D.10 MCM 113-02 - WAIVED TESTING TEST SYSTEMSINSTRUMENTS - QUALITY CONTROL - REAGENT INFORMATION - ATTACHED.docx

D.10 MCM 113-02 - 36C26225R0004

VA SAN DIEGO HEALTHCARE SYSTEM MEMORANDUM 113-02

SAN DIEGO, CA January 31, 2024

D. 10 MCM 113-02 - WAIVED TESTING TEST SYSTEMS/INSTRUMENTS, QUALITY CONTROL, AND REAGENT INFORMATION

POINT OF CARE TESTING PROGRAM

1. PURPOSE: To establish policies and procedures for accurate and timely performance of laboratory tests at the point of care and to establish uniform quality control for all point of care testing in VA San Diego Healthcare System (VASDHS).

2. POLICY: This policy establishes scope of testing, staff responsibilities, training and supervision, quality management, reliability and limitations of testing performed outside the main laboratory environment using standard procedures approved by the Ancillary Testing Committee.

3. DEFINITIONS:

a. Point of Care Testing (also referred to as Ancillary Testing) is defined as definitive diagnostic testing performed outside the main laboratory within a facility or health services organization. The goal is to provide bedside and/or ward and clinic testing which is intended to provide more rapidly accessible test results than can be achieved in central or routine laboratory settings.

b. The Ancillary Testing Committee is an appointed committee when needed with representatives from the following: Ambulatory Care, Anesthesiology, Medicine, Nursing, Pharmacy, Pathology and Laboratory Medicine, and Performance Improvement Management Service.

c. Quality Control (QC) and/or Performance Monitors are procedures used to monitor the analytical process, including the performance of the operator, reagents and instruments.

d. Proficiency Testing is the testing of samples of unknown value and comparison to national results.

e. Competency Assessment is the process of evaluating or measuring the individual’s performance and ensuring that the testing personnel have knowledge, skills and abilities to perform waived and non-waived tests in accordance with standards of practice.

f. Critically Ill Patient :

1) A patient on mechanical ventilation with a mean arterial blood pressure less than 60 mmHg despite the use of pressors.

2) Any patient with decreased peripheral blood flow; examples might be an individual with severe dehydration, hypotension (mean arterial blood pressure 60 or less), shock, severe decompensated heart failure (requiring ICU level of care), or peripheral arterial occlusive disease.

g. Provider Performed Testing (PPT): PPT is defined by the College of American Pathologists (CAP) as testing that is personally performed by a physician, a physician assistant or a nurse practitioner credentialed and privileged by the institution’s medical staff. PPT includes certain “waived” tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) as well as Provider Performed Microscopy tests that meet certain CLIA’88 requirements. As defined by the CLIA’88, and indicated by Centers for Medicare or Medicaid Services (CMS), even though waived tests are described as simple to perform, erroneous results are possible and could produce unseemly patient outcomes.

h. Provider Performed Microscopy (PPM): Any microscopic test, analysis, or other examination performed by a healthcare provider as a diagnostic or monitoring procedure on a human specimen for patient care, disease prevention, or health assessment. Select PPM testing analysis is performed by a licensed physician, physician assistant, or nurse practitioner in conjunction with the physical examination or treatment of a patient. PPM is currently limited to the following tests: Potassium Hydroxide (KOH) preparations for Dermatology.

4. RESPONSIBLILITIES:

a. Director of Ancillary Testing:

1) Will be served by the Chief, Pathology and Laboratory Medicine Service (PALMS) or designee and named on the CLIA’88 Certificate.

2) Directs, authorizes, and oversees the Ancillary Testing Program, and solves issues relating directly to compliance with national, local, and institutional standards.

3) Approves a consistent approach for when waived or non-waived test results can be used for diagnosis and treatment and when follow-up testing is required.

4) Designates an Ancillary Testing Coordinator to coordinate the training, and service/maintenance of ancillary testing on a hospital system-wide basis, and to provide supervision and oversight of quality management, and quality control performed at ancillary testing sites.

5) Develops a process to ensure compliance for quality testing, compliance with policies, following standard procedures, adequate training, competency assurance, and close supervision for all ancillary testing.

6) The lab director performs on-site visit to the CBOCs with High Complexity testing (North County OPC, Oceanside, CA and Kearny Mesa VA Outpatient Clinic, San Diego, CA) two times per calendar year with a minimal interval of 4 months between visits.

b. The Ancillary Testing Committee:

1) Will be chaired by the Chief, PALMS or designee. This position must be held by an individual that meets the qualifications of a Laboratory Director as defined by CAP.

2) Determine which test(s) and/or instrumentation may be utilized outside the main clinical laboratory for diagnosis, treatment, or follow up purposes.

3) Develops protocols to assess the competency of health care personnel who perform the ancillary tests.

4) Define the reference range and critical values of the ancillary tests.

5) Provide a protocol for immediate evaluation of results and actions by non-laboratory testing personnel if a quality control test result is outside the specified range or quality control procedures are in non-compliance.

c. The Ancillary Testing Coordinator or designee:

1) Evaluates and provides appropriate training to all testing personnel within 30 days of their employment. This training may be by means of classes, train-the-trainer, direct observation, PowerPoint presentations, CD-ROM, or written instructions. Initial competency for all ancillary testing personnel will be assessed and documented and then reassessed at least annually thereafter.

2) Performs appropriate quality control studies on each new lot and shipment of reagents/kits/strips or replacement instruments, and providing technical oversight, advice and assistance to all ancillary testing sites for quality management.

3) Evaluates test methodologies, appropriate for the clinical use of test results.

4) Writes policies and standard operating procedures (SOP) for each test and test system. Ensure that standard operating procedures are available at each testing site.

5) Performs random audits of expired reagents/kits/strips from all testing sites; review QC on a monthly basis.

6) Selects and verifies methods and test procedures performed and establish the laboratory’s test performance characteristics, including correlation studies, validation studies, and precision and accuracy requirements.

7) Ensures that the laboratory’s licensure, regulatory and accreditation requirements are renewed and met in all routine laboratory and ancillary testing areas; ensures enrollment and participation in a proficiency-testing program to commensurate with accreditation requirements with testing services offered and to provide oversight for any necessary remedial action.

8) Establishes and supervises a quality control program with acceptable upper and lower levels of analytic performance and ensure that these levels are maintained through the entire testing process (pre- analytical, analytical, and post-analytical phases).

9) Ensures that criteria for confirmatory testing are followed as specified in the waived and non-waived testing written procedures. Recognizes and resolves technical problems with appropriate follow-up actions when test systems deviate from the laboratory’s established performance specifications.

10) Monitors, tracks and takes corrective actions when inappropriate patient/client results are reported and deviate from the laboratory’s policies.

d. Testing Personnel:

1) Follow the SOP for the test and perform only tests and procedures that are authorized by the Ancillary Testing Committee or the Point of Care Testing Director.

2) Complete and demonstrate competency for each of the point of care tests being performed which will be assessed annually using the following methods per person:

(a) Performance of blind specimen

(b) Observation

(c) Monitoring of Quality Control Performance

(d) Written Test

3) Understand that in no circumstance an ancillary test can be performed by a person with no or expired certification.

4) Follow approved documented protocols for specimen collection and processing, test analysis, result reporting, and perform preventive maintenance procedures on point of care instruments.

5) Ensure clinical use of patient results is consistent with the hospital’s policies and the manufacturer’s recommendations for ancillary testing.

6) Follow established corrective actions whenever test systems deviate from established acceptable levels of performance.

7) Ensure that quality control procedures are followed to reduce the likelihood of human errors.

8) Follow all institutional safety policies and infection control practices.

9) Follow policies for reporting of all critical results. Notify the provider of critical results, unless the operator is the provider, or the provider is physically present and document the notification in the patient’s records.

e. Providers:

1) When performing tests, follow the manufacturers recommended procedures.

2) Follow-up with each test ordered and ensure appropriate clinical decisions and/or actions are made accordingly.

5. PROCEDURES:

a. To ensure testing quality, a written standard procedure, containing principles of operation, stepwise instructions, lists of reagents and equipment if any, calibration, QC, linearity, result reporting, clinical usage and limitations, will be available for each analyte. These are available to each operator via any hospital computer, at the following link in SharePoint. https://dvagov.sharepoint.com/sites/VHAVASDNursing/Point%20of%20Care%20Testing/Forms/AllItems.aspx

b. Tests Performed in the Point of Care Testing Program:

1) Whole Blood Glucose:

(a) The glucometer shall be limited to testing non-critically ill patients.

(b) Glucose level of Critically Ill Patients shall be tested on i- STAT (see below) or in the main lab.

2) Dermatology KOH

3) i-STAT: Includes arterial blood gases EG7+, whole blood chemistries Chem8+, Urea Nitrogen, Creatinine, Hemoglobin/Hematocrit, activated clotting time ACT, whole blood Glucose in normal and in Critically Ill Patients, and Troponin I.

4) Urine Pregnancy testing

5) HemoCue hemoglobin testing

6) Blood Oximetries (Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin)

7) OraQuick HCV/HIV (Stand Down only)

8) Urine Dipstick (Stand Down only)

9) CoaguChek (Whole Blood PT/INR)

10) Pandemic Antigen Testing (e.g., COVID-19 Antigen Testing)

11) Urine Drug Screen qualitative testing

12) Viscoelastic testing

c. Training of Hospital and Clinic Personnel who perform the tests:

1) Minimum qualifications for physicians, nurses, technologists, and technicians performing ancillary testing include successful completion of an orientation program or other approved in-service training program and random periodic demonstration of competence in testing of the analyte. Individuals not meeting an acceptable level of competence will be re-trained and re-examined until deemed competent.

2) The training program will include the SOP for each analyte, expected range of analyte values with critical values and appropriate follow-up actions, proper techniques to obtain and handle samples along with infection control measures, recognition of potential sources of error specific to the system or the procedure and reporting results to the patient’s electronic record (CPRS) with the documentation of test results, name of the testing personnel, and QC record keeping.

d. When possible, only one brand of testing meter/analyzer/kit will be used for in-house ancillary testing for each analyte. Instrument maintenance will include calibration and cleaning according to manufacturers’ guidelines. Any new ancillary testing instrument must be approved and evaluated by the Ancillary Testing Committee, with preference to an instrument that has established connectivity to the Laboratory Information System, with positive patient identification functionality, ease of use, and acceptable correlation of test results with the main laboratory instruments. The Lab Director will make the final decision.

e. When possible, sufficient testing reagents/strips/kits and control solutions with the same lot number will be purchased to allow consistent evaluation and setting of ranges for controls. Reagents and/or test strips must be stored according to manufacturer’s specifications at all times.

f. Ancillary Testing quality control records, instrument repairs records, and patient test result records will be maintained in PALMS for a period of two years.

g. All ancillary testing, including PPM will be enrolled in CAP proficiency testing programs. For analytes where graded proficiency testing is not available, performance will be checked at least semi-annually with appropriate alternate test performance assessment approved by the Ancillary Testing Director. In addition, the Ancillary Testing Coordinator and the Ancillary Testing Director will ensure that ancillary testing establishes and/or maintains appropriate daily records in order to satisfy future accrediting agency inspections.

h. All critical ancillary testing results should be repeated for verification and reported to the healthcare provider. All critical results must be documented in the test report or in the medical record, including the result, date, time, testing individual, person notified and verification of a read-back per medical center policy. Questionable results or results that do not match the patient’s signs and symptoms will be repeated in the main laboratory on a new specimen.

6. REFERENCES:

a. VHA Handbook 1106.1, Chapter 7, Ancillary Testing.

b. Clinical Laboratory Improvements Amendment (CLIA) January 16, 2024, Federal Register.

c. VA Circular 10-91-043, “Policy for Ancillary Diagnostic Laboratory Testing in VA (Department of Veterans Affairs) Medical Centers.

d. NCCLS Document C20-T, Vol. 11, No. 8: “Ancillary (Bedside) Blood Glucose Testing in Acute and Chronic Care Facilities”

e. The Joint Commission Standards

f. FDA Labelling Change On Point Of Care (POC) Glucose Devices. VHA Pathology & Laboratory Medicine Service January 23, 2014

7. RECERTIFICATION DATE: January 2029

8. FOLLOW-UP RESPONSIBILITY: Chief, Pathology & Laboratory Medicine (113)

9. RECOMMENDED REVIEW DATE: January 2027.

10. RESCISSION: Memorandum 113-02, dated January 31, 2021.

11. DATE APPROVED BY MEC: May 15, 2024.

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