Standards and Guidelines for Doctoral Training Programs in Clinical Chemistry

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 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.

II. PREAMBLE

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/Co-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 Co-Director of a reference laboratory, and Director/Associate or Co-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.

GUIDELINES

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.

GUIDELINES

1. STIPENDS/BENEFITS

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.

4. RECORDS

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.
1. Quality management, including error reduction strategies and issues related to patient safety
2. 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:
1. Patient assessment and participation in clinical experiences to include clinical rounds and participation in inter-departmental clinical conferences.
2. 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

2. ADMISSION

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.

3. CURRICULUM

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.

GUIDELINES

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.

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, 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.

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.

Loss of Program Director

If for any reason a ComACC-accredited graduate or fellowship program loses its Program Director, due to relocation, retirement, incapacitation, or death, and thereby does not have a ComACC-qualified Program Director, the graduate or fellowship program no longer satisfies the requirements for accreditation. If this occurs, the program will be notified that it is on “Temporary Suspension/Inactivation of Accreditation” until the qualified Program Director requirement is met. When a program is on Temporary Suspension/Inactivation of Accreditation, the following restrictions will apply:

The program may not claim it is ComACC accredited on any promotional or informational materials, including brochures, web sites, posters, etc.
The ComACC listing of programs will be updated to indicate the program is inactive
ComACC will notify ABCC that the program is inactive
Any fellows currently in the program will be notified that the program is inactive, and their board examination eligibility may be affected

Temporary suspension or inactivation of accreditation does not mean, however, that the program must re-apply for accreditation or pay any of the fees associated with initial or re-accreditation before they are due in the regular accreditation cycle. Full accreditation will be re-evaluated when the program notifies the ComACC that it has a Program Director who meets all the requirements to direct a ComACC accredited graduate or fellowship program. The program must submit to the ComACC the section of the self-study providing information on the new Program Director, along with any other changes to the self-study that resulted from the change in leadership (e.g., change in mission statement, curriculum, description of facilities, etc.). The Commissioners will review the updated self-study materials, and with a majority vote, reinstate the full accreditation status effective immediately. If there are concerns regarding the Program Director, ComACC will contact the new PD as soon as possible. The new Program Director will be notified of the ComACC decision, and all restrictions listed above will be removed. The ComACC will notify ABCC and any fellows that the program has full accreditation status.

It is important to note that “Temporary Suspension/Inactivation of Accreditation” is not a punitive status, but rather acknowledges that a program, for whatever reason, temporarily does not have a qualified Program Director, and therefore cannot be considered an accredited program. This status is different from withdrawal of accreditation, such as might occur when a program becomes permanently inactive or does not meet accreditation standards on its normal reaccreditation review. After accreditation is withdrawn, a program must re-apply to be accredited, and pay all fees associated with a new program application.

STANDARD VI: REACCREDITATION PROCESS OVERVIEW

APPENDICES

APPENDIX I.

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

LABORATORY SAFETY

Fire, chemical, radiation and infection control
Waste disposal regulations
Blood and body fluid precautions
Applicable OSHA/TJC/CAP regulations and requirements

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

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
Electrochemistry
Electrophoresis
Chromatography
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
Fluorometers
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
Osmometers
Polymerase chain reaction cyclers, other amplification instruments, and detection systems including real-time analyzers
Refractometers
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
1. Adrenal
2. Thyroid
3. Parathyroid
4. Pancreatic endocrine
5. 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 and Adopted by the Commission on Accreditation in Clinical Chemistry (ComACC)
(November 20, 2014)
Revised August 2015
Revised September 2025

	Fully accredited programs reaccredit every five years.			A program may a program may choose to not seek reaccreditation. If a program chooses to end accreditation, they must restart the full initial process if seeking accreditation in the future.

	Submit a full self-study 6 months prior to expiration. $1,250 submission fee.			A program may not meet standards required. Corrective measures may be requested. A resubmission of full self-study would be required.

	Schedule a site visit. $4,000 in-person fee.			A program may not meet standards required. Corrective measures may be requested. Depending on circumstance, an additional site visit and/or resubmission of full self-study may be required.

	If approved, the program continues for a full 5-years accreditation period.			A fully accredited program must submit a reaccreditation self-study AND schedule a site visit every 5 years.