D22 LOCAL POLICY ANCILLARY TESTING.docx

ATTACHMENT D25 LOCAL POLICY ANCILLARY TESTING

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

G.V. (SONNY) MONTGOMERY VA MEDICAL CENTER

Medical Center Policy Number: F-113-47___________August 25, 2016____

PATHOLOGY AND LABORATORY MEDICINE SERVICE

ANCILLARY TESTING/POINT-OF-CARE TESTING POLICY

I. PURPOSE:

To establish policies, procedures, and requirements for performing and maintaining the Ancillary Testing/Point-of-Care Testing (POCT) Programs, in compliance with Joint Commission on Accreditation of Health care Organizations (JCAHO) standards, College of American Pathologists (CAP) standards and the Department of Veteran Affairs, Veterans Health Administration Handbook 1106.01, Pathology and Laboratory Medicine, Service Paragraph 8, “Ancillary Testing”.

II. POLICY:

A. Ancillary testing encompasses or includes all laboratory sites outside the physical limits or physical address of the main VA medical facility’s Pathology and Laboratory Service.

B. Waived testing performed outside the Main Clinical Laboratory consists of whole blood glucose testing performed by authorized testing personnel. Whole blood glucoses are regarded as definitive testing between the levels of 25 mg/dl and 500 mg/dl. Outside this range serum glucose must be performed. The site supervisor will be responsible for training and competency evaluation process for all individuals who will be authorized to perform whole blood glucose testing.

C. Provider Performed Microscopy Procedures (PPMP) consists of dermatological potassium hydroxide (KOH) preparations performed by privileged providers, and nurse practitioners. Assessment of competency is performed by Pathology and Laboratory Medicine Service (P&LMS).

D. Moderate complexity performed outside the Main Clinical Laboratory consists of the i-Stat Kaolin Active Clotting Time and Blood Gas testing. The site Supervisor/or designee that qualifies as a technical consultant, will be responsible for training and competency evaluation process for all individuals who will be authorized to perform Ancillary Testing. The Ancillary Testing Coordinator will provide oversight.

E. The Chief, Pathology and Laboratory Medicine Service in consultation with medical and nursing staff will decide which tests may be performed outside the Main Clinical Laboratory for patient care diagnostic and monitoring purposes and the equipment needed. All testing sites must be inspected and fully accredited by an appropriate “deemed” accrediting body nationally recognized by the Centers for Medicare & Medicaid Services (CMS).

F. Ancillary testing will be monitored by the Chief, Pathology and Laboratory Medicine Service as mandated by Veterans Health Administration. The Ancillary Testing coordinator or other staff appointed by the Chief, Pathology and Laboratory must participate in the planning, design, implementation, and assessment for all elements of the Ancillary Testing Program in each Ancillary Testing Site.

III. DEFINITIONS:

A. Test is defined as any activity that evaluates any substance removed from the human body for the purpose of providing information for diagnosis, prevention, or treatment of disease or impairment or for assessment of the health of human beings, and translates that evaluation to a result becomes a laboratory test regardless of where the testing is performed.

B. VA Laboratory is defined as any testing site that performs laboratory testing used in the diagnosis, treatment or assessment of patients (VA and non-VA) within a VA medical center and its affiliated testing sites is considered to be a VA laboratory and required to operate in compliance with the Veterans Health Administration Handbook 1106.01; this includes laboratories or testing sites that are not under the direct control of the Chief, Pathology and Laboratory Medicine.

C. Ancillary testing is defined as all testing laboratory sites that are outside the physical limits or physical address of the main VA medical facility’s Pathology and Laboratory Medicine Service and also includes all sites that fall under the auspices of the main parent facility even when they may be under a separate director, Clinical Laboratory Improvement Amendments (CLIA) registration number, or separate accreditation. Point of Care Testing (POCT) and Home-based Health Care (HBHC) when such testing is performed by a VA employee or contracted service employee in the patient’s home or mobile unit is also included.

D. Waived testing is defined as test systems that are cleared by the Food and Drug Administration (FDA) that employ methodologies that are simple and accurate as to render the likeliness of erroneous results negligible and pose no reasonable risk or harm to the patient if the test is performed incorrectly.

E. Provider Performed microscopy (PPM) is limited to unstained microscopic bright field exams performed by a privileged provider or nurse practitioner as part of the patient’s physical exam.

F. Privileged Provider is an individual who meets the personnel qualifications for provider performed microscopy (PPM) as defined in the CLIA regulations, 42 CFR 493.1363 and is privileged by the medical staff credentialing process to perform testing as part of their scope of practice.

G. Moderate complexity test is the rating given by the FDA to commercially marketed diagnostic test based on the risk to public health. Sites that perform moderate complexity tests must be inspected, and meet the CLIA quality standards described in 42 CFR 493.17 which specifies quality standards for proficiency test, facility administration, general laboratory systems, preanalytic, analytic, and postanalytic systems, personnel qualifications and responsibilities, quality control, quality assessment.

IV. RESPONSIBILITIES:

A. The Chief, Pathology and Laboratory in consultation with the medical and nursing staff decides, which test may be performed outside the main clinical laboratory for patient care diagnostic or monitoring purposes, and the equipment needed.

B. Chief, Pathology and Laboratory Medicine Service is responsible for the oversight of all ancillary testing quality management and will serve as a consultant for all ancillary testing sites. Pathology and Laboratory Medicine Service will be responsible for the certification/authorization process for all individuals who will be performing whole blood glucose, activated clotting time and blood gas test.

C. Ancillary Testing Coordinator (ATC) will:

(1) Act as a technical oversight supervisor to all POCT and ancillary testing sites.

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

(3) Participate in the validation of methods and the establishment of test performance characteristics, including precision and accuracy, and the Quality Management Program of all POCT and ancillary testing sites.

(4) Participate in the planning, implementation, and assessment for all elements of the POCT Quality Management Program.

(5) Ensure enrollment and participation in a proficiency program and oversee necessary remedial action when necessary.

(6) Monitor the quality control (QC), quality assessment (QA), and instrument maintenance documentation for all POCT and ancillary testing sites.

(7) Document the training and annual competency assessment of all individuals authorized to perform POCT.

(8) Ensure compliance with laboratory accreditation and Joint Commission on Accreditation of Healthcare Organizations requirements for POCT.

D. Ancillary Testing Site Directors: Each service performing ancillary testing will designate an Ancillary Testing Site Director. The Ancillary Testing Site Directors or designees:

(1) Are responsible for adherence to Joint Commission, College of American Pathologists (CAP), and applicable VA regulations at their ancillary testing sites.

(2) Will be responsible for instrument maintenance records, safety, and training at their site.

(3) Will develop protocols for individuals performing ancillary testing.

(4) Will monitor the competency of their personnel.

(5) Will assure that technical procedures are available at the testing personnel assigned work section.

(6) Will sign an authorization list for personnel performing ancillary testing.

(7) Will function as the first level of review for all QC, QA, and routine calibration.

E. Authorized Testing Personnel: Those individuals who have satisfactorily completed initial training on instruments/ methods applicable to their designated job.

(1) The testing personnel are responsible for proper performance and documentation of all assigned proficiency testing, daily documentation of quality control, preventive maintenance records and temperature charts.

Personnel files are maintained and include records of qualifications, degree or transcript, certification/registration, current license as required, and a competency assessment of each person to evaluate the employee’s ability to perform procedures, in which he/she was trained. Records for new and existing employees reflecting the specific skills assessed with the method of evaluation are maintained in each individual personnel record.

V. PROCEDURE:

A. Copies of quality management records, proficiency testing, preventive maintenance, authorizations, employee competency, calibration, continuing education, failure in QC, and temperature checks will be forwarded to the ATC for compliance if applicable. Records will be maintained in the ancillary testing sites and/or must be readily available to the ATC. These records should show clear evidence of review by a medical professional and a second-level reviewer.

B. The results of all ancillary testing must be entered into the official VA computer package. The Pathology and Laboratory Medicine Service's Automated Data Processing Applications Coordinator will coordinate this implementation.

C. Provider Performed microscopy procedure (KOH) results performed as part of the patient exam are noted in CPRS in the patient’s notes.

VI. REFERENCE: VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Policies, Paragraph 8, Ancillary Testing, October 6, 2008.

VII. RESCISSION: Center Policy Memorandum F-113-47, dated October 2013, August 2010, 2007.

/s/ David M. Walker, MD, MBA, DFAPA Medical Center Director

EXPIRATION DATE: August 25, 2019 RESPONSIBLE OFFICE: Pathology and Laboratory Medicine Service (113)

Attachment - Ancillary Testing Laboratory Sites

Ancillary Testing Laboratory Site:

Pulmonary Blood Gas Laboratory, Respiratory Care Service (123)

Point-of-Care Testing Sites:

Whole Blood Glucose Testing, Pathology and Laboratory Medicine Service (113)

Whole Blood Glucose Testing, Nursing Service (118)

Cardiac Catherization Lab, Medicine Service (111)

Provider Performed Microscopy Procedure (PPMP):

Potassium Hydroxide (KOH) Preparation (Dermatology), Medicine (111)