Standard Operating Procedure- SOP Name of institution Competency Assessment ID Code: Ap 16 Topic & Purpose: Review Period: This procedure describes the staff’s competency assessment 1 year Location: Distribution: Version number: Annex: V 1.0 1. Tests and procedures for each sub-specialty in the laboratory (to be developed) 2. Competency assessment checklist 3. Competency assessment logbook Written by: Name(s), Date(s) and Signature(s) of the Author(s) Reviewed by: Name(s), Date(s) and Signature(s) Authorized by: Name, Date and Signature Replaces the version: Not applicable (1st version) Changes to the last authorized version: Not applicable (1st version) Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 Competency Assessment Procedure Application ........................................................................................... 2 Objective .............................................................................................. 2 Definitions ............................................................................................ 2 References........................................................................................... 2 Responsibilities .................................................................................... 2 Operating mode ................................................................................... 3 Methodology ..................................................................................... 3 Competency assessment process.................................................... 3 Competency assessment failure ...................................................... 4 Related documents .............................................................................. 5 Annex 1 ................................................................................................ 5 Annex 2 ................................................................................................ 6 Annex 3 ................................................................................................ 7 Application This procedure ensures staff’s competency in the laboratory. Objective This procedure describes how to assess the staff’s competency. Definitions To be filled in if necessary References To be filled in if necessary Responsibilities The Laboratory Director is responsible for: ensuring the implementation and supervision of laboratory staff competency assessments; taking any required action as indicated by the assessment results. The Quality Manager assigns appropriate staff as Competency Assessors. The Competency Assessors are responsible for conducting the competency assessments and documenting the results. An observer is advisable if there are sufficient staffs. 2 Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 Operating mode Methodology The goal of a competency assessment is to identify potential problems with employee performance and to address these issues before they affect patient care. Observations followed by documentation of remediation are critical components of the competency assessment process. Competency assessment process 1. A consistent standard for evaluation of competency should be applied to all employees. 2. Competency assessment records are retained for the entire time an individual is employed at the laboratory. 3. The areas requiring competency in the laboratory have been defined. They are the following: List here the areas requiring competency in the laboratory XXX 4. A list of all tests and procedures for each sub-specialty in the laboratory has been made (Annex 1, to be developed). 5. The Competency Assessor, in discussion with the staff member’s supervisor, will select items from the test list and schedule the exercise to take place, with an observer if applicable, at a mutually convenient time. Competency assessment must be specific for each job description. 6. The assessor will fill in the corresponding checklist (Annex 2) by directly observing the employee and checking the different records needed for the assessment. The assessor will be in charge of filling in the competency assessment logbook (Annex 3). a) New employee For a new employee, direct observation is used to assess the employee's ability to accurately follow the laboratory procedure. An assessment of competence is done twice in the first year of employment and annually thereafter. b) Experienced employee An evaluation for ongoing competency for an experienced employee is performed by: directly observing performance of routine clinical tests; monitoring test result documentation and reporting processes; reviewing intermediate test results, QC records, proficiency testing results, and preventive maintenance records; directly observing instrument maintenance performance and function validation; 3 Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 assessing test performance by: o re-testing selected previously analyzed specimens to validate the reported results; o reviewing the results of internal blind testing samples or external proficiency testing samples. assessing problem-solving skills. Competency assessment failure 1. If an employee fails one or more areas of the competency assessment, the assessor will analyze the problem so that the proper corrective measures can be identified and implemented. Analysis of the problem starts with inspection of the protocols used for laboratory practice. The protocols should be clear and concise; if they are inadequate or confusing, this may account for the employee’s competency failure. In proficiency testing, it should be ensured that the proficiency sample is adequate and that a problem with the sample itself is not the cause of competency failure. 2. If the protocols are not the cause of the competency failure, the following questions should be answered: Did the employee perform the test incorrectly (i.e., did he/she not follow the proper test procedure)? Did the employee misunderstand the purpose or background of the performed test (i.e., is he/she unable to solve problems or adapt the test results to the clinical situation)? Did the employee misunderstand the components of the test or instrument being used? Was the employee unable to resolve QC problems? Did the employee perform the test accurately but make an error in the documentation? 3. Discussion of the protocol with the employee that fails competency is warranted to assess if further action is necessary, based on the employee's verbal response. This may be sufficient to identify the reason for competency failure. 4. Actions that can be taken with an employee who fails competency include: having the employee reread the protocol and discuss it with the supervisor in order to clarify any misinterpretations; having the employee produce a flow chart to assist him or her in properly performing the protocol; having the employee observe another trained and competent employee; 4 Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 having the employee practice the failed protocol with known specimens; having the employee correctly retest the specimen originally tested during the failed competency assessment. 5. Reinstitution of formal training will be necessary if the above mentioned methods fail to confirm that the employee is competent. 6. Regardless of the selected corrective measures, it is necessary to repeat the competency assessment once the corrective measures have been completed. Successful accomplishment of competency for the employee who has failed the original competency assessment is to be documented. 7. Discussion of test and QC procedures in a quality assurance-QC meeting with all employees could help staff to understand how certain types of errors can be avoided. 8. As a last resort, the employee can be permanently removed from selected duties and reassigned to another work area. Related documents Filled in competency assessment checklist/form will be filed with records Ref XXX Competency assessment logbook Ref XXX Annex 1 Tests and procedures for each sub-specialty in the laboratory To be developed 5 Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 Annex 2 Competency assessment checklist Example: COMPETENCY ASSESSMENT Date of assessment: Assessor name: Observer name (if applicable): Analyst name: Evaluation period: Title: To Method procedure: Reading of pertinent portions of the SOP Yes No N/A Comments Direct observation Safety policies followed Preparation of work area Work area neat and organized Follows policies, procedures and rules pertaining to assignment Preparation/handling of specimen Preparation/handling of reagents Preparation/handling of QC Preparation/handling of equipment and maintenance activities Knowledge of criteria for acceptable specimen Knowledge of criteria for unacceptable specimen 6 Institution: Version: 1.0 Date: Number of pages: Name of 7 procedure: Competency Assessment Procedure ID Code: Ap 16 QM chapter: 9 Annex 3 Competency assessment logbook Example: Competency assessment logbook Name of the laboratory Employee Date Task Assessor Appraisal Comment Acceptable Reassess 7