CLINICAL MICROBIOLOGY REVIEWS, July 2004, p. 681–694 Vol. 17, No.

3
0893-8512/04/$08.00⫹0 DOI: 10.1128/CMR.17.3.681–694.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Competency Assessment in the Clinical Microbiology Laboratory

Susan E. Sharp1* and B. Laurel Elder2
Department of Pathology, Kaiser Permanente and Pathology Regional Laboratory, Oregon Health Science University,
Portland, Oregon 97230,1 and Department of Microbiology, CompuNet Clinical Laboratories and
Wright State University, Moraine, Ohio 454592

INTRODUCTION: HISTORY AND OVERVIEW OF CLIA ’67 AND ’88..........................................................681

Code of Federal Regulations—42CFR493.1445. Standard: Laboratory Director Responsibilities .............683
Code of Federal Regulations—42CFR493.1451. Standard: Technical Supervisor Responsibilities............683
ACCREDITATION .....................................................................................................................................................683
College of American Pathologists .........................................................................................................................683
The Joint Commission on Accreditation of Health Care Organizations ........................................................683
ELEMENTS OF A COMPETENCY ASSESSMENT PROGRAM.......................................................................685
Direct Observation of Routine Patient Test Performance ................................................................................685
Monitoring the Recording and Reporting of Test Results ...............................................................................685
Review of Intermediate Test Results or Worksheets, QC Records, Proficiency Testing Results,
and Preventive Maintenance Records..............................................................................................................687
Direct Observation of Performance of Instrument Maintenance and Function Checks..............................687
Assessment of Test Performance through Testing Previously Analyzed Specimens,
Internal Blind Testing Samples, or External Proficiency Testing Samples ...............................................687
Assessment of Problem-Solving Skills .................................................................................................................689
DEVELOPMENT OF A COMPETENCY PROGRAM..........................................................................................691
Define Areas Requiring Competency Assessment ..............................................................................................691
Identify Methods of Competency Assessment.....................................................................................................691
Determine Who Will Perform Competency Assessment....................................................................................692
Define the Documentation of Competency Assessment.....................................................................................692
REMEDIATION..........................................................................................................................................................692
QUALITY RESULTS..................................................................................................................................................693
REFERENCES ............................................................................................................................................................693

INTRODUCTION: HISTORY AND OVERVIEW left laboratories located in physicians’ offices or other small
OF CLIA ’67 AND ’88 health care facilities largely unregulated.
Prior to 1988, fewer than 10% of all clinical laboratories
Few regulations for laboratory testing existed before the late
were required by the government to meet minimum quality
1960s. However, soon after the introduction of Medicare and
standards, and a significant percentage of patient testing per-
Medicaid in the mid-1960s, a decades-long and continuing

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

effort by the U.S. Government to regulate costs and ensure a formed in laboratories was not subject to minimum quality
high quality of health care ensued. To see that the system was standards (8). Concerns raised by the media about the quality
not abused financially and that the quality of laboratory results of cytology testing services, especially Pap smears, were a ma-
was high, in 1967 Congress passed the federal Clinical Labo- jor catalyst behind passage of the Clinical Laboratory Improve-
ratory Improvement Act (CLIA ’67) (1). The Health Care ment Amendments of 1988 (CLIA ’88). A series of articles that
Finance Administration, now the Center for Medicare and appeared in the Wall Street Journal in the 1980s reported on the
Medicaid Services, was created as part of the Department of deaths of women from uterine and ovarian cancer whose Pap
Health and Human Services to oversee the enforcement of the smears had been misread, exposed “PAP mills,” and called into
CLIA ’67 regulations as well as to oversee the Medicare and question the quality of laboratories in general (3, 5, 19).
Medicaid programs. However, CLIA ’67 required only hospi- Congress held hearings at which people who had been
tals and large clinical laboratories to adhere to strict quality harmed by laboratory errors testified. These hearings revealed
control, proficiency testing, test performance, and personnel serious deficiencies in the quality of work from physician office
standards. Each testing facility had to have a certificate and laboratories and in Pap smear testing results (R. D. Feld,
was subject to a compliance inspection every other year. CLIA M. Schwabbauer, and J. D. Olson, 2001, The Clinical Labora-
’67 affected only laboratories engaged in interstate commerce tory Improvement Act [CLIA] and the physician’s office labo-
and covered approximately 12,000 laboratories (mainly com- ratory; Virtual Hospital, University of Iowa College of Medi-
mercial and hospital). With the exception of a few states, this cine [www.vh.org/adult/provider/pathology/CLIA/CLIAHP
.html]). In 1988, Congress once again responded to public
concerns about the quality of laboratory testing by passing
CLIA ’88. CLIA ’88 expanded the laboratory standards set by
* Corresponding author. Mailing address: Pathology Regional Lab-
oratory, Kaiser Permanente, Oregon Health Science University, 13705 CLIA ’67 and extended them to include any facility performing
N.E. Airport Way, Portland, OR 97230. a clinical test. Currently, under CLIA ’88, all ⬃170,000 clinical

681
682 SHARP AND ELDER CLIN. MICROBIOL. REV.

laboratories, including physician office laboratories, are regu- institutional competency assessment practices, to assess the
lated. compliance of each institution with its own practices, and to
CLIA ’88 greatly broadened the definition of a laboratory. determine the competency of specimen-processing personnel.
CLIA ’88 defines a laboratory as “a place where materials This three-part study consisted of a questionnaire concerning
derived from the human body are examined for the purpose of current competency assessment practices, evaluation of com-
providing information for the diagnosis, prevention or treat- pliance with these practices using personnel records, and a
ment of any disease or impairment of, or assessment of the written appraisal of the competence of five specimen-process-
health of human beings. Laboratories may be located in hos- ing staff members per institution. The study surveyed a total of
pitals, freestanding facilities or physician offices” (11). For the 552 institutions that participated in the CAP 1996 QProbes
first time, federal laboratory regulation was site neutral. The program (12). Their results showed that 89.2% of institutions
level of regulation was determined by the complexity of the had a written competency plan and that of those, 90.3% used
tests performed by the laboratory rather than where the labo- their plan for microbiology. Approximately 98% of institutions
ratory was located. Physician office laboratories, dialysis units, reported reviewing employee competence at least annually;
health fairs, and nursing homes were all covered under the new this consisted of direct observation in 87.5% of laboratories
law, along with other previously exempt and nonexempt labo- surveyed, review of test or QC results in 77.4%, review of
ratories. The CLIA ’88 regulation unified and replaced past instrument preventive maintenance in 60%, written testing in
standards with a single set of requirements that applied to all 52.2%, and other methods of assessment in 20.8%. When mea-
laboratory testing of human specimens. Standards for labora- suring adherence to the laboratory’s own competence plan, it
tory personnel, quality control (QC), and quality assurance was found that the percentage of laboratory employees who
were established based on test complexity and potential harm complied was 89.7% when assessed using direct observation,
to the patient. The regulations also established application 85.8% when assessed by reviewing QC and patient test results,
procedures and fees for CLIA registration as well as enforce- 78% when assessed by reviewing instrument records, and 74%
ment procedures and sanctions applicable when laboratories when assessed using written testing; 90.4% of new employees
fail to meet standards. were assessed as indicated per policy, and 90% of employees
The purpose of CLIA ’88 is to ensure that all laboratory were found to have responded satisfactorily to a written com-
testing, wherever performed, is done accurately and according petency assessment regarding specimen processing. Failure to
to good scientific practices and to provide assurance to the comply with the laboratory’s own competence plan ranged
public that access to safe, accurate laboratory testing is avail- from ca. 1 to 6.4%, and employees who failed competency
able. The ability to make this assurance has become even more assessment were not allow to continue their usual work in 8.6%
urgent as knowledge of the impact of medical errors has of institutions.
reached both the medical and public arenas (13). One of the This study concluded that opportunities for improvement in
essential components identified as necessary to ensure high- employee competency assessments were numerous. Toward
quality test results for patients was employee training and these improvements, the CAP provided several suggestions
competency. Thus, CLIA ’88 set forth requirements for per- which included the suggestion that direct observation can be
formance and documentation of initial personnel training and used for assessing technical skills (as can patient and QC spec-
ongoing assessment of competency (11). imens), judgment and analytical decision-making processes,
The following section outlines the sections of CLIA ’88 that and teaching and training of personnel. The CAP also noted
pertain to personnel training and competency assessment. As that communication, judgment, and analytical decision making

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

stated above, current governmental mandates make it neces- are essential skills that are rarely evaluated but that when they
sary to assess the competency of all laboratory workers who are evaluated, written testing should be used since interpreta-
handle patient specimens. The mandates are specific in what tion of these skills using direct observation is highly subjective.
must be assessed; however, they do allow for considerable In addition, the CAP recommended that laboratory employees
discretion on how to implement some of these specific assess- who fail an assessment should not be allowed to perform these
ments in a laboratory setting. tasks if the competency assessment is a valid test of their skills,
CLIA ’88 outlines six areas that must be included as part knowledge, and abilities. The CAP also concluded that written
of a laboratory competency assessment program; these are testing was the one method of evaluation with the poorest
(i) direct observation of routine patient test performance; compliance; thus, it did not recommend that written testing be
(ii) monitoring the recording and reporting of test results; used as an element of a competency assessment plan unless it
(iii) review of intermediate test results, QC records, profi- can be performed consistently or is used as part of an assess-
ciency testing results, and preventive maintenance records; (iv) ment of communication and judgement skills.
direct observation of performance of instrument maintenance The CAP QProbe suggested that “opportunities for im-
and function checks; (v) assessment of test performance provement in employee competency assessment are numer-
through testing previously analyzed specimens, internal blind ous” (12), and our own experiences in presenting workshops
testing samples, or external proficiency testing samples; and on this topic at the American Society for Microbiology general
(vi) assessment of problem-solving skills (11). meetings confirm that many laboratories continue to struggle
To measure compliance with the CLIA ’88 regulations, the with the design of a competency assessment program. The
College of American Pathologists (CAP) conducted a study in following is intended to provide guidance to supervisory per-
1996 (CAP QProbes program) to survey employee competence sonnel in clinical microbiology laboratories in the development
assessment practices in departments of pathology and labora- and implementation of an effective competency assessment
tory medicine (12). The goals of the study were to measure program and is taken, in part, from the 2003 Cumitech entitled
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 683

Competency Assessment in the Clinical Microbiology Laboratory 2. Monitoring the recording and reporting of test results.
(4). 3. Review of intermediate test results or worksheets, quality
Competency assessment in the clinical laboratory, as man- control records, proficiency testing results, and preventive
dated in U.S. law since 1988 as part of CLIA ’88, is published maintenance records.
in the Federal Register as part of the Code of Federal Regula- 4. Direct observation of performance of instrument main-
tions (CFR). The CFR defines the requirements for initial tenance and function checks.
training verification, initial competency assessment, and ongo- 5. Assessment of test performance through testing previ-
ing competency assessments of laboratory personnel (11). As a ously analyzed specimens, internal blind testing samples
brief explanation of the regulation titles, the number “42” or external proficiency testing samples.
indicates “Public Health,” CFR stands for “Code of Federal 6. Assessment of problem solving skills.”
Regulations,” “493” indicates “Laboratory Requirements,”
and the numbers “1445” or “1451” are the section standards. ACCREDITATION
These standards were enacted on 28 February 1992, amended
on 19 January 1993, and revised on 1 October 2002. They can The three most widely used CMS-approved accreditation pro-
be accessed online at www.gpoaccess.giv/cfr/Index/html. In- grams are the Laboratory Accreditation Program from the CAP,
cluded below are the pertinent CFRs relating to competency the Joint Commission on Accreditation of Healthcare Organiza-
assessments in the clinical laboratory. tions (JCAHO), and COLA, formerly known as the Commission
on Office Laboratory Accreditation. Although each organiza-
tion’s testing requirements are at least equivalent to those of
Code of Federal Regulations—42CFR493.1445. Standard:
CLIA ’88, they have somewhat different testing standards and
Laboratory Director Responsibilities
philosophies in reaching the goal of quality laboratory testing.
“Ensure that prior to testing patient’s specimens, all person- The CAP and the JCAHO have guidelines that include several
nel have the appropriate education and experience, receive the items dealing with initial training and competency assessment of
appropriate training for the type and complexity of the services laboratory personnel as a requirement for laboratory certification
offered, and have demonstrated that they can perform all test- or accreditation. The requirements for competency assessment by
ing operations reliably to provide and report accurate results. each of these organizations are discussed below.
“Ensure that policies and procedures are established for
monitoring individuals who conduct pre-analytical, analytical, College of American Pathologists
and post-analytical phases of testing to assure that they are
competent and maintain their competency to process speci- The CAP survey checklists currently include questions
mens, perform test procedures and report test results promptly pertaining to CLIA ’88 and assessment of competency for
and proficiently, and whenever necessary, identify needs for laboratory personnel (CAP 2003, Commission on Laboratory
remedial training or continuing education to improve skills. Accreditation, Laboratory Accreditation Program, Laboratory
“Specify, in writing, the responsibilities and duties of each General Checklist: http://www.cap.org/apps/docs/laboratory
consultant and each supervisor, as well as each person engaged _accreditation/checklists/checklistftp.html). These questions
in the performance of the pre-analytical, analytical, and post- are included in the GENERAL area of the laboratory check-
analytical phases of testing. This should identify which exam- lists in the PERSONNEL section. Specific questions, as well as
inations and procedures each individual is authorized to per- “Notes” and “Commentary,” contained in the 2003 CAP check-

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

form, whether supervision is required for specimen processing, lists are indicated below. As a point of explanation, CAP guide-
test performance or result reporting and whether supervisory lines are divided into “Phase I” and “Phase II” deficiencies.
or director review is required prior to reporting patient test These deficiencies are defined by CAP as follows: “Deficien-
results.” cies to Phase I questions do not seriously affect the quality of
patient care or significantly endanger the welfare of a labora-
tory worker. If a laboratory is cited with a Phase I deficiency,
Code of Federal Regulations—42CFR493.1451. Standard:
a written response to the CAP is required, but supportive
Technical Supervisor Responsibilities
documentation of deficiency correction is not needed. Defi-
“The technical supervisor is responsible for identifying train- ciencies to Phase II questions may seriously affect the quality
ing needs and assuring that each individual performing tests of patient care or the health and safety of hospital or labora-
receives regular in-service training and education appropriate tory personnel. All Phase II deficiencies must be corrected
for the type and complexity of the laboratory services per- before accreditation is granted by the CLA. Correction re-
formed. quires both a plan of action and supporting documentation
“The technical supervisor is responsible for evaluating the that the plan has been implemented.” The CAP guidelines that
competency of all testing personnel and assuring that the staff address competency assessment are included in Table 1. CAP
maintain their competency to perform test procedures and guidelines can be accessed at www.cap.org.
report test results promptly, accurately and proficiently. The
procedures for evaluation of the staff must include, but are not The Joint Commission on Accreditation of
limited to— Health Care Organizations
“1. Direct observation of routine patient test performance,
including patient preparation, if applicable, specimen The JCAHO began evaluating hospital laboratory services in
handling, processing and testing. 1979. Since 1995, clinical laboratories surveyed using JCAHO
684 SHARP AND ELDER CLIN. MICROBIOL. REV.

TABLE 1. CAP guidelines addressing competency assessment

Phase
CAP no. Question Note Commentary
deficiency

GEN.54750 II For laboratories subject to U.S. There must be evidence in personnel All testing personnel in the laboratory
federal regulations, do all testing records that all testing personnel have must meet the requirements specified in
personnel meet CLIA ’88 been evaluated against CLIA ’88 re- CLIA ’88. There must be an indication
requirements? quirements, and that all individuals in personnel records that testing per-
qualify. sonnel’s qualifications have been evalu-
ated and met.

GEN.55200 II Are there annual reviews of the The laboratory must conduct an annual
performance of existing employ- performance review of all employees.
ees and an initial review of new New employees must be reviewed
employees within the first 6 within 6 months of employment, and
months? annually thereafter.

GEN.55500 II Has the competency of each per- The manual that describes training activ- The competency of each person to per-
son to perform his/her assigned ities and evaluations must be specific form the duties assigned must be as-
duties been assessed? for each job description. Activities re- sessed following training and periodi-
quiring judgment or interpretive skills cally thereafter. Retraining and
must be included. The records must reassessment of employee competency
make it possible for the inspector to must be done when problems are iden-
determine what skills were assessed tified with employee performance. The
and how those skills were measured. training and assessment program must
The competency of each person to be documented and should be specific
perform duties assigned must be as- for each job description. Activities re-
sessed following training, and periodi- quiring judgment or interpretive skills
cally thereafter. Some elements of must be included. The records must
competency assessment include, but make it possible for the inspector to be
are not limited to, direct observations able to determine which skills were as-
of routine patient test performance, sessed and how those skills were mea-
including patient preparation (if appli- sured. Some elements of competency
cable), specimen handling, processing assessment include, but are not limited
and testing; monitoring the recording to, direct observations of routine pa-
and reporting of test results; review of tient test performance, including patient
intermediate test results or work- preparation, if applicable, specimen
sheets, QC records, proficiency testing handling, processing and testing; moni-
results, and preventive maintenance toring the recording and reporting of
records; direct observation of perfor- test results; review of intermediate test
mance of instrument maintenance and results or worksheets, QC records, pro-
function checks; assessment of test ficiency testing results, and preventive
performance through testing previ- maintenance records; direct observation
ously analyzed specimens, internal of performance of instrument mainte-
blind testing samples, or external pro- nance and function checks; assessment
ficiency testing samples; and evalua- of test performance through testing pre-
tion of problem-solving skills. viously analyzed specimens, internal
blind testing samples, or external profi-

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

ciency testing samples; and evaluation
of problem-solving skills.

GEN.57000 I If an employee fails to demonstrate If it is determined that there are gaps in The laboratory should have a documented
satisfactory performance on the the individual’s knowledge, the em- corrective-action plan to retrain and
competency assessment, does the ployee should be reeducated and al- reassess employee competency when
laboratory have a plan of correc- lowed to retake the portions of the problems are identified with employee
tive action to retrain and reas- assessment that fell below the labora- performance. If, after reeducation and
sess the employee’s competency? tory’s guidelines. If, after reeducation training, the employee is unable to sat-
and training, the employee is unable isfactorily pass the assessment, then fur-
to satisfactorily pass the assessment, ther action should be taken, which, may
then further action should be taken, include supervisory review of work, re-
which may include supervisory review assignment of duties, or other actions
of work, reassignment of duties, or deemed appropriate by the Laboratory
other actions deemed appropriate by Director.
the Laboratory Director.

GEN.58500 I Is there documentation of retrain- Documentation of retraining and reassess-

ing and reassessment for employ- ment of employees who initially fail
ees who initially fail to demon- competency assessment should be avail-
strate satisfactory performance able.
on competency assessment?

standards have been deemed to be certifiable under CLIA ’88 provide for competent staff either through traditional employ-
requirements. The current JCAHO laboratory standards in- er-employee arrangements or through contractual arrange-
clude competency assessment of personnel under the Human ments with other entities or persons (Joint Commission of
Resources requirements and mandate that the organization Accreditation of Health Care Organizations, 2003, 2004 Lab-
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 685

oratory Standards: http://www.jcaho.org). JCAHO requires an reprinted from Cumitech 39 (4) and included in Fig. 1; a par-
initial review of credentials and qualifications of employees; it tially completed form is included in Fig. 2 as an example of
also requires that experience, education, and abilities be con- how this form can be used. The reader is referred to Cumitech
firmed during orientation. JCAHO also mandates that the 39 for additional examples of competency assessment forms (4).
organization provide ongoing in-service and other education The six areas that must be included as part of a competency
and training to increase staff knowledge of specific work-re- assessment program are discussed in detail in the following
lated issues and perform ongoing, periodic competence assess- sections.
ment to evaluate the continuing abilities of staff members to
perform throughout their association with the organization Direct Observation of Routine Patient Test Performance
(http://www.jcaho.org). The specific JCAHO standards involv-
ing competency assessment are indicated in Table 2. Direct observation is the actual observation of work as it is
being performed by laboratory staff. These observations are
not limited to test performance but include all processes in
ELEMENTS OF A COMPETENCY
which the employee is involved, including specimen collection,
ASSESSMENT PROGRAM
preparation of the specimen for laboratory testing, and the
For a laboratory to comply with federal regulations and actual testing of the specimen. Direct observation can be the
national accrediting agencies guidelines, a system must be in most time-consuming way to monitor employee competency
place that will allow verification of the initial training of staff (particularly when the laboratory is large), and the areas to
and assessment of competence twice in the first year of em- monitor should be carefully selected to maximize gains from
ployment and annually thereafter. Although CLIA ’88 defines the time spent in the process. For example, areas which involve
what must be tested in order to assess competence in labora- a higher-than-average degree of decision making, which may
tory employees, it does not specifically spell out how to do this have a major impact on patient care if performed incorrectly,
assessment. Reflecting this was a study performed by Christian or which have been found over time to have a greater degree
et al., who interviewed a sample of 20 laboratories including of employee variability might all be good prospects for direct
hospital, blood bank, commercial reference, physician office, observation. Smaller laboratories with only a few staff mem-
and independent laboratories from 12 states (2). They found bers may find direct observation to be less onerous, and these
that assessing the competence of laboratory personnel was a laboratories can be more inclusive in the areas chosen for
complex issue reflecting the dynamics and environment of each observation. Elder and Sharp provide an example that utilizes
unique laboratory. Their research found no consistent method a statement included in the laboratory’s competency assess-
of implementation of competency assessment. This is because ment program indicating that a certain percentage of routine
there are many approaches and tools that can be utilized to work is observed through direct visual evaluation. This can be
meet the federal regulations. Four additional articles, specifi- followed by either a specific listing of tests to be observed or a
cally targeting competency assessment in clinical microbiology, general listing of tests that may be included in the direct-
have been published and can be reviewed prior to designing a observation portion of competency assessment (4). McCaskey
competency assessment program for a microbiology laboratory and LaRocco utilized direct observation in employee compe-
(4, 14, 15, 18). In addition, tools and programs for use in tency assessment of processing and reporting of new positive
laboratory competency assessment have also been included in blood cultures, reading and reporting of positive routine cul-
publications concerning laboratory disciplines other than mi- tures, automated identification procedures, susceptibility

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

crobiology (6, 7, 9, 10, 20). One must also keep in mind that testing, rapid antigen testing, direct smears and fluorescent
parts of a competency assessment program may be intimidat- smears, as well as a large variety of biochemical testing per-
ing to some employees, some of whom may feel that it could formed (15). They also included a variety of checks while
jeopardize their relationship with coworkers. Care must be performing direct observation, including adherence to written
taken to assure the staff that the purpose of these programs, protocols, accurate interpretation of test reactions, and appro-
although required to meet governmental and accreditation priate notification of results, as well as many others. McCarter
agency requirements, is to identify areas where improvements and Robinson utilized direct observation to assess safety and
can be made to ensure quality patient care. specimen-processing procedures in mycobacteriology and QC
As stated above, there are six areas that must be included as (14). One must keep in mind that CLIA ’88 mandates that “at
part of a competency assessment program: (i) direct observa- least” routine patient test performance, as discussed here, and
tion of routine patient test performance; (ii) monitoring the performance of instrument maintenance and function checks
recording and reporting of test results; (iii) review of interme- (see below) be assessed by direct observation.
diate test results, QC records, proficiency testing results, and
preventive maintenance records; (iv) direct observation of per- Monitoring the Recording and Reporting of Test Results
formance of instrument maintenance and function checks; (v)
assessment of test performance through testing previously an- Elder and Sharp indicate that monitoring the recording and
alyzed specimens, internal blind testing samples, or external reporting of test results requires a review of results for the
proficiency testing samples; and (vi) assessment of problem- proper and correct recording and reporting of patient testing
solving skills (11). Ways to include each of the above six areas (4). This is most easily accomplished either by documentation
in a competency assessment program is discussed in greater of observation of an employee writing or entering patient test
detail in the following sections and summarized in Table 3. An results on report forms or into the computer or by a review of
example of a competency assessment form for bacteriology is worksheets with computer entries for appropriate recording of
686 SHARP AND ELDER CLIN. MICROBIOL. REV.

TABLE 2. JACHO standards regarding competency assessment

Standard no. Standard Explanation

HR.2.10 Orientation provides initial job As appropriate, each staff member, student, and volunteer is oriented and then assessed to the following:
training and information. The organization assesses and documents each person’s ability to carry out assigned responsibilities
safely, competently, and in a timely manner on completion of orientation.
The organization documents that each person has completed orientation and has been evaluated for
competency in performing required laboratory tasks as well as other parameters defined in his or her
job descriptions.
Documentation of orientation participation includes written approval by the laboratory director or ap-
propriate supervisor noting that the individual is capable of performing laboratory duties and confir-
mation by the employee that he or she feels qualified after orientation to perform the tasks required.

HR.2.30 Ongoing education, including The following occurs for staff, students, and volunteers who work in the same capacity as staff providing
in-services, training, and oth- care, treatment, and services:
er activities, maintains and Training occurs when job responsibilities or duties change.
improves competence. Participation in ongoing in-services, training, or other activities occurs to increase staff, student, or vol-
unteer knowledge of work-related issues.
Ongoing in-services and other education and training are appropriate to the needs of the population(s)
served and comply with law and regulation.
Ongoing in-services, training, or other activities emphasize specific job-related aspects of safety and in-
fection prevention and control.
Ongoing in-services, training, or other education incorporate methods of team training, when appropriate.
Ongoing in-services, training, or other education reinforce the need and ways to report unanticipated
adverse events.
Ongoing in-services or other education is offered in response to learning needs identified through per-
formance improvement findings and other data analysis (that is, data from staff surveys, performance
evaluations, or other needs assessments).
Ongoing education is documented.
At a minimum, for supervisory staff, attendance at outside workshops, institutes, and local, regional, or
national society meetings occurs as feasible.

Standard Competence to perform job Competency assessment is systematic and allows for a measurable assessment of the person’s ability to per-
HR.3.10 responsibilities is assessed, form required activities. Information used as part of competency assessment may include data from
demonstrated, and main- performance evaluations, performance improvement, and aggregate data on competency, as well as
tained. the assessment of learning needs. This standard encompasses the following:
The laboratory director or appropriate laboratory supervisor regularly assesses the continued compe-
tency of staff on all laboratory work shifts through performance evaluations.
Staff members are evaluated for competency in performing required laboratory tasks as applicable, as
well as for all other parameters defined in their job descriptions.
Supervisory staff are evaluated for performance of their job responsibilities, as defined in their job de-
scriptions.
A job description and a completed competency assessment, an evaluation, or an appraisal tool are on
file for each contracted or employed individual.
Each staff member’s performance is evaluated and documented after orientation and annually thereafter.
An individual qualified to provide technical judgments about performance evaluates technical staff.
The procedures to assess and document annually the competency of technical staff include but are not
limited to the following:

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

Routine patient test performance, including patient preparation, if applicable, and specimen collec-
tion, handling, processing, and testing.
The recording and reporting of test results.
QC, proficiency testing, and preventive maintenance performance.
Instrument function checks and calibration performance.
Test performance assessment as defined by laboratory policy (e.g., testing previously analyzed speci-
mens, internal blind testing samples, and external proficiency or testing samples).
Assessment of problem-solving skills as appropriate to the job.
If a test method or instrumentation changes or the individual’s duties change, his or her performance is
reevaluated to include skills in the areas of change.
Each laboratory employee performing such tests participates in the program.
Acceptable performance criteria are established.
Performance levels are documented.
When indicated, remedial action is taken and documented.

Standard The laboratory director is re- The director determines the procedures and tests that staff members are qualified and authorized to per-
LD.2.90 sponsible for determining the form and is responsible for determining the competence and qualifications of laboratory staff. The direc-
qualifications and compe- tor ensures that the level of supervision provided and the level of testing complexity is commensurate
tence of laboratory staff. with the education, training, and experience of staff. The director must also require that staff demon-
strate the ability to perform all duties before actually testing patient specimens and that staff maintain
competencies to perform required tasks.

patient results. This review can be done at the time a final and patient records in bacteriology to assess blood culture
report is verified (before the results have been released) or competency. This method was also applied in their laboratory
after verification through comparison of worksheets and com- to selected areas of the mycobacteriology, mycology, virology
puter printouts. McCarter and Robinson reviewed worksheets and serology sections (14).
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 687

TABLE 3. Summary of competency assessmenta

Items that must be included in a
Description of each item Examples of each item
competency assessment program

Direct observation of routine This is the actual observation of work as it is being per- Direct observation is used for areas involving a higher
patient test performance formed by the laboratory staff. These observations degree of decision making or which have a significant
are not limited to test performance but include all impact on patient care (e.g., new positive blood cul-
processes in which the employee is involved, includ- tures, positive cerebrospinal fluid specimens, suscepti-
ing specimen collection and preparation, as well as bility testing, accurate interpretation of test reactions,
the actual testing of the specimen. following appropriate work instructions).

Monitoring the recording and Review of patient results for the proper and correct This can be accomplished by the documentation of ob-
reporting of test results recording and reporting. servation of an employee writing or entering patient
test results on report forms or into the computer or
by review of worksheets with report forms or com-
puter entries.

Review of intermediate test This is as it is implied: one must review intermediate This can be accomplished by review of worksheets or
results, QC records, profi- patient results, QC records, proficiency testing results computer entries for accurate recording of patient
ciency testing results, and and preventive maintenance records. results, review of QC worksheets or printouts for ac-
preventive maintenance ceptable results (within QC parameters) and for re-
records view of preventive maintenance records for the ap-
propriate and timely checks and documentation.

Direct observation of perfor- Direct observation must be used when employees are One must directly observe an employee when perform-
mance of instrument mainte- performing maintenance procedures and check of ing maintenance procedures and function checks on
nance and function checks instruments. instruments in the laboratory, such as the automated
identification/susceptibility testing instrument, molec-
ular diagnostic instrumentation, and blood culture
instrumentation.

Assessment of test performance One must assess employee competence by giving them This can be accomplished by split-sample analysis, pre-
through testing previously unknown samples to evaluate as they would evaluate viously analyzed specimens, blind internal proficiency
analyzed specimens, internal patient samples in the laboratory. testing, or external proficiency testing such as CAP
blind testing samples, or ex- surveys, etc.
ternal proficiency testing
samples

Assessment of problem-solving One must assess the ability of employees to solve prob- This can be accomplished by (i) asking the employees
skills lems that arise during their practice. to write up a situation where they had to solve a prob-
lem that related to an investigation they performed
or (ii) giving a fictitious (or real) example of a prob-
lem encountered in the laboratory and asking the
employee how he or she would handle the situation.
a
This table summarizes the information included in the “Elements of a competency assessment program” section of this paper, to include the six areas of CLIA
required assessment, a description of each requirement, and examples of how each could be accomplished.

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

Review of Intermediate Test Results or Worksheets, Direct Observation of Performance of Instrument
QC Records, Proficiency Testing Results, Maintenance and Function Checks
and Preventive Maintenance Records
Direct observation must be done when employees are per-
Review of results and records may also be accomplished by forming maintenance procedures and checks of instruments.
directly observing an employee when writing or entering pre- Documentation of these observations is necessary for compe-
liminary patient test results onto report forms or into the tency assessment and cannot be performed by an alternative
method (4, 11). This should be assessed for each piece of
computer or by reviewing worksheets or computer entries for
equipment that the person being assessed is trained to operate
appropriate recording of preliminary patient results (4). Un-
(4). McCaskey and LaRocco utilized direct observation in all
less all worksheets or reports are going to be reviewed, effort
activities related to instrument monitoring, maintenance, and
should again be taken to ensure that the time spent reviewing function checks, while McCarter and Robinson utilized direct
test recording and reporting provides the best assessment of observation for instrument function checks for RPR (Rapid
competency (e.g., review of positive cultures, review of results Plasma Reagin) testing in the serology section (14, 15).
from critical specimens, and review of worksheets from culture
types with complicated workups). Supervisor (or designee) re-
view of QC records, proficiency testing results, and preventa- Assessment of Test Performance through Testing Previously
Analyzed Specimens, Internal Blind Testing Samples, or
tive maintenance records is most easily performed as a docu-
External Proficiency Testing Samples
mented review of previous data entries, as is already routinely
performed in laboratories to meet the QC requirements for Blind retesting of previously analyzed specimens can be used
accreditation (4). as an assessment in a number of different areas of the labora-
688 SHARP AND ELDER CLIN. MICROBIOL. REV.

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

FIG. 1. Example of how the six areas of required CLIA competency assessment can be addressed and documented. FQ, fluoroquinolones.
Reprinted from reference 4 with permission.

tory, such as appropriate setup based on the source of the ples as part of a proficiency testing program or as part of an
unknown organisms, correct identification of unknown organ- internal quality assurance program can serve to meet this re-
isms, appropriate titers of infectious-diseases serologies, test- quirement (4). Optimally, each employee is assigned at least
ing and reporting of antimicrobial susceptibility results, and one proficiency testing sample that applies to each area in-
many more (4). In addition to using previously analyzed spec- cluded in his or her scope of responsibility per competency
imens, performing testing on unknown samples or split sam- evaluation period (15). Utilizing internal blind unknown sam-
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 689

FIG. 1—Continued.

ples prepared by the supervisory staff from known organisms, bation. The technologist (Tech 1) noticed this situation and
seeded specimens, or previously analyzed samples can accom- questioned whether patient B’s sample may have been contam-
plish this goal. As another example, McCarter and Robinson inated by the smear-positive sample from patient A. It was

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

utilized previously analyzed specimens to assess competency decided, after consultation with the supervisor, that both M.
for agglutination and enzyme immunoassay testing in the se- tuberculosis isolates would be sent for molecular testing to
rology section. Employees were expected to retrieve specimens determine if they were in fact the same organism. Tech 1
from coded samples maintained at ⫺70°C and incorporate discussed the situation with the less experienced technologist
them into their daily testing (14). (Tech 2) who initially processed the specimens, in order to
determine how this might have happened. No obvious reason
Assessment of Problem-Solving Skills was identified. Tech 1 and the supervisor decided that compe-
tency assessment might shed some light on the situation, and
Assessment of problem-solving skills may be accomplished
Tech 1 was assigned to carry out direct observation of Tech 2
in several ways (4). Examples include (i) asking employees to
as she processed specimens for mycobacterial smear and cul-
respond orally or in writing to simulated technical or proce-
ture. While carrying out this observation, Tech 1 found that
dural problems (perhaps in the form of case studies) and (ii)
asking employees to document actual problem-solving issues Tech 2 was not capping specimen transfer tubes after adding a
that they have handled in the laboratory within the last year. patient’s sample prior to transferring specimen from the next
A specific example of a problem-solving skill as utilized by a patient. Tech 1 discussed this with the supervisor, and both
microbiology technologist is outlined as follows. An occasion believed that this break in protocol may have led to the sus-
developed where cultures from two patients that were pro- pected contamination (which was subsequently confirmed by
cessed for mycobacteria on the same day both grew Mycobac- molecular testing). Due to this deviation from the standard
terium tuberculosis. One of the patients (patient A) was smear protocol by Tech 2, the supervisor decided that direct obser-
positive with numerous acid-fast bacilli, while the other patient vations were warranted for all the Mycobacterium-processing
(patient B) was smear negative for acid-fast bacilli. The culture technologists to ensure that proper techniques were being ad-
from patient A was positive after 10 days of incubation, while hered to by everyone. In this instance, the problem-solving
the culture from patient B was positive after 18 days of incu- skills of Tech 1 led to competency assessment by direct obser-
690 SHARP AND ELDER CLIN. MICROBIOL. REV.

FIG. 2. Example of how the assessment form can be used for documentation of competency.

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

vation of Tech 2, which solved the issue at hand and assisted identify the problem, (ii) perform and document steps taken to
the laboratory in improving the quality of future results from correct the problem, (iii) resolve the problem by adhering to
the mycobacteriology laboratory. and correctly applying hospital and departmental procedures,
The above example was taken, in part, from the American and (iv) if resolution is not possible, document the reason why
Society for Microbiology’s Division C web site on Compe- a resolution could not be reached and indicate suggestions for
tency Assessment (www.asm.org/Division/c/competency.htm; further action that may contribute to resolution of the problem
accessed 21 December 2003; reprinted with permission). This (15).
site also includes other examples of problem solving as well as Both McCaskey and LaRocco (15) and McCarter and Rob-
other issues dealing with competency assessment in the clinical inson (14) utilized written tests to assess the individual’s scope
microbiology laboratory. of knowledge in a specific area. However, the use of examina-
Laboratory employees solve problems very often but are tions (written or practical), although aiding the process of com-
frequently not aware that they are doing so. Encouraging the petency assessment, will not completely satisfy the regulatory
employees to document problem-solving situations as they oc- requirements or provide a complete look at an employee’s com-
cur during the year (rather than once a year when summarizing petence (14, 15; Virtual Hospital [www.vh.org/adult/provider
competency assessments) will facilitate this portion of the as- /pathology/CLIA/CLIAHP.html]). Written examinations can
sessment process. McCarter and Robinson required at least be particularly useful in providing problem-solving scenarios
three problem-solving examples per year per employee (14), but are generally unable to comprehensively reflect the many
while McCaskey and LaRocco required five separate examples different facets of knowledge and judgement that must be used
in writing of problem-solving skills per competency evaluation by employees in job performance. Written testing is not highly
period (15). Further, they required an employee to include recommended by the CAP since it was the method of evalua-
four areas in their problem-solving examples, which were to (i) tion with the poorest compliance. The CAP recommends that
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 691

written testing not be used as an element of a competency Category 1 items were competencies that were deemed most
assessment plan unless it can be performed consistently (12). critical for patient care, and employees were to be evaluated in
all category 1 items during each evaluation period. In other
categories, the employee could choose from several items for
DEVELOPMENT OF A COMPETENCY PROGRAM
inclusion in their evaluation process (15). Similar to McCaskey
The initial task of developing a competency assessment pro- and LaRocco, McCarter and Robinson created forms based on
gram can seem daunting, but it can be approached in a number procedure-oriented tasks for each specialty area to be used in
of different ways. The steps taken to define the program should their competency assessment program (14). Competency as-
be included as part of the laboratory’s competency program sessment must also be specific for each job description; this
procedure. The steps commonly performed during the devel- must be taken into account when defining areas required for
opment of a program are discussed in the following sections. competency assessment, and competencies specific for each
position within the microbiology laboratory must be included
(12).
Define Areas Requiring Competency Assessment
One of the challenges for any laboratory in establishing a
One of the most time-consuming portions of program de- competency assessment program is defining the extent of as-
velopment is identification of the areas requiring competency sessment that will be performed in each area once training is
assessment, and this necessitates analysis of like tasks and skills completed (4). Is it adequate to observe an employee work up
(4). For example, identification of an isolate from a blood agar one blood culture, or do 5 or 10 blood culture workups need to
plate will be done in a similar fashion regardless of the source be observed? Should an employee be asked to demonstrate his
(e.g., urine, blood, or tissue) of the specimen. Therefore, it is or her ability to solve problems in each area of the laboratory,
not necessary to assess individual competency in each work or is it sufficient to document problem-solving skills in only two
area or division in the laboratory. On the other hand, the or three key areas? Each laboratory will need to determine the
ability to assess whether an organism needs to be identified will extent of assessment in a way that best fits its size and com-
vary from source to source. Similarly, the performance, record- plexity. For example, performing five anaerobic cultures for a
ing, and QC of simple latex tests will not vary considerably successful competency assessment might prove quite impossi-
from kit to kit and may be adequately assessed through eval- ble for a small laboratory where only one or two anaerobic
uation of the employee’s performance with any one of several cultures are performed per week or equally difficult for a large
different kits. Performance of this first step in program devel- laboratory where multiple technologists perform anaerobic
opment must be done in sufficient detail that it is clear (to the cultures. In this situation, instead of observing individuals
person performing the assessment as well as to an inspector) performing anaerobic culture workup, direct observation of
what will be assessed, but with consideration of the similarity competency might be achieved through the use of a practical
between many laboratory tasks. Organization of the areas to be examination. Plates with important anaerobes and mixed or-
assessed may be performed by bench assignment (respiratory ganisms could be prepared and used to observe the employee’s
specimens, stool specimens, etc.) or by test type (biochemical subsequent workup. If all employees performing anaerobic
test, serologic test, etc.). As an example, areas requiring com- cultures were tested at the same time, the setup time would be
petency assessment for the anaerobe bench might include cul- reduced (4).
ture setup, selection of appropriate organisms for identifica- A helpful approach to solving the problem of how much to
tion, identification of organisms, utilization of the anaerobic include in a competency assessment is to incorporate this goal

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

chamber, reporting of test results, and notification of critical into the integral part of other activities already occurring rou-
values. One approach is to emphasize areas or methods in the tinely in the laboratory (4). For example, performing compe-
design of the competency assessment program that are either tency assessments during routine review of QC records, review
problem prone or at high risk for error. Data from the labo- of positive-culture worksheets by a supervisor or designee, and
ratory’s quality improvement processes (reviews of amended review of results of proficiency testing surveys in which em-
reports, incident reports, etc.) may be helpful in making this ployees have participated are ways to incorporate the compe-
determination. tency assessment program into the daily activities of the labo-
McCaskey and LaRocco used a team-based approach to ratory and lessen the workload associated with mandated
define ongoing activities in QC and quality assurance that competency assessments (4).
could easily be included in the competency program (15). They
drafted lists for all tests and procedures for each subspecialty Identify Methods of Competency Assessment
and developed a program where an employee participated in
the process by selecting items from the test lists and scheduling The methods used in competency assessment should initially
the exercise to take place with an observer at a mutually con- be driven by what is required by CLIA ’88 as listed in the CFR
venient time. They felt that this participation created a more for routine patient test performances (observation, review,
cooperative spirit between the observer and the person being proficiency testing, etc.).
evaluated and helped to eliminate negative associations with Each type of assessment does not need to be performed for
the competency assessment exercises. Care must be taken with each area being assessed, and the type of assessment tool
this approach that employees are not always calling on their selected for use should be based on whether it will provide an
friends to act as observer for competency assessment, which accurate reflection of employee competency (4). As part of this
may sway the impact of the program. These authors also strat- process, it is very helpful to define what will be considered a
ified their activities into categories (category 1, 2, 3, or 4). successful demonstration of competency. This may be consid-
692 SHARP AND ELDER CLIN. MICROBIOL. REV.

erably different when an employee is being trained in a new also perform patient testing (4). The ability of certain staff
area and is demonstrating competency for the first time and members to serve as assessors of competency of other employ-
when an employee is demonstrating ongoing competency. For ees should be documented on their own competency assess-
example, criteria established for an employee being evaluated ment, e.g., “This employee has demonstrated competency in
following initial training in the anaerobe area will primarily the area of {. . .} within the laboratory and is capable of as-
utilize direct observation to assess the employee’s ability to sessing the competency of others in this area” (4). In this way,
correctly follow the laboratory procedure while inoculating and is it obvious to an inspector that a qualified employee per-
incubating specimens for anaerobic culture; to identify inap- formed the competency assessment.
propriate specimens for anaerobic culture; to demonstrate or
describe the procedure followed when inappropriate speci- Define the Documentation of Competency Assessment
mens are received in the laboratory; to appropriately follow
laboratory procedures while interpreting, working up, and re- A variety of manual and computerized tools are available for
porting the results of anaerobic cultures; and to perform all documentation of competency assessment, and examples of
required maintenance of the anaerobic chamber. In contrast, these are included in selected references (4, 6, 7, 9, 14–18;
an evaluation for ongoing competency in the area of anaerobes ASM Division C website [www.asm.org/Division/c/competency
for an experienced employee could be performed by a combi- .html]; and in Antimicrobial Susceptibility Testing—a self-
nation of several of the following: direct observation of the study program, Department of Health and Human Services
employee’s workup of several cultures, indicating no deviations and the CDC Foundation, 2002 [www.aphl.org/ast.cfm]). There
from written procedures; daily supervisor review of employee are also a variety of commercially available manual guides (4,
worksheets of positive cultures, indicating that the employee 16) and web-based or software systems (SoftETC [www.soft
correctly selects appropriate identification and susceptibility -etc.com]; Comptec-ASCP [www.asco.org]; Media Lab, Inc.
tests and has followed the critical-value policy correctly; dem- [www.medialabinc.net]; GramStain-Tutor [medical.software
onstration by the employee of the required maintenance for -directory.com]; and ExamManager [www.exammanager.com])
the anaerobic chamber; demonstration (through documenta- available to assist in the development of a laboratory competency
tion from actual examples or through a practical examination) assessment program. Unless a decision is made to utilize one of
of the employee’s ability to correctly identify and resolve prob- these systems, easily used forms will have to be developed for
lem situations with anaerobic cultures; or the use of proficiency documentation and to provide evidence of who was evaluated,
testing samples to assess the ability of the employee to cor- what was evaluated, how it was evaluated, when it was evaluated,
rectly identify anaerobic bacterial pathogens (4). who performed the evaluation, what was done if problems were
Problem solving, as already mentioned, could also be docu- identified, whether the employee is authorized to perform and
mented by employees throughout the year. One suggestion is release results independently or whether review of the work is
to provide employees with a notebook, which will fit in a lab required before results are released, and whether the employee
coat pocket, that can be used for documentation as situations can serve as a competency assessor for other employees. Since the
occur and that will then be turned in to the manager at a medical director is ultimately responsible under CLIA ’88 for
scheduled time (4). This booklet could also include a schedule determining who will be allowed to work in the laboratory and
of other required elements of annual competency assessment what testing they can perform with or without supervision, it is
(e.g., observed instrument maintenance) that the employee prudent for the medical director to either review and sign the
would be responsible for scheduling with a supervisor or des- employee competency documentation or to delegate this task in

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

ignee. Use of such a booklet also helps place responsibility for writing to the supervisor or other appropriate personnel. Com-
part of the competency assessment with the employee. CLIA petency assessment records and forms should be retained for the
’88 does not make clear the number of assessments that must entire time an individual is employed at the laboratory. Once an
be performed in this area, only that it must be done. Each individual is no longer employed, discussions with Human Re-
individual laboratory will have to determine the number of sources personnel can determine the appropriate length of time
competency assessments in this area that it will require or the that competency records should be maintained for that facility.
areas in which problem solving must occur.
REMEDIATION
Determine Who Will Perform Competency Assessment
The goal of competency assessment is to identify potential
Part of the written procedure for a competency program problems with employee performance and to address these
should include how competency assessment is determined and issues before they affect patient care. Thus, performance and
who will be allowed to perform the assessment. Although documentation of remediation is a critical component of the
CLIA ’88 states that the supervisor is responsible for compe- competency assessment process and is required by both CAP
tency assessment, it does not state that all assessments must be and JCAHO. Unless an employee has been deliberately neg-
performed by the supervisor. Supervisors may choose to des- ligent in the performance of his or her work, remediation
ignate certain employees (e.g., lead technologists or employees should not be punitive but should, instead, be educational, and
with several years of documented successful competency) to it should always be directed at improving performance (4).
assist with assessments (14, 15). These employees may be au- Employees who recognize that their mistakes will be addressed
thorized to perform assessment in only a few tests or in mul- with the aim of performance improvement will be far more
tiple laboratory areas. In addition, these employees can per- likely to seek assistance and admit problems than those who
form competency assessment of supervisory personnel who fear embarrassment, disciplinary action, or termination. (D.
VOL. 17, 2004 COMPETENCY ASSESSMENT IN THE LABORATORY 693

Marx, 2001, Patient safety and the “just culture”: a primer for Similarly, McCarter and Robinson did not permit employees
health care executives; Columbia University. [http://www.mers who failed competency assessment to perform testing in that
.tm.net/support/Marx_Primer.pdf]). area until corrective action was determined (14). Following
A number of approaches can be taken to remedy problems corrective action, the employee was reevaluated, and if the
identified through the competency assessment process, and corrective action had been effective, the employee was consid-
some of these are outlined below (4). Since problems may ered to be competent. If the corrective action was not effective,
develop because of the system rather than the employee, the the individual was not permitted to perform testing in the
first step is to analyze the problem so that the proper reme- affected area until remedial training was successfully com-
diation can be identified and implemented. Analysis of the pleted. In general, remediation should be instituted as quickly
problem starts with looking at the protocols used for labora- as possible after identification of a potential problem with
tory practice. The protocols should be clear and concise; if they employee competency. Each situation can be assessed initially
are inadequate or confusing, this may account for the failure of to determine the extent of the problem and to determine if the
competency of the employee. In proficiency testing, it should employee understands the situation that has occurred, as well
be ensured that the sample used as an unknown is adequate as the way it should have been handled. Based on this initial
and that a problem with the sample itself is not what caused the assessment, a decision can be made at that time about whether
competency failure. Also, the tools used for evaluation of com- the employee should be allowed to continue to work indepen-
petency should be clear, so that a consistent standard is applied dently in the area while further remediation or competency
to all employees. assessment (for example, direct observation) is carried out or
If the above protocols are deemed sufficient and are not the whether the employee’s work should be restricted until reme-
cause of the competency failure, then one needs to identify the diation and competence are fully documented.
problem the employee is having. Is it a methodology problem,
did the employee not perform the test correctly (i.e., did he or QUALITY RESULTS
she not follow procedure), did the employee not understand
the purpose or background of test (i.e., is he or she unable to A formal defined competency program provides the labora-
solve problems or relate the test to the clinical situation), did tory with a valuable tool for identifying and correcting issues of
the employee not understand the components of the test or employee competency. Just as valuable is the use of compe-
instrument being used, was the employee unable to resolve QC tency assessment as an ongoing part of the laboratory’s quality
problems, or did the employee perform correctly but made an assurance program to assist managers and supervisors in en-
error in documentation? suring that high-quality results are reported. Competency as-
If necessary, an appropriate remedial action should be se- sessment is an integral part of problem analysis and becomes a
lected (4). First, discussion of the procedure with the employee key tool in ensuring that errors identified through the quality
is warranted to assess if further action is necessary based on the assurance processes are prevented from recurring. Compe-
employee’s verbal response. This step may be all that is nec- tency assessment procedures can help to identify problems
essary to identify the reason for the competency failure. Dis- occurring in the technical aspects of laboratory practice and
cussion of the procedure in a quality assurance-QC meeting assess performance deficiencies before they develop into major
with all employees could help everybody to understand how problems (7, 9, 10, 18).
this type of error can be avoided. Additional actions that can Competency assessment is also an opportunity to provide
be taken with an employee who fails competency include hav- continuing education and performance feedback to employees

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.

ing the employee reread the procedure and discuss it with the and to document valuable objective information for perfor-
supervisor to clarify any misinterpretations, having the em- mance evaluations (15). It should and can be used as a positive
ployee produce a flow chart to assist him or her in properly experience that helps to ensure that employees and employers
performing a procedure, having the employee observe another can perform assigned tasks.
trained and competent employee, having the employee prac-
REFERENCES
tice the failed procedure with known specimens, or having the
employee correctly retest the same specimen with the proce- 1. Berger, D. 1999. A brief history of medical diagnosis and the birth of the
clinical laboratory. 3. Medicare, government regulation, and competency
dure that originally failed. Reinstitution of formal training may certification. Med. Lab. Obs. 31(12):38–42.
be necessary if the above opportunities fail to show that the 2. Christian, L. E., K. M. Peddecord, D. P. Francis, and J. M. Krolak. 1997.
Competency assessment—an exploratory study. Clin. Lab. Manage. Rev.
employee is competent. Regardless of the method selected for 11:374–381.
remediation, it is necessary to repeat the competency assess- 3. Davey, D. D. 1997. Papanicolaou smear 5-year retrospective review. What is
ment once remediation has been completed in order to docu- required by the Clinical Laboratory Improvement Admendments of 1988?
Arch. Pathol. Lab. Med. 121:296–298.
ment successful attainment of competency. As a last resort, it 4. Elder, B. L., and S. E. Sharp. 2003. Cumitech 39, Competency assessment in
may be necessary to permanently remove an employee from the clinical microbiology laboratory. Coordinating ed., S. E. Sharp. ASM
selected duties and reassign him or her to another work area. Press, Washington, D.C.
5. Frable, W. J. 1997. “Litigation cells” in the Papanicoulaou smear. Extramu-
When an error or failure of competency was noted by Mc- ral review of smears by “experts.” Arch. Pathol. Lab. Med. 121:293–295.
Caskey and LaRocco, corrective action was necessary within 30 6. George, K. A. 1996. The right way: staff training and competency assessment.
Med. Lab. Obs. 28(12):44–47.
days of the finding at their institution (15). If their corrective 7. Gerbasi, S. 2000. Competency assessment in a team-based laboratory. Med.
action did not resolve the failure, the employee was not al- Lab. Obs. 32(9):46–54.
lowed to perform patient testing in that area until he or she 8. Hassemer, D. J. 2003. Wisconsin State Laboratory of Hygiene’s role in the
clinical laboratory improvement. Wisc. Med. J. 102(6):56–59.
had completed further remedial action and had his or her 9. Haun D. E., and A. P. Leach. 2003. Performing poorly but testing perfectly.
competency reevaluated and was determined to be acceptable. 2003. Clin. Lab. Manage. Rev. 17(2):85–87.
694 SHARP AND ELDER CLIN. MICROBIOL. REV.

10. Haun D. E., A. P. Leach, and R. Vivero. 2000. Takin care of Mama—from 15. McCaskey L., and M. LaRocco. 1995. Competency testing in clinical micro-
competency assessment to competency improvement. Lab. Med. 31:106–110. biology. Lab. Med. 26:343–349.
11. Health Care Financing Administration. 1992. Medicare, Medicaid, and 16. National Committee for Clinical Laboratory Standards. 1995. Training ver-
CLIA programs. Regulations implementing the Clinical Laboratory Im- ification for laboratory personnel. Approved guideline GP21-A. National
provement Amendments of 1988 (CLIA). Fed. Regist. 57:7002–7186. Committee for Clinical Laboratory Standards, Wayne, Pa.
12. Howanitz, P. J., P. N. Valenstein, and G. Fine. 1996. Employee competency 17. Nevalainen, D. E. and L. M. Berte. 1993. Training, verification and assess-
ment: keys to quality management. Clinical Laboratory Management Asso-
evaluation 96–04. Q-Probes. College of American Pathologists, Northfield,
ciation, Malvern, Pa.
Ill.
18. Sharp, S. E. 2001. Initial verification and competency assessment in the
13. Institute of Medicine. 2000. To err is human: building a safer health system. clinical microbiology laboratory. Clin. Microbiol. Newsl. 23:79–81.
(L. T. Kohn, J. M. Corrigan, and M. S. Donaldson, ed.) National Academies 19. Steigman C. K., and J. P. Vernick. 2002. The Pap smear: a victim of its own
Press, Washington, D.C. success? Med. Lab. Obs. 34(8):8–14.
14. McCarter, Y. S., and A. Robinson. 1997. Competency assessment in clinical 20. Tiehen, A. 1999. Competency assessment: establishing a program. Clin. Lab.
microbiology. Clin. Microbiol. Newsl. 19:97–101. Manage. Rev. 13:275–285.

Downloaded from https://journals.asm.org/journal/cmr on 13 January 2025 by 37.40.1.54.