D.10 NMVAHCS - MCP 113-14 - Ancillary Testing.pdf

ANCILLARY TESTING

New Mexico VA Health Care System

Albuquerque, NM

MCP 113-14

Signatory Authority

Director NMVAHCS

Rescinded Document

MCP 113-14 Ancillary Testing Policy dated January 9, 2017

Service Line

Pathology & Laboratory Medicine (P&LMS)

Effective Date

June 2022

Responsible for Updates

Chief, P&LMS

Recertification Date

June 30, 2027

1. POLICY

a. This medical center policy (MCP) establishes NMVAHCS policy for the coordinated program for the monitoring of Ancillary Testing (AT), also known as Point of Care

Testing (POCT).

b. All AT falls under the direction, authority, jurisdiction, and responsibility of the

Chief, Pathology and Laboratory Medicine Service (P&LMS).

c. All NMVAHCS AT testing sites must continuously meet all accreditation requirements to maintain testing privileges.

d. Ancillary Testing procedures are performed at the NMVAHCS by certified operators in the following services: Ambulatory Care, Anesthesiology, Behavioral

Health, Emergency Medicine, Geriatrics and Extended Care, Imaging, Medicine, Nursing, Spinal Cord Injuries and Disorders, and Surgical.

2. JUSTIFICATION

This policy is established to fulfill a local policy mandate to meet Joint Commission requirements.

3. SUMMARY OF CHANGES

a. Reformatted to updated MCP template.

b. Updated 6. (c) Accreditation for AT sites in the organization.

4. DEFINITIONS

a. AT Site. Any location within the NMVAHCS where laboratory testing is performed outside the main clinical laboratory. AT is performed by certified employees at

June 2022 MCP 113-14 sites within the following services: Ambulatory Care, Anesthesiology, Behavioral

Health, Emergency Medicine, Geriatrics and Extended Care, Imaging, Medicine, Nursing, Spinal Cord Injuries and Disorders and Surgical.

b. Ancillary Testing (AT). Tests designed for use at or near the patient's location or performed outside the physical clinical laboratory. Intended to provide rapid results for therapeutic, screening, monitoring or diagnostic decisions when performed by a qualified NMVAHCS employee or contractor. Also called Point of

Care Testing (POCT).

c. AT Testing Personnel. Employees who have completed training and competency assessment and are certified to perform patient testing on specific AT test systems.

d. Clinical Laboratory Improvement Amendments (CLIA). Determines the requirements for staffing, management, procedures, and oversight of laboratory testing used in the diagnosis, treatment and prevention of disease in patients.

e. HBHC Testing. When patient testing is performed by a Home-Based Health Care

(HBHC) employee or contractor in a patient's home, the testing is considered

Ancillary Testing.

f. Non-Waived Testing. Refers to tests categorized by the FDA as either moderate complexity (including provider-performed microscopy) or high complexity.

g. Point of Care Testing (POCT). See definition for Ancillary Testing (AT).

h. PPE (Personal Protective Equipment). Equipment designed to protect the employee from bloodborne pathogens. This includes but is not limited to gloves and eye protection.

i. Pre-/Post- Analytical. Any procedure or process that takes place before or after the analysis of a specimen. Pre-analytical considerations include patient identification, specimen collection and handling and storage of testing supplies and reagents. Post-analytical considerations include the appropriate communication and documentation of test results and recognizing unusual or critical results.

j. Provider Performed Testing (PPT). Testing performed by a credentialed physician or other licensed practitioner staff in conjunction with the physical examination or treatment of a patient.

k. Provider Performed Microscopy (PPM). A subgroup of specific, moderate-complexity light microscopy procedures outlined in the CLIA regulations, which a physician or other licensed provider performs on a specimen obtained from the provider's patient.

l. Test System. The technical instrumentation, reagent strips, cuvettes, cartridges, slides, and other equipment or supplies utilized to perform laboratory tests according to an established testing procedure.

m. Waived Testing. A category of laboratory testing that uses specific test methods designated by the Food and Drug Administration (FDA) as CLIA waived; typically understood to be simple tests that carry a low risk for an incorrect result.

5. RESPONSIBILITIES

a. Chief Of Staff. The NMVAHCS Chief of Staff is responsible for ensuring that all laboratory testing performed outside of the main laboratory is managed under the ancillary testing program with oversight by the Chief, P&LMS, including all laboratory testing performed by providers (i.e., physicians, nurse practitioners, clinical pharmacists, and physician assistants).

b. The Chief or Director, P&LMS. The Chief or Director, P&LMS is responsible for:

(1) Working with the Chief of Staff to identify all laboratory testing performed within the facility and outreach clinics regardless of the complexity or location.

(2) Providing oversight of AT sites to ensure that all patient laboratory testing complies with 42 C.F.R. and VHA policies.

(3) Evaluating test appropriateness for the institution regardless of the testing site and, with the consultation of medical and nursing staff, selecting the tests that may be performed outside the main clinical laboratory for patient care diagnostic and monitoring purposes and the equipment needed.

(4) Approving written policies and procedures for patient testing, quality control and quality assurances before testing commences.

b. Service Chiefs of AT Sites. Service Chiefs for AT Sites are responsible for ensuring service personnel are compliant with the requirements of this policy.

c. AT Coordinator (ATC), P&LMS. The ATC acts as the technical oversight supervisor for all AT sites and is responsible for:

(1) Participating in the planning, design, implementation, and assessment of the

AT quality management program, including selecting and validating appropriate test methods.

(2) Ensuring enrollment and participation in a proficiency program for all AT testing sites and oversight of remedial action when necessary.

(3) Ensuring the completion of training and competency assessment for all persons who perform AT and employee records are complete.

(4) Ensuring the availability of written test procedures that include detailed instructions for specimen collection and preservation, instrument calibration, quality control, remedial action requirements, test performance and test reporting requirements specific to the test system.

(5) Maintaining training and competency assessment records, including a current list specifying each test system(s) that employees are authorized to use.

(6) Monitoring test site compliance with accreditation standards and providing feedback and consultation when these standards are not met.

(7) Providing quality management reports to AT sites following review of testing data and performance indicators for inclusion in AT test site quality processes and in P&LMS Quality Improvement meetings.

d. Personnel Performing AT. AT Testing Personnel are responsible for:

(1) Completing an initial orientation and training provided by the AT Coordinator or designee specific to the test system, demonstrating competency, and completing an ongoing competency assessment to maintain testing privileges.

(2) Reading written procedure documents specific to the test system used.

(3) Following established policies and procedures for all phases of test system operation, including pre- and post-analytical steps (i.e., device maintenance), quality control checks, proficiency testing, and proper documentation of results. NOTE: Operator testing privileges may be revoked for non-compliance.

(4) Adhering to NMVAHCS policies and procedures for patient identification, critical test result communication, safety precautions, infection control measures, and the communication of test results.

e. Managers/Supervisors at AT Test Sites. Managers/Supervisors of AT test sites are responsible for:

(1) Designating employee(s) to act as a point of contact and on-site trainer for AT

(2) Ensuring employees perform patient and quality control testing according to

Policy.

(3) Ensuring test results and critical test results are communicated and documented according to NMVAHCS policy.

(4) Communicating issues or concerns promptly to the AT Department.

(5) Ensuring time is allocated so that employees can complete required training and competency assessment.

(6) Notifying the AT Department when new personnel requires training and competency assessment.

(7) Reviewing testing records for completeness at the end of each month, including all temperature, maintenance, quality control and patient testing worksheets. Verifying temperature and maintenance checks were performed as required and that employees have entered dates and initials where required. If temperatures or quality controls are outside expected ranges, briefly document corrective action. Submit reviewed documents to the AT

Department at the end of each month.

6. OTHER PARAGRPHAHS

a. Requests for AT privileges. Requests submitted for authorization to perform diagnostic laboratory tests outside the main clinical laboratory must be in writing to the Chief of P&LMS for consideration and approval:

(1) All instruments purchased for AT sites and new ancillary laboratory test methods must be reviewed and approved by the Chief of P&LMS before use.

(2) Instruments and test methods not reviewed and approved are unauthorized and cannot be used.

(3) Test methodologies and instrumentation are evaluated for cost-benefit and analytical performance characteristics.

b. AT Regulatory and Quality Assurance Requirements.

(1) Test Procedure Documents. Written test system-specific procedures are available to personnel performing AT as a controlled hard copy or electronically on the P&LMS page of the NMVAHCS intranet.

(2) Recording and Reporting Patient Results. Patient test results obtained from AT systems will be:

(a) Documented in the patient's medical record. Results may download automatically from instrumentation or be entered manually by testing personnel using the VistA Fast Bypass option.

(b) Recorded legibly and dated and initialed by the employee performing the test on the patient testing worksheet, as applicable

(c) Reported to the responsible provider and documented in the medical record according to NMVAHCS policy when they fall within defined critical result ranges.

(3) Reagent Handling. Proper storage and handling of testing supplies are critical to accurate test system performance.

(a) Storage of Reagents will comply with the manufacturer's requirements or as stated in the applicable procedure.

(b) Reagent and supply expiration dates will be checked regularly by testing personnel.

(c) Expired reagents will be discarded following manufacturer instructions.

(d) Records will have the lot number, reagent preparation date, expiration dates, and the contents of commercial kits if used.

(4) Instrument Maintenance. Regular maintenance under the direction of the

Biomedical department ensures the proper function of test systems:

(a) Testing personnel will perform maintenance test according to the manufacturer's recommendations and established procedure to verify proper equipment function.

(b) Instructions for proper maintenance of equipment used in testing will be available in the test procedure.

(5) Quality Control (QC). QC checks will be performed to confirm that test systems produce accurate results:

(a) No patient testing will be performed unless quality control results are within expected ranges.

(b) QC checks will be performed by the same staff that performs patient testing.

(c) QC checks will be performed once each day or shift, as indicated by manufacturer instructions or accreditation standards, whichever is more frequent. Two levels of quality control will be performed (i.e., positive and negative or high and low).

(d) Quality control lot numbers and results are documented for review and trending.

(6) AT Site Safety & Infection Control.

(a) AT testing personnel will follow NMVAHCS infection control policies and use Standard Precautions when performing testing. Appropriate PPE is worn during testing events, hand hygiene performed, and gloves changed between patients.

(b) Only auto-disabling single-use fingerstick devices will be used to obtain fingertip capillary blood samples for testing.

(c) Handheld or portable testing devices, such as glucometers, will be disinfected after each patient use according to the manufacturer's guidelines for reusable medical devices.

(d) Each test system procedure will include specific instructions for the safe procurement, handling and disposal of specimens and reagents. Testing personnel will follow these handling guidelines.

(7) Document Review & Retention. VHA and accreditation standards require review and retention of AT testing records.

(a) The AT Coordinator or designee will review monthly training, competency assessment, temperature, equipment maintenance quality control, and patient testing records.

(b) The AT Department will maintain and store these records in the

Laboratory Ancillary Department office for accreditation and inspection purposes.

c. Accreditation

(1) CLIA Certificate and Test Complexity at the NMVAHCS. Testing sites have a CLIA certificate issued by the P&LMS National Enforcement Office appropriate to the complexity of testing performed at the site. Sites within the

NMVAHCS located on the same campus and under common direction possess a single CLIA certificate for testing sites within the same physical location.

(a) At the NMVAHCS, waived and non-waived test systems are under one

CLIA certificate, including the main laboratory and all AT sites on campus.

(b) Each CBOC has a separate, individual CLIA certificate for waived testing.

(2) Continuous Readiness.

(a) The AT Coordinator or designee will conduct ongoing monitoring of AT site compliance performance.

(b) Test site leadership will be notified of occurrences of non-compliance and participate in the development and performance of corrective action plans to return the site into compliance.

d. Participation In External Proficiency Testing (PT) Program.

(1) Mandatory Participation. All NMVAHCS AT test sites are enrolled in PT.

P&LMS provides proficiency samples to each AT site two to three times per year and as needed.

(2) Proficiency Challenge Event Requirements. Proficiency testing samples are integrated into the routine workload and analyzed by certified personnel using primary method systems. Communication between testing sites is prohibited until after the deadline for data submission to the proficiency testing provider. Proficiency testing material is not referred to an outside laboratory.

e. Provider Order for AT Testing. A documented provider order is required for an

AT patient test to be performed. Results are reported to the ordering provider.

f. Certification of Testing Personnel.

(1) Training. Testing personnel receives specific training for each test system used before conducting patient testing:

(a) A competency assessment follows the initial orientation and training.

(b) Employees are certified to perform patient tests when the ability to perform the identified tests correctly is successfully demonstrated.

(2) Competency Assessment. Testing personnel demonstrate ongoing competency to maintain testing privileges:

(a) Competency is assessed every 6 months during the first year and annually thereafter.

(b) The assessment includes a system knowledge quiz, demonstration of required skills with a simulated patient sample under direct observation by the AT Coordinator or a designated trainer, and review of device maintenance and other related testing records completed by the employee.

(c) Employees failing to demonstrate adequate competency are not allowed to perform patient testing until they have received additional training and are re-assessed.

(3) Designated Trainers. Employees from an AT site receive designation as trainers with the approval of the Chief, P&LMS or the AT Coordinator.

(a) Trainers meet education and experience qualifications appropriate to the complexity of the test system.

(b) Trainers provide documentation of these qualifications to the AT

Coordinator before being certified to conduct training and competency assessment.

g. Provider Performed Testing (PPT) and Provider Performed Microscopy

(PPM).

(1) PPT Oversight and Supervision. PPT at the NMVAHCS is considered AT and is subject to the requirements defined in this policy including training, competency assessment, quality management and proficiency testing participation.

(2) Approved PPT Procedures in the NMVAHCS.

(a) Fecal occult blood testing.

(b) Body fluid pH.

(c) Provider performed microscopy (PPM).

h. Suspension of Ancillary Testing (AT).

(1) Suspension or Removal of AT. AT may be removed from a site with evidence of recurrent non-compliance policy and procedures, compromised patient safety, failure to maintain proper competency assessments, or repeated failures on proficiency testing challenges.

(2) Suspension or Removal of Testing. Reasons for removal or suspension of testing include by are not limited to:

(a) Failure to follow the established standard operating procedure for patient testing.

(b) Failure to perform and document quality control as stated in the procedure.

(c) Failure to review quality control results and document corrective action for unacceptable results.

(d) Failure to document and take appropriate action for critical values.

(e) Failure to follow and document maintenance procedures.

(f) Unsatisfactory performance on external proficiency testing surveys.

(g) Falsifying documentation of maintenance, quality control, proficiency, or patient testing.

(3) Written Notification. The test site Service Chief receives a written notification that a test system is in jeopardy of being removed. As result, the

Chief develops an appropriate corrective action with the assistance of the AT

Coordinator.

(4) Reinstating Testing. Testing may be reinstated with the approval of the

Chief, P&LMS, with sufficient documentation of remediation specific to the nature of the non-conformances leading to suspension of testing.

7. REFERENCES

a. VHA Directive 1106, Pathology & Laboratory Medicine Service, dated July 27, 2018.

b. MCP 11-64, Critical Test Results, dated April 26, 2022.

c. The Joint Commission Comprehensive Accreditation Manuals for Hospital, Behavioral Health and Human Services, Home Care, Laboratory and Ambulatory https://dvagov.sharepoint.com/sites/VHAABQDCS/SitePages/New-Mexico-VA-HCS-Document-Control-System.aspx?sw=bypass https://vaww.qps.med.va.gov/divisions/qm/ea/jointcommission.aspx https://vaww.qps.med.va.gov/divisions/qm/ea/jointcommission.aspx

Programs E-dition, Joint Commission Resources, Accreditation Requirements.

Joint Commission Resources Portal. 2022.

8. RESCISSION

None

9. REVIEW

This MCP will be reviewed 120 days before recertification or sooner if when there are changes to governing documents cited in references above.

10. RECERTIFICATION

This MCP is scheduled for recertification on the last working day of June 2027. This

MCP will continue to serve as local Policy until it is recertified or rescinded. In the event of contradiction with national Policy, the national policy supersedes and controls.

SIGNATORY AUTHORITY

/S/ Robert McKenrick Director

NOTE: Signature remains valid until rescinded by appropriate administrative action.

https://vaww.qps.med.va.gov/divisions/qm/ea/jointcommission.aspx