NAACLS Standards for Accredited Programs

NAACLS Standards

for Accredited

Programs

Adopted 2012, Revised 9/2013, 1/2014, 4/2014, 10/2014, 11/2014,

10/2015, 4/2016, 6/2016, 11/2016, 11/2017, 5/2018, 11/2018, 5/2019,

10/2019, 5/2020, 11/2020, 5/2021, 10/2021, 06/2022, 10/2022,

04/2023, 09/2023, 05/2024

Contents

Core Standards .......................................................................................................................... 1

I. Sponsorship .................................................................................................................... 1

II. Assessment and Continuous Quality Improvement ......................................................... 3

III. Resources ....................................................................................................................... 4

IV. Students .......................................................................................................................... 5

V. Operational Policies......................................................................................................... 6

VI. Administrative: Maintaining Accreditation ........................................................................ 7

Unique Standards for the Biomedical Sciences (BMS) ............................................................... 8

VII. Professional Education Program Administration .............................................................. 9

VIII. BMS Program Curriculum Requirements ...................................................................... 12

Unique Standards for the Cytogenetic Technologist (CG) ........................................................ 14

VII. CG Program Administration ........................................................................................... 16

VIII. CG Curriculum Requirements ........................................................................................ 19

Unique Standards for the Diagnostic Molecular Scientist (DMS) .............................................. 21

VII. DMS Program Administration ........................................................................................ 23

VIII. DMS Curriculum Requirements ..................................................................................... 26

Unique Standards for the Histotechnician (HT) ........................................................................ 29

VII. HT Program Administration ........................................................................................... 30

VIII. HT Curriculum Requirements ........................................................................................ 34

Unique Standards for the Histotechnologist (HTL) .................................................................... 37

VII. HTL Program Administration ......................................................................................... 39

VIII. HTL Curriculum Requirements ...................................................................................... 42

Unique Standards for the Medical Laboratory Assistant (MLA) ................................................. 46

VII. MLA Program Administration ......................................................................................... 47

VIII. MLA Curriculum Requirements ..................................................................................... 50

Unique Standards Medical Laboratory Microbiologist (MLM) .................................................... 52

VII. MLM Program Administration ........................................................................................ 53

VIII. MLM Curriculum Requirements ..................................................................................... 56

Unique Standards Medical Laboratory Scientist (MLS)............................................................. 59

VII. MLS Program Administration ......................................................................................... 61

VIII. MLS Curriculum Requirements ...................................................................................... 64

Unique Standards Medical Laboratory Technician (MLT) ......................................................... 66

VII. MLT Program Administration ......................................................................................... 67

VIII. MLT Curriculum Requirements ...................................................................................... 70

Unique Standards for the Pathologists’ Assistant (PathA) ........................................................ 72

VII. PathA Program Administration ...................................................................................... 76

VIII. PathA Curriculum Requirements ................................................................................... 79

Unique Standards for the Phlebotomist (PBT) .......................................................................... 82

VII. PBT Program Administration ......................................................................................... 84

VIII. PBT Curriculum Requirements ...................................................................................... 87

Unique Standards Public Health Microbiologist (PHM) ............................................................. 88

VII. PHM Program Administration ........................................................................................ 89

VIII. PHM Curriculum Requirements ..................................................................................... 92

Core Standards Page 1

STANDARDS FOR ACCREDITED PROGRAMS

Core Standards

I. Sponsorship

A. Sponsoring Institution

The sponsor of an educational program must be one of the following:

1. A post-secondary academic institution accredited by an institutional

accrediting agency that is recognized by the U.S. Department of

Education and given the authority to provide post‐secondary education,

which awards a minimum of a certificate at the completion of the

program.

2. A hospital, medical center, or laboratory accredited or licensed by an

applicable recognized agency (see Standards Compliance Guide), which

awards a minimum of a certificate at the completion of the program.

3. A secondary or post‐secondary institution recognized by the state in

which it is located. (for Phlebotomy and Medical Laboratory Assistant

programs only)

4. An institution recognized by the national government or a

regional/national accrediting agency for higher education of the country in

which it is located as a post-secondary academic institution with degree

granting authority. (for programs outside of the United States)

5. A Public Health Laboratory or an organization/corporation of member

Public Health Laboratories recognized by the state in which it is located

and not affiliated with a hospital, medical center or accredited secondary

or post-secondary institution.

B. Consortium Sponsor

A separate and distinct entity consisting of two or more members that exists for

the purpose of operating an educational program. Where a consortium exists, at

least one member of the consortium must meet the requirements of a sponsoring

institution specified in I.A. The creation of the consortium must be clearly

documented as a formal memorandum of understanding and signed by all

members. This document shall contain the following elements:

Core Standards Page 2

1. governance of the consortium

2. lines of authority within the consortium for the educational program

3. responsibilities of each member in the delivery of the educational

program

C. Multi‐location Sponsor

1. A specified campus location of an entity that controls a system of

campuses, which is accredited by an institutional accrediting agency that

is recognized by the U.S. Department of Education and given the

authority to provide postsecondary education. The specified campus

location delivers the educational program in its entirety and awards a

minimum of a certificate at the completion of the program.

2. A specified location of an entity that controls a system of hospitals,

medical centers, or laboratories accredited or licensed by an applicable

recognized agency (see Standards Compliance Guide), which awards a

minimum of a certificate at the completion of the program.

D. Responsibilities of the Sponsor

1. The sponsor has primary responsibility for:

a. supporting curriculum planning and course selection by program

faculty and staff

b. appointing faculty and staff

c. maintaining student transcripts permanently

d. granting the degree and/or certificate documenting satisfactory

completion of the educational program

e. ensuring that appropriate personal safety measures are

addressed for students and faculty

f. ensuring that all provisions of the Standards are met

g. ensuring that graduates of the program have obtained or will

obtain the minimum degree and/or certificate upon completion of

the program

Core Standards Page 3

Pathologists’ Assistant programs: a master’s degree or higher, or

a certificate for students who hold or complete the required

degree

BMS, CG, DMS, HTL, MLM, MLS, and PHM programs: a

baccalaureate degree or higher, or a certificate for students who

hold or complete the required degree

HT and MLT programs: an associate degree or higher, or a

certificate for students who hold or complete the required degree

MLA and PBT programs: a certificate for the student

2. The sponsor must ensure that the activities assigned to students in the

clinical setting are educational.

3. There must be documented ongoing communication between the sponsor

and its affiliates for exchange of information and coordination of the

program.

4. The sponsor must provide eligible students the opportunity to participate

in applied clinical experiences.

5. The sponsor must have a formal affiliation agreement with all other

entities that are involved in the education of the students, which

describes:

a. the relationship

b. the roles

c. the responsibilities of the sponsor and that entity.

II. Assessment and Continuous Quality Improvement

A. Systematic Assessment

There must be a documented plan for continuous and systematic assessment of

the effectiveness of the program.

B. Outcome Measures

A review of the results of the following outcomes measures from the last three

active years must be documented, analyzed and used in program assessment

and continuous quality improvement of the program to include an annual

Core Standards Page 4

submission to NAACLS. If outcome measure(s) does/do not meet the stated

NAACLS approved benchmarks (see Standards Compliance Guide), then an

analysis and action plan must be submitted to correct the deficiency (ies).

1. External certification results

2. Graduation rates

3. Placement rates (i.e., employment positions in the field of study or pursuit

of further education)

4. Attrition rates

5. Other (optional): such as results of capstone projects, faculty feedback,

exit or final examinations, exit interviews with graduates, student and

graduate professional leadership, impact of the program on local and

regional healthcare, etc.

C. Program Assessment and Modification

The results of program outcomes measures and assessment must include

findings from graduate and employer feedback and be:

1. Reflected in ongoing curriculum development, resource

acquisition/allocation, and program modification.

2. Analyzed to demonstrate the effectiveness of any changes implemented.

III. Resources

A. General Resources

1. The sponsor must provide sufficient financial resources for the continued

operation of the education program to meet documented goals.

2. Resource assessment of personnel and physical resources must be a

part of continuous program evaluation.

B. Personnel

1. The sponsor must appoint sufficient number of personnel to achieve

program outcomes.

C. Physical Resources

Core Standards Page 5

1. The sponsor must provide physical resources such as facilities,

equipment and supplies, information resources, and instructional

resources sufficient to achieve program outcomes.

IV. Students

A. Publications and Disclosures

1. The following must be defined, published, and readily available to

prospective and enrolled students:

a. program mission statement;

b. program goals and graduate competencies;

c. programmatic accreditation status including the name, address

and contact information for NAACLS;

d. results of external certification outcomes, graduation rates

outcomes, placement rates outcomes of the last three active

years;

e. list of clinical facilities;

f. admission criteria, including essentials functions, advance

placement, transfer of credits and credits for experiential learning;

g. list of course descriptions including the number of academic

credit hours per course (if appropriate);

h. names and academic rank or title of the program director and

faculty; (and medical director for Pathologists’ Assistant programs)

i. current tuition and fees including withdrawals and refund policies;

j. policies and processes by which students may perform service

work must be published

k. policies and procedures for:

1. advising and guiding students through the program while

maintaining confidentiality and impartiality;

2. clinical assignment specifically addressing when placement

cannot be immediately guaranteed;

Core Standards Page 6

3. student grievance and appeals;

4. criteria for program completion including probation,

suspension, and dismissal

l. academic calendar

m. rules and regulations governing acceptable personal and

academic conduct, including behavior expectations for clinical

experience

B. Student Records

1. The program must maintain student records, conforming to any

governmental or sponsor regulations. Record examples include

admission, evaluation, counseling, advising, grades, credits, etc.

2. The student transcript/student record must be retained permanently by

the sponsor and contain at least:

a. legal name;

b. grades and credits;

c. dates of admission and completion

C. Health and Safety

1. Health

a. The program must provide evidence that the health and safety of

students, faculty, and patients during educational activities is

safeguarded.

2. Safety

a. The program must provide evidence that each student enrolled

has received biohazard and safety training.

V. Operational Policies

Fair Practices

A. Student recruitment and admission must be non‐discriminatory in accordance

with existing governmental regulations and those of the sponsor.

Core Standards Page 7

B. Faculty recruitment and employment practices must be non‐discriminatory in

accordance with existing governmental regulations and those of the sponsor.

C. The granting of the degree or certificate must not be contingent upon any type of

external certification or licensure examination.

D. A general plan must be provided, addressing temporary and permanent program

closure. In the event of such closure, a detailed plan must be submitted to

NAACLS within 30 days of the official announcement.

E. Service work by students in clinical settings outside of academic hours must be

noncompulsory.

F. Students may not be substituted for regular staff during their student

experiences.

VI. Administrative: Maintaining Accreditation

Program/Sponsoring Institution Responsibilities

Programs are required to comply with administrative requirements for maintaining

accreditation including:

A. Submitting required documentation by NAACLS by the established deadline.

These include but are not limited to Self‐Study Reports, Applications for

Continuing Accreditation and required Progress Reports, Interim Report and

Action Plans;

B. Paying accreditation fees, as determined by NAACLS, by the due date;

C. Informing NAACLS of relevant administrative and operational changes within 30

days. These include changes in program official names, physical addresses,

URL or telephone numbers; status (e.g. inactivity, closure) or location, and

institution name;

D. Agreeing to a site visit date before the end of the period for which accreditation is

awarded;

E. Submitting an outcomes report on an annual basis to NAACLS addressing major

changes, if any, and program assessment standards (Standard II) by the

established deadline date;

F. Verifying compliance with these Standards upon request from NAACLS, which

may include submitting to an off cycle site visit.

BMS Unique Standards Page 8

Unique Standards for the Biomedical Sciences (BMS)

PREAMBLE

Objectives

The purpose of these Standards and the Description of the Profession is to establish, maintain,

and promote standards of quality for educational programs in the biomedical sciences and to

provide recognition for educational programs which meet or exceed the minimum standards

outlined in this document.

The Standards are to be used for the development and evaluation of biomedical science

programs. Self- Study Reviewers and Site Visit teams assist in the evaluation of the program’s

compliance with the Standards. Lists of accredited programs are published for the information of

students, employers, and the public.

DESCRIPTION OF THE BIOMEDICAL SCIENTIST PROFESSION:

Several different professionals are encompassed under the NAACLS - defined umbrella of

biomedical scientist. The biomedical scientist is qualified by academic and applied science

education to provide service and/or research in existing or emerging professions outside of what

are considered traditional clinical laboratory environments. Examples may include clinical

embryologist or nanotechnologist. The specific scope of practice and entry level competencies

will vary depending on each unique profession, and these professionals may work in industry or

specialty clinics and laboratories.

Biomedical scientists practice independently and collaboratively, being responsible for their own

actions, as defined by the profession. They have the requisite knowledge and skills to educate

laboratory professionals, additional health care professionals, and others in laboratory practice

as well as the public.

The ability to relate to people, a capacity for calm and reasoned judgment and a demonstration

of commitment to the patient are essential qualities. Communications skills extend to

consultative interactions with members of the healthcare team, external relations, customer

service and patient education.

Biomedical scientists demonstrate ethical and moral attitudes and principles that are necessary

for gaining and maintaining the confidence of patients, professional associates, and the

community.

Description of Career Entry Level Competencies of the Biomedical Scientist Professional

At career entry level, the biomedical scientist will possess the competencies necessary to

perform or assess the full range of laboratory tests in the areas unique to their specific

discipline.

The biomedical scientist will have diverse responsibilities in areas of analysis and/or clinical

decision‐making, regulatory compliance with applicable regulations, education, and quality

BMS Unique Standards Page 9

assurance/performance improvement wherever laboratory testing is researched, developed or

performed.

At career entry level, the biomedical scientist will have the following professional competencies.

They will have the ability to:

A. Application of safety and governmental regulations and standards as applied to

the specific laboratory discipline;

B. Principles and practices of professional conduct and the significance of

continuing professional development;

C. Communications sufficient to serve the needs of patients, the public and

members of the health care team;

D. Principles and practices of administration and supervision as applied to the

specific laboratory discipline;

E. Educational methodologies and terminology sufficient to train/educate users and

providers of laboratory services;

F. Principles and practices of clinical study design, implementation and

dissemination of results;

VII. Professional Education Program Administration

A. Program Director

The program director must be a laboratory professional who:

1. Qualifications

a. has an earned master’s or doctoral degree;

b. holds relevant certification, licensure, or recognition appropriate

for the field.

c. has three years of teaching experience.

d. has knowledge of education methods and administration as well

as current NAACLS accreditation procedures and certification

procedures.

2. Responsibilities

The program director must:

a. be responsible for the organization, administration, instruction,

evaluation, continuous quality improvement, curriculum planning

BMS Unique Standards Page 10

and development, directing other program faculty/staff, and

general effectiveness of the program;

b. provide evidence that s/he participates in the budget preparation

process;

c. engage in a minimum of 36 hours of documented continuing

professional development every 3 years;

d. be responsible for maintaining NAACLS accreditation of the

program;

e. have regular and consistent contact with students, faculty,

administration, and program personnel;

3. Appointments

The program director must have a faculty or clinical appointment at the

sponsoring institution.

B. Site Program Coordinator (required for multi‐location programs only; assigned to

each participating site)

1. Qualifications

The site program coordinator must:

a. have an academic degree appropriate to the program level;

b. hold the same level certification required of a program director;

c. have at least one year of experience in laboratory science

education relevant to the program content area or field of practice.

2. Responsibilities

The site program coordinator, when required, is responsible for:

a. coordinating teaching and clinical education;

b. evaluating program effectiveness;

c. maintaining appropriate communications with the program

director.

C. Faculty

1. Didactic Instructor Appointments

The program must have qualified faculty/instructors who hold

appointments within the educational program (e.g., certified professionals

in their respective or related fields). The program must ensure and

BMS Unique Standards Page 11

document ongoing professional development of the program

faculty/instructors.

a. Qualifications

Faculty/instructors designated by the program must:

i. demonstrate adequate knowledge and proficiency in their

content areas;

ii. demonstrate the ability to teach effectively at the

appropriate level.

b. Responsibilities

The responsibilities of the faculty/instructors must include:

i. participation in teaching courses;

ii. evaluation of student achievement;

iii. development of curriculum, policy and procedures;

iv. assessment of program outcomes.

2. Clinical Liaison

At least one clinical liaison, who is employed by the clinical site, must be

designated at each clinical site affiliated with the program to coordinate

clinical experiences for students.

a. Qualifications

The clinical liaison must:

i. Be a laboratory professional who demonstrates the ability

to effectively coordinate clinical experiences of the

students;

ii. demonstrate knowledge of the program discipline;

iii. have at least one year experience as a medical laboratory

professional.

b. Responsibilities

The clinical liaison must be responsible for:

i. coordinating clinical instruction at the site;

ii. maintaining effective communication with the program

director or designee.

BMS Unique Standards Page 12

D. Advisory Committee

There must be an advisory committee composed of individuals from the

community of interest (e.g., practicing professionals, academic professionals,

scientific consultants, administrators, pathologists and other physicians, public

member) who have knowledge of laboratory science education or education

related to the specific discipline.

1. Responsibilities

The advisory committee of the program shall have input into the

program/curriculum to maintain current relevance and effectiveness.

VIII. BMS Curriculum Requirements

A. Instructional Areas

1. Prerequisite courses in biological sciences, chemistry and mathematics

that provide the foundation for course work required in the professional

program.

2. The curriculum must address pre‐analytical, analytical and post‐analytical

components of laboratory services. This includes principles and

methodologies, performance of assays, problem‐solving, troubleshooting

techniques, interpretation and evaluation of clinical procedures and

results, statistical approaches to data evaluation, principles and practices

of quality assurance/quality improvement, and continuous assessment of

laboratory services for all major areas practiced in the contemporary field

and level of practice.

3. Application of safety and governmental regulations and standards as

applied to the field of practice.

4. Principles and practices of professional conduct and the significance of

continuing professional development.

5. Communications sufficient to serve the needs of patients, the public and

members of the health care team and/or professional community.

6. Principles and practices of administration and supervision as applied to

the field of practice.

7. Educational methodologies and terminology sufficient to train/educate

users and providers of laboratory services.

8. Principles and practices of clinical study design, implementation and

dissemination of results.

BMS Unique Standards Page 13

B. Learning Experiences

1. Learning experiences (courses, practica, other required activities) must

be properly sequenced and include necessary content and activities to

enable students to achieve entry level competencies in each major

discipline as listed in Standard VIII.A.2.

2. After demonstrating competency, students, with qualified supervision,

may be permitted to perform procedures.

C. Evaluations

Evaluation systems must relate to course content and support program

competencies. If there is evidence that competencies are not adequately

achieved (through feedback mechanisms as described in Standard II.B) then

course objectives will be examined in detail to assure that the objectives are

behavioral, include all domains and relate directly to the evaluations used.

1. These evaluation systems must be employed frequently enough to

provide students and faculty with timely indications of the students’

academic standing and progress.

2. The evaluation systems must serve as a reliable indicator of the

effectiveness of instruction and course design.

CG Unique Standards Page 14

Unique Standards for the Cytogenetic Technologist (CG)

PREAMBLE

Objectives

The purpose of these Standards and the Description of the Profession is to establish, maintain,

and promote standards of quality for educational programs in the clinical laboratory sciences

and to provide recognition for educational programs which meet or exceed the minimum

standards outlined in this document.

The Standards are to be used for the development and evaluation of Cytogenetic Technology

programs. Paper reviewers and site visit teams assist in the evaluation of the program’s

compliance with the Standards. Lists of accredited programs are published for the information

of students, employers, and the public.

DESCRIPTION OF THE CYTOGENETICS PROFESSION

Cytogenetic technologist professionals are qualified by academic and applied science education

to provide service and research in classical cytogenetics (chromosome analysis) molecular

cytogenetics (fluorescent in situ hybridization – FISH), genomic analysis (array comparative

genome hybridization) and other related areas in rapidly changing and dynamic healthcare

delivery systems. They have diverse and multi‐level functions in the areas of chromosome and

genome analysis and clinical decision‐making, information management, regulatory compliance,

education, and quality assurance/performance improvement wherever constitutional or acquired

genetics testing is researched, marketed, developed or performed. Cytogenetic technology

professionals perform, develop, evaluate, correlate and assure accuracy and validity of

laboratory testing and procedures; direct and supervise laboratory resources and operations;

and collaborate in the diagnosis and treatment of patients. They possess skills for financial,

operations, marketing, and human resource management of the genetics laboratory.

Cytogenetic technologist professionals practice independently and collaboratively, being

responsible for their own actions, as defined by the profession. They have the requisite

knowledge and skills to educate laboratory professionals, health care professionals, and others

in laboratory practice, as well as the public.

The ability to relate to people, a capacity for calm and reasoned judgment, and a demonstration

of commitment to the patient are essential qualities. Communication skills extend to consultative

interactions with members of the healthcare team, external relations, customer service and

patient education. Cytogenetic technologist professionals demonstrate ethical and moral

attitudes and principles that are necessary for gaining and maintaining the confidence of

patients, professional associates, and the community.

Description of Entry Level Competencies of the Cytogenetic Technologist

CG Unique Standards Page 15

At entry level, the Cytogenetic Technologist will possess and be able to perform the following

entry level competencies under supervision:

A. Recommend and instruct in appropriate specimen collection, transport and

storage conditions for each specimen type and testing modality;

B. Receive, accession and evaluate for appropriateness each specimen type;

C. Process specimens for each culture type, fixation or DNA extraction based on

reason for referral;

D. Set‐up, maintain and select cultures for harvest while maintaining aseptic

conditions;

E. Perform harvest of all culture types;

F. Manipulate environmental and slide conditions to prepare specimen slides for

chromosome banding, and FISH probing;

G. Perform chromosome banding, staining, and FISH;

H. Perform analysis by G‐banding, FISH or aCGH;

I. Apply principles of brightfield, phase contract and fluorescent microscopy;

J. Apply principles of computer imaging for case documentation and to produce

analyzable images;

K. Identify and interpret chromosome and genomic abnormalities as correlated to

clinical conditions/referral request and differentiate from

polymorphism/CNV;

L. Recognize appropriate concepts and principles of laboratory reporting

mechanisms;

M. Perform and monitor quality control indicators recognizing factors that affect

procedures and results, take appropriate action within predetermined limits when

corrections are indicated, and notify when appropriate the chain of command;

N. Recognize and apply principles of laboratory safety;

O. Demonstrate professional conduct, interpersonal and communication skills when

dealing with co‐workers, other health care professionals, patients and the public;

P. Recognize and act upon individual needs for continuing education to maintain

certification and competencies as a function of continued growth and

development.

CG Unique Standards Page 16

At entry level, the Cytogenetic Technologist will have the following basic knowledge and

skills in:

A. Application of safety and governmental regulations and standards as applied to

cytogenetics;

B. Principles of interpersonal and interdisciplinary communication and team‐building

skills and the significance of continuing professional development;

C. Principles and practices of administration and supervision;

D. Educational methodologies and terminology sufficient to train/educate users and

providers of laboratory services;

E. Principles and practices of clinical study design, implementation and

dissemination of results.

VII. CG Program Administration

A. Program Director

The program must have a NAACLS approved medical laboratory professional

serving as program director who meets the following qualifications and executes

all required responsibilities.

1. Qualifications

a. has an earned master’s or doctoral degree;

b. holds ASCP‐BOC or ASCP

-BOC certification in cytogenetics or

ABMGG certification in clinical cytogenetics;

c. has three years of teaching experience;

d. has knowledge of education methods and administration as well

as current NAACLS accreditation and certification procedures.

2. Responsibilities

The program director must:

a. be responsible for the organization, administration, instruction,

evaluation, continuous quality improvement, curriculum planning

and development, directing other program faculty/staff, and

general effectiveness of the program;

CG Unique Standards Page 17

b. provide evidence that s/he participates in the budget preparation

process;

c. engage in a minimum of 36 hours of documented continuing

professional development every 3 years;

d. be responsible for maintaining NAACLS accreditation of the

program;

e. have regular and consistent contact with students, faculty, and

program personnel.

3. Appointments

The program director must have a faculty or clinical appointment at the

sponsoring institution.

Program Directors who have been approved as a program director of a NAACLS

accredited CG program prior to October 1, 2013 remain eligible as a program

director.

B. Site Program Coordinator (required for multi‐location programs only; assigned to

each participating site)

1. Qualifications

The site program coordinator must:

a. have an academic degree appropriate to the program level;

b. hold the same level certification required of a program director;

c. have at least one year of experience in medical laboratory science

education.

2. Responsibilities

The site program coordinator, when required, is responsible for:

a. coordinating teaching and clinical education;

b. evaluating program effectiveness;

c. maintaining appropriate communications with the program

director.

C. Faculty

CG Unique Standards Page 18

1. Didactic Instructor Appointments

The program must have qualified faculty/instructors who hold

appointments within the educational program (e.g., certified professionals

in their respective or related fields). The program must ensure and

document ongoing professional development of the program

faculty/instructors.

a. Qualifications

Faculty/instructors designated by the program must:

i. demonstrate adequate knowledge and proficiency in their

content areas;

ii. demonstrate the ability to teach effectively at the appropriate

level.

b. Responsibilities

The responsibilities of the faculty/instructors must include:

i. participation in teaching courses;

ii. evaluation of student achievement;

iii. development of curriculum, policy and procedures;

iv. assessment of program outcomes.

2. Clinical Liaison

At least one clinical liaison, who is employed by the clinical site, must be

designated at each clinical site affiliated with the program to coordinate

clinical experiences for students.

a. Qualifications

The clinical liaison must:

i. Be a medical laboratory professional who demonstrates the

ability to effectively coordinate clinical experiences of the

students;

ii. demonstrate knowledge of the program discipline;

iii. have at least one year experience as a medical laboratory

professional.

CG Unique Standards Page 19

b. Responsibilities

The clinical liaison must be responsible for:

i. coordinating clinical instruction at the site;

ii. maintaining effective communication with the program director

or designee.

D. Advisory Committee

There must be an advisory committee composed of individuals from the

community of interest (e.g. practicing professionals, academic professionals,

scientific consultants, administrators, pathologists and other physicians, public

member) who have knowledge of clinical laboratory science education.

1. Responsibilities

The advisory committee of the program shall have input into the

program/curriculum to maintain current relevancy and effectiveness.

VIII. CG Curriculum Requirements

A. Instructional Areas

1. Prerequisite content in biological sciences, chemistry and mathematics

that provides the foundation for course work required in the laboratory

science program.

2. The program curriculum must include the following scientific content:

Specimen Preparation (sample acquisition, transport/storage,

preparation, culture, harvest, slide preparation, and staining);

Molecular Cytogenetic Testing (utilize appropriate techniques for

preparation and analysis of molecular cytogenetic specimens, including

array analysis);

Chromosome Analysis and Imaging (selection, analysis, and description

of suitable metaphase or interphase cells using microscopy and imaging);

Laboratory Operations (general laboratory skills, guidelines/ government

regulations, safety, quality assurance/control and professional standards

and conduct).

CG Unique Standards Page 20

3. Principles of interpersonal and interdisciplinary communication and

team‐building skills and the significance of continuing professional

development;

4. Principles and practices of administration and supervision;

5. Educational methodologies and terminology sufficient to train/educator

users and providers of laboratory services sufficient for future clinical

faculty);

6. Principles and practices of clinical study design, implementation and

dissemination of results.

B. Learning Experiences

1. Learning experiences (courses, practica, other required activities) must

be properly sequenced and include necessary content and activities to

enable students to achieve entry level competencies in each major

discipline as listed in Standard VIII.A.2.

2. After demonstrating competency, students, with qualified supervision,

may be permitted to perform procedures.

C. Evaluations

Evaluation systems must relate to course content and support program

competencies. If there is evidence that competencies are not adequately

achieved (through feedback mechanisms as described in Standard II.B) then

course objectives will be examined in detail to assure that the objectives are

behavioral, include all domains and relate directly to the evaluations used.

1. These evaluation systems must be employed frequently enough to

provide students and faculty with timely indications of the students’

academic standing and progress.

2. The evaluation systems must serve as a reliable indicator of the

effectiveness of instruction and course design.

DMS Unique Standards Page 21

Unique Standards for the Diagnostic Molecular Scientist (DMS)

PREAMBLE

Objectives

The purpose of these Standards and the Description of the Profession is to establish,

maintain, and promote standards of quality for educational programs in the clinical

laboratory sciences and to provide recognition for educational programs which meet or

exceed the minimum standards outlined in this document.

The Standards are to be used for the development and evaluation of diagnostic molecular

science programs. Self-study reviewers and site visit teams assist in the evaluation of the

program’s compliance with the Standards. Lists of accredited programs are published for

the information of students, employers, and the public.

DESCRIPTION OF THE DIAGNOSTIC MOLECULAR SCIENTIST PROFESSION

Diagnostic molecular scientist professionals are qualified by academic and applied science

education to provide service and research in the molecular diagnosis of acquired, inherited,

and infectious diseases. They have diverse and multi‐level functions in the areas of analysis

and clinical decision‐making, information management, regulatory compliance, education,

and quality assurance/performance improvement. Diagnostic molecular scientists perform,

develop, evaluate, correlate, and assure accuracy and validity of laboratory testing and

procedures; direct and supervise laboratory resources and operations; and collaborate in

the diagnosis and treatment of patients. They possess skills for financial, operations,

marketing, and human resource management of the molecular pathology laboratory.

Diagnostic molecular scientists practice independently and collaboratively, being

responsible for their own actions, as defined by the profession. They have the requisite

knowledge and skills to educate laboratory professionals, health care professionals, and

others in laboratory practice, as well as the public.

The ability to relate to people, a capacity for calm and reasoned judgment, and a

demonstration of commitment to the patient are essential qualities. Communication skills

extend to consultative interactions with members of the healthcare team, external relations,

customer service and patient education. Diagnostic molecular scientists demonstrate ethical

and moral attitudes and principles that are necessary for gaining and maintaining the

confidence of patients, professional associates, and the community. An attitude of respect

for the patient and confidentiality of the patient’s record and/or diagnosis must be

maintained.

Description of Career Entry Competencies of the Diagnostic Molecular Scientist

At career entry, the Diagnostic Molecular Scientists will be able to demonstrate entry

level competencies such as:

DMS Unique Standards Page 22

• Evaluating and monitoring methods of collection, transport and handling of various

specimen types for molecular analysis;

• Applying appropriate advanced principles and techniques to prepare specimens for

molecular based testing, as well as troubleshooting and evaluating appropriate actions

for problem resolution;

• Applying basic and advanced principles, practices and applications of molecular based

testing for clinical laboratory diagnostic purposes;

• Performing appropriate techniques utilizing instrumentation for molecular analysis and

correlating results with acquired, inherited and infectious diseases, and

pharmacogenomics;

• Utilizing bioinformatic techniques and resources to evaluate genomic information for

performing techniques, analyze molecular assays and genomic assays, and correlate

assay results;

• Applying the principles and techniques of first, second, and third generation sequencing,

correlating results with acquired, inherited, and infectious diseases;

• Complying with and performing preventive and corrective maintenance programs for

instruments and equipment, as well as troubleshooting and evaluating appropriate

actions for problem resolution;

• Investigating and applying advanced molecular principles, practices, and quality

assurance to develop new assays or procedures as a result of studies on new

technologies, as well as troubleshooting and evaluating appropriate solutions;

• Applying principles of quality control that evaluate data, including sequencing data, for

necessity of repeat analysis, correlation with disease states, organism identification and

disease diagnosis;

• Applying principles of quality assurance and performing measurements to assure validity

and accuracy of laboratory data generated

• Complying with laws, regulations and accrediting standards, as well as guidelines of

relevant governmental and non‐governmental agencies;

• Utilizing resource management strategies to maintain optimal laboratory efficiency;

DMS Unique Standards Page 23

• Exercising established procedures for general laboratory safety, biohazard containment

and waste disposal;

• Demonstrating leadership, professional and ethical conduct and interpersonal skills for

patients, clients, healthcare professionals and the public;

• Formulating a short-term and long-term plan for professional career development.

VII. DMS Program Administration

A. Program Director

The program must have a NAACLS approved medical laboratory professional

serving as program director who meets the following qualifications and executes

all required responsibilities.

1. Qualifications

a. has an earned master’s or doctoral degree;

b. holds ASCP‐BOC or ASCP

-BOC certification in Molecular Biology

or ABMGG certification in Molecular Biology.

c. has three years of teaching experience;

d. has knowledge of education methods and administration as well

as current NAACLS accreditation procedures and certification

procedures.

2. Responsibilities

The program director must:

a. be responsible for the organization, administration, instruction,

evaluation, continuous quality improvement, curriculum planning

and development, directing other program faculty/staff, and

general effectiveness of the program;

b. provide evidence that s/he participates in the budget preparation

process;

c. engage in a minimum of 36 hours of documented continuing

professional development every 3 years;

d. be responsible for maintaining NAACLS accreditation of the

program;

DMS Unique Standards Page 24

e. have regular and consistent contact with students, faculty, and

program personnel;

3. Appointments

The program director must have a faculty or clinical appointment at the

sponsoring institution.

Program Directors who have been approved as a program director of a NAACLS

accredited DMS program prior to October 1, 2013 remain eligible as a program

director.

B. Site Program Coordinator (required for multi‐location programs only; assigned to

each participating site)

1. Qualifications

The site program coordinator must:

a. have an academic degree appropriate to the program level;

b. hold the same level certification required of a program director;

c. have at least one year of experience in medical laboratory science

education.

2. Responsibilities

The site program coordinator, when required, is responsible for:

a. coordinating teaching and clinical education,

b. evaluating program effectiveness;

c. maintaining appropriate communications with the program

director.

C. Faculty

1. Didactic Instructor Appointments

The program must have qualified faculty/instructors who hold

appointments within the educational program (e.g., certified professionals

in their respective or related fields). The program must ensure and

DMS Unique Standards Page 25

document ongoing professional development of the program

faculty/instructors.

a. Qualifications

Faculty/instructors designated by the program must:

i. demonstrate adequate knowledge and proficiency in their

content areas;

ii. demonstrate the ability to teach effectively at the appropriate

level.

b. Responsibilities

The responsibilities of the faculty/instructors must include:

i. participation in teaching courses;

ii. evaluation of student achievement;

iii. development of curriculum, policy and procedures;

iv. assessment of program outcomes

2. Clinical Liaison

At least one clinical liaison, who is employed by the clinical site, must be

designated at each clinical site affiliated with the program to coordinate

clinical experiences for students.

a. Qualifications

The clinical liaison must:

i. Be a medical laboratory professional who demonstrates the

ability to effectively coordinate clinical experiences of the

students;

ii. demonstrate knowledge of the program discipline;

iii. have at least one year experience as a medical laboratory

professional.

b. Responsibilities

The clinical liaison must be responsible for:

DMS Unique Standards Page 26

i. coordinating clinical instruction at the site;

ii. maintaining effective communication with the program director

or designee.

D. Advisory Committee

There must be an advisory committee composed of individuals from the

community of interest (e.g. practicing professionals, academic professionals,

scientific consultants, administrators, pathologists and other physicians, public

member) who have knowledge of clinical laboratory science education.

1. Responsibilities

The advisory committee of the program shall have input into the

program/curriculum to maintain current relevancy and effectiveness.

VIII. DMS Curriculum Requirements

A. Instructional Areas

1. Prerequisite courses in biological sciences including genetics, chemistry

and mathematics that provide the foundation for course work required in

the laboratory science program.

2. The curriculum must address pre‐analytical, analytical and post‐analytical

components of diagnostic molecular laboratory services covering

diagnostic molecular tests used to detect or diagnose acquired (infectious

and noninfectious) diseases and genetic predisposition or disorders. This

includes principles and methodologies, performance of assays,

problem‐solving, troubleshooting techniques, interpretation and

evaluation of clinical procedures and results, statistical approaches to

data evaluation, principles and practices of quality assurance/quality

improvement, and continuous assessment of laboratory services.

The program curriculum must include the following scientific content:

a. Organic and/or biochemistry, genetics, cell biology, microbiology,

immunology, and diagnostic molecular biology;

b. Principles, methodologies, and applications of molecular

microbiology (infectious diseases), molecular pathology

(hematology/oncology), and molecular genetics. Techniques of

molecular science must include current techniques in each of

DMS Unique Standards Page 27

separation and detection, amplification, and sequence analysis,

for example Sanger sequencing;

c. Clinical significance of laboratory procedures in diagnosis and

treatment

3. Application of safety and governmental regulations and standards as

applied to diagnostic molecular science.

4. Principles and practices of professional conduct and the significance of

continuing professional development.

5. Communications sufficient to serve the needs of patients, the public and

members of the health care team.

6. Principles and practices of administration, supervision, and quality

management as applied to diagnostic molecular science.

7. Educational methodologies and terminology sufficient to train/educate

users and providers of laboratory services.

8. Principles and practices of applied study design, implementation and

dissemination of results.

B. Learning Experiences

1. Learning experiences (courses, practica, other required activities) must

be properly sequenced and include necessary content and activities to

enable students to achieve entry level competencies in each major

discipline as listed in Standard VIII.A.2.

2. After demonstrating competency, students, with qualified supervision,

may be permitted to perform procedures.

C. Evaluations

Evaluation systems must relate to course content and support program

competencies. If there is evidence that competencies are not adequately

achieved (through feedback mechanisms as described in Standard II.B) then

course objectives will be examined in detail to assure that the objectives are

behavioral, include all domains and relate directly to the evaluations used.

1. These evaluation systems must be employed frequently enough to

provide students and faculty with timely indications of the students’

academic standing and progress.

DMS Unique Standards Page 28

2. The evaluation systems must serve as a reliable indicator of the

effectiveness of instruction and course design.

HT Unique Standards Page 29

Unique Standards for the Histotechnician (HT)

PREAMBLE

Objectives

The purpose of these Standards and the Description of the Profession is to establish,

maintain, and promote standards of quality for educational programs in the clinical

laboratory sciences and to provide recognition for educational programs which meet or

exceed the minimum standards outlined in this document.

The Standards are to be used for the development and evaluation of histotechnician

programs. Paper reviewers and site visit teams assist in the evaluation of the program’s

compliance with the Standards. Lists of accredited programs are published for the

information of students, employers, and the public.

DESCRIPTION OF THE HISTOTECHNOLOGY PROFESSION

Histotechnology professionals are qualified by academic and applied science education to

provide service and research in histotechnology and related areas in rapidly changing and

dynamic healthcare delivery systems. They have diverse and multi‐level functions in the

areas of analysis and clinical decision‐making, information management, regulatory

compliance, education, and quality assurance/performance improvement wherever

anatomic pathology testing is researched, marketed, developed or performed.

Histotechnology professionals perform, develop, evaluate, correlate and assure accuracy

and validity of laboratory testing and procedures; direct and supervise anatomic pathology

laboratory resources and operations; and collaborate in the diagnosis and treatment of

patients. They possess skills for financial, operations, marketing, and human resource

management of the histopathology laboratory.

Histotechnology professionals practice independently and collaboratively, being responsible

for their own actions, as defined by the profession. They have the requisite knowledge and

skills to educate laboratory professionals, health care professionals, and others in laboratory

practice, as well as the public.

The ability to relate to people, a capacity for calm and reasoned judgment, and a

demonstration of commitment to the patient are essential qualities. Communication skills

extend to consultative interactions with members of the healthcare team, external relations,

customer service and patient education. Histotechnology professionals demonstrate ethical

and moral attitudes and principles that are necessary for gaining and maintaining the

confidence of patients, professional associates, and the community.

Description of Career Entry Competencies of the Histotechnician

At career entry, the histotechnician will be able to perform routine histologic procedures

such as:

A. Receiving and accessioning tissue specimens;

HT Unique Standards Page 30

B. Preparing tissue specimens for microscopic examinations, including all routine

procedures;

C. Assisting with gross examination and frozen section procedures in

histopathology;

D. Identifying tissue structures and their staining characteristics;

E. Performing preventive and corrective maintenance of equipment and instruments

or referring to appropriate sources for repairs;

F. Recognizing factors that affect procedures and results, and taking appropriate

action within predetermined limits when corrections are indicated;

G. Performing and monitoring quality control within predetermined limits;

H. Applying principles of safety;

I. Demonstrating professional conduct and interpersonal communication skills with

patients, laboratory personnel, other health care professionals, and with the

public;

J. Recognizing the responsibilities of other laboratory and healthcare professionals

and interacting with them with respect for their jobs and patient care;

K. Recognizing and acting upon individual needs for continuing education as a

function of growth and maintenance of professional competence; and,

L. Exercising principles of management, safety, and supervision, as the primary

analyst making specimen oriented decisions on predetermined criteria, including

a working knowledge of criteria values. Communications skills will extend to

frequent interactions with members of the healthcare team, external relations,

customer service, and patient education. The levels of analysis range from

routine tissue processing to complex histopathology laboratory procedures in the

various major areas of anatomic pathology. The histotechnician will have diverse

functions in areas of pre‐analytic, analytic, and post‐analytic processes. The

histotechnician will have responsibilities for information processing, training, and

quality control monitoring wherever histologic procedures are performed.

VII. HT Program Administration

A. Program Director

The program must have a NAACLS approved medical laboratory professional

serving as program director who meets the following qualifications and executes

all required responsibilities.

1. Qualifications

a. has a baccalaureate degree or higher;

HT Unique Standards Page 31

b. holds ASCP‐BOC or ASCP

-BOC certification as a

Histotechnologist or Histotechnician. If the program director does

not hold ASCP‐BOC or ASCP

-BOC certification as a

Histotechnologist or Histotechnician, a qualified professional who

does hold ASCP‐BOC or ASCP

-BOC certification as a

Histotechnologist or Histotechnician must hold appointment as

education coordinator;

c. has three years of experience in medical or laboratory education

that includes:

teaching courses, conducting and managing learning

experiences;

evaluating student achievement;

providing input into curriculum development, policy and

procedure formulation;

evaluating program effectiveness.

d. has knowledge of NAACLS accreditation;

e. has knowledge of certification procedures.

2. Responsibilities

The program director must:

a. be responsible for the organization, administration, instruction,

evaluation, continuous quality improvement, curriculum planning

and development, directing other program faculty/staff, and

general effectiveness of the program;

b. provide evidence that s/he participates in the budget preparation

process;

c. engage in a minimum of 36 hours of documented continuing

professional development every 3 years;

d. be responsible for maintaining NAACLS accreditation of the

program;

e. have regular and consistent contact with students, faculty, and

program personnel.

3. Appointments

The program director must have a faculty or clinical appointment at the

sponsoring institution.

HT Unique Standards Page 32

Program Directors who have been approved as a program director of a NAACLS

accredited HT program prior to October 1, 2013 remain eligible as a program

director.

B. Site Program Coordinator (required for multi‐location programs only; assigned to

each participating site)

1. Qualifications

The site program coordinator must:

a. have an academic degree appropriate to the program level;

b. hold the same level certification required of a program director;

c. have at least one year of experience in medical laboratory science

education.

2. Responsibilities

The site program coordinator, when required, is responsible for:

a. coordinating teaching and clinical education,

b. evaluating program effectiveness;

c. maintaining appropriate communications with the program

director.

C. Faculty

1. Didactic Instructor Appointments

a. Qualifications

The program must have qualified faculty/instructors who hold

appointments within the educational program (e.g., certified

professionals in their respective or related fields). The program

must ensure and document ongoing professional development of

the program faculty/instructors.

Faculty/instructors designated by the program must:

i. demonstrate adequate knowledge and proficiency in their

content areas;

ii. demonstrate the ability to teach effectively at the appropriate

level.

b. Responsibilities

The responsibilities of the faculty/instructors must include:

i. participation in teaching courses;

HT Unique Standards Page 33

ii. evaluation of student achievement;

iii. development of curriculum, policy and procedures;

iv. assessment of program outcomes.

2. Clinical Liaison

At least one clinical liaison, who is employed by the clinical site, must be

designated at each clinical site affiliated with the program to coordinate

clinical experiences for students.

a. Qualifications

The clinical liaison must:

i. Be a medical laboratory professional who demonstrates the

ability to effectively coordinate clinical experiences of the

students;

ii. demonstrate knowledge of the program discipline;

iii. have at least one year experience as a medical laboratory

professional.

b. Responsibilities

The clinical liaison must be responsible for:

i. coordinating clinical instruction at the site;

ii. maintaining effective communication with the program director

or designee.

D. Advisory Committee

There must be an advisory committee composed of individuals from the

community of interest (e.g. practicing professionals, academic professionals,

scientific consultants, administrators, pathologists and other physicians, public

member) who have knowledge of clinical laboratory science education.

1. Responsibilities

a. The advisory committee of the program shall have input into the

program/curriculum to maintain current relevancy and

effectiveness.

E. Education Coordinator (when required)

1. Qualifications

a. The education coordinator, when required, must be a medical

laboratory professional who:

HT Unique Standards Page 34

b. has at least an associate’s degree and three years of experience

in the program discipline.;

c. holds ASCP‐BOC U.S. certification as a Histotechnologist or

Histotechnician;

d. has knowledge of NAACLS accreditation and current certification

procedures.

2. Responsibilities

a. The education coordinator, when required, must provide

supervision and coordination of the instructional faculty in the

academic and clinical phases of the education program.

VIII. HT Curriculum Requirements

A. Instructional Areas

1. Prerequisite content in biological sciences, chemistry and mathematics

that provides the foundation for course work required in the laboratory

science program.

2. Applications of histology, immunohistochemistry, enzyme histochemistry,

cytology specimen preparation, electron microscopy and light microscopy.

This includes principles and methodologies, problem‐solving, and

troubleshooting, for all major areas practiced in the contemporary

histopathology laboratory.

3. Concepts and principles of laboratory operations must include:

a. Fixation

Tissue identification

Parameters

Reagents

b. Processing

Decalcification

Frozen sections

Enzymes

Immunohistochemistry

Cytology

c. Embedding/Microtomy

HT Unique Standards Page 35

d. Staining

Procedures, reagents, and quality control

Hematoxylin and Eosin

Special Staining procedures

Basic Immunohistochemistry

Cytology

e. Laboratory Operations

Safety

Laboratory mathematics

Instrumentation

Quality control

4. Application of safety and governmental regulations and standards as

applied to histotechnology.

5. Principles and practices of professional conduct and the significance of

continuing professional development.

6. Communications sufficient to serve the needs of patients, the public and

members of the health care team.

7. Principles and practices of safety as applied to histotechnology.

B. Learning Experiences

1. Learning experiences (courses, practica, other required activities) must

be properly sequenced and include necessary content and activities to

enable students to achieve entry level competencies in each major

discipline as listed in Standard VIII.A.2.

2. After demonstrating competency, students, with qualified supervision,

may be permitted to perform procedures.

C. Evaluations

Evaluation systems must relate to course content and support program

competencies. If there is evidence that competencies are not adequately

achieved (through feedback mechanisms as described in Standard II.B) then

course objectives will be examined in detail to assure that the objectives are

behavioral, include all domains and relate directly to the evaluations used.

1. These evaluation systems must be employed frequently enough to

provide students and faculty with timely indications of the students’

academic standing and progress.

HT Unique Standards Page 36

2. The evaluation systems must serve as a reliable indicator of the

effectiveness of instruction and course design.

HTL Unique Standards Page 37

Unique Standards for the Histotechnologist (HTL)

PREAMBLE

Objectives

The purpose of these Standards and the Description of the Profession is to establish,

maintain, and promote standards of quality for educational programs in the clinical

laboratory sciences and to provide recognition for educational programs which meet or

exceed the minimum standards outlined in this document.

The Standards are to be used for the development and evaluation of histotechnologist