Cumitech 39: Competency Assessment in the Clinical Microbiology Laboratory

Competency Assessment the Clinical

in

Cumitech 1B Cumitech ZB Cumitech 3A Cumitech jA Cumitech 6.A Cumitech 7.4 Cumitech Cumitech Cumitech

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Cumitech 18.4 Cumitech 19.4 Cumitcch 2 1 Cumitech 23

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33

Cumitech 3-l Cumitech 35 Cumitech 36 Cumitech 3’ Cumitech 3S Cumitech 39

Cumitechs should Clinical Microb/oiogy

be cited as follows, e.g.: Laboratory. Coordinating

Eider, B. L., and S. E. Sha:p. 2003. Cum/tech ed., S. E. Sharp. ASM Press, Washington, D.C.

Editorial Board for ASM Cumitechs: Alice S. Weissfeld, Chair; Marla D. Appleman, Burken, Roberta Carey, Linda Cook, Lynne Garcia, Richard M. Jamlson, Karen Krisher. Sewell, Daniel Shapiro, Susan E. Sharp, James W. Snyder, Allan Truant.

\/i&e Susan

39,

Co,m,oetency

Assessmen:

;,n the

Baselski, B Kay Btxhanan, ivlltche,l L. Mottlce, Nlcnael Sauootle, David

I L.

Effective as of January 2000, the purpose of the Cumitech series IS to provide consensus reccml-endat ons regarding tt-e judicious use of clinical mlcrobiology and immunology laboratories and their role in patien: care. Each Ctii?:!;ech s :vritter by a team of clinicians, iaboratorians. and other interested stakeholders to provide a broad overview of varlox aspec:s of rfect ous disease testing. These aspects include a discussion of relevant clinical conslderatioqs; collec:lon t-ansoort, orocess,rg, ard interpretive guidelines; the cllnica! utility of culture-based and non-culture-based methods ard energirg tecnlologles: and ssJes surrounding coding, medical necessity, frequency limits, and reimbursement. The recorrmerda;lors V- Cun?:?eci?.s oo not represert the official views or policies of any thrrd-party payer. Copyright 0 2003 ASM Press American Society for Microbiology 1752 N Street NW WashIngton. DC 20036-2904 All Rights

Reserved

ComPetencv Assessment in the --- - ----Chcbl M&biology Laboratory B. Laurel Elder CompuNet

Clinical Laboratories,

2308 Sandridge Rd. Moraine,

OH 45459

Susan E. Sharp Diagnostic

Microbiology

Laboratories,

Diagnostic

Microbiology

Laboratories,

Health Midwest,

2316 East Meyer Blvd., Kansas City, MO 64132

COORDINATING EDITOR: Health Midwest,

Susan E. Sharp

2316 East Meyer Blvd., Kansas City, MO 64132

.. .. .. . .. .. .. . .. .. .. . .. .. . .. .. .. . .. . .. .. .. . .. .. . .. . .. .. . .. .. . .. . .. .. .. .. . .. .. . .. .. .. .. .. . 1 Introduction 2 The Law .............................................................................................. 42CFR493.1445. 42CFR493.1451.

Standard: Laboratory Director Responsibrlrties ..................................... Standard: Technical Supervrsor Responsrbllrtles ..................................

2 2

Accreditation

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.....................................

2

The CAP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...*.*...*............*.,

Elements

of a Competency

Assessment

Program

. . . . . ..*. .***..............a

....................................

Direct Observation of Routine Patient Test Performance ........................................ ........................... Monitoring the Recording and Reporting of Test Results .................. Review of Intermediate Test Results or Worksheets, QC Records, Proficiency Testing .............. Results, and Preventive Maintenance Records .................................... Direct Observation of Performance of Instrument Maintenance and Function Checks ...... ......................... Assessment of Problem-Solving Skills ................................................

Development

of a Competency

Assessment

Program

3 3 3 3 4

. .. . .. .. . .. .. .. . .. .. .. . .. ... .. 4

Step 1: Identify Areas Requiring Competency Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Step 2: Identify Method of Competency Assessment To Be Used for Each of the Areas Identified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..a.... . . ..,.. . . . . ..*............*........................................ Step 3: Identify Who WIII Be Performing Competency Assessment . . . . . . . . . ..*..........a......... Step 4. Define Method To Be Used for Documentation of Competency Assessment . . . . . .

Remediation

2

3

........................................................................................

.................................................... Analyze the Problem ............................................. Select Appropriate Remedial Action (If Needed) ............................................................

4 4 5 5

6 6 7

Quality Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 7 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..‘.............. Appendix A: Two Approaches to Competency Assessment and . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*....... 7 Documentation 13 Appendix B: Case Studies . . . . . . . . . . . . . ..*.................................................... 15 ..,....................................,................................,...,............ References

INTRODUCTION

Q-Probe performed by the College of American Pathologists (3) suggested that “opportunities for improvement in employee competency assessment are numerous,” and our own experiences in presenting workshops on this topic at the American Society for Microbiology annual meetings confirm that many laboratories continue to struggle with the design of a competency assessment program. This Cumitech has been developed to provide guidance to supervisory personnel in the clinical microbiology laboratory in

overnmental mandates make it necessary to assess all laboratory workers who handle patient specimens for competency in their respective job positions. The mandates are specific in what must be assessed and how these assessments must be performed and documented. However, they do allow for considerable discretion on how to implement these specific assessments in a laboratory setting. A 1996 t-

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Elder and Sharp

the development and implementation competency assessment program.

of an effective

THE LAW Competency assessment of clinical microbiology personnel has been mandated in U.S. law since 1988 as part of the Clinical Laboratory Improvement Amendments (CLIA ‘8 8). This act was an amendment made to the original CLIA of 1967, was published in the Federal Register as part of the Code of Federal Regulations, and clearly defines the requirements for initial training verification, initial competency assessment, and ongoing competency assessments of laboratory personnel (2). The pertinent information from the Code of Federal Regulations is detailed below. 42CFR493.1445. Responsibilities

Standard:

Laboratory

Director

The laboratory director must ensure that, prior to testing patients’ specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and demonstrate that they can perform all testing operations reliably to provide and report accurate results. The laboratory director must also ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures, and report test results promptly and proficiently. Whenever necessary, the director must also identify needs for remedial training or continuing education to improve skills. Finally, the laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytical, analytical, and postanalytical phases of testing. This should identify which examinations and procedures each individual is authorized to perform; whether supervision is required for specimen processing, test performance, or result reporting; and whether supervisory or director review is required prior to reporting patient test results. 42CFR493.1451. Responsibilities

Standard:

Technical

Supervisor

The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. The technical supervisor is responsible for evaluat-

39

ing the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the staff must include, but are not limited to, the following: 1. Direct observation of routine patient test performance, including patient preparation (if applicable) and specimen handling, processing, and testing 2. Monitoring the recording and reporting of test results 3. Review of intermediate test res ults or worksheets, quality control (QC) records, proficiency testing results, and preventive maintenance records 4. Direct observation of performance of instrument maintenance and function checks 5. Assessment of problem solving skills

ACCREDITATION Competency assessment of laboratory personnel is also a requirement of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for accreditation. The CAP and the JCAHO have guidelines that include several items dealing with initial training and competency assessment of laboratory personnel as a requirement for laboratory certification and accreditation. The CAP The CAP survey checklists currently include questions about competency assessment, such as “Do technical personnel records include a summary of training and experience?, ” “Do technical personnel records include annual review of the performance of existing employees and initial 6-month review of new employees?,” and “Has the competency of each person to perform his/her assigned duties been assessed?” The CAP general checklist states that training activities and assessment evaluations must be documented and specific for each job description and that those activities requiring judgment of interpretive skills must also be included. The CAP further states that records must make it possible for the inspector to be able to determine which skills were assessed and how those skills were measured. The CAP also requires retraining and reassessment of employee competency when problems with employee performance are identified 0 In order for a laboratory to comply with these federal regulations and national accrediting agencies’ guidelines, a system must be in place to allow verification of the initial training of staff and assessment of

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39

Competency

competence twice in the first year of empl .oymen t and annually thereafter.

As previously stated, there are five areas that must be included as part of a competency assessment program, including (i) direct observation of routine patient test performance; (ii) monitoring the recording and reporting of test results; (iii) review of intermediate test results, QC records, proficiency testing results, and preventive maintenance records; (iv) direct observation of performance of instrument maintenance and function checks; and (v) assessment of problem-solving skills. There are many approaches and tools that can be utilized to achieve the above elements (4, 5, 6), and these are described in greater detail below. The use of exams (written or practical) can also aid in competency assessment, although exams by themselves cannot completely satisfy the regulatory requirements or provide a complete look at an employee’s competence. Written exams can be particularly useful in providing problem-solving scenarios but are generally unable to comprehensively reflect the many different facets of knowledge and judgment that employees must use in job performance. of Routine

Patient

Test

Direct observation is the actual observation of work while it is being performed by laboratory staff. These observations are not limited to test performance but include all processes that the employee is involved in, including specimen collection, preparation of the specimen for laboratory testing, and the actual testing of the specimen. Direct observation is the most timeconsuming way to monitor employee competency (particularly when the laboratory is large), and the areas to monitor should be carefully selected to maximize gains from the time spent in the process. For example, areas which involve a higher degree of decision making, which may have a major impact on patient care if performed incorrectly, or which have been found over time to have a greater degree of employee variability might all be good prospects for direct observation. Small laboratories with only a few staff members may find direct observation to be less onerous and can be more inclusive in the areas chosen for observation. In either case, if desired, a statement can be included in the laboratory’s competency assessment program indicating that a certain percentage of routine work is observed through direct visual evaluation. This can be followed by either a specific listing of tests to be observed or a general listing of tests that

in the Laboratory

3

may be included in the direct o bserva tion portion of competency assessment Monitoring the Recording Test Results

ELEMENTS OF A COMPETENCY ASSESSMENT PROGRAM

Direct Observation Performance

Assessment

and Reporting

of

Monitoring the recording and reporting of test results requires the review of reported results for the proper and correct recording and reporting of patient results. This is most easily accomplished either by documentation of observation of an employee writing or entering patient test results on report forms or into the computer or by review of worksheets with computer entries for appropriate recording of patient results. This review can be done at the time a final report is verified (before results have been released) or postverification, through comparison of worksheets and computer printouts. Unless all worksheets or reports are going to be reviewed, effort should again be taken to ensure that the time spent reviewing test recording and reporting provides the best assessment of competency (e.g., review of primarily positive cultures, review of results from critical specimens, and review of worksheets from culture types with complicated workups). Review of Intermediate Test Results Worksheets, QC Records, Proficiency Results, and Preventive Maintenance

or Testing Records

Review of intermediate test results or worksheets, QC records, etc., may also be accomplished by directly observing an employee when he or she is writing or entering preliminary patient test results onto report forms or into the computer or by review of worksheets or computer entries for appropriate recording of preliminary patient results. The testing of unknown samples in the laboratory through submission of blind samples, proficiency testing samples, previously analyzed specimens, or split samples can be utilized for meeting the requirement for proficiency testing. Likewise, supervisor review of QC records and preventative maintenance records is most easily performed as a documented review of previous data entries and is already routinely performed in laboratories to meet the QC requirements for accreditation. To serve dual purposes, however (e.g., utilizing QC review or proficiency testing as part of the laboratory competency assessment program), the supervisor must clearly document as part of the employee’s competency record when problems are found and must indicate the employee remediation that was initiated as a result the identified problem. Direct Observation of Performance of Instrument Maintenance and Function

Checks

Direct observation must be performed when employees are performing maintenance procedures and

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Elder and Sharp

CUMITECH

checks of instruments. Documentation of these observations is necessary for competency assessment and cannot be performed by an alternative method (e.g., review of QC results as an indirect measure of correct instrument maintenance). Assessment

of Problem-Solving

Skills

This area of competency may or may not be assessed through any of the routine assessment methods described above, but assessment can be accomplished in several ways. Examples include 1. asking employees to respond orally or in writing to simulated technical or procedural problems (perhaps in the form of case studies) 2. asking employees to document actual problemsolving issues that they have handled in the laboratory within the last year Laboratory employees solve problems very often but are frequently not aware that they are doing so. Encouraging the employees to document problem-solving situations as they occur during the year (rather than once a year when summarizing competency assessments) will facilitate this portion of the assessment process.

DEVELOPMENT OF A COMPETENCY ASSESSMENT PROGRAM The initial task of developing a competency assessment program can seem daunting, but it can be approached in a number of different ways. The steps taken to define the program should be included as part of the laboratory’s competency assessment program procedure. Steps commonly performed during the development of a program include the following. Step 1: Identify Assessment

Areas Requiring

Competency

This is one of the most time-consuming portions of program development, and it requires analysis of like tasks and skills. For example, the identification of an isolate from a blood agar plate is done in similar fashion regardless of the source (e.g., urine, blood, or tissue) of the specimen. Thus, it is not necessary to assess individual competency in each work area or division in the laboratory. On the other hand, the ability to assess whether an organism needs to be identified varies from source to source. Similarly, the performance, recording, and QC of simple latex tests do not vary considerably from kit to kit and may be adequately assessed through evaluation of the performance of any one of several different kits. Performance of this first step in program development must be done in sufficient detail that it is clear (to the assessor as well as to an inspector) what will be

39

assessed, but with consideration of the similarity between many laboratory tasks. For example, it is insufficient to simply list “bacteriology, mycology, parasitology, and mycobacteriology” when defining the areas requiring competency assessment unless a detailed description of the work performed in each discipline is included in the design of the competency assessment program. Organization of the areas to be assessed may also be by bench assignment (e.g., respiratory specimens) or by test type (e.g., serologic tests). As an example, when defining areas requiring competency assessment for the anaerobe bench, the following might be included: 1. Culture setup 2 . Selection of appropriate organisms for identification 3 . Identification of organisms a. Disk testing b. Identification kit 4 Utilization of the anaerobic chamber S: Reporting of test results 6 . Notification of critical values Step 2: Identify Method of Competency Assessment To Be Used for Each of the Areas Identified This step can simply be organized through development of a spreadsheet, but it must incorporate each of the required elements listed in the CFR. Not every type of assessment needs to be performed for each area being assessed, and the selection of the type of assessment tool should be based on whether it will provide an accurate reflection of employee competency. As part of this process, it is very helpful to define what will be considered a successful demonstration of competency. These demonstrations may be considerably different when an employee is being trained in a new area and is demonstrating competency for the first time than when ongoing competency is being demonstrated. For exa mple, criteria established for an employee being evaluated following initial training in the anaerobe area will primarily involve direct observation and might be stated as follows (please note that the quantities given are not recommendations but are designed to serve as examples). Direct observation of the employee indicates that he or she can 1. correctly follow procedure while inoculating and incubating at least 25 specimens for anaerobic culture 2. identify inappropriate specimens for anaerobic culture and demonstrate or describe the procedure followed when these are received in the laboratory 3. appropriately follow laboratory procedures while

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39

interpreting, working up, and reporting on a minimum of 50 anaerobic cultures 4. perform all required maintenance of the anaerobic chamber and describe the principles behind the function of the chamber In contrast, an example of evaluation criteria for ongoing competency in the area of anaerobes could include 1 direct observation that the employee’s workup of five cultures indicates no deviations from written procedures 2 . daily supervisor review of employee worksheets of positive cultures indicating that the employee correctly selects appropriate identification and susceptibility tests and has followed the critical-value policy correctly 100% of the time 3 . employee demonstration of knowledge and ability to perform required maintenance for the anaerobic chamber 4 correct employee identification and resolution of problem situations with anaerobic cultures (documented from actual examples or through a practical exam) correct employee identification of bacterial pathogens (including anaerobic organisms) on proficiency-testing samples l

l

5

.

One of the challenges for any laboratory in establishing a competency program is defining the extent of assessment that will be performed in each area once training is completed. Is it adequate to observe an employee working up one culture from the blood bench, or do 5 or 10 culture workups need to be observed? Should an employee be asked to demonstrate his or her ability to solve problems in each area of the laboratory, or is it sufficient to document problem-solving in only one or two key areas? Each laboratory will need to determine the extent of assessment in a way that best fits its size and complexity. For example, the five cultures specified in item 1 of the example above might be quite impossible for a small laboratory performing only one or two anaerobic cultures per week or equally difficult for a large laboratory where multiple technologists perform anaerobic cultures. In this situation, instead of observation of individuals performing anaerobic culture workup, direct observation of employee competency might be achieved through use of a practical exam. Plates with important anaerobes and mixed organisms could be prepared and used to observe the employees’ subsequent workup. If all employees performing anaerobic cultures were tested at the same time, setup time would be reduced. A helpful approach to solving the problem of how much competency assessment is necessary is to include competency assessment as an integral part of

Competency

Assessment

in the Laboratory

5

other activities already occurring routinely in the laboratory. For example, during routine review of QC records, problems (e.g., failure to document followup action when QC is out of range) can be documented and addressed with the employees at that time. Documentation of the employee follow-up could be made on a QC review sheet (if one is used) or in the employee’s competency file. If worksheets are reviewed by a supervisor or designee, procedural deviations and subsequent follow-up can also be identified when they occur. The documentation need not be intensive (Fig. 1) and could be summarized in an employee’s formal competency file at a later date. Problem solving, as already mentioned, could also be documented by employees throughout the year. One suggestion is to provide employees with a notebook which will fit in a laboratory coat pocket that they can use for documentation as situations occur and which they will then turn in to their manager at a scheduled time. This booklet could also include a schedule of other required elements of annual competency assessment (e.g., observed instrument maintenance) that the employee would be responsible for scheduling with a supervisor or designee. Use of such a booklet also helps place responsibility for part of the competency assessment with the employee. Step 3: Identify Who Will Be Performing Competency Assessment Part of the written procedure for a competency program should include a definition of how who will be allowed to perform competency assessment is determined. Although CLIA ‘88 states that the supervisor is responsible for competency assessment, it does not state that all assessments must be performed by the supervisor. Supervisors may choose to designate certain employees (e.g., lead technologists or employees with several years of documented successful competency) to assist with assessments. These employees may be authorized to perform assessment in only a few tests or in multiple laboratory areas. In addition, these employees can perform competency assessment of supervisory personnel who also perform patient testing. Step 4: Define Method To Be Used for Documentation of Competency Assessment A variety of manual and computerized tools are available for documentation of competency assessment, and examples of these are included in Appendix A as well as in selected references (5,6). Unless a decision is made to purchase one of the commercially available software systems, forms will need to be developed that are easily used for documentation and that provide evidence of

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Employee Date Deviation corn procedure: 0 Organisms reported incorrectly ClGram stain/culture correlation not performed/documented ClUnusual susceptibility pattern not rechecked CJCritical value not called to physician ClUnusual organism identified for source without confirmation or consultation D Other Reviewed with Employee on (date) Further competency assessmentrequired? 0 yes Clno Supervisor Signature FIGURE 1.

l l l l l l l

Problem documentation

who was evaluated what was evaluated how it was evaluated when it was evaluated who performed the evaluation what was done if problems were identified whether the employee is authorized to perform and release results independently or whether review of the work is required before results are released

This is also a logical place to indicate if an employee is authorized to perform competency assessment of other employees in this area. The medical director is ultimately responsible under CLIA ‘88 for determining who will be allowed to work in the laboratory and with what degree of autonomy; it is therefore prudent for the medical director either to review and sign the employee competency documentation or to delegate this task in writing to the supervisor.

REMEDIATION The goal of competency assessment is to identify potential problems with employee performance and to address these issues before they affect patient care. Thus, performance and documentation of remediation are critical components of the competency assessment process. Unless an employee has been deliberately negligent in the performance of his or her work, remediation should not be punitive but educational and should always be directed at improving perfor-

follow-up

form.

mance. Employees who recognize that their mistakes will be addressed with the aim of performance improvement will be far more likely to seek assistance and admit problems than those who fear embarrassment, disciplinary action, or termination (http://www. mers-tm.net/support/Marx-Primer.pdf). A number of approaches can be taken to remediate problems identified through the competency assessment process, and some of these are outlined below. Since problems may develop because of the system rather than the employee, the first step is to analyze the problem so that the proper remediation can be identified and implemented. Analyze

the Problem

Identify system problems. Is the standard operating procedure inadequate? 0 Are wet samples inadequate? l Is the assessment tool unclear? l Identify technologist problems. l Identify methodology problems. l Does the employee perform the test correctly (or does the employee not follow procedure)? l Does the employee understand the purpose or background of test (is the employee unable to solve problems or relate the test to a clinical situation)? l Does the employee understand the components of test, instrumentation, etc., or is he or she unable to resolve QC problems? l How is the employee’s system of documentation l l

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Competency

39

(does he or she perform the task right but record it wrong) ? Select Appropriate

Remedial

Action

(If Needed)

Discuss procedure with employee; assess necessary further action based on verbal response. Modify procedure and reassess once retraining is completed. Discuss procedure in a quality assurance (QA)-QC meeting with all employees. Have employee reread procedure and discuss to clarify (having the employee produce a flowchart can be of assistance if the employee is having difficulty following a procedure). Have employee observe another trained employee. Have employee practice procedure with known specimens. Have employee correctly retest samespecimen. Have employee review problem with technical supervisor. Have employee perform the original (or a similar) exercise. Reinstitute formal training. Remove employee from duties and reassign.

QUALITY RESULTS The formal defined competency program provides the laboratory with a valuable tool for identifying and correcting issues of employee competency. Just as valuable is the use of competency assessment as an ongoing part of the laboratory’s QA program to assist managers and supervisors in assuring that quality results are reported on patient samples. Competency assessment is an integral part of problem analysis and becomes a key tool in insuring that errors identified through QA processes are prevented from recurring. Several case studies that utilize competency assessment methods to investigate quality issues in the laboratory are included in Appendix B.

APPENDIX

Assessment

in the Laboratory

A

TWO APPROACHES TO COMPETENCY ASSESSMENT AND DOCUMENTATION The following are examples of the approaches taken to organize and document competency assessment in two different laboratories. These reflect the procedures and work flow of the individual laboratories and are designed to serve only as examples and not as guidelines on how competency assessment must be organized or performed.

LABORATORY A Approach

to Competency

Assessment

This laboratory has analyzed its organization and work flow and chosen to approach both training and competency assessment from a bench assignment perspective. The laboratory is organized primarily by culture types (e.g., there is a blood bench, a respiratory bench, a wound bench, etc.), and technologists may work on one or more benches in a day. Work is written onto worksheets, and the department manager (or lead technologist) reviews and verifies all worksheets for positive cultures before the final results are released. Preliminary results, negative cultures, and work from the weekends are released by the technologists working in the department. Work concerning positive cultures from the weekend is reviewed the following Monday morning by a supervisor. Training and competency documents have been prepared for each area and are organized into a training notebook for use by trainers. Examples of four of these documents are included in the following section. Many of the objectives for demonstration of competency are identical for different procedures and are based on the fact that the work from all positive cultures is reviewed by the manager or lead technologist and used as a key component of competency assessment. Documentation of competency is done by combining the objectives from the individual documents into a single form. An abbreviated example of this form is found below (Fig. Al). Four Examples Documents

of Training

and Annual

Competency

Urine Culture Expected

Outcome

of Training

The employee will be able to

The laboratory comprises an invaluable part of the total health care provided to patients. Competency assessment is one method by which we can verify that our employees are competent to perform laboratory testing and report patient results. We address competency assessment in our laboratories not only because it is mandated by the federal government or our accreditation agencies but also because we understand that it can assist us in providing our part of excellent health care to our patients.

1. describe for urine each and transport

the various methods used to collect specimens culture and the advantages and disadvantages of to list the requirements for specimen storage and to prevent bacterial growth in the specimen

2. describe the procedures used to process specimens (clean catch, catheterized, suprapubic aspirate, etc.) for quantitative urine culture 3. calculate the original concentration in the specimen of each of the organisms present in the culture 4. list potential urinary tract pathogens and recognize which organisms most commonly represent urethral or vaginal contamination of the specimen

Name

Competency

P - Problem

Medical

Signature

0

R

0

R

M

M

P

U

M

FIGURE

Al.

should be attached to this form

is required,

*If remediation

complete documentation

Employee demonstrates to supervisor the required instrument maintenance, performing and documenting all required functions correctly. Ongoing review of Quality Control records indicates that the employee has performed and recorded kit QC appropriately, with 52 instances offailure to respond to QCfailure identiJied per year 1 Employee correctly demonstrates how to perform 1 one spot and one kit identljication test to the

Automated Susceptibility Testing Bacterial Identification Kits

Bacterial Identification

Director

Date of Hire

Bactl

riology

documentation

M - Monitoring 1 Date

competency

solving U - Unknowns or PT 1 Assessment 1 Assessor Method M

Ongoing supervisor and director review of quality control results indicates that organism results are out of range ~2% of the time without an obvious

1 Ongoing supervisor and director review of 1 susceptibility reports indicates that the employee 1 correctly detects and rechecks unusual susceptibility results (reviewer is required to recheck ~3% of results released by technologist

Ongoing supervisor review of worksheets of 1 positive cultures indicates that the employee 1 averages 52 nonclerical corrected reports per month and 53 procedural deviations per month Ongoing supervisor review of employee worksheets ofpositive cultures indicates that the employee correctly selects appropriate identl$cation and susceptibility tests (~2 errors detected/year) Employee correctly identifies bacterial pathogens on proficiency testing samples Employee demonstrates ability to solve problems through documentation of laboratory incidents Correlation of Gram stains with culture indicates that the employee recognizes discrepancies and reviews smears and culture for accuracy (51 unrecognized discrepancy/month).

of QC

Form

Automated Susceptibility Testing

Wounds, Lower Respiratory, Sterile Body Fluids. Tissues Automated Susceptibility Testing

All Areas

‘rAll Areas

All Areas

R - Review

Documentation

Assessment Codes: 0 - Observation Procedure 1 Assessment

Method

Period (e.g., year) Assessed

Employee

Bacteriology

form.

of Test Results 1 Remediation Required?*

Date

1 Approved to perform work independently?

Comments

CUMITECH

Competency

39

5. recognize the morphologies of potential pathogens and nonpathogens on blood agar and MacConkey agar 6. correctly identify which organisms require full identification and susceptibility testing based on their quantities and the presence of other organisms in the culture 7. correctly report pathogenic isms in the computer Documents

and References

and nonpathogenic

organ-

Training

Directory of services specimen co11.ection section Bacteriology procedure manua l Training

Methods

To Be Used

1. Reading of procedure in manual 2. Reading of specimen collection guidelines in directory of service 3. Supervised interpretation, workup, and reporting of urine cultures Evaluation

Criteria

for Successful

Performance

1. When presented with case histories describing collection and storage, the employee will identify improper procedures and the likely effect these may have had on the culture results. 2. The employee will successfully read, interpret, work up, and report on at least 100 urine cultures. Evaluation tency

Criteria

Verification

of

1. Ongoing supervisor review of worksheets of positive cultures (including urine cultures) indicates that the employee averages two or fewer reports corrected for nonclerical reasons per month and three or fewer procedural deviations per month. 2. Ongoing supervisor review of employee worksheets of positive cultures (including urine cultures) indicates that the employee correctly selects appropriate identification and susceptibility tests (with fewer than two errors detected per year). 3. Employee correctly identifies bacterial pathogens on proficiency testing samples. 4. Employee demonstrates ability to resolve problems through documentation of actual laboratory incidents. Superficial Wound, Skin, and Aspirate Cultures Expected

Outcome

of Training

The employee will be able to 1. list the four specimen groups into which superficial wound, skin, and aspirate cultures have been placed and describe the different workups used for each group 2. list the common potential bacterial pathogens causing superficial wound, skin, and aspirate infections; recognize the colonial morphologies of these organisms on bacterial media; and correctly select and perform the appropriate identification tests 3. list the common nonpathogenic skin flora which can be found contaminating superficial wound, skin, and aspirate specimens and recognize the morphology of these organisms on bacterial media 4. identify organisms requiring susceptibility testing and

9

in the Laboratory

identify the correct susceptibility test to use (automated, disk diffusion, gradient diffusion, or beta-lactamase) 5. correctly report in the computer pathogenic and nonpathogenic flora for each specimen type Documents

Bacteriology To Be Used during

Assessment

Training

and References

To Be Used during

Training

procedure manual Methods

To Be Used

1. Reading of procedure in manual 2. Demonstration of pathogenic and nonpathogenic colonial morphologies by qualified employee 3. Supervised interpretation, workup, and reporting of superficial wound, skin, and aspirate cultures Evaluation

Criteria

for Successful

Performance

Employee correctly interprets, works up, and reports a minimum of 50 superficial wound, skin, and aspirate cultures following laboratory procedure. Evaluation tency

Criteria

for

Ongoing

Verification

of Compe-

1. Ongoing supervisor review of worksheets of positive cultures (including wound cultures) indicates that the employee averages two or fewer reports corrected for nonclerical reasons per month and three or fewer procedural deviations per month. 2. Correlation of Gram stains (when ordered) with culture indicates that the employee recognizes discrepancies and reviews smears and culture for accuracy (with one or no unrecognized discrepancies per month). 3. Employee correctly identifies bacterial pathogens on proficiency testing samples. 4. Employee demonstrates ability to resolve problems through documentation of actual laboratory incidents. Antimicrobial Expected

Susceptibility Outcome

Testing (Automated)

of Training

The employee will be able to 1. inoculate instrument panels using organisms in the log phase or direct methods for organism preparation 2. utilize the instrument interface to download demographic data and upload identification and susceptibility results 3. manually interpret biochemical reactions on gram-positive and gram-negative identification panels and manually read and interpret MIC endpoints 4. resolve problems review list

listed on the instrument

supervisory

5. perform required daily and weekly maintenance instrument

of the

6. describe the required QC organisms and frequency of testing for the instrument system and perform QC of new reagents placed on the instruments 7. review susceptibility test results and correlate the organism identifications and susceptibility patterns, identifying and rechecking inappropriate reactions as described in the bacteriology manual, and suppress appropriate antimicrobials based on reporting algorithms

10

Elder and Sharp

Documents

CUMITECH

and References

To Be Used during

Training

Bacteriology procedure manual II Video on antibiotic classes and agents: their modes of action, expected spectra, and resistance mechanisms Lecture or discussion of antibiotics and susceptibility patterns with laboratory director Training

Methods

To Be Used

1. Reading of procedures in manual 2. Demonstration of interface, panel setup, instrument maintenance, and QC by qualified employee 3. Viewing of videotape reviewing antibiotic classes, actions, and resistance mechanisms 4. Lecture and discussion of susceptibility patterns with laboratory director 5. Resolution of problems on instrument supervisory review list under supervision of qualified employee 6. Review of instrument reports and suppression of antibiotics under supervision of qualified employee Evaluation

Criteria

for Successful

Performance

Criteria

for

Ongoing

Verification

of Compe-

*. ungoing supervisor ana airector review or susceptibinty reports indicates that the employee correctly detects and rechecks unusual susceptibility results (reviewer is required to recheck <3 % of results released by technologist as acceptable). 2. Ongoing supervisor and director review of QC results indicates that organism results are out of range ~2% of the time without an obvious reason (e.g., contamination). 3. Employee demonstrates to supervisor the required instrument maintenance, performing and documenting all required functions correctly. Bacterial Identification Expected

Outcome

Tests and Kits of Training

The employee will be able to 1. follow the instructions for each test to correctly perform the complete assay (including inoculation, interpretation, recording, and troubleshooting) 2. perform and record the necessary QC to demonstrate that the test is functioning properly Documents

and References

To Be Used during

Bacteriology procedure manual II Policies and QC manual

Methods

To Be Used

1. Reading of procedures in manual 2. Performance and recording of tests and QC under supervision of qualified employee Evaluation

Criteria

for Successful

Performance

Employee correctly performs and records results for spot tests, identification kits, and rapid identification tests. As a minimum, the employee must demonstrate to the supervisor or other qualified employee that they are able to perform spot indole or oxidase test disk test such as beta-lactamase or butyrate hydrolysis test slide and tube coagulase test overnight kit identification rapid (4-h) kit identification bile solubility

method method

test

streptococcal latex agglutination

1. Employee inoculates instrument panel with QC organisms, and all results are found to fall within required ranges. 2. Employee demonstrates ability to correctly manually interpret biochemical and MIC results (~98 % accuracy) to supervisor or qualified employee. 3. Employee performs required instrument maintenance for supervisor, performing all required functions correctly. Employee evaluates a minimum of 100 susceptibility reports for appropriateness of results. Director review finds results on ~5% of reports which were not appropriately questioned or checked. Evaluation tency

Training

Training

39

test

catalase test -. Employee correctly performs and records the required daily or weekly QC on the above tests and performs and records the required kit QC on at least one multiwell identification kit. Evaluation tency

Criteria

for

Verification

of

1. Ongoing review of QC records indicates that the employee has performed and recorded kit QC appropriately, with two or fewer instances of failure to respond to QC failure identified per year. 2. Employee correctly demonstrates how to perform one spot and one kit identification test to the department supervisor or designee.

LABORATORY B Approach

to Competency

Assessment

This laboratory has analyzed its organization and work flow and chosen to approach competency assessment from a discipline perspective. The laboratory works up bacteriology cultures according to each patient’s name: hence, the work is distributed according to the alphabet (e.g., names beginning with A through G, H through M, and 0 through 2). Technologists work on all of one patient’s specimens on the same bench (e.g., the patient’s urine culture, positive blood culture, and sputum culture) . Work is entered into computers and released as preliminary or final reports, with the department manager (or designee) reviewing all positive results on the next routine working day. Work concerning positive results from the weekend is reviewed the following Monday morning by the manager or designee. Training and competency documents have been prepared for each area of the laboratory (bacteriology, mycology, mycobacteriology, etc.). Direct observation is the cornerstone of competency assessment in this laboratory, and flexibility is given to the observer in each area. Four areas of responsibility in the microbiology area are indicated below.

Area 1: Specimen Receipt/Processing Competency Assessment documentation PLEASE PRINT EMPLOYEE: EE #:

EE #:

Policy Review Direct Observation C. Document Review

A. B.

HOW COMPETENCY MEASURED:

form:

TITLE:

TITLE:

Supervisor

Medical

Signature

Annual

Date

DEPT #:

DEPT #:

THE ABILITIES NECESSARY OF THIS JOB.

Technologist

POSSESSES AND DEMONSTRATES FOR THE QUALITY PERFORMANCE COMPETENCIES

Employee

This IS a representative sampling of the competencresnecessaryfor safe, effective performance

VALIDATOR:

NOTE:

Y

K E

DATE

C

Approprrate dehvery of routine and stat tests to the approprrateperson for testing

Correct entry of specimensinto the computer fillrng m all required fields

Initial

B and/or

C

Rejectron of Inadequatespecimens(computer entry and non&anon)

Verificatron that all pertinent mformatron accompaniesspecrmens

B and/or

C

Correct handling of sendout specimenssent to referral laboratorres (correct computer entry, correct specimen storage,oversrght of referral laboratory pickup)

VALIDATOR INITIALS

B and/or

C

HOW MEASURED B and/or C

B and/or

Correct handling of reports mcomrng from referral laboratories (retrreving from referral laboratory computer, m-house computer entry and filing)

Approprrate culture of specnnens(moculatron of medra,plate streaking, incubatron)

C

C

Gram stain preparatron

B and/or

A or B

Specimen rejectron

Reportrng out appropriate patrent data over the telephone only to appropriate personnel

A, B, or C

O&P preparation

C

AorB

Stat reporting

LEVEL

OF COMPETENCE

Comments:

form.

1. Little or no experrence 2. Some experience (may require practice or assistance) 3. Competent and can perform mdependently 4. Competent and can perform independently and IS able to assessthe competency of others. LEVEL OF COMPETENCE (1,2,3, or 4)

documentation

B and/or

C

assessment

Appropriate documentatronof all testrng

competency

C

receipt and processtng

Group B streptococcal antrgendetection acceptedonly on CSF from Infants <3 months (age-specrfic competency)

Specimen

C

FfGURE A2

DATE

K E Y

NOTE:

EE #:

VALIDATOR:

EE #:

EMPLOYEE:

form:

TITLE:

TITLE:

Technoiogist

Supervisor

Medical

Annual

FIGURE A3.

Blank competency

assessment

documentation

This is a representative sampling of the competencies necessary for safe, effective performance. HOW COMPETENCY MEASURED: Employee Signature Date A. Policy Review B. Direct Observation POSSESSES AND DEMONSTRATES THE ABILITIES C. Document Review NECESSARY FOR THE QUALITY PERFORMANCE OF THIS JOB. HOW VALIDATOR COMPETENCIES MEASURED INITIALS

PLEASE PRINT

Area: Competency Assessment documentation

form.

LEVEL OF COMPETENCE Comments:

(1,2,3,

or 4)

LEVEL OF COMPETENCE 1. Little or no experience 2. Some experience (may require practice or assistance) 3. Competent and can perform independently 4. Competent and can perform independently and is able to assess the competency of others

DEPT #:

DEPT #:

Initial

CUMITECH

39

Competency

Assessment

in the

Laboratory

13

An example of one of these four areas with the accompanying documentation form is included in the following section (Fig. A2)J Documentation forms for the other areas can be created by placing the respective competencies listed below into a blank document form (Fig. A3).

drate, hippurate hydrolysis, indole spot, optochin, porphyrin, salt broth [6.5%], and tube medium tests [e.g., triple sugar iron]) Latex agglutination tests for staphylococcal and streptococcal identification

Examples

Motility (wet prep and interpretation semisolid media)

of Annual

Competencies

Microbiology Competencies The following will outline what might normally be observed and/or documented when competencies in microbiology are assessed. Approximately 70 to 80% of the following procedures should be reviewed when direct observations are made in each competency area. If performance on a proficiency testing survey is utilized in assessment of competency, a copy of the work performed by the employee should accompany the documentation. Competency

Area

Verification specimens

that all pertinent

information

Correct entry of specimens into the computer, required fields

accompanies

kit, and spot tests)

(automated

and manual)

and gonococcus

amplification

Appropriate Age-specific held 48 h

documentation of all testing competencies example: infant urine cultures

Competency

Area

3

subculturing

and growth

Changing of parasitology Staining QC

readings

of QC

reagents as appropriate

Serology QC Assessment of laboratory

inventory

Water cultures Maintaining isms

anaerobic

chamber

and anaerobic

Labeling and recording receipt of all purchased pared media, reagents, etc. Weekly AST testing (manual

organand pre-

and automated)

Reporting appropriate patient data over the telephone only to appropriate personnel Appropriate culture of specimens (inoculation of media, plate streaking, and incubation)

Preparation of reagents Biochemicals and other identification

Gram stain preparation

Appropriate

Proper use of the cytocentrifuge Specimen rejection

Corrective

Identification procedures by manual and automated methods and with miscellaneous kits and reagents

Competency

specimen preparation

detection

entry and result reporting of stat patient results

Appropriate organisms

filling in all

Correct handling of reports coming from referral laboratories (retrieving from referral laboratory computer and performing in-house computer entry and filing)

documentation

media or reagents

of all testing

action if QC unacceptable Area

4

Reporting of stat patient results Appropriate documentation of all testing

The employee demonstrates the ability to perform and/or document instrument maintenance, which includes the following:

Age-specific competencies (example: group B streptococcal antigen detection accepted only on cerebrospinal fluid from infants ~3 months old)

l l l

Competency

Area

2

l

The employee demonstrates the ability to perform and/or document bacteriology procedures, which includes the following:

l

(automated,

procedures

The employee demonstrates the ability to perform and/or document QC procedures, which includes the following:

Correct handling of specimens sent to referral laboratories (correct computer entry, correct specimen storage, and oversight of referral laboratory pickup)

l

procedures

Susceptibility Computer Reporting

Appropriate delivery of routine and urgent tests to the appropriate person for testing Rejection of inadequate specimens (with computer entry and notification of the appropriate person)

Ova-and-parasite

of

Identification Chlamydia

1

The employee demonstrates the ability to receive and/or nrocess specimens, which includes the following:

of inoculation

l

Blood culture instrumentation Anaerobic chamber Susceptibility system Serological instrumentation Amplified Chlamydia trachomatis

APPENDIX

instrumentation

B

Gram stains (specimen, plate, broth, and blood culture)

CASE STUDIES

Enzymatic tests (beta-lactamase, idase, pyruvate, and urea tests)

The following case studies demonstrate the role that competency assessment assumes as a critical component of the laboratory QA program.

catalase, coagulase, ox-

. Chemical tests (bile esculin agar, bile solubility,

carbohy-

14

Elder and Sharp

CASE I TB OR NOT TB: THAT IS THE QUESTION A PROBLEM OF PROCEDURAL DRIFT Cultures from two patients that were processed for mycobacteria on the same day both grew Mycobacteriwn tuberculosis. One of the patients (patient A) was smear positive for this organism, with numerous acid-fast bacilli, while the other patient (patient B) was smear negative for acid-fast bacilli. The culture from patient A was positive after 10 days of incubation, while the culture from patient B was positive after 18 days of incubation. Contamination of patient B’s sample from the smear-positive sample from patient A was suspected. Both M. tuberculosis isolates were sent for molecular testing to determine if they were in fact the same organism. The supervisor questioned the senior technologist who initially processed the specimens in order to determine how this might have happened. No obvious reason was identified. The supervisor decided that competency assessment might shed some light on the situation, and she directly observed the technologist processing specimens for mycobacterial smear and culture. Upon this interaction, the supervisor found that the technologist was not capping specimen transfer tubes after adding a patient’s sample prior to transferring the specimen from the next patient. The supervisor believed that this break in protocol led to the suspected contamination (which was subsequently confirmed by molecular testing). The technologist stated that she was not the only person following this nonstandard procedure. Due to this deviation from the standard protocol, it was decided that direct observations were warranted for all the mycobacteriology processing technologists to ensure that adherence to proper techniques was followed by everyone. An additional minor deviation from protocol was observed during these competency assessments that was corrected for all the technical staff. In this instance, competency assessment by direct observation assisted the laboratory in improving the quality of future results from the mycobacteriology laboratory.

CASE 2 BUBBLE, BUBBLE, TOIL AND TROUBLE A PROBLEM OF AN UNEXPECTED PROCEDURAL VARIABLE After 7 days of expensive workup on a blood culture isolate, the organism was finally referred to a reference laboratory for identification. When the result was received back in the laboratory several weeks later, the supervisor was surprised at the identification, since the organism identified was catalase positive, and the laboratory had consistently gotten negative catalase results in-house. Initial competency testing did not reveal a problem. Review of QC records indicated that QC had been consistently performed using isolates of staphylococci and streptococci. The two technologists involved in the initial identification of the organism were experienced and immediately demonstrated their competence to the supervisor upon request. The supervisor asked to see the original bottle of hydrogen peroxide that served as the source of the individual bench aliquots. The bottle was

CUMITECH

39

retrieved from a shelf in the laboratory, where it had been placed by a technologist for easy access. Also located on the shelf, immediately adjacent to the bottle, was the slide warmer used to dry Gram stain slides. The bottle felt warm to the supervisor’s hands. The supervisor educated all the staff about this incident at the next staff meeting. In addition, the slide warmer was moved to the end of the shelf away from any laboratory reagents. In this case, the individual competency of the staff was not the issue; they were performing the test correctly. QC had not detected the problem since the strongly positive staphylococcus used for QC was still positive despite reagent deterioration. However, competency assessment did reveal a problem that could be corrected to improve laboratory performance.

CASE 3 SPOT OR STRIP? A PROBLEM OF SUBJECTIVE INTERPRETATION The microbiology laboratory at a 3OO-bed hospital routinely identifies Escherichia co/i from superficial wounds based on colonial morphology on MacConkey agar and spot indole reaction. Colonies not meeting the requirements are identified with an overnight kit identification strip at a cost of approximately $3.00 per organism. Part of the ongoing competency assessment of the laboratory is a review of all positive culture worksheets by the department supervisor. As part of this review, the supervisor notices that one of her employees seldom reports an E. coli result without performing a strip test. The supervisor’s impression is that the technologist performs far more strip tests than other technologists in the laboratory. The supervisor does not want to discourage the technologist from performing strip tests when appropriate, but the supervisor also does not want unnecessary expense on her tight microbiology budget. How might the supervisor proceed? The supervisor assessed the technologist’s understanding of the protocol for working up superficial wound cultures, as well as her competency in the interpretation of colonial morphology. This was done by first reviewing the situation with the technologist and ensuring that she completely understood the criteria for organism workup in this area. It was clear that the technologist understood the protocol, so direct observation by the supervisor of the technologist as she interpreted colonial morphology helped to further identify the source of the problem. The technologist required guidance in understanding the limits of interpretationhow she should work up young colonies, if colony morphology is slightly abnormal (e.g., a more mucoid colony), etc. Once it was determined that the technologist could both describe and follow the protocol, the supervisor encouraged the technologist to bring any future isolates to her for consultation if there were any uncertainty about whether they fit the morphologic criteria. Finally, the supervisor continued to monitor the technologist’s work (and performed spot checks if deemed necessary) to ensure that the problem had been resolved.

CUMITECH

39

Competency

CASE 4 EXTENDED WHAT? A PROBLEM OF EDUCATION WITHOUT ASSESSMENT An 87-year-old nursing home patient was admitted through the emergency room with a diagnosis of pneumonia. She was started on intravenous ceftriaxone and levofloxacin and transferred to the intensive-care unit. A sputum specimen was collected in the emergency room that showed many neutrophils and many gram-negative rods resembling enteric pathogens on Gram-stained culture. The culture grew many E. coli bacteria, and the organisms underwent antimicrobial susceptibility testing (AST). The results of the AST were as follows: Susceptible (S): aztreonam, ceftriaxone, cefepime, gentamitin, piperacillin, tobramycin, and imipenem Resistant (R): ampicillin, cefazolin, and trimethoprim-sulfamethoxazole Intermediate (I): ceftazidime and levofloxacin As per the laboratory’s reported the following

cascading protocol, the technologist results on the patient chart:

ampicillin: R cefazolin: R ceftriaxone: S gentamicin: S levofloxacin: I piperacillin: R trimethoprim-sulfamethoxazole:

R

Based on the AST report from the laboratory, the physicians in the intensive-care unit discontinued levofloxacin and left the patient on ceftriaxone only. The patient showed no improvement and developed shaking chills and fever spikes. Blood cultures were obtained. The blood cultures were positive within 24 h for E. coli that had the same susceptibility pattern as the isolate from the sputum culture. An infectious disease consult was called. The infectious disease physician came to the laboratory to review the antibiotic pattern for both of these organisms. She switched the patient to imipenem, and the patient showed rapid improvement. The AST on this organism indicated the possibility of an E. coli strain that harbored an extended-spectrum betalactamase (ESBL). Confirmation testing for these organisms is recommended by the NCCLS. If confirmed as an ESBLproducing organism, the organism would be resistant to all cephalosporins (including ceftriaxone), all penicillins, and aztreonam (this organism would rtot be resistant to the cephamycins, e.g., cefoxitin and cefotetan). For this organism, confirmation testing for possible ESBL production should

Assessment

in the Laboratory

15

have been performed, and if ESBL production had been confirmed, the results should have been reported as follows: ampicillin: R cefazolin: R ceftriaxone: R ceftazidime: R gentamicin: S levofloxacin: I piperacillin: R trimethoprim-sulfamethoxazole: R This error led to morbidity to the patient and increased length of stay in the hospital that could have been avoided if the laboratory personnel had been competent in recognizing this atypical AST pattern as that of a possible ESBL-producing organism. Competency assessment in this case indicated that the employee was unfamiliar with the pattern for a suspected ESBL producer. The supervisor had relied on a group laboratory inservice to educate the technologists on this topic but had not individually assessed competency at a later time. In this case, the supervisor has several options, including ongoing education of staff accompanied by competency assessment or mandatory second checks of all AST patterns by a few technologists (or supervisors) whose competency has been demonstrated. 1. College of American Pathologists. 200 1. Commission on Laboratory Accreditation General Laboratory Inspection Checklist, p. 80- 84. College of American Pathologists, Northfield, Ill. 1992. Medi2 Health Care Financing Administration. care, Medicaid, and CLIA programs. Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Fed. Regist. 57:70027186. 3 Howanitz, I?. J., I?. N. Valenstein, and G. Fine. 1996. Employee Competency Evaluation 96-04. Q-Probes. College of American Pathologists, Northfield, Ill. Committee for Clinical Laboratory Stan4. National dards. 1995. Training Verification for Laboratory Personnel. Approved guideline GP2 1-A. National Committee for Clinical Laboratory Standards, Wayne, Pa. 5. Nevalainen, D. E., and L. M. Berte. 1993. Training, Verification and Assessment: Keys to Quality Management. Clinical Laboratory Management Association, Malvern, Pa. 6. Sharp, S. E. 2001. Initial verification and competency assessment in the clinical microbiology laboratory. Clin. Microbial. Newsl. 23:79 - 8 1.