Approved and Adopted by the Commission on Accreditation in Clinical Chemistry (ComACC)
(20 November 2014)
The Commission on Accreditation in Clinical Chemistry (ComACC) is an independent non-profit organization that accredits training programs in clinical chemistry at the doctoral and postdoctoral level. Application for accreditation of doctoral training programs by ComACC is open to any institution legally authorized under applicable regional authority or state law to provide postsecondary education and being able to approve the granting of the PhD degree.
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.
The standards and associated guidelines in this document have been established to define the standards of quality in doctoral clinical chemistry programs recognized by ComACC accreditation. They are provided for the benefit of 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 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 training in clinical chemistry leading to a PhD degree and to assist them in assuring that their programs meet the standards and requirements for accreditation by ComACC.
Clinical chemists are doctoral level scientists and/or physicians who have expertise in clinical chemistry or chemical pathology. The path to reaching the goal of becoming a clinical chemist can begin with exposure to the field during graduate education including general clinical chemistry, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, biochemical urinalysis, biochemical genetics, pharmacogenomics, and molecular diagnostics. Once doctoral level training is successfully completed, post-doctoral training can lead to a career as 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 reference laboratory, and Director/Associate or Assistant Director of a public health laboratory.
The principal objective of a doctoral training program should be to educate, train, and prepare graduates for post-doctoral training in the field of clinical chemistry and other areas of clinical laboratory medicine. Graduates should expect to be active in clinical laboratory service, research and/or teaching. Therefore, in order to prepare the student for these various professional opportunities, the well-balanced program provides basic training in patient care, clinical service, management, research, education, and administration.
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 education of the trainee is effective.
1. PROGRAM DIRECTOR
- The program must have a director who has ultimate responsibility for oversight and operation of the operation of the entire program.
- The Program Director must be a clinical chemist who holds a faculty appointment at the sponsoring institution and who is certified as a Clinical Chemist by the American Board of Clinical Chemistry (ABCC). The program director must be active academically in clinical chemistry research, education, service, and administration at the sponsoring institution. Ideally the program director will have at least five years of academic and service experience in the field and will have demonstrated teaching expertise at the graduate level. Individuals who have completed formal postdoctoral training in clinical chemistry will be particularly well suited to function as directors of training programs. Program Directors are expected to maintain Active Diplomate Status by meeting the requirements for demonstration of continued competency specified by the ABCC. Individuals with certifications in either Toxicological Chemistry or Molecular Diagnostics from the American Board of Clinical Chemistry can be considered for Program Directorships.
- Program Directors seeking first-time accreditation are encouraged to seek input and mentorship from established programs at both the doctoral and post-doctoral level. Directors of existing programs are expected to provide expertise and guidance as demonstration of their commitment to training.
2. TEACHING FACULTY
- Faculty affiliated with a training program must devote sufficient time to the educational program to fulfill their defined teaching responsibilities. Faculty must participate in teaching trainees, supervising research, evaluating trainee achievement, and evaluating program effectiveness. Non-doctoral staff may assist with instruction of operational tasks, but should not substitute for faculty.
- Ideally, there will be additional ABCC-certified faculty to provide expertise and assist with the training in basic clinical chemistry topics. Clinical chemistry faculty members are encouraged to maintain Active Diplomate Status by meeting the requirements for demonstration of continued competency specified by the ABCC. Faculty members who are certified in other disciplines are encouraged to maintain certification in the discipline.
B. STANDARD II: INSTITUTIONAL SUPPORT
The sponsoring institution must be accredited by a recognized state or regional agency with accrediting authority. The sponsoring 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.
If not available at the sponsoring institution, access to a teaching hospital with diagnostic diversity and health care expertise is highly recommended.
Stipends and benefits must meet institutional requirements. Where stipends require teaching/teaching assistance, this activity should not detract from the primary learning mission of the student. Where it is possible, teaching/teaching assistance should be in the field of clinical chemistry to provide the student with experience as an educator in the field.
2. LABORATORY FACILITIES
- It is essential that training in clinical chemistry be conducted and associated with a broad based clinical laboratory, with student rotations in areas such as general clinical chemistry, endocrinology, toxicology, therapeutic drug monitoring, nutrition, serology and immunology, biochemical urinalysis. Specialty areas such as biochemical genetics, pharmacogenomics, hematology/coagulation and molecular diagnostics are recommended for the trainees where possible. The structure and length of such training and rotations is up to the individual program. At a minimum, students should understand the clinical significance of testing performed, technologies used, and workflow for these laboratory areas.
- 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 the Commission (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 the Commission’s own findings at the time of a site visit by an inspection team.
3. LIBRARY/COMPUTER SERVICES/OFFICE FACILITIES
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. Computing services, such as electronic mail addresses and access to on-line literature search functions must be available.
The institution shall maintain, and have available for inspection by the Commission upon request, the records of faculty and trainees’ 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 should include, but are not limited to:
- Recruitment/selection documentation
- Rotation/course schedules and activity logs
- 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 post-doctoral training, certification status and current position
C. STANDARD III: CURRICULUM AND INSTRUCTION
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. Training programs should typically include the equivalent of 3 years of full-time graduate study with the appropriate credit load defined by the sponsoring institution. A research project with thesis is expected in a field relevant to clinical chemistry.
1. PROGRAM OBJECTIVES
The major goal of training at the doctoral level is to prepare the trainee with sufficient practical experience to join a clinical chemistry post-doctoral fellowship program. The program should be flexible in providing training in the following areas, particularly if the student has not had previous clinical laboratory experience:
- Pathophysiology of human disease, including epidemiology and pharmacology
- Clinical laboratory results interpretation and, where possible, clinical consultation
- At a minimum, didactic exposure to the following. Practical exposure through clinical rotations is recommended.
- Quality management, including error reduction strategies and issues related to patient safety
- Regulatory requirements, including new test/instrument implementation, licensure, liability, ethics, privacy protection, etc
3. Theory, operation, and maintenance of instrumentation, methodology, and the quality control measures applicable to the modern clinical laboratory
- For programs that have an association with a teaching hospital, it is recommended that students be exposed to:
- Patient assessment and participation in clinical experiences to include clinical rounds and participation in inter-departmental clinical conferences.
- Collecting and applying information from patient records
- Programs must be cognizant of the ABCC eligibility requirements and the curriculum should provide trainees access to coursework to meet the Page 6 of 12 ABCC requirements (currently 30 semester hours of chemistry coursework).
- Applied or translational research as required by the sponsoring institution. Integral components will include research design, statistics, grant writing, protection of human subjects, and research ethics.
- Written and oral presentations
Trainees must be admitted according to the sponsoring institution’s requirements for equal employment opportunity and any additional local requirements. At a minimum, applicants must have a bachelor’s degree or higher from a regionally accredited institution.
Training should be sufficient to allow the trainee to assume post-doctoral training. Specifically:
- The 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.
- The training period should be sufficient to teach trainees the fundamentals of clinical chemistry, pathophysiology of human diseases, biostatistics, quality assessment, and principles of instrumentation, as well as to provide exposure to the management and supervisory concepts of a broad based clinical chemistry laboratory.
- Training should consist of didactic and hands on laboratory teaching, supervised decision making responsibilities, design of research projects and development of presentation and teaching skills.
- The specific content of the training program curriculum is left largely up to the Program Director and Teaching Faculty. However, the curriculum for the effective training of clinical chemists should provide the necessary education, training, and practice 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 and should be explored to provide for clinical laboratory exposure.
- 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.
STANDARD IV: PROGRAM EVALUATION
There must be an assessment process for continually and systematically reviewing the effectiveness of the program.
- 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, acceptance into ComACC accredited post-doctoral training programs, 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 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.
FUNDAMENTAL CONCEPTS AND PROCEDURES
LABORATORY MANAGEMENT, ORGANIZATION AND OPERATION
- Principles of leadership and organization
- Medico-legal requirements (confidentiality, record keeping)
- Accreditation requirements
- Quality management, including day to day quality control, quality assurance, and long-term quality improvement techniques such a Lean Six Sigma.
- Introduction to Informatics
- Fire, chemical, radiation and infection control
- Waste disposal regulations
- Blood and body fluid precautions
- Applicable OSHA/TJC/CAP regulations and requirements
- 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
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 including special patient populations
- Anticoagulants, preservatives and gel separators
- 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
- Proficiency testing – external, internal and basic requirements
- Principles of new method introduction
- Point-of-Care testing instrumentation
- Principles of instrumentation and automation and strategies to select appropriate instruments
INTRODUCTION TO TECHNIQUES USED IN CLINICAL CHEMISTRY
- General Techniques: Volumetric techniques, weighing, filtration, liquid-liquid and solid-phase extractions; selection and preparation of buffers; concentration; calibration techniques
- Spectrophotometric Techniques
- Mass spectrometry
- Clinical Enzymology
- Immunoassay techniques
- Isotope Techniques
- Molecular Diagnostics
- Proteomics and Protein Arrays
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 may want to consider opportunities for trainees to visit other laboratories in order to broaden their instrumentation/automation exposure and experience.
- Amino-acid analyzers
- Atomic absorption spectrophotometers
- Automated and semi-automated analyzers for general clinical 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, co-oximeters, ion-selective electrodes
- Electrophoresis (including capillary zone, immune-fixation, and isoelectric focusing) and densitometer equipment
- Flow cytometers
- Gas chromatographs
- 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
- Laboratory automation (front-end, track systems, back-end/storage and retrieval)
- Liquid scintillation and gamma counters
- Mass spectrometers (quadrupole and tandem)
- Nuclear magnetic resonance
- Polymerase chain reaction cyclers, other amplification instruments, and detection systems including real-time analyzers
- Small instruments for satellite and point-of-care testing
- Spectrophotometers, reflectometers and nephelometers
APPENDIX IV. PRINCIPLES OF LABORATORY MEDICINE
RELATIONSHIP OF THE LABORATORY TO MEDICAL PRACTICE
- Understand the basics of 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
- Understand the principles and application of evidence-based laboratory medicine in test implementation and patient evaluation
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, genetics, fasting and 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, genetic mutation analysis
- Develop and demonstrate (via activity logs and assessment by faculty) application of the above skills through liaison and consultative interaction with medical staff and other laboratory professionals
CLINICAL PATHOLOGY AND LABORATORY EVALUATION OF DISEASE
Understand basic human biochemistry and physiology, specific biochemical alterations with an introduction to the laboratory tests and testing strategies, including algorithms, for the following:
- Cardiovascular and related diseases
- Endocrine disorders including
- Pituitary- hypothalamic
- Pancreatic endocrine
- Ovarian, placental and testicular hormones
- Gastro-intestinal and exocrine pancreatic disease
- Genetic diseases
- Hematologic/coagulation disorders
- Infectious Diseases
- Hepatobiliary diseases
- Immune system disorders
- Kidney and urinary tract diseases
- Lipid and lipoprotein disorders
- Mineral and bone disorders
- Nutrition and protein disorders
- Pregnancy and reproductive disorders
- Toxicology and clinical pharmacology
- Water, electrolyte and acid-base disorders
- Pediatric Clinical Chemistry, including neo-natal screening
- Laboratory evaluation of neoplasia
Approved by the Commissioners of ComACC on 20 November 2014
Revised August 2015