WHY DO IT? 

Why do what?

Why perform training verification and competency assessment in clinical microbiology?

There are several reasons for performing and documenting initial training verification and competency assessment of clinical microbiology personnel.  One: It has been mandated by U.S. law since 1988 as part of the Clinical Laboratory Improvement Amendments.  This act was an amendment made to the original Clinical Laboratory Improvement Act of 1967, and clearly defines in the Code of Federal Regulations, CFR, (published by the Federal Register) the requirements for initial training verification, initial competency assessment and on-going competency assessments of laboratory personnel. 

The pertinent CFRs are detailed below:

42CFR493.1445.  Standard:  Laboratory Director Responsibilities.

                Ensure that prior to testing patient’s specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.

                Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.

                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, that identifies 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.  Standard:  Technical Supervisor Responsibilities.

                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 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 evaluation of the staff must include, but are not limited to –

1.        Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing.

2.        Monitoring the recording and reporting of test results.

3.        Review of intermediate test results or worksheets, quality control 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.

A second reason for performing competency assessment with laboratory  personnel is that it is a requirement of the College of American Pathologist (CAP) and The Joint Commission for the Accreditation of Hospitals Organization (JACHO) 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/accreditation.

The 1999-0 Edition of the CAP General Inspection Checklist includes the following:

GEN.00132  Phase II

Do technical personnel records include summary of training and experience?

GEN.00141  Phase II

Do technical personnel records include annual review of the performance of existing employees and initial 6-month review of new employees?

GEN.10493  Phase II

Has the competency of each person to perform his/her assigned duties been assessed?

NOTE:  The manual that describes training activities and evaluations must be specific for each job description.  Those activities requiring judgment of interpretive skills must be included.  The records must make it possible for the inspector to be able to determine what skills were assessed and how those skills were measured.

COMMENTARY:  Retraining and reassessment of employee competency must occur when problems are identified with employee performance.  The training and assessment program must be documented and specific for each job description.  In order for your laboratory to comply with these federal regulations and national accrediting agencies guidelines, you must have a system in place that will allow you to verify the initial training of your staff and assess their competence twice in their first year of employment and annually thereafter.