Director Signature Date Clinical Laboratories Point of Care Testing POCT EMPLOYEE & MEDICAL STAFF COMPETENCY I PURPOSE CLIA 88, Centers for Medicare and Medicaid Services, and the State of California Laboratory regulations require that all laboratories have on-going mechanisms to monitor accurate patient test management. Competency assessment is one method used to ensure that staff (employees and Medical staff) who perform Point of Care Testing are proficient in test procedure(s) and reporting test result(s). All staff who perform Point of Care Testing must be trained and have their competency assessed at scheduled intervals to ensure that patients at UCSF Medical Center receive quality care. Specifically, Physicians may perform non-instrument waived testing based on training and scope of practice with appropriate privileging obtained through the credentialing process. All non-physician users may perform non-instrument waived testing once they have been trained and demonstrated competency. Competency must be reassessed annually thereafter. To perform instrument based waived testing and all non-waived (moderately complex) testing, physicians and healthcare staff must be trained and demonstrated competency. Competency must be reassessed annually thereafter. Only licensed healthcare staff may perform POC testing in the inpatient setting. Unlicensed staff, with appropriate training and supervision may perform waived testing in the outpatient setting. Only providers who have completed the PPM training and competency, and have been granted privileges through the credentialing process may perform PPM. II OBJECTIVES A. To improve performance and ensure high quality care for patients. B. To ensure that employees are competent to performed assigned tests. C. To comply with federal and state regulations. D. To provide performance feedback. E. To ascertain the consequence of new policies. F. To review existent policies and procedures. 1 of 4
G. To provide employees with continuing education. H. To provide information for employee performance evaluation. III PROCEDURE All staff are trained and evaluated for competency on each Point of Care tests they perform. When new test methodology or instrumentation is instituted, employees are retrained and reevaluated. The POCT coordinator and department supervisors will develop a program for competency assessment and acceptability standards based on the training protocol, procedure manual, and department policies. Supervisors will evaluate common group deficiencies, review current policies and procedures, and take corrective action to improve performance. A. Waived Competency 1. Competence for waived testing is assessed at the time of orientation and annually thereafter. 2. Competency for waived testing is assessed using at least two of the following methods per person per test: - Performance of a test on a blind specimen - Periodic observation of routine work by the supervisor or qualified designee - Monitoring of each user's quality control performance - Use of a written test specific to the test assessed 3. This competency is documented and place in employee personnel file B. Non-Waived Competency 1. Competency for non-waived testing is accessed initially and at 6 months post-training and annually thereafter. 2. Competency assessment includes the following: - Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing, and testing - Monitoring, recording, and reporting of test results - Review of intermediate test results or worksheets, quality control, proficiency testing, and preventive maintenance performance - Direct observation of performance of instrument maintenance function checks and calibration - Test performance as defined by laboratory policy (for example, testing previously analyzed specimens, internal blind testing samples, external proficiency, or testing samples) - Problem-solving skills as appropriate to the job 3. This competency is documented and place in employee personnel file C. Permission to perform PPMP (Provider Performed Microscopy Procedures) is based on credentialing. All UCSF providers who perform PPMP are required to take and pass an on-line PPMP Competency assessment before initial PPMP privileges are granted. Maintenance of privileges require that all providers who perform PPMP pass the on-line competency assessment annually. 1. New applicants request PPMP privileges to the MSO Credential Analyst (Medical Staff Office) 2 of 4
a. MSO Governance Analyst communicates the request to Clinical Lab. b. Clinical Lab notifies provider to complete PPM Competency test. Web based competency from the University of Washington. MTS (MedTrainingSolutions) at www.medtraining.org. c. Pass: i. Notification from Clinical Lab on a monthly PPMP update list indicates P ii. MSO Governance Analyst forwards the request to Credentials Committee, EMB, and GAC iii. After approval, MSO Governance Analyst assigns privileges in MSO System. iv. MSO Governance Analyst mails Board Action Letters with new / additional privileges to providers. d. Fail: i. Notification from Clinical Lab on a monthly PPMP update list indicates F ii. MSO Governance Analyst implements mentoring process with provider, including list of available mentors (i.e. providers in the same department with PPMP privileges) iii. Provider completes mentoring process iv. MSO Governance Analyst notifies Clinical Lab IV CORRECTIVE ACTION The supervisor or program administrator will take corrective action on unsatisfactory employee or staff performance to improve or restore competency. Actions taken are documented. V REFERENCES 2012 Laboratory Accreditation Standards, The Joint Commission Accreditation- Laboratory, The Joint Commission, One Renaissance Boulevard, Oakbrook Terrace, IL 60181 National Committee for Clinical Laboratory Standards, Ancillary (Bedside) Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline. NCCLS document C30- A, Villanova, Penn. 1994 U.S. Department of Health and Human Services, CLIA 88 Final Rules, Federal Register, 1992, Sections 493.1421, 493. 1423, 493. 1425, U.S. Government Printing Office, Wash. DC, Vol. 57, No. 40. February 28, 1992 Hargrove, C., Developing a More Effective Training Program, Medical Laboratory Observer Vol. 25 (9): 50 Laboratory Field Services. Laws and Regulations Relating to Clinical Laboratories, Excerpts from the California Business and Professional Code and the California Code of Regulations, Berkeley, CA, January 1, 1991. 3 of 4
PROCEDURE REVIEW HISTORY Procedure Title: POCT Employee and Version: 2.0 Medical Staff Competency Author: Sandra Tye Date 05/11/2001 Director: Tim Hamill, M.D. Date 05/11/2001 In Use Date 05/11/2001 Discontinued Date: Approved By: Tim Hamill, M.D. Version: 1.0 Date 05/11/2001 Revised By: Betty Yalich Version: 1.1 Date 07/30/2003 Approved By: Tim Hamill, M.D. Date 07/30/2003 Revised By: Betty Yalich Version 1.2 Date 01/25/2005 Approved By: Tim Hamill, M.D. Date 03/02/2005 Reviewed By: Tim Hamill, M.D. Date 04/27/2006 Reviewed By: Betty Yalich Date 03/02/2007 Reviewed By: Betty Yalich Date 03/18/2008 Reviewed By: Betty Yalich Date 03/20/2009 Revised By: Betty Yalich Version 1.3 Date 2/18/2010 Approved By: Tim Hamill, M.D. Date 03/19/2010 Reviewed By: Cynthia Ishizaki Version 2.0 Date 12/01/2012 Approved By Tim Hamill, M.D. Date 12/6/2012 See Signature Manifest 4 of 4
Signature Manifest Document Number: SOP-0002 Revision: 2 Title: POCT Employee & Medical Staff Competency All dates and times are in Pacific Standard Time. POCT Employee & Medical Staff Comp SR Sup Review Name/Signature Title Date Meaning/Reason Cynthia Ishizaki (024044224) POC SR SUP 20 Jun 2013, 03:20:57 PM Reviewed Med Dir Apprvl Name/Signature Title Date Meaning/Reason Tim Hamill (023335003) PA CB MED DIRECTOR 26 Jun 2013, 01:37:01 PM Approved