D.7 Ancillary (Point of Care) Testing Program.pdf

JOHN D. DINGELL VA MEDICAL CENTER 11LAB-10

DETROIT, MI 48201 April 25, 2019

Policy and procedures cannot possibly address all situations. Please make sure that you exercise good judgment and common sense. Remember, patient needs always come first. Remember that patient needs always come first. The hospital prohibits discrimination based on age, race, ethnicity, religion, culture, language, physical or mental disability, socioeconomic status, sex, sexual orientation, and gender identity or expression.

ANCILLARY (POINT OF CARE) TESTING PROGRAM

1. PURPOSE

To provide direction and guidance regarding all point of care testing. Ancillary testing is defined as any laboratory testing or services performed within this VA medical center or its outreach functions (clinic, et. al.), but outside the physical facilities of the main clinical laboratory. This includes testing performed by a VA employee or a contracted service employee in a patient’s home under the Home Base Primary Care Program (HBPC) or testing done as Point of Care at bedside. NOTE: Non-laboratory personnel often perform these tests.

2. POLICY

a. All ancillary testing sites are required to be under the technical direction of the ACOS, Pathology and Laboratory Medicine Service and inspected and fully accredited by an appropriate, nationally recognized CMS “deemed” accrediting body. In this facility, all ancillary testing sites must comply with The Joint Commission (JC) and College of American Pathologists (CAP) standards and must follow the operational and quality management standards required by the Clinical Laboratory Improvement Act (CLIA) 88 and its revisions. The inspection of all ancillary testing sites within the medical facility, including bedside testing, will be performed during, the same CAP and JC inspection visits for the VA medical center’s main clinical laboratory.

b. Quality management records for all VA ancillary-testing sites are under the quality management oversight of the ACOS, Pathology and Laboratory Medicine Service and should be maintained within the main clinical laboratory.

c. A laboratory test is defined as a diagnostic or monitoring procedure on a patient specimen to determine specific information for patient care.

d. Results from each of these tests are to be used definitively unless specific conditions exist as defined within their individual procedures. Conditions such as exceeding critical values (i.e. glucose <50 and >400) can necessitate additional testing by the main clinical laboratory. In essence, any such test result would be switched from a definitive value to a screening value.

e. Any other patient testing performed at the bedside or in the clinics and entered in the patient chart is unauthorized and contrary to medical center policy.

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Medical Center Numbered Memorandum 11LAB-10

f. The results of all ancillary testing must be entered into the official VA laboratory computer package. Privileged providers performing waived or PPM testing as part of their routine exam may enter testing results in the progress notes. The VHA Handbook

1106.01 minimal requirements for documentation must be met.

g. All test results entered in the patient computer record must originate in the laboratory, with the exception of any authorized ancillary test obtained by specifically trained personnel. This training must be documented. All testing personnel, including privileged providers performing must undergo initial training, annual competency review and proficiency testing. (See Appendix A)

3. RESPONSIBILITY

a. The Chief of Staff or Chief, Patient Care Services will provide the ACOS, Pathology and Laboratory Medicine Service with the location and type of all ancillary testing equipment, including bedside testing sites, methodology to be used, and the estimated number of tests to be performed annually. The list will be updated each time new methods and/or instruments are added or deleted.

b. The ACOS, Pathology and Laboratory Medicine Service, decides, in consultation with the medical and nursing staff, which tests may be performed outside the main clinical laboratory for patient care, diagnostic and/or monitoring purposes and the equipment needed.

c. The Ancillary Testing Coordinator, the individual responsible for the laboratory portion of the ancillary-testing program, must be a fully qualified, certified medical technologist with experience in appropriate areas of laboratory testing. This individual:

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

(2) Participates in the selection of 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 https://dvagov.sharepoint.com/sites/VHADetroit/Policies/11Lab-10%20Appendix%20A%202019.docx

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4. PROCEDURE

a. Laboratory testing by ancillary testing devices must at a minimum, be conducted according to the manufacturer’s standard operating procedures, including calibration and maintenance procedures, accreditation requirements, and VA minimal testing requirements.

b. Ancillary testing sites identified by the Ancillary Testing Coordinator and/or

ACOS, PALMS as failing to follow laboratory testing requirements will not be allowed to continue performing laboratory tests on patients.

c. Routine maintenance and cleaning must be performed as specified by the manufacturer.

d. Correlation studies must be performed, as required, for those tests performed by different methods or on different instruments. It is required that all testing personnel know the limitations of each test they perform and the conditions under which further action or additional tests must be taken.

e. It is required that all testing personnel know the limitations of each test they perform and the conditions under which further action or additional tests must be taken.

All critical patient results must be immediately reported to the responsible provider.

f. When testing is performed by a VA employee or a contracted service employee in a patient’s home under the HBHC Program, the testing is considered Ancillary Testing and all standards apply.

g. When patients are in a VA inpatient or ambulatory care setting, they may not perform self-testing except when self-testing is required as part of a patient education program or the patient is in a domiciliary or similar situation and adjusting their own medication. Results from patient self-testing may not be utilized by VA providers for patient diagnosis or treatment. Laboratory personnel must be available to participate in patient education on the maintenance and cleaning of self-testing devices.

5. REFERENCES

Chief of Staff’s Memorandum on Ancillary Testing Policy dated April 13, 1998 VHA Directive 1106 and VHA Handbook 1106.1, Paragraph 7, January 29, 2016 The Joint Commission Accreditation Manual for Pathology and Clinical Laboratory Services, Current Edition.

6. FOLLOW-UP RESPONSIBILITY

Pathology and Laboratory Medicine Service is responsible for the content of this Medical Center Numbered Memorandum. Questions may be referred to the ACOS, Pathology and Laboratory Medicine Service.

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7. RESCISSIONS

Medical Center Numbered Memorandum 11LAB-10, dated February 22, 2016

8. EXPIRATION DATE

April 25, 2024

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Pamela Reeves, M.D.

Medical Center Director

Distribution: Facility Wide