D.18 ANCILLARY TESTING POLICY.pdf

D.18 ANCILLARY TESTING POLICY

36C25922R0102

DEPARTMENT OF VETERANS AFFAIRS HEALTH CARE SYSTEM

Oklahoma City, Oklahoma

Center Memorandum 113-14 January 30, 2018

ANCILLARY TESTING POLICY

1. Summary: Center Memorandum 113-14 dated February 27, 2013 is rescinded and reissued. This revised memo contains minor changes.

2. Purpose: To establish policies, procedures, and requirements for performing and maintaining the ancillary testing program in compliance with standards of the Joint Commission, College of American Pathologists (CAP), and Department of Veterans Affairs

(VA).

3. Policy: This memorandum pertains to all personnel involved in ancillary testing.

a. Inspections. All Ancillary Testing sites are required to be inspected and fully accredited by Joint Commission and CAP. These sites will be inspected during the same inspection visit for the VA Medical Center's main clinical laboratory.

b. Oversite. All Ancillary Testing must be under the quality management oversight of Pathology and Laboratory Medicine Service. Quality Management records for all ancillary testing sites will be maintained in the main clinical laboratory.

c. Definitions:

(1) Laboratory Test. A diagnostic or monitoring procedure on a human specimen to determine specific information for patient care, the prevention of disease, and to detect the impairment of health status or assess the health of human beings.

(2) Ancillary Testing. Laboratory testing within a VA Medical Center or its outreach functions (community based outpatient clinics) performed outside the physical facilities of the main clinical laboratory.

4. Procedures:

a. Approval of New Tests. Requests to perform new tests or tests not currently authorized for a specific site must be presented to the Ancillary Testing Coordinator who will then present to the Chief of Pathology and Laboratory Medicine Service during the monthly Pathology and Laboratory Service meeting.

(1) Requests. May be scheduled on the committee agenda.

(2) Requests. Must address the following issues:

(a) Medical and fiscal rationale for testing.

Center Memorandum 113-14, January 30, 2018

(b) Identity of ancillary testing site director and on-site supervisor.

(c) Test method and equipment to be used.

(d) Identity and number of testing personnel.

(e) Plan for training and competency evaluation of testing personnel.

(f) Estimate of number of tests to be performed per month.

b. Performance Evaluation of Test Method. Performance characteristics of the test method must be approved by the ancillary testing committee prior to implementation.

(1) Initial Testing. Accuracy, precision, and linearity testing must be performed and documented per regulatory guidelines. Documentation must be retained for two years beyond the life of the instrument or two years longer than the method is in use.

(2) Multiple Instruments. After the initial verification has been completed, subsequent instruments of the same type may be evaluated with an abbreviated procedure; e.g., comparison to initial instrument with a limited number of control or patient specimens.

(3) Linearity. Each applicable instrument must be verified and documented at least semi-annually.

c. Procedure Manual. A complete procedure must be written in compliance with NCCLS GP2-A4, or the most recent revision of this document and in use for each test performed. The use of inserts provided by manufacturers is not acceptable in place of a procedure manual, except where it can be shown that the insert meets the same standards.

(1) Procedure Approval. Ancillary Testing Director (Chief of Pathology and Laboratory Medicine) must approve all procedures initially and bi-annually, or whenever they are revised. If there is a change in directorship, the new laboratory director must re-approve all procedures within 30 days.

(2) Hard Copy. A hard copy of the procedure manual will be kept in the Ancillary Testing Coordinator’s office. All ancillary testing sites can access procedures via OKL- Shares\Lab\Public\Ancillary Testing (POC).

(3) Personnel. Testing site personnel must be knowledgeable of all ancillary-testing procedures pertaining to their area.

(4) Discontinued Procedures. Copies of discontinued procedures must be kept in Pathology & Laboratory Medicine Service for at least two years, with date of initial use and date of retirement documented.

d. Authorization of Testing Personnel: Only those individuals who participate in an approved training program and demonstrate clinical competency may perform Ancillary testing.

(1) Continued authorization. Depends upon satisfactory performance of quality control, proficiency, and patient testing and adherence to policies and procedures.

(2) Authorization. Will be renewed quarterly unless otherwise indicated.

(3) Initial Non-Compliance. Individuals performing tests incorrectly or not complying with stated policies will be counseled and re-trained prior to receiving renewed authorization.

(4) Continued Non-Compliance. Individuals who repeatedly perform tests incorrectly or do not comply with stated policies after counseling and training will be removed from the list of authorized personnel.

(5) List. A current list of authorized personnel will be maintained in Pathology & Laboratory Medicine Service.

e. Quality Control (QC) Testing: Controls are samples that are periodically tested like patient samples to ensure that all test system variables (i.e., instruments, reagents, operator technique) are performing as expected.

(1) Participation. All individuals who are authorized to perform ancillary testing must participate in the quality control program established for each ancillary testing site.

(2) Results. QC test results must be permanently recorded either on test worksheets or in a data management system.

(3) Ranges. QC acceptable ranges will be established within the hospital, using tolerance limits of 2-3 standard deviations (SD) of the method precision as determined on-site.

(4) Corrective Action. If a control value falls outside the hospital's established acceptable range, corrective action must be taken and documented before any patient test results can be reported. Unresolved problems must be reported to the ancillary testing coordinator.

(5) Monthly Review. All QC results must be sent monthly to Pathology & Laboratory Medicine Service for review of actual mean, SD, and coefficient of variation (CV). The on-site supervisor will be notified if corrective measures are needed.

f. Quality Management: Each ancillary testing site falls under the Pathology & Laboratory quality management program for ancillary testing to identify and correct problems, assure the accuracy, reliable, and prompt reporting of test results, and assure the adequacy and competency of testing personnel.

(1) Participation. All individuals authorized to perform ancillary testing must participate in the quality management program established for each ancillary testing site.

(2) Records. The training and competency documentation along with a list of current authorized personnel will be maintained in Pathology & Laboratory Medicine Service.

(3) Corrective Action. If any ancillary testing site shows a high degree of reporting unacceptable QC or proficiency test results, the instrument or test system in question will be thoroughly checked and corrective action taken if needed. If reporting of unacceptable results continues, testing at that site may be discontinued.

g. Proficiency Testing: Ancillary test sites must participate in the recommended external proficiency program for each test performed.

(1) Testing. Periodically, commercially prepared survey specimens will be received by Pathology & Laboratory Medicine Service and distributed to ancillary test sites for analysis. These specimens must be analyzed by personnel who routinely test patient samples in the same manner as patient samples.

(2) Evaluation. The results are evaluated by an external agency, which determines the acceptability of the results. The final analysis will be reviewed by the ancillary testing director and ancillary coordinator.

(3) Corrective Action. If unacceptable results are reported, the instrument involved will be thoroughly checked and corrective action taken if necessary. If the instrument performance is satisfactory, the technique of the involved individual will be reviewed and corrected, if necessary.

(4) Discontinued Testing. If reporting of unacceptable results continues, testing at that site may be discontinued.

h. Specimen Handling. Proper specimen collection and handling are critical for correct laboratory results. While Point Of Care Testing systems require very small amounts of blood, this is not universally the case. Every effort must be made to minimize unnecessarily large blood draw volumes. Specific instructions for each test may be found in the procedure manual.

(1) Patient Identification. Testing personnel must carefully identify each patient by checking the patient's wristband or asking the patient his/her name.

(2) Patient Specimens. Patient specimens must be taken directly from the patient to the analyzer, either in the same or adjacent room, with no specimens from other patients being analyzed at the same time.

(3) Precautions. Standard precautions must be observed.

i. Reporting Results. All test results must be carefully reviewed and verified by testing personnel before they are reported.

(1) Quality Control Results. Test results cannot be released unless quality control results are within acceptable range.

(2) Inconsistent Results. To prevent possible analytical errors, all patient results that appear inconsistent with clinically relevant criteria must be verified by repeat analysis.

(3) CPRS/VISTA. Test results must be permanently entered into the hospital computer system (CPRS/VISTA) and must include:

(a) Patient name and social security number.

(b) Date and time of specimen collection.

(c) Name of test performed.

(d) Reference (normal) values (On CPRS/VISTA system).

(e) Test result.

(f) Name of analyst .

(g) Location of testing.

(h) Ordering physician.

(4) Flow Sheets. When recorded in the patient chart, results of frequently repeated tests, such as capillary blood glucose or activated clotting time, should be entered on a flow sheet that clearly delineates the results as well as therapeutic interventions.

(5) Notification. The physician must be notified, by testing personnel, of any patient result that falls within the established notification range for each test. The date, time, and individual notified must be documented with the test result.

(6) Reportable. Upper and lower limits of reportable ranges, determined during instrument or reagent evaluation, must be defined so that results which fall outside these limits are verified before reporting.

j. Reagents. All testing sites must verify and document reagent performance.

(1) Ordering and Usage. When possible, sufficient quantities of reagents or controls with the same lot number must be purchased to allow consistency in testing. Only one lot number of reagents or controls should be used at one time. Different lot numbers of reagent kits with multiple components cannot be shared.

(2) New Lots. New lot numbers of reagents must be checked by routine quality control testing before being used for patient testing.

(3) Labeling and Expiration. All reagents must be properly labeled with date received, date placed into service, date of expiration, and must be used within their indicated expiration dates. Expired reagents are to be discarded by appropriate mechanisms.

k. Maintenance. All testing sites must follow the manufacturer's routine maintenance guidelines to ensure continued accuracy of the test system.

(1) Maintenance Logs. Maintenance logs will be kept in the Ancillary Testing Coordinator’s office.

(2) Maintenance Help. Pathology & Laboratory Medicine Service will assist in any in-depth maintenance, troubleshooting, or repair.

l. Infection Control. All testing must follow the guidelines of standard blood/body fluid precautions and hospital safety policies.

5. References:

a. College of American Pathologists, Commission on Laboratory Accreditation, Laboratory Accreditation Program, Inspection Checklist for Ancillary Testing, 2017.

b. Department of Veterans Affairs, Veterans Health Administration, Washington, D.C.

Veterans Health Administration Manual M-2, Part VI, Chapter 10.

c. The Joint Commission Comprehensive Accreditation Manual for Hospitals, current edition.

6. Follow-up Responsibility: Chief, Pathology & Laboratory Medicine Service (113).

7. Concurrence Responsibility: Nursing, Radiology, Respiratory, Dental

8. Renewal Date: January 30, 2022

Wade Vlosich Health Care System Director