Job Description

Responsible for monitoring, developing, and/or modifying all aspects of Point-of-Care Testing at approved POC testing locations for both Waived and Non-Waived tests. Responsibilities include:

• Oversees the daily operations of Point-of-Care and related testing.
• Operates and troubleshooting of Point-of-Care instruments and equipment.
• Performing monthly, quarterly, and semiannually audits at POC testing locations, generating monthly QC statistic reports.
• Monitoring POC quality control results and assuring appropriate corrective action is taken. Auditing QC logs and POC compliance activities.
• Providing staff training of both non-waived and waived POC and competency validation.
• Writes and updates test procedures.
• Troubleshooting POC software, tracking POC instruments, and implementation of new POC sites to include installation and instrument connectivity.
• Duties also include licensure application and renewal, information management, quality assurance, proficiency testing, validation studies.

%

of time

Essential Function (Yes/No)

Key Responsibilities

50Yes

TASK A: Oversees the QA/QC Compliance Activities and Auditing at Point of Care Testing Locations for both Non-waived and Waived Tests

Standards:

1. Works without close or continual supervision.
2. Makes effective decisions and exercises good judgment.
3. Maintains an awareness of problems that may affect work or quality of work, and keeps immediate supervisor informed of relevant problems.
4. Troubleshoots problems and acts in a responsible manner to solve them.
5. Monitors daily compliance with established quality control procedures (liquid and electronic).
6. Monitors appropriate controls are tested and reported each day of patient testing.
7. Maintains up-to-date and accurate records of all quality control and quality assurance related problems and issues.
8. Devises collection methods, databases/spreadsheets, logs and reporting mechanisms in order to complete assigned auditing projects.
9. Performs monthly, quarterly, and semiannually audits in a timely fashion in order to meet assigned reporting deadlines.
10. Audits QC logs and monitors discrepancies.
11. Monitors POC quality control results and assuring appropriate corrective action is taken.
12. Request follow up response and corrective action from unit directors of hospital and clinic sites.
13. Maintains audit documentation in an organized fashion readily accessible to others requiring information.
14. Monitors that all procedures are performed according to written protocol.
15. Serves as technical resource to assure that supplies, controls and reagents are properly used, stored and maintained at adequate levels for use.
16. Assists each site in maintaining up-to-date and accurate inventory of supplies and controls.
17. Initiates the use of back-up equipment when primary instrument is not operational.
18. Acts as a technical resource to personnel performing the testing.
19. Operates equipment in a proper manner without close or continual supervision.
20. Works closely with manufacturer in coordinating the replacement of broken instruments and the issuing of loaner instruments if needed.
21. Through database management, ensures compliance with the protection of patient information when meters are loaned or returned for repair or replacement.
22. Troubleshoots connectivity problems at existing sites, to include configuring data servers.
23. Works closely with LIS and IT to troubleshoot instrument connectivity issues.

10

Task B: Creates and Reviews Monthly POC Instruments QC Reports for both Non-waived and Waived tests

Standards:

1. For instruments with connectivity, assures the daily transfer of QC data from point of care instruments into the laboratory computer system.
2. Produces monthly QC reports on both non-waived and waived instruments and documents follow-up when required.
3. Validates new lot controls perform within manufacturer’s range and establishes new lot control ranges for each instrument.
4. Reports on compliance with established quality control procedures and equipment maintenance schedules and makes recommendations to correct compliance failures

10

Task C: Provide Trainings and Competency Assessments of POC Tests and Instruments to Staff at Point of Care Testing Locations for both Non-waived and Waived Tests

Standards:

1. Trains personnel in the use of point-of-care instruments and equipment. Instructs personnel in relevant technical aspects of equipment and test results.
2. Trains personnel in the correct performance of QC activities and documentation of QC data, to include appropriate follow up for failed QC results.
3. Develops training check lists and quizzes, appropriate for each non-waived and waived test.
4. Is knowledgeable about National Patient Safety Goals and use of Standard Precautions, incorporating these concepts into POC training as appropriate.
5. Maintains appropriate training records.

10

Task D: Performs compliance related duties

Standards:

1. Performs calibration verification of assays at required intervals.
2. Coordinates inter-instruments comparisons between POC instruments and Clinical Labs instruments.
3. Ensures that proficiency test samples are completed by staff at POC testing locations and submitted the results by the deadline.
4. Oversees assuring compliance of all Federal and regulatory issues pertinent to the licensing and accreditation of Point-of-Care testing.
5. Initiates new policies and procedures as needed for compliance with regulatory issues.
6. Initiates, monitors and evaluates verification of Manufacturer’s normal range, correlation studies, method comparisons, calibration verification and precision studies as required for non-waived POC testing.

10

Task E: Troubleshooting POC software, tracking POC instruments, and implementation of new POC sites to include installation and instrument connectivity

Standards:

1. For instruments lacking connectivity, works with LIS to develop and maintain programs for monthly download of QC data from POCT instrumentation.
2. Evaluates equipment performance and notifies the Supervisor or Sr. Supervisor of any malfunction.
3. Initiates troubleshooting of instrument when a malfunction occurs. Never modifies or alters the equipment without consulting the Supervisor or Sr. Supervisor.
4. Performs maintenance of equipment as instructed by manufacturer
5. Troubleshoots connectivity problems at existing sites, to include configuring data servers.
6. Works closely with LIS and IT to troubleshoot instrument connectivity issues.

5

Task F: Updates existing test procedures and develops new ones

Standards:

1. Participates in the evaluation of new instruments and new test procedures.
2. Reviews the literature to establish a thorough understanding of the instrument and tests.
3. Collects and organizes data for reports.
4. Writes up a test procedure using the existing computer procedure format.
5. Performs all quality control:
6. Determines linearity and precision
7. Compares patient results (existing method vs. new method)
8. Develops normal range
9. Develops control range
10. Interacts with the LIS/IT to establish any necessary computer programs and/or hook-ups.
11. Organizes training of staff at POC testing locations.
12. Integrates new instruments into working procedures for personnel operating the instruments.
13. Maintains, updates point-of-care procedures and initiates new procedures as needed
14. Assists in reviewing and updating POC procedures at least once/year all existing procedures.

5

Task G: Perform additional duties, projects, and/or special assignments as designated by the Supervisors.

Standards:

1. Performs additional duties as instructed by the POCT Supervisor and/or Senior Supervisor of QA / POCT.
2. Acts in accordance with the organization and department’s mission, vision, values and goals.
3. Participates in and supports Performance Improvement activities.
4. Demonstrates cultural sensitivity and a respectful manner toward patients, visitors and staff.
5. Is courteous, respectful, and professional to both internal and external customers.
6. Promotes positive work relationships with peers, supervisors and others.
7. Demonstrates effectiveness in spoken and written communications.
8. Is reliable in work habits, attendance, and completing assignments.
9. Demonstrates an understanding of and adheres to safety and infection control policies and procedures.
10. Completes project within the time frame agreed upon with the POCT Supervisor, Senior Supervisor, or Medical Directors.

100%

REQUIRED QUALIFICATIONS:

• College Graduate with a BS or BA in a related science
• Valid California Clinical Laboratory Scientist license
• 2 Years recent experience in clinical laboratory
• Demonstrated superior theoretical knowledge, technical judgment and skills and the ability to work with a minimum of supervision

• Assumes responsibilities for keeping abreast of technical developments through current literature review. As requested by a POCT Supervisor, evaluates new procedures and makes recommendations

PREFERRED QUALIFICATIONS:

• ASCP or ASMT desirable
• Experience with current Chemistry and/or Hematology automated equipment.
• Experience with current POCT equipment
• Experience in technical training and competency assessment of healthcare professionals.
• Experience in statistical analysis of new methods
• Experience in high-volume hospital clinical laboratory setting
• Writing SOP

• Word processing, spreadsheet and database applications

REQUIRED LICENSES/CERTIFICATIONS:

Valid California Clinical Laboratory Scientist license or temporary license pending passing the next scheduled licensure exam