Point of Care Testing (POCT) General Policy.pdf

Point-of-Care Testing (POCT) General Policy

MCP NUMBER 118-20-255

Montana VA Health Care System Fort Harrison, MT 59636

Signatory Authority:

Executive Director

Responsible Owner:

Chief of Pharmacy

Rescinded Document: None

Effective Date:

July 6, 2020

Recertification Date:

July 6, 2025

1. POLICY

A. Any laboratory testing, including testing that is performed outside of the laboratory by non-laboratory personal must conform to VA, state and federal regulations.

B. Only those employees who have been trained and deemed competent by the Ancillary Testing Coordinator (ATC) may perform POCT.

C. All Clinical Laboratory Improvements Amendments (CLIA) of 1988 waived tests performed by non-laboratory staff within VA Montana will require quality control materials to be performed, judged acceptable, and recorded as required by test system.

In addition, all sites and personnel performing such testing are required to participate in proficiency testing challenges.

D. Results of these point-of-care tests are used for screening as well as treatment decisions.

E. Community-Based Outpatient Clinics (CBOCs) will have at least one site visit by the ATC per year.

F. Each testing site will perform proficiency testing a minimum of two times per year for each test system in use.

2. JUSTIFICATION

To provide a standardized set of guidelines by which POCT will be performed.

3. RESPONSIBILITIES

a. Individuals performing POCT. The individual is responsible for:

(1) Demonstrate competency in the performance of POCT during the orientation period, within 6 months of original training, and annually thereafter.

July 6, 2020 118-20-255

(2) Write a new expiration date on all QC, calibration standards and/or reagent containers when opening the container changes the manufacturer expiration date shown on the container

(3) Perform QC as required for each test system in a work area/group.

(4) Determine that QC results fall within pre – defined limits before patient tests are performed.

(5) Repeat out – of – range QC, comment of what was done, and document the results.

(6) Notify the ATC if a second QC attempt fails.

(7) Follow test procedures defining the proper technique for operating and/or performing an instrument and/or test system.

(8) Repeat testing for alert values and document results. If alert value is replicated, report the results to the physician and obtain verification by the clinical laboratory, if ordered by the physician.

(9) Participate in Proficiency Testing as needed to comply with regulatory requirements.

b. Ancillary Testing Coordinator. The Ancillary Testing Coordinator is responsible for:

(1) Provides technical oversight for all ancillary testing sites.

(2) Participates in the selection of the methodologies appropriate for the clinical use of the test results.

(3) Participates in the validation of methods and test procedures performed and the establishment of the test performance characteristics.

(4) Participates in the planning, design, implementation, and assessment for all elements of the ancillary testing quality management program.

(5) Ensures that training and competency assessment for all persons who perform ancillary testing is completed and that employee records are complete.

(6) Ensures enrollment and participation in a proficiency program for all ancillary sites commensurate with the testing services offered and oversees necessary remedial action when necessary.

c. The Chief of Pathology

(1) The Chief or Director, P&LMS, in concert with the Chief of Staff or Director of Clinical Services, identifies the location and type of all ancillary laboratory testing performed within the health care system, including point of care testing, PPM testing, HBHC testing, testing performed in satellite laboratories, and testing performed for patient care in research laboratories.

(2)

(2) The Chief or Director, P&LMS decides, in consultation with the medical and nursing staff, which tests may be performed outside the main clinical laboratory for patient care diagnostic or monitoring purposes, and the equipment needed.

(3) Quality management records for all VA ancillary testing sites must be reviewed by the Chief or Director, P&LMS or designee.

(4) The Chief or Director, P&LMS must appoint an ancillary testing coordinator to provide oversight for ancillary testing within the health care system.

4. OTHER PARAGRAPHS

Procedures

A. Accurate and precise test results obtained during POCT depend upon the health care provider consistently following and successfully adhering to test procedures, sample collection and QC.

B. Any test systems and devices used for clinical patient results must meet the standards set in the POCT quality assurance program.

C. Compliance with QC requirements and test procedures are mandated by the CLIA, CAP, and TJC.

D. All patients will be identified using two unique identifiers before the procedure is performed.

5. DEFINITIONS

a. Competency Assessment: The validation of operator adherence to test procedures. May be achieved via analysis of an unknown or proficiency sample, monitored performance of quality control, direct observation, and/or written knowledge assessments.

b. Point-of-Care Testing (POCT): Analytical patient testing activities provided within the institution but performed outside the physical facilities of the clinical laboratories.

c. Proficiency Testing: Analysis of blind samples performed by randomly selected operators for the purpose of validating test systems and operators. Proficiency testing may be used as a competency assessment for the selected operators.

d. Quality Assurance (QA): Activities and processes intended to provide maximum confidence that the quality of patient care will satisfy stated or implied requirements/needs through specimen integrity and accurate test results.

e. Quality Control (QC): Analysis of samples with known responses for the purpose of validating the proper performance of the test system.

f. Clinical Laboratory Improvement Amendments (CLIA): Laws used by the Centers for Medicare & Medicaid to regulate laboratory testing

g. College of American Pathologists (CAP): an organization that provides proficiency testing, accreditation and oversight to many laboratories

h. The Joint Commission (TJC): an organization that provides accreditation and oversight to many healthcare facilities.

6. REFERENCES

A. Clinical Laboratory Improvements Amendments of 1988 B. VHA Handbook 1106.01, Pathology and Laboratory Medicine Service

Procedures C. The Joint Commission Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing, 2013 D. Clinical and Laboratory Standards Institute, Point-of-Care Glucose Testing in

Acute and Chronic Care Facilities; Approved Guideline--Second Edition, Volume 22, Number 17

7. RESCISSION

None

8. REVIEW July 2025

9. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of July 2025.

This MCP will continue to serve as local policy until it is recertified or rescinded. In the event of contradiction with national policy, the national policy supersedes and controls.

10. SIGNATORY AUTHORITY

Judy Hayman, Ph.D.

Executive Director

Date Approved: July 6, 2020

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

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