D.09 Ancillary Testing Policy 113-14.docx

113/LWM/MM

ANCILLARY TESTING POLICY

1. Policy: The New Mexico Veterans Affairs Health Care System (NMVAHCS) will establish and maintain a coordinated program for the monitoring of Ancillary Testing (AT). It is the policy of the NMVAHCS that all AT will be under the direction, authority, jurisdiction, and responsibility of the Chief, Pathology and Laboratory Medicine Service (P&LMS).

a. Ancillary Testing (AT) is defined as laboratory testing or services performed within a Veterans Administration medical center or its outreach functions, but outside the physical facilities of the main clinical laboratory and is intended to provide rapid results of sufficient accuracy and reliability for therapeutic, screening, monitoring or diagnostic decisions. It is also called Point of Care Testing (POCT). Guidelines for implementation, performance, quality assessment and improvement, and test methodology standardization of AT at the NMVAHCS will be defined.

b. Testing sites will receive biennial accreditation inspections by the College of American Pathologists (CAP) and triennial surveys by the Joint Commission (TJC) during accreditation events for the NMVAHCS. To maintain testing privileges testing sites will meet all CAP, TJC, and Veterans Health Administration (VHA) requirements.

2. Responsibility:

a. Pathology & Laboratory Medicine Service:

(1) The Chief or Director, Pathology and Laboratory Medicine Service will have responsibility for overall policy, standards development and operational quality management of AT.

(2) The Chief of P&LMS will select, in consultation with the medical and nursing staff, which tests may be performed outside the main clinical laboratory for patient care diagnostic or monitoring purposes, and the equipment needed. Written policies and procedures for patient testing, quality control and quality assurance will be approved by the Chief of P&LMS prior to the commencement of testing. The AT Program follows manufacturer instructions for all test systems without modification.

(3) The AT Coordinator (ATC), a laboratory supervisor designated by the Chief of P&LMS, will:

(a) Act as technical oversight supervisor for all AT sites.

(b) Participate in the selection of and validation of appropriate test methods.

(c) Participate in the planning, design, implementation, and assessment for all elements of the AT Quality Management Program.

(d) Ensure enrollment and participation in a proficiency program for all ancillary sites and oversee necessary remedial action when necessary.

(e) Ensure that training and competency assessment for all persons who perform AT is completed and that employee records are complete.

(f) Maintain a current list specifying each test employees are authorized to perform.

b. AT Sites & Testing Personnel:

(1) AT is performed by certified employees in the following services: Ambulatory Care, Anesthesiology, Behavioral Health, Emergency Medicine, Geriatrics and Extended Care, Imaging, Medicine, Nursing, Spinal Cord Injuries and Disorders and Surgery. Service Chiefs for these testing sites will ensure employee policy compliance.

Memorandum 113-14 Subj: Ancillary Testing Policy January 9, 2017 2.

(2) Testing Personnel:

(a) Employees that have been trained and certified to perform AT procedures will follow established policies and procedures for all phases test system operation including the pre-analytical and post-analytical steps.

(b) Testing privileges may be revoked if the employee knowingly fails to follow established policies and procedures.

(c) Testing personnel are responsible for completing training and competency assessments on schedule to maintain testing privileges.

(3) Testing Site Managers/Supervisors will:

(a) Designate an employee who will act as point of contact and an on-site trainer for AT procedures.

(b) Ensure employees perform patient and quality control testing according to policy.

(c) Ensure test results and critical test results are communicated and documented according to NMVAHCS policy.

(d) Ensure reagent, temperature, quality control and patient testing records are maintained according to procedure, including review and transfer to the AT Department each month.

(e) Communicate issues or concerns promptly to the AT Department

(f) Notify the AT Department when new personnel require training and competency assessment.

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

3. Procedures:

a. Requesting AT Privileges for a Clinical Site

(1) All instruments purchased for AT sites or new ancillary laboratory test methods must be reviewed and approved by the Chief of P&LMS. Instruments and test methods not reviewed and approved are unauthorized and cannot be used.

(2) Requests for authorization to perform diagnostic laboratory tests outside the main clinical laboratory must be submitted in writing to the Chief of P&LMS for consideration and approval.

(3) Requested test methodologies and instrumentation will be evaluated for cost benefit and analytical performance characteristics.

b. Certification of Testing Personnel

(1) Testing personnel will receive specific training for each test system used.

(2) Testing personnel must demonstrate competency to maintain testing privileges.

Competency will be assessed every six months during the first year and annually thereafter.

c. Provider Performed Testing

(1) Provider Performed Testing (PPT) is testing personally performed by a credentialed physician or midlevel practitioner staff in conjunction with the physical examination or treatment of a patient. It includes fecal occult blood testing, body fluid pH, and provider performed microscopy.

Memorandum 113-14 Subj: Ancillary Testing Policy January 9, 2017 3.

(2) PPT at the NMVAHCS is considered AT and as such is subject to the requirements defined in this policy to include training, competency assessment, quality management and proficiency testing requirements.

d. Suspension of AT at a Test Site

(1) AT may be suspended or removed from a test site with evidence of recurrent incidents of failures to follow policy and procedures, compromised patient safety, failure to maintain proper competency assessments, or repeated failures on proficiency testing.

(2) Testing may be reinstated with the approval of the Chief of P&LMS with sufficient documentation of remediation.

(a) See Attachment A for more specific procedures.

4. References: VHA Directive 1106; VHA Handbook 1106.1 for Pathology and Laboratory Medicine Service, Procedures; College of American Pathology Inspection Checklist, Point of Care Testing; The Joint Commission’s Comprehensive Manual for Laboratory Accreditation Manual for Laboratory and Point of Care Testing; Medical Center Memorandum 11-64, Critical Tests and Critical Test Results.

5. Rescission: Medical Center Memorandum 113-14, Ancillary Testing Policy dated November 25, 2013.

6. Expiration Date: January 9, 2020. February 2, 2020.

Signed MCM in D/FMO File Andrew M. Welch, MHA, FACHE Director

Attachment

Distribution: “M”

Memorandum 113-4 Attachment A

1. General Procedures

a. Testing Personnel:

(1) Initial orientation and training will be followed by competency assessment.

Employees will be certified to perform tests when the ability to correctly perform the identified tests is successfully demonstrated.

(2) Upon initial certification testing personnel must:

(a) Read the entire Policy & Procedure for the test certified.

(b) Successfully pass a competency quiz and/or demonstrate competency by successfully performing a simulated patient sample while directly observed by the Ancillary Testing Coordinator or a designated trainer.

(c) Designated trainers must meet education and experience qualifications appropriate to the complexity of the test system. Employees must provide documentation of these qualifications before being approved to conduct training of competency assessment.

(3) Competency will be assessed every six months during the first year and annually thereafter.

(4) Employees who do not demonstrate adequate competency will not be allowed to perform patient testing until they have received additional training and are re-assessed.

(5) Records of training and competency assessment will be maintained by the AT Department. The department maintains a current list specifying each test employees are authorized to perform.

b. Test Procedure:

(1) Will be present at the testing site in hard copy form or available on the P&LMS page on the NMVAHCS intranet.

(2) Will include procedures on specimen collection and preservation, instrument calibration, quality control, remedial action requirements, test performance and test reporting requirements.

(3) Will be read by testing personnel at AT sites.

c. Patient Identification Verification:

(1) The patient must be identified using at least two patient identifiers (patient’s name and Social Security Number). The patient’s room/bed number is not to be used as a patient identifier.

(2) Samples collected for testing performed away from the bedside must be labeled with two identifiers in the presence of the patient.

d. Provider’s Order for Testing: No AT procedures will be performed without a provider’s order. Results must be reported to the responsible provider.

e. Recording and Reporting Patient Results:

(1) When applicable, results will be recorded legibly on the patient testing worksheet.

Results will be clear, dated and initialed by the employee performing the test.

(2) Patient test results must be 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.

(3) Critical results will be reported to the responsible provider and documented in the medical record according to NMVAHCS policy.

f. Reagents:

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

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

Expired reagents will be discarded.

A-1 Memorandum 113-4 Attachment A

(3) Reagents must be stored according to the manufacturer’s requirements or as stated in the applicable procedure.

g. Instrument Maintenance:

(1) Testing personnel will perform maintenance according to established procedure to ensure proper equipment function. This maintenance will be documented.

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

h. Quality Control (QC):

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

(2) 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 (e.g. positive and negative or high and low).

(3) No patient testing will take place unless quality control results are within expected ranges.

(4) Quality control lot numbers and results must be documented for review and trending.

i. Proficiency Testing:

(1) P&LMS will provide proficiency samples to each AT site two to three times per year.

(2) Proficiency testing samples will be integrated into the routine workload, and analyzed by certified personnel who routinely test patient samples, using primary method systems. Communication between testing sites concerning proficiency-testing samples is prohibited until after the deadline for submission of data to the proficiency testing provider. No proficiency testing material will be referred to an outside laboratory.

j. Safety & Infection Control

(1) Testing personnel will follow NMVAHCS infection control policies and use Standard Precautions when performing testing. Gloves must be worn during testing events, hand hygiene performed, and gloves changed between patients.

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

(3) Handheld or portable testing devices, such as glucometers, will be disinfected after each patient use according to manufacturer’s guidelines and NMVAHCS Infection Control policy for reusable medical equipment.

(4) Specific instructions for the safe procurement, handling and disposal of specimens and reagents will be included in each test procedure. Testing personnel will follow these handling guidelines and all NMVAHCS Safety and Infection Control policies.

k. Document Review & Maintenance

(1) All required documentation with regard to personnel training, quality control, proficiency testing and instrument maintenance will be kept current and reviewed for completeness by designated supervisory personnel at each testing site.

(2) Test Site Manager/Supervisor:

(a) Each month they will review, sign, and date all temperature, maintenance, quality control and patient testing worksheets.

(b) Review worksheets for completeness. Verify 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.

A-2 Memorandum 113-4 Attachment A

(c) Submit reviewed documents to the AT Department by the 10th working day of the month.

(3) AT Coordinator or Designee

(a) Reviews training, competency assessment, temperature, equipment maintenance quality control, and patient testing records monthly.

(b) The AT Department will maintain and store these records in the Ancillary Department office for accreditation and inspection purposes.

l. Suspension or Removal of AT Privileges

(1) Reasons for suspension or removal of AT from an area includes, but is not limited to:

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

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

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

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

(6) Failure to follow and document maintenance procedures.

(7) Unsatisfactory performance on external proficiency testing surveys.

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

(a) The Test Site Service Chief will receive a written notification that a test is in jeopardy of being removed and will be asked to develop an appropriate corrective action with the assistance of the AT Coordinator. Testing may be reinstated with the approval of the Chief of P&LMS with documentation of remediation.

m. Quality Management Reports: Summary review reports will be submitted by the Ancillary Testing Coordinator or designee to the participating AT sites for follow up, corrective action, if indicated, and inclusion in the site’s Quality Management process. These reports will also be presented at P&LMS Quality Improvement meetings.