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cap proficiency testing manualThe PT program utilizes clinically-based samples to assess a laboratory’s ability to accurately perform its analyses. All surveys are graded using established criteria with oversight by ASHl’s Proficiency Testing Committee. If your laboratory is accredited by CAP, ASHI is able to report your ASHI PT Survey Performance Reports directly to CAP. Haven't registered yet? ASHI is professionally managed by Association Headquarters, a charter accredited association management company. A Proof of Concept Study The CAP provides multiple proficiency testing (PT) samples annually to laboratories to be tested per their routine procedures. For many bacterial challenges, PT samples consist of fiber swabs inoculated with organisms that are to be processed manually per CAP instructions. However, some laboratories are processing patient samples using laboratory automation (LA); thus, there is a need for these laboratories to have information on the appropriate automated method for processing PT samples. This study was undertaken to design a workflow which would allow CAP PT samples to be processed using LA. One from each concentration was processed manually per CAP instructions (method 1), the remaining swabs were processed using 4 different automated methods (2A, 2B, 3A, 3B). Plates were incubated using Full Laboratory Automation system. WASPLabTM and images of growth taken after 18, 24, 36 and 48 hours of incubation. Briefly, method 3A consisted of vigorously mixing the PT fiber swab in 1ml of ESwabTM Amies medium, then pressing and rotating the swab against the side to the tube before discarding.This will allow the laboratory to assess its performance using its routine automated workflow, as well as follow CLIA PT guidance in processing PT samples in a similar manner to that used for patient specimens. Privacy Policy By continuing to use this site, you accept the use of our cookies.http://www.brasilcom.com.br/unicef/arquivos/crossbow-weider-manual.xml
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Data collected from this website is processed and stored in the United States, please see our Privacy Policy for details.Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information. It is mandatory to procure user consent prior to running these cookies on your website. Transforming patient care. But, did you know that 60-70 of CAP failures and non-compliance issues are due to manual error. Inaccurate data entry, and incomplete or erroneous form submissions result in mistaken proficiency testing failures that can put your lab at risk. Contact Us Sign up here to receive updates directly to your inbox. But did you know that there is more toWhether you utilize samples from the CAP, API, or have developed your ownIn the first of this 3-partBut outside of the regulations stating you must Similar to utilizing an affiliated QCWaived testing is exempt from PT requirements; although it is still recommended that participation occur if an evaluation program is available. Additionally, this only applies to your primary instrumentation. For example, if you have an automated urinalysis reader and your backup methodology is to read dipsticks manually, you are only required to participate in PT for the primary methodology. (Your backup method would then be evaluated for accuracy through semi-annual correlation studies.) Analysis.http://flying-vikings.net/UserFiles/cross-connection-control-manual-accepted-procedure-and-practice.xml Unless otherwise instructed by the provider of your PT samples, PT samples areMeaning they are handled, prepared,You cannot have the laboratory perform PTAdditionally. PT samples should be rotated among all staff members who perform patientAnalysis:PT samples. You cannot run a PT sample in duplicate “just to make sure.” PatientBut only after the submission date has passed. Communication. You cannot discuss the results or samples from a PT survey with any otherDoing so before that time would beEntering results for more than one permit number byUser groups are aYou are not permitted to forward or share your PT samples with any otherSimilarly, if your laboratory hasIf you would routinely send a positiveThe reference laboratory will have their own PTEnsure your testing menu is up to date and accurate so that your PT provider isRetention. Ensure that all records and documents related to the testing of PT samples areThis is not just a way to track who performed the test, but is a legal bindingTop 5 in the 40 Under Forty recognition program. She has worked in the In her current Notify me of new posts via email. Learn how your comment data is processed. This article is intended to help clarify CLIA’s current PT requirements for laboratories. Only those laboratories that hold Certificates of Waiver are exempt from the requirement to perform and pass PT. All laboratories that hold Certificates of Compliance or Certificates of Accreditation are monitored for successful PT participation by CMS or one of six CMS-approved accreditation organizations ( Table 2 ) ( ). In some cases, accreditation organizations, such as the College of American Pathologists (CAP), require their laboratories to participate in PT for more than just the CLIA-required analytes or tests. Two states, New York and Washington, have exempt status under CLIA because their requirements are judged to be at least as stringent as CLIA regulations. New York State requires laboratories to use its PT program, while Washington State allows laboratories to use any CMS-approved PT program. Congress enacted CLIA ’88 to promote uniform quality and standards among all clinical testing sites in the United States. 1 Prior to passage of the 1988 Amendments, laboratories were subject to an earlier law (The Clinical Laboratories Improvement Act of 1967) that applied only to hospital laboratories and laboratories engaged in interstate commerce by performing testing on specimens that crossed state boundaries. 4 Only laboratories of these types were required by federal regulations to adhere to quality standards, including performance of PT. For many reasons, it has been assumed that PT performance is an indicator of the quality of patient testing, and this has been borne out in some specific studies. 5,6 Shahangian has reviewed the studies that have linked PT performance to other laboratory characteristics. 7 Clearly, while CLIA has been in effect, PT scores have improved gradually. While there are, no doubt, many reasons for improved PT performance, the impact has been greatest on laboratories that had not previously been required to participate in PT before 1988. 8,9 Overall, successful performance is defined on the basis of satisfactory performance on individual PT events, which generally occur three times per year. In most cases, there are five challenges per analyte per event. Laboratories must get at least four of the five challenges correct (80), or the event will be considered as unsatisfactory; for most analytes in the specialty of immunohematology, the requirement for satisfactory performance is five of five challenges correct (100). There are no sanctions if the laboratory has an occasional, isolated unsatisfactory PT event for a specific PT analyte. However, if a laboratory has two unsatisfactory events out of three consecutive events, it will be cited with a deficiency for unsuccessful PT performance.http://hamlettocarinas.com/images/cap-drill-team-manual.pdf It is important to remember that a laboratory will usually obtain a score of 0 for an event if it does not submit its results to the PT program on time or fails to submit them at all. For example, if there is a problem with one or more challenge samples, perhaps due to contamination, which results in failure to achieve the required consensus to assign the target values to those sample(s), then all participants will pass the event with a 100 score. In other instances, individual laboratories may temporarily be excused from participating in PT, such as a case in which an analyzer is being repaired and not being used for patient testing or a natural disaster has occurred. In this type of extenuating circumstance, the laboratory can avoid an unsatisfactory score (and possibly the more serious unsuccessful score) provided it notifies CMS or its accreditation organization when factors beyond its control prevent normal performance of PT. In addition, in the specialty of hematology, the presence or absence of a certain cell type or the correct identification of various cells or cell inclusions are considered qualitative results. To be considered a correct PT result the answer must match the qualitative target value, i.e., the result that is considered to be correct. For qualitative analytes, the target value is determined by the overall participant consensus, or it may be established by a group of at least ten referee laboratories selected by the PT program. In either case, a minimum of 80 consensus is required to grade the challenge. As with qualitative analytes, for quantitative analytes the target value may be set using the overall average of participant responses, after removal of outliers, or it may be established by a minimum of ten referee laboratories. Although CLIA established the idea that a National Reference System for the Clinical Laboratory would use definitive or reference methods to establish targets, that approach was not possible, and it is uncommon to set the target value using a reference method. Quantitative analytes are not graded if there is not at least 80 agreement, which in this case means at least 80 of results are within the criteria for acceptable performance as specified in Subpart I of the CLIA regulations ( Table 3 and Figure 1 ). It is determined by the acceptance limit around a target value. This example shows two peer groups with different targets and different dispersions. In this example, the acceptance limits are 3 standard deviations (SDs) for each peer group. In this case, laboratories’ results are judged against the average results in their peer group. Peer grouping was determined to be necessary for many analytes because the modified constituents of PT samples can sometimes affect test results (matrix effects), and these inaccuracies cannot be corrected. The causes of matrix effects can include lyophilization (freeze-drying), addition of stabilizers and preservatives, and other manipulations that cause PT materials to behave differently than unmodified patient specimens. 10,11 These materials can work well to assess relative accuracy within a peer group, but they may not be useful to assess absolute accuracy if they are not commutable with patient specimens. The term “commutability” means that PT specimens behave like patient specimens when tested on different test systems. Commutability of PT specimens cannot be assumed unless unaltered patient specimens are used in PT, and this has not been possible for large scale PT programs, except in a few cases. Miller et al showed the viability of using patient materials for PT. 12 It uses unmodified patient materials that are not subject to matrix effects, so that there is only one target value, with no need for peer-grouping. 13 Early results suggest that this approach is feasible, at least on a limited scale. The advantage is that real differences between peer groups, for example due to calibration errors, are not ignored under the guise of matrix effects. CLIA does not require the use of unmodified, accuracy-based PT, but it is certainly permissible. The other concept that is important for establishing a criterion for acceptable performance for each analyte or test is the acceptance limit. Together, the target and acceptance limit constitute the criterion for acceptable performance ( Figure 1 ). Although PT programs have latitude in how they assemble peer groups, they must use the acceptance limits specified in Subpart I of CLIA for each required analyte. Acceptance limits are variously listed as percentages, concentration limits, or standard deviations. In several cases, mixed criteria are used to accommodate the relatively greater error observed at low concentrations for most test systems. Simple qualitative analytes allow only two ways results can be reported, while acceptance limits for tests expressed as dilutions are typically plus or minus two dilutions. CLIA requires that PT samples be tested in the same manner as patient specimens. For example, testing must be performed by integrating the sample into the normal patient workload, without assigning to the “best techs” for analysis, and without repeat testing, unless repeat testing is routinely performed on patient specimens. Of course, relevant documentation must be retained. For more explanation on the rules that apply to PT, readers are referred to Interpretive Guidelines for Laboratories and Laboratory Services (Appendix C) of the CLIA regulations ( ) or the CMS CLIA brochure on PT ( ). No flexibility in the application of sanctions was given to CMS to allow for cases in which a laboratory might arguably have been acting in good faith and intended merely to treat the PT sample as it would treat a patient specimen, including referring it to another laboratory for additional testing. It is important to avoid splitting a PT specimen for testing with any other laboratory that has a different CLIA number, whether internal or external to your laboratory system. Likewise, laboratory staff may not discuss PT results with laboratories in their system that have a different CLIA number or with external laboratory staff, as may be possible when they work two jobs. Rather, CLIA requires laboratories to enroll in PT for each subspecialty of microbiology (bacteriology, mycobacteriology, mycology, parasitology, and virology) for which they perform testing. It would not be feasible to require laboratories to test five challenges for every organism they might possibly encounter. Instead, the focus is on demonstrating overall proficiency to perform certain stains, detect or identify organisms in each subspecialty, and, in some cases, perform antimicrobial susceptibility testing, consistent with the laboratory’s level of service for patient testing. Individuals who do not achieve a passing score of 90 on the annual ten-slide test set must be retested. If the individual does not achieve a passing score on the second test, he or she must receive remediation, and gynecologic slides he or she examines must be rescreened before the individual is again retested using a 20-slide test set. If the individual does not achieve a passing score on the third test, he or she must cease examining gynecologic slides and receive 35 hours of continuing education in diagnostic cytopathology that focuses on the examination of gynecologic slides. The individual may not resume examining gynecologic slides until he or she achieves a passing score of 90. If the laboratory fails to ensure that individuals are tested and obtain the applicable retesting and required remediation, CMS will initiate immediate sanctions or limit the certificate to exclude cytology and may suspend Medicare and Medicaid payments for cytology testing. For each PT event, the criteria for acceptable performance for ABO group, Rh typing, and compatibility testing is 100 accuracy. For these analytes, a PT program must compare the laboratory’s response for each analyte with the response that reflects 100 agreement of ten or more referee laboratories or 95 or more of all participating laboratories to be considered satisfactory. For identification of unexpected antibodies, the requirement for satisfactory performance in the event is the same as other specialties: 80 of challenges must be correct. Readers who still have questions are encouraged to contact their PT program representatives, their accreditation organization or CMS state representative, as appropriate, or their state agency or CMS regional office:. See Table 3 for a list of analytes specifically required in Subpart I. Of course, voluntary participation in a PT program could meet this requirement, but there are other ways to verify accuracy. One method that can be used is splitting some patient specimens with a colleague in a nearby laboratory who uses the same test system. Readers can refer to Clinical and Laboratory Standards Institute’s (CLSI) GP29 14 for guidelines on ways that accuracy can be evaluated without participation in a formal PT program. In these cases, it is still necessary for the laboratory to do something to document that its test system is performing with acceptable accuracy. Failure to do so after an ungraded event may result in a deficiency citation. In this case, splitting patient specimens could demonstrate accuracy, and CLSI GP29 14 provides additional ideas. Which one do I use for PT? There is a separate CLIA requirement for evaluating and defining the relationship between test results for the same test or analyte performed using different methods or test systems. If your laboratory has not yet participated in the survey, your laboratory director or quality manager is encouraged to visit. CDC LPSB is currently working with CMS to update CLIA regulations for PT. Sponsored by PointofCareNet. June 15, 2012. f. Accessed June 28, 2013. Proficiency test performance as a predictor of accuracy of routine patient testing for theophylline. Clin Chem. 1993;39(1):76-81. Effectiveness of overt proficiency testing as a regulatory tool for assessing laboratory performance for blood lead. In: Krolak JM, O’Connor A, Thompson P, eds. Proceedings of 1995 Institute on Critical Issues in Health Laboratory Practice: Frontiers in Laboratory Practice Research. Atlanta, GA: Centers for Disease Control and Prevention. 1996:400. Abstract. Arch Pathol Lab Med. 1998;122(1):15-30. Variation in proficiency testing performance by testing site. JAMA. 1998;279(6):463-467. Proficiency testing performance in U.S. laboratories. Results reported to the Centers for Medicare and Medicaid Services, 1994 through 2006. Arch Pathol Lab Med. 2010;134(5):751-758. Two decades of development in the commutability of enzyme quality control materials. Arch Pathol Lab Med. 1993;117(4):352-364. Creatinine Measurement. State of the art in accuracy and interlaboratory harmonization. Arch Pathol Lab Med. 2005;129(3):297-304. Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline—Second Edition. CLSI document GP29-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008. All rights reserved. Please upgrade your browser or activate Google Chrome Frame to improve your experience. To furnish them with the services of either a laboratory director or a consultant, laboratory physicians have negotiated various contractual arrangements. Although no specific requirements have been imposed by any regulatory agency the medical profession accepts the premise that it is the responsibility of the visiting laboratory physician to adopt and implement acceptable standards of practice. The pathologist has multiple responsibilities - to the patient, the clinician and the hospital or institution. In many instances these responsibilities and other professional parameters affecting visiting laboratory physicians have not been spelled out or definitely established. Simply stated, it is hard for a laboratory physician to know whether he or she is fulfilling basic professional requirements when no formal guidelines exist. Moreover, government bodies, regulatory agencies, hospital administrators and clinicians need to be familiar with the role of visiting laboratory physicians in underserviced areas. Recently there have been recommendations 1,2 that pathologists in all laboratories, in consultation with clinicians, develop protocols for requesting tests, investigate the advantages of cooperating with laboratories in other districts and make the best use of capital equipment. Despite the time limitations of a visiting pathologist it is essential in areas where access to pathologists is difficult that these medical specialist services be provided for the diagnosis, treatment and monitoring of disease. The efficient use of diagnostic tests, utilization reviews and the cost-effective delivery of laboratory services are other priorities. A cooperative relationship between clinicians and laboratory physicians should result in substantial clinical and economic benefits and in improved performance by both groups. The Section of Clinical Pathology of the Canadian Association of Pathologist (CAP) formulated guidelines that were published in draft form early in 1991 3 after review by the provincial associations of patologists and the provincial colleges of physicians and surgeons. The comments of the provincial colleges are in Appendix 1. The guidelines were finally approved by the CAP executive and council June 23, 1991. Role of pathologist The pathologist must be involved in the technical aspects of the laboratory operation to properly assume final responsibility as the laboratory physician. The depth of involvement must be sufficient to ensure reliable results, which depend also on the presence of a well-trained chief technologist and technologists who carefully follow the instructions of the laboratory physician as defined in the contractual agreement. The services provided by the laboratory physician include supervision of clinical areas, chemistry, hematology, blood bank, microbiology, surgical pathology, cytology and autopsies. For these services, he or she is responsible for the timely production of medically useful and accurate information. Role of laboratory manager In many instances the laboratory physician is simply unable to shoulder his or her professional activities and provide personal care while administering another laboratory. In such situations he or she is not required to perform all the responsibilities personally: an on-site laboratory worker can be designated to assume various duties. The laboratory manager is responsible for overseeing the entire operation of the laboratory in accordance with the instructions of the laboratory director, to whom he or she reports and who is ultimately responsible for the operation of the laboratory. These precepts have been recognized and accepted by administrators and external licensing bodies. Relationship to institutions without an on-site pathologist A pathologist faced with the responsibility of providing laboratory services usually has to custom build a system that can function effectively within the limitations of the particular institution and the pathologist's time, while ensuring high-quality services. The scope of activities provided depends on whether the pathologist is a director of the laboratory or a consultant, a generalist or a subspecialist. (A medical director of laboratories and a consultant laboratory physician are medical practitioners who have been certified by the Royal College of Physicians and Surgeons of Canada in general pathology or in a laboratory subspecialty or have specialist qualifications deemed equivalent; their responsibilities are discussed later.) The contractual agreement with the institution also governs the range of duties. Contracts can be made with or without appropriate legal counsel. The number of laboratories that a pathologist can supervise is governed by his or her ability and by individual provincial licensing authorities. Laboratories in remote areas have difficulty in recruiting the services of a laboratory physician, and some pathologists may be required to service many laboratories. The laboratory physician is expected to confer with the administrator, laboratory manager and medical staff to identify hospital and laboratory needs. He or she should be a member of the local medical advisory committee. Personal on-site discussions are important, and periodic telephone conferences with the administrator, laboratory manager and medical staff are also helpful. Regularly scheduled visits are essential, the frequency depending on the needs of the particular facility and staff. Visits may be supplemented by scheduled visits from other pathologists in a group practice or by a medical technologist supervisor. Coverage for weekends and vacations may be necessary. Responsibilities of a medical director of laboratories The responsibilities of a laboratory director are diverse. The director is responsible for the administration and technical operation of the laboratory to ensure high-quality service. The instruments, equipment and technologies should be up to date, meet the hospital's needs and match the resources allocated to maintain the service. Staffing levels must be adequate. Budget preparation, cost accounting, employee selection and supervision of all delegated tests are important aspects of the director's role. Other key factors are instrument and supply purchase, management of personnel, quality assurance, quality control, safety, appropriate disposal of waster, and the addition of new tests and the elimination of old ones. The laboratory director is responsible for the inspection, accreditation and proficiency testing of the laboratory by external agencies. Responsibilities of a consultant laboratory physician The primary function of a laboratory consultant is to provide expertise and professional services as a full or subspecialty consultant and as an adviser. The consultant does not have the wide range of functions of a laboratory director and is not legally accountable for the entire laboratory operation. Although the consultant is not responsible for the inspection, accreditation or proficiency testing of the laboratory by external agencies, the consultant may act as an adviser and may assist in such practices. Recommendations For laboratories without an on-site laboratory physician the medical director has direct authority over or the consultant advises on the following duties. Administrative duties We thank the representatives of the provincial associations of pathologists and the provincial colleges of physicians and surgeons who reviewed and contributed to the final document. We thank Dr. E. Anne Shuttleworth, of Calgary Diagnostic Laboratories, and Dr. Trygve E. Larsen, of Calgary Medical Laboratories, for specific contributions to the recommendations in this article. References 1. Audit Commission: The Pathology Services: a Management Review, HMSO, London, 1991 2. The well-managed laboratory, BMJ 1991; 302:198-199 3. Rasaiah B, Hoag G: Guidelines for a laboratory physician who acts as director or visiting consultant to a laboratory without an on-site pathologist. Canadian Association of Pathologists Newsletter 1991;34 (1): 5-7 Appendix 1: Specific comments of provincial colleges of physicians and surgeons on the draft guidelines for laboratory physicians acting as directors of or visiting consultants to laboratories without an on-site pathologist College of Physicians and Surgeons of British Columbia: To take or collect human samples, perform laboratory tests on them, and express test results and possibly an opinion on those results fall within the practice of medicine as defined in section 72 of the Medical Practitioners Act of British Columbia, 1979, and, as such, must remain the final responsibility of a physician duly qualified and licensed by the college (Dr.Thomas F. Handley, registrar of the college: personal communication, 1990). College of Physicians and Surgeons of Saskatchewan: As a means of dealing with the concerns of laboratory management and with issues of resource allocation the provincial government introduced the Medical Laboratory Licensing Act in 1989. However, the regulations under that act are still in the final stages of development. When available a copy of them can be obtained from Ms. Pauline Rousseau, director of support services and regulatory affairs, Laboratory and Disease Control Services Branch, Saskatchewan Health, 3211 Albert St., Regina, SK S4S 5W6 (Dr. Dennis A. Kendel, registrar of the college: personal communication, 1990). College of Physicians and Surgeons of Manitoba: The laboratory physician is the person responsible for the overall operation of the laboratory. The pathologist may delegate certain tasks to qualified people, but an experienced medical laboratory technologist must be on site for such tasks to be adequately carried out.