CONTINUING EDUCATION TEST Glucose meters: current regulatory guidance for manufacturers and providers April 2019 [This form may be photocopied. It is no longer valid for CEUs after October 31, 2020.)

TEST QUESTIONS Circles must be filled in, or test will not be graded. Shade circles like this: O Not like this:O

1. FDA published guidance documents for glucose meters are intended for use by

{a. providers. {b. manufacturers. {c. patients. {d. all of the above

2. What regulatory body provides accreditation and oversight of provider compliance for glucose meters?

{a. CMS {b. FDA {c. CLIA ‘88 {d. The Joint Commission

3. FDA guidance documents make a clear distinction between device use of glucose meters in the home vs. glucose meters for prescription point of care (POC).

{a. True {b. False

4. The FDA’s purpose for creating the guidelines were due to adverse events and numerous deaths when

{a. self-monitoring blood glucose systems (SMBG) for over-the-counter (OTC) use { migrated into the hospital.

c. glucose monitors for POC testing were taken home by the patient for personal { use.

d. none of the above

5. When the FDA was creating new guidance for manufacturers, what problems were identified with original guidelines about performance criteria?

7. After the FDA clearance of the only glucose monitoring device, there was growing concern that the device did not include the use of

b. capillary whole blood testing in acute care patients within all healthcare { settings.

{a. arterial whole blood testing in acute care { patients within all healthcare settings.

c. arterial whole blood testing in critically { ill patients within all healthcare settings.

d. capillary whole blood testing in critically ill patients within all healthcare settings.

8. The only FDA cleared glucose monitoring device was not approved for use by CLIA- waived operators.

{a. True {b. False

9. An OTC SMBG device used in a hospital setting is considered

{a. off-label. {b. on-label. {c. CLIA un-waived. {d. none of the above

b. glucose monitors for POC testing use { weren’t calibrated by the user each day.

10. Compliance with rules and regulations of an off-label glucose monitor poses regulatory and legal concerns for providers and patients.

{a. True {b. False

11. When are glucose monitors considered high complexity testing?

{a. lack of evidence of device performance { in all patient care settings

b. lack of evidence of device performance { with all specimen types

{c. both a. and b.

{a. 0 {b. 1 {c. 5 {d. 10

d. none of the above

6. Currently there is/are __________ device(s) that is/are cleared and classified by the FDA as a blood glucose monitoring test system (BGMS) for prescription POC use.

{a. When the hospital demonstrates compliance to all regulatory and compliance rules regarding { the use of the meter.

d. all of the above

13. Legal consequences can occur with the use of off-label glucose meters and the liability(ies) than can occur is/are

{a. patient negligence. {b. hospital corporate negligence. {c. CLIA ‘88 compliance. {d. all of the above

14. Tort liability can occur if

{a. a facility uses an FDA cleared glucose meter with a critically ill patient that { results in patient injury.

c. a breach of standard of care is { identified.

b. a facility uses an off-label glucose meter with a critically ill patient that results in { patient injury.

d. there is no communication to the patient informing them of their risk.

15. If informed consent is not provided to patients in regard to off-label use of glucose monitors, liability can occur under the theory of

{a. respondeat inferior. {b. respondeat superior. {c. despondeat inferior. {d. despondeat superior.

16. Medical facilities are protected and are not directly liable for a patient’s injuries in the use of off-label glucose meters.

{a. True {b. False

17. What departments of a healthcare institution should a lab work with in the use of off-label blood glucose monitors?

b. When the hospital uses an FDA-cleared { meter.

c. When a hospital chooses to use an { off-label meter.

12. When a hospital chooses to use an OTC SMBG, the hospital and labs must

{a. meet any applicable state regulations. {b. establish performance specifications { and other performance characteristics.

d. all of the above

{a. human resources and patient advocate {b. risk management and human resources {c. risk management and legal {d. legal and human resources

c. have a CLIA certificate of compliance and meet additional CLIA regulatory { requirements for high complexity testing.

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Send your $20 check payable to Northern Illinois University with this form to: University Outreach Services, Northern Illinois University, DeKalb, IL 60115-2860 Phone: 815-753-0031 FEE NOT REFUNDABLE OR TRANSFERABLE

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MLO and Northern Illinois University (NIU), DeKalb, IL, are co-sponsors in offering continuing education units (CEUs) for this issue’s CE article. CEUs or contact hours are granted by the College of Health and Human Sciences at Northern Illinois University, which has been approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® program. Approval as a provider of continuing education programs has been granted by the state of Florida (Provider No. JP0000496). Continuing education credits awarded for successful completion of this test are acceptable for the ASCP Board of Registry Continuing Competence Recognition Program. Readers who pass the test successfully (scoring 70% or higher) will receive a certificate for 1 contact hour of P.A.C.E.®

credit. Participants should allow three to five weeks for receipt of certificate. The fee for this continuing education test is $20. This test was prepared by Amanda Voelker, MPH, MT(ASCP), MLS, Clinical Education Coordinator, School of HealthStudies, Northern Illinois University, DeKalb, IL. HOME WORK

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