It s Just a Waived Glucose, Isn t It?
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1 It s Just a Waived Glucose, Isn t It? What Is the Next Step? Becky Damiani, MT (ASCP), Senior Inspection Specialist Laboratory Accreditation Program
2 Objectives Understand the CLIA requirements surrounding Whole Blood Glucose and critically ill patients Explain the challenges Discuss directions moving forward 2015 College of American Pathologists. All rights reserved. 2
3 Critical Illness and Glucose Monitoring Critical illness is often associated with impaired glucose regulation Hyperglycemia can be caused by several factors such as increased cortisol, catecholamine, glucagon, growth factor Hyperglycemia can be caused by the stress of surgery, sepsis, trauma Insulin resistivity may also play a factor Hypoglycemia can be caused by liver and kidney failure, certain mediations, e.g. glucocorticoids, vasopressors, antibiotics,
4 Critical Illness and Glucose Monitoring Previously hyperglycemia considered an adaptive responsive therefore not routinely treated in ICU Recently more studies have shown that uncontrolled hyperglycemia is associated with poor clinical outcomes Increased mortality rate, increased length of stay, nosocomial infection This has resulted in an increased effort for glycemic control in critically ill patients
5 Critical Illness and Glucose Monitoring Determine the definition of hypoglycemia and hyperglycemia in the critically ill patient >180 mg/dl hyperglycemic <=70 mg/dl hypoglycemic Optimal target range for BG remains unclear? 140 to 180 mg/dl <180 mg/dl
6 Critical Illness and Glucose Monitoring Many conditions in the critically ill patient can cause inaccurate capillary BG results Dehydration Hematocrit outside of the defined range, e.g. <20% Hypotension and shock Potential Interferences Ascorbic Acid/Vitamin C Acetaminophen
7 Background Blood Glucose Monitoring Systems Discussion of Regulatory Guidance Documents 2015 College of American Pathologists. All rights reserved. 7
8 FDA Draft Guidance Documents On January 7, 2014 FDA published two draft guidance documents concerning blood glucose meters Blood Glucose Monitoring Test Systems for Prescription POC Use Self-Monitoring Blood Glucose Test Systems for the Over-the-Counter Use
9 FDA Draft Guidance Documents Work with manufacturers to determine whether the use of their devices is appropriate in critically ill patients Provide regulatory submissions that contain data that will allow FDA marketing authorization to use these products in critically ill patients.
10 FDA Draft Guidance Documents Draft Guidance Published by FDA Why Now? Need for tighter regulatory standards Diabetes treatment and management changes Technology improvements
11 Critical Illness and Glucose Monitoring Current Standards In Use Blood Glucose >= 75 mg/dl, 95% need to be within +/- 20% of the reference value (lab result) Blood Glucose < =75 mg/dl, 95% need to be within +/-15% of the reference value (lab result) CLSI guideline; C30-A2; Point-of-Care Blood Glucose Testing In Acute and Chronic Care Facilities 2002 FDA is calling for higher manufacturer standards for BGMS (ISO 15197)
12 CMS Blood Glucose Monitoring System Guidance In Jan 2014 NY State Department of Health also issued a letter to lab directors that many of the uses of glucose meters will be off-label Cannot use in health fairs Cannot use on critically ill patients Cannot use to diagnosis or screen for diabetes
13 CMS Blood Glucose Monitoring System Guidance On November 21, 2014 CMS published a memorandum, Ref: S&C: CLIA Directions on the Off-Label/Modified Use of Waived Blood Glucose Monitoring Systems (BGMS)
14 CMS Blood Glucose Monitoring System Guidance On November 21, 2014 CMS published a memorandum, Ref: S&C: CLIA, continued: CLIA-certified lab must follow all manufacturer s guidelines for BGMS Manufacturer s Instructions for Intended use, e.g. specimen type, is it diagnostic or screening
15 CMS Blood Glucose Monitoring System Guidance CLIA-certified lab must follow all manufacturer s guidelines for BGMS, continued: Manufacturer s Limitations and Precautions: e.g. conditions that can affect test results such as patients with circulatory problems limitations indicating that the device has not been cleared for use on critically ill patients
16 CMS Off-Label Use Blood Glucose Devices CLIA-certified lab must follow all manufacturer s guidelines for BGMS, continued: Off-label Use: the lab is using a test outside of the FDA approved intended use, limitations or precautions as indicated in the manufacturer s instructions
17 CMS Off-Label Use Blood Glucose Devices Off-Label Use of BGMS continued: Applies to waived and non-waived Test is considered modified and defaults to high complexity testing Examples of Off-Label Use BG run on patients with hematocrits higher than specified by the manufacturer
18 CMS Off-Label Use Blood Glucose Devices CMS memorandum published November 21, 2014, Ref: S&C: CLIA, continued: When using the BGMS off-label the lab must meet the CLIA requirements for high complexity testing: Accuracy, precision, sensitivity, specificity, reportable range, reference intervals, and personnel must meet the requirements for high complexity testing
19 CMS Off-Label Use Blood Glucose Devices CMS memorandum published November 21, 2014, Ref: S&C: CLIA, continued: Off-Label Use of BGMS CLIA surveyors will cite for non-compliance
20 CMS Blood Glucose Monitoring System Guidance On Mar 13, 2015 temporary withdrawal of S&C: CLIA and reissuance as draft Obtain more feedback regarding the use of BGMS and identify any issues from hospitals/providers Promote education regarding current CLIA requirements
21 Where are We Now And Where Do We Go Next? Verification of Off-Label Use of FDAcleared/approved BGMS 2015 College of American Pathologists. All rights reserved. 21
22 Where Are We Now? Most facilities are still trying to define a critically ill patient Some labs say their policy defines limiting substances say this is ok Most labs have done nothing and are taking a wait & see approach Only one meter is currently FDA approved for critically ill patients 2015 College of American Pathologists. All rights reserved. 22
23 Where Are We Now? Most labs are struggling with the definition of a critically ill patient Is it an ICU patient? Patients on vasopressors or dialysis? Patients that are hemodynamically unstable? No federal/regulatory definition of a critically ill patient It is up to the facility to determine the definition of a critically ill patient
24 Step 1: Review of Manufacturers Instructions Review manufacturer package insert for applicability for the patient population served (COM.4025) Evaluate if the manufacturers instructions are being followed Laboratories that use glucose monitoring devices for purposes or in populations beyond the Intended Use and Limitations stated in the manufacturer s package insert are engaging in off-label use If off-label use the test is now subject to CLIA and CAP requirements for high complexity testing & modified tests
25 Step 2: Define Critical Ill Patient It is the responsibility of the laboratory to define critically ill patient population for its particular clinical setting Done in conjunction with the manufacturer instructions for Intended Use and Limitations Work collaboratively with medical and nursing staff Review existing literature and studies
26 Step 3 Evaluation of BGMS for High Complexity Testing Off-label use of a FDA-cleared/approved device is considered a modification to the test system (COM.40250) and requires validation of the modification Method performance specifications Formulate validation plan Study data can be collected retrospectively
27 Step 3 Evaluation of BGMS for High Complexity Testing Review and approval of method validation By medical director or designee who meets CAP director qualification (COM.40000) Policy/procedure revision and approval to reflect change in testing complexity Communicate changes to nursing and medical staff
28 Step 4: Training and Education Laboratory must ensure that personnel meet high complexity testing qualifications Information can be found at: GEN Testing Personnel Qualifications, 2015 edition CAP Personnel Requirements by Test Complexity (under e- labs/cap Accreditation Resources/Accreditation Guidance Documents) CLIA regulation 42CFR
29 Step 4: Training and Education Competency must now be assessed using all 6 elements of assessment For new employees during the first year of an individual s duties competency must now be assessed semiannually
30 Step 5: Ongoing Reagent & Quality Control Perform semiannual instrument comparisons Perform AMR verification every 6 months Perform lot-to-lot reagent verification Perform quality control according to non-waived requirements Proficiency testing (nonwaived program enrollment)
31 Point of Care Inspection Whole Blood Glucose Testing It is Not Just Waived Testing Any More 2015 College of American Pathologists. All rights reserved. 31
32 Inspecting Glucose Meters Inspect Using the Point of Care (POC) Checklist The POC checklist may also be used to inspect FDAcleared/approved point-of-care tests that are modified by the laboratory. Modified FDA-cleared/approved tests are subject to the nonwaived checklist requirements and high complexity personnel qualifications
33 Inspecting Blood Glucose Meters Verify the activity menu Waived versus nonwaived (COM.01200) Identify the blood glucose monitoring system in use Review the package insert or manufacturer instructions for Intended Use & Limitations Verify that the lab has defined critically ill patient population (COM.40250)
34 Inspecting Blood Glucose Meters If the meter is being used off-label ensure the following requirements will apply: The testing is nonwaived and the CLIA license should reflect this change
35 Inspecting Blood Glucose Meters If the meter is being used off-label ensure the following requirements will apply: Competency assessment (POC.09600) Personnel qualifications (GEN.54750) Method performance specification (COM COM.40600) Proficiency testing (nonwaived program enrollment) Quality control requirements for nonwaived testing
36 Inspecting Blood Glucose Meters If the meter is being used off-label ensure the following requirements will apply, continued: Lot-to-lot reagent verification (COM.30450) Semiannual instrument comparison (COM.04250) Analytical measurement range or AMR (POC.8450 POC.8600)
37 Inspecting Blood Glucose Meters If the meter is being used according to the manufacturer's instructions for Intended Use and Limitation, inspect as a waived test using the appropriate requirements in the in the Point-of-Care Checklist Follow manufacturer instructions
38 Questions 2015 College of American Pathologists. All rights reserved. 38
39 Contact: Becky Damiani: CAP:
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