Standard Document
Third Edition
Point-of-Care Testing

CLSI POCT12

Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline

CLSI POCT12A3 provides laboratories with guidelines for proper performance of point-of-care blood glucose meter systems, stressing quality control, training, and administrative responsibility.

January 30, 2013
David B. Sacks, MD

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Abstract

Clinical and Laboratory Standards Institute document POCT12-A3—Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition provides information for use by acute and chronic care facilities with laboratory support for structuring a point-of-care (POC) blood glucose testing service intended to ensure quality test results, as well as high-quality patient care. POCT12 introduces policy-related issues with respect to administration of the program, persons who perform the tests, selection of measurement procedures, reporting of results, and the QA aspects of POC blood glucose testing. Also discussed are the uses of POC blood glucose testing, authorization of operators, meter system verification, and procedural steps.

Overview of Changes

Updates in this third edition include the following: 

• Implications of point-of-care (POC) glucose testing programs designed to limit the range of blood glucose levels, or tight glycemic control 

• Various limitations to POC blood glucose meter systems, including potential biological and pharmacological interferences 

• Responsibilities of the laboratory service director with oversight for POC glucose testing programs 

• Considerations for performing blood testing using samples obtained from alternate anatomic sites in acute patient care

Scope

This guideline provides instructions and recommendations concerning the administration of point-of-care (POC) blood glucose monitoring programs at acute and chronic care facilities where laboratory support is available. POC blood glucose meter systems provide rapid results required by medical staff members to make therapeutic decisions. 

This document applies to quantitative in-vitro POC blood glucose meter systems intended for use by health care professionals for management of patients with diabetes mellitus and other conditions with fluctuations in glucose homeostasis. These test systems may be indicated for use with arterial, venous, or capillary whole blood samples obtained from adults, children, or neonates. 

This guideline does not pertain to glucose measurement for self-monitoring of blood glucose, screening for diabetes, or diagnosing diabetes mellitus or other disorders of glucose metabolism. As criteria for accepting a POC glucose meter are included in this document, manufacturers may wish to refer to this document as an indication of clinical requirements in the marketplace. Automated medical laboratory systems or analyzers used to perform routine and stat glucose testing on plasma, serum, whole blood, urine, and cerebrospinal fluid are not included in the scope of this guideline.

Product Details
POCT12A3E
1-56238-868-1
64
Additional Details

This document is available in electronic format only.

Authors
David B. Sacks, MD
David E. Bruns, MD
Judy Horton, DA, MS, MT(ASCP)
Stellan Lindberg, MSc
John J. Mahoney
Stephen Manzella, PhD
Eugene T. Reilly, MSc
Mitchell G. Scott, PhD
Abstract

Clinical and Laboratory Standards Institute document POCT12-A3—Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition provides information for use by acute and chronic care facilities with laboratory support for structuring a point-of-care (POC) blood glucose testing service intended to ensure quality test results, as well as high-quality patient care. POCT12 introduces policy-related issues with respect to administration of the program, persons who perform the tests, selection of measurement procedures, reporting of results, and the QA aspects of POC blood glucose testing. Also discussed are the uses of POC blood glucose testing, authorization of operators, meter system verification, and procedural steps.

Overview of Changes

Updates in this third edition include the following: 

• Implications of point-of-care (POC) glucose testing programs designed to limit the range of blood glucose levels, or tight glycemic control 

• Various limitations to POC blood glucose meter systems, including potential biological and pharmacological interferences 

• Responsibilities of the laboratory service director with oversight for POC glucose testing programs 

• Considerations for performing blood testing using samples obtained from alternate anatomic sites in acute patient care

Scope

This guideline provides instructions and recommendations concerning the administration of point-of-care (POC) blood glucose monitoring programs at acute and chronic care facilities where laboratory support is available. POC blood glucose meter systems provide rapid results required by medical staff members to make therapeutic decisions. 

This document applies to quantitative in-vitro POC blood glucose meter systems intended for use by health care professionals for management of patients with diabetes mellitus and other conditions with fluctuations in glucose homeostasis. These test systems may be indicated for use with arterial, venous, or capillary whole blood samples obtained from adults, children, or neonates. 

This guideline does not pertain to glucose measurement for self-monitoring of blood glucose, screening for diabetes, or diagnosing diabetes mellitus or other disorders of glucose metabolism. As criteria for accepting a POC glucose meter are included in this document, manufacturers may wish to refer to this document as an indication of clinical requirements in the marketplace. Automated medical laboratory systems or analyzers used to perform routine and stat glucose testing on plasma, serum, whole blood, urine, and cerebrospinal fluid are not included in the scope of this guideline.

Additional Details

This document is available in electronic format only.

Authors
David B. Sacks, MD
David E. Bruns, MD
Judy Horton, DA, MS, MT(ASCP)
Stellan Lindberg, MSc
John J. Mahoney
Stephen Manzella, PhD
Eugene T. Reilly, MSc
Mitchell G. Scott, PhD