Standards and Guidelines for Postdoctoral Programs in Clinical Chemistry

Approved and Adopted by the Commission on Accreditation in Clinical Chemistry (COMACC)

I. PURPOSE

The Commission on Accreditation in Clinical Chemistry (ComACC) is an independent non-profit organization that accredits training programs in clinical chemistry at the postdoctoral level. The purpose of granting accreditation to training programs is to foster their excellence, to provide recognition to accredited programs, and to attract qualified individuals to training centers of excellence. This process is intended to assure the trainee that the standards of education and training are consistent across programs and are aligned with progress in medicine and clinical laboratory sciences.

These standards and associated guidelines have been established to define the standards of quality in postdoctoral clinical chemistry programs recognized by ComACC accreditation. They are provided for the benefit of fellowship programs and associated institutions to help them to achieve a level of excellence in their educational efforts yet provide flexibility in achieving the standards through program-specific delivery of education material. The program director is considered a critical component to the success of any fellowship program and ComACC will strive to assure that excellence begins with the program leadership and associated faculty.

This document is intended as a guideline/resource for program directors responsible for providing leadership in organizing local resources for postdoctoral training in clinical chemistry and to assist them in assuring that their programs meet the standards and requirements for accreditation by COMACC.

These standards and associated guidelines have been established to define the standards of quality in postdoctoral clinical chemistry programs recognized by ComACC accreditation. They are provided for the benefit of fellowship programs and associated institutions to help them to achieve a level of excellence in their educational efforts yet provide flexibility in achieving the standards through program-specific delivery of educational material. The program director is considered a critical component to the success of any fellowship program, and ComACC strives to ensure that excellence begins with the program leadership and associated faculty.

II. PREAMBLE

Clinical chemists are doctoral level scientists and/or physicians who have expertise in clinical chemistry or clinical pathology. Clinical chemistry is a broad field that includes routine diagnostic testing, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, biochemical urinalysis, pharmacogenomics, and molecular diagnostics. The principal professional opportunities for graduates of ComACC-approved fellowship programs may include:

Director, Associate/Assistant Director of clinical laboratories in an assortment of medical centers and hospitals,
Director or Associate staff in Research and Development departments in pharmaceutical and/or diagnostics industrial firms
Director/Associate or Assistant Director of a commercial laboratory
Director/Associate or Assistant Director of a public health laboratory
Director/Associate or Assistant Director for other medical/pharmaceutical company
Medical Scientific Affairs Director for an in-vitro diagnostic company

Clinical Chemists are specifically and uniquely trained for the responsibility of oversight of a clinical laboratory, providing expertise in the area of testing, interpretation of laboratory results, and quality management.

The principal objective of a training program should be to educate, train, and prepare clinical chemists to provide leadership in the field of clinical chemistry and other areas of clinical laboratory science, who will be active in research, and who will serve the needs of physicians and patients. The training program should be sufficiently broad in scope that it provides the essentials necessary for the trainee to sit for the American Board of Clinical Chemistry Board examination in clinical chemistry or toxicology, and to have career mobility and to be able to succeed in the professional environment. Therefore, in order to prepare the clinical chemist for these various professional opportunities, a well-balanced program integrates patient care, clinical service, management, research, education, and administration in training.

III. STANDARDS AND GUIDELINES

A. STANDARD I: FACULTY

Educational programs in clinical chemistry must be staffed with adequate, qualified faculty (e.g., clinical chemists and/or clinical pathologists) to assure the quality of the program is consistent with program objectives and trainee education aligns with ABCC-ComACC core competencies.

GUIDELINES

1. PROGRAM DIRECTOR

The program must have a director or co-directors who have ultimate responsibility for oversight and operation of the entire program.
The program director or co-directors must be clinical chemists who hold a faculty appointment at the sponsoring institution, or institutions.
The program director must meet all of the following qualifications:
1. Be a diplomate of the ABCC or fellow of the CACB (Other certifications will not be recognized by ComACC)
2. Have five or more years of experience directing a high complexity clinical chemistry laboratory licensed by a recognized government regulatory body with medical-scientific oversight to provide patient testing.
  - For programs in the United States, this experience must be in a CLIA certified laboratory environment.
  - Program directors in countries other than the United States must have experience directing a clinical laboratory accredited by the governing body of the country in which they are located.
3. Hold a record of a suitable academic appointment at the proposed institutions for 1 year or greater prior to assuming the role of program director.
Co-directors must meet all of the following qualifications:
1. Be a diplomate of the ABCC or fellow of the CACB (Other certifications will not be recognized by ComACC)
2. Have five or more years of experience directing a high complexity clinical chemistry laboratory licensed by a recognized government regulatory body with medical-scientific oversight to provide patient testing.
  - For programs in the United States, this experience must be in a CLIA certified laboratory environment.
  - Program co-directors in countries other than the United States must have experience directing a clinical laboratory accredited by the governing body of the country in which they are located.
3. Hold a record of a suitable academic appointment at the proposed institutions for 1 year or greater prior to assuming the role of co-director.
Associate directors must meet all of the following minimum qualifications
1. Be a diplomate of the ABCC or fellow of the CACB (NRCC will not be recognized)
2. Hold a record of a suitable academic appointment at the proposed institution for 1 year or greater
3. Associate directors must be accompanied by a program director meeting the criteria defined above.Note: Programs may have up to one director and one co-director, OR one director and one associate director. No more than two directors of any kind will be recognized by ComACC. The term “assistant director” will no longer be recognized by ComACC. Note: Programs may have up to one director and one co-director, OR one director and one associate director. No more than two directors of any kind will be recognized by ComACC. The term “assistant director” will no longer be recognized by ComACC.
The program director(s) must be active academically in clinical chemistry research, education, service, and administration at the sponsoring institution.
If there is a change in directorship, and there is no remaining director/co-director with five years of experience, the program is permitted up to 12 months to recruit a qualified individual to maintain accreditation.
Program directors are expected to maintain active diplomate status by meeting the requirements for demonstration of continued competency specified by the ABCC, or maintain fellow in Good Standing with the CACB. Individuals with certifications in either toxicological chemistry or molecular diagnostics from the American Board of Clinical Chemistry can be considered for program directorships, but must be reviewed by ComACC to assure they are actively participating in and have sufficient experience in general clinical chemistry service, education and research.
Program directors seeking first-time accreditation are encouraged to seek input and mentorship from established programs. Directors of existing programs are expected to provide expertise and guidance as demonstration of their commitment to training.

Note: If one or more faculty requirements are not met, the program may submit an appeal to ComACC describing the suitability of faculty preceptors and mitigation strategies, as appropriate.

2. TEACHING FACULTY

FACULTY REQUIREMENTS

Each institution must maintain a 1:1 ratio of ABCC/CACB-certified faculty to fellows at all times.
Example: If the program plans to have two fellows simultaneously, there must be two ABCC/CACB certified faculty, regardless of whether the fellows are at the same stage of training, or one senior fellow and one junior fellow.
Faculty affiliated with a training program must devote sufficient time to the educational program to fulfill their defined teaching responsibilities. They must have appropriate subject matter expertise to provide instruction and guidance. Faculty must participate in teaching trainees, supervising clinical learning experiences and research, evaluating trainee achievement, and evaluating program effectiveness.
Non-doctoral staff may assist with instruction of operational tasks, but should not substitute for faculty.

Note: If one or more faculty requirements are not met, the program may submit an appeal to ComACC describing the suitability of faculty preceptors and mitigation strategies, as appropriate.

B. STANDARD II: INSTITUTIONAL SUPPORT

The parent institution of an accredited educational program in clinical chemistry shall provide adequate space as well as administrative and logistical support to facilitate the effective, efficient operation of the training activity.

In programs where education is provided in two or more institutions, responsibilities of the sponsoring institution(s) and each affiliate for program administration, instruction and supervision must be documented and signed by both parties. There must be a regular review and renewal process for the agreement, no less frequently than the accreditation cycle. The program director must assume overall responsibility for all training not at the sponsoring institution.

Funding resources: Any major changes in funding source or status should be communicated to ComACC.

GUIDELINES

1. SALARY/BENEFITS

The fellow salary must be equivalent (within 95%-105%) of clinical PGY-1 trainees at the institution. Funds may be supplemented by the department or other sources, but the fellow salary must be equivalent to a PGY-1 salary. Advancing the fellow’s salary to be the equivalent to the PGY-2 salary during their second year of fellowship is recommended but not required.

The fellow must also be offered a benefits package similar to pathology residents at the same institution. The precise title of the trainee may vary from institution to institution. Whatever the title, training should be the primary activity of all fellows.

2. LABORATORY FACILITIES

It is essential that training in clinical chemistry be conducted and associated with a broad based clinical laboratory, with rotations in many specialty areas such as routine diagnostic testing, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, biochemical urinalysis, pharmacogenomics, hematology/coagulation, and molecular diagnostics being available to the trainees where possible.
It is highly recommended that postdoctoral trainees have the opportunity to rotate at institutions with special patient populations such as pediatric hospitals, veterans’ administration medical centers, forensic laboratories and/or other educational modalities. If rotations are not feasible, didactic lectures or other educational modalities may be used to provide exposure to these populations/environments.
Any clinical chemistry laboratory used for training shall meet the requirements for local, state or federal licensure or, where no such requirements exist, be approved by an organization acceptable to ComACC (such as the College of American Pathologists, The Joint Commission, or the Center for Medicare and Medicaid Services). Exceptions to this rule may be made on the basis of ComACC’s own findings at the time of a site visit by an inspection team.

3. LIBRARY

Training institutions must have library and/or other services that provide an adequate, readily available basic collection of reference books as well as books in the sciences fundamental to clinical chemistry, pathology, and laboratory medicine. In addition, the library should provide access to a wide range of on-line medical/biochemical journals in the fields of clinical chemistry.

4. COMPUTER SERVICES

The institution will provide the trainee with full access to a personal computer and on-line services. Postdoctoral trainees must have an electronic mail address and access to Medline/PubMed or similar on-line literature search function. It is essential that all trainees have access to any additional computer systems necessary for training and patient care, such as the LIS (Laboratory Information System) and EMR (Electronic Medical Record) and can demonstrate their proficiency for the Commission upon request.

5. RECORDS

The institution shall maintain, and have available for inspection by the Commission, upon request, the records of program’s curriculum offerings, program activities, trainee attendance, and evaluation documents. The records should be prepared in a manner consistent with federal right to privacy legislation. Records may include, but are not limited to:

Recruitment/selection documentation
Rotation/course schedules and activity logs
Documentation for clinical consultation i.e., on-call experience
Trainee performance evaluations by faculty
Program and faculty evaluations by trainees
Trainee scholarly performance (publications, abstract, presentations), which may be part of CV’s provided.
List of past trainees, including certification status and current position

C. STANDARD III: CURRICULUM AND INSTRUCTION

1. PROGRAM OBJECTIVES

The curriculum and instruction, both didactic and clinical, of an accredited training program in clinical chemistry shall demonstrate a pursuit toward excellence and the achievement of preset educational objectives. The curriculum and instruction shall demonstrate, but not be restricted to, compliance with minimum requirements defined by the Commission.

A trained clinical chemist should be able to demonstrate competency in directing clinical services and proficiency for initiating independent or collaborative research projects.
A trained clinical chemist must be able to teach others (e.g., residents, graduate students, medical students, medical technologists, etc).
A trained clinical chemist should have administrative skills. Most training programs devote part of the program to supervised managerial training, in which a trainee will assume the graduated responsibilities of the laboratory director for a defined period of time (at least 6 months total) with documented goals and objectives.
Competency in the following areas:
1. A clinical chemist must serve effectively as a consultant to physicians in the interpretation of reported laboratory values and in the relationship of biochemical and genetic findings of disease. He/she should have a cordial relationship with the medical staff.
2. A clinical chemist must be familiar and up to date with the newest tests, disease markers and technologies in the field of clinical chemistry.
3. A clinical chemist must be thoroughly grounded in the theory, operation, and maintenance of instrumentation, methodology, and the quality control measures applicable to the modern clinical laboratory.
4. As an administrator, a clinical chemist must be a reasonably competent manager of people, and have a working knowledge of capital equipment, budgetary resources, the ethics of medicine and science. A trainee must demonstrate graduated accumulation of knowledge and complete an acting directorship that allows the trainee the opportunity to utilize the administrative, methodologic, and consultative skills obtained during their training.

2. ADMISSION

Postdoctoral trainees in clinical chemistry must hold an earned PhD in a chemical, physical, biological or clinical laboratory science or a MD, DO, DPM or DMD degree from an appropriately accredited university or college. Sufficient courses in chemistry, biochemistry or other acceptable subjects should have been completed to qualify the student for certification eligibility with the American Board of Clinical Chemistry prior to admission into the training program. Students who feel that additional course-work would be of benefit (human physiology, molecular diagnostics, etc.) should be offered the opportunity while in training. Trainee selection should conform to institutional requirements for equal employment opportunity and be based solely on qualifications related to successful completion of the training program.

3. CURRICULUM

Postdoctoral training should be sufficient to allow the trainee to assume immediate responsibility for the clinical chemistry laboratory in a medium–sized hospital or to direct a laboratory subject to regulations (local, state, or federal). Specifically:

The postdoctoral trainee must acquire a competency for independent decision-making and assume a responsible role in providing the most accurate laboratory results and interpretation to his/her medical colleagues. This should include the responsibility of handling calls from technical and medical staff during the training period with appropriate graded responsibilities and oversight.
The postdoctoral training period must be a minimum of two years in duration. This time usually is required to teach trainees the fundamentals of clinical chemistry, pathophysiology of human diseases, biostatistics, quality assessment, and principles of instrumentation, as well as to provide sufficient exposure to the management and supervisory aspects of a broad based clinical chemistry laboratory.
Training will consist of didactic and hands on laboratory teaching, supervised decision–making responsibilities, design of clinically oriented research projects and development of presentation skills.

GUIDELINES

The specific content of the training program curriculum is left largely up to the Program Director and Teaching Faculty. However, the curriculum for an effective training of clinical chemists should provide the necessary education, training, and practice (where feasible) in the essential areas of clinical chemistry and laboratory practice that are outlined in Appendices I through IV. It is recognized that not all programs will be able to provide hands-on training in all areas. The use of off-site rotations and visits to specialty organizations is an effective way to provide additional training, but is not required.
Additional guidance for development of a training program curriculum may be found on the ComACC website and include recommendations for assessment of competencies in clinical pathology based on the six areas of competency defined by the Accreditation Council for Graduate Medical Education (ACGME) – patient care, medical knowledge, practice-based learning and improvement, interpersonal and communication skills, professionalism, and systems-based practice.
Trainee experiences must be educational and balanced so that all competencies can be achieved. Trainees are expected to be students first with priority in the allotment of trainee time and energy given to the didactic and clinical education of the trainee. The learning objectives of the program must not be compromised by reliance on trainees to fulfill service obligations.
1. Moonlighting within or outside of the institution must be clearly separated from the training program experiences and not interfere with the ability of the trainee to achieve the goals and objectives of the program. If moonlighting or performance of billable clinical activities is allowed during the training period, there must be a defined policy outlining the scope of such activities.
2. Any program wishing to enroll trainees part-time or in a research track must develop detailed policies and procedures to assure that the trainee receives the same level of training as those who are full time. These policies must demonstrate how the modules, rotations, on-call activities and other trainee experiences are measured and found to be equal to full-time clinical fellows.

STANDARD IV: PROGRAM EVALUATION

There must be an assessment process for continually and systematically reviewing the effectiveness of the program.

GUIDELINES

The program should define a series of outcome measures from the last four active years. The data must be documented, analyzed, and used in the program evaluation.
Examples of outcome measures include publications by trainees, practice certification examinations, certification examination results (ABCC or others), and/or surveys of graduates, their current employers, or staff who interact with the trainees or graduates.

STANDARD V: MAINTAINING ACCREDITATION

Programs are required to comply with administrative requirements for maintaining accreditation including:

Submission of the self-study report or any required progress reports as determined by ComACC.
Payment of accreditation fees as determined by ComACC.
Notification of changes to administrative and operational information provided to ComACC within 60 days. Information includes program director(s), mailing addresses, email, phone numbers, clinical affiliates indicated at the last inspection, or institutional names.
Submission of all reports and responses requested by ComACC within established deadlines. Failure after 30 days to meet any deadline will result in a suspension of accreditation for 30 days followed by revocation of accreditation status if no response is received within that time period. Notification will be sent to ABCC and NRCC of revocation. After revocation, the program will be required to apply as a new program for accreditation by ComACC. Programs seeking reinstatement following de-accreditation will be subject to all the requirements established for accreditation of new programs.

ComACC Accredited Program Annual Report:

All ComACC accredited programs are required to recertify their accreditation annually via submission of a report form. The form will be sent out annually by ComACC administrator and completion by program director is required within 30 days. The form will also serve as a reminder for the program leadership to review their program description on the ComACC website.

In brief, the form will include the following questions.

Detail the current number of trainees in the program and their status, including board examination information
Information on training interruptions or lack of progression in fellow training
Funding changes
Faculty changes (program director/co-director, or other faculty that provide fellow training)

If accredited programs do not submit their report by the deadline, ComACC leadership may elect to:

Provide the program with an official letter of warning with a set deadline for compliance.
Continued non-compliance will trigger an off cycle visit at institution’s expense, and if indicated, revocation of accreditation (as determined by, and at the discretion of ComACC.

Reinstatement following loss of accreditation requires submission of a new program application. In addition, programs seeking reinstatement will be subject to all the requirements established for accreditation of new programs.

Based on information submitted during the annual report, ComACC may elect to take one of the following actions:

Require submission of additional documentation
Require implementation of changes to the program along with submission of supporting documentation
Require an off-cycle site visit at the institution’s expense.

ComACC reserves the right to revoke accreditation of a program even if a program is still within its 5-year accreditation period if a program continuously fails to meet requirements outlined in the ComACC Standards and Guidelines.

Reaccreditation:

ComACC may, at the time of accreditation renewal opt for any of the following options for reaccreditation of a program based on the results of review of a self-study or site visit.

Reaccredit the program for 5 years with no conditions
Reaccredit the program for 1 year, with a requirement for implementation of changes required by ComACC in conjunction with submission of supporting documentation 60 days prior to the end of the 1 year accreditation period. Upon review of the submitted documentation, ComACC will then evaluate the program and determine the program’s accreditation status.
Reaccredit the program for 1 year, with a requirement for submission of supporting documentation requested by ComACC 60 days before the end of the 1 year period, along with completion of an additional site visit (at the institution’s expense). Upon completion of the site visit, ComACC will evaluate the program and determine the program’s accreditation status.
Not reaccredit the program.

The above options will apply to all currently accredited programs, including newly accredited programs.

Inactive Programs:

If a fellowship program has not trained a fellow in the last three years, the program will be required to provide justification and documentation for continuation, as well as a recruitment strategy to solicit fellows.
If a fellowship program has not trained a fellow in the last five years, the program will be converted to inactive.
The inactive status will be placed on the ComACC website, until a strategy to re-activate the program is put in place by the program and approved by ComACC.

APPENDICES

APPENDIX I. FUNDAMENTAL CONCEPTS AND PROCEDURES LABORATORY MANAGEMENT, ORGANIZATION AND OPERATION

Principles of leadership and organization
Laboratory facilities and design
Centralized versus Point-of-Care Testing
Laboratory test ordering and reporting systems
Medico-legal requirements (confidentiality, record keeping)
Accreditation requirements
Workload reporting and cost accounting
Billing and reimbursement concepts and issues
Preparation and maintenance of proper laboratory manuals
Quality management, including day to day quality control and quality assurance and long-term quality improvement.
Informatics (EMR, HIS, LIS)

LABORATORY SAFETY

Fire, chemical, radiation and infection control
Waste disposal regulations
Blood and body fluid precautions
Applicable OSHA/JCAHO regulations and requirements
Material Safety Data Sheets (MSDS) interpretation
Any other laboratory or institutional safety practices and policies in effect (e.g., ergonomics)

BASIC STATISTICS

Descriptive statistical measures, e.g., mean, median, mode and standard deviation
Comparative statistics, e.g., confidence limits, t-test, F-test, analysis of variance, Chi- square, linear and other regression and difference plots
Concepts of parametric and non-parametric statistics

APPENDIX II. PRINCIPLES OF ANALYSIS AND TECHNIQUES USED IN CLINICAL CHEMISTRY

SPECIMEN COLLECTION AND PROCESSING

Specimen collection, identification, transport, delivery, preparation and preservation
Patient preparation for tests
• Special collection requirements, e.g., neonates
Anticoagulants, preservatives and gel separators
Regulations and precautions regarding transport of biological specimens
Pre-analytical errors
• Special considerations for specimens other than blood (urine, CSF, body fluids)

PRINCIPLES OF ANALYSIS

Solute/solvent concepts and calculations
Units of measurement – Conventional, SI, and unit conversions
Basic laboratory techniques, e.g., pipetting, weighing, filtering, centrifugation
Fundamental analytic concepts such as spectrophotometry and other optical techniques, electrochemistry, electrophoresis, chromatography, mass spectrometry, enzymology, immunochemistry, radioimmunoassay, etc.
Chemicals, water, primary and secondary standards; reference materials (International reference materials) and reference methods
Internal and external quality control concepts and procedures
- Control charts (e.g. Levey-Jennings)
- QC rules (e.g. Westgard)
- Moving averages
Proficiency testing – external, internal
Principles of new method introduction:
- Principles of analytic error assessment
- Assessment of accuracy, precision, interferences, sensitivity and limits of detection, method bias, total allowable error, etc.
- To include including regulatory requirements for introduction of a new method (FDA-approved, and laboratory developed tests (LDTs), and analyte specific reagents (ASRs)
Principles of instrumentation and automation and strategies to select appropriate instruments

TECHNIQUES USED IN CLINICAL CHEMISTRY

General Techniques: Volumetric techniques, weighing, filtration, liquid-liquid and solid- phase extractions, partition coefficients; selection and preparation of buffers; freeze drying; dialysis; concentration, desalting, ultra-filtration; preparation of derivatives; calibration techniques
Spectrophotometric Techniques: Molar absorptivity, reflectance, absorbance, transmittance, fluorometry, fluorescence polarization, bioluminescence, chemiluminescence, electroluminescence, nephelometry and turbidimetry
Electrochemistry: Potentiometry, ion-selective electrodes, voltammetry and amperometry, conductometry, coulometry and biosensors
• Electrophoresis: Conventional, capillary, microchip, polyacrylamide, capillary zone, isotachophoresis, isoelectric focusing, immunofixation, two dimensional (2D)
Chromatography: Planar vs. column, gas vs. liquid, adsorption, affinity, ion-exchange, partition and size-exclusion techniques, direct and reverse phase liquid chromatography, highperformance liquid chromatography, solid phase extraction techniques, gas chromatography
Mass spectrometry: GC-MS, LC-MS, LC-MS-MS, MALDI-TOF, SELDI, ICP-MS
Clinical Enzymology: Enzyme kinetics, enzymes as reagents, coupled enzymatic reactions, zero-order (enzyme) assays, first-order (substrate) assays
Immunoassay techniques: Preparation, assessment and storage of antisera, methods of assessing analytical sensitivity and specificity, standardization issues, isotopic and non-isotopic, liquid or solid-phase, competitive, non-competitive or immunometric, specific techniques (radioreceptor, immunodiffusion, immunoelectrophoresis, immunoblotting and immunofixation, enzyme-linked immunoassays, nephelometric, turbidimetric, chemiluminescent and fluorometric immunoassays
Isotope Techniques: Physical principles and types of radioactive isotopes, counting techniques and their statistical evaluation, half-life and specific activity concepts and calculations, units of radioactivity, radioimmunoassay techniques, radiation safety and legal requirements for storage and disposal
Molecular Diagnostics: Principles and methods of DNA and RNA isolation, purification, polymerase chain reaction (PCR); DNA probes (radioactive and non-radioactive labels), hybridization, restriction fragment length polymorphism (RFLP), blotting techniques, DNA chips/microarrays, sequencing, Real Time PCR, fluorescent in situ Hybridization (FISH), other methods of genomic analysis
Proteomics and Protein Arrays: Qualitative and quantitative methods for proteome characterization such as 2-D gel electrophoresis, SELDI-TOF MS, MALDI-TOF MS, protein profiling, fluorescence resonance energy transfer (FRET), and surface plasmon resonance (SPR)

APPENDIX III. INSTRUMENTATION IN CLINICAL CHEMISTRY

The following are examples of the array of instruments often found in a clinical laboratory and with which the trainee should be familiar. For those programs not possessing a broad array of instrumentation, trainees are nevertheless expected to develop an understanding of the principles and potential uses for the instruments listed below. In addition, program directors should provide opportunities for trainees to visit other laboratories in order to broaden their instrumentation/automation exposure and experience.

Amino-acid analyzer
Atomic absorption spectrophotometers
Automated and semi-automated analyzers for general chemistry, automatic sampling and pipetting devices, immunologic techniques, chemiluminescence, fluorescence polarization; random access and batch analyzers; reagent cassette and thin film analyzers
Blood gas apparatus and co-oximeters
Capillary zone electrophoresis and immuno-fixation electrophoresis
Electrophoresis and densitometer equipment
Flow cytometers
Fluorometers
Gas chromatographs with FID, NPD and mass detection
General laboratory equipment such as centrifuges, dry and water baths, balances, microscopes, pH meters, shakers, thermometers, vortex mixers, etc.
High performance liquid chromatographs and associated detection systems
Infrared spectrophotometers
Ion specific electrodes (electrolyte measurement and other applications
Isoelectric focusing
Laboratory automation (front-end, track systems, back-end/storage and retrieval)
Liquid scintillation and gamma counters
Mass spectrometers (quadrupole and tandem)
Nuclear magnetic resonance
Osmometers
Polymerase chain reaction cyclers and other amplification instruments
Refractometers
Small instruments for satellite and point-of-care testing
Spectrophotometers, reflectometers and nephelometers
Tonometers
Ultracentrifuge
Water purification systems, stills, de-ionizers, reverse osmosis units

APPENDIX IV. PRINCIPLES OF LABORATORY MEDICINE RELATIONSHIP OF THE LABORATORY TO MEDICAL PRACTICE

Understand the roles (screening, diagnosis, monitoring) and limitations for laboratory testing in clinical practice
Understand the structure, use and limitations of the medical record (paper or electronic); develop proficiency in extracting and interpreting laboratory and medical information
Be able to design studies and appropriately analyze and interpret data related to determination of diagnostic performance
- Design and performance of outcome studies
- Sensitivity, specificity, predictive value, odds ratio, hazard ratios, and ROC studies
- Economic evaluation of diagnostic testing and application of principles of evidence-based laboratory medicine
Understand the principles and application of evidence-based laboratory medicine in test implementation and patient evaluation
Implementation of appropriate test utilization practices

INTERPRETATION OF LABORATORY TEST RESULTS

Understand the establishment and appropriate use of reference ranges and critical values
Understand the sources and effects of analytic variables on laboratory tests
Understand the sources and effects of physiological variables (diurnal and individual variations, rest, exercise, age, gender, fasting and the pharmacologic effects) on test results
Understand the effects of disease on test results and recognize typical disease patterns
Recognize the use and limitations of current disease-related testing strategies/algorithms, e.g., use of cardiac markers for AMI and ACS, lipid screening, for CHD, diabetes screening, PSA screening, etc.
Develop and demonstrate (via activity logs) application of the above skills through liaison and consultative interaction with medical staff and other laboratory professionals; participate in service rounds, autopsy reports and related seminars and case reports
Understand the principles of screening, confirmatory and reflex testing

CLINICAL PATHOLOGY AND LABORATORY EVALUATION OF DISEASE

Understand basic human biochemistry and physiology, specific biochemical alterations and laboratory tests and testing strategies for the following:

Cardiovascular and related diseases
1. Biochemistry and physiology of normal circulatory function
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of acute myocardial infarction, acute coronary syndromes and congestive heart failure
3. Role of the laboratory in diagnosis and management of primary and secondary hypertension
Endocrine disorders
1. Biochemistry and physiology of endocrine hormones, including:
  1. Pituitary- hypothalamic
  2. Adrenal
  3. Thyroid
  4. arathyroid
  5. Pancreatic endocrine
  6. Ovarian, placental and testicular hormones
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of disorders of the above listed systems
3. The use of stimulation/suppression tests in the assessment of endocrine function
Gastro-intestinal and exocrine pancreatic disease
1. Biochemistry and physiology of GI metabolites and hormones, including:
  1. Pancreatic digestive enzymes
  2. Hydrochloric acid and bicarbonate
  3. Gastro-intestinal hormones
2. b. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of gastro-intestinal and exocrine pancreatic disease, including
  1. Malabsorption
  2. Secretory disorders (neoplastic and non-neoplastic)
  3. Immunologic disorders (e.g. celiac disease)
3. c. The use of stimulation/suppression tests in the assessment of gastric function/disease
Genetic diseases
1. Gene structure, mechanisms of damage and repair and phenotypic manifestations
2. Specific genetic defects, inheritance patterns and biochemical, cytogenetic, and molecular diagnostic approaches for genetic diseases
3. Recommended tests and newborn screening strategies for inherited disorders
Hematologic/coagulation disorders
1. Principles of blood homeostasis and morphology and function of cellular elements of blood
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of hematologic diseases and disordered hemostasis with biochemical implications including:
  1. Hemolysis, hemoglobinopathies and thalassemias
  2. Coagulopathies, primary and secondary causes
  3. Porphyrias
  4. soimmunization (Rh/ABO)
  5. Anemias and disordered iron metabolism
3. Interpretive skills for evaluation of electrophoretic and HPLC results for the diagnosis of hemoglobinopathies and thalassemias
Infectious Diseases
1. Principles of infectious diseases
2. Pathophysiology, clinical features, and recommended laboratory test for diagnosis and management of (per CDC and/or local guidelines):
  1. HIV
  2. Hepatitis A
  3. Hepatitis B
  4. Hepatitis C
3. Interpretation of all results
Hepatobiliary diseases
1. Hepatic structure, physiology and biochemistry
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of hepatobiliary diseases, including:
  1. Hepatocellular diseases
  2. Cholestatic disorders
  3. Immunologic and neoplastic liver diseases
  4. Inherited disorders of bilirubin metabolism
Immune system disorders
1. Immunoglobulin production, structure and function
2. Principles of cellular and humoral immune reactions
3. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of immunologic diseases/alterations in immune function, including:
  1. Immunoglobulin deficiency/overproduction (e.g. immune deficiency syndromes, monoclonal gammopathies, cryoglobulinemia)
  2. Immunologic impact of transplantation
  3. Autoimmune diseases
  4. Allergy testing
4. Interpretive skills for evaluation of electrophoretic and immunofixation results in serum, urine and CSF for monoclonal and/or oligoclonal gammopathies.
Kidney and urinary tract diseases
1. Biochemistry and physiology of normal kidney function
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of acute and chronic kidney diseases, including:
  1. Glomerular dysfunction
  2. Renal tubular disease
  3. Diseases of renal endocrine dysfunction
  4. Diabetic nephropathy
3. The physiologic basis and limitations of various renal clearance tests and estimates of glomerular filtration rate
Lipid and lipoprotein disorders
1. Structure, synthesis and metabolism of the various lipoprotein classes
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of primary and secondary lipid disorders
3. Pathophysiology and utility of various testing modalities (e.g., lipid panel, apolipoproteins, lipoprotein subfractions) for risk stratification and management of coronary heart disease
Mineral and bone disorders
1. Biochemistry of calcium, phosphorus and vitamin D metabolism and of bone formation/resorption
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of primary and secondary bone diseases (e.g. osteoporosis, Paget’s disease, lytic bone diseases)
Nutrition and protein disorders
1. Biochemistry of plasma proteins and amino acids
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of:
  1. Dysproteinemias and dysproteinurias
  2. Malnutrition
  3. Genetic and acquired amino acid disorders
  4. Vitamin deficiencies
3. Interpretive skills for evaluating plasma protein patterns from electrophoretic testing of serum and urine
Pregnancy and reproductive disorders
1. Biochemistry and physiology of normal pregnancy
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of obstetrical complications and diseases of the prenatal and perinatal period
3. Recommended laboratory screening tests and testing strategies for prenatal diagnosis of inherited disease (e.g., trisomy 21)
4. Recommended laboratory tests and testing strategies for fetal lung maturation
5. Tests for risk of preterm labor and/or rupture of fetal membranes
Toxicology and clinical pharmacology
1. Classification of major classes of drugs and toxins and their biochemical/physiologic effects
2. Appropriate sample collection, laboratory test methods, testing sequence and interpretive guidelines for workup of suspected poisoning or toxic exposures by various classes of toxins
3. Understanding of pharmacokinetics and pharmacodynamics
4. Pharmacogenetics
5. Appropriate sample collection and timing, laboratory test methods, testing sequence and interpretive guidelines for therapeutic drug monitoring, work-place drug testing, and testing in support of pain management programs
Water, electrolyte and acid-base disorders
1. Basic intracellular and extracellular fluid and electrolyte homeostasis
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of fluid and electrolyte disorders, including:
  1. Dehydration (e.g. fluid deprivation, diabetes insipidus)
  2. Water excess (e.g., SIADH)
  3. Hyper-/hyponatremia; hyper-/hypokalemia
  4. Oncotic disorders (e.g., edema and ascites)
3. The physiologic basis, use and limitations of various fluids/electrolytes formulae (e.g., anion gap, osmolar gap, serum/urine electrolyte ratios) for detection and differentiation of various fluid and electrolyte abnormalities)
Pediatric Clinical Chemistry
1. Considerations and requirements for pediatric testing as related to:
  1. Sample collection requirements and limitations
  2. Reference intervals
2. Pathophysiology, clinical features and recommended laboratory tests for diagnosis and management of diseases of childhood (e.g., respiratory distress syndrome, hyperbilirubinemia, neuroblastoma, congenital hypothyroidism)
3. Develop interpretive skills for evaluating urine/plasma amino acid and organic acid patterns characteristic of inherited pediatric metabolic disorders
Laboratory evaluation of neoplasia
1. Etiology and clinical manifestations of cancer
2. Recommended laboratory tests for screening, diagnosis, staging and management of specific human cancers, including:
  1. Biochemical markers
  2. Biogenic amines
  3. Oncofetal tumor markers
  4. Enzymes
  5. Cellular markers
  6. Genetic screening both for risk assessment and treatment modalities
3. Clinical performance and limitations of tumor markers

COMACC Curriculum Committee. Approved 09/28/2012 by the Commission. Revised August 2015; April 26, 2016, April 14, 2023