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Competency assessment in the transfusion service.

These new procedures and innovative forms can help blood bankers meet CLIA's personnel evaluation requirements.

DOCUMENTING the ability of the laboratory staff to perform their assigned duties is required by CLIA '88. Transfusion services, which are regulated by the College of American Pathologists (CAP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the American Association of Blood Banks (AABB), should already have a staff competency assessment program in place. It is likely, however, that most of these programs will need to be expanded to comply with CLIA rules.

The regulations for competency assessment are not contained in the quality assurance sections of the CLIA final rules, where laboratorians might logically expect to find them. The competency requirements are included in the personnel sections of CLIA, under the responsibilities of the technical supervisor in laboratories where high complexity testing is performed.

* The technical supervisor's job. According to CLIA as published in the Federal Register on Feb. 28, 1992, the following responsibilities fall to the technical supervisor:

1. Evaluating 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 assessing the competency of the staff must include, but are not limited to:

* Directly observing routine test performance, including patient preparation (if applicable), specimen handling, processing, and testing.

* Monitoring the recording and reporting of test results.

* Reviewing intermediate test results or worksheets and quality control (QC), proficiency testing (PT), and preventive maintenance records.

* Directly observing the performance of instrument maintenance and function checks.

* Assessing test performance through testing previously analyzed specimens or through the use of internal blind testing or external PT specimens.

* Assessing problem solving skills.

2. Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year those persons test patient specimens. Thereafter, evaluating them at least annually unless test methodology or instrumentation changes. In that case, before reporting patient test results, the testing individual's performance must be reevaluated to include use of the new test methodology or instrumentation.|1~

* Delegating responsibility. If you haven't yet waded through the four pages of technical qualifications for laboratories performing high complexity testing, you may be surprised to learn that, according to CLIA's definition, most transfusion service supervisors and managers do not qualify to be technical supervisors.

The technical supervisor must be a physician, according to CLIA. Traditionally, however, the positions of transfusion service supervisor or manager (general supervisors, according to CLIA) are filled by MTs. The rules allow the technical supervisor to delegate the responsibility for staff competency assessment to the general supervisor and, in most cases, it is an MT who does the job.

* Assessing competency. Since all compatibility tests are categorized as high complexity, most hospital transfusion services are required to assess the competency of staff as outlined above.

CAP and JCAHO both require staff competency assessment but do not go into detail regarding methods or frequency. The AABB, in the fourth edition of its Accreditation Requirements Manual (ARM), requires competency assessment when an employee is hired and every year thereafter. The ARM also lists many helpful suggestions and examples and, in addition, requires that a procedure for the competency assessment program be in each facility's procedure manual.

* Varying recommendations. I was a member of the steering committee of our local community blood center user group,|2~ which decided to put together a presentation for local hospital blood banks on the subject of CLIA's competency assessment regulations. We wanted to suggest ways we could comply with the new rules while taking into account the competency assessment requirements and recommendations of other regulatory agencies.

We looked at each of the six CLIA competency requirements and made suggestions for compliance. It's likely that several of the rules are already a routine part of every transfusion service's quality assessment and improvement plan. Other rules will require developing new procedures and forms for documentation. For our user group presentation, we created sample forms and a generic procedure you might adapt to your transfusion service.

* Meeting the regulations. Our suggestions for meeting the six regulations are as follows:

1. Directly observe routine test performance, including patient preparation (if applicable), and specimen handling, processing, and testing. Many transfusion service supervisors already do this in a casual way as they watch their staff perform their daily duties. CLIA requires a more formal procedure with, of course, documentation.

Figure 1 shows a fairly simple checklist|3~ that can help document test performance. Similar lists can be developed for the other tests performed in the transfusion service. Use the list during observation to document competency at each step or phase. Every technologist who performs tests must be assessed in this manner.

2. Monitor the recording and reporting of test results. This activity is almost certainly performed and documented on a regular basis by every transfusion service supervisor or manager. The monitoring usually includes the review of manual- or computer-generated patient reports and results.

The technical or general supervisor can document the review by recording his or her initials and the date directly on the records or in a supervisory review log.

3. Review intermediate test results or worksheets, QC records, PT results, and preventive maintenance records. As is true for the preceding requirement, review is required by several regulatory agencies and is probably already in place at most transfusion services. Perform and document supervisory review of patient worksheets or logbooks, QC activities, PT, and preventive maintenance records.

4. Directly observe performance of instrument maintenance and function checks. Similar to the requirement for direct observation of test performance, compliance with this rule can be undertaken in much the same way. Simply alter the form to reflect the specific activity.

Such activities may include the following: functional alarm testing, centrifuge calibration, centrifuge speed determination, and centrifuge timer calibration. Note that only those technologists who routinely perform these checks need be assessed.

5. Assess test performance through testing previously analyzed specimens, internal blind testing samples, or external PT specimens. This regulation is intended to demonstrate the ability of technologists to manage unknown specimens. It can be met in several ways. The method you choose will depend on the resources you have available in your laboratory.

Transfusion services that employ a technologist dedicated to educational activities (such as MT or MLT student and pathology resident training) may already have a library of specimens that are used in wet lab or bench teaching. A segment of our user group presentation included the details of one institution's experience with this sort of "wet competency evaluation."

As a result of that experience, I strongly recommend that you keep the quantity and difficulty of the unknown specimens at a moderate level. Maintain a clear focus on routine competencies. It is probably unnecessary to assess every technologist's ability to identify 10 samples, each containing three or four antibodies, for example. On the other hand, it is important to be sure that every technologist can recognize an ABO grouping discrepancy or mixed field agglutination. Use two or three specimens to assess such skills.

If preparation of in-house specimens is not feasible, a number of commercial surveys are available. They are reasonably priced and will save you the time-consuming effort of preparing specimens for competency evaluation. In our user group presentation, we provided examples of all of the currently available surveys from our blood bank reagent vendors. For smaller transfusion services, it may be feasible to rotate PT specimens (also required by CLIA) so that each technologist can be assessed at least once throughout the year.

You can also use a combination of these methods to comply with the regulation. Whatever method you use, remember to document both the activity and the outcome.

6. Assess problem-solving skills. Problems come to the transfusion service every day in many different forms. The advantage of problems is that they can be used to assess the competency of the transfusion service technologist.

Among useful problems are identification of atypical red blood cell antibodies, unusual requests for blood components (or requests for unusual blood components), mismatched forward and reverse ABO groupings, transfusion reaction workups, mislabeled pre-transfusion blood specimens, and nettlesome decisions regarding blood component inventory. Any or all of these difficulties can be used for staff competency assessment.

Use your supervisory review of antibody identification workups to assess and document the problem-solving skills of the technologists who handled them. If you have prepared in-house specimens to fulfill the preceding regulation (testing previously analyzed specimens), include some thought-provoking questions designed to evaluate problem-solving skills.

You can also assess problem-solving skills while encouraging the transfusion service staff to become familiar with and use the procedure manual. Devise questions that relate directly to specific procedures in the manual. Technologists will then reference the manual as they answer the questions.

* Frequency of assessment. CLIA requires the evaluation and documentation of each of the aforementioned six elements at least annually for all personnel and at least twice in the first year for a new employee. In addition, if you introduce a new test, methodology, or instrument, the staff must be assessed for their ability to use the new technique.

* Procedure manual. After determining the design of your competency assessment program, you must document that design in a procedure. Although this is not strictly required by CLIA regulations, the ARM requires it.|4~ You can take the statement of purpose of the procedure almost verbatim from the regulation. The purpose? To evaluate the competency of all testing personnel and assure that employees maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently.

Write the procedure by outlining the CLIA technical supervisor/consultant responsibilities for staff competency assessment. The procedure can be divided into four main sections: direct observation, assessment of problem-solving skills, assessment of test performance, and supervisory reviews. The direct observation section should include both routine test performance and instrument maintenance and function checks. Further subdivisions under supervisory review include the five requirements for monitoring and reviewing results and records.

The sections for assessment of problem-solving skills and test performance will vary greatly from one transfusion service to another, depending on the method(s) selected for assessment.

* Competency failure. You should think about what you will do if you experience a competency assessment failure. It is impossible to predict every kind of failure. If one should occur, you will need to develop a written plan for corrective action. What if, during direct observation of the performance of the ABO-grouping procedure, the technologist fails to look for previous patient records? The technical supervisor must insure that the technologist is retrained and then reassessed for competency in that particular area.

In this example, the technologist could be counseled or required to review the written procedure and then be reassessed. If the competency assessment failure is due to a technical or skill deficiency, more rigorous retraining may be required. You should document the corrective action and the results of the reassessment.

* More involvement. CLIA requires that we take a more active role in the assessment of the competency of our staff to perform their assigned duties. Although it may seem like a formidable task at first glance, with a little organization and planning it can become a routine part of the employee performance appraisal process. Moreover, competency assessment gives us the opportunity to identify and assess personnel performance deficiencies before they become problems.


1. Medicare, Medicaid, and CLIA Programs; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Department of Health and Human Services, Health Care Financing Administration. Federal Register. Feb. 28, 1992; 57(40): 7,180-7,181.

2. Tiehan A, Greene D, Hoster M, Krainz P. A community blood center user group. MLO. 1991; 23(7):47-50.

3. Inspection Checklist, Section I, Laboratory General. Northfield, Ill: College of American Pathologists; 1991.

4. Jones FS, ed. Accreditation Requirements Manual. 4th ed. Bethesda, Md: American Association of Blood Banks; 1992.

Suggested reading

Joint Commission on Accreditation of Healthcare Organizations. Accreditation Manual for Hospitals. Oakbrook Terrace, Ill: JCAHO; 1993.

Ellinger P, South SF. Proficiency/Competency Testing. |teleconference~. Bethesda, Md: American Association of Blood Banks; 1992.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Author:Tiehen, Ann
Publication:Medical Laboratory Observer
Date:Oct 1, 1993
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