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TOPIC: MTE 360 Lab operation
: 15.04.2017 19:10
MTE 360: Lab Operations, Management, and Education LASA 3 â€“ Instrument Selection and Method Validation Exercises Background Selecting new instruments, determining the need for new test methodologies, and coordinating method evaluation studies are necessary skills for the laboratory manager. For this final LASA in MTE 360 you will complete three exercises: (1) Research and comparison of two instruments, (2) Evaluation of instrument selection case studies, and (3) Evaluation of method validation scenarios. Instructions for each exercise are listed below. The instrument selection case studies and method validation scenarios are uploaded as separate documents in Doc sharing. Please contact the instructor if you have any questions about how to proceed with the assignment after you have reviewed the instructions. Instructions â€“ Instrument Comparison Exercise You are a laboratory manager and have been given the task of selecting a new instrument to replace outdated equipment in your facility. This project is still in the early stages, so your supervisor has requested that you select two instruments and develop a comparison table that will be used by the managerial team when the final decision is made. Follow the instructions below to complete this exercise: 1. Select two specific examples of instruments from one of the following categories â€¢ Categories â€¢ Hematology analyzer (capable of performing cell counts, reticulocyte count, and 5 part differential) â€¢ Coagulation analyzer (capable of performing routine coagulation assays as well as factor and inhibitor assays) â€¢ Chemistry analyzer (capable of performing assays for electrolytes, enzymes, proteins, and hormones) â€¢ Histology tissue processor â€¢ Histology embedding center 2. Submit your category and instrument choices to the Instrument Comparison Topic Selection dropbox in module 11 3. Research your selected instruments and put together a comparison table that includes the following (at minimum, although you may choose to provide more information): â€¢ Tests/functions that can be performed by selected instruments â€¢ Reagent/Supply needs â€¢ General information about type and stability, donâ€™t need to evaluate cost! â€¢ Throughput â€¢ Ease of operation â€¢ Review information from manufacturer and determine level of expertise needed to operate the selected instrument â€¢ Ability for expansion â€¢ Can more tests/more procedures be added at later date? Can modules be added on to increase functionality of instrument? â€¢ Calibration and quality control requirements â€¢ Size of instrument, special electrical or plumbing needs Instructions â€“ Instrument Selection Case Studies 1. Download the document titled â€œLASA 3 Instrument Selection Case Studiesâ€ 2. Review each case study, describe the key needs that need to be addressed when selecting a new instrument, and use the internet to identify 2 possible instruments that could meet the needs you have identified. Instructions â€“ Method Validation Scenarios 1. Download the document titled LASA 3 Method Validation Scenariosâ€ 2. Review each scenario and answer the associated questions. a. NOTE: Some scenarios may require you to perform calculations. You may perform these calculations manually or using an Excel spreadsheet. Regardless of which method you use to perform calculations, you must show your work to receive full credit, by attaching the appropriate documents. Contact your instructor if you have questions about this requirement. Submission Instructions Submit the selected category and names of the two instruments you have chosen to compare to the appropriate drop box by the end of module 11. All exercises must be completed and submitted by the end of the term, including any supporting documents (i.e. Excel spreadsheets). The exact due date can be found on the current semester lecture schedule. The assignment is worth 50 points. Good luck! MTE 360: Lab Operations, Management, and Education LASA 3 â€“ Instrument Selection Case Studies Review each case study, describe the key needs that need to be addressed when selecting a new instrument, and use the internet to identify 2 possible instruments that could meet the needs you have identified. Case 1 You are the supervisor of a laboratory in a thirty-bed hospital that is located fifty miles from a major medical center. Your facility has no emergency room and airlifts criticalpatients to the medical center. There is no obstetrics service, but there are two operating rooms and approximately fifteen surgeries are performed per week. There is no outpatient clinic, so all samples tested are from patients in your facility. The bulk of the work is routine testing (general chemistries) presurgery and testing of routine medical patients (diabetics, alcoholics, the elderly, physical exams, etc.) The average number of chemistry tests per week is around 3500. Approximately 85% of testing is done on the 7 a.m. to 3 p.m. shift. Less than 10% of testing is done on a STAT basis. Your old instrument for chemistry testing is on its last legs. You need to determine what type of new instrument to buy In a meeting with the pathologist, he states that no expansion Is planned for the next five to seven years, that cost containment is a primary consideration (especially labor costs), and that the patient load should remain about the same. The physicians at the facility feel more profits could be generated if a grater variety of tests were availableinstead of sending so many tests to the referencelab. They especially wish to monitor the drug levels (for prescribed medications) in their elderly patients. They also wouldlike more exotic tests done besides electrolytes and general chemistries. 1. What are at least three key needs (features) that need to be addressed when selecting a new chemistry analyzer? 2. Identify two instruments that could meet the needs you have identified for this facility? Case 2 You are a medical technologist in a larger reference lab in a major metropolitan area. You collect samples in your facility, but the majority are collected from physiciansâ€™ offices in fifteen surrounding counties. Most of the samples enter your facility after 3 p.m. because of the distances traveled from office to you; few of the samples are emergencies. One of your advertised policies is that all routine hematology and chemistry panels will be performed and the data transmitted to the physiciansâ€™ office before 8 a.m. the next day. Special and unusual tests are guaranteed within two days. Your supervisor has asked you as a technologist working in the chemistry laboratory to serve on an advisory committee to determine which new chemistry analyzer the laboratory needs. Currently you perform chemistry panels on approximately 1600 patients per night, and most are 24 tests per panel. Your goal is to complete all testing between 3 p.m. and 6 a.m. At the first committee meeting the pathologist outlines his concerns, which include improved safety, increasing the workload ten percent a year for the next five years, and keeping personnel costs minimum. No new technologists will be hired in the next two years, although workload will increase. Routine test panels are the main emphasis and job of this lab, and other instruments will handle the special and unusual testing 1. What are at least three key needs (features) that need to be addressed when selecting a new chemistry analyzer? 2. Identify two instruments that could meet the needs you have identified for this facility? Case 3 You are a technologist in a very large medical center and have been working in clinical chemistry for ten years. The medical center ahs in excess of 1500 beds in three buildings, and also has very large day surgery and ambulatory care centers. The center has a class I (level I) trauma center and treats more than 600 cases per month of life-threatening trauma and 6000 les serious emergency cases per month. The five=year management plan for the center includes expansion of emergency services. During the planning stages of the expanded trauma facility, the committee has discovered that the doctors at the emergency facilities are dissatisfied with the lab services provided. They are pleased with the large array of specialty and unusual tests the large lab can provided, but do not feel that the tests needed in an emergency (usually Na, K, CO2, Cl, glucose, BUN, and enyzmes for heart attack) are done quickly enough. It has been proposed that a new lab facility for emergency testing only be opened in the new trauma center. You have been asked to become the chemistry supervisor of this new lab and are to present a proposal detailing the kind of instrumentation you will need. 1. What are at least three key needs (features) that need to be addressed when selecting a new chemistry analyzer? 2. Identify two instruments that could meet the needs you have identified for this facility? MTE 360: Lab Operations, Management, and Education LASA 3 â€“ Method Validation Scenarios Review each scenario and answer the associated questions. Scenario 1 Several of the internal medicine physicians went to a workshop recently and learned about a new test method. They returned to the hospital and came to the laboratory requesting that you implement this new test method. The following are the facts you determine after researching the new method: Old Method New Method Cost per Specimen = $5.00/test Cost per Specimen = $20/test Diagnostic Specificity = 90% Diagnostic Specificity = 98% Diagnostic Sensitivity = 95% Diagnostic Sensitivity = 98% Already have instrumentation Requires purchase of new instrument Tech time = 2 hours Tech time = 1.5 hours Simple to perform Difficult to perform 1. Compose a formal report with your recommendation regarding which method to pursue and the reasons for your recommendation. Scenario 2 You have just accepted the position as administrative chief technologist at Tishomingo Lake medical Center in Corinth, Mississippi. This facility is a 68-bed acute-care facility that includes general medical, surgical, cardiac, and emergency services. The nearest two medical facilities are approximately 100 miles in proximity (one is located to the west in Southaven, Mississippi with a bed size of 160, and one is located to the south in Tupelo, Mississippi, with a bed size of 450). Your facility is staffed with 15 full-time physicians, 45 nurses, 3 phlebotomists (one for each laboratory shift), and 12 clinical laboratory scientists (6 on day shift, 3 on evening shift, and three on night shift). There are no section supervisors and all changes in laboratory policy and procedure, whether it is purchasing or leasing new equipment, changing test methods, or requesting time off must meet with your approval. This facility may not be compared to the 650-bed acute-care facility in Memphis Tennessee, where you previouslyworked as transfusion services supervisor. At that facility, you were a specialist in blood bank and rarely performed any type of testing in other departments in the laboratory, and only made decisions in regard to updating or changing blood bank policy and procedures. A sales representative from JADA Corporation is currently soliciting your laboratory to purchase a new D-Dimer test for the detection of deep vein thrombosis and/or pulmonary embolism 1. What is the first thing you should do before implementing this particular assay? 2. What are two examples of questions that you should ask the sales representative concerning this new test? Why should you ask these questions? 3. What are some examples of research (besides interviewing the vendor) that may be necessary before deciding to add this particular assay to your laboratory test menu? Why should you utilize these research avenues? Scenario 3 You are the lead technologist in the clinical chemistry department and have been assigned to evaluate the results of several comparison studies in progress. The first study is evaluating two different kits used to measure urine hCG to detect pregnancy. The second study is evaluating two methods used to measure glucose concentrations. The third study is evaluating two methods used to measure tacrolimus concentrations. 1. Calculate the sensitivity, specificity, efficiency, positive predictive value, and negative predictive value for the new hCG test method, using the results in the table below Pregnant? Positive Urine hCG test Negative Urine hCG test Yes 42 60 No 7 168 2. A precision study was performed using the new glucose methodology and a standard with the known concentration of 120 mg/dL. Testing was performed over several days on each shift, and the following results were obtained: 18, 120, 121, 119, 125, 118, 122, 116, 124, 123, 117, 117, 121, 120, 120, 119, 121, 123, 120, and 122. Calculate the mean, SD, and %CV for the standard used in the glucose precision study, and determine if the precision is acceptable. 3. A recovery study was performed using the new tacrolimus methodology. Use the results from the table below to calculate the percent recovery for each of the individual experiments and the average of all recovery experiments. What do the results of this study indicate? Sample 0.9 mL Blood + 0.1 mL of Water 0.9 mL Blood + 0.1 mL of 50 Î¼g/L Standard 0.9 mL Blood + 0.1 mL of 100 Î¼g/L Standard A 6.0 11.0 15.6 B 6.3 11.2 16.0 C 8.6 13.6 18.5 D 13.0 17.8 23.1 E 22.5 27.0 32.0 4. An interference study was performed during the method evaluation for the new glucose test. The experiments were performed by adding 0.1 mL of a 150 mg/dL ascorbic acid standard to 0.9 mL of five different patient samples. A similar dilution was prepared for each patient sample using water as the diluent. Use the interference data in the table below to calculate the concentration of bilirubin added the interference for each individual sample, and the average interference for the group of patient samples. What do the results of this study indicate? Sample 0.9 mL Serum + 0.1 mL of Water 0.9 mL Serum + 0.1 mL of Bilirubin Standard A 54 40 B 99 80 C 122 101 D 162 133 E 297 256
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