S02 - SOLICITATION ATTACHMENT - D.20 Ancillary Laboratory Testing Guidelines.pdf

D.20 – ANCILLARY TESTING GUIDELINES

DEPARTMENT OF VETERANS AFFAIRS

VA HEALTHCARE NETWORK

UPSTATE NEW YORK AT SYRACUSE

Medical Center Professional Memorandum September 2019 Pathology & Laboratory Medicine 11-52 113/Lab

ANCILLARY LABORATORY TESTING GUIDELINES

I. PURPOSE:

To establish guidelines for Ancillary Laboratory Testing. Ancillary Laboratory Testing is defined as: Performing testing outside the confines of the Clinical Laboratory on material derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease, and the impairment or assessment of the health of human beings.

II. POLICY:

Ancillary testing will not be performed unless it is submitted to and approved by the Clinical Laboratory. Ancillary testing may, in rare instances, be necessary for the management of patients. The cost and complexity of such testing can be quite extensive and therefore, should be kept to an absolute minimum.

III. PROCEDURE:

A. OVERALL REQUIREMENTS:

1. All ancillary testing personnel will be approved to perform the appropriate testing. All personnel will complete approved training on operation, calibration, and maintenance of any appropriate instrumentation.

2. All ancillary testing sites that perform tests for patient care Purposes must comply with Joint Commission and CAP standards.

3. All ancillary testing sites will follow the same operational and quality management standards required by the Clinical Laboratory Improvement Amendment of 1988.

4. Yearly competency records for finger stick glucose testing are located in the employee’s education folder and is kept by the manager on the employees assigned ward. All other ancillary

Medical Center Professional Memorandum September 2019 Pathology & Laboratory Medicine 11-52 Page 2 records will be centrally located in the Clinical Laboratory and maintained by the Ancillary Testing Coordinator.

5. All ancillary testing sites will maintain procedure manuals in the testing area that will be reviewed annually by appropriate supervisory personnel.

6. All ancillary testing sites will maintain reagents according to manufacturer's requirements.

7. All ancillary testing results will ultimately be maintained in the patient chart in a clear manner. Preceding the placement of the results into the chart, patient worksheets for recoding purposes may be maintained at the patient bedside or other acceptable location in the testing unit. Frequently repeated tests, such as capillary blood glucoses or blood gases during a procedure, should be entered on a flow worksheet that contains the following information:

• PATIENT NAME

• SOCIAL SECURITY NUMBER

• DATE & TIME OF SPECIMEN COLLECTION

• NAME OF TEST PERFORMED

• REFERENCE VALUES

• TEST RESULT

• NAME OF ANALYST

• NAME OF LOCATION OF SITE PERFORMING THE TEST

B. INPATIENT SERVICES:

1. The proposal for ancillary laboratory testing will be brought up to the Clinical Laboratory for consideration.

2. If the proposed ancillary testing requires instrumentation, the Appropriate Laboratory Section of the Clinical Laboratory will lend their expertise in evaluating appropriate methods.

3. All ancillary testing sites will have appropriate quality control performed at least once per day when testing is to be done. The control data will be sent to the Clinical Laboratory for evaluation by the appropriate Laboratory Section.

Medical Center Professional Memorandum September 2019 Pathology & Laboratory Medicine 11-52 Page 3

4. All ancillary testing sites will be standardized to current laboratory instrumentation to demonstrate accuracy of instrument testing.

5. All ancillary testing personnel will perform proficiency testing for the appropriate analytes to demonstrate proper technique.

C. OUTPATIENT SERVICES:

1. The proposal for ancillary laboratory testing will be brought up to the Clinical Laboratory.

IV. REFERENCES:

Department of Veterans Affairs, VHA Handbook 1106.1.

College of American Pathologists 2018 Inspection Checklist, "Point of Care Section POC.

Joint Commission Accreditation Manual for Hospitals, "Pathology & Medical Laboratory Services", PA.6.4 "Decentralized Laboratory Testing".

V. RESCISSION:

Medical Center Professional Memorandum 11-52 Guidelines for Ancillary

Laboratory Testing dated August 2016.

VI. REVIEW DATE:

September 2021

VII. RESPONSIBLE REVIEWER:

Pathology & Laboratory, 113

S ASIF ALI, MD

Chief of Staff