36C25819R0003-018.doc

Phoenix VA Health Care System

Policy Memorandum No. 113-06

Phoenix, Arizona August 9, 2018

September 30, 2013

ANCILLARY LABORATORY TESTING

1.

PURPOSE: To establish policy and procedure at the Phoenix VA Health Care System (PVAHCS) for laboratory testing performed outside the physical facilities of the main clinical laboratory, including testing performed by a VA employee or contracted service employee in a patient’s home under the Home Based Primary Care (HBPC) Program. All such testing is performed in accordance with Veterans Health Administration Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures.

2.

POLICY: Ancillary Laboratory Testing (ALT) procedures must comply with federal regulations and standards established by the Clinical Laboratory Improvement Amendments (CLIA), Food and Drug Administration (FDA), College of American Pathologists (CAP) and The Joint Commission (TJC). In the event there is overlap of multi-agency regulations governing ALT, the more stringent guidelines shall be followed. ALT must be FDA-cleared and shall be performed in strict accordance with manufacturer’s instructions. ALT requires documented user training prior to patient testing. To meet the requirements of the Centers for Medicare and Medicaid Services (CMS), ALT sites are inspected and fully accredited by an appropriate accrediting organization. PVAHCS sites having different physical addresses are each required to have their own unique CLIA numbered registration and certificate, the specific type of which is determined by the complexity level of testing being performed. Sites performing only waived testing require a CLIA Certificate of Waiver (least complex testing). Sites performing non-waived testing require the appropriate Certificate of Accreditation or Certificate of Provider Performed Microscopy (PPM), both of which are inclusive for waived testing.

3.

DEFINITIONS:

a. Ancillary Testing: A laboratory test performed at CTHVAMC, an affiliated CBOC or within the HBPC program, but always outside the physical facilities of the CTHVAMC main laboratory. ALT is often referred to as Point-of-Care Testing (POCT). See Appendix B for a comprehensive listing of ALT performed within the PVAHCS.

1) Waived Testing: Testing categorized as low complexity. As defined by CLIA, “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Joint Commission requires further delineation of waived testing as either screening or definitive.

a) Screening Test: A “test that requires additional information from further testing or procedures to make a treatment decision or diagnosis.”

b) Definitive Test: A “test that allows a clinical treatment decision or diagnosis to be made based upon the result.” Confirmatory, definitive (main lab) testing is not mandated, but may still be ordered at the physician’s discretion.

2) Non-waived Testing: Testing categorized as having moderate or high complexity, as determined by the FDA utilizing scoring criteria outlined within CLIA. Non-waived testing differs from waived testing in that it also requires a minimum level of documented education. Only moderate complexity, non-waived ALT is allowed within PVAHCS. High complexity testing is exclusive to main lab.

3) Provider-Performed Testing: Testing categorized as waived or moderate complexity (non-waived) Provider-Performed Microscopy (PPM). Regardless of complexity classification, Privileged Provider Minimal Testing Standards specified by VHA Handbook 1106.01 require enrollment in a formal proficiency testing (PT) program, whenever available. In compliance with this mandate, privileged providers participate in PT on a rotational basis.

a) Provider-Performed Waived Testing: Testing personally performed by a physician or midlevel practitioner, i.e. physician assistant or nurse practitioner, in conjunction with the physical examination or treatment of a patient.

(1) Tests performed: Fecal Occult Blood (FOBT), Gastroccult (GOCB) and Vaginal pH.

(2) In compliance with CAP requirements, all providers must satisfactorily complete one-time, web-based, documented training. Records are maintained by the Ancillary Testing Coordinator (ATC).

(3) Competency of PVAHCS physicians, physician assistants and nurse practitioners performing waived testing is established, documented and renewed biennially through the credentialing process under the authority of the Medical Executive Committee (MEC) and facility Director. Credentialing is granted on an individual basis and is limited to those specific waived tests, not involving use of an instrument, appropriate to the scope of practice.

b) Provider-Performed Microscopy: Federal regulations specified within CLIA and adopted by both CAP and TJC define PPM as non-waived, moderately complex testing utilizing a microscope, which is personally performed by a physician or mid-level practitioner on a patient specimen obtained during a patient visit.

(1) Tests performed:

Potassium hydroxide (KOH) preparation, vaginal wet mount preparation and scabies examination.

(2) Physicians and midlevel practitioners credentialed to perform PPM participate in training, as well as initial and annual competency assessment. Training is the responsibility of the service chief for the department performing the testing, i.e., gynecology or dermatology. Documented initial, 6-month (approximate) and annual competency assessment are administered and documented by the ATC. All competency assessment records are maintained by the ATC.

b.

Ancillary Testing Coordinator:

1) Appointed by the Chief, Pathology & Laboratory Medicine Service (P&LMS).

2) Must be a certified medical technologist generalist, further qualified under CLIA as a Technical Consultant. Must possess demonstrable administrative, technical and verbal/written communication ability.

3) Assumes the following functions:

a) Authors and revises, as needed, Standard Operating Procedure (SOP) governing individual ALT. Ensures ongoing electronic availability of the current SOP version via P&LMS Point of Care Website.

b) Provides technical oversight and personalized support to ALT sites.

c) Conducts documented ALT quality assurance review to ensure compliance with policy.

d) Maintains records of: critical value patient results, health fair patient result worksheets, employee training (except PPM), full-time employee competency assessment, equipment maintenance review, quality control results review and proficiency testing results review.

e) Submits a monthly report of ALT activities to the Chief, P&LMS, Laboratory Manager, Lab Quality Assurance Manager and hospital Quality Executive Board (QEB).

f) Ensures individual site participation in an appropriate proficiency testing program and updates the CAP Activity Menu upon implementation of new testing.

g) Provides documented training, administers competency assessment, technical support and in-servicing, as needed.

NOTE 1: During new employee orientation (NEO), Nursing Education provides initial training for whole blood glucose meter testing.

NOTE 2: Due to ATC inability to track the work status and location assignment for part-time nursing service employees, nursing service is responsible for all facets of such employees’ ongoing competency assessment.

h) Reviews critical value patient results and associated chart documentation to ensure employee compliance with policy.

i) Ensures preventative equipment maintenance is performed via documented review of maintenance logs.

j) Performs troubleshooting procedures and repairs malfunctioning equipment whenever possible. Initiates equipment replacement and manufacturer service visits when indicated.

k) Selects new ALT equipment in consultation with the Chief, P&LMS. Performs and documents method validation studies for new tests.

l) Maintains reagent supply inventory and performs documented new lot performance verification.

m) Performs semiannual verification of comparability studies between ALT and main lab equipment that test for the same analyte(s).

n) Monitors status of CLIA certificates for PVAHCS and ensures biennial renewals are submitted to the VA National Enforcement Office in a timely manner.

o) For each new CBOC location, completes and submits appropriate documents to register sites for their unique CLIA and CAP numbers.

c. ALT Site Supervisor:

1) Is selected by the Associate Chief of Nursing Service for which the site supervisor works. The site supervisor is the nurse manager or team leader at the site having direct supervisory authority and oversight responsibility for personnel performing ALT.

2) Is the responsible contact person for the ATC on all matters associated with site ALT.

3) Assists the ATC in facilitating employee participation in ALT training, in-servicing, proficiency testing and competency assessment procedures.

4) Counsels site employee(s) and takes corrective action, as necessary, when notified by the ATC of employee deviation from policy.

5) Ensures patient test results are entered into patient's medical record in accordance with policy.

6) Ensures quality control and any applicable maintenance is performed and documented in accordance with policy.

7) Ensures personnel performing ALT comply with manufacturer cleaning and disinfection procedures, as outlined in hospital Policy Memorandum No. PCS-01, Non-Critical Reusable Medical Equipment (RME) and specific ALT SOP’s utilizing an analyzer/meter/instrument.

8) Monitors inventory of testing supplies and notifies the ATC in a timely manner when resupply is needed.

9) Communicates important ALT activities to the respective Associate Chief of Nursing Service.

10) Ensures site refrigerator storing ALT materials is maintained within temperature specifications outlined in SOP. The site service line is responsible for acquisition, maintenance and repair of refrigerators utilized for storage of ALT materials.

4.

PROCEDURES

a. Specific ALT Requirements:

1) Detailed written testing procedures shall be continuously available to all sites via intranet-based P&LMS Point of Care Website . The ATC shall ensure the most recent version of each SOP is always posted. To maintain SOP availability in the event of prolonged computer downtime, ALT site supervisors must maintain a current hardcopy of each ALT SOP that their staff utilize.

2) Testing procedures: Must strictly comply with manufacturer’s instructions, be formatted in accordance with Clinical and Laboratory Standards Institute (CLSI) recommendations, be FDA-cleared and meet the requirements of VHA Handbook 1106.01, CLIA, CAP and The Joint Commission. Test procedures shall include the following components:

a) Specimen collection, processing and disposition, including all appropriate safety measures to be taken.

b) Test methodology and step-by-step testing instructions, including materials and equipment required.

c) Quality control procedure and action plan detailing steps to be taken when control values are unacceptable.

d) Calibration procedure, if applicable.

e) Results and interpretation, including reference ranges, critical values and what to do when a critical value is obtained.

f) Performance characteristics, including limitations and interferences.

g) Maintenance procedure, as applicable, including manufacturer equipment cleaning/disinfection requirements.

h) Proficiency testing requirements.

i) Training, certification and ongoing competency assessment requirements.

j) References.

3) Documents shall be retained in accordance with Record Retention Guidelines for Pathology & Laboratory Medicine, version 3.0, October 2016. Records are stored in the Office of the ATC, unless otherwise indicated.

a) Quality control records and Individualized Quality Control Plan (IQCP) - 2 years.

b) Patient results records (electronically stored within VISTA/CPRS, critical value printouts and health fair worksheets stored in room 4117) – 2 years.

c) Proficiency testing records – 2 years. Stored in lab conference room E211.

d) Temperature logs and instrument preventative maintenance records - 2 years.

e) Discontinued test procedures – 2 years

f) Original training records and annual competency assessment records - 5 years.

g) Equipment repair records – life of the instrument/analyzer.

4) Individual ALT sites must be subscribed to a formal external PT program aligned with their unique CAP and CLIA registration numbers. Site PT must encompass all tested analytes for which PT is available, regardless of individual testing complexity classification. For analytes that do not have formal PT available, an alternate method of assessment must be performed semiannually.

5) Personnel performing ALT must have:

a) Test-specific documented training.

b) Documented competency assessment, which shall be performed as often as necessary to meet accreditation standards.

c) At least a high school education or equivalent for non-waived testing.

d) Signed/dated approval of the ATC on the original training record.

b. Sites desiring to perform new ALT must complete the form Request for New Ancillary Test and submit the completed hardcopy to the ATC. Only new testing pre-approved by the Chief, P&LMS may be performed and only at the site(s) specified.

c. Chief, P&LMS, and the ATC shall assist ALT Site Supervisors, as needed, in all aspects of site ALT.

5. RESPONSIBILITIES: Chief, P&LMS is responsible for the overall operation of ALT including: ensuring the ALT program meets VA/CLIA/FDA requirements and CAP/TJC accreditation standards, approving/disapproving availability of specific ALT, monitoring activities of all involved parties in the ALT organization and initiating necessary action to ensure compliance with ALT policy. If an ALT site's testing performance remain unacceptable and/or in non-compliance with policy after having received additional appropriate training/assistance to meet acceptable standards of performance, Chief will recommend discontinuation of applicable ALT.

6.

RESPONSIBLE BOARD: Clinical Executive Board

7. REFERENCES:

a. VHA Handbook 1106.01, Pathology and Laboratory Medicine Department Procedures, January 29, 2016.

b. Clinical Laboratory Improvement Amendments of 1988, Title 42, Code of Federal Regulations (CFR) Part 493, Laboratory Requirements.

c. College of American Pathologists Accreditation Checklists: Laboratory General, Point-of-Care Testing and All Common, August 21, 2017.

d. The Joint Commission, TJC Manual E-dition for Laboratory, July 1, 2018.

e. Clinical and Laboratory Standards Institute, CLSI QMS02-A6:2013 Quality Management System: Development and management of Laboratory Documents, 6th Edition, February 2013.

8.

KEY WORDS:

Ancillary Testing; POC; Point-of-Care; ALT

9. RESCISSION: Policy Memorandum No. 113-06 dated October 7, 2015.

10. ATTACHMENTS:

a. Appendix A - Organizational Chart

b. Appendix B - Approved Tests and Locations 11.

FOLLOW-UP RESPONSIBILITY: Ancillary Testing Coordinator

12. EXPIRATION DATE: August 9, 2023

RIMAANN O. NELSON

Medical Center Director

ANCILLARY LABORATORY TESTING

Approved Tests and Locations

W=Waived

NW=Non-Waived

S=Screening

D=Definitive

Location

2C

3B

4C

4D

ICU

Chronic Pain

O.R.

PACU

SDS

Pre-Procedure

CLC-1

Derm/Allergy

5C

5D

BRITE

Hemodialysis

Cardiology

Radiology(IR)

CT Radiology

MRI

Nuc Med

GI Dept

Copper

Specialty

Amethyst

Emerald

Gold

Turquoise

Bronch Lab

CRRC/HPACT

Globe CBOC

T-Bird CBOC

Show Low CBOC

Southeast CBOC

Northwest CBOC

Northeast CBOC

Southwest CBOC

Midtown CBOC