D.16 Ancillary Testing Training and Competency Assessment.pdf

Ancillary Testing Manual-Ancillary Testing Training and Competency Assessment

ANCILLARY TESTING TRAINING AND COMPETENCY ASSESSMENT

SCOPE:

This policy is in effect for the Abie Abraham VA Healthcare Center & all of its ancillary testing sites i.e. the

Community Living Center, the five community-based outpatient clinics (CBOCs), and the domiciliary and for all of the ancillary testing procedures performed at these sites. This testing consists of Roche Inform II glucometer testing, Roche Coaguchek XS Plus INR testing, Afinion AS100 A1c testing, urine HCG testing and urine drugs of abuse screening testing.

PURPOSE:

To establish guidelines, procedures and personnel requirements for use in evaluating competency for all personnel who perform point of care (POC) testing.

1. A formal competency program provides the ancillary testing program with a valuable tool for identifying and correcting issues of employee competence. The use of competency assessment is also an ongoing part of the laboratory’s quality assurance program to assist in ensuring that high-quality results are reported.

Competency assessment is also an opportunity to provide continuing education and performance feedback to the POC operators and to document valuable objective information for a comprehensive assessment of competence of POC operators.

2. Competency evaluation is necessary to comply with federal regulations and national accrediting agencies guidelines. A system must be in place to verify initial training, and assessment of competency annually thereafter for the waived testing procedures that are provided under the aegis of the ancillary testing program. Ongoing competencies build on already established knowledge, skills, abilities and behaviors, and also reflect the new, changing, high-risk and problematic aspects of the ancillary testing program.

Competency evaluation is the ongoing assessment of each POC operator’s ability to perform work and to identify areas where improvements can be made to ensure quality patient care. Retraining and reassessment of employee competency will occur when problems are identified with the POC operator’s performance.

3. The goal of competency assessment is to identify potential problems with the POC operator’s performance and to address these issues before they affect patient care. Thus, performance and documentation of remediation is a critical component of the competency assessment process. Remediation should not be punitive but should be educational and it should always be directed at improving performance.

POLICY:

1. Competency must be evaluated and documented for all ancillary testing personnel for each test system for which they are responsible. A test system is the process that includes pre-analytic, analytic and post-analytic steps used to product a test result or a set of results.

2. Elements of competency assessment include but are not limited to the following six elements:

i. Direct Observation-patient test performance: Direct observation of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing.

ii. Monitoring results: Monitoring the recording and reporting of test results, including, as applicable, reporting of critical results.

iii. Review of results: Review of intermediate test results, as applicable, quality control results, proficiency testing results and preventive maintenance records.

iv. Direct Observation-instrument maintenance: Direct observation of performance of instrument maintenance and function checks.

v. Proficiency Testing: Assessment of test performance through testing previously analyzer specimens, internal blind testing samples, external proficiency testing samples; and

vi. Evaluation of problem-solving skills: Evaluation of problem-solving skills through such as instrument trouble shooting, quizzes/tests, etc.

3. Other elements of competency may be assessed as applicable. For waived tests (test systems that are simple laboratory examinations and procedures which are cleared by the FDA for home use, employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly), it is not necessary to assess all elements at each assessment event; the laboratory supervisor in coordination with the ancillary testing coordinator will determine which elements are to be assessed. Two elements must be used to assess the competency of waived testing.

RESPONSIBILITIES:

1. Chief of Staff has overall responsibility for assuring compliance with this policy.

2. Laboratory Director is responsible for the overall administration of the ancillary testing program. They decide which tests may be performed outside the main clinical laboratory for patient care diagnosis or monitoring.

3. Laboratory Supervisor has oversight over the Ancillary Testing Coordinator and is responsible for monitoring all aspects of ancillary testing. They work with the ATC to assure that all ancillary functions are up to date and satisfactory.

4. Ancillary Testing Coordinator (ATC) is a registered fully qualified medical technologist with at least 4 years of experience in laboratory testing and is a member of the Pathology and Laboratory Medicine Service. This individual:

a. Is responsible for the overall management of ancillary testing. They provide technical oversight for all testing sites.

b. Participate in the selection of proposed ancillary testing methodologies. They further provide the required validation testing of any new ancillary testing methodologies & establish test performance characteristics, including test precision and accuracy.

c. The ATC will monitor quality control, quality assurance, maintenance review, records control, proficiency testing completion, preparation for inspection and accreditation of ancillary testing sites, and provides competency assessment of all ancillary testing personnel.

d. The ATC monitors clinical competency partly through the proficiency testing program from College of American Pathologists and other approved proficiency testing providers. They ensure that all ancillary tests have an accompanying proficiency testing survey. They ensure that these surveys are sent & received by each of the ancillary testing sites, that this testing is rotated amongst all of the ancillary testing staff, and that survey results are submitted in a timely manner. They also assure corrective action for unacceptable proficiency testing survey results and the documentation of this corrective action.

5. Certified Instructor (Nurse Educator and/or Train-the-trainer): Is a nursing supervisor or a nursing educator.

They provide training of testing personnel in ancillary testing instrument operation and policy and procedure of the ancillary testing program. They also participate in the evaluation and documentation of clinical competency. It is acceptable to have the train-the-trainers conduct reassessment as long as they have a competency on record for the testing that they are assessing. They are expected to know, to demonstrate compliance to and to provide education as to the basic ancillary testing requirements as provided in this document. They do not answer to the ATC but are expected to coordinate with him/her. Any issues that arise between these two parties are to be communicated by the ATC or the train-the-trainer or both to the laboratory supervisor and to the train-the-trainer’s supervisor. They can provide the annual ancillary testing competency assessment on the ancillary testing procedures for which they have been trained however they will not be permitted to provide orientation training to any new trainees.

6. Supervisors and service chiefs have overall responsibility for adherence to the ancillary testing program policy and procedures. They will serve as contact persons for resolution of any incidents of non-compliance or proficiency testing issues.

7. Nurse managers serve as liaisons between the Ancillary Testing Coordinator and certified operators in their clinical areas. The nurse managers are responsible for informing the Ancillary Testing Coordinator of any test site problems that may occur and assisting the Ancillary Testing Coordinator in the scheduling of proficiency testing. They are to oversee inventory control and all manufacturer required maintenance, and to also oversee proper cleaning and disinfection of equipment.

8. Certified operator/Testing Personnel will be authorized to perform ancillary INR, glucose, pregnancy, and urine drug screen testing (UDS) on patients/residents at the VAMC and in the CBOC’s.

9. Pathology & Laboratory Medicine Service staff help with the distribution of all testing strips, quality control, reagents, and test kit to all testing sites.

10. Providers are responsible for ordering, interpreting, and prescribing therapies.

11. Logistics Services is responsible for supplying testing supplies such as test strips/cartridges, controls, lancets, etc. to the laboratory for distribution to the individual testing sites.

PROCEDURE:

Certification:

a. Authorization to perform ancillary testing in this facility will be limited to those health care personnel who have satisfied the certification requirements. These requirements include participation in an in-service training program by a certified instructor and demonstration of clinical competency.

b. Continued certification will be contingent upon successful recovery and interpretation of control data, adherence to policy and procedures. The ATC will notify medical center nursing supervisors, the CBOC nursing supervisors, the domiciliary clinical manager of any issues related to staff compliance.

i. Successful recovery and interpretation of control data is to be performed no less than once per year.

ii. Adherence to policy and procedure is continuous.

iii. Competency requirements will meet Joint Commission guidelines.

Initial training and competency assessment:

• The competency of each person to perform the duties of a POC operator must be assessed following training but before the person performs patient testing. Afterward, at the first year anniversary of the operator’s initial competency, competency must be reassessed and then annually thereafter or more frequently if indicated by unacceptable performance on quality control, proficiency testing, or lack of compliance to policy and procedure compliance, see Follow-up/Remedial Action section.

• Elements of competency assessments must include, but are not limited to the elements as previously stated:

1. Direct Observation-patient test performance

2. Monitoring Results

3. Review of Results

4. Direct Observation-instrument maintenance

5. Proficiency Testing

6. Evaluation of problem-solving skills

All of the ancillary testing methodologies in use at this facility are classified as waived complexity, therefore only two of the above performance elements are required to be used for competency assessment.

• The ATC will be expected to provide ancillary testing training to new employees for all ancillary testing procedures that the employee will be responsible for. Additionally, they will be expected to provide this training during the new employee orientation period.

• Generally, initial ancillary test training lasts for approximately three hours.

• Documentation: The ATC will provide all of the required documentation of competency assessment for all POC operators. This is expected to be provided for orientation training, annual training and any remedial training, as applicable. Records will be kept of all ancillary testing operator training & the dates for annual competency assessment. Notification of ancillary testing operators will be made prior to the date that their competency expires & arrangements will be made to reassess the operator’s competency.

Training Procedure:

1. The laboratory ancillary testing coordinator (ATC) will be provided with the name(s) of personnel who will be performing POC testing & who will therefore need to receive training for all of the POC testing procedures that they will be responsible for.

2. The ATC will schedule a date that training can be completed on. Training is expected to last for approximately 3 hours.

3. The ATC will provide the trainee with a copy of the ancillary testing post test training quizzes that they are to complete & pass at this time.

4. The trainee will be given a copy of the test procedure that they are to read before any actual testing is performed.

5. The ATC will first demonstrate the correct procedure to perform to do quality control testing & patient testing. They will also demonstrate, if applicable, any daily or weekly maintenance that must be performed on the instrument.

6. The ATC will have the trainee complete all of the POC procedures for which they are responsible which may consist of any of the following POC testing procedures: Roche Inform II glucometer training for capillary blood sugar, Roche Coaguchek XS Plus meter training for POC INR’s, Axis Afinion AS100 training for POC A1c’s, urine HCG training and urine drugs of abuse testing. Training will consist of quality control (QC) testing, patient testing, result entry via the meter interfacing capability of the glucometers and/or the POC INR meters or manual result entry through the bypass normal data entry option in Vista, maintenance of the meters, follow up & documentation of critical values. The candidate will learn the critical value ranges for the POC testing that has critical values in use, they will be able to assess the acceptability & the required frequency of QC testing, they will learn that no patient testing can be done unless the QC testing has been done & is acceptable, they will learn the required storage temperatures of the POC testing controls & reagents, etc. They will be observed successfully completing POC testing, documenting QC & patient POC testing results, troubleshooting testing, etc.

7. Once the candidate has successfully completed all initial training, they will be provided with an operator ID in the form of a DUZ code in Vista & the ATC will activate their access in the RALS system which is the interface between Vista and the POC testing meters.

8. The candidate at this point can start completing POC testing at their respective workplace location & can expect to again have their competency assessed in a year’s time. Annual reassessment may be completed by the ATC or by the nursing train-the-trainer however the nursing train-the-trainer must have current ancillary testing competency documentation on record.

9. Continued assessment will be made by having all operators at any one POC testing locations complete CAP proficiency testing on a rotating basis. Records of all CAP survey testing will be maintained. If unacceptable results are obtained for any CAP survey, corrective action will involve retesting of the survey samples, as available. If the survey samples cannot be retested due to the volatility of the sample, unknown samples with predetermined results will be sent for the respective operator to test.

Once the candidate has been found to be competent in the completion of the ancillary testing for which they are responsible for there are additional requirements that they must be aware of:

• All routine maintenance and cleaning must be performed as specified by the manufacturer.

• All sites are required to comply with current VA directives and other applicable standards related to infection control.

• The results of all ancillary testing must be entered into the Veterans Health Information Systems

Technology Architecture (VISTA) by the method specified in the testing procedure for that analyte.

• Critical Values: All critical values must be confirmed with repeat testing. All critical INR values must have a confirmation/follow-up PT/INR sent to the main laboratory. All critical capillary blood sugars must be followed with a serum glucose determination prior to treatment, at the discretion of the provider. All nursing personnel are to follow established nursing protocol for critical value notification and documentation. Documentation protocols are provided in the test procedure for each analyte being tested and are all available in the Medical Center share point site in the Laboratory Policy Manual.

Successful Assessment: A trainee will be considered to have successfully completed their orientation training if all of the competency elements in use were completed correctly.

Follow-up/Remedial Action

• In the event that a technologist fails to demonstrate satisfactory performance on a competency assessment or if it is observed that the new operator is not completing POC testing according to the requirements that the ATC has advised them of i.e. they are completing patient testing without first completing QC testing at the required frequency, they are not processing patients having critical values correctly, they are not correctly entering results, etc., they will need to have their competencies reassessed by completing an additional training session as soon as possible. If the operator’s work station is at one of the CBOC locations, they may receive retraining by the trained local trainer. It is important to note the during this time of reassessment that the operator will not have their RALS access suspended., a corrective action plan will be written & implemented. The corrective action plan will provide a period of time that it is expected that the operator will be retrained & when they can resume patient testing. The reassessment is expected to be completed within one month of the date when the operator is found to be not competent. The plan will also provide the name of the person who will be reassessing the operator’s competency i.e. the ATC or the train-the-trainer. Finally, the plan will clearly list the six elements that may be used and because these are waived complexity tests, they must demonstrate that two of these elements were used to reassess the operator’s competence and the dates on which they were used. The competency reassessment will be signed & dated both by the trainer & the trainee.

• NOTE: RALS access will not be revoked at any time by the ATC unless there is complete agreement & authorization by the laboratory supervisor. Access will not be revoked until there has been a complete review of the operator’s performance to include review of QC & patient test results, follow-up testing of critical values & the documentation thereof, etc. The

ATC will not be solely in charge of any suspension of any operator’s access rather this action needs to have the complete approval of the laboratory supervisor.

• Also, a complete list is maintained in the laboratory of the individuals who are considered competent and are authorized to perform ancillary testing will be maintained.

On-site visits:

(a) The Ancillary Testing Coordinator will conduct quarterly on-site visits for all clinical areas and for all CBOC locations where testing is performed.

(b) The Ancillary Testing Coordinator will observe and review all activities during these visits including quality control and patient testing, as available, and the competencies of operators. They will check that the current CAP and CLIA licenses are openly displayed and are not expired. They will check all testing supplies including phlebotomy supplies and ancillary testing test strips/cartridges; controls, etc. to assure that they are also not expired. These visits will be documented on the “CBOC Inspection Log” and records thereof maintained by the ancillary testing coordinator. Any problems that were noted during the inspection will be communicated to the laboratory supervisor.

REFERENCES:

a. Pathology and Laboratory Medicine Service Policies, VHA Handbook 1106.01, January 29, 2016.

b. CAP, Commission on Laboratory Standards, Inspection Checklist for Ancillary Testing, August 2018.

A copy of the competency log sheet that is currently in use follows this policy.

VA Butler Healthcare Pathology and Laboratory Medicine Program

Competency Assessment-Ancillary Testing Procedures

Competency Evaluation: [ ] Initial After Training [ ] 1st year semi-annual [ ] Annual

Name: ___________________ Position/Title: ___________________ Shift: 1st 2nd Competency Validation Codes:

Testing that is listed on this assessment is waived complexity, therefore only 2 of the following elements need to be used to assess operator’s competency

1. Direct observations of routine patient test performance

2. Monitoring the recording and reporting of test results/critical results

3. Review of worksheets, QC, PT records and preventive maintenance records

4. Direct observation of performance of instrument maintenance and function checks

5. Test performance: CAP or Blind Testing Sample

6. Evaluation of problem-solving skills C = Competent NT = Needs Training NA=Not Applicable

Test System: 1 2 3 4 C, NT or

NA?

Date Assessed?

C, NT or

NA?

Date Assessed?

C, NT or

NA?

Date Assessed?

C, NT or

NA?

Date Assessed?

Inform Glucometer**

Coaguchek XS **

Axis Afinion **

Urine HCG **

Key Split Cup **

5. Test System CAP Survey or unknown /date (see attached) Results OK?

yes/no Inform Glucometer** Coaguchek XS ** Axis Afinion (API Survey) **

6. Test System Problem Solving Skill: indicate skill assessed, date and initial. C = Competent

NT = Needs Training

Skill Assessed: Date Assessed:

By:

(Initials)

Inform Glucometer**

Coaguchek XS **

Axis Afinion **

Competency Assessment Acceptable? Yes No

Evaluator Completion Date

** Waived test (Minimum of 2 competency elements required)