D11 NM 113-2 Ancillary (POC )Testing Program.docx

Southeast Louisiana Veterans Health Care System New Orleans, LA 70112

Department of Veterans Affairs

Numbered Memorandum

113-2 June 30, 2017

ANCILLARY (POINT OF CARE) TESTING PROGRAM

1. PURPOSE: The purpose of this Numbered Memorandum (NM) is to establish policy and procedures to govern all laboratory testing and laboratory testing sites that occur outside of the physical facilities of the Pathology and Laboratory Medicine Service (P&LMS) of Southeast Louisiana Veterans Health Care System (SLVHCS).

2. POLICY: The policy is to assure compliance by all ancillary testing sites and personnel with accepted principles of laboratory science to include, but not limited to, standards of equipment operations and maintenance, specimen handling, reagent preparation and storage, procedure manuals, personnel training and orientation, quality control, reporting, proficiency testing and safety, and to provide instruction required to clean and disinfect point of care instruments (e.g. glucose meters) per manufacturer’s instructions. Point of Care (Ancillary) testing is considered as definitive for the purpose of patient care. Diagnostic and confirmatory testing is performed by P&LMS when clinically required for management of a patient. Whole blood glucose meters utilizing samples obtained by finger stick will not be used on critically ill patients as defined by SLVHCS medical staff.

3. RESPONSIBILITIES:

a. The Ancillary Testing Committee, as established by the Medical Center Director (MCD), will develop overall policy, standards, operational quality management procedures, and has oversight responsibility for all ancillary testing sites.

b. The Chief, P&LMS or designee will chair the Ancillary Testing Committee and provide guidance and technical/quality control support for all ancillary testing and ancillary testing sites.

c. The Ancillary Testing Coordinator, a qualified Medical Technologist, will assist the Chief as a technical supervisor of ancillary testing, coordinate proficiency testing surveys, monitor the ancillary testing sites for compliance with the quality management protocols established by the Ancillary Testing Committee, serve as an advisor to individual service line Ancillary Test Site supervisors, and as a member of the Committee. The Ancillary Testing Coordinator is responsible for the maintenance and management of all required documentation regarding ancillary testing including, but not limited to, a current list of ancillary testing sites, staff training records, quality control records, proficiency testing results, instrument records, etc. This documentation will be centrally filed and stored in the P&LMS.

d. Each Service in which ancillary testing is performed will designate an Ancillary Test Site supervisor (e.g., the community-based outpatient clinic (CBOC) Nurse Manager) who will assure compliance with the policies and procedures of the committee and who will either serve as or report to the respective Service’s representative to the Ancillary Testing Committee. The Service Ancillary Test Site supervisor is responsible for the compliance and availability of all required documentation regarding ancillary testing in his/her Service Line.

e. Each member of the Health Care System (HCS) staff (i.e., nurses, physicians, etc.) who performs ancillary testing will comply with the procedures, standards and requirements developed by the Ancillary Testing Committee. Failure to comply may result in appropriate disciplinary action.

f. Patients to whom ancillary testing equipment is issued are responsible for the proper operation and maintenance of the equipment.

g. This NM governs testing performed by SLVHCS employees. Home Glucose monitoring and other Patient Self-Testing is not governed by this policy, and is addressed in NM, “Home Glucose Monitoring Program.” Please see NM as well as 4c.(2) below for additional information.

4. PROCEDURES:

a. Establishing a New Ancillary Test or Testing Site:

(1) The Ancillary Testing Committee decides where and which tests may be performed outside of the P&LMS. Requests to become a designated Point of Care (Ancillary) testing site and to perform specifically identified tests must be submitted by the requesting Service, with concurrence from the Service Chief, to the Committee for approval. Testing shall not take place until the Committee has approved the ancillary tests and site. Requests will include the following information:

(a) Specific test(s) to be performed;

(b) Manufacturers, type and model of testing equipment to be used;

(c) Classification and number of individuals to be trained to perform the tests;

(d) How patient care will be enhanced by the performance of this procedure at the Point of Care (Ancillary) testing site;

(e) Cost analysis to include initial costs, recurring cost and a cost per test analysis; and

(f) The name of the individual designated as the Ancillary Test Site supervisor who will be administratively responsible for this ancillary testing site and will serve as liaison to the Committee.

(2) The requesting service must obtain funding approval for the testing through the standard Resource Management Committee (RMC) approval process; and

(3) The Ancillary Testing Committee will maintain a current listing of all sites where ancillary testing is performed and what specific tests are performed at each site. Guidelines for the approval of ancillary testing sites and the list of approved sites and tests are listed in Attachment A.

b. Monitoring Point of Care (Ancillary) Testing Sites:

(1) The goal of monitoring the program is to assure accuracy of ancillary testing results that are used for the screening or monitoring of patient care. Failure to comply with the standards of ancillary testing or repetitive unabated deficiencies may result in a decision by the Ancillary Testing Committee to cancel ancillary testing at a specific site;

(2) The designated Service Ancillary Test Site supervisor will provide reports at least annually to the Ancillary Test Committee regarding the performance of the Point of Care (Ancillary) test sites under his/her jurisdiction. Compliance by personnel performing ancillary tests with accepted testing standards (including safety, reagent handling, specimen handling, and reporting) will be assessed; and

(3) The Ancillary Testing Coordinator or designee will review procedure manuals, quality control, and instrument maintenance records and data entry for completeness. Proficiency testing results and documentation of corrective action in response to unacceptable results will be provided. Corrective action to abate any deficiency of compliance with accepted standards of ancillary testing will be documented and reported to the Committee.

c. Personnel:

(1) Only designated, authorized personnel who have received adequate training and orientation to perform specified point of care tests are allowed to perform such tests. Service Ancillary Test Site supervisors and the Ancillary Testing Coordinator will maintain a current list of personnel who are authorized to perform testing. The list will specify what test(s) individuals are authorized to perform. Competency will be assessed at the Clinical Laboratory Improvement Amendment (CLIA) required intervals. Documentation on the competency assessment record of an annual review of the testing procedures by all authorized testing personnel will be maintained by the Service Ancillary Testing Site supervisor. Training and orientation will be the responsibility of the Ancillary Testing Coordinator; Associate Nurse Executive (ANE), and Service Ancillary Test Site supervisors. Unauthorized personnel will not be allowed to perform point of care (ancillary) testing. Results generated by unauthorized personnel will not be reported or recorded and will not be used for the screening or monitoring of patient care; and

(2) Guidelines for the issuance of glucose meters to the patient are listed in Numbered Memorandum, “Home Glucose Monitoring Program.” Patients who perform self-testing will receive training and orientation to perform specified tests and cleaning and disinfection of the equipment. This orientation will include training in instrument quality control and remedial action, maintenance and record keeping. Training and orientation for patients will be the responsibility of designated nursing staff. A patient will not be issued ancillary testing equipment unless the patient is able to fully comply with all prescribed standards applicable to ancillary testing.

d. Ancillary Test Sites:

(1) Ancillary testing sites will maintain a testing (procedure) manual containing the following information for each test performed at that site. The procedure manual will be reviewed at least annually by qualified supervisory P&LMS personnel. The procedure manual shall contain:

(a) Procedures on specimen collection;

(b) Specimen processing (if applicable);

(c) Procedure for specimen analysis;

(d) Quality control requirements and corrective action if needed;

(e) Reporting and recording of results (including “panic value” results);

(f) Expected test performance characteristics; and

(g) Procedures for cleaning and maintenance of instruments per manufacturer’s instructions.

(2) Ancillary Testing Sites will maintain the following records as specified for each testing system:

(a) For each day that testing is performed written and/or electronic records are maintained of patient results and quality control results of suitable positive and negative reference samples. The record of patient results includes patient identification, date and time specimen collected, identification of person performing testing, reference ranges and results. Corrective action in response to unacceptable quality control results must be documented either in written or electronic format;

(b) Reagent preparation, lot numbers, expiration dates and storage records;

(c) Instrument maintenance records in accordance with manufacturer’s specification;

(f) For sites performing reagent strip urinalysis, records demonstrating acceptable proficiency testing results, and correlation of chemistry test results with P&LMS reference methods must be maintained at the site. The Service Ancillary Test Site supervisor is responsible for the compliance and documentation of this data;

(g) For sites performing Provider Performed Microscopy (PPM), records demonstrating acceptable proficiency testing results must be maintained at the site. The Service Ancillary Test Site supervisor is responsible for the compliance and documentation of this data;

(h) For sites performing urine human choriaonic gonadatropin (HCG) testing, records demonstrating acceptable proficiency testing results must be maintained at the site. The Service Ancillary Test Site supervisor is responsible for the compliance and documentation of this data; and

(i) For sites performing Blood Gas testing, records demonstrating acceptable proficiency testing results must be maintained at the site. The Service Ancillary Test Site supervisor is responsible for the compliance and documentation of this data.

e. Central Record Storage:

(1) Electronic or written quality control, correction actions, and operator identification records will be securely stored in a central site in P&LMS; and

(2) Records of proficiency testing results showing active review of results and corrective action in response to unacceptable results will be maintained in P&LMS.

f. Patient Ancillary Testing Equipment:

(1) Refer to NM, “Home Glucose Monitoring Program.”

(2) Ancillary Testing Equipment Selection: The Ancillary Testing Committee will advise the Commodity Standards Committee on the purchase of ancillary testing equipment, reagents, and supplies. Consensus will be achieved, if at all possible, to have uniformity of equipment and supplies for a specific test at all point of care testing sites. Committee decisions will be based upon the following:

(a) Reliability of equipment;

(b) Accuracy of results;

g. Safety: All point of care (ancillary) testing sites will comply with established Health Care System safety regulations to minimize hazards to staff and patients from the operation, analysis, and disposal of materials used in ancillary testing.

h. Accreditation: All point of care (ancillary) testing sites will be inspected and fully accredited by College of American Pathologists (CAP) and/or the Joint Commission.

5. RESCISSION: NM, Ancillary (Point of Care) Testing Program dated March 5, 2016.

6. REFERENCES: Veterans Health Administration (VHA) Directive 1106.1; CAP Accreditation Standards for Ancillary Testing; and The Joint Commission (TJC), current edition; TJC Laboratory Accreditation, current edition; and CLIA.

7. FOLLOW-UP RESPONSIBILITY: Chief, Pathology and Laboratory Medicine Service (113)

8. EXPIRATION DATE: June 30, 2020

(Signed) Fernando O. Rivera, FACHE SLVHCS Medical Center Director

Attachment:

SUMMATION OF POLICY & PROCEDURE CHANGES: None.

Numbered Memorandum 113-2

GUIDELINES FOR THE APPROVAL OF ANCILLARY TEST SITE AND TESTS

1. It must be the majority opinion of the Ancillary Test Committee that implementation of the proposed ancillary test site or tests is appropriate and will significantly enhance the quality of patient care.

2. There is appropriate assurance that the Point of Care (Ancillary) Test Site and tests performed there will comply with all the policies and procedures of the Ancillary Testing Program. Failure to comply will result in deactivation of the test site.

3. The documentation requested in paragraph 4.a. of this Numbered Memorandum (NM) will be compiled by the requesting service line and will be deemed acceptable to a majority of the Ancillary Testing Committee.

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