D.21 Ancillary Diagnostic Laboratory Testing Program (MCM658-113-02).pdf

Department of Veterans Affairs VAMC MEMORANDUM 658-113-02 VA Medical Center March 7, 2019 Salem, VA 24153 Ancillary Diagnostic Laboratory Testing Program

ANCILLARY DIAGNOSTIC LABORATORY TESTING PROGRAM

1. PURPOSE: To establish a policy for performing and maintaining the Ancillary Testing Program. Ancillary or Point of Care (POC) testing is defined as laboratory testing or services performed within a Veterans Affairs Medical Center or its outreach functions (e.g. clinics), but outside the physical facilities of the main clinical laboratory. Testing is performed by qualified providers and other non-laboratory personnel.

2. POLICY:

a. All ancillary testing sites are required to be under the quality oversight and technical direction of the Chief of Pathology and Laboratory Medicine Service (P&LMS) and inspected and fully accredited by an appropriate, nationally recognized Center for Medicare and Medicaid Services (CMS) “deemed” accrediting body.

b. Quality Management records for all ancillary testing sites that are under the quality management oversight of the Chief of P&LMS will be maintained within the main clinical laboratory.

3. RESPONSIBILITIES:

a. The Chief of P&LMS, in consultation with the medical, nursing and other staff, is responsible for:

(1) Approving the tests which may be performed outside the main clinical laboratory for patient care screening or diagnostic purposes and the equipment needed.

(2) Providing medical appropriateness guidance.

(3) Establishing the protocols for the performance of testing results interpretation (including the definition of critical values) and recording of test results.

(4) Monitoring patient safety concerns.

b. The Service Line Chiefs will be responsible for providing inspection and accreditation support.

c. The Ancillary Testing Coordinator (ATC) must be a fully-qualified medical technologist with at least 4 years of experience in appropriate areas of laboratory testing. The ATC will:

(1) Act as technical oversight supervisor for all ancillary testing sites.

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

(3) Participate in the verification of methods and test procedures performed and the establishment of the performance characteristics, including precision and accuracy.

D.21 Ancillary Diagnostic Laboratory Testing Program (MCM658-113-02) 36C24621R0068

VAMC MEMORANDUM 658-113-02

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

(5) Document training, authorization, and annual competency evaluation for all persons who perform ancillary testing.

(6) Ensure enrollment and participation in a proficiency program commensurate with the testing services offered and oversee necessary remedial action when necessary.

(7) Serve as a resource for preparation of appropriate staff in services and patient education.

(8) Review instrument maintenance records.

(9) Ensure that all testing devices are checked for calibration according to laboratory established procedures and frequencies.

(10) Maintain current Clinical Laboratory Improvement Amendments (CLIA) certificates and/or accreditation documentation for Salem VA affiliated and/or contracted Community-Based Outpatient Clinics (CBOCs) and reference laboratories.

(11) The coordinator will report any areas that are not in compliance to the Ancillary Testing Site Nurse Manager, and to the Chief of P&LMS, or designee.

d. Ancillary testing site Nurse Managers and/or Practice Managers are responsible for all personnel who perform ancillary testing. The ancillary site Nurse Manager or Practice Manager will work with the Ancillary Testing Coordinator (ATC) to assure that all ancillary functions are up to date and/or adequate. These include, but are not limited to:

(1) Personnel training and certification.

(2) Evaluation of clinical/technical competency.

(3) Maintenance of laboratory equipment, including infection control and supply checks.

(4) Monitoring adherence to Quality Control (QC) requirements, established laboratory policies and procedures, and proper test utilization.

4. ACTIONS:

a. Documentation: Written records and requirements for tests performed outside the main clinical laboratory will be maintained, including identification of personnel performing tests.

b. Authorization:

(1) Protocols will be developed for healthcare persons performing testing for assessing their levels of competency and assuring annual certification. Clinical limits of acceptable variability for each type of test performed outside the clinical laboratory will be defined and a protocol for immediate evaluation of results and actions by non-laboratory testing personnel if a test result is outside the specified range.

(2) Authorization to perform ancillary testing will be limited to those individuals who have satisfied the authorization requirements established for the specific test method. Continual authorization will be dependent upon satisfactory QC records and proficiency challenge performance as established by review of the ATC along with adherence to procedures.

(3) Authorization will be renewed annually unless otherwise indicated by performance on routine QC, performance on proficiency challenges, or lack of policy and procedure compliance.

(4) Individuals not complying with the stated policy or incorrectly performing tests will be removed from the list of authorized personnel. Reinstatement will occur only after participation in additional training program and after technical competency is demonstrated.

c. Quality Control and Proficiency Testing:

(1) All individuals who are authorized to perform ancillary tests must participate in the QC program.

(2) Each site performing ancillary testing must participate in proficiency testing.

d. Maintenance: Maintenance of instruments will be performed as specified by manufacturer’s guidelines. Maintenance procedures will be outlined in the test procedures, written to meet The Clinical and Laboratory Standards Institute (CLSI) guidelines. All maintenance and repair work will be documented.

e. Infection Control: Infection Control will be included in the approved training program.

Authorized individuals must be familiar with universal blood/body fluid precautions and all other hospital safety policies.

f. Patient self-testing: Patient self-testing may not be performed on medical center devices in the inpatient or ambulatory care setting. (NOTE: Return demonstrations for patient education on Food & Drug Administration (FDA)-approved devices prescribed for individual patient use are not included.)

g. Ancillary/POC Test Orders: Test orders for point of care testing are required by an approved provider, authorizing testing personnel to perform ancillary/POC testing on patients.

h. Ancillary testing results: Test results must be entered appropriately and promptly into the permanent medical record in accordance with established reporting procedures.

5. ETHICAL DOMAINS:

a. Shared Decision Making with Patients

b. Patient Privacy and Confidentiality

c. Professionalism in Patient Care

6. REFERENCES:

a. VHA Handbook 1106.01 dated January 29, 2016

b. College of American Pathologists Checklists: Point of Care, All Common, and Laboratory General

c. The Joint Commission Accreditation Standards

7. FOLLOW-UP RESPONSIBILITY: The Chief, Pathology & Laboratory Medicine Service, is responsible for the contents of this medical center memorandum.

8. RESCISSION: Medical Center Memorandum 658-113-02, “Ancillary Diagnostic Laboratory

Testing Program”, dated March 7, 2016.

9. EXPIRATION DATE: March 7, 2022.

REBECCA J. STACKHOUSE, CTRS, FACHE

Medical Center Director

Attachment

Department of Veterans Affairs VAMC MEMORANDUM 658-113-02A VA Medical Center March 7, 2019 Salem, VA 24153 Ancillary Diagnostic Laboratory Testing Program Attachment A

TABLE OF APPROVED ANCILLARY TESTS

TEST NAME

TESTING

LOCATIONS

UTILIZATION CRITERIA

Activated Clotting

Time

(ACT)

CCL,

CCRU

Operating Room (OR) Radiology

PCU

SICU

Monitoring heparin therapy for:

1. Cardiac and Peripheral Vascular Catherization

2. Femoral Sheath Removal

3. Endovascular Aneurism Repair

4. OR Vascular Cases

5. Intensive Care-Heparin Protocol

Whole Blood

Glucose

4J, 4H, Renal, SICU, PCU, PACU, ER, Quick Care Clinic, 2-2, 2-3, 170, 7-1, 9-2, 11-2, Clinic 1, Clinic 2, Clinic 3, 2J, CCRU, Day Unit, Women's Clinic, Diabetes Ed., Danville CBOC, Lynchburg CBOC, Staunton CBOC, Wytheville CBOC

Used as an aid in monitoring the effectiveness of diabetes control programs for known diabetic patients.

Blood Gas/ Chem/HCT

OR

Radiology

Monitoring for pH, pC02, p02, Na, K, iCa, Glu and HCT during OR cases

Oximetry

CCL

Determination of the oxyhemoglobin saturation and total hemoglobin concentration in a sample of whole blood during cardiac procedures.

Creatinine

Radiology

Quantitative measurement of creatinine in whole blood to determine renal function for CT and/or MRI procedures.

Urine HCG

Danville CBOC, Lynchburg CBOC, Staunton CBOC, Wytheville CBOC

BHCG test measures the level of Human Chorionic Gonadotropin (HCG) in the urine. HCG is a hormone produced during pregnancy. HCG urine test aids in the diagnosis of early pregnancy.