(Formerly NCCLS) Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards

Transcription

1 (Formerly NCCLS) Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards

2 Clinical and Laboratory Standards Institute Providing NCCLS standards and guidelines, ISO/TC 212 standards, and ISO/TC 76 standards The Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues. Our process is based on the principle that consensus is an effective and cost-effective way to improve patient testing and healthcare services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS A document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The CLSI voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus proposed and approved. Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level. Proposed A consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line-by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following CLSI s established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at customerservice@clsi.org or for additional information on committee participation.

3 ISBN Volume 25 Number 12 ISSN Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition Louis J. Dunka, Jr., PhD, FACB John Rex Astles, PhD, FACB Patricia Bernhardt, MT(ASCP) Barbara M. Goldsmith, PhD Davida F. Kruger, MSN, APRN, BC-ADM Ronald Ng, PhD Donald Parker, PhD Abstract Clinical and Laboratory Standards Institute document, Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition was developed for personnel monitoring glucose levels at sites other than a hospital laboratory. In a question and answer format, the document provides recommendations related to administrative structure, operator authorization, test system selection, quality assurance, and test procedure. Also included are samples of a written evaluation and quality control logs. The second half of the guideline can be used to create an on-site procedure manual. Clinical and Laboratory Standards Institute (CLSI). Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition. CLSI document (ISBN ). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania USA, The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the healthcare community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: ; Fax: ; customerservice@clsi.org; Website:

4 Number 12 This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute, except as stated below. Clinical and Laboratory Standards Institute hereby grants permission to reproduce limited portions of this publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in educational programs provided that multiple copies of such reproduction shall include the following notice, be distributed without charge, and, in no event, contain more than 20% of the document s text. Reproduced with permission, from CLSI publication Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition (ISBN ). Copies of the current edition may be obtained from Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania , USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from Clinical and Laboratory Standards Institute by written request. To request such permission, address inquiries to the Executive Vice President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania , USA. Copyright Clinical and Laboratory Standards Institute. Suggested Citation (Clinical and Laboratory Standards Institute. Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition. CLSI document [ISBN ]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania USA, 2005.) Proposed Guideline December 1996 Approved Guideline June 1999 Approved Guideline Second Edition May 2005 ISBN ISSN ii

5 Volume 25 Committee Membership Area Committee on Clinical Chemistry and Toxicology W. Gregory Miller, PhD Chairholder Virginia Commonwealth University Richmond, Virginia David A. Armbruster, PhD, DABCC, FACB Vice-Chairholder Abbott Laboratories Abbott Park, Illinois John Rex Astles, PhD, FACB Centers for Disease Control and Prevention Atlanta, Georgia David M. Bunk, PhD National Institute of Standards and Technology Gaithersburg, Maryland Neil Greenberg, PhD Ortho-Clinical Diagnostics Rochester, New York Christopher M. Lehman, MD University of Utah Health Sciences Center Salt Lake City, Utah Richard R. Miller, Jr. Dade Behring Inc. Newark, Delaware Michael E. Ottlinger, PhD, DABT U.S. Environmental Protection Agency Cincinnati, Ohio Linda Thienpont, PhD University of Ghent Gent, Belgium Thomas L. Williams, MD Methodist Hospital Omaha, Nebraska Advisors Larry D. Bowers, PhD, DABCC U.S. Anti-Doping Agency Colorado Springs, Colorado Robert W. Burnett, PhD Hartford Hospital Farmington, Connecticut Mary F. Burritt, PhD Mayo Clinic Rochester, Minnesota Paul D Orazio, PhD Instrumentation Laboratory Lexington, Massachusetts Carl C. Garber, PhD, FACB Quest Diagnostics, Incorporated Lyndhurst, New Jersey Uttam Garg, PhD, DABCC The Children s Mercy Hospital Kansas City, Missouri David E. Goldstein, MD University of Missouri School of Medicine Columbia, Missouri Harvey W. Kaufman, MD Quest Diagnostics, Incorporated Lyndhurst, New Jersey Gary L. Myers, PhD Centers for Disease Control and Prevention Atlanta, Georgia David B. Sacks, MD Brigham and Women s Hospital and Harvard Medical School Boston, Massachusetts Bette Seamonds, PhD Mercy Health Laboratory Swarthmore, Pennsylvania Dietmar Stöckl, PhD University of Ghent Gent, Belgium Hubert Vesper, PhD Centers for Disease Control and Prevention Atlanta, Georgia Jack Zakowski, PhD, FACB Beckman Coulter, Inc. Brea, California Working Group on Blood Glucose Testing Louis J. Dunka, Jr., PhD, FACB Chairholder LifeScan, Inc. Milpitas, California John Rex Astles, PhD, FACB Centers for Disease Control and Prevention Atlanta, Georgia Patricia Bernhardt, MT(ASCP) FDA Center for Devices and Radiological Health Rockville, Maryland Barbara M. Goldsmith, PhD, FACB St. Elizabeth s Medical Center Boston, Massachusetts Davida Kruger, MSN, APRN, BC-ADM Henry Ford Health System Detroit, Michigan Ronald H. Ng, PhD, DABCC, FACB Abbott Diabetes Care Alameda, California Donald R. Parker, PhD Bayer Healthcare, LLC Elkhart, Indiana Staff Clinical and Laboratory Standards Institute Wayne, Pennsylvania Tracy A. Dooley, MLT(ASCP) Staff Liaison Patrice E. Polgar Project Manager Donna M. Wilhelm Editor Melissa A. Lewis Assistant Editor iii

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7 Volume 25 Contents Abstract...i Committee Membership... iii Foreword... vii 1 Scope Who Should Use This Guideline? Where Should This Guideline Be Used? What Is Included in This Guideline? How Is This Guideline Organized? Introduction Why Is This Guideline Important? How Can This Guideline Be Used? Are Blood Glucose Monitoring Systems as Accurate as Laboratory Instruments? Standard Precautions Definitions Information for the Coordinator Why Is a Coordinator Needed? What Are the Responsibilities of a Coordinator? What Should the Coordinator Do to Start a Glucose Monitoring Program? What Considerations Should Guide the Choice of a Glucose Monitoring System? Why Is a Procedure Manual Needed and What Should It Contain? What Are the Components of a Quality Assurance (QA) Program? What Should Be Included in a Training Program for Operators? How Should the Competence of Operators Be Determined? Information for the Operator Who Can Perform This Testing? What Is Needed to Perform Glucose Monitoring? What Should Be Done Before Testing? What Should Be Included in Recording Test Results? What Are Appropriate Responses to Abnormal Blood Glucose Concentrations? Outline for Procedure Manual Procedure...22 References...26 Appendix A. Possible Actions When a Person s Glucose Concentration Is Very High or Very Low...27 Appendix B. New Technologies...30 Appendix C. Common Problems With the Use of Glucose Meters...32 Summary of Delegate Comments and Working Group Responses...34 v

8 Number 12 Contents (Continued) The Quality System Approach...38 Related CLSI/NCCLS Publications...39 vi

9 Volume 25 Foreword This revision of CLSI/NCCLS document AST4 Glucose Monitoring in Settings Without Laboratory Support includes several modifications of the earlier version, which was last published in June 1999: Newer technologies have been addressed. Newer devices which measure glucose continuously, as opposed to episodically, may require new approaches. Additionally, some devices measure glucose in interstitial fluid rather than blood. Substantial information on appropriate operation of blood glucose monitoring devices has been included, as well as the effects of inappropriate operation of the devices. Several new definitions have been included and the terms and definitions have been harmonized with ISO terminology. A section has been included that addresses the differences between glucose concentration in capillary and venous blood as well as between plasma and whole blood. A comprehensive section on troubleshooting has been included. Where possible, the document has been harmonized with a companion CLSI/NCCLS document, C30 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities. Illustrations of appropriate skin puncture sites have been included. The format has been made consistent with other CLSI/NCCLS documents. A Summary of Consensus Comments on the previous edition of this document (AST4-A) has not been included in the current edition, as all comments were editorial in nature. A Note on Terminology Clinical and Laboratory Standards Institute (CLSI), as a global leader in standardization, is firmly committed to achieving global harmonization wherever possible. Harmonization is a process of recognizing, understanding, and explaining differences while taking steps to achieve worldwide uniformity. CLSI recognizes that medical conventions in the global metrological community have evolved differently in the United States, Europe, and elsewhere; that these differences are reflected in CLSI, ISO, and CEN documents; and that legally required use of terms, regional usage, and different consensus timelines are all obstacles to harmonization. Despite these obstacles, CLSI recognizes that harmonization of terms facilitates the global application of standards and is an area that needs immediate attention. Implementation of this policy must be an evolutionary and educational process that begins with new projects and revisions of existing documents. In keeping with CLSI s commitment to align terminology with that of ISO, the following terms are used in AST4: Accuracy refers to the closeness of agreement between a single test result and the accepted reference value; whereas Trueness is used when referring to the closeness of the agreement between the average value obtained from a large series of test results and an accepted reference value; and Precision refers to the closeness of agreement between independent test results obtained under stipulated conditions. See the Definitions section of the guideline. Key Words Authorization, blood glucose, coordinator, diabetes, glucose monitoring system, meter, operator, quality assurance, quality control, training, verification vii

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11 Volume 25 1 Scope Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline Second Edition 1.1 Who Should Use This Guideline? This guideline has been developed for authorized personnel directly involved in the establishment, management, and implementation of a blood glucose monitoring program at sites without support from hospital laboratories. For the purposes of this document, these authorized personnel will be referred to as Operators. In settings where there is more than one Operator, one individual should be designated to coordinate the testing program; and for the purposes of this document, this individual will be referred to as the Coordinator. 1.2 Where Should This Guideline Be Used? This guideline should be used in settings where there is no laboratory support, such as those mentioned below, to be defined by each institution. All areas of use shall be staffed with personnel who are authorized by the institution to use blood glucose testing meters. This guideline is not intended for use in acute and chronic care facilities with on-site laboratory support. Operators monitoring glucose levels in these types of settings should refer to the most current edition of CLSI/NCCLS document C30 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities. This guideline for glucose monitoring may be used in a variety of locations which include, but are not limited to: physicians offices; camps attended by people with diabetes; mobile emergency medical facilities; free-standing dialysis and surgical centers; home healthcare settings (not applicable to individuals with diabetes who do their own testing); visiting nursing programs; public health facilities; mobile or free-standing clinics (e.g., migrant worker clinics, other clinics in remote locations); occupational health facilities; pharmacies; prisons; Clinical and Laboratory Standards Institute. All rights reserved. 1

12 Number 12 residential care communities; schools and student health facilities; urgent care centers; and day care centers. 1.3 What Is Included in This Guideline? This guideline provides information related to specimen collection, use of the blood glucose test strips and meters, and the necessary actions to be taken when finding abnormally high or abnormally low blood glucose concentrations. It is intended to help Coordinators: select a glucose monitoring system; develop a procedure manual; implement a QA program; implement a program for maintenance of glucose monitoring systems; develop a documentation system for recording test and QC results; and train and authorize Operators. It is intended to help Operators: understand the qualifications for operation of glucose monitoring devices; understand the need for and performance of quality control; perform maintenance procedures for the blood glucose meter; properly collect and safely handle blood specimens; properly calibrate or code the meters; perform blood glucose tests; understand the technique needed for obtaining accurate test results; and understand the appropriate use of the blood glucose test results. 1.4 How Is This Guideline Organized? This guideline is organized into nine sections: Scope; 2 Clinical and Laboratory Standards Institute. All rights reserved.

13 Volume 25 Introduction; Standard Precautions; Definitions; Information for Coordinators; Information for Operators: If you are the only Operator at a testing location, you should be familiar with the information in both the Operator and the Coordinator sections, because you will fill both roles; Procedure Manual: This section provides an outline for developing a procedure manual that is specific for the blood glucose measuring system being used; Sample Forms for Recordkeeping: This section provides sample forms for recording blood glucose results, QC testing, and meter maintenance activities; and Appendixes. 2 Introduction 2.1 Why Is This Guideline Important? Blood glucose monitoring is a valuable tool for the management of blood glucose concentrations in persons with diabetes or other conditions, such as those listed in Section 2.2. Blood glucose concentrations in such persons, especially those with Type 1 diabetes mellitus, often fluctuate and frequent adjustments in the person s insulin dosage may be necessary. It is often impractical in these circumstances to obtain laboratory blood glucose measurements as frequently or as rapidly as is required. Persons with Type 1 diabetes do not produce insulin and must administer insulin to maintain blood glucose concentrations at or near normal levels. Persons with Type 2 diabetes produce insulin, but have developed insulin resistance. Typically, diet, exercise, and oral agents are used to maintain their glucose concentrations at or near normal levels. For both types of diabetes, the majority of testing takes place outside the traditional clinical laboratory. Proper procedures for testing blood glucose using blood glucose meters are likely to produce accurate test results, avoiding potential harm to the individual tested. Proper blood sample collection, adherence to an approved testing procedure, and adequate maintenance of the blood glucose meters and test strips all contribute to the accuracy and reliability of the test results. 2.2 How Can This Guideline Be Used? a Applications of blood glucose monitoring include, but are not limited to, the following: the management of therapy to regulate blood glucose concentrations in persons with diabetes; the rapid detection of extreme blood glucose concentrations in persons whose symptoms and/or signs suggest hypoglycemia or severe hyperglycemia; a In the U.S., glucose monitoring systems do not have regulatory clearance to be used for screening or diagnosis of diabetes mellitus. Clinical and Laboratory Standards Institute. All rights reserved. 3

14 Number 12 the intraoperative and perioperative management of blood glucose concentrations in surgical patients in free standing surgical units; the rapid identification of extreme blood glucose concentrations in patients who present with a coma of unknown origin, especially in the emergency department; the monitoring of persons who receive medication likely to affect their blood glucose concentrations; and education for diabetes management. 2.3 Are Blood Glucose Monitoring Systems as Accurate as Laboratory Instruments? It is important to recognize that, in certain circumstances, there are inherent limitations to blood glucose monitoring systems. For a variety of reasons, most blood glucose meters are less accurate than laboratory instruments. With certain systems, significant errors in blood glucose testing results may occur when samples from individuals with a very low or very high packed cell volume (PCV; hematocrit) are tested if the operator does not understand the potential interferences or limitations of the system. For example, some systems may have an inherent bias. In tests done on hypoglycemic individuals, the error may be clinically significant. NOTE: In all cases, users of blood glucose testing meters should be aware of all limitations described by the manufacturer and ensure that the proper instructions for use are followed. 3 Standard Precautions Because it is often impossible to know what might be infectious, all patient and laboratory specimens are treated as infectious and handled according to standard precautions. Standard precautions are guidelines that combine the major features of universal precautions and body substance isolation practices. Standard precautions cover the transmission of all infectious agents and thus are more comprehensive than universal precautions which are intended to apply only to transmission of blood-borne pathogens. Standard and universal precaution guidelines are available from the U.S. Centers for Disease Control and Prevention (Guideline for Isolation Precautions in Hospitals. Infection Control and Hospital Epidemiology. CDC. 1996;17(1):53-80 and MMWR 1988;37: ). For specific precautions for preventing the laboratory transmission of all infectious agents from laboratory instruments and materials and for recommendations for the management of exposure to all infectious disease, refer to the most current edition of CLSI document M29 Protection of Laboratory Workers from Occupationally Acquired Infections. 4 Definitions accepted reference value a value that serves as an agreed-upon reference for comparison and which is derived as: a theoretical or established value based on scientific principles; an assigned value based on experimental work of some national or international organization; or a consensus value based on collaborative experimental work under the auspices of a scientific or engineering group (ISO ). 1 accuracy closeness of agreement between a single test result and the accepted reference value (modified from ISO ); NOTE: See accepted reference value above, and precision and trueness, below. 4 Clinical and Laboratory Standards Institute. All rights reserved.

15 Volume 25 authorization recognition of a person who has satisfied the qualification requirements to perform blood glucose testing (BGT) within an institution. blood circulating intravascular component of the body, consisting of the suspended formed elements and fluid plasma (ISO/CD 17593) 3 ; NOTE: In this standard, the term refers to fresh, non-anticoagulated whole blood. blood specimen the discrete portion of blood taken for examination, study, or analysis of one or more quantities or characteristics to determine the character of the whole. blood specimen, arterial blood obtained by arterial puncture or from an individual arterial line, catheter, or extracorporeal circuit. blood specimen, capillary blood collected after puncturing any of the minute vessels that connect the arterioles and venules, often obtained by pricking a fingertip; capillary blood is usually collected without additives such as anticoagulants or preservatives, therefore, it is inherently unstable (modified from ISO/CD 17593). 3 blood specimen, venous blood collected after directly puncturing a vein, usually with a needle and syringe, or other collection device; venous blood may be collected without additives such as anticoagulants or preservatives, and if so, will be inherently unstable; venous blood may also be collected into containers containing additives or preservatives with the intent to stabilize specific components (modified from ISO/CD 17593). 3 calibration set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards (VIM93). 4 NOTE: According to the U.S. Code of Federal Regulations, calibration is the process of testing and adjustment of an instrument, kit, or test system, to provide a known relationship between the measurement response and the value of the substance being measured by the test procedure (42 CFR ). 5 clinical decision point (critical value) decision limits determined on the basis of scientific and/or medical knowledge, often based on a medical condition. coding a process that adjusts the glucose meter to use the proper calibration. competency following successful completion of a training program, the assessment of a person s ability to perform BGT. coordinator an individual who is responsible for oversight of activities related to a blood glucose monitoring program. fasting glucose the concentration of glucose in whole blood or plasma after refraining from consumption of food or sugar-containing beverages for at least eight hours; NOTE: In contrast, see randomly timed glucose, below. glucose monitoring system a combination of an instrument, a disposable element, and ancillary materials such as lancing devices and control solutions used for monitoring glucose levels in blood or other body fluids; NOTE: ISO defines a glucose monitoring system as a measuring system consisting of a portable instrument and reagents used for the in vitro monitoring of glucose concentrations in blood. Clinical and Laboratory Standards Institute. All rights reserved. 5

16 Number 12 granulation the quality of being homogeneous; NOTE: As applied to blood, it refers to cellular elements. hyperglycemia glucose values above the target level or an abnormally high level of glucose in the blood (i.e., blood glucose concentration above 7.7 mmol/l [140 mg/dl]) postprandial and 5.6 mmol/l (100 mg/dl) fasting. hypoglycemia an abnormally low level of glucose in the blood (i.e., blood glucose concentration below 3.8 mmol/l [70 mg/dl]). interstitial fluid a liquid found between the cells of the body that provides much of the liquid environment of the body: extracellular fluid. ISO The International Organization for Standardization, based in Geneva, Switzerland. operator a person who is authorized to perform BGT. out of range when an instrument or measuring device (used interchangeably) is used, control results outside of preset limits (out-of-range) indicate some degree of change in the performance of the overall measurement system, such as within the instrument system (electronic, mechanical, or flow), reagent system, or the control samples. packed cell volume//hematocrit the measure of the ratio of the volume occupied by the red blood cells to the volume of whole blood, expressed as a fraction or percentage; NOTE: The term hematocrit has been and often is used for this quantity. plasma in vivo, the liquid portion of whole blood that does not contain cells; in vitro, the liquid portion of anticoagulated whole blood that does not contain cells. point-of-care (POC) testing//bedside, near-patient testing testing performed in an alternate site, outside a central laboratory environment, generally nearer to, or at the site of, the person being tested. precision (of measurement) the closeness of agreement between independent test results obtained under stipulated conditions (ISO ) 2 ; NOTE 1: For example, how close the results of a particular run are to each other; NOTE 2: See accepted reference value and accuracy, above, and trueness, below. quality assurance (QA) part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000) 7 ; NOTE: The practice that encompasses all procedures and activities directed toward ensuring that a specified quality of product is achieved and maintained. In the testing environment, this includes monitoring all the raw materials, supplies, instruments, procedures, sample collection/transport/storage/processing, recordkeeping, calibrating and maintenance of equipment, quality control, proficiency testing, training of personnel, and all else involved in the production of the data reported. quality control (QC) part of quality management focused on fulfilling quality requirements (ISO 9000) 7 ; NOTE 1: This includes the operational techniques and activities that are used to fulfill requirements for quality; NOTE 2: In healthcare testing, the set of procedures designed to monitor the test method and the results to ensure test system performance; NOTE 3: QC includes testing control materials, charting the results and analyzing them to identify sources of error, and evaluating and documenting any remedial action taken as a result of this analysis. 6 Clinical and Laboratory Standards Institute. All rights reserved.

17 Volume 25 randomly timed glucose/casual/nonfasting a glucose measurement taken at any time; NOTE 1: It may be shortly after ingesting food or sugar-containing beverages, taking medication, or exercising; NOTE 2: See fasting glucose, above. reagent lot a discrete number of units of disposables [reagent strips or sensors] for testing, which the manufacturer asserts gives equivalent performance for all units contained in the lot. threshold a glucose concentration above or below which a specific action is indicated. trueness (of measurement) the closeness of agreement between the average value obtained from a large series of test results and an accepted reference value (ISO ) 2 ; NOTE: See accepted reference value, accuracy, and precision above. validation Confirmation through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled (ISO 9000) 7 ; NOTE 1: WHO defines validation as the action {or process} of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended result (WHO-BS/ ) 8 ; NOTE 2: The components of validation are quality control, proficiency testing, validation of employee competency, instrument calibration, and correlation with clinical findings. verification confirmation through the provision of objective evidence that specified requirements have been fulfilled. (ISO 9000) 7 ; NOTE: A one-time process completed to determine or confirm test performance characteristics before the test system is used for patient testing. viscosity the property of a fluid that resists the force tending to force the fluid to flow. WHO World Health Organization. whole blood blood that contains all of its cellular and plasma components (WHO BS/ ) 8 ; NOTE 1: It may be collected in an anticoagulant solution, with or without the addition of nutrients or it may be derived directly from a fingerstick sample; NOTE 2: In the context of this document, whole blood refers primarily to blood derived from a fingerstick. within range quality control results that are within preset limits. 5 Information for the Coordinator 5.1 Why Is a Coordinator Needed? When there is more than one Operator, it is important that one person assume responsibility to ensure that proper and consistent procedures are followed as well as to provide QA oversight. If there is only one Operator, that person assumes the functions of the Coordinator as well as those of an Operator. 5.2 What Are the Responsibilities of a Coordinator? The Coordinator of the glucose monitoring program is responsible for: overall direction and operation of the glucose monitoring program; implementation and management of a QA program including, QC review and competency assessment; Clinical and Laboratory Standards Institute. All rights reserved. 7

18 Number 12 selection and authorization of Operators; coordination and supervision of Operator training; thorough understanding of the appropriate responses to abnormal or inappropriate glucose results (results inconsistent with the clinical condition); and establishment of thresholds for actions in response to abnormal or inappropriate and/or extremely high- or low-glucose values, developed in consultation with appropriate healthcare professionals. In establishing and maintaining a glucose monitoring program, the Coordinator should seek guidance from professionals knowledgeable about diabetes management in consultation with the medical director. Appropriate resources include hospitals or laboratories, technical consultants, nursing services, medical staff, manufacturers of blood glucose meters, and diabetes educators. 5.3 What Should the Coordinator Do to Start a Glucose Monitoring Program? Once the decision has been made to start a glucose monitoring program, the Coordinator should: select an appropriate test system; develop a procedure manual describing specimen collection, test performance, Operator safety, reporting of results, and disposal of waste material; implement a QA program; and train the Operators and evaluate the competency of experienced Operators and authorize them. NOTE: Manufacturers often provide procedure manual templates, QA programs, teaching materials, and other resources. 5.4 What Considerations Should Guide the Choice of a Glucose Monitoring System? Things to consider when choosing a glucose monitoring system include: trueness and precision of the system, especially at clinical decision points; ease of use, which includes testing, maintenance, and QC procedures; availability of the supplies; cost of equipment, supplies, and staff time; technical service support, including warranties and service contracts; range of blood glucose concentrations measured by the system, compared to ranges likely in the user population; environmental considerations, (e.g., temperature, humidity, and altitude ranges) for correct operation of the system; professional recommendations from medical agencies with which the site is affiliated; 8 Clinical and Laboratory Standards Institute. All rights reserved.

19 Volume 25 availability and quality of training materials; impact of interferences (including medications, abnormal hematocrits, etc.) on the test system; and accessories required (e.g., software for data management). It is recommended that only one type of glucose monitoring system be used in an individual facility. Use of multiple systems at one facility can introduce potentially confusing differences among the various systems for testing and QC procedures. In the near future, continuous blood glucose monitoring systems and trend analysis of glucose results are likely to provide additional value in management of glycemia for individuals with diabetes. This is likely to be particularly true for newly diagnosed diabetics, gestational diabetes, individuals with poorly controlled diabetes and for critically ill hospitalized and surgical patients (both diabetics and nondiabetics). A number of recent publications have provided guidance on the need for continuous blood glucose monitoring systems and associated trending analysis to maintain glycemic control while preventing or alerting the user to the potential risk for the occurrence of hypoglycemia. 9, Why Is a Procedure Manual Needed and What Should It Contain? Use of a procedure manual ensures that all steps of the glucose monitoring program are consistently and properly understood by staff. The procedure manual defines the steps of glucose monitoring and the policies of the program. The procedure manual should be readily available to all Operators in each testing facility. Operators should use it as a resource for troubleshooting and for periodic review of the procedures. Coordinators should update the manual as needed and review it at least annually. Any changes in the procedure should be approved by the Coordinator, documented in the manual, and communicated to Operators. A procedure manual should provide procedures for: Specimen Collection. See CLSI/NCCLS documents H4 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens, and M29 Protection of Laboratory Workers from Occupationally Acquired Infections. Test performance, technical support, and troubleshooting. The manufacturer s instructions, including package insert for test strips, controls, and lancing devices, if applicable, should be placed in this section. QC testing. This section should describe the procedures and policies for QC. For assistance, contact the manufacturer s customer service representative. Reporting of test results. This section should include a system for permanent recording of blood glucose and QC test results in the individual s record or instrument QA records, as appropriate. NOTE: The Coordinator should seek expert medical advice to determine the abnormally high or abnormally low values for which specific action should be taken when encountering such test results. Disposal of waste. This section details the appropriate disposal of used lancets, strips, cotton, wipes, and other blood-contaminated items. The Coordinator should consult with experts from local public health agencies when designing the disposal program. Clinical and Laboratory Standards Institute. All rights reserved. 9

20 Number 12 Storage. This section should include instructions on storage of the testing system, test strips, and other components according to the manufacturer s instructions. Maintenance (e.g., cleaning and disinfecting). 5.6 What Are the Components of a Quality Assurance (QA) Program? A QA program is a system of multiple checks which assures reliable testing results, taking into consideration specimen collection, QC procedures, maintenance and service of meters, recordkeeping, and training. The QA program should meet all regulatory requirements and/or accreditation standards applicable to the site or location Quality Assurance (QA) Records QA records, which include QC results, maintenance and service records, and other relevant documentation, should be maintained for each test system. QA records should be reviewed by the Coordinator at least once a week, and should be kept for at least two years or according to the facility s policy Quality Control (QC) QC, a central component of the QA program, is the use of control solutions to assess Operator technique and the performance of test strips and meter. All Operators must participate in the QC program. QC does not assess specimen collection procedures or system accuracy. Control Solution. Manufacturers of each glucose monitoring system provide QC solutions. These solutions contain glucose with target concentrations and acceptable ranges for QC test results specific for the system. The purpose of the solutions is to verify correct performance. Generally, a QC program should use two solutions: one with a high glucose concentration and one with a low glucose concentration. Good QA practices dictate routine use of control solutions to assess system performance. NOTE: If using QC solutions that are not provided by the manufacturer of the system, be sure to check the package insert of the control solution to determine if the solution is suitable for use with the meter and the test strips you are using. The acceptable ranges assigned to third party control solutions may not be acceptable to verify the manufacturer s claims for device performance. Frequency of Meter QC. Each day, prior to glucose monitoring, the Operator should check each meter with both a high and a low control, and if applicable, electronic QC. Additional QC Checks. In addition, QC checks should be performed each time a reagent lot is changed; a new container of strips is opened; batteries are replaced; as well as when investigating possible meter damage or reagent deterioration after questionable results were obtained, and before additional testing. The manufacturer s instructions will also recommend additional times to run QC Proficiency Testing Proficiency testing programs are intended to check the performance of the testing system (meter, strips, and Operator) in comparison to that of similar testing systems. The providers of these programs periodically send several samples of materials with unknown levels of glucose to all program participants. The users test the samples with their meter systems and send the sample test results back to the proficiency testing provider. The sample test results are then rated in comparison to those obtained from the same system (peer group comparisons). At present, participation in these programs is voluntary. If you 10 Clinical and Laboratory Standards Institute. All rights reserved.

21 Volume 25 are interested in participating, contact the manufacturer, local regulatory agency, or local hospital laboratory to identify providers of proficiency testing programs. b Maintenance and Service Manufacturers recommendations should be followed to implement a plan for regular maintenance procedures of glucose monitoring systems. For testing materials and instructions, refer to the manufacturer s recommendations contained in the package insert or meter operating manual. 5.7 What Should Be Included in a Training Program for Operators? The training should follow a defined, functional format, preferably including, but not limited to, audiovisual material and other educational materials supplied by the manufacturer, as well as educational materials from professional resources such as hospitals, diabetes educators, and laboratories. Training programs should closely follow the manufacturer s system user guide or manual and include the following details with site-specific modifications, when appropriate: intended use and limitations of glucose monitoring; storage conditions for the meter test strips, and QC material; acceptable testing environment. Effect of environmental conditions on test results including QC results (e.g., humidity, temperature [see manufacturer s information]). specimen collection Rationale for when to perform the test, in relation to eating and time of medication. Glucose concentrations in blood (whether capillary, venous, or arterial blood) are functions of dynamically changing physiological events which are affected by a number of factors. Two of the more important affecting factors, from the point of view of management of diabetes, are the glucose loading provided by food intake and the administration of glycemia-controlling medications such as insulin. A key consideration for measurement of glucose in diabetes management is that glucose concentration is always dynamic, increasing or decreasing with food intake and medication/metabolism, respectively. The dynamic nature of glucose levels in plasma and whole blood are most easily understood with an examination of time-based changes in glucose after food intake or medication. The following graph presents an example of glucose concentration change rates that occur with time after ingestion of a glucose bolus. b In the U.S., go to for a list of PT providers. Clinical and Laboratory Standards Institute. All rights reserved. 11

22 Number 12 Figure 1. Plasma Glucose Tolerance Response In Figure 1, the constant and often rapid changes in glucose concentration create an ongoing challenge for the individual performing blood glucose monitoring. With increasing severity of diabetes, the amount and rapidity of change in glucose levels is greater. NOTE: The glucose monitoring results may also be reported in mmol/l (SI units). Another key specimen collection issue is the well-demonstrated fact that glucose concentrations may differ significantly in capillary, venous, and arterial blood The percent differences that can be seen between capillary and venous samples are characterized in the following diagram, which shows the relative comparative glucose results obtained on capillary plasma (Cap. PL ), capillary whole blood (Cap. WB ), venous plasma (Ven. PL ), and venous whole blood (Ven. WB ) samples from 883 individuals with diabetes. 11 Figure 2. Approximate Differences in Glucose Concentrations Between Capillary and Venous Samples. From Davidson JK, Parker DR. Monitoring of blood and urine glucose and ketone levels. In: Davidson JK, ed. Clinical Diabetes Mellitus: A Problem-Oriented Approach. 3 rd ed. New York: Thieme Medical Publishers, Inc.; 2000:461. Reprinted by permission. 12 Clinical and Laboratory Standards Institute. All rights reserved.

23 Volume 25 The data in Figures 1 and 2 confirm the following fundamentally important facts: Capillary blood contains more glucose than venous blood from the same individual. This difference has been shown to be negligible when study subjects were in the fasting state, but differences as great as 1.1 to 1.7 mmol/l (20 to 30 mg/dl) occurred after 100 grams of glucose were ingested Plasma contains more glucose than whole blood due to the presence of red blood cells and, thereby, exclusion of water from the sample volume in whole blood. In a given set of paired and nonfasting samples, plasma contains approximately 11% more glucose than does whole blood, with the difference being dependent on sample hematocrit. 15,16 When specimens are drawn from the same individual at different times, glucose levels can change rapidly with time, which must be considered when making results comparisons. For any blood glucose monitoring system, use only the sample types specifically verified for use and recommended by the manufacturer. Instruction/demonstration on the operation of the appropriate sampling device and procedures to obtain adequate blood samples from fingertip, heel (infants), and flushed heparinized lines, as appropriate to the individuals tested. A detailed description and explanation of proper specimen collection by skin puncture can be found in the most current edition of CLSI/NCCLS document H4 Procedures for the Collection of Diagnostic Capillary Blood Specimens. Blood collection should be consistent with the manufacturer s recommendations and requirements. Medical conditions that could affect test results (e.g., severe anemia; edema or injury at the collection site; severe dehydration). 17,18 Procedure Operation of the specific glucose monitoring system. (Use of educational materials supplied by the manufacturer is highly recommended.) Procedures for meter calibration, cleaning, maintenance, and troubleshooting. See the definitions of calibration and coding in Section 4. Quality Control (QC). Please see Section 4.2 in the current edition of CLSI/NCCLS document EP18 Quality Management for Unit-Use Testing. Quality Assurance (QA). Please see Section 4.2 in the current edition of CLSI/NCCLS document EP18 Quality Management for Unit-Use Testing. Test Results Desirable range of blood glucose values in specific populations (e.g., people with insulindependent diabetes, diabetes during pregnancy, children, and elderly people with diabetes) in consultation with a healthcare provider. Critical glucose results (clinical decision concentrations), with appropriate action and follow-up. Differences between glucose results obtained using blood glucose monitoring systems and well-characterized laboratory methods can be explained as follows: Clinical and Laboratory Standards Institute. All rights reserved. 13

24 Number 12 Blood glucose monitoring systems can be (and are) calibrated or referenced to reflect either whole blood-equivalent or plasma-equivalent glucose results. This is accomplished using an algorithm that relates the concentration of glucose in whole blood to the concentration of glucose in the sample plasma over the dynamic range claimed by each individual meter system manufacturer for their meter system. Based on recommendations from the American Diabetes Association (ADA), the International Federation for Clinical Chemistry (IFCC), and CLSI/NCCLS document C30 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities, results should be reported as plasma equivalent. With a new blood glucose monitoring system, always check the manufacturer s product labeling materials to confirm whether the meter system being used is calibrated to report whole blood-referenced glucose or plasma referenced glucose results. If a blood glucose monitoring system is used to measure a whole blood sample and is referenced to whole blood glucose, the test results can be expected to be 10 to 15% lower than results from well-characterized laboratory methods that use serum or plasma samples (i.e., cell-free component of blood). The specific difference obtained for a blood glucose monitoring system result is a function of the water content of the whole blood in relation to the water content of the plasma sample. At a capillary blood hematocrit of 43%, for example, the water content of the whole blood sample is 84% and the water content of the plasma sample is 93%. Using these water contents, the whole blood to plasma glucose difference is 11% (0.93/0.84 = 1.11). 8 At lower hematocrits (<30%), a smaller difference will be obtained due to the greater water content of the low hematocrit sample (e.g., at 20% hematocrit, the calculated plasma to whole blood glucose difference is 1.07, a 7% difference). At higher hematocrits (>60 %), a larger difference will be obtained due to the lower water content of the high hematocrit sample (e.g., at 60% hematocrit, the calculated plasma to whole blood ratio is 1.17, a 17% difference). Additional sources of preanalytical and/or analytical error include: Errors due to analysis of portions of the same capillary blood specimen at different times. Red blood cells contain glycolytic enzymes that will decrease the glucose concentration by as much as 7% per hour on standing at room temperature. 19 If capillary blood samples are allowed to stand on the finger for extended times (30 to 60 seconds), the glucose results will increase due to concentration by evaporation. The surface area on a 3 to 5 µl drop of capillary blood is so large that evaporation occurs very quickly, particularly in a normal-to-low relative humidity environment. As described previously, blood glucose monitoring system results from capillary and venous bloods may give different glucose results. Very low levels of oxygen (i.e., in venous blood) or very high levels of oxygen (i.e., in arterial blood samples from persons on oxygen therapy) may affect the accuracy of some glucose monitoring systems. Users are advised to review the test strip package insert for such information. Plasma or aqueous glucose samples will give falsely elevated glucose results if tested on most blood glucose monitoring systems. The meter systems are designed for testing of whole blood samples, which have the inherent viscosity and granulation resulting from the cellular and protein matrix of the whole blood sample. This analytical effect, with some test systems, is independent of the effect mentioned above. Applying an insufficient volume of blood to the test strip can result in erroneous glucose results with some blood glucose monitoring systems, particularly older models. With some meter systems, addition of more sample after the reaction timing has been initiated will give incorrect glucose results. 14 Clinical and Laboratory Standards Institute. All rights reserved.

25 Volume 25 Due to physiological differences, glucose concentrations in samples obtained from the finger may differ significantly from concentrations in samples obtained from sampling sites other than the finger at times when glucose is rapidly changing. Users should follow the labeling instructions for appropriate use of alternative site testing. Documentation of blood glucose results (individual and QC). Potential Sources of Error and Troubleshooting (1) Review possible sources of error in the performance of glucose monitoring (e.g., edema [excess fluid] at the site of the fingerstick; shock or hypotension [very low blood pressure]; and glycolysis, if the sample was not immediately applied to the strip). (2) Review possible sources of error for the specific brand of glucose monitoring equipment, such as testing technique errors and timing errors. (3) Define the recommended troubleshooting responses if blood glucose test results are inconsistent with the person s clinical condition (abnormally high or abnormally low), or if control results are out of range. Examples of troubleshooting responses include: repeating the test, replacing test strips that are out of date or have been exposed to excess heat or moisture; and reviewing the proper test procedure and checking for possible meter damage, assuring that no procedural errors have occurred repeating (or performing) QC. After potential sources of error have been found and corrected, repeat the test. Troubleshooting responses are listed in most product inserts. Safety and Prevention of Infection (1) Include information on safety, prevention of infection at the puncture site, and disposal of contaminated material, in conformity with local regulations. (2) Because it is often impossible to know what might be infectious, all patient and laboratory specimens are treated as infectious and handled according to standard precautions. Standard precautions are guidelines that combine the major features of universal precautions and body substance isolation practices. Standard precautions cover the transmission of all infectious agents and thus are more comprehensive than universal precautions which are intended to apply only to transmission of blood-borne pathogens. Standard and universal precaution guidelines are available from the U.S. Centers for Disease Control and Prevention (Guideline for Isolation Precautions in Hospitals. Infection Control and Hospital Epidemiology. CDC. 1996;17(1):53-80 and MMWR 1988;37: ). For specific precautions for preventing the laboratory transmission of all infectious agents from laboratory instruments and materials and for recommendations for the management of exposure to all infectious disease, refer to the most current edition of CLSI document M29 Protection of Laboratory Workers from Occupationally Acquired Infections. 5.8 How Should the Competence of Operators Be Determined? The Coordinator should develop and implement a program to confirm the competence of each Operator who performs blood glucose tests. For individuals who are both the Operator and Coordinator, competence should be checked by another source, such as a hospital laboratory staff member, a diabetes educator, or a manufacturer s representative. Where possible, direct observation of the testing technique is preferable. At a minimum, written examination should be administered to test knowledge of the educational material outlined in Section 5.7. Each program should establish a minimum passing score before administering the exam. A written exam should be specified for the policies and procedures of the specific testing system and institution. Clinical and Laboratory Standards Institute. All rights reserved. 15

26 Number Test Procedure Competence The Operator should demonstrate competence in performing the test procedure. This competence should be documented using a skill checklist specific to the meter system. The Coordinator should validate competence by observing the Operator while performing a blood glucose test. This check should be repeated: periodically using a QC sample (suggested three to four times per year); and at least once a year, performing the complete glucose test procedure, which includes collection of a specimen Continuing Authorization The duration of authorization to perform testing should be established in accordance with local, state, and federal regulations or accreditation requirements Reauthorization When the blood glucose test method and/or procedure is changed, the Operator should be retrained and should demonstrate competence with the new system. Also, when authorization is withdrawn, the operator must be reauthorized Withdrawal of Glucose Monitoring Authorization Operators not following QA or documentation guidelines and/or performing blood glucose tests inappropriately should be removed from the list of authorized Operators and prohibited from performing blood glucose tests. A policy and protocol should be established to determine what conditions need to be met to reauthorize the Operator People With Diabetes Performing Self-Testing People with diabetes who perform self-testing while attending camps or when residing in a care center will normally not have been certified by a competence authorization process. Therefore, the glucose monitoring program should not assume responsibility for the accuracy of their results. Each program should establish policies and procedures for use of the results from self-testing. 6 Information for the Operator 6.1 Who Can Perform This Testing? Institutional policy determines who can perform blood glucose monitoring. c Calibration Check Most meters need to be calibrated (coded) for the specific lot number of the test strips to be used. It is important to do this to assure correct test results, including QC test results. There is typically a calibration code (numbers and/or letters) on each lot of test strips. Once entered, this code is stored in the memory of the meter and should be verified before testing to ensure that the correct lot of test strips is being used. c In the U.S., if the results of the testing are used for clinical treatment, the Operator must meet the minimum requirement for education, training, and continuing education required by CLIA. 16 Clinical and Laboratory Standards Institute. All rights reserved.

27 Volume 25 NOTE: Thoroughly review the manufacturer s instructions for use before calibrating (coding) the system Meter QC On each day of meter use and prior to glucose monitoring, an authorized Operator should check each meter with the control solutions provided by the manufacturer. At least two control solutions (both the low/normal level and the high level) are tested daily. If control solutions are not provided, the manufacturer should be consulted for recommendations on where to purchase appropriate QC solutions Additional Quality Control In addition, QC checks (low or normal control and high control) should be made each time a different lot of test strips is used, each time a new package of strips is opened, after the batteries are replaced, after maintenance procedures, and whenever investigating possible meter damage or test strip deterioration. Follow manufacturers recommendations Troubleshooting Checking sources of error before testing is preferable and can prevent unnecessary troubleshooting (see Section 6.3.1). If any control test results outside the target range (out-of-range) are obtained, or the Operator has any reason to doubt the accuracy of meter system glucose results, the Operator must not proceed with glucose monitoring, because inaccurate test results may result. The Operator should first investigate the cause of the out-of-range control or questionable capillary blood glucose result, identify a corrective action, correct the problem, repeat the control tests, and obtain control results within the control range. The troubleshooting section of the meter system operating manual should be consulted to help identify problems. Key QA activities include, at a minimum: Routinely performing QC testing with glucose control solutions manufactured specifically for the meter system being used; Examining QC data over time and correlating any changes in QC with modifications to the analyzer or reagents; Confirming that all blood glucose monitoring system reagent strips and control solutions are within unopened and opened expiration dates, as shown on the reagent packaging; Repeating the control solution measurement, ensuring that the control results are within the target range; Inspecting the meter to assure that it does not require cleaning; Reviewing the operating procedure for the meter system to ensure that it is being used as directed by the manufacturer; Confirming that the meter system is properly coded or calibrated for the lot of test strips being used; Confirming that the meter system battery charge is sufficient for proper functioning; Checking the performance of the meter with a check strip or internal electronic control system, if available; If an error is suspected for a capillary blood sample, comparing with a laboratory glucose result on a fresh capillary plasma sample can confirm the accuracy of meter system testing. Fresh venous plasma may be used for this comparison, but the results obtained will be lower than those of capillary plasma, as described in Figure 2; If an error is suspected for a capillary blood sample, confirming that the sample types recommended by the manufacturer were used for the assay (usually, fresh capillary whole blood); Clinical and Laboratory Standards Institute. All rights reserved. 17

28 Number 12 If out-of-range control results or questionable blood glucose results are still obtained, do not continue to test. Contact the manufacturer s customer assistance department for resolution of the system performance issue(s). CLSI/NCCLS document EP18 Quality Management for Unit-Use Testing contains a checklist in Appendix A titled, System-Specific Sources of Error Matrix. A quick review of this compendium will help identify other potential sources of preanalytical and analytical error that should be assessed for resolution of performance concerns or issues Documentation of Quality Control Results and Meter Maintenance Each meter should have two logs, one for recording QC results and one for maintenance and service records. (See Tables 1 and 2 in Section 7.) Documentation for QC should include: QC test results; whether results are acceptable; date and time of testing; meter recalibration, if indicated by manufacturers directions; strip lot number and expiration date; control solution lot number and expiration date; meter identification or serial number; initials of the Operator performing the test (as well as a key to the identity of the people whose initials are listed). These logs should be kept for a period of time consistent with regulatory requirements and other legal considerations. The acceptable limits for QC solutions, as specified by the manufacturer, should be posted so that users can determine if QC results are in range or are out of range. All QC results should be recorded in the QC log. In addition, any corrective action taken to restore an out of range situation (e.g., recalibration to a different lot of strips or the lot of control) should be carefully recorded in the log. 6.2 What Is Needed to Perform Glucose Monitoring? To perform a blood glucose test, first collect the following supplies: glucose monitoring meter; strips appropriate for the meter; coding or calibration materials (code chip or code number) for the lot or strips used; blood collection device (e.g., lancets); tissues or cotton balls; soap and water (alcohol if water is not available); disposable barrier gloves* (be aware of potential sensitivity of Operators and those tested to latex); sharps disposal container*; and biosafety trash container.* *Safety Alert A new pair of disposable barrier gloves must be worn for each person tested. This is necessary to minimize risk of cross infection between persons being tested and to protect the Operator. Lancets must be discarded in a rigid, puncture-resistant, disposable container. The container must have a lid and a conspicuous biohazard label. If a lancing device is labeled for single use, dispose of 18 Clinical and Laboratory Standards Institute. All rights reserved.

29 Volume 25 immediately after use. If the lancing device is for multiple use, ensure that for each patient, the end cap is changed if removable, or if not removable, the end cap is disinfected per manufacturer s instructions. Tissues, cotton balls, and gloves must be discarded in a waste container with a biohazard bag or in an appropriate trash receptacle, consistent with the policies of the Operator s institution. 6.3 What Should Be Done Before Testing? Test Preparation Prior to using a meter for testing blood glucose levels, as well as for testing QC solution, the Operator should: check that the test strips and control materials have been properly stored; check the expiration date of the test strips; clean all blood and debris from the window and strip holder, if a photometric (color-reading) meter is used; check the expiration date of the controls (see below); make sure the meter has been calibrated (coded) properly (see below); and do not use strips that have expired, have been left open, or that appear discolored. Each day, before performing the first blood glucose test, prepare the test meter by confirming correct calibration and performing a QC check according to the manufacturer s instructions. Use of at least two control levels is recommended. Also, make sure the test strips are within their expiration date and that the meter is cleaned. Prepare the skin puncture site, as recommended in the current edition of CLSI/NCCLS document H4 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens. Prior to skin puncture, wash the area with soap and warm water (warming can increase blood flow, making it easier to obtain a specimen). If washing is impractical, rubbing alcohol may be used. The site should be thoroughly dried prior to skin puncture. Holding the arm down for 30 seconds and shaking the hand may increase blood flow to the fingers. Capillary blood samples are used and can be obtained by puncturing the finger, or in infants, the side of the heel (see Figures 3 and 4). Swollen, infected, or rash covered areas should not be used. Use an appropriate device to perform the skin puncture and follow manufacturers directions for loading and disposal of the skin puncture device. If rubbing alcohol was used for cleaning the skin, be sure the puncture site is thoroughly dried before performing the puncture. Based on the ability to test with very small volumes of blood, several systems are now cleared for testing at sites other than the finger and heel. Typical sites are forearm, upper arm, thigh, and palm. Due to physiologic differences, glucose measurements on fingertip samples may differ significantly from measurements on samples obtained from these alternative sampling sites at times when glucose is rapidly changing, although this does not seem to be the case with the palm. The labeling of these products Clinical and Laboratory Standards Institute. All rights reserved. 19

30 Number 12 indicates that these alternative sites should not be tested within two hours after eating, exercising, or taking medication. Alternative sites should only be used when permitted by product labeling. Figure 3. Recommended Skin Puncture Site in Adults and Older Children. Photograph provided by the Center for Phlebotomy Education, Inc. Reprinted with permission. Figure 4. Recommendations for Skin Puncture Sites in Newborn Infants. Shaded areas indicated by arrows represent recommended areas for infant puncture. (Reprinted with permission. From McCall RE, Tankersley CM. Phlebotomy Essentials. Lippincott Williams & Wilkins NOTE: When puncturing a newborn s heel, skin puncture must be no deeper than 2.0 mm. 20 Clinical and Laboratory Standards Institute. All rights reserved.