interpersonal skills in functioning as a member of a multidisciplinary healthcare team.
Systems-Based Practice
- Demonstrate understanding of the role of the clinical laboratory in the healthcare system.
- Demonstrate the ability to design resource-effective diagnostic plans based on knowledge of best practices in collaboration with other clinicians.
- Demonstrate knowledge of basic healthcare reimbursement methods.
- Demonstrate knowledge of the laboratory regulatory environment, including licensing authorities; federal, state, and local public health rules and regulations; regulatory agencies such as the Centers for Medicare and Medicaid Services and the US Food and Drug Administration; and accrediting agencies such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), CAP, and the ACGME.
- Understand and implement policies to continually improve patient safety as they relate to clinical laboratory testing at all levels.
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Didactic Methodologies
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The curriculum should emphasize knowledge-based and skills-based activities. Rotations in specific laboratories should emphasize graduated responsibility for clinical consultation and interpretation of unusual results, allowing the use of a case-oriented learning format. The resident should be included as a junior practitioner in the daily clinical workload of the laboratories. "Sign-out" responsibilities are usually accompanied by workstation-oriented teaching of pathophysiology and analytical issues, which in turn may be accompanied, as appropriate, by hands-on experience. Alternatively, a resident could generate a case portfolio including cases involving each of the major areas of laboratory testing. Case discussions should include a sufficient amount of detail demonstrating the resident’s analytical and consultative skills. The information created should demonstrate the ability of the resident to recognize problems in testing and interpretation, make recommendations for additional testing, and understand the clinical utility of test results. Rotations should also generally include active involvement in daily rounds and weekly supervisory meetings in which residents participate in discussions and decisions concerning quality assurance, proficiency testing, personnel management, budgeting, and instrument and procedure evaluations. Didactic sessions, case presentations in a grand-rounds format, research seminars, journal clubs, subspecialty conferences, and participation in multidisciplinary conferences are all useful exercises. Exit examinations held at the end of rotations are helpful in providing feedback to trainees. Principles of training common to all residency programs, such as stress management and maintenance of a nurturing educational environment, are also important parts of the didactic approach.
On-call responsibilities with comprehensive attending pathologist backup and feedback are critical to CP training. Indeed, we believe that all laboratory medicine training programs should have a 24/7 call system. In many programs, a single resident will take calls for all issues and consults at night and on weekends; other programs may want to delegate some areas, for example, blood bank, to a separate resident. The resident is the front-line recipient of calls, and a system of logging cases is essential. There should be an appropriate on-call orientation and training process, appropriate 24/7 backup by faculty members, and appropriate documentation and evaluation on a periodic basis. Although different formats are possible, discussion of these consultations with the entire resident staff in a morning-report format (even if only weekly) has been found to be useful in some programs.
Because project management in the development and implementation of laboratory assays is an integral part of the clinical activities of a laboratory medicine physician, it is recommended that each trainee be actively involved in these activities during his/her CP rotations. The experience should be meaningful and substantive and involve the trainee in all aspects of project management and research, including conception, design, execution, analysis, and communication. The process per se is a more important aspect of the training than the exact target of inquiry. As such, fewer, more involved experiences are preferred over a series of short projects in each rotation. The nature of the project or research should be tailored to the trainee’s career goals/roles and thus can range from assay validation or concordance studies, to utilization guideline construction, to a long-term basic research program. Some of these aspects of training are best incorporated as integral parts of each subdiscipline, whereas other aspects should be approached as free-standing electives. This committee does not recommend a specific structure for this training but emphasizes its central inclusion in the overall training program.
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Basic Schedule of Rotations
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It is important for residents to undertake graduated responsibilities during their training because the educational process is, of course, not just one of knowledge acquisition but, as importantly, one of attaining progressively more "attending-like" professional skills and mature judgment. In the schema used below, reaching skill levels I and II corresponds to those achievements that are required for minimal competency as a generalist in CP—these skills would normally be acquired in 18–24 months of training. We have used skill levels for pedagogical reasons, so as to suggest a sequence of teaching activities that builds on earlier knowledge and achievement. Individual programs may choose to alter this learning sequence to better fit their local environment. Serving as a guide for curriculum construction, skill level I corresponds roughly to the types of activities and responsibilities that a first- and/or second-year AP/CP resident (or a first-year CP-only resident) would be engaged in, that is, the level of achievement to be attained during the resident’s first exposure to the subdiscipline as a postgraduate. Skill level II corresponds to the achievements expected of a third- and/or fourth-year AP/CP resident (or second-year CP-only resident), that is, the higher level of responsibility and expertise that one would acquire and consolidate during repeat exposure to a subdiscipline. This 18–24 months of training (skill levels I and II) is used to acquire the minimal general skills in all areas sufficient to meet the competency levels required by the American Board of Pathology for eventual certification in CP. Because of the relative brevity of an 18-month course of training in CP, some programs may choose to have no elective time during that period, especially if the overall course of study for a particular AP/CP resident’s career goals will include a predominant AP emphasis; it is then possible to focus on "crossover" aspects of training during months 19–24 (for example, molecular pathology, informatics, management, and morphometric hematopathology). It is expected that for a program that includes 24 months of CP level I and II training, the last 6 months will usually include elective time and offer a degree of flexible emphasis in 1 or 2 areas for months 19–24.
Skill level III refers to the higher level of competency, responsibility, and breadth of knowledge required for those whose career path involves a major or exclusive emphasis on CP in their practice. This would usually correspond to a third year of training (total training of 36 months), such as that required for individuals training in CP without concomitant AP training or certification. In some cases, it might correspond to the last 6–12 months of CP training for an AP/CP resident whose 4-year program involves an emphasis on CP. Because this higher level of training is best individualized depending on career path and because only a subset of pathology programs have the resources to provide such training, suggestions for skill level III training are included as a separate portion of the curriculum in a later section of this document and not as part of the subdiscipline-oriented portion outlined below.
It is recognized that basic residency training in CP, like that in AP, is designed to produce a generalist pathologist. In an era of ever-increasing medical complexity, the role for subspecialization by at least a subset of pathologists is therefore increasing, and fellowship-trained subspecialists are likely to become increasingly important in medical care delivery systems.
In keeping with the prior recommendations of the Graylyn Conference and based on accepted educational practices, it is generally recommended that the core rotations be structured as subdiscipline-specific, concentrated, and protected rotations (for example, a rotation in chemical pathology rather than a joint rotation in chemical pathology and microbiology). Some rotations at higher levels and in more advanced years of training, when the trainee has acquired basic skills, may be productively cross-disciplinary within the broad field of pathology. As noted earlier, the sound principle of graduated responsibility makes a system of at least 2 distinct rotations in each major subdiscipline a generally preferable approach to education.
The general outline for rotations is conceived as follows:
- Chemical pathology (includes toxicology/xenobiotic management): level I (3–5 months); level II (1–2 months)
- Hematology (includes flow cytometry, coagulation, and medical microscopy): level I (3–5 months); level II (1–2 months)
- Microbiology (includes bacteriology, mycology, parasitology, and virology): level I (3–5 months); level II (1–2 months)
- Transfusion medicine (includes apheresis and cellular therapeutics): level I (3–5 months); level II (1–2 months)
- Immunopathology (includes tissue typing): level I (1 month); level II, sometimes combined with other rotations, especially chemical pathology or microbiology
- Molecular diagnostics (includes cytogenetics): level I/II (1–2 months)
- Management and informatics: level I/II (1–2 months equivalent; level I and II may both be incorporated as an integral part of other rotations)
It is recognized that there are areas of overlap between disciplines and that, therefore, some institutions may choose to include portions of the curriculum in different rotations compared with those in which they are subcategorized in this document. In addition, some aspects of the CP knowledge base and skill set are common across disciplines; hence programs may choose to emphasize some of these common areas in different rotations from those in which they are arbitrarily categorized here ("principles of laboratory medicine", management, quality assurance procedures, instrumentation, technical methodologies, and method development are such examples). Where possible, cross-references are indicated in the text. Similarly, there are areas of overlap between traditional AP and CP disciplines that may provide opportunities for programs to alter traditional rotation schedules, especially following minimal core training in AP and CP. Moreover, there are some rotations in the current curriculum of most institutions, and reiterated here, that are based to some extent on technology rather than on clinical field—molecular diagnostics to some extent fits this description—and programs may have different approaches as to how best to include education in these areas within their particular structures. Finally, there are aspects of laboratory medicine that are significantly influenced by characteristics of the patient populations, for example, pediatric and geriatric practice, and some programs may choose to utilize specialized rotations in different clinical settings to provide optimal training in these areas (for example, a pediatric hospital rotation). In summary, curriculum is in constant evolution, and, within the somewhat broad confines of the principles elucidated here, final determination of a training curriculum is best left in the hands of individual programs, which may choose to experiment with innovative organizational structures. Because of these considerations, a web page has been designed as an accompaniment to the current document (www.aclps.org). It is the expectation of ACLPS as sponsor of this web page that it will provide a mechanism for dynamic changes in curriculum recommendations as laboratory medicine evolves, as well as creating a mechanism for discussion on the frontiers of curriculum development and for including additional material that may be of use to training programs.
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Curriculum for Subdiscipline-Specific Rotations
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The curriculum outlined below attempts to identify most of the major areas needed for CP training in each classic subdiscipline. It is not designed to assess the relative weight to be given to each topic mentioned nor, for the sake of conciseness, is it completely comprehensive. As mentioned earlier, it is hoped that this can form the basis for discussion and for an evolutionary improvement in delineation of curriculum over time and for further work by both general and subspecialty groups of pathologists. In addition, there are some topics that apply to all subdisciplines but which may receive different emphasis in each section or be included predominantly as one of the general competencies outlined earlier. The importance of understanding the unique aspects of pediatric CP would be such an example. Each section ends with a listing of competencies specific to a subdiscipline and with a few possible reference materials. Again, there are many fine reference books available, and the list is by no means comprehensive. Several general texts in laboratory medicine are listed below and not reiterated in each section.
General Reference Materials:
Henry JB, ed. Clinical Diagnosis and Management by Laboratory Methods, 20th ed. Philadelphia: WB Saunders, 2001.
Laposata M, ed. Laboratory Medicine: Clinical Pathology in the Practice of Medicine. Chicago: ASCP Press, 2002.
Mcclatchey KD, ed. Clinical Laboratory Medicine. Philadelphia: Lippincott Williams & Wilkins, 2002.
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Chemistry
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I. Analytical Techniques and Instrumentation
Skill Level I
- Understand the principles and operational characteristics of analytical chemistry techniques, including photometric, electrochemical, enzymatic, electrophoretic, radiometric, chromatographic, mass spectrometric, and immunologic methods (see also the Immunology and Immunogenetics section).
- Understand different types of random-access automated analyzers and the measurement principles employed in these systems, including spectrophotometric, ion-selective electrode, and electrochemical methods, as well as immunologic methods, including enzyme multiplied immunoassay technique, cloned enzyme donor immunoassay, fluorescence polarization immunoassay, microparticle enzyme immunoassay, electrochemiluminescence, ELISA, turbidimetry, and nephelometry.
- Understand the basic biology of, and analytical methods for, determination of qualitative and quantitative changes in blood and fluid proteins and amino acids (enzymes, biomarkers, hormones, and cytokines), carbohydrates, lipids and lipoproteins, and clinically relevant small molecules (including metals, trace elements, and vitamins).
Skill Level II
- Understand the principles of laboratory robotics and automation strategies.
- Understand the general principles of assay calibration, QC, and the need for calibration verification.
- Understand the causes of both positive and negative interferences as well as how to detect and avoid them.
- Understand the techniques employed for specific extraction of analytes from biological fluids.
- Identify factors influencing separation and resolution in electrophoresis and chromatography, including mechanism of separation and mobile/stationary phases.
- For chromatography, understand the importance of internal standards, the relative retention time, carryover, and matrix effects.
- For mass spectrometry, understand the pitfalls of ion suppression and the need for defining characteristic ion ratios for reliable compound identification.
II. Organ-Based Biochemical Pathophysiology
1. assessment of pulmonary function: blood gases and oxygen saturation
Skill Level I
- Understand the principles of partial pressure of gases and the need for an O2 carrier. Be able to describe the alveolar-arterial O2 gradient and anion gap.
- Know the pathophysiology of ketoacidosis and lactic acidosis.
- Understand the significance of P50, O2 content, O2 capacity, and O2 saturation and be able to distinguish between O2 saturation and PO2.
- Be able to describe the hemoglobin-oxygen dissociation curve and factors that affect the curve and P50.
- Understand the principles of integrated blood gas, electrolyte, and CO-oximetry systems.
2. acid-base chemistry, electrolytes, and relevant disorders
Skill Level I
- Define the Henderson–Hasselbach equation. Be familiar with physiologic buffer systems and the role of respiratory and renal compensation. Understand categories of clinical disorders of acid–base balance (metabolic and respiratory acidosis, metabolic and respiratory alkalosis, mixed disorders).
- Know the differential diagnosis of common electrolyte disorders.
3. assessment of renal function
Skill Level I
- Know the basic physiology of renal function. Understand the basic categories of renal diseases (e.g., pre-renal azotemia, obstructive azotemia, glomerulonephritis, acute vs chronic renal failure, uremic syndrome) and be familiar with the National Kidney Foundation practice guidelines for these conditions. Know the laboratory analytical methods (e.g., Jaffe vs creatinase) for the assessment of renal function (creatinine, urea nitrogen, glomerular filtration rate) and proteinuria. Understand the concept of creatinine clearance, how it can be used to estimate glomerular filtration rate, and the various methods employed to measure it. Understand renal handling of electrolytes and key metabolites and the interpretation of urinary electrolyte measurements.
- Understand the definition of osmolality, molecules in serum that contribute to osmolality, and calculation of osmolal gap as well as the principle of the osmometer. Understand the common pitfalls and sources of error during estimation of the osmolal gap (e.g., hyperproteinemia, hyperlipidemia, hypermagnesemia). Understand the differential diagnosis of an unexplained, increased osmolal gap, including alcohol or glycol ingestion, alcoholic or diabetic ketosis or ketoacidosis, and osmotherapy (e.g., mannitol or glycerol administration), among others. Understand the principles of fluid balance.
4. cardiac biomarkers for the assessment of coronary artery diseases
Skill Level I
- Know the current definition of myocardial infarction by the European Society of Cardiology/American College of Cardiology guidelines and the New York Heart Association classifications and understand the interaction of diagnostic modalities in its definition (electrocardiogram, laboratory testing, and imaging).
- Know the diagnostic and prognostic significance as well as the limitations of current coronary artery disease biomarkers [troponins I and T, creatinine kinase (CK-MB index and isoforms), and myoglobin].
- Know the pathophysiology and evaluation of congestive heart failure. Understand the markers of congestive heart failure [B-type natriuretic peptide (BNP) and N-terminal fragment of the BNP prohormone (NT-proBNP)] and their biological and technical limitations.
- Understand the utility of markers of inflammation in the evaluation of cardiac risk (e.g., homocysteine and C-reactive protein).
5. assessment of liver and biliary tract status
Skill Level I
- Understand the dynamics and mechanisms of liver enzyme release and the clinical utility of measuring hepatic enzymes (e.g., aspartate aminotransferase, alanine aminotransferase,
-glutamyltransferase, alkaline phosphatase, and lactate dehydrogenase).
- Know the biochemical assessment of liver function by nonenzyme analytes such as albumin, ammonia, bile acids, bilirubin, urea nitrogen, cholesterol, total protein, and triglycerides.
- Understand bilirubin metabolism, fractionation of bilirubin (conjugated, unconjugated,
-bilirubin, direct vs indirect) and unique aspects of neonatal bilirubin. Understand the conditions and genetic defects that affect bilirubin metabolism, transport and clearance (e.g., Gilbert disease and Dubin–Johnson syndrome).
6. assessment of thyroid function
Skill Level I
- Understand the structure, biosynthesis, secretion, and metabolism of thyroid hormones [thyroxine (T4), triiodothyronine (T3), and reverse T3 (rT3)]. Know thyroid physiology and control of thyroid function [thyrotropin-releasing hormone (TRH) and thyrotropin (TSH)].
- Know the common causes of hypothyroidism and hyperthyroidism.
- Know the laboratory tests for evaluation of thyroid disorders and be able to interpret these analytes in their clinical context with an appreciation for the euthyroid sick state.
- Be familiar with current analytical methodologies for thyroid testing (TSH methods: 1st-, 2nd-, and 3rd-generation assays; isotopic and nonisotopic methods; T4; free T3 methods; T-uptake methods; TSH suppression and stimulation tests).
7. assessment of pituitary function
Skill Level II
- Understand the physiological action, biochemistry, and regulation of anterior pituitary hormones [adrenocorticotropic hormone (ACTH), growth hormone (GH), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH)] and of posterior pituitary hormones [antidiuretic hormone (ADH) and oxytocin].
- Understand endocrine tests of hypothalamic-pituitary function (cosyntropin test/rapid ACTH stimulation test, insulin hypoglycemia test, metyrapone test, levodopa test, arginine infusion test, glucose-GH suppression test, TRH test, gonadotropin-releasing hormone (GnRH) test, clomiphene test, corticotropin-releasing hormone (CRH) test, gonadotropin-releasing hormone test, water deprivation test, saline infusion test, and water loading test). Understand the pathophysiology of disorders of the pituitary.
8. assessment of adrenal function
Skill Level I
- Understand the physiological action, biochemistry, biosynthesis, chemical structure, and metabolism of glucocorticoids and mineralocorticoids.
- Understand the physiological regulation of the renin-angiotensin-aldosterone system.
- Understand clinical conditions associated with excess and deficiency of adrenal cortex hormones. Understand testing of the functional status of the adrenal cortex [basal values vs stimulation tests and suppression tests, circadian rhythm of corticosteroids, morning ACTH, cortisol (urinary, random, and free), rapid ACTH cortisol stimulation test, multiday ACTH stimulation, metyrapone stimulation, CRH stimulation, and quantitative serum and urinary steroid hormone panels].
- Understand the synthesis and metabolism of biogenic amines, including catecholamines and serotonin.
- Be familiar with the strengths and weaknesses of tests available for evaluation of disorders of the adrenal medulla, such as pheochromocytoma or neuroblastoma.
9. assessment of reproductive function, pregnancy, and prenatal testing
Skill Level II
- Understand the role of sex hormones in reproduction and the evaluation of pregnancy and reproductive dysfunction, such as menstrual disorders and infertility.
- Understand the importance of demographic data and biochemical assessment in prenatal testing for fetal defects.
10. assessment of gastric, pancreatic, and intestinal function
Skill Level I
- Understand the clinical manifestations of gastric, pancreatic, and intestinal disease and diagnostic methodologies such as the breath tests for Helicobacter pylori, fecal occult blood, lipase, and amylase (e.g., fractionation of amylase; pancreatic vs salivary and amylase/creatinine clearance ratio).
- Appreciate the role of gastrointestinal hormones and enzymes in digestion and the evaluation of malabsorption and diarrheal syndromes.
11. assessment of glucose and evaluation of diabetes mellitus
Skill Level I
- Understand the metabolism of carbohydrates (insulin, C-peptide, and other regulatory hormones) and be familiar with the American Diabetes Association (ADA) definitions of impaired fasting glucose, impaired glucose tolerance, type 1 and type 2 diabetes mellitus, criteria for diabetic ketoacidosis and hyperosmolar hyperglycemic state, as well as gestational diabetes. Understand the underlying pathophysiology of different forms of diabetes.
- Understand the diagnosis and laboratory assessment of diabetes (blood glucose, oral glucose tolerance test, hemoglobin A1c, fructosamine, and urinary microalbumin) and its complications.
- Understand the diagnosis and evaluation of hypoglycemia.
12. assessment of mineral and bone metabolism
Skill Level I
- Understand the biochemistry and physiology of calcium, phosphate, and magnesium.
- Know the hormones that regulate mineral metabolism [parathyroid hormone (PTH), calcitonin, and vitamin D] as well as parathyroid hormone-related protein (PTHrP). Understand various PTH assays, including biointact PTH and intraoperative PTH.
- Know the pathophysiology of metabolic bone diseases such as osteoporosis, osteomalacia, and Paget disease.
13. assessment of porphyrins and disorders of porphyrin metabolism
Skill Level II
- Understand the biochemistry of heme and porphyrins.
- Understand the porphyrias and be able to consult on the selection and interpretation of both screening and diagnostic tests for each disorder.
14. tumor biomarkers
Skill Level I
- Be familiar with the definition, classification, biochemistry, and distribution of tumor markers, both protein and carbohydrate, including, but not limited to, prostate-specific antigen, calcitonin, human chorionic gonadotropin,
-fetoprotein, carcinoembryonic antigen, CA 15-3, CA 125, and CA 19-9.
- Know the limitations of laboratory assessment of various tumor markers and the factors affecting the results of different analytical procedures.
- Understand the conceptual basis of assays used to screen for malignancy, including Bayes theorem.
Skill Level II
- Be familiar with ongoing efforts to identify proteomic patterns for cancer detection.
15. assessment of fetal lung maturity
Skill Level I
- Understand the physiology of respiratory distress syndrome.
- Understand fetal lung maturity testing [lecithin/sphingomyelin (L/S) ratio, phosphatidyl glycerol (PG), foam stability index (FSI or shake test), fluorescence polarization, and counting of lamellar bodies]. Understand the biochemistry, physiology, and diagnostic performance of fetal fibronectin.
16. trace element assessment
Skill Level II
- Understand the biochemistry, physiology, and metabolism of trace elements (iron, magnesium, zinc, copper, selenium, cobalt, and fluoride). Know the biochemistry and clinical significance of metal-binding proteins such as transferrin, ferritin, and ceruloplasmin.
- Know the clinical assessments of trace elements (serum iron, iron-binding capacity, transferrin, transferrin saturation, serum ferritin, zinc protoporphyrin, and serum ceruloplasmin).
17. vitamin assessment
Skill Level I
- Know the definition and classification of vitamins: fat-soluble vitamins (A, D, E, and K) and water-soluble vitamins [B1, B2, B6, B12 (cobalamin), C, niacin, nicotinamide, folic acid, biotin, and pantothenic acid].
- Understand the clinical disorders associated with the deficiency as well as toxicity of vitamins.
18. cholesterol and lipid assessment
Skill Level I
- Understand the chemical structures, biosynthesis, classification, function, and metabolism of lipids and lipoproteins.
- Understand the Fredrickson classification and the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) classification of hyperlipidemia.
- Understand the pathophysiology of lipid disorders.
- Know the principles of analytical techniques for laboratory assessment of lipids.
19. serum and fluid protein and amino acid assessment
Skill Level I
- Understand the principles of protein analysis in body fluids (e.g., Kjeldahl and Biuret methods, refractometry, and qualitative dipstick).
- Know the principles of serum, urine, and cerebrospinal fluid (CSF) protein electrophoresis. Recognize key patterns of dysproteinemias and monoclonal gammopathies (see also the Immunology and Immunogenetics section).
- Understand approaches for distinguishing transudates vs exudates in fluids.
- Know the analytical methods involved in genetic and acquired aminoacidurias and the current guidelines for screening neonates for these disorders.
Skill Level II
- Understand the emerging technology of proteomics and its potential applications in clinical diagnostics.
20. clinical enzyme kinetics
Skill Level II
- Understand the principles of enzyme kinetics (e.g., Michaelis–Menten equation, concepts of Km, Vmax, and zero-order and first-order kinetics) and clinical enzymology, including isoenzymes, isoforms, and tissue distribution.
- Be familiar with the principles of analytical enzymology and know the concepts of activity vs mass assays (e.g., CK vs CK-MB assays).
21. pediatric biochemistry
Skill Level II
- Understand the differences and unique aspects of pediatric and neonatal chemistry, including reference ranges.
III. Therapeutic Drug Monitoring and Toxicology
1. pharmacokinetics
Skill Level I
- Understand the concepts of drug absorption, bioavailability, volume of distribution, and distribution phases (multicompartment models) and be able to predict peak drug levels.
- Understand the differences between first- and zero-order kinetics of drug metabolism/elimination.
- Understand the concepts of drug clearance, half-life, and the exponential rate constant. Be able to calculate steady-state drug levels and estimate peak and trough drug levels throughout a dosing cycle.
- Understand the origin and consequences of nonlinear or zero-order pharmacokinetics on drug pharmacokinetics.
- Understand the differences between measurement of total, free, and protein-bound drug levels and be able to assess the consequences of altered protein binding on pharmacokinetics and therapeutic drug monitoring.
2. drug metabolism
Skill Level I
- Understand the differences between phase I and phase II drug metabolism reactions.
- Appreciate the various consequences of competing metabolic pathways to modulate both the efficacy and toxicity of administered medications.
- Appreciate the frequent interindividual variability of drug-metabolizing enzymes and its impact on the variability of drug response.
3. pharmacodynamics
Skill Level I
- Understand the general mechanisms of drug action, including drug–receptor interactions, modulation of metabolic pathways, and nucleic acid biochemistry.
- Understand how reference ranges for therapeutic drug monitoring are established and understand the varying utility of trough, peak, or steady-state drug levels for monitoring both drug efficacy and toxicity. Understand the therapeutic index.
4. therapeutic drug monitoring of specific drug classes
Skill Level I
- Understand the principles and practice of therapeutic drug monitoring of antidepressants, mood stabilizers, and antipsychotics; anticonvulsants; cardioactive drugs; bronchodilators; antibiotics; and immunosuppressants.
- Understand the relative significance of peak and trough levels for monitoring of these drug classes.
5. toxicologic syndromes
Skill Level II
- Understand the pathophysiological basis and be able to recognize the five major toxicologic syndromes (cholinergic, anticholinergic, sympathomimetic, opiate, and sedative-hypnotic).
- Be able to formulate a toxicologic differential diagnosis and be able to design a clinical laboratory testing protocol for each of the syndromes.
- Understand the basic therapeutic approach to each syndrome.
6. laboratory evaluation and management of overdosed or poisoned patients
Skill Level I
- Be familiar with the National Academy of Clinical Biochemistry guidelines for Emergency Toxicology.
- Understand the important differences between urine and blood (including serum and plasma) for monitoring and detection of drugs/xenobiotics.
- Understand how to design and implement standardized STAT panels of laboratory tests for evaluation of overdosed/poisoned patients.
- Understand the limitations of drug "screening" protocols and be able to consult on the design of more extensive drug-testing protocols to supplement the standard STAT panels.
Skill Level II
- Understand the toxicologic profiles of specific agents, including acetaminophen, salicylates, alcohols and glycols, barbiturates, tricyclic antidepressants, carbon monoxide, organophosphates and carbamate, digoxin, lead, iron, and cyanide.
- Understand the general supportive measures, the role of alkalinization, the importance of specific antidotes, and the variable efficacy of exchange transfusion, hemodialysis, plasmapheresis, and charcoal hemoperfusion of blood in the management of specific agents.
7. laboratory evaluation of drugs of abuse
Skill Level I
- Understand the generic methodology of the routine immunoassays for drugs-of-abuse testing.
- Be familiar with the major drugs of abuse and their clinical manifestations.
- Know the common methods for adulteration of urine and the techniques available in the laboratory to detect them.
Skill Level II
- Know the specific reactivities of each immunoassay, the standard cutoffs for detection, and whether the assay is capable of detecting the parent drug, its metabolites, or both. Know which members of a drug class are poorly or well detected by a generic immunoassay (e.g., oxycodone detection by the opiate immunoassay) and know the common causes of false positives due to cross-reactivities.
8. pharmacogenomics
Skill Level II
See the Molecular Pathology section.
additional competencies specific to chemistry
Patient Care
- Understand "chain of custody" and other legal requirements for forensic chemical pathology.
Professionalism
- Demonstrate understanding of the social consequences of testing for drugs of abuse.
Chemistry Reference Materials:
See also the General Reference Materials.
American College of Cardiology. Myocardial Infarction Redefined—A Consensus Document of The Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. http://www.acc.org/clinical/consensus/mi_redefined/.
American Diabetes Association Clinical Practice Guidelines. http://www.diabetes.org/for-health-professionals-and-scientists/cpr.jsp.
American Society for Clinical Oncology. 2000 Update of Recommendations for the Use of Tumor Markers in Breast and Colorectal Cancer. http://www.asco.org/ac/1,1003,_12-002130,00.asp.
Burtis CA, Ashwood EA, Bruns DE, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Saunders, 2006.
Kaplan LA, Pesce A, Kazmierczak S, eds. Clinical Chemistry: Theory, Analysis, Correlation, 4th ed. St. Louis, MO: CV Mosby, 2003.
National Academy of Clinical Biochemistry. NACB Laboratory Practice Guidelines. http://www.nacb.org/lmpg/main.stm.
National Heart, Lung, and Blood Institute, National Institutes of Health. Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). http://www.nhlbi.nih.gov/guidelines/cholesterol/.
Point-of-Care Testing
Point-of-care testing (POCT) occurs across all disciplines, but because there are important common issues in its clinical use, it has been made a separate, distinct part of the curriculum in this document. The POCT curriculum may be taught in a concentrated fashion in any of the subdisciplines, depending on what is most appropriate to the institution.
Skill Level I
- Understand definitions of POC and waived testing.
- Understand the range of analytes available in devices used at the point of care.
- Understand the impact of POCT on clinical care, in terms of volume of tests performed, turnaround time, and the utilization of common POC tests (e.g., bedside glucose, rapid strep, and activated clotting time).
- Understand the differences in reference ranges and test performance characteristics between POCT and central laboratory assays.
- Appreciate the difference between POCT and near-patient testing and the personnel resources that best accomplish quality testing in these distinct situations.
Skill Level II
- Understand the principles of performance for common POC tests such as glucose, urine drugs of abuse, rapid microbial antigen, and activated clotting time. Understand the performance characteristics of the common POC devices used for these tests. Know the issues surrounding specimen collection and preparation and the limitations and interpretation of results.
- Understand the quality principles of POCT, including QC of unit-use testing devices, and proficiency/competency assessment of testing with multiple sites and operators and diverse testing personnel.
- Understand the regulatory, administrative, and operational context of POC, waived, and home testing.
- Be able to assess economic, workflow, human resources, and clinical factors driving the decision to perform testing at the point of care vs the central laboratory.
- Know the most common test systems used in POCT.
- Develop an appreciation of emerging POCT technologies, including microelectrical mechanical systems (MEMS) and other biosensor techniques, and their potential clinical applicability.
additional competencies specific to poct
Systems-Based Practice
- Demonstrate the ability to design and communicate effective quality plans for nonlaboratorians performing POCT.
POCT Reference Materials:
See also the General Reference Materials.
Joint Commission on Accreditation of Healthcare Organizations. Quality Point of Care Testing: A Joint Commission Handbook. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, 1999.
Price CP, St John A. Point of care testing. In: Burtis CA, Ashwood EA, Bruns DE, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Saunders, 2006:299–320.
Price CP, St John A, Hicks JM. Point of Care Testing, 2nd ed. Washington: AACC Press, 2004.
Threatte GA. Physician office laboratories. In: Henry JB, ed. Clinical Diagnosis and Management by Laboratory Methods, 20th ed. Philadelphia: WB Saunders, 2001.
Hematology
I. Hematology/Body Fluids/Urinalysis
1. automated hematology
Skill Level I
- Understand clinical indications for peripheral blood cell enumeration and differential analysis.
- Know the components of a complete blood count and understand the information provided by each.
- Understand the principles of automated cell counting, including red blood cell (RBC) indices and their derivation.
- Understand how "absolute values" are determined and how they differ from "relative percent".
- Identify spurious white blood cell (WBC), RBC, hemoglobin, and platelet determinations and be able to propose a course of action to be followed for reporting results.
- Understand appropriate WBC correction for the presence of nucleated RBCs.
- Understand automated differential analysis and manual review criteria.
- Understand the absolute neutrophil count and its clinical utility, as well as problems associated with band counts.
- Understand QC procedures specific to cell counters, such as Rumke limits on differential cell counts and Bull analysis of indices.
- Understand principles of automated and manual reticulocyte enumeration and their respective technical limitations.
Skill Level II
- Interpret results of automated and manual cell counts and understand the relevant technical limitations.
- Recommend appropriate steps for abnormal sample processing, analysis, and result reporting.
- Review abnormal results and correlate results with peripheral blood smear findings and clinical history.
2. peripheral blood smear analysis
Skill Level I
- Know proper preparation and handling of peripheral blood smears, including standard stains and special stains used to identify cellular structures and inclusions.
- Understand normal RBC, WBC, and platelet morphology.
- Be able to estimate WBC and platelet counts.
Skill Level II
- Recognize abnormal RBC, WBC, and platelet morphology; formulate a differential diagnosis; and suggest appropriate laboratory testing for follow-up.
- Recognize technical artifacts in WBC, RBC, and platelet morphology.
- Recognize infectious disorders that can be diagnosed by blood smear.
- Recognize storage disorders and congenital disorders that have morphologic manifestations in the peripheral blood smear.
- Correlate peripheral blood smear findings with bone marrow morphology.
3. body fluid analysis: csf, ascitic/pleural fluid, joint fluid
Skill Level I
- Understand clinical indications for body fluid analysis.
- Understand manual hemocytometer cell counting.
- Understand cytocentrifuge sample preparation and slide staining.
- Identify blood and body fluid cell morphology.
Skill Level II
- Interpret results of body fluid analyses in the appropriate clinical context.
- Recognize malignant cells and recommend appropriate confirmatory tests.
- Correlate abnormal body fluid cell morphology with cytology, flow cytometry, and other relevant diagnostic test results.
- Identify body fluid crystals. Distinguish between urate and calcium pyrophosphate crystals, using polarized light.
4. manual hematology methods
Skill Level I
- Understand principles of microhematocrit determination and its technical limitations.
- Understand the principles of erythrocyte sedimentation rate.
- Understand the principle and utility of supravital stains, including reticulocyte stain, hemoglobin H preparation, and Heinz body preparation.
5. urinalysis
Skill Level I
- Understand the clinical indications for and utility of urinalysis.
- Understand the principles of methods involved in urine chemistry and urine sediment analysis.
- Understand the limitations of manual and automated urine chemistry and sediment analysis.
Skill Level II
- Interpret routine urine chemistry results and identify abnormal cells and organisms. Provide clinical follow-up as appropriate.
II. Special Laboratory Tests in Hematology
1. wbc disorders
See Section IV (Flow Cytometry) and Section V (Hematopathology) below.
2. rbc disorders
Skill Level I
- Learn the clinical indications for laboratory tests involved in the assessment of intrinsic and extrinsic RBC defects/disorders.
- Know the pathophysiology and characteristic laboratory findings of the major disorders causing normocytic, microcytic, and macrocytic anemia.
- Describe iron metabolism and laboratory tests for iron depletion.
- Understand hemoglobin synthesis and degradation.
- Understand the principles of hemoglobin screening by HPLC and electrophoresis at acid and alkaline pH.
- Understand the principle and clinical utility of screening tests for the presence of hemoglobin S.
- Know the pathophysiology and laboratory features of intravascular and extravascular hemolysis.
- Understand the principle and clinical utility of Kleihauer–Betke and/or flow cytometric analysis for fetal hemoglobin.
Skill Level II
- Interpret hemoglobin electrophoretic patterns and ancillary tests for the diagnosis of
- Major hemoglobinopathies;
- Disorders related to enzyme defects;
- Hereditary spherocytosis and other RBC membrane/cytoskeletal defects;
- Paroxysmal nocturnal hemoglobinuria;
- Hemolytic anemia;
- Congenital dyserythropoietic anemias.
3. platelet disorders
Skill Level I
- Understand the pathophysiology of thrombocytopenia and thrombocytosis:
- Differentiate between reactive and malignant processes;
- Understand the pathophysiology of immune thrombocytopenia and thrombotic thrombocytopenic purpura.
- Demonstrate competency in taking a bleeding history.
- Understand the clinical utility of platelet function testing.
- Understand general principles of platelet function testing.
- Understand the pathophysiology of acquired and congenital platelet function disorders.
- Understand the pathophysiology leading to major von Willebrand disease subtypes and expected laboratory results.
- Recognize acquired platelet function abnormalities associated with antiplatelet therapy.
Skill Level II
- Interpret platelet function studies, including screening tests, platelet aggregation, and platelet secretion studies.
- Interpret studies performed for the evaluation of von Willebrand disease.
III. Coagulation
Skill Level I
- Understand the clinical utility of coagulation and thrombosis testing.
- Develop basic understanding of hemostatic and thrombotic disorders:
- Understand the coagulopathy of liver disease;
- Understand the pathophysiology of vitamin K deficiency and antagonism;
- Understand the laboratory evaluation of disseminated intravascular coagulation;
- Understand the pathophysiology of the hemophilias (A, B, and C).
- Understand the pathophysiology of arterial and venous thrombosis.
- Understand the general principles of screening coagulation tests (e.g., prothrombin time, activated partial thromboplastin time, fibrinogen, and thrombin time).
- Understand the International Normalized Ratio derivation and its clinical significance.
- Understand the effect of hematocrit and blood-drawing technique on anticoagulation of blood samples for coagulation testing.
- Demonstrate competency in taking a bleeding and thrombosis history.
- Understand results of mixing studies and factor assays to guide further coagulation testing.
- Understand the principles of tests involved in the identification of lupus anticoagulant and antiphospholipid antibody syndromes.
- Recognize the effect of circulating anticoagulants on coagulation testing.
- Understand the monitoring of anticoagulation therapy.
- Understand the method of action of direct thrombin inhibitors and their effect on coagulation testing.
- Understand the principles of molecular analysis of thrombotic risk factors [e.g., factor V Leiden, prothrombin G20210A, and methylenetetrahydrofolate reductase (MTHFR)].
- Understand the principles of functional and antigenic assays for proteins of the anticoagulation and fibrinolytic systems.
Skill Level II
- Interpret results of coagulation and hypercoagulability testing and recommend further studies as needed.
- Summarize laboratory evidence for hemostatic and thrombotic disorders and be able to assess and explain bleeding and thrombosis risk.
- Interpret results of Bethesda assays for factor inhibitors.
- Interpret results of coagulation tests in the setting of fibrinolytic therapy.
- Interpret results of heparin-induced thrombocytopenia testing (ELISA tests vs serotonin release assay/platelet aggregation studies) in the appropriate clinical context.
- Understand monitoring and complications of biologics as drugs (e.g., recombinant activated protein C and recombinant F VIIa).
IV. Flow Cytometry
Skill Level I
- Understand clinical indications for flow cytometric evaluation of blood, marrow, solid tissue, or fluid cells.
- Understand the physical components and operating principles of a flow cytometer.
- Understand QC procedures unique to flow cytometry assays (e.g., nature of controls and accounting for all lymphocyte subsets in a blood sample).
- Understand the principles of routine flow cytometry evaluation of leukocytes, including both surface and intracellular markers, and recognition of clonal abnormalities.
- Understand principles of tests designed to evaluate DNA content (ploidy) and cell cycle, as used in the evaluation of products of conception and other tissues.
- Understand platelet antibody testing by flow cytometry and its clinical applications.
- Understand the diagnostic and prognostic information provided by flow cytometry.
- Understand the principles of lymphocyte subset analysis: know the commonly used antigens to define T-cell subsets, natural killer, and B cells.
- Appreciate the effect of age on lymphocyte subset normal ranges.
- Observe/perform lymphoma/leukemia panel on blood and/or bone marrow.
- Observe/perform lymphoma panel on lymph node or spleen specimens.
Skill Level II
- Evaluate and interpret results of flow cytometry in conjunction with cytochemistry, immunocytochemistry, immunohistochemistry studies, and lymph node pathology as related to hematopoietic and lymphoproliferative diseases:
- Understand the characteristic clinical, morphologic, immunophenotypic, cytochemical, and cytogenetic/molecular features of acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndromes, paroxysmal nocturnal hemoglobinemia, multiple myeloma, monoclonal gammopathy of undetermined significance, non-Hodgkin and Hodgkin lymphoma, neuroblastoma, chronic lymphoproliferative disorders, lymphomatoid granulomatosis, posttransplant lymphoproliferative disorder, polymorphic and lymphomatoid papulosis, and histiocytic disorders.
- Interpret specific flow cytometric abnormalities associated with immunodeficiency syndromes.
- Interpret CD34 counts for stem cell transplantation and for prognostication in myeloproliferative disorders.
- Understand the principles and interpretation of reticulated platelet analysis.
- Understand the principles of, and interpret analyses for, minimal residual disease.
V. Hematopathology
1. bone marrow
Skill Level I
- Understand the clinical indications for bone marrow evaluation.
- Understand the diagnostic limitations of bone marrow aspirate and biopsy sections.
- Learn technical aspects of performing and analyzing bone marrow aspiration and biopsy. Encourage performance of bone marrow aspiration and biopsy.
- Identify sites for the acquisition of bone marrow in children and adults.
- Learn handling, preparation and interpretation of bone marrow specimens, including special stains (e.g., silver stain and Prussian blue).
- Correctly assess bone marrow cellularity and M-E ratio.
- Recognize effects of chemotherapy and growth factor stimulation on blood and bone marrow.
- Understand common drug effects leading to benign cytopenias.
- Correctly identify storage iron and assess adequacy.
- Understand hematopoiesis and distinguish the stages for cells in each hematopoietic cell series.
- Know the major hematopoietic regulatory factors/cytokines.
- Recognize normal WBC, RBC, and platelet maturation as well as cellular dysplasia.
- Understand diagnostic principles involved in distinguishing transient myeloproliferative syndromes (such as associated with Down syndrome), transient cytopenias, and transient lymphocytoses from clonal disorders.
Skill Level II
- Understand the pathophysiology, clinical findings, etiology, and expected bone marrow morphology for vitamin deficiency anemias, hemoglobinopathies, thalassemias, aplastic anemia, red cell aplasia, leukemias, myeloproliferative disorders, myelodysplastic syndromes, plasma cell dyscrasias, and mast cell diseases.
- Integrate morphology, cytochemistry, immunophenotype, and molecular and cytogenetics in the differential diagnosis of acute and chronic leukemia, lymphoma, and myeloproliferative and myelodysplastic diseases.
- Integrate peripheral blood smear and bone marrow findings and render a preliminary diagnosis.
- Know the post-therapy findings seen after treatment for leukemia and the temporal relationships to marrow regeneration post therapy.
- Recognize the bone marrow manifestations of infections (e.g., viral, fungal, and hemophagocytic syndromes).
- Recognize the bone marrow manifestations of noninfectious systemic diseases (e.g., alcoholism, collagen vascular disease, and nonhematologic malignancies).
2. lymph nodes
Skill Level I
- Understand principles of gross examination of lymph nodes and the indications and procedures for proper specimen preparation of lymph node tissue for special studies.
- Recognize normal lymph node and spleen morphology and understand normal patterns of lymphocyte development and trafficking in lymph nodes.
Skill Level II
- Recognize and be able to diagnose changes in lymph node morphology associated with lymphoma and other lymphoproliferative disorders; understand the relative value of different diagnostic modalities in this setting.
- Recognize and be able to diagnose reactive autoimmune and infectious lymphadenopathies, storage disease, and histiocytic disorders in lymph nodes; the changes associated with these disorders in bone marrow; and the approach to effective differential diagnosis involving all available modalities (molecular studies, immunohistochemistry, flow cytometry, cytogenetics, and others as indicated).
- Recognize the presence of metastatic disease in lymph nodes and bone marrow and understand the ancillary diagnostic modalities that may be useful in this setting.
additional competencies specific to hematology
Patient Care
- Appreciate special considerations in pediatric hematology/coagulation and hematopathology.
- Understand the different types of hematopoietic stem cell transplants.
- Understand procedural aspects of bone marrow aspiration and biopsy.
Hematology Reference Materials:
See also the General Reference Materials.
Beutler E, Lichtman M, Collet B, Kipps T, Seligson U, eds. William’s Hematology, 6th ed. New York: McGraw-Hill, 2001.
Carr JH, Rodak BF. Clinical Hematology Atlas. Philadelphia: WB Saunders, 1999.
Colman RW, Hirsh J, Marder VJ, Clowes AW, George JN. Hemostasis and Thrombosis: Basic Principles and Clinical Practice, 4th ed. (5th edition in press). Philadelphia: Lippincott Williams & Wilkins, 2000.
Darzynkiewicz Z, Crissman HA, Robinson JP, eds. Methods in Cell Biology, Cytometry, 3rd ed., Part A, Vol. 63. New York: Academic Press, 2000.
Foucar K. Bone Marrow Pathology, 2nd ed. Chicago, IL: American Society of Clinical Pathology, 2001.
Glassy EF, ed. Color Atlas of Hematology: An Illustrated Field Guide Based on Proficiency Testing. Chicago, IL: American Society of Clinical Pathology, 1998.
Goodnight SH Jr, Hathaway WE. Disorders of Hemostasis and Thrombosis: A Clinical Guide. New York: McGraw-Hill, 2001.
Hoffman R, Benz E, Shattil S, Furie B, Cohen H. Hematology: Basic Principles and Practice, 4th ed. New York: Churchill Livingstone, 2004.
Hoyer JD, Kroft SH, eds. Color Atlas of Hemoglobin Disorders: A Compendium Based on Proficiency Testing. Chicago, IL: American Society of Clinical Pathology, 2003.
Jaffee ES, Harris NL, Stein H, Vardiman JW, eds. World Health Organization Classification of Tumors. Pathogenesis and Genetics of Tumors of Hematopoietic and Lymphoid Tissues. Lyon, France: IARC Press, 2001.
Keren DF, McCoy JP, Carey JL, eds. Flow Cytometry in Clinical Diagnosis, 3rd ed. Chicago, IL: American Society of Clinical Pathology, 2001.
King-Strasinger S, Schaub Di Lorenzo M. Urinalysis and Body Fluids, 4th ed. Philadelphia: FA Davis, 2005.
Kjeldsberg C, ed. Practical Diagnosis of Hematologic Disorders, 3rd ed. Chicago, IL: American Society of Clinical Pathology, 2000.
Knowles DM. Neoplastic Hematopathology, 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 2000.
Loscalzo J, Schafer AI, eds. Thrombosis and Hemorrhage, 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 2003.
Nathan DG, Orkin SH, Ginsburg D, Look TA, Oski FA. Hematology of Infancy and Childhood, 6th ed. Philadelphia: WB Saunders, 2003.
Majerus PW, Perlmutter RM, Varmus H, Stamatoyannopoulos G, eds. The Molecular Basis of Blood Diseases, 3rd ed. Philadelphia: WB Saunders, 2001.
Stewart CC, Nicholson JKA, eds. Cytometric Cellular Analysis: Immunophenotyping. New York: Wiley-Liss, 2000.
Microbiology
I. General Microbiology
Skill Level I
- Understand dynamics of bacterial growth (log and stationary phase).
- Demonstrate knowledge of infectious disease serology as described in the Immunology and Immunogenetics section of this document.
- Understand QC testing and proficiency testing needed for optimum identification of infectious agents in clinical specimens.
- Acquire knowledge of safety issues in microbiology/virology, including handling of infectious agents and chemicals, recommended biosafety levels, and disposal of hazardous waste.
- Understand infection control principles and the importance of collaboration between Infection Control and the Microbiology/Virology Laboratory for prevention of nosocomial infections.
- Understand basic public health principles and the vital interaction between diagnostic laboratories and public health agencies.
Skill Level II
- Develop knowledge of the laws and regulations defining select agents and identify resources for information on bioterrorism agents.
- Understand the importance of biofilms in infectious diseases.
II. Bacteriology
Skill Level I
- Describe characteristics of infectious diseases caused by major aerobic and anaerobic bacteria and aerobic actinomycetes, including clinical presentation, transmission, pathophysiology, and epidemiology.
- Understand proper specimen collection, appropriate methods for transportation of specimens, and appropriate plating methods used for optimum detection of bacteria in clinical specimens.
- Demonstrate proficiency in reading and interpreting Gram stains of organisms from cultures, positive blood culture bottles, and patient specimens (e.g., CSF and urine).
- Describe the basic types of plating media and broths used to isolate bacteria from various clinical specimens, including 5% sheep blood agar, chocolate agar, MacConkey agar, CNA agar, PEA agar, specialized agar for recovery of stool and genital pathogens, BHI broth, and thioglycolate broth.
- Describe factors important for optimum recovery of pathogens from blood cultures, including optimum volume, timing, and number of cultures to collect, and discuss advantages and disadvantages of available blood culture instruments and blood culture media.
- Understand typical Gram stain appearance, colony morphology, and hemolysis patterns for commonly isolated gram-positive (Staphylococcus, Streptococcus, Enterococci) and gram-negative (Enterobacteriaceae, Pseudomonas, Hemophilus, and pathogenic Neisseria) pathogens.
- Be able to interpret colony appearance, media reactions, and rapid test results used to classify common gram-positive and gram-negative pathogens, and determine clinical significance of organisms isolated from various body sites, i.e., blood, CSF, urine, body fluids, wounds, stool, and respiratory specimens.
- Demonstrate knowledge of methods for culture and identification of anaerobic bacteria, including optimum specimen collection, media used for anaerobic culture, and methods used to generate anaerobic conditions.
- Describe characteristics of bacterial pathogens that could be used as agents of bioterrorism, including Bacillus anthracis, Brucella spp, and Francisella tularensis.
- Understand rapid and other non–culture-based testing methods available for diagnosis of disease due to major bacterial pathogens, including group A streptococci, group B streptococci, methicillin-resistant Staphylococcus aureus, Clostridium difficile, Legionella spp, Bordetella pertussis, H. pylori, and Streptococcus pneumoniae.
- Understand the advantages and disadvantages of molecular assays available for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in clinical specimens.
Skill Level II
- Know the media used for isolation of less common or fastidious bacteria, including BCYE agar (Legionella spp), TCBS agar (Vibrio spp), Regan-Lowe agar (Bordetella pertussis), CIN agar (Yersinia spp), MacConkey Sorbitol agar (Escherichia coli 0157).
- Understand the advantages and disadvantages of methods used to identify bacteria, including automated systems and manual methods (including biochemical reactions such as oxidase, catalase, PYR, lactose fermentation, and metabolism of glucose and other carbohydrates).
- Acquire advanced skills in microscopy, including the ability to read and interpret respiratory and wound Gram stains and fluorescent stains.
- Describe the steps necessary for validation of new testing methods in bacteriology.
- Understand the role of QC procedures to ensure optimal performance of microbiological media, reagents, and assay kits.
III. Susceptibility Testing
Skill Level I
- Describe the mechanism of action of the major classes of antimicrobial agents used to treat bacterial, fungal, viral, and parasitic infections.
- Understand basic principles of in vitro susceptibility testing, including achievable serum drug concentrations, minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), and breakpoints.
- Compare and contrast susceptibility testing methods that may be used in the clinical laboratory, including broth dilution methods, disk diffusion testing, agar dilution testing, and the Etest.
- Understand the Disk Approximation Test used to detect a "D zone" and describe when it should be performed.
- Describe methods used for screening and confirmation of extended-spectrum ß-lactamases in gram-negative bacteria.
Skill Level II
- Describe mechanisms and special detection methods for the following phenotypes: vancomycin-resistant enterococci, methicillin-resistant staphylococci, vancomycin-resistant staphylococci, penicillin-resistant S. pneumoniae, resistance to extended-spectrum ß-lactams in E. coli and Klebsiella spp, and inducible clindamycin resistance in Staphylococci spp.
- Develop the ability to interpret susceptibility testing results using CLSI guidelines.
- Understand the operational and clinical factors involved in selecting particular susceptibility methods for a clinical microbiology laboratory, including staffing levels, routine workflow, and the patient population being tested.
IV. Mycobacteriology
Skill Level I
- Understand the major characteristics of diseases caused by mycobacteria, including clinical presentation, transmission, pathophysiology, epidemiology, infection control issues, and public health concerns.
- Describe decontamination/concentration procedures used to process specimens sent for culture of acid-fast bacilli (AFB).
- Describe the staining methods for AFB, including fluorochrome and carbolfuchsin stains.
- Read and interpret fluorochrome- and carbolfuchsin-stained smears.
- Understand the advantages and disadvantages of liquid and solid media used to culture AFB organisms.
- Define rapid grower, scotochromogen, photochromogen, and nonchromogen and provide examples of mycobacteria in each category.
- Demonstrate knowledge of hybridization probes used for culture identification.
- Understand safety issues associated with culture of AFB organisms.
- Compare and contrast the Mantoux skin test and the Quantiferon test for detection of latent tuberculosis.
- Name the primary antituberculosis agents and the most important drug used in treatment of disease due to Mycobacterium avium complex.
Skill Level II
- Compare and contrast the direct nucleic acid amplification methods available for Mycobacterium tuberculosis and their role in the diagnosis of tuberculosis.
- Describe susceptibility testing methods used to detect drug resistance in mycobacteria.
- Demonstrate knowledge of reference laboratory methods for mycobacterial identification, including rDNA sequencing and HPLC.
- Describe culture methods for thermosensitive and fastidious Mycobacterium spp including M. marinum, M. hemophilum, and M. genavense.
V. Mycology
Skill Level I
- Understand the major characteristics of infectious diseases caused by fungal pathogens, including clinical presentation, transmission, pathophysiology, and epidemiology.
- Describe fungal pathogens that cause disease in specific patient populations, including children, immunocompromised patients, and transplant patients.
- Describe methods for detection of fungal pathogens in clinical specimens, including methods for direct examination of specimens (e.g., KOH smears, vaginal wet preps, and Calcofluor White stain).
- Understand the benefits and limitations of the following nonculture tests for diagnosis of invasive fungal infections: cryptococcal antigen test, urine Histoplasma antigen test, Candida antigen tests, galactomannan enzyme immunoassay.
- Describe appropriate specimen collection and processing methods for fungal cultures.
- Become familiar with commonly used plating media for fungal cultures, including antimicrobial agents used in primary plates for specimens from nonsterile sites.
- Understand testing algorithms for fungal identification, including colony morphology on standard media, the germ tube test, cornmeal agar, slide cultures, special agars (e.g., CHROmagar Candida media) and biochemical tests.
- Identify Pneumocystis jiroveci in respiratory specimens and describe available staining methods for this organism.
- Identify the following fungi based on colony morphology and microscopic appearance: Aspergillus spp, Penicillium spp, Histoplasma capsulatum, Coccidioides immitis, Fusarium spp, Penicillium marneffei, Pseudallescheria boydii, and Zygomycetes.
- Identify the following fungi based on their appearance in tissue: C. immitis, Blastomyces dermatitidis, H. capsulatum, and P. jiroveci.
- List the major classes of antimicrobial agents used to treat fungal infections.
Skill Level II
- Interpret culture results using morphological characteristics of major fungal pathogens and predict clinical significance of an isolate.
- Describe susceptibility testing methods for yeast and fungi and discuss interpretation of susceptibility testing results.
- Name the Candida spp that are typically resistant or have reduced susceptibility to azole antifungal agents.
VI. Parasitology
Skill Level I
- Understand the major characteristics of diseases caused by parasites including clinical presentation, transmission, pathophysiology, and epidemiology.
- Describe the life cycles of intestinal, tissue, and blood parasites.
- Describe clinical presentation and the morphological characteristics used to identify Plasmodium spp (P. falciparum, P. vivax, P. ovale, and P. malariae) and Babesia spp.
- Understand proper specimen collection, transportation of specimens, and processing methods for optimum ova and parasite examinations.
- Understand advantages and disadvantages of preservatives, reagents, and stains used in the ova and parasite examination.
- Be able to recognize important morphological characteristics used to identify pathogenic and nonpathogenic parasites in stool ova and parasite permanent smears and concentrates.
- Demonstrate knowledge of available immunoassays for detection of parasites and describe advantages and disadvantages associated with use of these assays.
Skill Level II
- Gain an understanding of the morphological appearance of parasitic larva or adult worms that may be directly observed in clinical specimens.
- Learn important characteristics used to identify common arthropods brought to the microbiology laboratory for identification.
- Name important antiparasitic agents and the parasites against which they are effective.
VII. Virology
Skill Level I
- Understand the major characteristics of diseases caused by viral pathogens, including clinical presentation, transmission, pathophysiology, and epidemiology.
- Describe viral pathogens that cause disease in specific patient populations, including children, immunocompromised patients, and transplant patients.
- Demonstrate an understanding of proper specimen collection, specimen transportation, and processing methods used for viral culture.
- Demonstrate knowledge of tissue culture techniques and cell types used to grow viral pathogens.
- Describe the hemadsorption test and immunofluorescent staining techniques used for identification of viruses grown in tissue culture.
- Demonstrate knowledge of serological testing methods used to detect HIV antibodies (e.g., enzyme immunoassay, Western blot, and immunofluorescent assay) and describe appropriate HIV testing strategies for adults, children, and neonates.
- Describe advantages and limitations of rapid serological tests used to detect HIV and respiratory viruses.
- Be able to interpret results of antibody tests for hepatitis viruses, herpes viruses, and other important viral pathogens.
Skill Level II
- Identify typical cytopathic effects seen with growth of commonly isolated viruses in tissue culture (e.g., cytomegalovirus, herpes simples virus, varicella zoster virus, adenovirus, enteroviruses, influenza viruses, and respiratory viruses).
- Demonstrate knowledge of antiviral agents, resistance mechanisms, and susceptibility testing methods for antiviral agents.
additional competencies specific for microbiology
Patient Care
- Be able to interpret results from cultures, serology, and molecular testing in conjunction with other laboratory data and clinical presentation to be able to make recommendations for effective testing strategies.
- Understand the use and limitations of drug susceptibility testing, be able to communicate susceptibility results clearly to clinicians, and be able to make knowledgeable choices for testing and reporting of additional or unusual drugs.
Medical Knowledge
- Obtain a satisfactory knowledge of major diseases caused by infectious agents and methods used in the microbiology/virology laboratory to identify pathogens in clinical specimens.
- Demonstrate knowledge of important preanalytical steps in microbiology/virology laboratory testing, such as proper specimen collection, transportation, and processing of specimens as well as important postanalytical issues relating to clear and clinically relevant reporting of test results.
- Demonstrate knowledge of safety issues related to the microbiology/virology laboratory, including handling of infectious agents, chemicals, and possible agents of bioterrorism.
Microbiology Reference Materials:
CDC/NIH. Biosafety in Microbiological and Biomedical Laboratories, 4th ed. Washington: US Government Printing Office, 1999.
Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; 15th Informational Supplement. CLSI document M100-S15. Wayne, PA: CLSI, 2005.
Fields BN, Howley PM, Griffin DE, Lamb RA, Martin MA, Roizman B, Straus SE, Knipe DM, eds. Field’s Virology, 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2001.
Forbes BA, Sahm DF, Weissfeld AS, eds. Trevino EA, photographer. Bailey and Scott’s Diagnostic Microbiology, 11th ed. St. Louis: CV Mosby, 2002.
Garcia LS. Diagnostic Medical Parasitology, 4th ed. Washington: ASM Press, 2001.
Isenberg HD, ed. Clinical Microbiology Procedures Handbook, 2nd ed. Washington: ASM Press, 2004.
Jousimies-Somer H, Summanen P, Citron D, Baron E, Wexler H, Finegold S. Wadsworth–KLT Anaerobic Bacteriology Manual, 6th ed. Belmont, CA: Star Publishing, 2002.
Koneman ED, Allen SD, Janda WM, Schreckenberger PC, Winn WC, eds. Color Atlas and Textbook of Diagnostic Microbiology, 5th ed. Philadelphia: Lippincott Williams & Wilkins, 1997.
Larone DH. Medically Important Fungi, 4th ed. Washington: ASM Press, 2002.
Lorian V. Antibiotics in Laboratory Medicine, 5th ed. Philadelphia: Lippincott Williams & Wilkins, 2005.
Mandell GL, Bennett JE, Dolin R, eds. Principles and Practice of Infectious Diseases, 6th ed. New York: Churchill Livingstone, 2004.
Marler LM. Direct Smear Atlas. Philadelphia: Lippincott Williams & Wilkins, 2001.
Miller JM. A Guide to Specimen Management in Clinical Microbiology, 2nd ed. Washington: ASM Press, 1999.
Mayhall CG. Hospital Epidemiology and Infection Control, 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 2004.
Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH, eds. Manual of Clinical Microbiology, 8th ed. Washington: ASM Press, 2003.
National Committee for Clinical and Laboratory Standards (now CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard–Sixth Edition. NCCLS document M7-A6. Wayne, PA: NCCLS, 2003.
National Committee for Clinical and Laboratory Standards (now CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard–Eighth Edition. NCCLS document M2-A8. Wayne, PA: NCCLS, 2003.
Smith JA, ed. Laboratory Safety in Clinical Microbiology. Washington: ASM Press, 1996.
Storch GA. Essentials of Diagnostic Virology. New York: Churchill Livingstone, 2000.
Transfusion Medicine
I. Transfusion Service
Skill Level I
- Demonstrate knowledge of the principles of patient/unit identification and pretransfusion testing, including ABO/Rh testing, RBC antibody screen, and antibody identification.
- Recognize the symptoms and signs of hemolytic and nonhemolytic transfusion reactions and demonstrate knowledge of the pathophysiology, treatment, and prevention of these complications.
- Identify the major infectious complications of blood transfusions and the current risk of these infections, and explain how these infections can be prevented.
- Identify the major noninfectious complications of blood transfusions, including transfusion-related acute lung injury, the risk of these complications, and strategies to prevent them.
- Choose appropriate blood components and derivatives based on a thorough knowledge of the indications for transfusion.
- Demonstrate knowledge of the pathophysiology, prevention, and treatment of hemolytic disease of the newborn. Recognize those antibodies in pregnant patients that are clinically significant and make appropriate recommendations for blood products.
- Demonstrate knowledge of the pathophysiology and treatment of neonatal alloimmune thrombocytopenia.
- Demonstrate proficiency in the evaluation and appropriate transfusion therapy of thrombocytopenic patients (both adult and pediatric).
- Apply the principles of a massive transfusion protocol.
- Demonstrate a working knowledge of the principles of hemostasis and coagulation and proficiency in the initial treatment of patients with bleeding disorders (see also the Hematology section).
- Demonstrate knowledge of the transfusion requirements of special patient populations (e.g., hematology/oncology, pediatrics, geriatrics, transplantation, and burn/trauma).
- Demonstrate knowledge of landmark published studies in transfusion medicine.
- Demonstrate proficiency in evaluating and presenting findings from recent peer-reviewed journal articles related to transfusion medicine.
Skill Level II
- Identify clinically significant RBC antibodies from an antibody panel including multiple alloantibodies and mixtures of alloantibodies and autoantibodies; determine how difficult it will be to obtain blood for this patient, and effectively communicate these results to clinicians.
- Demonstrate proficiency in evaluating and recommending treatment plans for complex transfusion reactions.
- Demonstrate familiarity with the appropriate use of highly specialized blood products (e.g., granulocytes, donor lymphocyte infusions, HLA-matched platelets, and coagulation factor concentrates).
- Demonstrate familiarity with the requirements of all applicable regulatory and accrediting agencies [e.g., JCAHO, CAP, American Association of Blood Banks (AABB), and US Food and Drug Administration].
- Compare and contrast the various means of performing blood utilization reviews.
- Demonstrate competence in the management of blood inventory and the ability to communicate effectively the hospital’s needs to the blood supplier.
- Demonstrate knowledge of various methods of blood conservation, including pre- and perioperative autologous blood collection, and approaches to "bloodless" surgery.
- Demonstrate proficiency in evaluating patients refractory to platelet transfusions. Outline the principles of histocompatibility testing and platelet cross-matching and apply this knowledge in selecting appropriate platelet products when indicated (see also the Immunology and Immunogenetics section).
- Demonstrate proficiency in the evaluation of patients with immune-mediated and non–immune-mediated hemolytic anemia and in the appropriate transfusion management of these patients.
II. Blood Collection/Blood Center/Cell Processing Responsibilities
Skill Level I
- Compare and contrast the eligibility requirements for allogeneic and autologous blood donations.
- Demonstrate knowledge of the indications for therapeutic phlebotomy.
- Demonstrate proficiency in evaluating and treating adverse reactions associated with blood donation/phlebotomy (whole blood and apheresis donations).
- Outline the assay principles of required donor blood tests and the associated confirmatory testing and describe donor re-entry algorithms.
- Demonstrate professionalism in interactions with prospective donors.
- Summarize the steps in blood component and blood derivative preparation.
- Describe the factors that influence the motivation of volunteers to donate blood.
- Explain the operational logistics required in determining appropriate blood inventory for a geographic region and the process of meeting daily, weekly, and monthly collection goals.
Skill Level II
- Outline the necessary steps in donor notification and counseling associated with positive infectious disease testing results, and the donor look-back process.
- Demonstrate knowledge concerning the requirements of all applicable regulatory and accrediting agencies.
- Demonstrate knowledge of the principles of hematopoietic stem cell transplantation, including collection, processing, and storage of these stem cell products, and the indications for use (e.g., bone marrow, peripheral blood, and cord blood).
- Demonstrate understanding of the elements of current good manufacturing practices and current good tissue practices as they apply to the collection, processing, ex vivo manipulation, and storage of all cellular therapeutic products (e.g., pancreatic islet cells, negative/positive selection/purging of hematopoietic stem cells, gene manipulations, donor lymphocyte infusions, dendritic cell vaccines, and ex vivo expansion of progenitor cells).
- Develop an understanding of emerging areas of cellular therapy, including hematopoietic graft engineering and cellular immunotherapeutics.
III. Therapeutic Apheresis
Skill Level I
- Summarize the principles of apheresis technology, including centrifugation, filtration, and immunoadsorption.
- Demonstrate knowledge of the indications for therapeutic apheresis and of the appropriate replacement fluids to be used in various situations.
- Demonstrate proficiency in evaluating and preparing patients for therapeutic apheresis, including discussion with the patient of the risks and benefits associated with apheresis procedures.
- Communicate effectively with clinicians and housestaff regarding emergent or scheduled therapeutic apheresis procedures through conversations and writing of consult notes.
Skill Level II
- Demonstrate proficiency in evaluating and treating adverse reactions associated with therapeutic apheresis.
- Demonstrate proficiency in the treatment of patients using specialized methods (e.g., photopheresis and immunoadsorption columns).
additional competencies specific to transfusion medicine
Patient Care
- Correctly classify transfusion reactions and give appropriate treatment recommendations.
- Choose appropriate cross-matching methods for various patients (e.g., electronic, immediate spin, and antiglobulin).
- Recognize and appropriately refer serological evaluations that are beyond the scope of a hospital-based transfusion service/blood bank.
- Correctly choose (or recommend) the appropriate blood product for patients with special needs.
- Triage and screen requests for blood components appropriately during inventory shortages.
- Demonstrate the ability to perform blood utilization reviews.
- Perform a donor interview and exam.
- Evaluate and perform initial management of whole blood and apheresis donor reactions.
- Write physician orders for peripheral blood hematopoietic stem cell collections and therapeutic apheresis procedures.
- Appropriately manage reactions that occur during peripheral blood hematopoietic stem cell collections or therapeutic apheresis procedures.
Medical Knowledge
- Demonstrate understanding of and ability to interpret major regulations and guidelines that are applicable to collection, processing, storage, and release of blood and other cellular therapeutic products.
Practice-Based Learning and Improvement
- Demonstrate the ability to develop new policies and procedures or change existing policies and procedures based on a review of the literature or issuance of new guidelines by regulatory agencies.
Interpersonal and Communication Skills
- Demonstrate the ability to discuss the process of therapeutic apheresis with patients, and/or family members where appropriate; answer their questions; and obtain informed consent.
Transfusion Medicine Reference Materials:
See also the General Reference Materials.
AABB web site. http://www.aabb.org.
AABB Standards for Blood Banks and Transfusion Services, 23rd ed. Bethesda, MD: AABB Press, 2005.
AABB Standards for Cellular Therapy Product Services, 1st ed. Bethesda, MD: AABB Press, 2004.
AABB Technical Manual, 15th ed. Bethesda, MD: AABB Press, 2005.
McLeod BC, Price TH, Weinstein RA. Apheresis: Principles and Practice, 2nd ed. Bethesda, MD: AABB Press, 2003.
Blackall DP, Helekar PS, Triulzi DJ. Transfusion Medicine: Self-Assessment and Review. Bethesda, MD: AABB Press, 2002.
Harmening DM. Modern Blood Banking and Transfusion Practices, 5th ed. Philadelphia: FA Davis, 2005.
Blajchman MA. Landmark studies that have changed the practice of transfusion medicine. Transfusion 2005;45:1523–30.
Hillyer CD, Silberstein LE, Ness PM, Anderson KC, Roush KS. Blood Banking and Transfusion Medicine: Basic Principles and Practice. New York: Churchill Livingstone, 2003.
Mintz PD. Transfusion Therapy: Clinical Principles and Practice, 2nd ed. Bethesda, MD: AABB Press, 2005.
Mollison PL, Engelfriet CP, Contreras M. Blood Transfusion in Clinical Medicine, 10th ed. Oxon, UK: Blackwell Science, 1997.
Petz LD, Garratty G. Immune Hemolytic Anemias, 2nd ed. New York: Churchill Livingstone, 2004.
Reid ME, Lomas-Francis C. The Blood Group Antigen Facts Book, 2nd ed. Amsterdam: Elsevier, 2004.
Simon TL, Dzik WH, Snyder EL, Rossi EC, Stowell CP, Strauss RG. Rossi’s Principles of Transfusion Medicine, 3rd ed. Philadelphia: Lippincott Williams & Wilkins, 2002.
US Department of Labor. Occupational Safety & Health Administration. Bloodborne pathogens and needlestick prevention. http://www.osha.gov/SLTC/bloodbornepathogens/.
US Food and Drug Administration. Center for Biologics Evaluation and Research. Blood. http://www.fda.gov/cber/blood.htm.
Immunology and Immunogenetics
I. Clinical Practice and Science of Immunodiagnosis and Clinical Immunology Consultation
1. immunoglobulin quantitative and qualitative disorders
Skill Level I
- Understand the basic biology of immunoglobulins.
- Know the structure of immunoglobulin molecules.
- Know the classes of immunoglobulins and the types of immunoglobulin fragments.
- Understand the function and binding sites of various portions of immunoglobulin molecules.
- Understand the mechanisms for generation of immunoglobulin diversity.
- Understand the mechanisms of heavy chain class switching and the major regulators of class switching.
- Understand the timing and pattern of antibody development after normal immunization and in response to acute and chronic infection.
- Understand the principles of protein electrophoresis and immunofixation.
- Interpret the protein electrophoresis patterns observed in normal serum, normal plasma, normal urine, and in large monoclonal gammopathies such as multiple myeloma and Waldenstrom macroglobulinemia.
- Interpret protein and clinical findings in patients with monoclonal gammopathy of undetermined significance.
- Understand findings and electrophoresis patterns in immunoglobulin light chain (AL) amyloidosis.
- Understand and interpret findings in sera with oligoclonal banding.
- Understand and interpret CSF oligoclonal banding patterns.
- Understand and interpret pattern of proteinuria in nephrotic syndrome.
Skill Level II
- Develop proficiency in interpretation of protein electrophoresis and immunofixation tests.
- Be able to recommend follow-up testing for abnormal or equivocal cases.
- Be able to recommend and interpret special electrophoretic procedures, including chemical reduction, use of special antisera, etc.
2. autoimmune diseases
Skill Level I
- Understand the principles of autoimmunity and the major autoimmune diseases.
- Understand theories of immunological tolerance and anergy.
- Understand clinical features, pathogenic principles, and diagnostic approaches to multisystem autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, antiphospholipid syndrome, and related autoimmune rheumatic diseases.
- Understand patterns observed in immunofluorescence tests for antibodies to nuclear antigens and understand the use and interpretation of tests for antibodies to specific antigens such as DNA, Sm, RNP, SSA/Ro, SSB/La, Jo-1, and Scl-70/topoisomerase.
- Understand tests for rheumatoid factors and antibodies to cyclic citrullinated peptide (antiCCP) in rheumatoid arthritis evaluation.
- Understand the principles and performance of tests for antibodies to cardiolipin, ß-2 glycoprotein I, and related phospholipids and phospholipid-binding proteins, and know integrated interpretation of those tests together with lupus inhibitor tests.
- Understand the interpretation of complement protein and functional measurements in immune complex–mediated disorders.
- Understand the clinical features and immunologic approaches to evaluation of organ-specific autoimmune diseases, such as autoimmune thyroid disease, pernicious anemia, type I diabetes mellitus, celiac disease, and immune-mediated liver disease.
- Be familiar with tests for antibodies to thyroglobulin, thyroid peroxidase/microsomes, and TSH receptor; parietal cells and intrinsic factor; insulin, glutamic acid decarboxylase, and islet cells (including ICA512/IA-2); tissue transglutaminase, gliadin, and endomysium; and mitochondria, smooth muscle, soluble liver antigen, and liver-kidney-mitochondria antigens.
- Understand the clinical features and diagnostic approaches to autoimmune hematologic diseases, including immune-mediated hemolytic anemia and immune thrombocytopenia.
- Understand theories of pathogenesis of multiple sclerosis and know how to interpret CSF findings associated with multiple sclerosis.
Skill Level II
- Develop proficiency in interpretation of direct and indirect immunofluorescence microscopy tests for diagnosis of autoimmune diseases.
- Develop proficiency in use of clinical and laboratory data to diagnose and assess disease activity of autoimmune diseases.
3. infectious disease serology: principles and general applications
Skill Level I
- Understand the typical time course of appearance and disappearance of serum antigens and antibodies used in diagnosis of major infectious diseases, including:
- Viral infections: HIV, hepatitis A, hepatitis B, hepatitis C, Epstein–Barr virus (both specific antibodies and heterophile antibodies), cytomegalovirus, and herpes simplex virus (HSV) 1 and 2;
- Bacterial infections: Lyme disease, syphilis, and group A streptococcus;
- Fungal diseases: understand serological tests (e.g., immunodiffusion and complement fixation) used to assess exposure to Aspergillus spp, H. capsulatum, and C. immitis.
- Protozoal infections: understand immunologic approaches to assessment of exposure to toxoplasma, schistosoma, trypanosoma, and others.
- Understand and be able to interpret nontreponemal and treponemal antibody tests used to diagnose syphilis.
- Understand typical antibody response to immunization with hepatitis A vaccine, hepatitis B vaccine, and rubella vaccine.
Skill Level II
- Be able to provide consultation regarding need for immunization after measurement of antibodies to determine protective levels of antibodies.
- Develop competence in ability to provide recommendations regarding need for passive immunization with antibody preparations after exposure of vulnerable patients.
4. laboratory assessment of allergic diseases
Skill Level I
- Understand the use of measurement of antigen-specific IgE concentrations to assess diagnosis of specific allergies and comparison with use of in vivo skin tests.
- Understand principles of pathogenesis of allergic disorders and laboratory tests to assess mast cell degranulation.
5. innate immunity and inflammation
Skill Level I
- Understand the role of the complement system or proteins in health and disease.
- Understand the use of complement protein measurements to assess inherited and acquired deficiency states, including deficiency of complement components and deficiency of regulatory proteins such as C1-esterase inhibitor.
- Understand the role of complement protein measurements to assess activation of the complement system.
- Understand the acute-phase response and acute-phase proteins, such as C-reactive protein, to assess inflammatory conditions.
- Understand cytokines as mediators and markers of immune and inflammatory responses. Understand classification of cytokines, including those associated with helper T-cell subsets (Th1 and Th2), inflammatory conditions, etc.
- Understand principles of inflammatory response mediated by cellular receptors (e.g., toll-like receptors) for substances with repeating molecular patterns, such as lipopolysaccharide/endotoxin, DNA, and RNA.
- Be familiar with the proposed role of natural killer cells in innate immune response to tumors and infectious agents.
6. immune deficiency disorders
Skill Level I
- Understand the cells that comprise the immune system and the principles of structural and functional evaluation of B cells, T cells, natural killer cells, and phagocytic cells.
- Understand the role of the T-cell receptor, processed antigen peptides, HLA class I and class II molecules, cytokines, and accessory molecules/costimulation in antigen presentation and formation of the acquired immune response.
- Understand the principles of lymphocyte development, including rearrangements of the B-cell receptor/immunoglobulin genes and the T-cell receptor genes.
- Understand the principles of classification of primary immune deficiency diseases, including defects in humoral immunity, cellular immunity, phagocytic cell function, and complement components, and the infections and neoplasms typically associated with each type of defect.
- Know the more common primary immune deficiency disorders.
- Understand the role of flow cytometry, gene studies, and functional assessments in evaluation of immune deficiency disorders.
- Understand assessment of lymphocyte immunophenotyping and activation, and be able to interpret flow cytometry data used to characterize leukocyte populations.
- Understand the immune pathogenic principles of acquired immunodeficiency disorders.
Skill Level II
- Understand mechanisms of immunosuppressive and major antiinflammatory drugs, including effects of alkylating agents such as cyclophosphamide; antimetabolites such as methotrexate and mycophenolate; cytokine antagonists, including tumor necrosis factor- antagonists; adhesion molecule inhibitors; and costimulatory molecule inhibitors and antagonists.
- Understand effects of drugs designed to deplete target cell populations, such as rituximab to deplete B cells and anti-thymocyte globulin to deplete T cells, and uses of flow cytometry and other techniques to monitor efficacy or toxicity of those drugs.
- Be able to recommend appropriate algorithms for evaluation of patients with undiagnosed immune deficiency disorders.
- Understand interpretation of complex, multimodality testing for diagnosis of immunodeficiency.
- Understand principles of neutrophil and phagocyte function assays and methods to evaluate results.
7. immunogenetic methods and indications and alloimmune testing
Skill Level I
- Know the nomenclature and be able to describe the organization and polymorphism of the human major histocompatibility complex, including HLA class I, II, and III genes.
- Understand the basic function, protein structure, and cell expression of HLA class I and class II gene products.
- Understand the role of HLA typing in organ and bone marrow/stem cell transplantation and how HLA antigen mismatching results in allogeneic reactions in recipients.
- Understand clinical presentations and laboratory assessment of acute and chronic graft-vs-host disease.
- Understand clinical presentations and basic mechanisms of rejection, including hyperacute rejection, acute rejection, and chronic rejection of various organs.
- Know HLA typing techniques, including serological methods, microcytotoxicity assays, nucleic acid assays (such as sequence-specific primer amplification, direct sequencing, and sequence-specific oligonucleotide hybridization), and lymphocyte culture techniques.
- Understand approaches to evaluate the humoral response to transplantation antigens, including cross-matching and panel reactive antibody (PRA) screens using cell-based methods (e.g., cytotoxicity and flow cytometry) and antigen-based methods (e.g., ELISA and bead counters).
- Understand the association of particular HLA alleles with disease and understand the test procedures used for nontransplant clinical purposes, e.g., to test for HLA-B27 in assessment of disease association or risk.
Skill Level II
- Demonstrate familiarity with standards for histocompatibility and reporting set forth by the United Network for Organ Sharing, American Society of Histocompatibility and Immunogenetics, National Marrow Donor Program, and CAP.
- Understand the HLA test procedures and protocols (including initial evaluation and living and deceased donor workups) used for solid-organ transplantation.
- Understand the procedures, including testing for PRAs, used for the periodic update of patient eligibility.
- Understand classification of donor and recipient matching and mismatching, including criteria for unacceptable HLA antigen matches.
- Be aware of laboratory tests required to prevent infections spread by transplantation.
- Understand the HLA test procedures and protocols used for hematopoietic stem cell/bone marrow transplantation, including initial evaluation and final donor selection for both related and unrelated donors, and role of identity testing to assess engraftment.
- Understand the HLA test procedures and protocols used for transfusion support, particularly regarding initial evaluation and selection of HLA matched platelets.
- Demonstrate an ability to select appropriate HLA test methodologies.
- Demonstrate competence in troubleshooting and resolving technical problems.
- Demonstrate an ability to prepare comprehensive HLA test reports that include pertinent information and test interpretation.
- Show an ability to assist requesting physicians in the appropriate use and interpretation of HLA tests.
- Understand methods to assess chimerism after stem cell or bone marrow transplants.
- Understand methods to test parentage.
- Understand management of histocompatibility laboratory operations, such as the need for emergency typing and cross-matching and laboratory receiving and processing functions.
II. Methods of Clinical Immunology Laboratory Testing
Skill Level I
- Understand methods of antigen and antibody testing, and reasons for choosing different types of assays for different analytes based on sensitivity/minimal detectable dose, reagent costs, purity of immunizing substances, etc.
- Understand principles of test performance, QC, and troubleshooting for immune methods including:
- Methods based on protein and particle aggregation, such as agglutination, nephelometry, and turbidimetry; double diffusion; and immunofixation after protein electrophoresis;
- Methods based on detection of labeled antigen or antibody in competitive and noncompetitive sandwich immunometric assays, including RIA, enzyme-linked immunoassays, and chemiluminescence immunoassays;
- Tissue-based immunoassays, including immunofluorescence microscopy and immunohistochemistry;
- RAST tests and other tests for allergen-specific IgE;
- Immune complex assays, including tests for cryoglobulins;
- Flow cytometry methods.
- Cell-mediated immunity tests, such as proliferation, ELISPOT, and cytolytic activity assays as well as skin tests.
- Phagocytic function tests.
- Molecular biological techniques as applied to immunology testing.
- Understand and know how to evaluate, prevent, and correct for immunological interferences associated with immunoassays, including:
- Human anti-mouse antibodies;
- Rheumatoid factors;
- Heterophilic antibodies reacting with immunoglobulins from multiple species;
- Autoantibodies to measured substances;
- Cryoglobulins and cold agglutinins.
additional competencies specific to immunology
Professionalism
- Be cognizant of the potential paternity implications of tissue typing.
Immunology Reference Materials:
See also the General Reference Materials.
Abbas AK, Lichtman AH. Cellular and Molecular Immunology, 5th ed. Philadelphia: WB Saunders, 2005.
Austen A, Frank MM, Atkinson JP, Cantor HI. Samter’s Immunologic Diseases, 6th ed. Philadelphia: Lippincott Williams & Wilkins, 2001.
Buckley RH. Primary immunodeficiency diseases due to defects in phagocytes. New Engl J Med 2000;343:1313–24.
Davison A, Diamond B. Autoimmune diseases. New Engl J Med 2001;345:340–50.
Delves PJ, Roitt IM. The immune system [two parts]. New Engl J Med 2000;343:37–49, 108–17.
Folds JD, Normansell, DE. Pocket Guide to Clinical Immunology. Washington: American Society for Microbiology, 1999.
Janeway CA, Travers P, Walport M, Shlomchik MJ. Immunobiology: The Immune System in Health and Disease, 6th ed. New York: Garland Science, 2004.
Kamradt T, Mitchison NA. Tolerance and autoimmunity. New Engl J Med 2001;344:655–64.
Kavanaugh A, Tomar R, Reveille J, Solomon DH, Homburger HA. Guidelines for clinical use of the antinuclear antibody test and tests for specific autoantibodies to nuclear antigens. Arch Pathol Lab Med 2000;124:71–81.
Kay AB. Allergy and allergic diseases [two parts]. New Engl J Med 2001;344:30–7, 109–13.
Lekstrom-Himes JA, Gallin JI. Immunodeficiency diseases caused by defects in phagocytes. New Engl J Med 2000;343:1703–14.
Medzhitov R, Janeway C. Innate immunity. New Engl J Med 2000;343:338–44.
Rose NR, Hamilton RG, Detrick B. Manual of Clinical Laboratory Immunology, 6th ed. Washington: American Society for Microbiology, 2002.
Schumacher RH. Primer in the Rheumatic Diseases, 12th ed. Atlanta, GA: Arthritis Foundation, 2001.
Stiehm ER, Ochs HD, Winkelstein JA. Immunologic Disorders in Infants and Children, 5th ed. Philadelphia: WB Saunders, 2004.
Turgeon ML. Immunology and Serology in Laboratory Medicine, 3rd ed. St. Louis, MO: Mosby, 2003.
Walport MJ. Complement [two parts]. New Engl J Med 2001;344:1058–66, 1140–4.
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Molecular Pathology (including Cytogenetics)
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I. Cytogenetics
1. acquisition of knowledge of specific tests using cytogenetic methods
Skill Level I
- Understand basic cytogenetic concepts.
- Recognize abnormal karyotyping in prenatal specimens, including, but not limited to, Turner syndrome and trisomy 21.
- Recognize constitutional/postnatal abnormal karyotyping, such as Robertsonian rearrangements.
- Be able to correlate chromosomal abnormalities with specific hematologic disorders such as myelodysplastic syndromes, hematologic malignancies, and myeloproliferative disorders.
Skill Level II
- Understand the use of fluorescence in situ hybridization (FISH) analysis for common disorders involving aneuploidies, microdeletions, or chromosomal translocations, including hematologic disorders such as acute promyelocytic leukemia and chronic myelogenous leukemia.
- Understand imprinting disorders such as Prader–Willi and Angelman syndromes and mitochondrial diseases.
2. analytical and technical training
Skill Level I
- Have awareness of sample types, preparation, and storage conditions for cytogenetic tests.
- Understand sample preparation from peripheral blood, bone marrow, amniocytes, chorionic villi, skin, and products of conception for karyotyping.
- Understand harvesting, slide preparation, banding, and staining.
- Understand microscopic analysis for karyotyping.
- Have knowledge of FISH for both single-copy probes and chromosome painting.
- Understand photomicrography and dark room techniques.
- Be familiar with basic cell and tissue culture techniques.
Skill Level II
- Understand the specific applications of different banding techniques.
- Acquire rudimentary abilities in chromosome identification.
- Understand standard cytogenetic nomenclature.
- Recognize the major chromosomal abnormalities and their association with congenital syndromes, human malignancies, and spontaneous abortion.
- Be able to determine band resolution and develop standards to monitor resolution.
- Be able to develop minimum standards for the numbers of cells to count and/or analyze for karyotyping and FISH.
- Be able to develop FISH probes and determine their chromosomal localization.
3. consultation and presentation of cases using cytogenetic data
Skill Level II
- Demonstrate familiarity with chromosome identification, chromosomal abnormalities, and their relation to disease, and the standard cytogenetic nomenclature based on the Paris Conference of 1971 and An International System for Human Cytogenetic Nomenclature, 1985 (Cancer Supplement, 1991), which is used to describe all karyotypes.
- Be able to discuss the theoretical basis of chromosome technology, chromosome structure, cell cycle and chromosomal abnormalities, and their applications in clinical medicine.
- Interpret and report cytogenetic findings as a final diagnosis.
II. Molecular Pathology
1. acquisition of knowledge of specific tests using molecular biology methods
Skill Level I
- Understand basic molecular biology concepts.
- Know molecular testing methods for inherited causes for thrombophilia, such as factor V Leiden, prothrombin 20210 mutation, MTHFR, and platelet glycoprotein III polymorphisms (PlA 1/2).
- Understand molecular testing and interpretation for cystic fibrosis diagnosis and screening.
- Understand molecular testing for hematologic malignancies, including non-Hodgkin lymphomas (T- and B-cell gene rearrangements) and chronic myelogenous leukemia (bcr-abl detection and quantitation for therapeutic monitoring), and other translocation detection or quantitation assays.
- Understand molecular diagnostic tests for detection and speciation of pathogenic organisms, including Chlamydia trachomatis, N. gonorrhoeae, M. tuberculosis, high-risk human papillomaviruses, and viruses that cause encephalitis/meningitis (HSV and enteroviruses).
- Understand qualitative and quantitative methods used to determine viral load in human immunodeficiency virus, cytomegalovirus, Epstein–Barr virus, and hepatitis C virus, as well as human immunodeficiency virus and hepatitis C virus genotyping to direct therapy.
- Be familiar with molecular testing for trinucleotide repeats diseases, such as fragile X.
Skill Level II
- Understand pharmacogenomic testing for cytochrome p450 mutations and other mutations that affect sensitivity to chemotherapeutic agents, such as thiopurine methyltransferase (TPMT), or other drugs.
- Be familiar with molecular testing for hereditary hemochromatosis, including the C282Y and H53D polymorphisms.
- Understand the principles behind human identity testing for transplant (see also the Immunology and Immunogenetics section).
- Understand prenatal and preimplantation genetic testing interpretation.
- Understand molecular testing for metabolic diseases such as medium-chain acyl-CoA dehydrogenase deficiency.
2. analytical and technical training
Skill Level I
- Have awareness of sample types, preparation, and storage for molecular biology tests.
- Understand applicability of testing to samples of blood, bone marrow, body fluids (e.g., CSF, pleural, and peritoneal samples), lymph node, and spleen.
- Understand the use of whole blood from heel stick and mass screening studies.
- Understand storage media and conditions for cells, DNA, and RNA.
- Understand DNA extraction and purification from a variety of biological specimens.
- Understand quantitation of purified DNA by spectrophotometry/fluorometry and QC of DNA preparations.
- Have knowledge of restriction endonuclease digestion of purified DNA or amplified DNA.
- Understand electrophoretic separation of DNA fragments, native DNA gel electrophoresis for verification of DNA quality, photographic documentation of gels, and capillary electrophoresis methods.
- Have knowledge of total cellular RNA extraction, quantitation, separation of mRNA, and reverse transcription to generate cDNA.
- Understand southern blot DNA hybridization.
- Understand DNA sequencing.
- Have experience and knowledge of in vitro DNA amplification using the PCR and alternative amplification systems, as well as awareness of methods to prevent contamination.
- Understand varying means of analyzing PCR products, e.g., electrophoresis, sequencing, and restriction enzyme digestion.
Skill Level II
- Understand mutation detection and scanning technologies for single- and multiple-mutation platforms.
- Understand real-time quantitative PCR and reverse-transcription-PCR.
- Understand DNA and gene expression microarrays.
- Understand purification methods for cell subsets for subsequent molecular assays.
- Be able to review the literature to evaluate new molecular markers of disease.
- Develop experience in the use of web-based genomic data bases, e.g., for sequence search and single-nucleotide polymorphism identification.
- Understand the utility of genetic markers based on population-at-risk and disease prevalence.
- Be aware of the legal, ethical, and social implications of genetic testing.
3. consultation and presentation of cases using molecular techniques/data
Skill Level II
- Understand and use pedigrees for familial genetic assessments.
- Interpret and report molecular results in association with pathologic and laboratory findings and clinical history to reach a final diagnosis.
- Make recommendations for follow-up or confirmatory studies.
- Assess the sensitivity and specificity of testing for an individual patient’s disease state.
- Understand use of Bayesian analysis for risk assessments.
additional competencies specific to molecular pathology
Patient Care
- Gather accurate clinical and genetic information to generate an appropriate family pedigree.
- Demonstrate the ability to identify family members in need of further testing.
- Understand genetic counseling principles.
Professionalism
- Demonstrate knowledge of regulatory and Health Insurance Portability and Accountability Act (HIPAA) issues pertaining to the use of genetic testing in human research and clinical molecular practice.
Systems-Based Practice
- Understand the principles involved in public-health perinatal genetic testing paradigms.
Molecular Pathology Reference Materials:
See also the General Reference Materials.
Association for Molecular Pathology. Recommendations for in-house development and operation of molecular diagnostics tests. Am J Clin Pathol 1999;111:449.
Barch MJ, Knutsen T, Spurbeck JL, eds. The ACT Cytogenetics Laboratory Manual, 3rd ed. New York: Raven Press, 1997.
Burtis CA, Ashwood EA, Bruns DE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Saunders, 2006.
Coleman, WB, Tsongalis GJ. Molecular Diagnostics for the Clinical Laboratorian, 2nd ed. Totowa, NJ: Humana Press, 2002.
Gardner RJM, Sutherland GR. Chromosome Abnormalities and Genetic Counseling, 2nd ed. New York: Oxford University Press, 1996.
Geren S, Keagle M. The Principles of Clinical Cytogenetics. Totowa, NJ: Humana Press, 1998.
Heim S, Mitelman F. Cancer Cytogenetics, 2nd ed. New York: Wiley-Liss, 1995.
Killeen AA. Principles of Molecular Pathology. Totowa, NJ:, Humana Press, 2004.
Leonard DGB. Diagnostic Molecular Pathology. Philadelphia: WB Saunders, 2003.
Persing DH, Tenover FC, Versalovic J, Tang Y-W, Unger ER, Relman DA, White TJ, eds. Molecular Microbiology: Diagnostic Principles and Practice. Washington: ASM Press, 2003.
Rooney DE, Czepulkowski BH, eds. Human Cytogenetics – A Practical Approach, Vols. I and II, 2nd ed. Oxford: IRL Press, 1992.
Scriver CR, Sly WS, Childs B, Beaudet AL, Valle D, Kinzler KW, Vogelstein B. The Metabolic and Molecular Bases of Inherited Disease, 8th ed. New York: McGraw-Hill, 2000.
Sen F, Vega F, Medeiros LJ. Molecular genetic methods in the diagnosis of hematologic neoplasms. Semin Diagn Pathol 2002;19:72–93.
Shaffer LG, Tommerup N, eds. ISCN 2005: An International System for Human Cytogenetic Nomenclature. Basel, Switzerland: S Karger, 2005.
Strachan T, Read AP. Human Molecular Genetics, 3rd ed. London: Garland Press, 2004.
Therman E, Susman M. Human Chromosomes, 4th ed. New York: Springer-Verlag, 2001.
Thompson MW, McInnes RR, Willard HF, eds. Thompson & Thompson: Genetics in Medicine, 5th ed. Philadelphia: WB Saunders, 2002.
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Laboratory Management
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I. Organizational and Leadership Skills
Skill Level I
- Understand the fundamental principles of human behavior in organizations, of management structure and function, and of organizational structures. Compare and contrast the structure of differing practice settings (e.g., hospital-based, specialty practice, independent laboratory, etc.).
- Develop the interpersonal skills required to effectively manage, lead, and motivate others, including professional peers.
- Develop an understanding of the role of ethics in medical and managerial decision-making.
- Appreciate the conflicting responsibilities and rewards of pathologists, administrators, and technologists, and even the competing interests within each group as necessary to the positive functioning of the laboratory.
- Understand the nature of the relationships between pathologists, hospitals, and medical staffs, including a basic understanding of contracts, decision-making, and effective negotiation.
- Develop skills to project an environment of patient-oriented and ethical service.
- Understand the organization of the laboratory, including preanalytical sample acquisition, accessioning and processing, structure of analytical units, and postanalytical sample resulting. Recognize the different skill sets required of personnel in all of these areas. Be able to analyze work flow in the laboratory.
Skill Level II
- Understand human resource systems, including effective processes for recruitment, retention, and performance management of technical and professional staff.
II. Financial Skills
Skill Level I
- Understand the fundamentals of financial data collection and financial statement presentation and analysis.
- Understand the role of the budget process for operational planning, managing, and control.
- Understand how to properly assign Current Procedural Terminology (CPT) codes to procedures in the laboratory.
Skill Level II
- Understand how to assess the need for new instrumentation as well as the process of financial justification of capital equipment investments such as these.
- Understand the nature and behavior of costs in the laboratory, including test-cost accounting.
- Understand the applicable forms and requirements of reimbursement, particularly Medicare reimbursement, for both clinical laboratories and pathologists.
- Understand how to monitor utilization and become familiar with strategies to effectively manage utilization in a healthcare organization.
III. Regulatory Skills
Skill Level I
- Become familiar with the accrediting agencies relevant to laboratory certification and licensure [e.g., CAP, AABB, Occupational Health and Safety Administration, CMS, Clinical Laboratory Improvement Amendments (CLIA), and JCAHO], and participate in at least one CAP "mock" or "self-inspection" of the laboratory.
- Become familiar with the "test complexity" models under CLIA for clinical laboratory tests (i.e., high complexity, moderate complexity, waived, and physician-performed microscopy).
- Understand the regulatory and compliance environment for laboratories, including CLIA and the Office of the Inspector General model compliance plan, and the implications that these have for the laboratory management team.
- Become familiar with the patient privacy and data security requirements of the HIPAA, including the use of institutional review board (IRB) protocols for conducting clinical research.
- Understand training, certification, licensing, and competency assessment standards for laboratory professionals, including medical technologists and medical laboratory technicians.
- Understand the importance of a comprehensive laboratory safety policy and program.
- Understand how Standard Operating Procedures (SOPs) are used in the routine operation of clinical laboratories.
- Understand how SOPs are developed, authored, and reviewed and their importance in mandatory laboratory inspection by various accrediting agencies (e.g., CAP, JCAHO, and AABB).
Skill Level II
- Understand the role of risk management in the laboratory and become familiar with the nature of medical malpractice, patient safety initiatives, institutional risk mitigation, and forensic testing.
- Become familiar with the process of long-range planning and strategic management, and the implications that this process has for successful management.
- Become familiar with the fundamental principles of marketing, sales, and a market-oriented service delivery strategy.
- Become familiar with the process for creating and/or critically reviewing a business plan for a new or proposed service.
- Become familiar with the different forms that practice relationships can take (e.g., sole proprietorship, partnership, and corporation), and the advantages and disadvantages of each.
- Participate in the development and authorship, and/or review and revision of SOPs.
IV. Quality Assurance, Quality Control, Pre- and Postanalytic Management
Skill Level I
- Understand the role of quality assurance, quality management, and process improvement principles in laboratory operation and planning.
- Understand the role of interlaboratory proficiency surveys, such as the CAP proficiency surveys.
- Be able to develop templates for introduction of new analyte testing in the clinical laboratory, with defined responsibilities at each level of personnel functions.
- Know fundamental statistical concepts for laboratory diagnostics, including descriptive methods, inference regarding population means, confidence intervals, parametric and nonparametric statistics, measures of variance and error, sources of analytical error, methodologic bias, ROC curves, Bayes theorem, reportable range, analytical range, and linearity. Utilize these methodologies to select and validate new diagnostic tests and analytical methods.
- Understand principles of specimen collection (e.g., phlebotomy technique, safety, and specimen tubes) and specimen processing.
- Recognize sources of preanalytical variation and the role of biological variability in laboratory assessment.
- Know how to employ appropriate use of delta checks in detecting preanalytical, analytical, and postanalytical errors.
- Understand the principles of postanalytical result processing and data delivery (see also the Informatics section).
Skill Level II
- Understand the principles involved in determination of reference ranges and the limitations of reference range determinations.
- Understand how to choose, use, and monitor the performance of reference laboratories.
competencies specific to laboratory management
Medical Knowledge
- Understand the most common forms of clinical laboratory organizational structure.
- Understand management theory and the difference between leadership and management.
- Understand the general elements of an income statement and balance sheet.
- Understand the basic approach to creating a budget for the clinical laboratory.
- Be able to assign correct CPT codes for common pathology and laboratory medicine procedures.
- Understand the basic elements of the laboratory safety program.
- Understand the essential elements of choosing a reference laboratory.
- Understand the necessary elements of test cost accounting in the laboratory and be able to cost account a common laboratory procedure.
- Understand how to perform a new instrument evaluation and prepare a financial justification analysis.
- Be able to conduct a performance appraisal.
- Understand the necessary elements of a risk management program and be able to describe how to effectively manage an incident.
- Be able to conduct a management meeting within the laboratory.
- Know how to review external proficiency surveys and respond to identified problems or questions.
- Be able to design a program for test evaluation and validation.
- Be able to participate in a quality process improvement project.
- Understand how to seek and obtain IRB approval for clinical research studies.
Practice-Based Learning and Improvement
- Be able to perform a CAP self-inspection or mock inspection.
- Understand the basic elements of the model compliance plan for laboratories.
- Understand the basic elements of the strategic planning process.
- Be able to participate in a quality process improvement process.
Interpersonal and Communication Skills
- Understand how to conduct an interview for a new employee.
Systems-Based Practice
- Understand the differences between different forms of professional practice.
- Understand the essential elements of professional employment and practice group contracts.
- Understand how to develop a business plan, together with a marketing and sales plan for hospital laboratory outreach program.
Laboratory Management Reference Materials:
See also the General Reference Materials.
American Medical Association. Current Procedural Terminology: CPT 2006. Chicago, IL: American Medical Association, 2005.
College of American Pathologists. Compliance Guidelines for Pathologists. Northfield, IL: CAP, 1998.
College of American Pathologists. Professional Relations Manual, 12th ed. Northfield, IL: CAP, 2003.
Davis GG. Pathology and the Law. A Practical Guide for the Pathologist. New York: Springer, 2004.
Farnsworth JR, Weiss RL. A mentor-based laboratory management elective for residents. Am J Clin Pathol 1999;111:156–60.
Garcia LS, Baselski VS, Burke MD, Schwab DA, Sewell DL, Steele JCH Jr, Weissfield AS, Wilkinson DS, and Winn WC Jr, eds. Clinical Laboratory Management, Washington: ASM Press, 2004.
Horowitz RE. The successful community hospital pathologist: what it takes. Hum Pathol 1998;29:211–4.
Horowitz RE, Naritoku W, Wagar EA. Management training for pathology residents: a regional approach. Arch Pathol Lab Med 2004;128:59–63.
Kurec AS, Schofield S, Waters MC. The CLMA Guide to Managing a Clinical Laboratory. Wayne, PA: Clinical Laboratory Management Association, 1995.
Sims K, Darcy TA. A leadership-management training curriculum for pathology residents. Am J Clin Pathol 1997;108:90–5.
Travers EM. Clinical Laboratory Management. Philadelphia: Lippincott, Williams & Wilkins, 1997.
Weiss RL. A clinical laboratory management elective for residents. Arch Pathol Lab Med 1992;116:108–10.
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Informatics
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I. Basic Computer Skills
Skill Level I
- Understand terms and concepts related to computer hardware and software.
- Understand basic computer networking concepts.
- Understand how to use word processing, spreadsheet, presentation graphics, and statistical software.
II. Laboratory Information System Concepts
Skill Level I
- Understand the major features of a laboratory information system.
- Know the basic data elements of a laboratory information system.
- Demonstrate an awareness of the enterprise information system architecture and how the laboratory information system fits within it.
- Be able to extract data from the laboratory information system.
III. Security and Privacy
Skill Level I
- Understand HIPAA guidelines for security and privacy of protected health information.
IV. The Internet and World Wide Web
Skill Level I
- Know internet-related terms and concepts.
- Be able to utilize the internet to
- Access internet-based databases;
- Perform literature searches.
V. Communication and Standards
Skill Level I
- Develop basic understanding of how the laboratory information system shares data with other networked systems within the enterprise.
Skill Level II
- Develop basic understanding of laboratory instrument interfaces.
- Understand data standards and encoding schemes, such as Health Level Seven (HL7), Logical Observation Identifier Names and Codes (LOINC), Systematized Nomenclature of Medicine by the CAP (SNOMED), International Classification of Diseases (ICD-9 and ICD-10), and CPT.
VI. Emerging Technologies
Skill Level II
- Develop a basic understanding of telepathology systems and concepts.
- Develop a basic understanding of bioinformatics concepts with an emphasis on the critical evaluation of evolving bioinformatics tools. Develop a basic understanding of evolving multiparameter diagnostic approaches.
additional competencies unique to informatics
Medical Knowledge
- Understand the rudiments of laboratory instrument interfaces and laboratory automation systems.
Professionalism
- Understand HIPAA requirements for security and privacy.
Systems-Based Practice
- Understand how and where laboratory data are shared among information systems within the healthcare enterprise.
Informatics Reference Materials:
See also the General Reference Materials.
van Bemmel J, Musen MA, eds. Handbook of Medical Informatics. New York: Springer, 1997.
Wiederhold G, Shortliffe EH, Fagan LM, Perreault LE, eds. Medical Informatics: Computer Applications in Health Care and Biomedicine, 2nd ed. New York: Springer, 2000.
Skill Level II I Curriculum
Due to the great diversity of career paths available in laboratory medicine, a curriculum for the third year of training must encompass the greatest opportunity for individualization and creativity on the part of all training programs. At the level of third-year (senior or sometimes chief resident) activities, the resident often assumes a significant amount of teaching responsibilities for more junior residents and medical students—an educational exercise that often helps to coalesce knowledge and practice for the third-year resident. It is beyond the scope of this document to provide a full curriculum for third-year training, but examples of appropriate curricula would include:
- Investigative Laboratory Medicine Track. Individuals in this track would be expected to spend at least 20% of their third year in longitudinal clinical work, often as an attending apprentice in one laboratory under the mentorship of the laboratory director, and the remaining time in research. The research must be within the broad discipline of laboratory medicine and have clinical relevance but may involve basic bench, translational, or primary clinical investigation. On-call clinical activities along with conferences such as morning report and case presentations are usually continued through this third year. In many cases, this is followed by further year(s) of research training before independence.
- Clinical Subspecialization Track. Individuals in this track would be expected to spend 60%–80% of their time specializing in one subdiscipline, often as an attending apprentice. Specialization would include work in test development and implementation or changes in practice parameters. In some cases, this track may be followed by a subspecialty fellowship.
- Management Track. Individuals in this track would be expected to spend at least 50% of their time obtaining broad knowledge of the "business" of medicine and learning high-level management skills similar to those taught as part of an MBA program. The remaining time would generally involve application of this knowledge base in the practical laboratory setting. This track sometimes is combined with an actual degree in medical management, requiring an extension of the training timetable.
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Assessment of Competency
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Different programs will want to utilize different means of assessing general and rotation-specific competencies. Extensive work in this area has been carried out by an ACGME/American Board of Medical Specialties joint initiative on assessment of the 6 general competencies, which resulted in publication of the Toolbox of Assessment Methods© (http://www.acgme.org/outcome/assess/toolbox.asp). Although details of that work will not be reviewed here, it may be useful to outline the tools that are most applicable to CP training. These are outlined below and summarized in Table 3
. This is not to imply that other tools may not also be appropriate but rather that these are the tools that appear to be most easily implemented in CP training. It is expected that comprehensive evaluation of competency will use more than one tool.
Programs are strongly encouraged to review the materials and references available in the Toolbox document and elsewhere from ACGME and the American Board of Medical Specialties. As of July 2004, all pathology residents are also expected to register in the ACGME Case Log System.
360° Evaluation.
This consists of questionnaires or similar tools completed by multiple individuals in the training sphere of influence that assess performance of the trainee. It is considered most useful to assess interpersonal/communication skills, professional behavior, systems-based practice, and some aspects of patient care. Individuals appropriate to query in this fashion concerning resident performance include supervisory faculty, medical technologists (in particular, laboratory managers or "chief technologists"), clinicians (e.g., pathologists and nonpathologists, attending and resident/fellow staff) with whom the CP resident has consultative interactions, and patients whose care the resident participates in (especially, but not exclusively, during transfusion medicine rotations). In some settings, advanced residents may also have contact with administrative personnel.
Checklist Evaluation.
A checklist may define specific behaviors or activities that make up a more complex competency, either as a pass/fail for each behavior or as a performance judgment (excellent, good, fair, poor). Checklists may be tailored to each laboratory’s skill set but may also include globally accepted basic competencies. This can also be especially useful for assessing procedural competencies, such as performance of a bone marrow aspirate/biopsy or fine-needle aspiration. Interpersonal skills, such as a phone consultation, multidisciplinary conference participation, or "morning report" presentations, may also be effectively evaluated by this method.
Global Rating.
Here a rater judges general categories of ability and does so retrospectively based on impressions over time. Typically, an end-of-rotation evaluation that combines information derived from multiple sources would fall in this category. Generally, qualitative indicators are used. Written comments are important to explain the ratings. All categories may be assessed in this fashion in CP training.
Case and Procedure Logs.
Maintaining a logbook is commonly used in CP training programs. Residents will usually include in a logbook phone and face-to-face case consultations that do not result in a note in the patient chart (a frequent and clinically crucial event in CP) as well as recording procedures (e.g., marrow examinations and apheresis procedures). The logbook serves as a record of overall clinical exposure that can be used to assure adequate breadth of experience for the resident, although the number of cases/procedures recorded is not, per se, an index of competency. Faculty review of the logbook, either in the setting of a morning report or on an individual basis, is recommended. Such a review, if conducted in standardized fashion by an examiner using a well-established protocol and scoring procedure, can be used as the equivalent of a chart-stimulated recall oral examination, although relatively few programs appear to use such an approach at the current time.
Portfolios.
A portfolio is a collection of products prepared by the resident that provides evidence of achievement relative to the curriculum and demonstrates performance, growth, and effort. It may include written documents or video-/audio-recordings, photographs and the like. In CP, this can include computer slide case presentations (case conferences), written materials prepared for journal club, materials generated for morning report, and particular laboratory procedures that the resident has written, revised, or reviewed. It may also contain copies of anonymized patient reports, chart notes, and other clinical interpretations. A portfolio is more than a resident scrapbook—it is most powerful when coupled with resident self reflection. It is a tool to promote self-knowledge and self-esteem and at the same time it can be used to identify areas of strength and areas needing improvement.
Simulations.
Simulations consisting of standardized unknown cases may be used to assess competency in interpretation of various assays. Simulations of QC aberrancies can also be used. Mock CAP inspections in which the resident acts either as the lab director or the inspector are used as an assessment and learning tool in some programs.
Standardized Oral Examination.
The oral examination can be used to assess the resident’s interpretive skills. The exam should utilize realistic cases and problems, and the resident should be evaluated on reasoning and not just medical knowledge. Systems-based practice performance, such as regulatory requirements, can also be assessed by this approach.
Written Examination.
A beginning- and/or end-of-rotation written examination can be effectively used. Often these are multiple choice examinations, but all types can be used.
Record Review.
This can be an effective evaluation tool for chart-based activities of residents, such as evaluation of transfusion reactions, clinical consultations, and interpretations of assay results. This does not imply that the actual patient chart itself must be reviewed because in many cases the laboratory copy of what was sent to the chart is more easily accessible.
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Notes
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This document was prepared by an ad hoc committee of the Academy of Clinical Laboratory Physicians and Scientists (ACLPS) composed of Brian R. Smith, MD (Yale University) and Alan Wells, MD, DMSc (University of Pittsburgh) as chair and co-chair of the committee; C. Bruce Alexander, MD (University of Alabama at Birmingham) and Edwin Bovill, MD (University of Vermont) as members of the steering committee; and, in alphabetical order Sheldon Campbell, MD, PhD (Yale); Amitava Dasgupta, PhD (University of Texas at Houston); Mark Fung, MD, PhD (University of Vermont); Barbara Haller, MD, PhD (University of California at San Francisco); John G. Howe, PhD (Yale); Curtis Parvin, PhD (Washington University); Ellinor Peerschke, PhD (Weill Cornell School of Medicine); Henry Rinder, MD (Yale); Steven Spitalnik, MD (Columbia University); Ronald Weiss, MD (University of Utah); and Mark Wener, MD (University of Washington), along with the assistance of many other members of ACLPS, some of whom are noted below.
This article is also being published in Human Pathology and the American Journal of Clinical Pathology in 2006.
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Acknowledgments
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Many people have contributed substantially to this manuscript. Major participants in the composition of the document include (in alphabetical order): Qasim Ansari, Leonard Boral, Kendall Crookston, Teresa Darcy, Uttam Garg, Michael Hodsdon, Malek Kamoun, Robin Lorenz, Elaine Lyon, Moon Nahn, Peter Perrotta, SM Hossein Sadrzadeh, Thomas Williams, and Kiang-Teck Jerry Yeo. Reviewers of the document include Michael Brown, Grant Bullock, Desmond Burke, David Chou, Richard Eisen, John Fisk, Elizabeth Frank, Timothy Hamill, Michael Hodsdon, Peter Jatlow, Prasad Koduru, Loren Joseph, Jeffrey Kant, Debra Leonard, Dolores Lopez-Terrada, Marisa Marques, Jonathan Miller, Paul Mintz, May Nakagawa, A. William Pasculle, Luke Perkocha, Petrie Rainey, Leigh Thorne, John Thorson, Richard Torres, Darrell Triulzi, Abraham Tzou, Mark Velleca, Elizabeth Wagar, David Wilkinson, Gail Woods, Yan Wu, and Arthur Zieske. The Executive Council of ACLPS, who also reviewed the document and supported this effort, in addition to those included above, consisted of Fred Apple, David Bruns, Tony Butch, Brad Cookson, William Roberts, David Sacks, Eric Spitzer, and Ana Stankovic.
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Footnotes
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1 Nonstandard abbreviations: CP, clinical pathology; CAP, College of American Pathologists; ACLPS, Academy of Clinical Laboratory Physicians and Scientists; ACGME, Accreditation Council for Graduate Medical Education; AP, anatomic pathology; QC, quality control; CLSI, Clinical Laboratory Standards Institute (formerly NCCLS); JCAHO, Joint Commission on Accreditation of Healthcare Organizations; CK, creatine kinase; BNP, B-type natriuretic peptide; T4, thyroxine; T3, triiodothyronine; PTH, parathyroid hormone; CSF, cerebrospinal fluid; POCT, point-of-care testing; WBC, white blood cell; RBC, red blood cell; AFB, acid-fast bacilli; FISH, fluorescence in situ hybridization; HIPAA, Health Insurance Portability and Accountability Act; and IRB, institutional review board. 
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Abstract
Introduction