XL-I 2011: Understanding and Explaining the CAP POCT Checklist: A Tool for Laboratorians to Use With POCT Staff

Transcription

1 Case Study, Presentation John Tran is a medical technologist who has worked in an automated laboratory but is newly hired as a hospital point-of-care coordinator (POCC) for the Rapidly Growing Health System (HS) that includes several hospitals, a number of clinics, and several specialty physician practices. Currently, point-of-care testing (POCT) has only been under the direction of the central laboratories within each hospital, but with the growth of the HS, administrators want to consolidate and standardize POCT and its oversight. While the hospitals have done well with POCT inspections, John is unfamiliar with the organization or performance of POCT in the clinics and specialty practices. He has been asked to prepare each POCT site to be inspected by the College of American Pathologists (CAP), since the HS wants uniform inspection processes. John will meet with each POCT site to introduce himself to staff, familiarize himself with site specific testing, and compare their different procedures. He wants to understand the history and issues associated with POCT and work as a collaborative partner with each testing site. INTRODUCTION The Clinical Laboratory Improvement Amendments (CLIA88) were introduced in response to several prominent newspaper reports of error associated with laboratory testing, especially with Pap smears and cholesterol testing. CLIA88 was also an attempt to rectify what were considered to be some deficiencies in the original Clinical Laboratory Improvement Act of 1967 (CLIA67) regulations. While the intent of CLIA88 may have been to introduce site neutrality to laboratory testing, so that any test performed at any site was reliable, one of its most notable effects has been the introduction of the complexity model, creating tiers of laboratory testing and stimulating the growth of POCT. While the government wanted to standardize laboratory testing requirements, concerns were raised from physician office laboratories (POLs) and clinics that the new regulations were too onerous for all laboratories to follow and many of the tests they used, such as finger-stick glucose monitoring, urine pregnancy testing, urine dipstick testing, or fecal occult blood screening, were essential components of medical practice. These sites argued that imposing stricter CLIA88 regulations would limit patient access to medical testing and care. In response, the complexity model of testing was introduced and allowed for the group of waived tests to be exempted from many of the major requirements set by CLIA88. CLIA88 regulations defined waived testing as: Test systems that are simple laboratory examinations or procedures which are cleared by the FDA for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly. Many people regard this definition as deeply flawed, and in one article concerning errors in POCT the authors describe the problem with POCT as incoherent regulations. 1 Most people involved with POCT or any type of laboratory testing know that any test system, no matter how simple, may produce erroneous results under the right conditions, and no laboratory test can be so negligible as to eliminate the risk of 1 - Education

2 harm to a patient if results are not reliable. Patients may be misclassified, over or under treated, or subjected to unnecessary and potentially harmful procedures if results are inaccurate. Health care may also be inefficient or overly expensive in these situations. Waived testing only requires that a user obtain a Certificate of Waiver (COW), follow manufacturers instructions, pay a modest biennial fee, and be prepared for the very small possibility of being inspected by an applicable federal or state agency. Therefore, many testing sites limit themselves to waived testing, and the in vitro diagnostics (IVD) industry has vigorously promoted and developed waived testing. Laboratories that perform non-waived testing must follow a host of CLIA88 requirements for: proficiency testing, quality management and quality control, procedure manuals, specimen handling, results reporting, instruments and equipment, personnel standards, and safety issues along with site administration, inspections, and penalties. The number of original waived analytes has grown from 8 9 to over 100 currently offered by more than 1600 test systems. The number of laboratories with certificates of waiver has grown from about 40% of 154,000 laboratories in 1993 to 64% of the 221,000 laboratories in the US in It is estimated that POCT accounts for one quarter to one third of all laboratory testing now. Most COW labs are in POLs, nursing facilities, specialty care sites, or clinics, but manufacturers are trying to develop and promote more waived tests in many higher acuity settings such as hospitals, intensive care units, emergency departments, and specialty care settings. POINT-OF-CARE TESTING AND PATIENT SAFETY POCT has many potential advantages that include: Rapid testing turnaround times (TAT) More workflow efficiency and better use of patient care resources Improved decision-making with quicker access to results Improved patient disposition or care logistics Better patient outcomes Patient and provider satisfaction More access to patient testing in more sites Smaller sample volumes and better specimen integrity 2 - Education

3 While the technology for waived testing has greatly improved and incorporated many safeguards to ensure accuracy and data management, and result reporting uses more computer enhancements, there have always been concerns about the potential for error in POCT and patient safety. These sources of concern include: Lack of official personnel standards for operators Lack of staff experience and familiarity with laboratory methods or best practices Increased number of operators who need oversight More frequent turnover of operators Resources needed to manage POCT Manual methods or kits that are subject to operator variability and need manual QC documentation and manual results reporting No requirement to have formal documented standard operating procedures (SOPs) Failure to document that the manufacturers instructions being used are the most current Inconsistency in operators following manufacturers instructions No requirement for training or competency assessment of the many operators Inconsistent training and competency assessment when they are in place Failure of operators to perform, document, or act on routine QC Failure of operators to monitor reagent or device functions or the testing environment (eg, temperature) No requirement for external assessment or proficiency testing No requirement for quality management or safety programs Lack of appreciation for the potential differences between POCT and central laboratory results for the same analyte Some moderately complex methods have also been introduced at the point-of-care and used by operators who are not formally trained in laboratory science. While those tests have more stringent performance requirements, they share many of the problems associated with waived testing. Those problems include the operator issues noted above, the need for formal oversight and attention to good laboratory practices, and documentation of all those practices. Another reason for the increased potential for errors in POCT may be less involvement or partnership of the laboratory community with POCT activities and stakeholders. As noted below, many consider active education and oversight of POCT operators to be a key contribution of laboratorians to ensure accuracy and patient safety for POCT. Case Study, cont d John wants to be able to explain why the new inspection requirements may be more detailed for some of the testing sites that only perform waived testing and have not previously had formal inspections. He wants to work with the sites to be motivated to be active partners in the new processes. 3 - Education

4 POINT-OF-CARE TESTING AND THE INSPECTION PROCESS Because the CLIA88 regulations were considered minimal laboratory standards, other accrediting organizations, like the College of American Pathologists (CAP), The Joint Commission, and some states, appreciated the potential for POCT errors and have promoted and maintained higher standards and requirements for POCT. Such accrediting organizations are deemed by the Centers or Medicare and Medicaid Services (CMS) that administers CLIA88 to perform laboratory inspections and provide laboratory accreditation as long as they meet CLIA88 s minimal standards. They can, and generally do, promote best laboratory practice requirements for POCT. These organizations or agencies set higher inspection standards and recognize the potential for POCT problems. However, accrediting bodies must also be practical about setting realistic inspection processes for POCT COW labs. See discussion below. RISKS INHERENT IN POINT-OF-CARE TESTING Potential problems with POCT have been described in a number of publications. While a full discussion of the literature on errors associated with POCT is beyond the intent of this activity, review of the basic documented risks inherent in POCT can help laboratories mitigate these risks, especially using the inspection process to educate and motivate POCT stakeholders and operators. Review of the basic documented risks inherent in POCT can help laboratories mitigate these risks, especially using the inspection process to educate and motivate POCT stakeholders and operators. Kost suggests that errors in POCT be analyzed according to the phases of testing: pre-, intra- and postanalytic, and surveyed a number of POCT experts to suggest improvements and strategies for quality POCT. 2 A number of those suggestions were related to the technology and data management or connectivity capacity of POCT, but other suggestions addressed operator certification, monitoring invalid use, operator competence, quality compliance, and quality improvement efforts. Meier and Jones, in a frequently cited paper, expand on POCT error and state that the three most frequent sources of POCT error are operator incompetence, non-adherence to test procedures, and the use of uncontrolled reagents and equipment. 1 They further cite that these errors are amplified by incoherent regulations and rapid therapeutic intervention based on the immediate availability of results, eg, an erroneous result may produce an intervention before other test results are available. They suggested direct observation of test functionality, structured observation of test performance, testing operator competency, and autonomation of devices along Autonomation or intelligent automation is a process in which instruments or equipment can detect malfunctions or defects, stop themselves, and alert users. 4 - Education

5 with documenting orders, patient identification, specimen integrity and result reporting as part of an error reduction effort. O Kane et al believe that the potential for POCT errors is greater than central laboratory testing partly because POCT has a greater opportunity for error in the actual testing or analytic phase, unlike central laboratory error rates that show more mistakes in the pre-analytic phase. 3 They also believe that many of the POCT errors might have been prevented by better training or greater adherence to protocols by operators. Lewandrowski et al reviewed progress in POCT for assuring quality. 4 The value and benefits of POCT accreditation standards developed by the CAP and The Joint Commission were recognized along with technology and connectivity improvements. However, the authors noted the most important element for assuring quality in POCT was an effective POCT management program with multidisciplinary involvement, systematic evaluation, validation and implementation of testing, training and competency assessment of operators, and adequate resources for POCT management. Nichols comprehensively covers considerations and sources of error for POCT in an excellent resource. 5 He cites standardization of POCT technology as an important step to improve POCT quality, but he also cites operator training and competency assessment to be key in the ongoing improvement and assurance of POCT quality. Plebani, Laposata, and Lundberg discuss problems with laboratory-to-clinician communication and understanding of laboratory testing ( brain-to-brain loop ) in general and address specific concerns related to POCT. 6 They conclude that for POCT a high level of cooperation between laboratory professionals and clinicians is necessary to ensure best practices, including the training of POCT personnel. The largest and most frequently cited study on quality in waived testing is a 2005 MMWR publication combining findings from CMS and Center for Disease Control and Prevention (CDC) inspections of over 4000 COW laboratories. 7 Concerns about performance and quality are summarized on the next page and attributed to high personnel turnover, lack of understanding about good laboratory practices, and inadequate training. The report also recommended best laboratory practices for waived testing which are also summarized on the next page. Importantly, the report states: continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase. These findings and recommendations support higher standards and oversight practices for waived testing. Laboratorians can use these recommendations in partnership with POCT stakeholders and operators to establish stronger programs. 5 - Education

6 Continued monitoring of waived testing with a focus on personnel education and training is needed to improve practices and enhance patient safety as waived testing continues to increase. Table 1. Number and Percentage of Quality Deficiencies Related to Following Manufacturer s Instructions and Documentation in Certificate of Waiver sites, from the Centers for Medicare & Medicaid Services Surveyed Sites,* Education

7 Elements of good laboratory practices for waived testing, as recommended in the MMWR 2005 report are as follows: 1. Considerations before introducing or offering waived testing Management responsibility Staffing Regulatory requirements Documents and records Testing space and facilities Personnel adequacy, training, Safety issues competency Benefits and costs 2. Processes needed before testing is started Written test procedures Personnel training Competency assessment established Support resources for staff Test ordering, patient identification and patient preparation Specimen collection, handling, identification, and storage Proper testing area, reagents, kits, controls, equipment 3. Practices during testing Quality control procedures and documentation Following manufacturer s instructions Proper interpretation of results Problem resolution Result recording 4. Practices after testing Test reports including critical values Supplemental or confirmatory testing Public health reporting Biohazard waste disposal 5. General practices Maintenance of documents and records Quality assessment program Internal assessment including selfinspections, supervisory oversight External assessment including voluntary external inspections and proficiency testing 7 - Education

8 Case Study, cont d John is aware that each hospital has a multidisciplinary POCT committee that reviews POCT requests and practices. He proposes that those committees consider joining on behalf of the HS and include the clinics and specialty practice sites in their membership. He thinks that all POCT sites could benefit from a common educational and stakeholder approach to improving quality and practices in POCT. The committees have strong leadership from the laboratory directors and POCCs, who serve as technical resources so they can also be advocates for best practices and educators of POCT stakeholders. A common theme from all these reports is the need for awareness of error potential in POCT and the importance of operator education and training with continued oversight to understand and perform testing procedures reliably. The most credible source of that education and oversight should come from laboratorians who understand the discipline of laboratory testing but also appreciate the value of POCT and the patient care needs of the clinical sites that use it. It is important for POCT operators to be adequately educated and trained on testing procedures and understand the discipline of laboratory testing with continued oversight to perform testing procedures reliably. Ideally, these activities should be a sustained collaboration between all the stakeholders with POCT. The CAP has supported this concept with its education and inspection programs (ie, EXCEL, Surveys, Laboratory Accreditation Program [LAP]). It has also supported POCT through its Point-of-Care Testing Committee (POCT) that has developed a web-based POCT Tool Kit that serves to educate and provide useful tools to implement and direct POCT and promotes laboratory director leadership in POCT. The activity urges readers to access the Tool Kit for an orientation to POCT and suggestions for best practices. This educational activity is part of the CAP s effort to support laboratorians as educators and leaders in POCT. Despite years of advocating best POCT practices through its inspection checklists and educational activities, the CAP still sees persistent predictable inspection deficiencies or citations for the POCT sites it inspects. These are listed below. 8 - Education

9 Table 2. CAP Most Common POCT Accreditation Deficiencies Phase Phase 1 Deficiency Deficiency % Does the laboratory's current CAP Activity Menu accurately reflect the testing 8.50% performed? Is the system for reporting PPT results adequate? 0.30% Are POCT personnel tested for difficulty with visual color discrimination? 0.20% Phase 2 Is there a documented program to ensure that each person performing POCT 5.80% maintains satisfactory levels of competence? Is there documentation of at least biennial review of all policies and 5.50% procedures for POCT by the current director or designee? Are calibrators, reagents, and solutions properly labeled, as applicable and 5.00% appropriate, with the following elements? If the laboratory/poct program uses more than one instrument/method to 4.70% test for a given analyte, are the instruments/methods checked against each other at least twice a year for correlation of results? Are control results documented for quantitative and qualitative tests, as 4.60% applicable? Is there ongoing evaluation of PT and alternative assessment results, with 3.60% prompt corrective action taken for unacceptable results? Is a complete procedure manual available in the work areas? 3.40% When applicable, are all patient results reported with accompanying reference 3.40% (normal) intervals or interpretive ranges? Does the POCT program integrate all proficiency testing samples within the 3.20% routine workload, and are those samples analyzed by personnel who routinely test patient samples, using the same primary method systems as for patient samples? For all waived tests, does the POC Program follow manufacturer instructions 3.10% for handling and storing reagents? Does the point-of-care testing program have a written QM program? 3.00% Is there evidence of ongoing evaluation of results of instrument maintenance 2.60% and function, temperature, etc. for all procedures on all shifts? Are controls run daily for quantitative and qualitative tests? 2.60% Are all reagents stored as recommended by the manufacturer? 2.50% Does the laboratory participate in the appropriate required CAP Surveys or 2.40% another proficiency testing (PT) program accepted by CAP for the patient testing performed? Are all reagents used within their indicated expiration date? 2.30% For tests for which CAP does not require PT, does the POCT program at least 2.20% semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing? Does the POCT program have a system documenting that all personnel are 2.00% knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities? 9 - Education

10 While it is important to have high standards for any patient testing, the laboratory should be practical and meet the clinical team at a level they can understand and appreciate. All stakeholders should be involved in creating workable and sustainable POCT programs that promote quality testing but also fit reliably into realworld clinical practice and have operator understanding and buy-in to succeed. Using the CAP Checklists, this education activity will follow an outline to help equip laboratorians, POCCs, and laboratory directors in explaining checklist requirements and why they are important. It will also provide suggestions for crafting or implementing processes to fulfill checklist and best practice intents. The outline includes a useful definition of each checklist component and readers may find this helpful in communicating with operators. The definitions are usually paraphrased from official sources or sites, such as the CAP Laboratory Accreditation Program (LAP) glossary, Clinical Laboratory Standards Institute (CLSI) or International Standards Organization (ISO). The language is simplified and the outline format is used so that laboratorians might customize or use the information more easily in discussions or activities with a POCT audience. Checklist statements are not referenced by number, because numbers or specific wording may change over time. Rather, each major section area is covered as a general concept or topic. Hopefully, this education activity will promote interaction between laboratorians and other POCT stakeholders. While the activity, especially considerations and suggestions for improvement, may not be all inclusive, it should stimulate readers and other laboratorians to explain and discuss these issues with POCT managers and operators in an effort to improve practices and strengthen the role of the laboratory in supporting POCT. Considerations and suggestions for laboratory testing improvement should be discussed with POCT managers and operators in an effort to improve practices and strengthen the role of the laboratory in supporting POCT. The activity may also assist readers in developing better processes for their own laboratory sites or communicating more effectively with laboratory staff. In either case, better compliance with checklist requirements may be achieved, either at the point-of-care or within a laboratory setting. Importantly, this educational activity will be attached to the POCT Tool Kit that allows reader input. The CAP POCT Committee hopes that readers will access the TK and give their own suggestions and examples of ways to promote best POCT practices Education

11 UNDERSTANDING CAP CHECKLISTS Each CAP Checklist provides specific introductions and explanations for use. Key instructions for the POCT Checklist include: 1. Quality control, reagents, and calibration requirements are treated differently for waived versus nonwaived testing as part of an effort to recognize the CLIA regulations and accommodate a practical approach to waived POCT. 2. Proficiency testing, quality management, procedure manuals, specimen handling, results reporting, instruments and equipment, personnel, and safety requirements are the same for waived or nonwaived testing as part of the CAP s effort to support high standards for all testing. 3. If a POCT program is part of a central laboratory with a single CLIA number, the Team Leader and Laboratory General checklists cover all sections of the laboratory, including POCT. 4. If POCT records are centrally maintained by a designated coordinator, only one checklist is needed. If records are not maintained centrally, each POCT site must be separately inspected with a separate checklist. 5. For POCT sites with separate CLIA numbers, separate Team Leader and Laboratory General checklists are needed at this time. Those checklists are not addressed in this activity. Case Study, cont d John proposes that the combined POCT committees review the checklist requirements and develop a common program to explain basic requirements to the nursing supervisors in each site and solicit input from those supervisors on how best to involve and educate operators. John thinks weekly updates or a skills fair to explain the key checklist requirements would be good, but he wants the nursing leaders to suggest practical and effective approaches. He is hoping that this will be the beginning of an ongoing interaction between POCCs and clinical operators. John begins his review with the quality management (QM) checklist section. He would like staff to appreciate some of the useful outcomes of QM and how it might make testing more accurate and clinical processes more efficient and easier for operators. Individual POCT Checklist sections are addressed below. A complete, helpful discussion of most of the POCT Checklist sections is included in the web-based POCT Tool Kit. It also serves to educate and provide useful tools to implement and direct POCT Education

12 Checklist Section: Quality Management (QM) Definition: QM is a set of systematic activities to achieve quality. It includes setting goals, planning, quality control checks, and performance improvement efforts. Importance: Quality is a measure of excellence and includes being free from defects or errors. For POCT, it means producing accurate results and protecting patient and operator safety. QM should reduce risks, improve results, patient outcomes, satisfaction, and efficiency, while reducing costs and waste. QM may help an organization to be more competitive. Risks if not followed: Difference between waived and non-waived testing: Errors, which may be repetitive, not detected, or not corrected Poor quality and patient safety issues Less patient or provider satisfaction Inefficiency Higher costs Competitive disadvantage Poor reputation Regulatory issues Principles should be the same POCT may have more variables including more operators who are less experienced and less trained and there may be less direct control of testing processes and less appreciation of quality practices More and different stakeholders need to be involved in QM for POCT How to improve: Unusual lab results (part of the QM section): Make QM part of an overall quality system affecting all operations Include all steps in the process (pre, intra, post analytic) Define all processes in POCT Involve stakeholders to define, construct, oversee, evaluate, and improve or change processes, especially ones that are prone to errors Have a written structure but involve all stakeholders, and regularly report findings, progress, and improvements or corrective actions that need tracking Monitor or create programs to promote sustained outcomes Manual systems have a higher potential for errors Reliably reporting regular and critical results is part of quality There is no improvement in real TAT and benefits of POCT if results are not reported and processed or acted upon quickly Look for systematic and common ways to enter all manual results Have a system to document and report critical values Try to automate all processes or have connectivity with data entry Audit regularly and report findings 12 - Education

13 Checklist Section: Specimen Handling Definition: Procedures for collecting, preserving and transporting of specimens so that they are sufficiently stable to provide accurate and precise results suitable for clinical interpretation. Importance and considerations: Specimens, per CLIA88, include whole blood, serum, plasma, urine, feces, saliva, spinal fluid, synovial, amniotic, pleural, pericardial, and peritoneal fluids along with solid tissues. Most of these are used in POCT but it is important to be aware that POCT methods are approved only for certain specimen types and using nonapproved specimen types can produce unreliable results Different results may also be obtained from different types of blood specimens, eg, whole blood, plasma, or serum, based on water and cell content, so knowing the type of blood specimen required is important. It is critical to know from the manufacturer s instructions what specimen type is approved for the method or kit being used Specimens should be obtained in the appropriate way, eg, fresh finger-stick whole blood versus anticoagulated whole blood, not subjected to delays in testing, without clots or bubbles that will interfere with testing, and applied to a device properly so that there is not too much or too little specimen for analysis. Some newer POCT devices can alert users to improper or substandard specimens, but older or manual test systems may not detect these errors Appreciate the importance of proper identification so that the results actually belong to the correct patient Teach good practices such as not pre-labeling tubes and attaching labels in a systematic process to ensure accuracy Hand written labels are more difficult to manage than computer generated labels but preprinted labels may have greater risk to be misplaced and put on the wrong specimens If it is not practical to label a specimen or test (eg, finger-stick glucose) be sure to have an orderly process for testing and only test one patient at a time Use devices that include patient identification upgrades such as demographic entry, bar code readers, or order entry capability Patients should be part of the identification and collection process to ensure accuracy. They should confirm their identification and be able to give information about test conditions, such as when they took certain medications, when they last ate, their last menstrual period, etc. Patient preparation considerations include effects of timing of specimens for certain tests (eg, fasting or post eating), acquisition effects (tourniquet time, skin preparation with alcohol or contamination from the operators fingers, pressure with finger-sticks giving too much tissue fluid, factors that may cause hemolysis, etc.) Read method directions to appreciate effects of different patient conditions (eg, altitude, oxygenation status of the patient, fasting, interfering medications, etc.) or specimen variables (eg, contamination, deterioration, hemolysis, etc.) Preservation: - Are fresh or preserved specimens needed? Check specimen requirements in the manufacturers instructions - Understand the importance of potential deterioration of specimens, especially urine, but also blood specimens for electrolytes or blood gas analysis Accessioning or information requirements include: - Patient demographics, time of specimen, operator identification, specific testing method (eg,central laboratory versus POCT, etc.), site or type of 13 - Education

14 specimen (eg, finger-stick versus venipuncture, fasting versus random, etc.) Advantages of connectivity include: - Instructions to operators, patient information, entering results or reviewing data - If a manual system is in place, develop convenient operator tools or a common system to prompt operators and reliably capture data - Involve users in the construction of those systems - Patient and operator safety and universal precautions are part of specimen handling Risks: Wrong results on the wrong patient Erroneous results from poor specimen quality Over or under diagnosis resulting in patient harm Inappropriate use of resources, costs, satisfaction, etc. Difference between waived and non-waived testing: How to improve: May be none Consideration of fresh specimens used in POCT, contamination of site with fingers, disinfectants, etc. May not be able to put a label on single use device or cartridge tests Need a system to ensure an accurate process in a busy clinical setting with many distractions, different operators, and discontinuous testing Education, consistent training and competency assessment on processes Develop reproducible systems that are consistent, close to the patient care site, without interruptions, etc. Automate patient identification, orders, test, and result entry Understand and follow manufacturers instructions and standard procedures Tools: develop standardized procedures and logs with operator input Audits: regular and reported to all users with corrective actions cooperatively developed and tracked POCT methods are approved only for certain specimen types and using non-approved specimen types can produce unreliable results. Case Study, cont d When the combined committee meets with the nursing leaders, many people are surprised to learn that a kit or method may not be used for any body fluid. One site has been testing nipple secretions, nasal fluids, and wound drainage using a kit for fecal occult blood Education

15 Checklist Section: Results Reporting Definition: Results: The value, either numerical or qualitative, that a test produces. A result may be a number, a positive or negative finding, or a range, depending on the test, method, or clinical need. Reference range: The normal or usual variation of test results based on a healthy population. Using an entire population may include people with certain health conditions so it is important to define a healthy or reference group for an analyte, eg, cholesterol values. Reference ranges may also need to be stratified by age, sex, and ethnicity since children, men, women, and different ethnic populations may have different levels of analytes. Instead of reference ranges, for some analytes it may be more appropriate to consider optimal ranges of analytes, eg, glucose or cholesterol or a target range, eg, PT/INR for patients on coumadin therapy. Importance and considerations: Risks if not done: Difference between waived and non-waived testing: Results must be systematically and reliably recorded and available in a timely fashion for all the providers caring for a patient Manually recorded results must be legible so they are properly interpreted POCT is primarily valuable because of rapid TAT and availability or communication of results Providers also need a reference or medical decision level so the significance of the result can be judged Sites should know the source and accuracy of the reference, optimal, or target ranges they use, and whether those depend on age, gender, or ethnicity of the population The identity of the person performing the test is important to document so that results can be traced, problem solving can occur, operator activity and competency can be tracked, and to comply with regulations, etc. Urine drugs of abuse (DOA): It is important to know the classes or limitations of drugs tested, performance limits of results, sample type, and timing to interpret findings. Providers need to know whether a result is a screening test or whether confirmatory testing is pending. Unconfirmed results cannot be used for legal or employment purposes Improper interpretation and patient harm or safety risks Potential over or under patient treatment Result not available or properly interpretable Unable to trace results, operator input, etc. Usually none It may be difficult to do specific POCT reference range studies but sites should have access to good reference range data More manual entry or results with potential errors More operators to train and oversee How to improve: Implement as much connectivity as possible Develop practical, reliable systems with operator input and include user-friendly tools, logs, etc. Audit regularly with reports and corrective actions 15 - Education

16 Case Study, cont d During the combined meeting one clinic POCT site shares examples of result logs their staff uses for manual tests. The other sites are impressed with how easy the log is to use and decide to share it with their staff to see if it can be introduced throughout the HS. The laboratory directors and POCCs discuss their investigations to phase in computer connectivity to all POCT sites. They explain that connectivity should help to standardize processes, devices, result entry, and data review. Connectivity will also facilitate getting POCT data into the electronic medical record (EMR). Checklist Section: Reagents Definition: The components of a diagnostic medical device that produce a reaction and signal and allow an analyte quantity to be detected and its value measured in a sample. May also be called a reagent system. Importance and considerations: Reagents are biological and chemical materials that can deteriorate and lose their reactivity They have different life spans or expiration dates under different conditions, eg, unopened, frozen, opened, at room temperature, etc. Reagents cannot be used after expiration dates or if they do not produce accurate results (see QC) Factors affecting reagent life span or performance include storage, temperature, humidity or moisture, exposure to light or air, evaporation, contamination, etc. Manufacturers also evaluate and optimize reagents so that they perform together under specified conditions to give accurate and predictable results Reagents are optimized and approved by manufacturers in lots or batches and compared for accurate performance between lots. Lots of reagents may also need to be keyed to devices so that the device reacts appropriately to them Mixing lot numbers of reagents within kits may produce erroneous results Using reagents between different kit types will also produce erroneous results, eg, using Hemoccult developer with Gastroccult testing or using reagents from one fecal occult blood method with another fecal occult blood method Users need to follow manufacturer instructions for using, mixing, or storing reagents Labeling reagents for storage and expiration is required for accuracy and regulations. Labeling requirements are specified in the checklists When new reagent lots are introduced, they need to be compared to existing reagent lots before being used to guarantee that new results are acceptable and equivalent to prior test results Risks if not done: Difference between waived and non-waived testing: Inaccurate, unreliable results Patient harm or safety problems Liability and regulatory problems Damaged reputation and poor customer satisfaction Waived testing reagents are usually pre-packaged and don t require special higher skill levels preparation Non-waived testing may have more steps in reagent preparation or handling that require and may introduce more chances for error For waived testing, users must only follow manufacturers instructions for reagent handling; however, manufacturers always follow best reagent practices or instruct users in the correct way to use the reagents 16 - Education

17 How to improve: Selection of methods that simplify reagent handling Standardization of kits and methods to simplify and control variation in reagent handling User education, training, with competency assessment tools Practical and reliable tools and logs for documentation, especially for environmental temperature checks User input for practical and workable systems Centralized or limited control of reagents or kits with organized distribution and oversight Audits with reports to users and corrective actions with user input and tracking for effectiveness Case Study, cont d Several sites are surprised that reagent bottles need to be capped to avoid evaporation. They leave bottles open during clinic hours so that testing is quicker. Other sites are surprised that different lot numbers cannot be mixed. They have not wanted to waste reagents so they combine bottles from different kits until all the contents are used. One site stores dipsticks under a sink so they are not exposed to light but is surprised to learn that moisture can also affect the strips performance. Finally, another site realizes that storing reagent bottles on a window sill might expose them to unacceptable light, heat, or cold depending on the season or weather conditions. Checklist Section: Instruments and Equipment Definition: Single apparatus or set of apparatuses needed to perform a set of tasks. For laboratory testing these include handheld, small bench top, or automated instruments along with centrifuges, incubators, etc. and tools such as glassware, pipettes, etc. Importance and considerations: Risks if not done: Difference between waived and non-waived testing: A POCT director or program should review all equipment requests and test implementations to assure appropriateness and reliability for testing along with site requirements such as space, power, computer connections, etc. Standardization of methods, equipment, and instruments is desirable to allow more efficient oversight and better comparison of results across sites Equipment or instruments may lose optimal performance over time due to drift in response, breakdown or aging of parts, contamination, misuse, damage, or normal wear and may not perform to specifications Regular maintenance evaluation is necessary to avoid the above problems and guarantee accurate performance Inaccurate or unpredictable results Patient or operator harm Inability to provide services if instruments or equipment break down Liability and regulatory problems Damaged reputation and poor customer service Potential operator safety issues if equipment malfunctions, eg, bad electrical connections or equipment is broken, eg, glassware, specimen leaks, etc. Waived testing: Follow manufacturers instructions. Usually minimal to no maintenance. Problems require vendor or POCC support Non-waived testing: Generally instruments and equipment require more maintenance and higher technical skills to maintain. Operators may perform some troubleshooting or repairs if needed 17 - Education

18 How to improve: User education, training and competency assessment Central support from laboratory staff and manufacturers Practical, reliable and standardized schedules and procedures, tools and logs for performing and documenting functions User input for practical systems to ensure checks and following instructions Audits with regular reports and corrective actions developed with user input and corrective actions tracked Checklist Section: Personnel Definition: Staff who comprise all of the approved administrators and operators of POCT. Importance and considerations: Having a qualified pathologist or laboratory director knowledgeable in laboratory sciences, POCT, and able to guide appropriate and reliable POCT is essential for the effectiveness of a program. That person can serve as a leader, resource, educator, and advocate for best practices and oversee successful regulatory compliance Training is the foundation of proper performance and understanding of POCT and must cover a documented checklist of all essential functions associated with each test or procedure performed Operators should sign off on this process An authorized list of operators is necessary to ensure that a site knows who has been properly trained and had competency assessment to assure they can reliably perform testing Competency must be assessed before an operator starts testing and as required periodically to assure that operators continue to perform testing reliably, understand all the procedures associated with testing, such as instrument checks, QC, safety issues, and interpretation of results. Competency assessment also helps leadership to see areas of needed improvement in staff performance Color discrimination is essential for the interpretation of some manual tests. Color discrimination may vary over time and testing requirements, so sites may want to check it periodically. Color discrimination may also vary by lighting in the testing area Risks if not done: Poorly trained and inadequate staff that make errors in testing and obtain erroneous results Patient harm and safety issues Staff safety Substandard result documentation, problem solving and interpretive skills Liability and regulatory problems 18 - Education

19 Difference between waived and non-waived testing: How to improve: CLIA88 has no specific personnel requirements for waived testing staff, but specific states, institutions, sites, or organizations may require higher standards similar to non-waived personnel Competency assessment requirements may be more extensive for non-waived testing then waived testing, but some organizations may not differentiate between the two levels of testing CMS requires that all six elements of competency assessment be assessed at all required intervals for non-waived testing. They are as follows: - Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing - Monitoring the recording of test results - Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records - Direct observation of performance of instrument maintenance and function checks - Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples - Assessment of problem solving skills Currently, CMS allows waived testing sites to use a sample of the 6 competency elements for periodic or annual competency assessment. Initial competency assessment does require that all of the six elements be used. See link to the CAP POCT Tool Kit for a complete discussion of training and competency assessment. POCT Tool Kit Case Study, cont d Some of the specialty practices reveal that they have temporary staff who have not had formal POCT training but the tests are so simple that this is not really necessary. They assume that the temporary staff reads the kit instructions and are not sure if they have a list of all the temporary people who have performed testing. Checklist Section: Quality Control (QC) Definition: The set of mechanisms, processes, and procedures designed to monitor the measuring system and to ensure the results are reliable for the intended clinical use. QC includes testing of normal and abnormal control materials, recording the results, identifying sources of error, and evaluating or documenting any corrective action taken. These steps are performed either within a test device (internal QC) or by testing personnel (external QC) to ensure that a testing system is performing correctly. Importance and QC measures the overall performance of a test system prospectively or in real time, considerations: and may reveal problems with an instrument, reagents, or operator Methods and results may show drift or bias (systematic deviation), or imprecision (lack of reproducibility) over time These problems may be due to reagent and device performance, but operator technique or competency may also produce testing problems and inaccuracy Results must not be released if there is any evidence of system malfunction or inappropriate QC There must be at least monthly oversight of QC by a director or designee to make sure procedures are followed and no problems are missed To be effective, QC must be associated with problem solving so that weaknesses in the system can be defined and corrected before patient results are released or 19 - Education

20 Risks if not done: Difference between waived and non-waived testing: How to improve: there is any patient harm QC can help detect testing problems early, before inaccurate test results are released, if systems are in place to see early bias, imprecision, or irregular performance Inaccurate results with patient harm Lack of appreciation of problems before harm is done Liability and regulatory problems Damaged reputation and poor customer service For waived testing, QC must be performed and documented according to manufacturer instructions and no test results can be released with unacceptable QC results. Operators of waived test systems are not expected nor authorized to perform troubleshooting. They should call vendors or the POCCs for assistance For non-waived testing the checklists require more specific instructions and frequency of QC. Single use or cartridge-based devices have different issues for QC than traditional instruments, since the cartridge or strip is consumed with each test CMS currently requires that QC be performed on each test system, and defines a test system as a combination of a cartridge and the device that reads it. CMS review of this requirement may, allow laboratory directors to establish QC schedules that fit a test systems risk of error and control features See the attached link to the POCT Tool Kit which has a comprehensive discussion of POCT QC strategies. POCT Tool Kit Case Study, cont d Some of the sites complain that they are very busy and the tests always work so they don t do QC on some manual tests. The combined group agrees that they should look for standard devices or methods that prompt operators to do QC, don t allow testing unless QC is performed and within limits, and store the QC for record keeping. For manual testing without built-in QC, the combined group agrees that they need to review convenient processes that promote QC and perform regular audits to see that it is done. Checklist Section: Calibration Definition: The process of testing and adjusting an instrument, kit, or test system to provide a known relationship between the measurement response and the value of the substance measured by the test procedure. Importance and considerations: Calibration is not QC and calibrator materials are not the same as QC materials Instrument or test system response for measuring an analyte is established by a manufacturer but must be confirmed or re-verified periodically by users Specific events that require calibration verification include changes of reagent lots, abnormal QC results, after a major instrument maintenance or adjustment, as recommended by the manufacturer, and at least every six months If calibration verification fails to show the proper instrument response, then calibration must be re-established using known calibrators or by calling the vendor The upper and lower limits of the analytical measuring range (AMR) for non-waived testing must be determined or verified so the user knows whether to report or retest values at those limits. There are specific procedures and schedules to test and confirm the AMR but these must be performed by qualified personnel 20 - Education

21 Risks if not done: Difference between waived and non-waived testing: How to improve: Inaccurate results due to wrong instrument response or reagents that do not perform properly The entire range of an assay, including low, mid and high level results, needs to be periodically checked so that users know if a method performs accurately for all levels Patient harm Liability and regulatory problems Damaged reputation and poor satisfaction For waived testing, only manufacturers instructions need to be followed The more detailed procedures are used for non-waived testing and performed by trained personnel Educate, train and periodically assess operators on procedures Create flags or alerts when calibrations need to be performed or verified Regular oversight by qualified personnel, eg, POCC, to check for issues requiring calibration checks Checklist Section: Blood Gases Definition: Analysis of the gases that are dissolved in blood plasma. For routine medical purposes this includes oxygen and carbon dioxide and ph for acid base status. Importance and considerations: Oxygen, carbon dioxide and acid base status are critical indicators of a person s health. Deviations in them can reflect critical conditions that may need rapid treatment Blood gas analysis is a frequent, non-waived point-of-care test because of its importance as an indicator of health or disease and need for potential rapid intervention Because of the importance of blood gas results, there are strict requirements for specimen collection, avoidance of clots or fibrin strands, prevention of specimen contamination by air, instrument operation, and use of calibration and QC QC requirements specify not only high and low levels of QC needed daily to check instrument function, but require frequent QC checks so that an instrument is ready for use and documented to perform accurately with each specimen. The checklist specifies different frequencies of QC that can meet these requirements It is important for operators to know that some cartridge systems have waived testing but that does NOT include blood gas testing Risks if not done: Difference between waived and non-waived testing: Inaccurate measurement of critical analytes with potential for severe patient harm Liability and regulatory problems Damaged reputation and poor customer satisfaction NA 21 - Education

22 How to improve: Strict attention to manufacturer s instructions Use of newer instruments that have automatic instrument checks Trained and educated personnel who appreciate the importance of specimen and instrument requirements Rapid analysis of specimens with rapid and documented result reporting both to preserve specimen integrity and deliver results to providers Strict attention to critical value reporting QM monitoring for quality results and service levels Case Study, cont d The combined group agrees that it should select standard blood gas analyzers across the HS that automatically detect or filter clots, run QC, and perform calibrations at defined intervals to assure that requirements are met and results are reliable. Checklist Section: Safety Definition: Freedom from unacceptable risk. Importance and The POCT checklist only specifies that a program exists considerations: Elements of a safety program are included in the Laboratory General Checklist Safety programs include attention to patient and personnel safety and encompass chemical, environmental, and biologic hazards A POCT program should either be part of a complete institutional program or ensure that it has independently addressed all pertinent risks Any test system or activity of a POCT program should be evaluated for its safety issues, with documentation of oversight, findings and corrective actions Infection control issues are important safety considerations with POCT, especially for devices that are used on multiple patients and can be associated with disease transmission, eg, nosocomial infections, antibiotic resistant organisms, and hepatitis B The CDC recommends cleaning of each device between use on different patients Case Study, continued The combined group agrees that the infection control coordinators across the HS should be involved with them in developing and standardizing a process for cleaning and tracking POCT devices used at the bedside for multiple patients Education

23 Provider Performed Testing (PPT) Definition: Under CLIA88, Provider Performed Microscopy (PPM) is a sub-category of moderate complexity testing which is personally performed by a physician, dentist, or mid level practitioner who is examining a patient or performing a test on a patient being seen in his/her practice, is a labile specimen or one which would be compromised if testing is not done immediately, has no control materials, and is read by a microscope using bright field or phase contrast microscopy. PPM includes wet mount analysis for microorganisms or cellular elements, potassium hydroxide preparations, pinworm examinations, fern tests, post coital qualitative examination of cervical or vaginal mucous, urine sediment examination, nasal smears for granulocytes, fecal leukocyte smears, and qualitative semen analysis. PPT is a separate CAP designation that includes other waived tests along with the microscopic tests under PPM. Those additional tests include: ph of body fluids, gastric biopsy urease, fecal or gastric occult blood, and urine dipstick analysis. Importance and PPT allows qualified practitioners to use a rapidly analyzed specimen to assist in considerations: evaluating a patient they are currently examining Results can be integrated in context of the clinical evaluation Difference between waived and non-waived testing: PPM is a CLIA88 subcategory of moderately complex testing while PPT also includes several waived tests CAP requirements: The scope of practice (or qualifications) of the practitioners should be documented and there should be a procedure manual detailing specimen handling information Some institutions include responsibility for PPM or PPT under their specific medical or surgical departments. The chair of a clinical department must establish and document evidence of the provider s competency at the time of appointment or reappointment for privileges. This is called credentialing. Institutions may require that a provider also be included under a POCT program for training and competency assessment There should be a QM program that includes QC of stains, instrument maintenance (microscopes and centrifuges), and assurance that manufacturer instructions are followed Document the training of providers in performing these tests Competency assessment needs to be performed but the CAP does not require annual competency assessment since these tests are performed by physicians, dentists, or mid level providers. Some programs include PPT in proficiency testing programs and require providers to participate so that they can demonstrate levels of competency Results of PPT should be included in the patient s record and include pertinent data elements 23 - Education

24 Case Study, Conclusion The combined POCT group and nursing leaders agree that education for POCT operators is important and that the POCCs and laboratory directors are essential resources, but they think that a train the trainer approach would work more reliably. The nurse leaders think the POCT operators want to do quality work but they are very harried with all their clinical responsibilities. The nurses welcome the opportunity to systematically educate the operators about POCT but they also believe that specific examples of requirements and ways to comply effectively should be an ongoing and repetitive activity. Importantly, they think that specific examples of what can go wrong with POCT and how to avoid those errors is important. John volunteers to work with a team of POCCs, nurses, and operators to start this process, but he stresses that all the sites must comply with the checklist requirements while the educational process proceeds. The combined group agrees that mock inspections should be conducted simultaneously with the ongoing educational efforts, and the results of those inspections should be part of the POCT QM program. SUMMARY POCT is a well established and rapidly growing form of patient testing that has both potential patient care advantages and problems with performance. Many technological advancements in devices and methodologies have been introduced and there are more options for computer enhancements to assure that processes are followed and data captured. However, operator issues involving training, understanding, following procedures, and result interpretation or follow up persist. As POCT expands, it is important for trained laboratorians to be resources and partners to help ensure best practices, test accuracy, and patient safety. No group understands or uses best laboratory testing practices to the degree that trained laboratorians do. This educational activity introduces background on POCT and CAP POCT Checklist concepts and tools that can help readers assume or promote the role of laboratorians who are POCT resources, educators, and partners in the best interest of patient care Education

25 References 1. Meier AM, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med. 2005;129(10): Kost GJ. Preventing medical errors in point-of-care testing: security, validation, safeguards, and connectivity. Arch Pathol Lab Med. 2001;125(10): O Kane MJ, McManus P, McGowman N, Lynch M. Quality error rates in point-of-care testing. Clin Chem. 2011;57(9): Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med. 2011;135(11): Nichols JH. Point-of-care testing. Clin Lab Med. 2007;27: Plebani M, Laposata M, Lundberg GD. The brain to brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol. 2011;136(6): Howerton D, Anderson N, Bosse D, Granade S, Westbrook G. Good Laboratory Practices for Waived Testing Sites: Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing. MMWR. November 11, 2005;54(RR-13):1-25. Additional Resources Centers for Medicaid and Medicare Services. Accessed January 4, CDC. Ready Set Test. Accessed January 5, CLSI. POCT07-A. Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline. Accessed January 5, CLSI. POCT08-A. Quality Practices in Noninstrumental Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline. Accessed January 5, Education

26 Education Activity Authors Cynthia Foss Bowman, MD, FCAP: Cynthia Foss Bowman, MD, was Vice Chair of Laboratory Medicine in the Department of Pathology and Laboratory Medicine for the North Shore Long Island Jewish Health System and Medical Director of the Clinical Laboratories at the Long Island Jewish Medical Center (LIJMC). She is an Anatomic and Clinical Pathologist who has overseen POCT for over 20 years. She is actively engaged in professional projects. Dr. Bowman is the former Chair of the CAP POCT Committee and is a member of the Checklist Committee. James H. Nichols, PhD, DABCC, FACB: James H. Nichols, PhD, is a Professor of Pathology at Tufts University School of Medicine and Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA. Dr. Nichols has 20 years of experience in directing core laboratory automation, special chemistry, clinical toxicology, and point-of-care testing. He is a fellow of the National Academy of Clinical Biochemistry and the American Board of Clinical Chemistry and he is currently a consultant on the CAP POCT Committee Education

27 Learning Assessment Questions Directions: Reviewers, please try to answer the following 7 questions based on the content in this reading. 1. Certificate of waiver (COW) laboratories must do which of the following? A. Follow manufacturers instructions for testing B. Participate in an approved proficiency testing (PT) program C. Pay a monthly fee D. Hire registered medical technologists E. Allow scheduled CMS inspections every year 2. Why may point-of-care testing (POCT) be more prone to errors? A. Less involvement or partnership of the laboratory community with POCT activities and stakeholders B. Operators are usually not formally trained in best laboratory practices C. Regular QC, device maintenance, and reagent checks may not be performed, especially with manual testing D. Managing POCT requires resources to oversee many operators at multiple sites E. All of the above 3. A POCT quality management program should focus on pre-analytic testing factors, since that is when most testing errors occur. A. True B. False 4. Which of the following statements regarding reagents is TRUE? A. Reagents may deteriorate and expire B. Reagents must be matched by lot numbers, methods, and devices for accurate performance C. Reagents must be stored and handled according to manufacturers instructions D. Reagents need to be labeled properly to ensure expiration dates can be followed E. All of the above 5. QC is valuable because POCT operators can review testing after it is performed to see if any erroneous results were released. A. True B. False 27 - Education

28 6. Competency assessment must be performed before any operator can use a method or device and must be used at regular intervals to assure that operators perform reliably and understand the procedures associated with POCT. A. True B. False 7. Which special infection control consideration is associated with POCT? A. Checking reagents for bacterial growth B. Cleaning devices between patients to avoid transmission of infectious agents C. Avoiding aerosol formation of specimens D. Using gloves for patient or specimen contact 28 - Education

29 Directions: Reviewers, now check and see how you did. Please review the feedback for each of the questions below. Again, we look forward to your comments. 1. Certificate of waiver (COW) laboratories must do which of the following? A. Follow manufacturers instructions for testing B. Participate in an approved proficiency testing (PT) program C. Pay a monthly fee D. Hire registered medical technologists E. Allow scheduled CMS inspections every year A is correct. COW laboratories must follow manufacturers instructions for testing. B is incorrect. COW laboratories do not have to participate in an approved PT program. C is incorrect. COW laboratories pay a biennial fee, not a monthly fee. D is incorrect. COW laboratories do not have personnel requirements for waived testing. E is incorrect. COW laboratories can be inspected by state or federal (CMS) agencies at unspecified intervals. 2. Why may point-of-care testing (POCT) be more prone to errors? A. Less involvement or partnership of the laboratory community with POCT activities and stakeholders B. Operators are usually not formally trained in best laboratory practices C. Regular QC, device maintenance, and reagent checks may not be performed, especially with manual testing D. Managing POCT requires resources to oversee many operators at multiple sites E. All of the above E is correct. An increased potential for errors in POCT may occur because there may be less involvement or partnership of the laboratory community with POCT activities and stakeholders. Operators of POCT are usually not trained laboratorians and may not be familiar with best laboratory practices or possibilities for testing error. POCT also has a higher incidence of missed QC, device maintenance and correct reagent management. Dedicated resources are needed to train and oversee the multiple POCT operators at many different sites to ensure best practices for accurate testing. A is incorrect. An increased potential for errors in POCT may occur because there may be less involvement or partnership of the laboratory community with POCT activities and stakeholders; however, this response is not the best answer. B is incorrect. An increased potential for errors in POCT may occur because operators of POCT are usually not trained laboratorians and may not be familiar with best laboratory practices or possibilities for testing error; however, this response is not the best answer Education

30 C is incorrect. An increased potential for errors in POCT may occur because POCT has a higher incidence of missed QC, device maintenance, and correct reagent management; however, this response is not the best answer. D is incorrect. An increased potential for errors in POCT may occur because dedicated resources are needed to train and oversee the multiple POCT operators at many different sites to ensure best practices for accurate testing; however, this response is not the best answer. 3. A POCT quality management program should focus on pre-analytic testing factors, since that is when most testing errors occur. A. True B. False B (False) is correct. POCT has the potential for errors in all phases of testing and may have more errors in the analytic phase than central laboratory testing. A good QM POCT program should identify all processes in POCT and evaluate or study processes that are known to be prone to errors. A (True) is incorrect. POCT has the potential for errors in all phases of testing and may have more errors in the analytic phase than central laboratory testing. A good QM POCT program should identify all processes in POCT and evaluate or study processes that are known to be prone to errors. 4. Which of the following statements regarding reagents is TRUE? A. Reagents may deteriorate and expire B. Reagents must be matched by lot numbers, methods, and devices for accurate performance C. Reagents must be stored and handled according to manufacturers instructions D. Reagents need to be labeled properly to ensure expiration dates can be followed E. All of the above E is correct. All of the statements are true. Reagents are biologic or chemical materials that may deteriorate and expire; must be matched by lot numbers, methods, and devices for accurate performance; must be stored and handled according to manufacturers instructions; and need to be labeled properly to ensure expiration dates can be followed. A is incorrect. Reagents are biologic or chemical materials that may deteriorate and expire; however, this response is not the best answer. B is incorrect. Reagents must be matched by lot numbers, methods, and devices for accurate performance; however, this response is not the best answer. C is incorrect. Reagents must be stored and handled according to manufacturers instructions; however, this response is not the best answer. D is incorrect. Reagents need to be labeled properly to ensure expiration dates can be followed; however, this response is not the best answer Education

31 5. QC is valuable because POCT operators can review testing after it is performed to see if any erroneous results were released. A. True B. False B (False) is correct. Test results should never be released unless QC results are within acceptable ranges. QC should allow detection of test system problems before patient results are released. A (True) is incorrect. Test results should never be released unless QC results are within acceptable ranges. QC should allow detection of test system problems before patient results are released. 6. Competency assessment must be performed before any operator can use a method or device and must be used at regular intervals to assure that operators perform reliably and understand the procedures associated with POCT. A. True B. False A (True) is correct. Competency assessment must be performed before any operator can use a method or device and must be used at regular intervals to assure that operators perform reliably and understand the procedures associated with POCT. It can also be used when there are indications of problems with performance, but that is not its only or primary function. B (False) is incorrect. Competency assessment must be performed before any operator can use a method or device and must be used at regular intervals to assure that operators perform reliably and understand the procedures associated with POCT. It can also be used when there are indications of problems with performance, but that is not its only or primary function Education

32 7. Which special infection control consideration is associated with POCT? A. Checking reagents for bacterial growth B. Cleaning devices between patients to avoid transmission of infectious agents C. Avoiding aerosol formation of specimens D. Using gloves for patient or specimen contact B is correct. Using the same device on multiple patients has been associated with the transmission of hepatitis B, nosocomial agents or antibiotic resistant bacteria. A is incorrect. Reagents are usually not checked for bacterial growth and usually have preservatives. C is incorrect. Avoiding aerosols is a typical safety precaution for all aspects of patient care or laboratory practices. D is incorrect. Wearing gloves is a typical safety precaution for all aspects of patient care or laboratory practices Education