Point-of-Care Testing: Administration Within in a Health System

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1 C E U P D A T E P O I N T O F C A R E I V Rhonda Ingram Main, MHSA, SH(ASCP) Frederick L Kiechle, MD, PhD Point-of-Care Testing: Administration Within a Health System Administration of POCT in a Health System Key to having a successful point-of-care testing (POCT) program in a hospital is the establishment of a multidisciplinary POCT steering committee. 1-3 The committee needs to be empowered by all levels of hospital administration with the authority, as well as the responsibility, to make decisions and oversee all aspects of POCT. Although regulatory agencies such as the Health Care Financing Administration, Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and the College of American Pathologists consider POCT under the scope of the laboratory, 4-6 those who most frequently do the actual patient testing are nonlaboratory personnel. For example, nurses are the ones most often performing bedside glucose testing. 7 The oversight of POCT by a multidisciplinary committee provides the collective knowledge of the testing and patient-care process. The laboratory representatives on the committee can address the technical components of the testing process, including instrument evaluation and selection, limiting factors, quality control (QC), and regulatory requirements, as well as cost-benefit analysis. Nursing representatives will provide insight into the ease of instrument use, integration of patient results in the patient chart, and influence of results on the continuum of patient care. Physicians on the committee can speak to the clinical relevance of the POCT results, while a representative from ABSTRACT Point-of-care testing (POCT) is spreading throughout health care systems in the United States. This article outlines an administrative structure for establishing and managing a POCT program in a health care system and discusses the role of the POCT coordinator in maintaining a quality assurance and training program that meets all the regulatory requirements for POCT. Potential alternatives to POCT are also evaluated. This is the final article in a 4-part continuing education series on point-of-care testing (POCT). On completion of this article, the reader will be able to evaluate requests for new POCT programs, describe how to select a POCT device, and define the responsibilities of the POCT coordinator. infection control can ensure that products and procedures promote patient safety. With the introduction of POCT instruments data management capabilities, a representative from information services can provide valuable knowledge on the instruments ability to interface with the laboratory or hospital computer system. A representative from purchasing will be able to work with vendors to acquire quantities of dedicated lot numbers of reagents at suitable prices. The POCT steering committee can also benefit from the insights of the hospital quality assurance (QA) officer, because he or she has knowledge not only of the regulatory requirements, but also of how the POCT program fits into the overall hospital QA plan. Similar points can be made for including a hospital administrator on the steering committee. Because POCT programs can have a financial impact on the laboratory, as well as on the patient-care area performing the testing, it is From the Department of Clinical Pathology, William Beaumont Hospital, Royal Oak, MI. Reprint requests to Dr Kiechle, Department of Clinical Pathology, William Beaumont Hospital, 3601 W 13 Mile Rd, Royal Oak, MI ; fkiechle@beaumont. edu Section 4 Scientific Communications AUGUST 2000 VOLUME 31, NUMBER 8 LABORATORY MEDICINE 4 5 3

2 advantageous to have an administrator who understands the clinical, administrative, and financial impact of POCT and can champion the program. The chairman of the POCT steering committee is usually the individual to whom the POCT coordinator reports. Not all POCT procedures are performed by nursing personnel. Depending on the patient-care area and analyte being considered by the steering committee members, representatives from specific patient-care areas may also be included. For example, respiratory therapists may be included at meetings when blood gas analysis is under consideration, and cardiac catheterization technicians may be invited when activated clotting times in the angiography suite are discussed. Sharing of information by the different disciplines increases the knowledge base of the POCT steering committee, thus enabling them to develop comprehensive policies and procedures to govern the POCT program. Because all stakeholders are represented in the decision-making process, everyone is more supportive, and the subsequent implementation of new POCT procedures is easier. Requests for POCT The increase in POCT during the last 10 years has been made possible by a number of factors including advances in computer technology. 8 Because POCT methods and instruments require less sample, are easy to use, are smaller and more portable, and produce results on a variety of analytes more quickly than traditional laboratory instruments, their use appeals to both the medical and the nursing staff. Examples of analytes frequently performed by POCT methods or instruments include glucose, arterial blood gases, activated clotting time, electrolytes, hemoglobin, and cardiac markers. Because fast and easy does not always translate into better patient outcomes, 9-11 the medical unit that would like to perform POCT should first make a formal request to the POCT steering committee. The request may address the list of questions outlined in Table 1. In order to answer the question about the actual turnaround time, data should be gathered that looks at the time in 3 distinct phases: preanalytic, analytic, and postanalytic. Very often, the delays in obtaining laboratory results have more to do with the time it takes to order the test, collect the specimen, and transport it to the laboratory than they do with the actual time it takes to perform the test. Also, once the test results are generated, how and when they are presented to the clinician and acted upon can significantly add to the perception of a prolonged turnaround time. When the interval between receipt of test result to the initiation of a therapeutic intervention is added to the preanalytic, analytic, and postanalytic components, the time interval is called the therapeutic turnaround time. 12 Once data are collected on each phase of the testing process, it will be easier for the POCT steering committee to determine if POCT should be implemented or if there are other potential alternatives that may be introduced. Alternatives to POCT The alternatives available to POCT will vary by institution. Installing a pneumatic tube system to transport specimens can shorten the preanalytic phase of testing. 13 Using a whole blood analyzer and limited test menus in the central laboratory or at a central processing station can shorten laboratory testing time. Providing results on a computer screen directly at the patient s beside or directly into an operating room suite, for example, can decrease the postanalytic phase of testing. 14 Satellite laboratories located adjacent to emergency rooms, operating rooms, and critical care areas have also been used as alternatives to POCT. If the volume of testing in a satellite laboratory is low, however, and the associated productivity of the staff in the laboratory is less than 70%, the satellite laboratory should probably be closed. 14,15 It becomes an institutional decision LABORATORY MEDICINE VOLUME 31, NUMBER 8 AUGUST 2000

3 Table 1. Questions To Consider When Deciding on Point-of-Care-Testing What analyte(s) is (are) being considered for POCT? Why use a POCT device instead of the central laboratory? Is the need for a faster turnaround time real or a perception? Are there alternatives to POCT? Who is the patient population? Do their specimens have unique characteristics? Is POCT technology available that will produce accurate results? How often will the test be ordered? How many operators need to be trained and monitored? Who will hold the Clinical Laboratory Improvement Amendments (CLIA) license for the POCT program? Which regulatory guidelines will apply? Will POCT testing result in better patient outcomes or more efficient decision making? Is there a specific contact person in the patient-care area to help coordinate POCT activities? to decide if the satellite laboratory with low productivity serves a useful clinical service that may outweigh the high cost per test. If none of the alternatives are workable, the POCT steering committee may honor the request to establish POCT for a particular patient care area. POCT Program Characteristics Evaluation of a POCT method or testing system should go beyond the accuracy and precision studies normally conducted by the laboratory. Table 2 is a list of questions that need to be investigated before introducing a POCT instrument. Since some POCT technologies can be influenced by the quantity and type of specimen introduced (arterial, venous, capillary) 16 and the patient s blood pressure at the time of specimen collection, 17 a thorough evaluation should take into account the particular patient population being tested. For example, a newborn typically has a very high hematocrit, while a patient undergoing hemodialysis can be anemic. Glucose results on early-generation POCT glucose instruments were affected by hematocrit extremes. 18 Other less technical but consequential considerations include the availability of QC and proficiency testing materials, shelf life and storage requirements of reagents, portability of the instrument, data management capabilities, and the costs associated with the POCT program. Because documentation of both patient test results and QC results is a key component to establishing an audit trail for regulators, the ability to capture this information, as well as operator identities, gives data management increased importance. 8,14 The number of operators that will be performing POCT is a consideration for several reasons. All operators need to be trained in order to perform testing. The more operators there are, the more time and resources will be needed to train them in all aspects of testing. Frequency of testing can influence the skill of the operator as well as the cost of maintaining the program. Staff at 1 hospital reported that they had invested in training 42 nurses in the performance of bedside glucose testing, yet not 1 nurse had performed patient testing in the course of a year. 19 Responsibilities of a POCT Coordinator Table 3 outlines the responsibilities of the POCT coordinator once a program has been approved by the steering committee. The POCT coordinator ensures compliance with the regulatory agencies as well as with internal POCT policies and procedures, coordinates the training of the testing personnel, and implements all aspects of the QA program. The QA program should include monitoring operator performance, conducting proficiency testing, documentation of QC, monitoring patient results, evaluating equipment, checking inventory and reagents, writing procedure manuals, and serving as a liaison between the POCT Test Your Knowledge! Look for the CE Update exam on Point-of-Care (004) in this issue of Laboratory Medicine. Participants will earn 4 CMLE credit hours. Section 4 Scientific Communications AUGUST 2000 VOLUME 31, NUMBER 8 LABORATORY MEDICINE 4 5 5

4 Table 2. Considerations for Choosing a Point-of-Care Testing (POCT) Device Technology Is the technology under consideration appropriate for all patient populations such as neonates, critical care patients, dialysis patients, and hypotensive patients? Are there differences in results based on specimen type: arterial, venous, capillary? How do the results compare with those of the central laboratory? Quality control (QC) What control materials are available? Will QC consist of a combination of electronic and liquid controls? How often will QC be run, and how will it be documented? Reagents What is their shelf life, and do they need refrigeration? What is their stability at room temperature? Is it possible to obtain a large quantity of the same lot? Training How difficult will it be to provide comprehensive training to nonlaboratory operators? Are there operator-dependent variables that need special attention during training? Documentation Does the instrument have the ability to record both patient and quality control results along with operator identification? How will the results be entered into the patient record so that an audit trail is established? Portability What is the size of the instrument? How easy is it to move near the patent? Is it approved for use in a nonhospital setting? Data management If the results are recorded in the instrument, what is the memory capacity, and how frequently will the instrument need to be downloaded? Can patient results be transmitted electronically to the Laboratory Information System? Which quality assurance reports can be generated from the test system? Cost-effectiveness What are costs of the instrument, reagents, maintenance contract, and routine operation? Are these costs offset by cost savings associated with implementation of the POCT program? Table 3. Responsibilities of the Point-of-Care Testing (POCT) Coordinator Ensure compliance with the appropriate regulatory requirements Know which patient-care areas are performing POCT and what tests are performed Evaluate the POCT equipment and technologies available; know their limitations Write test procedures and update procedure manuals as necessary Establish and monitor a quality assurance program that encompasses quality control, proficiency testing, and documentation of test results Coordinate a training and competency program for all operators Provide feedback to the POCT steering committee, as well as to the patient-care areas that perform testing Serve as a liaison for the laboratory by interacting with other health care providers steering committee and the patient-care areas. The activities are ongoing and dynamic and are best served by consistent communication with feedback from nursing personnnel. Training In order to generate quality POCT results, the operators performing the test need to be trained in appropriate specimen collection, QC, instrument operation, and documentation. Part of knowing whether the instrument and reagents are working correctly is knowing when and how to perform QC and knowing how to evaluate QC results. Teaching an operator how to do these tasks correctly requires an organized approach and a certain time commitment to the task. Many manufacturers will offer educational materials, such as videos, manuals, and written quizzes, to help in the education process. Although these items are useful and can be incorporated into the overall learning process, they should not be a substitute for a hands-on demonstration of how to operate the instrument. 19 It is also important to expand the educational process to include items specific to the individual institution. Such items may include LABORATORY MEDICINE VOLUME 31, NUMBER 8 AUGUST 2000

5 policies for follow-up on high and low results, when to obtain laboratory verification, steps to follow if QC results are out of range, how to document results in the chart or Laboratory Information System, and where to obtain reagents and supplies. Performing QC more frequently than once per day serves a dual purpose for some hospital POCT programs. Evaluating an individual s performance with QC testing materials is considered by JCAHO an acceptable means for evaluating operator competency. 5 Many manufacturers of POCT instruments incorporate in their data management software the ability to look at the frequency with which each operator performs QC, the range of each operator s values, and how close those values come to the target value for a particular QC specimen. By performing QC testing as frequently as once per shift and rotating the responsibility among the various operators, competency testing can be documented. It should be noted that although having a mechanism to evaluate an operator s QC performance is presently an acceptable form of competency testing for regulators, it does not measure an operator s skill at obtaining the specimen from a patient. A quality fingerstick specimen is often difficult for some operators to obtain consistently and successfully. In this case, direct observation of the entire testing process, including specimen collection, by the POCT coordinator or his or her designee may be the more appropriate competency assessment. Another acceptable form of competency assessment is to have the operator run an unknown by splitting the specimen, running it on the POCT instrument, and sending part of the sample to the laboratory for analysis. The results can then be compared. An acceptable range for POCT results will need to be established in advance. For example, the American Diabetes Association maintains that a fasting glucose measurement on a POCT device should be within 15% of the laboratory measurement. 20 Training Options Three training options are generally available: training by a representative from the manufacturer, self-instruction modules, or institutional instructors. Each option has advantages and disadvantages that should be fully explored. In general, using motivated institutional instructors, whether they are from the laboratory or nursing, is more expensive and time consuming; however, good initial instruction in a classroom format with opportunity for questions and feedback is a predictor of better test performance than a self-instruction module. 21 A train-the-trainer approach multiplies the number of qualified individual trainers and decreases the time required to complete the training program. Training provided by a representative from the manufacturer is less time consuming and consequently less expensive for the institution, but it may not cover the issues of hospital policy, documentation, and troubleshooting. In order to relieve the POCT coordinator of some, if not all, of the training responsibilities, some institutions delegate the training to nurse educators or other committed individuals in the patient-care area. 22 No matter who does the actual training, ongoing communication between the POCT coordinator and the trainers is of great importance. Having a key contact person in each area who has advanced skills and can assist with troubleshooting also eases the burden on the POCT coordinator. No matter what training model an institution uses to train its POCT operators, regulatory agencies require that the initial training and ongoing competency training be documented. 4-6 Quality Assurance A key element to a comprehensive quality assurance program is the QC program. QC practices may vary by institution, analyte, technology, and regulatory agency. At a minimum, the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) requires that QC be performed on each day of patient testing. 6 Since the introduction of singleunit or cartridge technology, the appropriate QC program may consist of a combination of electronic and liquid controls. 4 For example, a QC Section 4 Scientific Communications AUGUST 2000 VOLUME 31, NUMBER 8 LABORATORY MEDICINE 4 5 7

6 program for the OPTI-Critical Care Blood Gas Analyzer (AVL Scientific Corp, Roswell, GA) could include using 2 levels of the standard reference cassettes (electronic QC) every 8 hours. Liquid controls are used when a new lot of blood gas cassettes is introduced, after a new gas tank is installed, or at a minimum, every 2 months. The frequency of QC testing outlined by the regulatory agencies is the minimum amount of QC testing acceptable. Based on good laboratory practice, the volume of patient testing, experience of testing personnel, and confidence of the laboratory director, some hospitals may choose to perform QC testing more frequently, acknowledging that there will be an increase in the cost of reagents. In a 1994 College of American Pathologists Q-Probes exercise, 40% of respondents reported performing POCT glucose QC testing every shift. 7 Documentation Documentation is key in each step of the POCT process. From a regulator s perspective, if the activity is not documented, it did not occur. Thus, the introduction of data management systems by various vendors is considered a welcome addition to many POCT coordinators. Systems are available that will capture training records, patient results, QC results, maintenance, corrective actions, proficiency testing, and reagent lots. By downloading the information to a personal computer, the data can be sorted, analyzed, and presented in a variety of report formats. 8,14 If these features are not available for a particular POCT method or instrument, the POCT coordinator will need to provide and evaluate written log sheets. Whether produced manually or by a data-management system, regular feedback to the testing personnel is essential. 23 A monthly QA report card will either reinforce their good performance or illustrate where performance needs improving. This QA report card may be distributed by mail, fax, or electronic message delivery. Patient-care areas that consistently perform poorly on their QA report should be brought to the attention of the POCT steering committee. The steering committee should have the authority to remove a POCT instrument from any patientcare area that is regularly out of compliance with the established QA program. 22 Conclusion Any POCT program should be implemented with the intention of adding value to the patient-care process. Decreases in reimbursement and increases in managed care have resulted in a shortened length of stay for patients. 24 Using the POCT technology available and establishing a POCT program may be an efficient method to assist in reducing patients length of stay by reducing therapeutic turnaround times. A POCT program will not be successful, however, if it is not organized in such a way that there is cooperation and communication among all the disciplines involved, and 1 person (or persons) is responsible for the day-today operations. Useful POCT Web sites are listed in the box below.l Acknowledgment The authors thank Pat Schmidt for preparing the manuscript. Useful POCT Internet Sites These sites were accessed on March 10, LABORATORY MEDICINE VOLUME 31, NUMBER 8 AUGUST 2000

7 References 1. NCCLS. Ancillary (Bedside) Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline. (C30- A). Wayne, PA: NCCLS; Kiechle FL, Ingram R, Karcher R, et al. Transfer of glucose measurements outside the laboratory. Lab Med. 1990;21: Kost GJ, Ehrmeyer SS, Chernow B, et al. The laboratory-clinical interface; point-of-care testing. Chest. 1999;115: College of American Pathologists. Point-of-Care-Testing Inspection Checklist, Section 30. Northfield, IL: College of American Pathologists, Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Comprehensive Accreditation Manual for Pathology and Clinical Laboratory Services. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, US Department of Health and Human Services. Medicare, Medicaid and CLIA Programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 57 Federal Register (1992). 7. Howanitz PJ, Jones BA. Bedside glucose monitoring: comparison of performance as studied by the College of American Pathologists Q-Probes program. Arch Pathol Lab Med. 1996;120: Ingram-Main R, Wright J, Kiechle FL. Data management for bedside glucose testing. Lab Med. 1994;25: Sands VM, Auerbach PS, Birnbaum J, et al. Evaluation of a portable clinical blood analyzer in the emergency department. Acad Emerg Med. 1995;2: Parvin CA, Lo SF, Deuser SM, et al. Impact of point-ofcare testing on patients length of stay in a large emergency department. Clin Chem. 1996;42: Kendall J, Reeves B, Clancy M. Point of care testing: randomized controlled trial of clinical outcome. BMJ. 1998;316: Kilgore ML, Steindel SJ, Smith JA. Evaluating stat testing options in an academic health center: therapeutic turnaround time and staff satisfaction. Clin Chem. 1998; 44: Green M. Successful alternatives to alternate site testing; use of a pneumatic tube system to the central laboratory. Arch Pathol Lab Med. 1995;119: Kiechle FL. Point-of-care Testing. Rainey P, ed. Washington DC: AACC Press; 1998: Kiechle FL, Aulakh V. Satellite laboratories: cost/benefit study. MLO Med Lab Obs. 1998;30: Maser RE, Butler MA, DeCherney GS. Use of arterial blood with bedside glucose reflectance meters in an intensive care unit: are they accurate? Crit Care Med. 1994;22: Atkin SH, Dasmahapatra A, Jaker MA, et al. Fingerstick glucose determination in shock. Ann Intern Med. 1991;114: Smith EA, Kilpatrick ES. Intra-operative blood glucose measurements: the effect of haematocrit on glucose test strips. Anaesthesia. 1994;49: Lee-Lewandrowski E, Laposata M, Eschenbach K, et al. Utilization and cost analysis of bedside capillary glucose testing in a large hospital: implications for managing point of care testing. Am J Med. 1994;97: American Diabetes Association. Consensus statement on self-monitoring of blood glucose. Diabetes Care. 1987;10: Kucler MA, Goormastic M, Hoogwert G. Influence of frequency, time interval from initial instruction and method of instruction on performance competency for blood glucose monitoring. Diabetes Care. 1990;13: Lewandrowski K, Cheek R, Nathan DM, et al. Implementation of capillary blood glucose monitoring in a teaching hospital and determination of program requirements to maintain quality testing. Am J Med. 1992;93: Jones HE, Cleave B, Zinman B, et al. Efficacy of feedback from quarterly laboratory comparison in maintaining quality of a hospital capillary blood glucose monitoring program. Diabetes Care. 1996;19: Goldsmith JC, Goran MJ, Nackel JG. Managed care comes of age. Clin Lab Manage Rev. 1996;42: Please let us know your opinion of the Point-of-Care (004) series. Place an X in one box for each question. Return this form (or a photocopy) by fax to: (312) ; or, mail to: ASCP Press Administration, 2100 W Harrison St, Chicago, IL Thank you for your input. 1 Defici Excell The series met the objectives stat 2 The series provided useful technical d 3 The information provided in the series was new and tim 4 Technical points were explained clearly and were easy 5 The text was organized 6. Illustrations, charts, and tables helped explain text Comments: (Attach additional pages, if necessary.) Section 4 Scientific Communications AUGUST 2000 VOLUME 31, NUMBER 8 LABORATORY MEDICINE 4 5 9

8 First Name Address City State Zip - Country Paymen CONTINUING EDUCATION UPDATE EXAM Point of Care (004) Signature (Required for all submissions) Last Name Credit Card ($25) [$30 if requesting by mail] Telephone Number ( ) - Date Completed (Required) / / To earn 4 CMLE credit hours, complete this exam form (or a photocopy) with your credit card information authorizing a $25 processing charge and fax it to (312) Mailed requests must be accompanied by a $30 processing fee, payable by credit card or check, and forwarded to ASCP, Dept , Chicago, IL Payment must be included with your examination. After processing this form, ASCP will mail you a certificate of participation and the answer key. NOTE: This examination must be received by October 31, CE Update is approved to meet licensure requirements for California, Florida, and other states. If you have questions regarding this exam, call us toll free at (877) ASCP PRESS [(877) ; in Illinois, (312) , ext 1292]. Please print carefully; this form will be read by a computer. Check ($30, payable to ASCP) Visa MasterCard Check # Credit Card Number Exp Date / Answers: Please select the 1 best answer for each item by placing an X in the box A B C D E Multiple-Choice Questions 1. What is the primary function of the coordinator of the Point-of-Care testing (POCT) program in a hospital? A. Select the equipment to be used B. Ensure compliance with regulatory guidelines C. Coordinate POCT standing committee meetings D. Attend scientific meetings on POCT E. Delegate all instrument troubleshooting to the testers 2. How is glucose analysis performed at the bedside best used? A. To diagnose diabetes mellitus B. To uncover calibration errors with the equipment in the central laboratory C. To monitor the insulin dose in a patient with diabetes mellitus D. To determine the glucose concentration in intravenous solutions 3. POCT is suitable for use in A. anticoagulation clinics. B. operating rooms. C. renal dialysis units. D. All of the above 4. POCT is A. defined as testing performed at or near the site of patient care. B. performed in the hospital. C. performed at home. D. A and C only E. A, B, and C 5. Inaccurate prothrombin time can result in A. renal failure. B. hepatic dysfunction. C. coronary thrombosis. D. all of the above. 6. Which element of in-service program design for teaching POCT regulations and equipment use has been shown to be unsuccessful? A. One-on-one instruction in small groups B. Annual reauthorization with review of policies and equipment use C. Instruction on quality control testing D. Self-instruction with videotapes and written material 7. POCT glucose determination should not be attempted during cardiopulmonary resuscitation because A. the total protein is below 4.0 g/dl (40 g/l). B. the patient may be sweating. C. the hematocrit is too low. D. the systolic blood pressure may be less than 80 mm Hg. 8. Which of the following is an advantage of POCT? A. Smaller sample volume B. Shorter therapeutic turnaround time C. Reduction of preanalytic and postanalytic errors D. All of the above 9. Which category of expenditure amounts to 52% of total health care costs for patients with diabetes? A. Physician services B. Hospital care C. Prescription drugs D. Nursing home care 10. The coagulation test most useful for monitoring heparinization during cardiovascular surgery is A. activated coagulation time. B. prothrombin time. C. partial thromboplastin time. D. thrombin time LABORATORY MEDICINE VOLUME 31, NUMBER 8 AUGUST 2000