VA257-17-R-0506-008.doc

D.7 VA257-17-R-0506

DEPARTMENT OF VETERANS AFFAIRS

NORTH TEXAS HEALTH CARE SYSTEM

May 5, 2016

549/113

VANTHCS MEMORANDUM NO. 113-03

ANCILLARY/ POINT OF CARE TESTING

1.

PURPOSE:

The purpose of this memorandum is to define the policy on all ancillary/point of care testing [waived, non-waived, and Provider Performed Testing (PPT) which includes Provider Performed Microscopy (PPM)] performed within VA North Texas Health Care System (VANTHCS), specifically for VA-owned and/or managed (leased) facilities; does not apply to contracted, non-VA sites, and to define the responsibilities of individuals who perform, document, or oversee such testing. The Chief, Pathology and Laboratory Medicine Service (P&LMS) (as named Medical Director for this facility’s Clinical Laboratory Improvement Amendments (CLIA) certificate) is required by The Joint Commission to establish policy and procedure for all laboratory testing.

2.

POLICY:

It is the policy of VANTHCS to ensure that only fully qualified and trained individuals with documented competencies perform ancillary testing. This policy establishes compliance with Veterans Health Administration Laboratory Testing (VHA Handbook 1106.01), The Joint Commission (PPM), College of American Pathologists (CAP) (PPT), and the CLIA of 1988 (PPM) standards regarding ancillary/point of care testing (waived, non-waived, and PPT testing).

3.

PROCEDURES:

P&LMS will periodically survey all services to identify and monitor any ancillary testing that is being performed. Testing will be reviewed by the Ancillary Testing Coordinators/Pathology & Laboratory Medicine Service (ATC/P&LMS) for compliance with the following: appropriate policy and procedures, qualified and trained staff, documentation of test data and quality control, equipment maintenance forms, participation in CAP proficiency testing, and ongoing competency assessments for designated staff.

a.

Definitions:

(1) Ancillary/point of care testing refers to testing performed outside the clinical laboratory. It includes waived, non-waived, and PPT.

(2) Waived testing, as defined by CLIA, is usually performed at the bedside of the patient, in the clinic, or other sites remote from the laboratory. It may be performed by approved staff and/or privileged providers at VANTHCS. See Attachment for waived tests performed at VANTHCS.

(3) Non-waived tests are CLIA “moderate complexity” level tests that may be performed outside or in the laboratory and must meet the requirements of 42 CFR Part 493. See Attachment for non-waived tests performed at VANTHCS.

(4) PPT, performed at VANTHCS (except Fecal Occult Blood), is “moderate complexity” level testing performed outside the laboratory. PPT is performed by privileged providers at the time of the patient’s physical exam. See Attachment for PPT performed at VANTHCS.

(5) Approved staff are testing personnel who have been oriented and trained for specific lab procedures performed outside the clinical laboratory. They have been approved by the Chief P&LMS through the Ancillary Testing and Lab Utilization Review (ATLUR) workgroup.

(6) Privileged providers are members of the medical staff, licensed independent practitioners, nurse practitioners, and physician assistants privileged through the medical staff credentialing process.

b.

Diagnostic vs. Screening: Each service providing waived testing will define to what extent (diagnostic vs. screening) the testing is utilized, and the purpose of the tests performed.

c.

Orientation and Training: The ATC/P&LMS or designee will conduct a thorough orientation and training for all new testing personnel before performing ancillary testing. Orientation and training for residents may be performed by the attending provider. Training applicable to the type and complexity of testing performed is documented. This training should be such that the person can demonstrate that he/she has the skills required for proper performance of pre-analytic, analytic, and post-analytic phases of testing.

d.

Competency: Documentation of assessed competency is required prior to performing testing, six months and one year after performing duties, and annually thereafter. Six month competency is not required for waived testing. Annual competency must be directed and documented by the immediate supervisor or designee (nurse educator, ATC/P&LMS) for each individual performing testing. Physicians performing Fecal Occult Blood tests (FOBT) are excluded from annual competency testing on that procedure. Elements of competency assessment include but are not limited to:

(1) Direct observation of patient test performance, including patient identification and preparation where applicable, sample handling, processing, and testing.

(2) Monitoring the recording and reporting of test results, including use of CPRS templates and, as applicable, reporting critical results.

(3) Review of immediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.

(4) Direct observation of performance of instrument maintenance and function checks, as applicable.

(5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.

(6) Evaluation of problem-solving skills.

Other elements of competency may be assessed, as applicable. For non-waived tests, all six elements (above) must be assessed annually. For waived tests, it is not necessary to assess all elements at each assessment event. The ATC/P&LMS may select which elements to assess for waived tests.

Ongoing review is an acceptable method of assessing competency for certain elements (for example, direct observation of test performance, instrument maintenance, problem solving skills, etc).

The ATC/P&LMS or testing service designee will document the competency assessment. Competency assessment records will be retained by the ATC/P&LMS and/or testing service. Documentation of annual competency must be readily available. Retraining must occur when problems are indentified with employee performance.

e.

Proficiency Testing:

(1) The ATC/P&LMS will determine CAP proficiency testing needs as required by accrediting agencies. The ATC/P&LMS will distribute proficiency testing surveys in a timely manner to the test sites upon receipt in P&LMS. The ATC/P&LMS will review proficiency testing results as they are received, communicate the results to the testing sites, and ensure that appropriate corrective actions are initiated and documented for all instances of unacceptable performance.

(2) Successful performance on proficiency testing is required in order to perform ancillary testing.

f.

Result Reporting: Results will be reported as per each individual test standard operating procedure.

g.

Policies and Procedures: The Ancillary/Point of Care Testing Policy and standard operating procedures are located in Proquis, the P&LMS document control program. Proquis is accessed through the facility intranet P&LMS sharepoint. Failover binders containing hard copies of procedures are maintained at each testing location for use during computer downtime only. The ATC/P&LMS will provide assistance in preparation of documents, as needed. The testing service will review the test procedures at least annually. Annual review will be documented.

4.

RESPONSIBILITIES:

a.

It is the responsibility of each service performing ancillary testing to:

(1) Notify the ATC/P&LMS of its intentions to perform testing, so that the proposed test can be brought before the P&LMS AT/LUR workgroup for review and approval.

(2) Report to P&LMS the specific locations performing waived, non-waived testing, and/or PPT within the service.

(3) Assess the use of each test performed and define the extent to which it will be used for diagnosis, treatment, or screening, with or without follow-up using confirmatory testing.

(4) Identify the staff responsible for the testing activity. Staff must meet CLIA ‘88 qualification standards. The identified staff must have received training specific to the testing activity, received orientation specific to the needs of the service, and have been documented to be competent to perform the test.

(5) Notify ATC/P&LMS of the addition of any new staff who will require initial training.

(6) Maintain quality control records, equipment maintenance records, and any other documentation related to this testing according to applicable accrediting agencies and VA guidelines.

(7) Maintain failover binders of current test procedures.

(8) Address non-compliance issues and carry out corrective actions (Nurse Manager/supervisor/designee).

b.

It is the responsibility of the ATC/P&LMS to:

(1) Administer and document specific training to qualified staff identified as responsible for performing ancillary testing.

(2) Ensure current competency of all staff performing ancillary testing.

(3) Ensure a current written procedure for each ancillary/point of care test is readily available. The procedure elements will include appropriate specimen collection and preservation guidelines, instrument calibration, quality control and remedial actions, equipment performance evaluation, reporting of results, and performance of the test.

(4) Perform and document periodic review for compliance with written procedures.

(5) Periodically survey all VANTHCS services to identify all ancillary testing that is performed, by whom, and for what purpose(s).

c.

It is the responsibility of all staff performing ancillary testing to:

(1) Explicitly follow the procedure manual and the manufacturer’s guidelines.

(2) Perform and document quality control checks as defined in the test procedure.

(3) Document patient test results in the patient’s medical record utilizing CPRS templates, when available.

(4) Participate in all mandatory competency assessment exercises.

(5) Perform CAP proficiency testing.

5.

REFERENCES:

VHA Handbook 1106.01, Chapter 1, October 6, 2008; Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services (CAMPCLS); The Joint Commission 2008; Code of Federal Regulations: 42 CFR Part 493, 2008.

6.

RESCISSION:

VANTHCS Memorandum No. 113-03, dated November 1, 2011.

Jeffery L. Milligan

Director

Attachment

Distribution: A

Attachment

Waived Tests

Glucose Finger Stick

Qualitative Urine HCG

Non-Waived Tests

Activated Clotting Time (ACT)

ABG PANEL-POC (pH, tHb, pCO2, pO2, sO2, O2hb, COHb, MetHb, HCO3, ABE, Cl-, K+, Na+, Glucose, Lactate, Ionized Calcium))

Oximetry (O2Hb, tHb)

Glomerular Filtration Rate

Provider Performed Testing (PPT) includes certain “waived” tests under CLIA as well as Provider Performed Microscopy (PPM).

KOH/Vaginal Wet Prep

KOH

Urine Sediment Microscopy

Fecal Occult Blood (Waived)

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