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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 CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a  '88. Transfusion services, which are regulated by the College of American Pathologists This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article.  (CAP), the Joint Commission on Accreditation of Healthcare Organizations Joint Commission on Accreditation of Healthcare Organizations, the United States body that accredits healthcare organizations.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO/TJC),
 (JCAHO JCAHO Joint Commission on Accreditation of Healthcare Organizations, see there ), and the American Association American Association refers to one of the following professional baseball leagues:
  • American Association (19th century), active from 1882 to 1891.
  • American Association (20th century), active from 1902 to 1962 and 1969 to 1997.
 of Blood Banks (AABB AABB American Association of Blood Banks.
AABB American Association of Blood Banks A professional, non-profit organization established in 1947 and dedicated to the education, formulation of standards, policy and other facets of
), 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 according to
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

 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 proficiency test nprueba de capacitación  (PT), and preventive maintenance The routine checking of hardware that is performed by a field engineer on a regularly scheduled basis. See remedial maintenance.

preventive maintenance - (PM) To bring down a machine for inspection or test purposes.

See provocative maintenance, scratch monkey.

* 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 blind testing,
n a clinical trial in which participants are unaware of whether they are in the experimental or control group of the study. Also called
 or external PT specimens.

* Assessing problem solving problem solving

Process involved in finding a solution to a problem. Many animals routinely solve problems of locomotion, food finding, and shelter through trial and error.

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 cat·e·go·rize  
tr.v. cat·e·go·rized, cat·e·go·riz·ing, cat·e·go·riz·es
To put into a category or categories; classify.

 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 steer·ing committee
A committee that sets agendas and schedules of business, as for a legislative body or other assemblage.

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 regulatory agency

Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S.

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 centrifuge (sĕn`trəfyj), device using centrifugal force to separate two or more substances of different density, e.g., two liquids or a liquid and a solid.  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 (MultiLink Trunking) See port aggregation.  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 In psychometrics, applied linguistics and education, competency evaluation is a means for teachers to determine the ability of their students in other ways besides the standardized test.

Usually this includes portfolio assessment.

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 ABO

See: Accumulated Benefit Obligation
 grouping discrepancy or mixed field agglutination agglutination, in biochemistry
agglutination, in biochemistry: see immunity.
agglutination, in linguistics
agglutination, in linguistics: see inflection.
. 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 reagent /re·a·gent/ (re-a´jent) a substance used to produce a chemical reaction so as to detect, measure, produce, etc., other substances.

 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 red blood cell: see blood.  antibodies, unusual requests for blood components (or requests for unusual blood components), mismatched forward and reverse ABO groupings, transfusion reaction transfusion reaction Blood transfusion reaction, incompatibility reaction Transfusion medicine Any untoward response to the transfusion of non-self blood products, in particular RBCs, which evokes febrile reactions that are either minor–occurring in 1:40  workups, mislabeled mis·la·bel  
tr.v. mis·la·beled also mis·la·belled, mis·la·bel·ing also mis·la·bel·ling, mis·la·bels also mis·la·bels
To label inaccurately.

Adj. 1.
 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 ver·ba·tim  
Using exactly the same words; corresponding word for word: a verbatim report of the conversation.

 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 A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or . 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 re·train  
tr. & intr.v. re·trained, re·train·ing, re·trains
To train or undergo training again.

 may be required. You should document the corrective action and the results of the reassessment Reassessment

The process of re-determining the value of property or land for tax purposes.

Property is usually reassessed on an annual basis. You may request a "reassessment" if you disagree with your assessment.

* 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 Performance appraisal, also known as employee appraisal, is a method by which the performance of an employee is evaluated (generally in terms of quality, quantity, cost and time).  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 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.  of 1988 (CLIA), Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
, Health Care Financing Administration Health Care Financing Administration, department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies.
. 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 MLO Mycoplasma-like organism(s) . 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.
COPYRIGHT 1993 Nelson Publishing
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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