ST.

ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Revision Code: 002 Page 1 of 4

Effectivity Date: May 2022
Document Title:
POINT OF CARE TESTING (POCT) POLICIES AND PROCEDURES

I. Introduction

POCT is a diagnostic testing performed promptly and conveniently in the vicinity of the patient.

II. Purpose

The purpose of this policy is to ensure that point of care testing performed at St. Andrew Hospital
Laboratory
 enhances the quality of patient care
 is held to the same standard as clinical laboratory testing
 is administered by a multi-disciplinary committee that reports to the appropriate
medical staff and administrative bodies
 meets hospital and laboratory accreditation standards.

III. Policy Statement

A point of care test is implemented only after formal approval by Quality Assurance and Patient
Safety Committee. Point of care testing that has not undergone application to the Committee and
received approval is considered unauthorized and the Clinical Program will be informed of this
violation and instructed to follow the established application process.
Implementation of a point of care test requires:
 evaluation and selection of instrumentation and procedures
 training and certification of non-laboratory personnel
 establishment of quality control procedures
 test protocols and records of equipment maintenance and troubleshooting
 protocols for test requisitioning and result reporting
 procedures addressing instrument maintenance and supplies.

Point of care testing instruments and materials are standardized within the hospital.
Point of care testing on a patient requires a documented prescriber’s order.
Point of care testing is performed only by trained and certified individuals and according to
written policies and procedures.
Flagrant disregard of policies or procedures results in termination of the ability to test.
Hospital POCT devices should be used for all POCT patient testing in the institution performed
by certified operators. However, patient self-testing using the patient’s POCT meter (e.g.
glucose) may be permitted and is decided by the Clinical Program
Prepared by: Recommended by: Approved by:
MonalynMarabi,M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Revision Code: 002 Page 2 of 4

Effectivity Date: May 2022
Document Title:
POINT OF CARE TESTING (POCT) POLICIES AND PROCEDURES

IV. Policy

1. Proposals for new point of care tests, or changes to existing tests are presented to the
Quality Assurance Committee and Patient Safety Committee who decide whether an
evaluation of the proposed test/method is warranted. The Committee requests a laboratory
evaluation through the Medical Director, Department of Laboratory Medicine Head of
Laboratory.
2. The laboratory conducts a formal evaluation of proposed point of care instruments or
methods. The evaluation includes comparison with laboratory instrumentation, analytical
range, linearity and precision studies, evaluation of potential for operator error and effect of
preanalytical variables on test results, assessment of technical service requirements.
3. If the instrument or method are found unsatisfactory on laboratory evaluation, a report is
presented to the Quality Assurance Committee and Patient Safety Committee.
4. If the laboratory evaluation is satisfactory, non-laboratory personnel participate in a clinical
evaluation to assess ease of use, operator acceptability, training, cost, and feasibility of
implementation in the proposed setting.
5. The Committee reviews the medical justification for the test and the evaluations and
considers the impact on standardization of testing in the hospital (standardization within the
hospital minimizes training requirements, potential operator error, and number of suppliers,
and simplifies maintenance and quality assurance). The Committee will assess operational
and cost impacts. The Committee decides whether to approve the test/instrument for
implementation. A Memorandum of Understanding is executed between the Clinical Program
and the Laboratory, which defines responsibilities and costs assumed by the Clinical
Program, prior to implementation.
6. Specific policies and procedures regarding training, certification and recertification of
operators are developed jointly by laboratory and operators.
7. Training, certification, and recertification are performed by laboratory personnel or delegated
to appropriately trained and certified non-laboratory personnel. Training includes all aspects
of testing included in the procedure manual.
8. An updated list of certified operators and trainers is maintained in the laboratory and at the
testing site.

Prepared by: Recommended by: Approved by:

MonalynMarabi,M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Revision Code: 002 Page 3 of 4

Effectivity Date: May 2022
Document Title:
POINT OF CARE TESTING (POCT) POLICIES AND PROCEDURES

9. Current written policies and procedures for testing are available at the test site and in the
laboratory. These include tests available, test ordering, instrument maintenance, reagents,
quality control, sample collection and acceptability, pre-analytical variables, testing, reporting,
reference ranges, follow-up of unusual results (critical values), and documentation of testing,
results, and quality control.
10. Policies and procedures are reviewed at least annually by designated laboratory and
nonlaboratory personnel and review is documented.
11. Point of care testing on a patient requires a documented provider’s order specifying the
test(s) to be done, and the frequency of repeat testing (if applicable).
12. A point of care test is performed only by a certified operator, following written policies and
procedures. An individual is eligible to become a certified operator only if the POCT test falls
within the scope of practice of that individual’s profession.
13. Operators are responsible for appropriate sample collection, quality control and reagent
checks, test performance, reporting, follow-up of unusual results, documentation, basic
maintenance (if applicable), and performance of proficiency testing.
14. Testing is not performed if a sample is unacceptable or pre-analytical instrument or quality
control checks fail.
15. The operator documents valid patient results in the hospital record, including date and time of
test, and operator identification. All patient testing, as well as quality control and equipment
maintenance, are also documented on appropriate records kept at the testing site and signed
by the operator.
16. The laboratory undertakes the following quality assurance activities for point of care testing:
 Designing appropriate internal quality control procedures and training operators
in their use.
 Regularly reviewing operators' testing, quality control and maintenance records.
 Designing appropriate external quality control programs, e.g., testing blind
controls, and arranging simultaneous sampling for analysis in the laboratory or
other procedures.
 Monitoring external proficiency testing results at least twice a year and provide
feedback to POCT Operators.
 Verifying that all operators known to be certified participate in quality control
activities.

Prepared by: Recommended by: Approved by:

MonalynMarabi,M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Revision Code: 002 Page 4 of 4

Effectivity Date: May 2022
Document Title:
POINT OF CARE TESTING (POCT) POLICIES AND PROCEDURES

 Timely reporting of test and quality control performance issues to operators by a

mutually determined mechanism.
 Checking reagents, instrument and/or operator performance as needed to
follow-up questionable test results, quality control failures, or other signs of
suboptimal test performance.
 Recommending retraining for operators who show inadequate test performance.
 Periodic monitoring of reagent integrity, instrument performance and
comparability with routine laboratory methods.
 Periodic monitoring of patient results, records, result reporting mechanisms and
follow up of critical results.
 Monitoring other quality assurance parameters such as sample quality, pre-
analytical variables result turnaround time.
 Monitoring cost and utilization of testing.
 Removing an instrument from use when policies and procedures are not
followed

17. All complaints will be reviewed and responded to by the laboratory department and taken to
the Hospital Quality Assurance and Safety Patient Committee if directed by the Medical
Director. When deemed necessary by the Medical Director any suggestions, changes,
improvements, concerns, and complaints regarding point of care testing will be presented to
the Committee.

Prepared by: Recommended by: Approved by:

MonalynMarabi,M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director