D8 - Attachment - Ancillary Testing Policy.pdf

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

G.V. (SONNY) MONTGOMERY VA MEDICAL CENTER

Medical Center Policy Number: F-113-47 Date: October 16, 2019

PATHOLOGY AND LABORATORY MEDICINE SERVICE

ANCILLARY TESTING LAB AND POINT-OF-CARE TESTING POLICY

I. PURPOSE:

To establish policies, procedures, and requirements for performing and maintaining the Ancillary Testing and Point-of-Care Testing (POCT) Programs, in compliance with: Joint Commission (JC) standards, College of American Pathologists (CAP) standards, Occupational Safety and Health Administration (OSHA) standards, Food and Drug Administration (FDA) standards, the Department of Veteran Affairs, Veterans Health Administration Handbook 1106.01 and 42 CFR Part 493, Clinical

Laboratory Improvement Amendments (CLIA).

II. POLICY:

A. Ancillary Testing: Encompasses or includes laboratory testing sites that are outside the physical limits or physical address of the main VA medical facility’s

Pathology and Laboratory Medicine Service.

1) Ancillary testing consists of Respiratory Care service performing (moderate complexity) Blood gas and oximetry test in the Blood Gas Laboratory.

B. Point of Care Test (POCT) are test performed near the site where the patient is located and are performed outside the Clinical Laboratory. The POCT are designated by complexity as waived, or moderately complexity category based on

Clinical Laboratory Improvement Amendments (CLIA) regulations.

1) Waived POCT consists of:

a. i-Stat Mobile Unit Chem 8+

b. Nursing Floors and ED Whole blood glucose

c. Radiology BUN/Creatinine

2) Moderate complexity POCT consists of:

a. Cardiac Cath Lab Kaolin Active Clotting Time and Blood Gases.

b. Emergency Department Troponin I

c. Dermatology Provider Performed Microscopy Procedures (PPMP) potassium hydroxide (KOH) preparations

C. Testing sites must maintain current accreditation by a VA designated, nationally recognized, CMS “deemed” accrediting body in compliance with CLIA, 42CFR

Part 493. Testing sites are subject to inspection and accreditation. Testing must be performed in compliance with any standards defined by the relevant accrediting organization.

D. To maintain accreditation requirements, all VA Laboratories and ancillary testing sites that perform testing must participate in Proficiency Testing (PT) programs from a CLIA approved provider for analytes of which PT is available. All testing sites must maintain a successful performance for all test methods and analytes.

1) A separate PT kit must be ordered for each instrument, method or site utilized for patient testing. All challenges provided in one kit must be for a specific analyte must be run on the same instrument, method, or site to allow tracking of the instrument, method, or site performance throughout the year.

2) The specimens in each kit must be handled as unique specimens and run in the same manner as if different patient specimens. Laboratories may not participate in any correlation or comparison of PT results prior to submission cut-off.

3) If the laboratory chooses to purchase PT from a vendor other than the

Vendor(s) under the VA contract, the laboratory must authorize the PT program to release copies of all PT evaluation reports to the VA National

Enforcement program.

III. DEFINITIONS:

A. Test is defined as any activity that evaluates any substance removed from the human body to provide 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 with in a VA medical facility or its ancillary testing sites that performs laboratory testing used in the diagnosis, treatment or assessment of patients. This includes any testing that may occur outside the physical facilities of the main laboratory.

C. Ancillary Testing is laboratory testing performed within and under the administration of the VA medical facility, health care system, or its outreach functions, but outside the physical facilities of the main clinical laboratory. This includes all laboratory testing sites, such as point of care testing, satellite or home-based health care (HBHC) when such testing is performed by a VA employee. Ancillary testing 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.

D. Waived testing refers to a category of tests defined as simple laboratory examinations. Testing sites performing waived tests must obtain a CLIA certificate for minimal complexity testing.

E. Moderate complexity test is the rating given by the FDA to commercially marketed in vitro 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 493.1. Testing sites performing moderate complexity testing must obtain a moderate complexity CLIA certificate.

F. Provider Performed Microscopy (PPM) testing is a limited to specific moderate complexity microscopic bright field procedures outlined in the CLIA regulations, which a privileged provider or midlevel practitioner as part of the patient’s physical exam.

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

H. Proficiency Testing is a program in which samples with unknown values are periodically sent to a laboratory for analysis in which each laboratory’s results are compared with peer laboratories and reported to the participating laboratory and the VA National Enforcement Program.

IV. RESPONSIBILITY:

A. The Chief, Pathology and Laboratory Service:

1) Ensures that quality patient services are provided, and that personnel operations and laboratory management are efficient and effective.

2) Monitor VA laboratory testing sites as mandated by Veterans Health

Administration.

3) Determine which test may be performed outside the main clinical laboratory for patient care diagnostic or monitoring purposes, and the equipment needed.

4) Is responsible for the oversight of all ancillary testing quality management and will serve as a consultant for all VA testing sites.

B. Ancillary Testing Coordinator (ATC) or other staff appointed by the Chief, Pathology and Laboratory must participate in the planning, design, implementation, and assessment for all elements of the testing program in each

VA laboratory testing Site. The 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 testing 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) Ensures standard operating procedures are available for ancillary testing devices according to the manufacturer’s instructions, including calibration, and maintenance procedures.

8) Ensure compliance with College of American Pathologists (CAP) accreditation and Joint Commission Standards for POCT.

9) Document training and perform competency assessments, of all individuals authorized to perform POCT, with delegation of certain elements of performance to testing site supervisors or superusers.

D. Testing Site Supervisors or Superusers: Each service performing testing will designate a Testing Site Supervisor or Superuser. The Testing Site Supervisor or

Superuser:

1) Are responsible for adherence to Joint Commission, College of American

Pathologists (CAP), and applicable VA regulations at their testing sites.

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

3) Will be responsible for training and competency of all individuals who will be authorized to perform test at the testing sites.

4) Will complete the elements of competency assessment as delegated with the

Ancillary Testing Coordinator’s oversight.

5) Will maintain the inventory and ordering supplies.

6) Will ensure QC is performed and documented as required.

7) Performing a second review to verify the documenting once daily temperature recordings of the refrigerator, and room temperature area, where the supplies are stored. Taking corrective action if temperature is out of acceptable limits.

8) Will be responsible for maintaining copies of the testing personnel’s safety, training and competency documents.

9) Will develop protocols for individuals performing testing.

10) 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.

Furthermore, individuals who perform laboratory procedures may only do so under the ancillary testing program and under the oversight of the Chief, P&LMS.

1) The testing personnel are responsible for proper performance and documentation of: proficiency testing, quality control, preventive maintenance, and temperature.

V. PROCEDURE:

A. Pathology and Laboratory Medical Service (P&LMS) provides the principal medical diagnostic laboratory testing in all VA medical facilities and sets the standards for quality, test methods, and procedures for laboratory testing for patients in the VA medical facility and support clinics.

1) The standards must be met for any laboratory service offered with in a VA medical facility and outreach clinic, regardless of the physical relationship to the main P&LMS or administrative service assigned to direct the personnel or technical aspects of the testing site.

2) The same standards must be met for contracted laboratory services performed on a VA site at a VA laboratory, outreach clinics, or testing sites.

3) All VA laboratories including Community Based Outpatient Clinics (CBOC) sites performing testing must be assigned a CLIA number as outlined in the interagency agreement between the Centers of Medicare and Medicaid Services

(CMS) and the VA.

a. Each testing site located at a separate address must apply for its own CLIA certificate. Laboratories with in a VA medical facility that are in contiguous buildings on the same campus and under common direction may file a single application for the lab sites within the physical location or address.

b. Each VA medical facility-based and independently accredited outpatient clinic laboratory must be issued a separate CLIA number.

4) All laboratory testing, regardless of location must undergo an on-site inspection by a VA-designated accrediting agency.

5) When the requirements of the accrediting agency and VA requirements differ, the more stringent requirements apply.

6) All laboratory testing, regardless of the complexity level or where it is performed, must be under the oversite of the Chief, P&LMS.

a. The Chief, P&LMS is required to provide oversight for all laboratory testing performed under the medical center and CBOC laboratory CLIA number(s) including ancillary testing sites, or specialty labs performing testing used for patient care.

b. The Chief, P&LMS is responsible for all aspects of laboratory testing performed under the laboratory’s accreditation umbrella and testing under

CLIA certificates for which the Chief serves as the laboratory director.

c. The Chief, P&LMS may choose to remove waived or PPM testing performed by privileged providers from underneath the accreditation umbrella of the laboratory. These testing sites must obtain their own separate CLIA numbers. While the Chief, P&LMS is not responsible for the results released by the provider, the chief must provide guidance for performing these laboratory procedures and ensure that they are carried out in compliance with 42 CFR Part 493 and current VA policies.

7) The scope of testing services provided in Clinical Pathology is appropriate for the nature of the patient care services. P&LMS either performs those tests and services required to provide quality care to patients or arranges for the services to be performed by an accredited laboratory.

B. 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 testing sites and/or must be readily available to the ATC. These records should show clear evidence of review by a testing site supervisor or superuser as a second review.

C. 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.

D. 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.

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

VII. REFERENCE: VHA Handbook 1106.01, Pathology and Laboratory

Medicine Service Policies, Paragraph 8, Ancillary Testing, January 29, 2016.

VIII. RESCISSION: Center Policy Memorandum F-113-47, August 28, 2016, October 2013, August 2010, August 2007.

/s/

David M. Walker, MD, MBA, DFAPA

Medical Center Director

ATTACHMENT:

Appendix A: List of Ancillary Testing Laboratory Site, Point of Care sites and Provider

Performed Microscopy.

EXPIRATION DATE: October 16, 2024

PROPONENT: Chief P&LMS (113)

Contact Chief P&LMS for comments or recommendations for change to policy.

RESPONSIBLE OFFICE: Pathology and Laboratory Medicine Service (113)

Appendix A:

Ancillary Testing Laboratory Site:

Pulmonary Blood Gas Laboratory, Respiratory Care Service (123)

Point-of-Care Testing Sites (POCT):

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

Whole Blood Glucose Testing, Nursing Service (118)

Cardiac Catherization Lab, Medicine Service (111) i-STAT, Radiology Service (114) i-STAT, Emergency Department, Nursing Service (118)

Provider Performed Microscopy Site (PPM):

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