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Standards and Competencies for an Approved Program for the Clinical Assistant
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The Standards are divided into eight sections, with the Competencies following:

Standards
PREAMBLE
- Clinical Assistant is the term NAACLS uses to designate a formally prepared multi-skilled healthcare provider.
- The Clinical Assistant Competencies define the required skills with a laboratory focus.
- The Clinical Assistant Standards are used to evaluate educational programs for the Clinical Assistant.
- For information regarding the level of laboratory testing appropriate for the Clinical Assistant, contact the Center for Disease Control or the United States Health Care Financing Administration.
- In accordance with its mission, NAACLS provides leadership in fostering innovative educational approaches and actively supporting cooperative efforts with other agencies. NAACLS encourages employers to formalize training programs for the Clinical Assistant using this approval process. NAACLS also supports the addition of this approved Clinical Assistant program to the competencies of other accredited health service programs.
Objective
The medical and health professions cooperate to establish,
maintain and promote standards of quality for educational
programs in the health professions and to provide recognition for
such programs that meet or exceed the minimum Standards.
These Standards are used for the development and evaluation of
clinical assistant programs. A list of approved programs is
published for students, employers and the public.
Description of the Occupation
Clinical Assistants are able to:
- define the role of the clinical assistant in the
healthcare delivery system.
- use common medical terminology.
- demonstrate knowledge of infection control and safety
practices.
- follow standard operating procedures to collect
specimens.
- prepare blood and body fluid specimens for analysis
according to standard operating procedures.
- prepare/reconstitute reagents, standards and controls
according to standard operating procedure.
- perform appropriate tests at the clinical assistant
level, according to standard operating procedures.
- perform and record vital sign measurements.
- follow established quality control protocols.
- communicate (verbally and non-verbally) effectively and
appropriately in the workplace.
- use information systems necessary to accomplish job
functions.
- identify and report potential pre-analytical errors that
may occur during specimen collection, labeling,
transporting and processing.
I. SPONSORSHIP
Standard 1
The sponsoring institution must provide post-secondary
education. The sponsoring institution and affiliates, if any,
must be accredited by a recognized national, regional or state
agency.
In programs in which academic and clinical education are
provided by two or more institutions, responsibilities of the
sponsoring institution and each affiliate for program
administration, instruction and supervision must be described in
writing and signed by both parties. Each current agreement, with
written documentation of continuing affiliation on an annual
basis, must address the following items:
A. General
- Reason for agreement
- Clinical Assistant program responsibilities
- Clinical affiliate responsibilities
- Joint responsibilities
B. Specific
- Supervisory responsibility for students
- Professional liability coverage for students
- Health and safety provision for students
- Provision for annual renewal or review of the agreement
- Termination clause providing for program completion of
enrolled students
View Content of the Self-Study
Report for this Standard.
Standard 2
Approved programs must be in:
- Colleges and universities
- Hospitals and medical centers
- Laboratories
- Other post-secondary institutions or consortia that meet
comparable standards
View Content of the Self-Study
Report for this Standard.
Standard 3
Approval is granted to the institution that assumes primary
responsibility for curriculum planning, teaching and selection of
course content; coordinating classroom teaching; supervising
clinical education; appointing faculty to the program; receiving
and processing applications for admission, and granting a
certificate documenting completion of the program.
- The sponsoring institution or consortium shall be
responsible for providing assurance that the activities
assigned to students in the clinical setting are
educational.
- There shall be documented ongoing communication between
the sponsoring institution and its affiliates for
exchange of information and coordination of the program.
A meeting shall be held at least annually between
representatives of the sponsoring institution or
consortium and the affiliates.
View Content of the Self-Study
Report for this Standard.
II. RESOURCES
Standard 4
General Resources
Resources must support the number of students
admitted into the program. The instructor/ student ratio shall be
adequate to achieve the stated goals of the program.
View Content of the Self-Study
Report for this Standard.
Standard 5
Program Director
- The program must designate a qualified program director.
- The program director shall be a clinical laboratory
scientist/medical technologist who holds nationally
recognized certification with a baccalaureate degree and
three years of experience in clinical laboratory science
education that includes teaching courses, conducting and
supervising clinical laboratory learning experiences,
evaluating student achievement, providing input into
curriculum development, policy and procedure formulation,
and evaluation of program effectiveness. The program
director shall have knowledge of educational methods and
current accreditation and certification procedures.
- Responsibilities
The program director shall be responsible for:
- coordinating education experiences in the program
- organizing the program
- evaluating the program's outcomes, and
- maintaining NAACLS approval of the program
View Content of the Self-Study
Report for this Standard.
Standard 6
Faculty
- Responsibilities
The faculty shall participate in teaching courses,
supervising clinical laboratory learning experiences,
evaluating student achievement, developing curriculum,
formulating policy and procedure, and evaluating program
effectiveness.
- Qualifications
Faculty designated by the program director must
demonstrate the ability to teach effectively at the
appropriate level.
View Content of the Self-Study
Report for this Standard.
Standard 7
Professional Development
The program shall assure and document ongoing
professional development of the program director and faculty.
View Content of the Self-Study
Report for this Standard.
Standard 8
Financial Resources
Financial resources for continued operation of
the program shall be ensured by an adequate, institutionally
approved budget or by a statement of continued financial support
from an executive officer of the sponsoring institution.
View Content of
the Self-Study Report for this Standard.
Standard 9
Physical Resources
- Facilities
Classrooms, laboratories, administrative offices and
other facilities shall be adequate, equipped for safety,
and be in compliance with pertinent federal and state
laws.
View Content of the
Self-Study Report for this Standard.
- Equipment and Supplies
Modern equipment and supplies in sufficient quantities
shall be provided.
View Content of the
Self-Study Report for this Standard.
- Library
A library shall be readily accessible and contain current
books, periodicals and other reference materials related
to the curriculum.
View Content of the
Self-Study Report for this Standard.
- Instructional Resources
Instructional resources such as clinical materials,
reference materials and demonstration and other
multimedia materials must be provided. Computer
technology must be provided.
View Content of the
Self-Study Report for this Standard.
III. CURRICULUM
Standard 10
NAACLS Clinical Assistant Competencies must be used to design
didactic and clinical experiences.
View Content of the
Self-Study Report for this Standard.
Standard 11
Instruction shall follow a plan that documents:
- A structured curriculum including clearly written program
goals and course syllabi that include individual course
schedules and objectives.
View Content of the
Self-Study Report for this Standard.
- Behavioral objectives for the didactic and
clinical aspects of the program which address the
cognitive, psychomotor and affective domains. Course
objectives, cross-referenced to the NAACLS Clinical
Assistant Competencies, must show progression to the
level consistent with the entry into the occupation.
View Content of the
Self-Study Report for this Standard.
- Learning experiences and curriculum sequencing to develop
the competencies, including instructional materials,
classroom presentations, discussions, demonstrations,
laboratory sessions, supervised practices and experiences
that support course objectives.
View Content of the
Self-Study Report for this Standard.
- Program length that is appropriate for the competencies
achieved.
View Content of the
Self-Study Report for this Standard.
- Student evaluation that documents:
1. Criteria for
passing, failing and progression in the program, and
2. Criterion-based evaluations for didactic and
clinical areas that identify the objectives to be
completed and state the criteria for evaluation.
Evaluations must ensure that all objectives have been
achieved. The criteria shall be given to each student at
the time of entry to the program.
View Content of the
Self-Study Report for this Standard.
- Evaluation that is employed frequently enough to provide
students and faculty with timely indications of the
students academic standing and progress and to
serve as a reliable indicator of the effectiveness of
instruction and course design.
View Content of the
Self-Study Report for this Standard.
IV. STUDENTS
Standard 12
Students shall be provided with a clear description of the
program and its content, including program goals, course
objectives, required competencies and supervised clinical
education assignments.
View Content of the
Self-Study Report for this Standard.
Standard 13
Publications
- Current publications that include a description of the
program and curriculum must be available.
- These publication(s) may be brochures, catalogs or
student handbooks that must contain the following items:
- Academic and non-academic admission criteria;
- Application procedures;
- A list of course descriptions;
- Tuition and fees with refund policies;
- All program policies and procedures, including
appeal procedures and policy for retention and
dismissal;
- A description of clinical facilities;
- Length of the program and
- Essential functions.
- Announcements and advertising must accurately reflect the
program offered.
View Content of the
Self-Study Report for this Standard.
Standard 14
Appeals
Appeal procedures shall be distributed to students at the
start of the program. They shall include provisions for academic
and nonacademic types of grievances and a mechanism for neutral
evaluation that insures due process. Rules and regulations
governing acceptable conduct must be clearly defined and
published.
View Content of
the Self-Study Report for this Standard.
Standard 15
Service Work
Policies and processes by which students may
perform service work must be compatible with the program.
Students must meet the NAACLS Clinical Assistant Competencies by
demonstrating proficiency before they are allowed to work
independently. Clinical Assistant students may receive
compensation during training.
View Content of
the Self-Study Report for this Standard.
Standard 16
Admission of students, including advanced
placement, shall be made in accordance with the clearly defined
and published practices of the institution. Specific academic
standards and essential functions required for admission to the
program shall be clearly defined, published and provided to
prospective students and made available to the public.
View Content of
the Self-Study Report for this Standard.
Standard 17
Student Capacity
The number of students admitted must be based on
the capacity of the clinical facilities to accommodate students.
View Content of
the Self-Study Report for this Standard.
Standard 18
Student Records
The program must have written policies and
procedures by which permanent student records are maintained for
enrolled students and graduates. The program shall
maintain the student records for a reasonable period of time and
conform to any federal or state regulations.
View Content of
the Self-Study Report for this Standard.
Standard 19
Health and Safety
There shall be a procedure for determining that
the applicants or students health will permit them to
meet the written essential functions of the program. Students
shall be informed of and have access to the usual student health
care services of the institution.
The program must insure that the safety of all
those involved (student, faculty, staff) in the program's
sponsoring and affiliated institutions is adequately protected.
Emergency medical care shall be available for students while in
attendance.
Programs must meet all established, federally
mandated safety standards and provide documentation of
appropriate training.
View Content of
the Self-Study Report for this Standard.
Standard 20
Guidance
Guidance shall be available to assist students in
understanding and observing program policies and practices, for
advising on professional and career issues, and for providing
counseling or referral for personal problems that may interfere
with progress in the program. Confidentiality and impartiality
shall be maintained in dealing with student problems.
View Content of
the Self-Study Report for this Standard.
V. OPERATIONAL POLICIES
Standard 21
Fair Practices
Announcements and advertising must
accurately reflect the program offered.
View Content of the
Self-Study Report for this Standard.
Student recruitment and admission shall
be non-discriminatory in accordance with local state and
federal regulations.
View Content of the
Self-Study Report for this Standard.
Faculty recruitment and employment
practices shall be non-discriminatory in accordance with
local state and federal regulations.
View Content of the
Self-Study Report for this Standard.
Academic credits and costs to the student
shall be accurately stated, published, and made known to
all applicants.
View Content of the
Self-Study Report for this Standard.
Policies and procedures for student
withdrawal and refunds of tuition and fees shall be
published and made known to all applicants.
View Content of the
Self-Study Report for this Standard.
If more than one level of clinical
laboratory science education program is offered at an
institution, the sponsoring institution must demonstrate
that each program is being conducted to ensure
appropriate instruction for the students at the different
educational levels.
View Content of the
Self-Study Report for this Standard.
The program must culminate in a
certificate or other award recognizing completion of the
program. The granting of the certificate or award must
not be contingent upon the student's passing any type of
external certification or licensure examination. Academic
standards for the program must be acceptable to the
institution that grants the certificate or award.
View Content of the
Self-Study Report for this Standard.
VI. PROGRAM EVALUATION
Standard 22
The program must have a continuing system for
periodically and systematically reviewing the effectiveness of
the program.
View Content of
the Self-Study Report for this Standard.
Standard 23
The results of program evaluation shall be
reflected in the curriculum and other elements of the program.
View Content of
the Self-Study Report for this Standard.
VII. MAINTAINING
APPROVAL
Standard 24
Program/Sponsoring Institution
Responsibilities
Programs are required to comply with
administrative requirements for maintaining approval, including:
Submitting the Self-Study Report, an
Application for Initial or Continuing Approval, or a
required Progress Report as determined by NAACLS;
Paying approval fees as determined by
NAACLS; and,
Completing an Annual Report provided by
NAACLS and returning it by the established deadline.

Core Module Competencies
These competencies describe duties at a level below that of the established Clinical Laboratory Technician/ Medical Laboratory Technician.
As a member of the health care delivery team, the clinical assistant works under the supervision of an appropriate qualified person. Note: The instructional content appropriate to the achievement of these Competencies should be consistent with the entry level job responsibilities.
- 1.0
- Define the role of the clinical assistant in the healthcare delivery system as it relates to the point-of-care or clinical laboratory environment.
- 2.0
- Use common medical terminology.
- 3.0
- Demonstrate knowledge of infection control and safety practices.
- 3.1
- Demonstrate accepted practices for infection control, isolation techniques, aseptic techniques and methods for disease prevention.
- 3.2
- Comply with federal, state and locally mandated regulations regarding safety practices.
- 3.21
- Use the OSHA Universal Precaution Standards.
- 3.22
- Use prescribed procedures to handle electrical, radiation, biological and fire hazards.
- 3.23
- Use appropriate practices, as outlined in the OSHA Hazard Communication Standard, including the correct use of the Material Safety Data Sheet as directed.
- 4.0
- Follow standard operating procedures to collect specimens.
- 4.1
- Demonstrate basic knowledge of the circulatory, urinary, and other body systems necessary to perform assigned specimen collection tasks.
- 4.2
- Describe the difference between whole blood, serum and plasma.
- 4.3
- Identify and use blood collection equipment.
- 4.31
- Identify the additive by the evacuated tube color.
- 4.32
- Identify and properly use equipment needed to collect blood by venipuncture and capillary (skin) puncture.
- 4.4
- Collect blood specimens by venipuncture.
- 4.5
- Collect blood specimens by capillary (skin) puncture.
- 4.6
- Identify special precautions necessary during blood collections by venipuncture and capillary (skin) puncture.
- 4.7
- List and apply the criteria that would lead to rejection or recollection of a patient sample.
- 4.8
- Instruct patients in the proper collection and preservation for various samples, including: blood sputum stools
- 5.0
- Prepare blood and body fluid specimens for analysis according to standard operating procedures.
- 5.1
- Follow standard operating procedures for labeling, transport and processing of specimens, including transport to reference laboratories.
- 5.2
- Describe and follow the criteria for specimens and test results that will be used as legal evidence.
- 6.0
- Prepare/reconstitute reagents, standards and controls according to standard operating procedure.
- 6.1
- Follow laboratory protocol for storage and suitability of reagents standards and controls.
- 6.2
- Recognize and report contamination and/or deterioration in reagents, standards and controls.
- 7.0
- Perform appropriate tests at the clinical assistant level, according to standard operating procedures.
- 7.1
- Compare test results to reference intervals.
- 7.2
- Record results by manual method or computer according to laboratory protocol.
- 7.3
- Report STAT results of completed tests according to laboratory protocol.
- 7.4
- Recognize critical values and follow established protocol regarding reporting.
- 7.5
- Clean glass and plastic labware.
- 7.6
- Use pipetting equipment.
- 7.7
- Use measurement equipment such as beakers and flasks.
- 8.0
- Perform and record vital sign measurements.
- 8.1
- Perform and record blood pressure measurement.
- 8.2
- Perform and record pulse rate.
- 8.3
- Perform and record body temperature.
- 8.4
- Recognize and report abnormal values for vital sign measurement using predetermined criteria.
- 9.0
- Follow established quality control protocols.
- 9.1
- Perform quality control procedures.
- 9.2
- Record quality control results.
- 9.3
- Identify and report control results that do not meet pre-determined criteria.
- 10.0
- Communicate (verbally and non-verbally) effectively and appropriately in the workplace.
- 10.1
- Maintain confidentiality of privileged information on individuals.
- 10.2
- Value diversity in the workplace..
- 10.3
- Interact appropriately and professionally with other individuals.
- 10.4
- Discuss the major points of the American Hospital Association's Patient's Bill of Rights or the Patient's Bill of Rights from the institution.
- 10.5
- Model professional appearance and appropriate behavior.
- 10.6
- Follow written and verbal instructions in carrying out testing procedures.
- 11.0
- Use information systems necessary to accomplish job functions.
- 12.0
- Identify and report potential pre-analytical errors that may occur during specimen collection, labeling, transporting and processing.

Chemistry Module Competencies
These competencies describe duties at a level below that of the established Clinical Laboratory Technician/ Medical Laboratory Technician.
As a member of the health care delivery team, the clinical assistant works under the supervision of an appropriate qualified person. Note: The instructional content appropriate to the achievement of these Competencies should be consistent with the entry level job responsibilities.
- 1.0
- Use common clinical chemistry terminology as it relates to the point-of-care or clinical laboratory environment.
- 2.0
- Prepare store and dispose of specimens for chemistry analysis according to standard operating procedures.
- 3.0
- Determine suitability of specimens for chemistry procedures according to:
- the test requested.
- appropriate patient preparation/method of collection.
- time of collection/processing.
- storage.
- hemolysis/lipemia and interfering substances.
- 4.0
- Assemble/prepare reagents, standards and controls for chemistry tests.
- 5.0
- Perform appropriate tests at the clinical assistant level.
- 6.0
- Recognize technical testing errors for each test performed.
- 7.0
- Report results of procedures using pre-determined criteria.
- 8.0
- Follow established quality control procedures specific to chemisty tests, including maintenance and instrument calibration.
- 9.0
- Maintain inventory control and supplies for chemistry tests.
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