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Training verification for lab personnel: a new guide.

A system is only as good as the training of the individuals who perform the work. By adapting the proposed training guideline outlined here, your lab will take an important step toward building a quality health care system.

A LAB CAN HAVE the finest testing equipment, the most expensive computers, and the best management team, but without a properly trained staff, it will never provide quality service. While undergraduate programs in medical technology furnish students with an educational foundation for a career in laboratory medicine, these professionals can only function optimally once they have received effective employee training.

Consider these facts:

* CLIA permits individuals without college degrees to perform complex laboratory testing.

* Increased attention by the FDA to good manufacturing practices has uncovered serious errors in blood banking systems and processes.

* Lab managers struggle to run their departments effectively with an insufficient number of employees.

It doesn't take much to realize that our profession requires a standardized training program. Organizations such as the Health Care Financing Administration (HCFA), the Food and Drug Administration (FDA), the Joint Commission oil Accreditation of Healthcare Organizations (JCAHO), the College of American Pathologists (CAP), and the Commission on Office Laboratory Accreditation (COLA) have all set laboratory quality standards that require a prescribed level of employee education and training. Unfortunately, training and documentation prerequisites in these standards are ambiguous.

* NCCLS steps in. In September 1993, the National Committee for Clinical Laboratory Standards (NCCLS) assembled a committee to draft a training verification guideline. The intent of the guideline is to furnish information needed to develop a training verification program that meets both quality and regulatory objectives.

Leaders from the health care industry, hospital and medical center labs, undergraduate laboratory educational programs, and state health departments from the U.S. and Canada were chosen as committee members and advisers. Others included were representatives from respiratory care and radiology, family physicians, and the FDA.

The final draft, Proposed Guideline GP21-P, Training Verification for Laboratory Personnel, was approved by the NCCLS board of directors in August 1994 and distributed to the lab community for comment in November 1994. Comments can now be submitted to the NCCLS until May 9, 1995, at which time all remarks will be reviewed, appropriate responses made, and an approved guideline published.

* Distinct pieces of the pie. The foundation of any quality system in the clinical laboratory is sound documentation coupled with appropriate training for all laboratorians. Organized training requires the development of well-written procedure and training manuals that tie into a system to verify such training. The role of training and training verification in total employee performance is shown in Figure 1. As the pie chart highlights, employee training verification is separate from competence assessment, performance standards, and performance appraisal.

The training verification process has two parts. Workers are trained in procedures related directly to their specific jobs and training is documented. According to CLIA '88, workers' competence in performing those procedures must also be assessed periodically. Performance standards are supervisors' expectations of employees regarding such things as interpersonal communication and teamwork skills in addition to technical skills. Finally, performance appraisal is the process by which employers evaluate workers' overall job performance for purposes of career development and wage modification.

The NCCLS guideline offers training assessment and documentation tools developed from properly prepared standard operating procedures (SOPs). For a detailed discussion on the interrelationships between process analysis and procedure development, procedure-based job descriptions, performance standards, and competence assessment, refer to the suggested reading list at the end of this article.

* Guideline specifics. Sections 1, 2, and 3 of NCCLS Proposed Guideline GP21-P offer an introduction, scope, and glossary of terms that set the stage for the remainder of the document. Sections 4 and 5 contain an implementation overview describing the development of training documents using flowchart analysis, procedure development, and procedure format.

Section 6 of GP21-P introduces how a training manual can be used to ready new employees during their orientation period and to incorporate new methods into their job duties. When a staff member's competence assessment reveals less-than-satisfactory performance, or when he/she has not performed a procedure within a specified period of time, the training manual can also be used for retraining.
Figure 2


How to verify the outcome of employee training


Measuring tools Method of documentation


Provide hands-on testing: Checklist


Blind specimens
PT specimens
Previously analyzed specimens


Administer Written test
written test


Observe outcome Observation form
of procedure


Assess responses to: Observation form


Problems (troubleshooting,
unexplained results)
Situations related
to procedure
Written case studies


Document critical Critical incident report
incidents related to
procedure


Critique oral response Observation form
to procedure queries


Assess completion of Checklist
learning objectives


As outlined in Section 6, a training document should be constructed for each SOP, or set of related procedures, in which laboratorians need training. Each form should include the procedure name and accompanying reference number; dates on which the SOP was prepared, adopted, reviewed, and/or revised; signatures of those who wrote/reviewed the SOP; and a list of all professionals who will receive a copy of the procedure.

The guideline suggests that each training document be given a reference number that relates to the SOP. Also included on this document should be a list of procedures that must be mastered as a prerequisite to the SOP in question.

A statement of psychomotor and cognitive learning objectives that employees must accomplish during their training should accompany this form, as should the method or process of training and criteria for successful performance. Training methods include the minimum steps that are required to read the procedure, observe a demonstration by a qualified trainer, practice the procedure, and complete an exercise to demonstrate and document a successful outcome.

The training document should contain a list of procedural steps and end with references for background, theory, principles, and applications. If performance standards are used, a section describing the cross-reference to a particular standard should be included.

Section 7 of the guideline proposes an implementation plan for employee training. Labs must identify which SOPs an employee should be trained in based on what position the worker holds and on his or her specific needs. To help supervisors identify procedures for which a particular employee must be responsible, the guideline recommends using a checklist format with employees' names listed along the top and procedures listed down the side. Sample audit forms to document training, retraining, competence assessments, and outcome comments are provided in the guideline, too.

Also, Section 7 provides a full description of the training tools available to lab managers for measuring employee performance. Documentation in the form of checklists, observation forms, written tests, and critical incident reports can all be used to verify the outcome of training exercises.

The appendix of the guideline includes examples of forms and documentation systems.

* Comments welcome. This proposed guideline is just that--a proposal for organizing a training verification system in your lab. As such, the NCCLS welcomes feedback on this guideline and encourages interested parties to respond in writing with comments, questions, and/or examples of tools and forms currently being implemented with success out in the field.

Copies of this guideline can be ordered by writing to NCCLS GP21-P, National Committee for Clinical Laboratory Standards, 771 E. Lancaster Ave., Villanova, PA 19085. Alternatively, lab professionals can call (610) 525-2435 or fax comments/requests to (610) 527-8399.

Suggested reading

Berte LM. Developing Performance Standards for Hospital Personnel. Chicago, Ill: American Society of Clinical Pathologists; 1989.

Ellinger PA, Tiehen AM. Competency testing for laboratory personnel: Planning, implementing, documenting. Workshops for Technologists. (Workshop/Teleconference Handout). Chicago, Ill: American Society of Clinical Pathologists; 1994.

Nevalainen DE, Berte LM. Training, Verification, and Assessment: Keys to Quality Management. Malvern, Pa: Clinical Laboratory Management Association; 1993.

Nevalainen DE, Callery MF. Quality Systems in the Blood Bank and Laboratory Environment. Bethesda, Md: American Association of Blood Banks; 1994.

Berte, a member of MLO's Editorial Advisory Board, is director of laboratory quality assurance and manager of the transfusion service at Elmhurst (Ill.) Memorial Hospital. Nevalainen is director of the Abbott Quality Institute, Abbott Laboratories, in Abbott Park, Ill. Both are members of the NCCLS training verification committee, WhiCh Nevalainen chairs.
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Author:Berte, Lucia M.; Nevalainen, David E.
Publication:Medical Laboratory Observer
Date:Jan 1, 1995
Words:1359
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