Journal of Health Occupations Education

Volume 14 | Number 2 Article 6

2000

Competency Assessment for Medical Laboratory

Practitioners and Existing Rules and Regulations
Rajeshree P. Parikh Ed.D., S.B.B., M.S., M.Ed., B.Ed., B.S.

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Recommended Citation
Parikh, Rajeshree P. Ed.D., S.B.B., M.S., M.Ed., B.Ed., B.S. (2000) "Competency Assessment for Medical Laboratory Practitioners and
Existing Rules and Regulations," Journal of Health Occupations Education: Vol. 14: No. 2, Article 6.
Available at: http://stars.library.ucf.edu/jhoe/vol14/iss2/6

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

Journal of Health Occupations Education

Fall 2000, Volume 14, Number 2

Competency Assessment for Medical Laboratory Practitioners and Existing Rules and

Regulations

by

Dr. Rajeshree P. Parikh

© 1998 Rajeshree P. Parikh

Ed.D. University of Central Florida, 1998

S.B.B. American Society of Clinical Pathologists, 1993
M.S. University of Central Florida, 1992
M.Ed. Gujarat University, 1975
B.Ed. Gujarat University, 1974
B.S. Gujarat University, 1972

An article based upon a presentation

at the Health Occupations Education session of the annual conference
Association for Career and Technical Education
Orlando Convention Center on December 12, 1999

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 Journal of Health Occupations Education, Vol. 14 [2000], No. 2, Art. 6

Competency Assessment for Medical Laboratory Practitioners and Existing Rules and
Regulations

Abstract

Some of the challenges clinical laboratories faces today are the design and

implementation of competency assessment programs. Section 493.1451 (b) (8) of the

Clinical Laboratory Improvement Amendments of 1988 (CLIA, 1988) regulations states

that technical supervisors are responsible for ensuring that staff maintain competency to

perform test procedures and report results promptly, accurately, and proficiently. CLIA

(1988) requires that the skills of technical personnel be assessed annually.

The purpose of this study was to compare the perceptions of certified medical

laboratory personnel who worked as educators, employers, or practitioners regarding the

required competencies of three levels of laboratory personnel: Medical laboratory

technician (MLT), medical laboratory technologist (MT) and clinical laboratory

Specialist.

Descriptive statistics, which included means, standard deviations, ranks, and

Spearman Rank-Order Correlation, revealed some degree of discrepancies among the

respondents. However, educator's response reflected the appropriateness of the

competencies in direct relation to increasing competency level of laboratory roles,

Medical Laboratory Technician (MLT), Technologists (MT) and Specialists. Employers

and Practitioners, on the other hand, rated MTs and Specialists as almost equal.

Furthermore, comparison among the practitioners revealed distinct discrepancies in the

perceptions of performing and evaluating laboratory tests. The greatest variation was

noted among practitioners in their rating of competency level required for specialist roles.

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

These specific results will be useful for further development of required personnel

qualifications and their relationship to competency-based performance evaluations

intended to maintain quality control practices and laboratory proficiency. Result of the

study will also provide guidelines for further discussing curriculum revision for

practitioners training and to establish distinct levels of competencies for three different

levels of medical laboratory personnel: MLTs, MTs, and Specialists.

Introduction

One of the challenges clinical laboratories have faced is the design and

implementation of competency assessment programs. Section §493.1451 (b) (8) of the

Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) regulations stated that

technical supervisors are responsible for ensuring that staff maintain competency to

perform test procedures and report results promptly, accurately, and proficiently (Federal

Register, 1992). CLIA’ 88 requires that the skills of technical personnel be assessed

annually. The accreditation standards (1992) of the Joint Commission on Accreditation of

Healthcare Organizations (JCAHO) emphasize the quality of interdepartmental functions

and performance improvement (Hansen, 1996). As a result of such rules and regulations

all laboratories were required to document competency assessment of their employees.

Over the past twenty years there has been significant investment in the laboratory to

improve and establish the roles and responsibilities for laboratory medical personnel.

Despite this, however, there is very little empirical evidence to suggest that competency

levels of laboratory personnel have been evaluated objectively.

During the 1990's, hospital administrators, physicians, insurance providers, and

patients have expected more for their health care dollars (Berte & Nevalainen, 1996).

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 Journal of Health Occupations Education, Vol. 14 [2000], No. 2, Art. 6

Health care costs have risen tremendously and the general public wants the costs reduced.

Furthermore, the impact of health care reform, managed care and prospective payment

systems (PPS) has led hospital management to make more concerted efforts to control

costs within their institutions (Karni, 1997).

The impact of managed care and PPS along with the increase of automation and

computerization has generated incentives to reduce laboratory testing and personnel. In

addition, because of simplified instrumentation, fewer individuals with baccalaureate or

advanced level degrees were required. On the other hand, more sophisticated procedures

and analyses, the emergence of new laboratory subspecialties, and laboratory

participation in test selection, utilization, and interpretation have suggested a need for

more personnel trained at the baccalaureate, masters, and doctoral levels (Karni, 1997).

According to the result of an American Society of Clinical Pathologists’ Board of

Registry (BOR) survey (1995), students have been facing increasing difficulties in

receiving training and finding jobs. Concurrently, however, many allied health care

industries have experienced personnel shortages due to the effects of restructuring,

reengineering, downsizing or rightsizing. Some schools of allied health in the United

States have made an effort to train multi-competent allied health professionals to meet the

personnel needs of small hospitals, physicians’ offices, clinics, comprehensive health

care centers, and rural areas (Bamberg & Blayney, 1984). However, the selection of

curriculum for clinical laboratory technology programs has presented an ongoing

problem for educators. In order to prepare students for entry-level positions and future

professional competence, educators have been seeking a way to make sound decisions

concerning curriculum content.

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

This article was prepared to provide information that would help in determining

an optimal competency-based performance evaluation. The focus of this article was to

identify how medical laboratory personnel view competency levels according to their

education, experience, on-the-job training, orientation, and employment status. The level

of congruency among various laboratory personnel levels was identified as a starting

point for dialogue and curriculum planning. However, since certifying agencies have

already established criteria for expected competency levels, this study was not intended

to define competency according to the laboratory personnel level. The question still

remains regarding the characteristics of performance levels expected of entry-level

personnel of medical technology programs.

The goal of clarifying expected competencies of the various personnel levels

serve a number of functions. Identification of desired competencies removes curricular

discussions from discipline-specific considerations and territorial issues, which in turn

facilitates a focus on desired characteristics of medical technology graduates. Results of

such a study can provide information about areas of mutual agreement among diverse

laboratory departments and different levels of laboratory personnel. This data may also

suggest a means for the restructuring of knowledge and technical skills in medical

technology education and on-the-job training. A competency-focused approach to

achieve quality performance goals may be valuable for addressing the educational needs

of a diverse population of students and employees. For educational leaders anticipating

curricular review or revision, knowledge of employer's expectations of competency for

the various levels of laboratory personnel can provide the groundwork for deliberation.

Many features of the laboratory have changed in recent years, but the underlying

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principles of laboratory analysis and work ethics have remained the same. Evaluation of

laboratory personnel was always documented in different ways, such as performance

evaluations, certifying examinations, and proficiency testing. Competency assessment is

another form of evaluation for laboratory personnel that does not eliminate traditional

patterns of evaluating, but instead refines these patterns to make them more objective. By

comparing the perceptions of medical laboratory professionals, it is assumed that a true

reflection of differences in competency levels in current medical laboratory practice can

be obtained. This seems to reflect the rater's experience of the real world in terms of

perception. In other words, it supports the definition of the Hutchinson Dictionary of

Ideas (1994) that perception is an individual's assessment or personal ideas of the real

world. People's perception of the world is necessarily based on incomplete or unreliable

information. Perception affects the attitude of people and events.

Griffin supported this notion of perception in 1988: "The most remarkable

capacity of the human perceptual system is that it can take in an array of ambiguous

information and construct a coherent, meaningful representation of the world. But we

generally do not realize how subjective this construction is. Perception seems so

immediate to us that we feel as if we are taking in a copy of the true world as it exists."

(5).

The BOR Research and Development Committee presented a 30-item list of

laboratory tasks, representing six broad categories of competency criteria used for the

performance evaluation of laboratory personnel: technical skills; judgement and

analytical decision making; knowledge base; communication; teaching and training; and

supervision, management, and administration. These categories are used by many

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

organizations to evaluate the performance of medical laboratory personnel. The majority

of employers directly observe a laboratory employee performing selected tasks in

assigned areas. They document participation in proficiency testing, quality control, and

an external competency assessment program to gauge technical performance as well as

cognitive skills (Minard, 1995).

Roles and Responsibilities Determined by the ASCP

Technically trained laboratory workers are usually categorized as technologists,

technicians, or specialists, depending upon their training, education and certification.

Although job descriptions and responsibilities can overlap, generally specialists have

more education and greater depth of experience than technologists do, and technicians are

expected to be capable of accepting greater responsibilities. Technologists, or clinical

laboratory scientists, as they are designated by the certification agency, are capable of

supervising and directing the technical components of even the most complex clinical

laboratory. Technicians are often required to work under the direct supervision of

technologists or specialists in a hospital or independent laboratory (Crowley & Tillman,

1986).

Each level represents a definition for the six competencies: technical skills,

judgement and analytical decision-making, knowledge base, communication, teaching

and training, and supervision and management. In evaluating responses across the six

competencies, the greatest amount of overlap between MT and MLT occurs in the

technically oriented categories: technical skills, knowledge base, and

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judgement/analytical decision making. As responsibilities increase in complexity,

autonomy, and authority, the differentiation between the MT and MLT increases as well.

The tables D1 to D6 presented in this article establishes a comparison in the

ASCP Professional Levels Definitions for each of the six skills in 1982 and 1996. In

these fourteen years, levels of competency requirements have changed dramatically for

technicians and technologists, while expected competencies of specialists have not

changed at all. Medical laboratory technicians are performing more routine testing and

medical technologists are becoming increasingly involved in supervision and

management. Medical technologists are performing more than expected work and has to

involve in training others and getting trained as well. To achieve reliable, cost effective

laboratory outcome, it is important that appropriately ordered tests are correctly done,

interpreted and reported.

Due to automation manual dexterity is not as great as it was emphasized in 1960s

and 1970s. It has been vicious cycle, and technologists are becoming increasingly

frustrated and angry at the process (Johns, 1996). Those who are very easily frustrated by

the ongoing changes may consider competency assessment as another quality fad and

continue business as usual, harboring bitterness about staff and resource cutbacks and

business as usual (Berte and Nevalainen, 1988).

It is no longer enough to be technically competent. In order to succeed in

competitive environment updated skills, flexibility, and positive attitude is very important

(Burke, and Rolen-Mark, 1996). It is important that undergraduate and professional

courses are firmly rooted in the basic sciences and liberal arts with professional

preparation in clinical laboratory science courses. It is essential that educators encourage

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

and enhance skills in communication, critical thinking, problem solving, and leadership

so laboratory personnel can become confident about what they learn and apply to

laboratory tasks and push their professional competency limits to the highest level.

What is Competency?

Competency is an outcome or demonstration of adequate ability as measured by a

relatively simple, observable behavior that can be clearly identified and precisely

measured as to its frequency of performance (Johnson, 1977). Competency defines the

ability to carry out the total performance responsibilities of the given practitioner’s

generic position (Wilson, 1976). Barrasso in 1981 defined competency as the combined

knowledge and skill factors necessary to fulfill work obligations adequately. In other

words, competency is the ability to carry out a specific task within given parameters of

control. Formal education is, perhaps, the most efficient route to achieving competence.

Continuing education ensures its maintenance. Validation of the initial achievement

occurs with successful completion of a certification examination.

The ability to communicate effectively is a generally accepted indication of

competency in general education. Various authorities of medical laboratory technology

educators have provided lists of competencies. Six of the competencies presented by the

American Society of Clinical Pathologists are technical skills, judgment and analytical

decision making, knowledge base, communication, teaching and training, and supervision

and management. Competency assurance is the certainty that the practitioner is able

throughout a career to carry out the responsibilities of the position filled (Wilson, 1977b).

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What is Competence?

The standard of Training Agency (1988) defines competence as a wide concept,

which embodies the ability to transfer skills and knowledge to new situations within the

occupational area. It encompasses organization and planning of work, innovation, and

coping with non-routine activities. It also includes those qualities of personal

effectiveness that are required in the workplace to deal with co-workers, managers, and

customers. Price (1978, 1981) defines competence in relation to definition of profession.

The definition of profession implies that a practitioner has certain intellectual and

technical skills as well as appropriate values and attitudes, which can be defined in terms

of competence (Brown, 1978). The competence required for clinical laboratory personnel

reflects performance in many dimensions such as knowledge, intelligence, technical

skills, problem solving abilities, interpersonal skills, and skills in oral and written

expression. If any one of these components is deficient or inadequate, performance by the

clinical laboratory employee may be affected. In the clinical laboratory science

curriculum, theoretical knowledge, technical skills are emphasized as key elements for

developing individual’s competency level. But interpersonal skills, attitudes, values,

feelings, and emotions are neglected in professional education and evaluation because of

the time and effort necessary to include them. In most cases effective objectives are

taught by example only or left to chance (Anderson, 1986).

Competencies may be defined as identified and assessable behaviors reflective of

requisite professional knowledge, performance skills, therapeutic applications and

attitudes. A competency-based curriculum, then, is a purposefully provided vehicle for

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

ensuring that learners possess predetermined professional attributes (Broski ET al.,

1977).

Why Competency Assessment is Necessary?

The introduction of recent health care reforms such as the Final Rule of Clinical

Laboratory Improvement Amendments of 1988 (CLIA '88) released on February 28,

1992; the Final Rule of Occupational Exposure to Blood-Borne Pathogens released on

December 6, 1991; the Final Rule of Occupational Exposure to Formaldehyde on May

27, 1992; and the 1992. The rules and regulations cited in the recent literatures are as

follows (Best, 1993; George, 1996; Hansen, 1996):

Joint Commission on Accreditation of Health Care Organizations (JCAHO)

standards will cause tremendous changes in the next five to ten years. Expanding areas in

the clinical laboratory of the twenty-first century will require a higher level of skills,

education, and training for medical laboratory personnel to perform highly sensitive and

complex assays. The American Society for Medical Technology (ASMT) published a

position paper in 1982 charting professional levels of laboratory skills at career entry for

CLA, MLT, MT, and specialists in the medical laboratory field. This philosophical

delineation of the laboratory personnel categories does not, however, describe differences

in required competency levels for the performance of tasks among levels.

Recent literature represents the anticipation of implementing the regulations of the

Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), which will address

the quality of laboratory testing and consumer safety. The ASCP noted that the statutory

revisions proposed would exempt nearly one-half of the nation's laboratories from any

quality standards or inspections. Laboratories not inspected under CLIA'88 would be

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those that historically have been shown to benefit the most by introducing quality

practices. Several issues under CLIA'88 remain to be addressed in future regulations that

include personnel standards, changes within the complexity models, and proficiency

testing. However, on December 6, 1994, the Health Care Financing Administration

(HCFA) and the US Public Health Service did release a final rule recognizing the ASCP

as a certifying agency for cytotechnologists. According to the regulation,

cytotechnologists certified by the ASCP now meet the cytotechnologist personnel

qualification requirements under CLIA'88. In its comments, the government stated that

"the qualifications used by the ASCP to qualify an individual as a cytotechnologist

include both educational and training components that are similar to or more stringent

than the current CLIA requirements for cytotechnologists (Stombler, 1995, p. 104)."

1. The new accreditation standards of the Joint Commission of Accreditation of

Healthcare Organizations (JCAHO) emphasize the quality of interdepartmental

functions and performance improvement.

2. The JCAHO requires assessment of a person's competency on the job as part of the

organization's quality improvement plan.

3. JCAHO requires individual competency to perform tests safely and accurately and to

prevent transfer of infection. The laboratory director must maintain competency of

staff initially and continuously.

4. The JCAHO team confers with representatives from departments throughout the

institute, reviews documentation as a proof of performance, interviews group of staff

members, and visits various areas of the institute, especially where staff members

directly serve patients.

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5. The Clinical Laboratory Improvement Amendments of 1988 (CLIA' 88) requires that

the competency of technical personnel performing moderately complex testing be

assessed semiannually during the first year of employment and annually thereafter.

6. CLIA' 88 requires that facilities participate in proficiency testing (PT) for all

regulated analytes. The legislation requires semiannual verification of unregulated

analytes.

7. The American Association of Blood Banks (AABB) requires that at least annually,

the employee must demonstrate their abilities to perform their duties.

8. AABB requires a quality assessment and improvement program to ensure personnel

are knowledgeable and skilled in their assigned duties.

9. College of American Pathologists (CAP) requires a sufficient work force with

adequate documented training and experiences to meet the needs of the laboratory

with periodic evaluation process.

Thus, The Joint Commission on the Accreditation of Health Care Organizations

(JCAHO) recently developed guidelines for clinical laboratory testing requires that for a

diagnostic clinical laboratory "personnel responsible for test performance and those

responsible for direction/supervision of the testing activity are identified. Personnel

performing tests have adequate and specific training and orientation to perform the tests

and demonstrate satisfactory levels of competence." The CLIA '88 demands that almost

all laboratories require certification based on the scope of testing offered. Physicians'

offices will be required to perform regular laboratories that offer similar services.

Although there is no standard number of tests that a physician must perform to acquire or

maintain competence, less than one procedure per month is thought to be not enough to

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attain competence. For physicians in practice, it is not known with what level of

competence simple laboratory procedures are performed.

On the other hand, technologists have moved from being on the bench and

running tests to consulting management and troubleshooting. They are also involved in

teaching, research, and development, and acting as liaisons for laboratory testing. The

education and training of medical laboratory technicians must be strengthened to

accommodate these increased demands. The major growth areas of testing in the 1990s

will be in flow cytometry, DNA probes, molecular biology, and cytogenetics. These areas

will continue to require the education, skills, and training of degree-holding medical

technologists. The final impact of CLIA '88 on the clinical laboratory will be the

disappearance of on-the-job trainees and certified laboratories by 1997. By 1997, all

high-complexity testing laboratory personnel will be required to have associate's degrees

in medical laboratory science.

Because CLIA '88 has legalized the use of less highly trained and educated

personnel for most technical and administrative laboratory functions except in the

cytology laboratory, hospital administrators may no longer see the need to differentiate

between the duties and responsibilities of medical technologists and those of technicians.

In many hospitals laboratory productivity will decrease and costs will increase as a result.

The traditional bachelor's degree in medical technology and four to six years of

experience required for supervisory positions may also be downgraded to an associate's

degree and two years of experience as a result of CLIA '88. This level of education and

training is insufficient to successfully manage a high complexity laboratory setting.

Because the quality of laboratory testing is more reliant on the qualifications of the

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

laboratory supervisor than on any other position, quality will be most affected by the

decreased standards. However, due to risk management factors, laboratories may

continue to hire the most qualified individuals for professional and technical positions.

The important factor that relates to this study is under CLIA '88. Medical

technologists must be assessed for competency semiannually during the first year of

employment and annually thereafter. This assessment must include all of the following:

direct observation, review of intermediate results, blind testing using proficiency testing

samples or internal samples, assessment of problem-solving skills, and monitoring. It

would be the responsibility of the technical supervisor to assure that medical

technologists are competent.

A grandfather provision was also recommended, allowing an individual serving as

a general supervisor on or before the date of the published rule to continue to qualify if he

or she meets the requirements. Such requirements include earning an associate degree in

laboratory science, medical technology, or its equivalent, which is defined as a total of

sixty semester hours; achieving two years of experience as general supervisor; graduating

from high school or attaining an equivalent degree; or receiving laboratory training as

described in the CLIA '88 rule for high-complexity testing, six years of which must be

taken in a supervisory role (McNett, 1993).

Furthermore, prevention of error is accomplished more through effective training

and continuing education than through surveillance. This system will force more

conscious attention to meeting the expectations of the many clients who must be satisfied

by laboratory services, including patients, physicians, third-party payers, and managed

care organizations.

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Modern health care managers are looking for better ways to motivate their

employees as well as to document and evaluate employee performance and competencies.

The term productivity is familiar to most health care managers, while the term efficiency

is less familiar. Productivity and efficiency are unique and valuable indicators of

effective employee performance. A performance-based incentive program using an

Intensive Pay Index Chart is proposed as a tool through which hospital or company

managers can provide technicians or technologists with ongoing motivation to improve

both their productivity and efficiency on the job (Lodge, 1991).

Training professionals must be able to respond to the needs of medical laboratory

personnel accurately, quickly, and cost-effectively. The best solution is a comprehensive

framework that delineates a distinct hierarchy of competencies required by the managers

in an organization. The competency domain model used for the Sandwith (1993) study

identifies and orders five domains of managerial competency: conceptual/creative,

leadership, interpersonal, administrative, and technical.

Substantial modification in the medical technology curriculum is needed to

prepare graduates for changing technological regulations, staffing requirements, and

operational changes that will occur in laboratory medicine in the 20th century. The

interdependent roles of laboratory technicians and technologists need to be more clearly

defined. Promotion of a career-ladder should be a continuous pattern, from phlebotomist

to laboratory assistant, then from laboratory assistant to technician. Curriculum reforms

are also necessary to improve the products and services that laboratory educators provide

to their customers (Best, 1993).

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How competency is measured?

Performance appraisals have recently become the focus of legal scrutiny. Because

the appraisal process may lead to salary adjustments, promotions, opportunities for

development, discipline, or even termination, issues such as fairness and discrimination

are raised. Snyder (1991) discussed specific constitutional and statutory laws that prohibit

discrimination in performance appraisals. In addition, specific rulings from selected court

cases illuminate key legal defense factors in performance appraisal. How to assess the

competency of each staff member represented below was published in Technical

Supervisor responsibilities, Section 493.1451 Federal Register, 1992, and literature

written by Allered and Steiner, 1994; Best, 1993; Berte and Nevalainen, 1995; George,

1996; Hansen, 1996; Christian, Peddecord, Francis, and Krolak, 1997.

1. Directly observe the individual performing routine tests including patient or donor

preparation, if applicable, specimen handling, processing and testing.

2. Monitor the individual recording and reporting test results.

3. Review the individual's intermediate test results or worksheets, proficiency-testing

results, quality control record, and preventive maintenance records.

4. Directly observe the individual checking functions on instruments and maintaining

instrumentation.

5. Provide hands on testing to assess test accuracy by requiring that the individual

analyze a previously analyzed specimen, internal blind testing samples, or external

proficiency-testing sample.

6. Administer written test.

7. Conduct oral test and critique oral responses to procedure queries.

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8. Document performance deficiencies or critical incidents related to procedure and use

to assess trouble-shooting skills.

9. Assess the individual's problem solving skills for example by case studies.

10. Assess completion of learning activities.

Benefits of Competency program

Competency assessment program would be useful to educators, employers and

employees. It provides information of employee's progress, objective documentation for

each task performance, and opportunity to employee to evaluate own strength and

weaknesses to perform required task for promotion and merit pay increases. Increases

supervisor's awareness of employee's performance level and improves communication

between supervisors and employees along with job performance and employee

satisfaction. Competency assessment program enhances employee understanding of what

is expected of them and how they are doing to facilitate employee orientation, training

and counseling. Furthermore, it identifies areas that requires training or retraining and

encourages employees to read carefully and review critically policies and procedures. In

addition to these benefits competency assessment criteria facilitates identification of

incompetent employees and provide appropriate training program to improve their

performance level. Improves ability to implement corrective action plan and self-

improvement opportunities. Improves quality of results, products, and services which

results in establishing image of competent staff to outside customers and assures

consistency of performance with personnel and instruments. This benefit promotes

confidence in peers and fosters better morale (Christian et. al., 1997).

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It is essential that progression of competency assessment be documented

appropriately. Use of checklists and forms for orientation, initial training checklists, form

for direct observation of each test with detail steps for required skills, method of

assessment of problem solving skills, and competency assurance checklist. Interactive

machines or computer programs to provide feedback and training for theory and practical

aspects or case studies for problem solving skills can be sued. Documentation of

proficiency testing, and required training to meet the demands during all shifts that

include operating new machines, quality control process, and common problem or

malfunctions. Checklists or documentation of case study discussions for enhancing

trouble-shooting skills demonstrate recognition of the problem and managing it by

finding the solution or taking corrective action.

Characteristics of competent staff

Study of Christian et. al (1997) identified seven major characteristics of a

competent staff, which are listed as follows:

1. Competent staff produces accurate results in a timely manner.

2. Recognizes problems and errors, trouble shoots, take initiatives and solves problems.

3. Makes no errors or few errors as possible.

4. Possess education, training and continuing education

5. Follows policies and procedures and correctly performs testing.

6. Knows what and why the test is needed to be done.

7. Processes good communication and interpersonal skills.

Failure to provide competent services includes three major principles (Fortune,

1976): Failure to stay current in their field; failure to make day-to-day adjustments to

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practice; and failure to one or more fundamental skill areas needed for competent

practice. In another words, factors that influence human performance includes but not

limited to are:

1. Deficiency in desired to reach optimum performance level, for example and incentive

or motivational deficiency.

2. Deficiency in skill or knowledge to understand the information and perform the task.

3. An environment or time constraints due to over work and interference from other job

responsibilities.

4. A physical deficiency such as visual acuity, color blindness, physical strength and

weakness, and motor dexterity.

5. Deficiency in problem solving and decision making skills.

Allred and Steiner (1994) supports the above principle stated by fortune and states

that prevention of problems by adequate initial training is far less costly than subsequent

detention of errors and corrective actions, which would have to include some degree of

retraining. CLIA regulations require personnel to be completely trained in procedures

before performing analysis.

According to Haynes (1991) there are three basic reasons for making an appraisal

for employee performance: 1) To encourage good behavior or to correct and discourage

substandard performance; 2) To satisfy employees' curiosity about how well they are

doing; and 3) To provide a firm foundation for later evaluations in an employee's career.

Such matters as pay raises, promotions, transfers, or separation can be handled more

smoothly if the employee is aware of the possibilities beforehand.

Elements of performance appraisals include:

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1. Competencies are derived from an assessment of the required knowledge, skills and

attitudes to perform the task.

2. Competencies are stated in observable and measurable terms.

3. Achievement of competencies are compared and evaluated against performance

standards

4. Committed to write instruction modules containing competency statements,

assessment of prerequisite skills, alternate learning activities, feedback and

motivational statements for the corrective action.

5. Aimed to improve performance

6. Regular, periodic scheduling that allow self-paced instruction to master each

competency.

5. Prepare set of measurement criteria for each competency level.

Unfortunately, there is no standardized curriculum or certification process for the

technologist or technician. There is also no licensure for them in most states, but there are

agencies that offer certification based on various educational and experimental

requirements. Certification requirements for technologists can range from a baccalaureate

degree to on-the-job training (OJT), depending on the agency (e.g., HEW, HHS). The

purpose for these examinations is to qualify technical personnel as technologists so

independent laboratories can meet Medicare's personnel standards. The diversity in

education and experience for persons certified at the technologist and technician levels

means that the employer must rely on personal interviews, references, and observation as

sources of information about a prospective employee's true capabilities.

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CONCLUSIONS AND RECOMMENDATIONS

Conclusions

Some of the challenges clinical laboratories face today is the design and

implementation of competency assessment programs. Section 493.1451 (b) (8) of the

Clinical Laboratory Improvement Amendments of 1988 (CLIA, 1988) regulations states

that technical supervisors are responsible for ensuring that staff maintain competency to

perform test procedures and report results promptly, accurately, and proficiently. CLIA

(1988) requires that the skills of technical personnel be assessed annually.

The purpose of this study was to compare the perceptions of certified medical

laboratory personnel who worked as educators, employers, or practitioners regarding the

required competencies of three levels of laboratory personnel: Medical laboratory

technician (MLT), medical laboratory technologist (MT) and clinical laboratory

Specialist. All respondents were certified by the American Society of Clinical

Pathologists.

Descriptive statistics, which included means, standard deviations, ranks, and

Spearman Rank-Order Correlation, revealed some degree of discrepancies among the

respondents. However, educator's response reflected the appropriateness of the

competencies in direct relation to increasing competency level of laboratory roles,

Medical Laboratory Technician (MLT), Technologists (MT) and Specialists. Employers

and Practitioners, on the other hand, rated MTs and Specialists as almost equal.

Furthermore, comparison among the practitioners revealed distinct discrepancies in the

perceptions of performing and evaluating laboratory tests. The greatest variation was

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

noted among practitioners in their rating of competency level required for specialist roles.

No apparent differences were found according to demographic factors.

Although educators, employers, and practitioners ranked competency statements

slightly differently for each section, it is apparent that all three groups were congruent in

their perceptions regarding Section IX, Supervision/Management as the least important

and Section I, Specimen Collection, as the most important. However, responses reflected

the appropriateness of the competencies for each of the levels of clinical laboratory

specialist, medical laboratory technologist and medical laboratory technician, with more

competencies and complexity of competencies attributed to the higher levels of practice.

The results of this study will be useful for further investigation and development

of required personnel qualifications and their relationship to competency-based

performance evaluations intended to maintain quality control practices and laboratory

proficiency. These results will be useful in discussing curriculum revision for practitioner

training. The study will also provide guidelines for employers to establish distinct levels

of competency for three different levels of practitioners in order to utilize the workforce

efficiently for what educators have prepared them.

Recommendations

The clinical laboratory field is changing dramatically, and opportunities are

shifting as well. It is no longer enough to be technically competent. Increasingly less

qualified people are doing less-technical testing, and more experienced people are taking

on supervisory roles. Rapid changes in the current health care environment raise the

importance of clarifying the roles of MLTs, MTs, and Specialists in the clinical

laboratory. These days it is the job of the MT to undergo the greatest change in the new

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health care environment and to require technical work and communication, problem

solving, management and consultation skills. The survey prepared for this research

included the tasks required to be performed by MTs as well as Specialists in the first year

on the job were included in the Competency survey. This notion was supported by the

comments of one respondent, who described the situation at her community hospital:

"The techs who work in this institution must be able to do everything…from drawing

blood to being able to answer insurance and billing questions, machine maintenance, QC

testing, CAP surveys, inspections by CAP and other agencies, etc.” Furthermore, her

comments elaborated the current position of smaller institutes by stating that because of

downsizing and budget cuts most small community hospitals are operating with "skeleton

staffs" that possess knowledge and abilities in five major areas of the lab.

What is needed first is a clear understanding of the functional role of the

laboratory, which includes job description, grouping of tasks involved, required skills,

responsibilities and accountability required from the employee or student. Understanding

of job description, performance standards, task analysis, amount of judgment and degree

of responsibility required for each task permit a job evaluation or competency assessment

rating that reflects hierarchical order on a career track.

It is essential that educators and employers understand the functional roles of the

different levels of certified personnel to help improve existing educational standards.

While educational experiences and academic competency scores should coincide with the

performance requirements of an entry-level position, it is the responsibility of the

employers to institute these standards.

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This research has provided information regarding perceptions of competency

levels for three different categories of laboratory personnel: MLT, MT and Specialist.

Competency is an interaction of knowledge, intelligence, technical skills, and attitude. If

any one of these skills is deficient or inadequate, performance by the clinical laboratory

personnel may be affected. CLIA’ 88 and JCAHO require competency assessment

documentation for all analysts performing moderately complex testing. However, the

precise mechanism of the annual certification of competency is not specified in the

regulations but is left up to the individual laboratory (Allred and Steiner, 1994). Many of

the competency aspects depend on how training was provided in the fundamentals of

laboratory science and in the practical aspects of performing analyses. Along with the

results obtained for the research, comparison of the professional definitions provided by

the ASCP (1982, and 1996) clearly points in the direction of curriculum reform. Since

roles and responsibilities have not been changed since 1982, it is reflected in the results

as MTs were almost equally rated as Specialist.

Optimal task performance of clinical laboratory personnel should be the greatest

concern of present and future laboratory medicine. The result of this study indicated that,

while there is a great deal of overlap in the levels of practice at career entry for MLT, MT

and Specialist, perceptions for the performance of tasks are not congruent among each

other. These findings were also supported by the comments of one respondent who wrote

that "the expertise of the individual is the key to their ability to perform laboratory

functions, not their registration level." The respondent explained by personal experience

the perception of incongruency between the various levels of laboratory personnel: "I

have personally seen ASCP (MT) techs that could not function as well as an MLT. It

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really boils down to the individual motivation and intelligence and not what level of

education or registry they have." Many respondents felt that specialist competency levels

were equivalent to those of MTs. This may indicate that specialists may not have the

opportunities to enhance their higher-level skills enough to distinguish their tasks from

MT-level performance.

It is certain that our clinical laboratory profession requires a standardized training

program. Organizations such as the Health Care Financing Administration (HCFA), the

Food and Drug Administration (FDA), JCAHO, the College of American Pathologists

(CAP), Commission on Office Laboratory Accreditation (COLA) and CLIA’88 have all

set laboratory quality standards that require a prescribed level of employee education and

training. However, training and documentation prerequisites in these standards are

ambiguous (Berte & Nevalainen, 1996).The discrepancy among practitioners for the

entry-level position presents a challenge to educators and to employers. Evaluating the

competency level of an individual is the most variable and unknown factor in testing and

is therefore the weak link in the analytical sequence.

However, Beck, Doing, and Nettles (1997) reported a comparison between

technicians and technologists, resulting in the identification of distinct differences

between the roles of different levels of personnel. While skills within the categories of

problem-solving, supervision, management, and interpersonal relations are often

overlapping between MTs and Specialists, the exclusion of these skills from the Beck,

Doing, and Nettles study eliminated the possibility of comparing job similarities between

the three levels of laboratory personnel.

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

Harmening (1995) and others asked program directors to assign a set of

competencies to MLTs, MTs, both groups, or neither group. They found the greatest

overlap between MLTs and MTs in the areas of technical skills, knowledge base, and

analytical decision-making skills. In view of these educators, the largest distinctions

between the MLT and MT levels of practice were in the communication, teaching and

supervision competencies. They concluded that the program directors in this study could

distinguish between the two levels of practice and that the MT has a broader scope of

practice than the MLT. However, they did not include the Specialist category as part of

the comparison. In addition, the survey items had more than one concept to establish

appropriate congruencies for each competency statement. A unipolar question provides

more reliable responses than one question containing double or triple concepts (Sudman

and Bradburn, 1982, 21, 41, 132-136). Therefore roles and responsibilities should be

reevaluated by developing appropriate survey instrument with one question referring to

one specific concept.

To meet these challenges, the educational experiences of MLT, MT, and specialist

programs and new employee training programs must change. In order to support the self-

directed team approach, laboratory personnel at all levels must develop problem solving,

interpersonal, and evaluative skills. Beck, Doing, and Nettles (1997) recommended that

educators must devote less educational time to teaching technical skills. On the other

hand employers must be willing to hire less technically proficient personnel at the entry

level if they want MTs to manage the laboratory, relate to other health care workers,

evaluate laboratory tests, and educate others. However, that would contradict the results

of a study reported by Harmening et.al (1995), Hunter and LoSuituto’s study (1993), and

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other research that conclude that performing analytical tests requiring technical skills is

the most important job competency for entry-level practitioners. Employers need to

acknowledge the training provided for each level and utilize it by hiring them for that

purpose. For example, if MTs are trained less in technical skills and more in supervisory

and teaching skills, then they should hire them to perform those tasks. Employers need to

provide new orientation programs that can allow new employees to rotate through

technical duties in addition to quality assurance, evaluation of results, personnel

management, purchasing reagents and instruments, etc.

The incentive for this sort of change involves the employers' and educators'

combined effort to build the bridge between the understanding of level of training

provided by the educators and expectations of the employers for entry-level personnel.

Educators must find a way to make sound decisions regarding curriculum content to

prepare students for entry-level positions that meet the required expectations of

employers for competency level. Educators and employers need to reengineer the

laboratory work force to create appropriate distinctions between the levels of practice and

to realize that educators are preparing them with distinct levels of skills. As stated by one

of the respondents in this study, in order to decrease the frustration and dissatisfaction

levels of employees; and to retain qualified, experienced, knowledgeable personnel who

wants to recognize their skills and knowledge in the workplace expectations of educators,

employers and practitioners should be unified: "I have given this survey a lot of thought

and time because I think technicians are being given too much responsibility for their

training and we need to unify expectations." However any person who has been trained

only in one institute with higher levels of competency should not be considered a

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

"technologist" capable of across-the-board laboratory testing. Eventually an industrious

person may acquire depth and breadth of knowledge in each discipline and then can be

considered as qualified as one who acquired knowledge of each discipline in formal

course work at a medical technology school (LaMotte, 1981).

Frustration exists within all three levels of laboratory personnel because the

assigned duties do not always reflect certification level. Although some entry-level MLT

personnel can perform tasks at specialist-level competency, opportunities for them to

achieve higher levels of authority are minimal. This same principle also applies to

specialists who may be qualified and trained to perform at the highest level of

competency, yet find their tasks equivalent to MT-level duties. As a result, specialists

often decide to change career goals in which they can perform according to their

competency level. Otherwise, those who remain in the field as MTs may experience a

lack of motivation to perform at the levels they are qualified for. Students of the medical

technology programs and Specialist programs should also focus of a didactic curriculum

that includes courses in hematology, blood banking, chemistry, and microbiology, and

get exposure to specialized areas such as flow cytometry, molecular biology, supervision

and management, and teaching and consulting. They should also broaden their scope with

computer and financial management of the health care industry.

Thus, result of the comparison of perceptions of competence for medical

laboratory personnel and provided review of the literature would be extremely valuable in

developing curriculum for the medical technology programs . It is important that

educational systems incorporate continuous education and clinical laboratory work

experience to facilitate the completion of higher-level degrees (i.e. MLT to MT, MT to

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Specialist). Computer courses would be an excellent method to promote the education of

those employees who do not have the opportunity to set aside time for attending in-class

courses. In addition to certification, objective competency assessment scales should be

used to determine the roles and responsibilities of each of the three medical laboratory

positions and to decrease frustration levels among the employees.

The comparision of ASCP Professional Levels Definitions, 1982 and 1996

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Table D-1

ASCP Professional Levels Definitions, 1982 and 1996: Knowledge

1982 1996

Technician • Has a working comprehension • Has a working comprehension

of the technical and procedural of the technical and procedural
aspects of laboratory tests. aspects of laboratory tests.
• Maintains an awareness and
complies with safety procedures
and ethical standards of practice.
• Correlates laboratory tests to
disease processes and
understands basic physiology,
recognizing appropriate test
selection and abnormal test
results.

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Technologi • Understands the underlying • Understands the underlying

scientific principles, as well as scientific principles of
st of the technical and procedural laboratory testing as well as the
aspects of laboratory testing. technical, procedural, and
• Has a general comprehension of problem-solving aspects.
the physiologic, biochemical, • Has a general comprehension of
immunologic, microbiologic, the many factors which affect
and genetic factors that affect health and disease, and
health and disease, laboratory recognizes the importance of
tests, and the importance of proper test selection, the
laboratory tests to medical care. numerous causes of discrepant
• Is familiar with the various test results, and ethics including
services available in the hospital result confidentiality.
and has an appreciation of the • Correlates abnormal laboratory
roles and relationships of data with pathologic states,
paramedical and other health- determines the validity of test
related fields. results and the need for
additional tests.
• Understands and enforces safety
regulations, uses statistical
methods and applies business
and economic data in decision-
making.
• Has an appreciation of the roles
and interrelationships of
paramedical and other health-
related fields and follows the
ethical code of conduct for the
profession.
Specialist • Has knowledge of advanced • Has knowledge of advanced
scientific principles, as well as scientific principles as well as
of the technical, procedural, and the technical, procedural, and
research aspects of laboratory research aspects of laboratory
testing in the specialty area and testing in the specialty area and
of factors that influence disease of factors which influence
processes and laboratory tests. disease processes and laboratory
• Has knowledge of the structure tests.
and function of the organization, • Has knowledge of the structure
principles of management and and function of the organization,
education, as well as of the roles principles of management and
of other members of the health education, as well as the roles of
care team. other members of the health care
team.

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Table D-2

ASCP Professional Levels Definitions, 1982 and 1996: Technical Skills

1982 1996
Technician • Can read and follow directions • Comprehends and follows
and perform those tests in a procedural guidelines of
clinical laboratory that are laboratory tests to include: 1)
considered to be of a quality control monitoring; 2)
straightforward nature. computer applications; 3)
• Has a practical understanding instrumentation
of quality control that is troubleshooting; and 4)
sufficient to enable him/her to specimen collection and
determine whether or not tests processing requirements.
are within ? limits and to make
requisite adjustments
according to specified
procedures.
• Is capable of performing
simple instrument
maintenance.
Technologist • Is capable of performing • Can perform and interpret
technically demanding tests. standard, complex, and
• Has an understanding of specialized tests.
quality assurance sufficient to • Has an understanding of
enable him/her to monitor and quality assurance sufficient to
implement quality control implement and monitor quality
programs. control programs.
• Can participate in the • Can participate in the
introduction and introduction, investigation and
implementation of new implementation of new
procedures, and in the procedures and in the
evaluation of new instruments. evaluation of new instruments.
• Has a basic knowledge of • Evaluates computer generated
accuracy, precision, normal data and troubleshoots
ranges, and correlation with problems.
existing methods. • Understands and uses
troubleshooting, validation,
statistical, computer, and
preventative maintenance
techniques to insure proper
laboratory operation.
Specialist • Can perform all laboratory • Can perform all laboratory
tests and appropriate tests and appropriate
equipment maintenance in the equipment maintenance in the

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specialty area. specialty area.

• Has the knowledge, ability, • Has the knowledge, ability,
and technical skill to research, and technical skill to research,
develop, implement, and develop, implement and
evaluate new and existing evaluate new and existing
methodologies, including methodologies, including
instrumentation and quality instrumentation and quality
assurance. assurance.

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Table D-3

ASCP Professional Levels Definitions, 1982 and 1996: Judgment and Decision-Making

1982 1996
Technician • Can recognize the existence of • Recognizes the existence of
common procedural and procedural and technical
technical problems to take problems and takes corrective
corrective action according to action according to
predetermined criteria. predetermined criteria.
• Prioritizes test requests to
maintain standard patient care
and maximal efficiency.
Technologist • Can exercise initiative and • Can exercise initiative and
independent judgment in independent judgment in
dealing with the broad scope of dealing with the broad scope of
procedural and technical procedural and technical
problems. problems.
• Can participate in, and may be • Can participate in, and may be
delegated the responsibility for delegated the responsibility for
decisions involving quality decisions involving: quality
control programs, instrument control/ quality assurance
selection, preventative programs, instrument and
maintenance, safety test methodology selection,
procedures, and reagent preventative maintenance,
purchases. safety procedures, reagent
purchases, test
selection/utilization, research
procedures,
computer/statistical data.
Specialist • Can implement and delegate • Can implement and delegate
decisions regarding laboratory decisions regarding laboratory
operation and of exercising operation and exercising
independent judgment in independent judgment in
problem solving. problem solving.
• Can anticipate and respond to • Can anticipate and respond to
unique situations regarding unique situations regarding
patients and/or samples in a patients and/or samples in a
laboratory setting. laboratory setting.
• Can participate in policy • Can participate in policy
decisions affecting laboratory decisions affecting laboratory
performance or laboratory performance or laboratory
personnel in the specialty area. personnel in the specialty area.

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Table D-4

ASCP Professional Levels Definitions, 1982 and 1996: Communication

1982 1996
Technician • Communicates straightforward • Communicates test results,
information, e.g., reports test reference ranges and specimen
results and quotes ? ranges and requirements to authorized
specimen requirements. sources.
• Prepares drafts of procedures
for laboratory tests according
to standardized format.
Technologist • Communicates technical or • Communicates pertinent
general information to technical information to
medical, paramedical, or lay medical, paramedical, or lay
persons, including problems or individuals through lectures,
matters of a scientific, conferences, work group
technical, and/or interaction, memberships,
administrative nature. publications, legislative
activities, and continuing
education.
• Develops acceptable criteria,
laboratory manuals, reports,
guidelines, and research
protocols.
Specialist • Can communicate in depth • Can communicate in depth
with other health care with other health care
personnel on the application personnel on the application
and validity of laboratory data, and validity of laboratory data
as well as on the policies and as well as the policies and
operation of the specialty area. operation of the specialty area.
• Can represent the specialty • Can represent the specialty
area to the community at large. area to the community at large.

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 Parikh: Competency Assessment for Medical Laboratory Practitioners

Table D-5

ASCP Professional Levels Definitions, 1982 and 1996: Teaching and Training
Responsibilities

1982 1996
Technician • Is capable of demonstrating ? • Trains new technicians and
technical skills. provides information to the
patient and public as needed
and participates in continuing
education lectures and
conferences for departmental
personnel, and demonstrates
technical laboratory skills to
students and new employees.
Technologist • Can provide instruction in the • Provides instruction in theory,
basic theory, technical skills, technical skills, safety
and application of laboratory protocols, and application of
test procedures. laboratory test procedures.
• May participate in the • Provides continuing education
evaluation of the effectiveness and professional development
of educational programs. for laboratory personnel.
• May participate in the
evaluation of the effectiveness
of educational programs.
Specialist • Can plan, implement, and • Can plan, implement, and
evaluate effective educational evaluate effective educational
programs. programs.

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Table D-6

ASCP Professional Levels Definitions, 1982 and 1996: Supervision and Management

1982 1996
Technologist • Has a basic understanding of • Has an understanding of
management theory and management theory, economic
functions. impact and management
• Can participate in and develop functions.
responsibility for • Participates in and takes
establishment of technical and responsibility for establishing
administrative procedures. technical and administrative
• Can supervise technicians, procedures, quality
aides, and clerical personnel as control/quality assurance,
directed. standards of practice, safety
and waste management
procedures, information
management and cost effective
measures.
• Supervises laboratory
personnel.
Specialist • Can perform and direct • Can perform and direct
administrative functions in the administrative functions in the
overall operation of the overall operation of the
laboratory in the specialty area. laboratory in the specialty area.
• Can provide direct supervision • Can provide direct supervision
of other personnel in that of other personnel in the
discipline. discipline.

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