IE 403 – Quality Planning and Control - A Mysterious Disease Case Study - Nursing Assignment Help

Assignment Task :

Case Study
Sensitivity: Public
On January 7 2020 CNN’s Health editors have published an article called “A mysterious virus is making China (and the rest of Asia) nervous. It's not SARS, so what is it?”. As the Quality Director in a reputable Turkish hospital chain, you have started to monitor the latest developments and the academic publications closely. The following are the chronological data you have processed.
 

Part 1
A total of 59 cases of unknown viral pneumonia have been reported in the city of Wuhan, central China, with seven patients in critical condition, the Wuhan Municipal Health Commission said in a statement on Sunday, January 5th that all patients are being treated in quarantine, and no deaths have been reported by that specific date. According to the Wuhan health commission, the infection broke out between December 12 and December 29, with some of the patients employed at a seafood market in the city. Local media reported that the virus might have been transmitted to humans from animals including birds, rabbits and snakes sold in the market.
Later on, researchers at the hospital in Wuhan have identified a coronavirus as the agent responsible for infection. They started taking records of the patients hospitalized with the following parameters.
• age (in years)
• market encounter (customer / worker)
• incubation period (in days)
The researchers have continued monitoring the patients closely and have also reported the following parameters for all of the first 59 patients in order to understand the mechanisms of the virus.
• hospitalization period (in days)
• time in intensive care unit (in days)
• ventilator required (yes/no)
• total infection time (in days calculated by incubation time + hospitalization time)
• status after hospitalization (X - dead / recovered)
The related data is given in Wuhan.mtw of the project file.
1. What is the mean, median and standard deviation of age of patients infected with the virus? Also show the distribution of data with graphical and statistical tools and comment.
2. What is the 95% confidence interval of the age of infected patients? Using the preliminary information you have acquired with question 1 and 2, what will be first announcement for precaution that you should report to authorities?
3. Is the data normally distributed for incubation period?
4. Is the average and standard deviation of incubation period varying with respect to market encounter? What is the practical interpretation of this result?
 

Case Study
Sensitivity: Public
5. What is the power of the test you have conducted in question 4 if 2 days is a significant difference to be observed between average of incubation time of groups of different market encounter?
6. Is there a relationship between incubation period and hospitalization period? Comment using graphs and statistical proofs by calculating the correlation coefficient.
7. Is there a relationship between total infection period vs. age and market encounter of patients? Comment using graphs and statistical proofs. What is the relationship equation and how much of the variation is explained by the model?
8. Are the assumptions of the model violated or not for question 7?
9. What will be the predicted average and standard deviation of total infection period for a customer in the age of 55?
10. Since the total infection period is calculated by addition of incubation period and hospitalization period, compare the individual averages and standard deviations of all three distributions graphically and statistically. Comment on the findings.
11. Model the relationship between status after hospitalization as the output and the factors of age and ventilator requirement. What is the event probability graph for recovery?
12. Are the assumptions of the model violated or not for question 11? How much of the variation is explained by the model?
13. What will be the predicted probability of recovery of a patient in the age of 75 with no ventilator requirement?
14. Based on the ratio of patients requiring ICU care and ventilators, what is the expected number of ICU beds and ventilators required for hospitalized patients in the Wuhan region if you estimate that 1% of the total population of 20 million will be diagnosed and hospitalized with the virus? What does this mean in practice?
15. Please compare the death rate of the first outbreak of this epidemic with the previous SARS epidemic whose recorded numbers equal 8,437 infected persons with 813 deaths over the course of 2 years. Are the death rates the same or different? If so, is your interpretation sound?
16. According to epidemiologic data, a person exposed to SARS enters an incubation period with a mean length of 6.4 days. Is the incubation time for this novel epidemic the same or greater than that of SARS?
 

Case Study
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Part 2
Wuhan Health Authority has reported the cases to the World Health Organization which has indeed called for other measures to be taken in prevention of the spread and discovery of a diagnosis of the viral infection and thereby lead to the creation of effective treatment methods. Today, there are tests for the virus itself, but there are also blood tests showing immunity or antibodies. The medicinal name that is given to the “regular” measurement of viral contamination is Real-time reverse transcriptase–polymerase chain reaction (rRT-PCR). A new rapid test offers results in minutes rather than hours or days, but deployment is yet to be defined.
Testing is important because asking people with mild symptoms just to stay home will lead to more infections in the household and community. If tested and positive, people can either be isolated in a facility or put on strict home isolation.
As the Quality Director you are now facing similar cases in Turkey and are testing the possible patients with the regular testing kits that require 4 days to complete. You have also acquired some rapid test kits from China and are interested in if these kits are as reliable as the regular method. You have initiated a study to investigate the capability of measuring the virus contamination concentration of patients in counts of viral presence. According to literature, a patient is said to be positive if the contamination level is greater than 15,9 million.
After the validation studies of the test measurements, different froups of 10 patients These patients were later subjected to 3 different protocols in order to discover the best treatment method. The patients’ viral contamination are measured as they are hospitalized and after 10 days of treatment with the potential treatment protocol using the regular test kit. Treatment 2 is the control group where the treatment is actually not a drug but a placebo.
The related data is given in test_kit.mtw. of the project file.
17. Looking at the description and sequence of the measurement procedure, what are the possible problems that the analyzer might be faced with?
18. Compare the measurement system capability for both of the test methods and comment on the results. Interpret the graphical output and the session window output.
19. What does the R chart represent in the Gage R&R graph?
20. If the patients are analyzed in the measurement analysis study is a representative sample of patients who come to the hospital for diagnosis, what is the likelihood of patients to be tested as negative?
21. Analyze the distribution of effectiveness of each treatment in terms of normality and comment.
22. What are the 95 % confidence intervals of average treatment effectiveness for each treatment?
23. Is there a difference in the variation of the effectiveness of different treatments? State your hypotheses and comment.

Case Study
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24. Is there a difference in the average of the effectiveness of different treatments? State your hypotheses and comment.
25. Are the assumptions of the model fulfilled or do you see any peculiarities? If so what can you do to prevent it from happening?
26. How much of the variation of effectiveness is explained by your model?
27. What is the best treatment method to be used from here on and what are the expected average and standard deviation of virus contamination reduction?
28. What is the maximum difference that you can see in effectiveness with a power value of 80 % and 90%?
 

Case Study
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Part 3
As the Quality Director, you have immediately asked your team to install thermal cameras at the entrance and various locations in the hospital as a necessary measure against prevention of the spread of the disease. After installation, you have sampled some visitors to pass underneath all the cameras twice and have recorded their fever in a OK/NOK scale. You have then transferred the visitors to a desk in the Emergency Room and their temperature is taken with a mouth thermometer; if the reading is higher than 38 degrees Centigrade, they are reported as having high fever.
Learning from the cases in Wuhan, in your baseline scenario you have estimated that 46% of infected patients would not be detected, depending on incubation period, sensitivity of exit and entry screening, and proportion of asymptomatic cases.
The related data is given in thermal_canera.mtw. of the project file.
29. Looking at the description and sequence of the measurement procedure, what are the possible problems that the analyzer might be faced with?
30. Compare the measurement system capability for all of the cameras and the ER’s manual control and comment on the results. Interpret the graphical output and the session window output.
31. Analyze how the Kappa statistics relate to your conclusions and identify the best camera that needs to be used if you are to make a selection.
32. Elaborate on the directors’s method in the set-up of the thermal cameras and the resulting capability analysis. If you were in his position, what would you do differently?
33. If Camera 1 is installed in the general entry to the hospital, compare your screening performance with your baseline scenario and comment.
34. If you do not use the cameras but instead do all the temperature measurements manually in the ER, how would your results compare to the scenario then?
 

Case Study
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Part 4
As the Quality Director, you are also very much concerned with the number of cases in Turkey and are closely monitoring the daily numbers reported by the Turkish Ministry of Health that contain the following information daily:
• Number of tests
• Confirmed cases
• Deaths
• Recoveries
• Severe cases in ICU
• Intubated patients
As of April 5, the related data and some cumulative figures are given in Yurkey.mtw. of the project file.
35. Design the necessary graphical control charts that you need to use to monitor the process.
36. Do you see any trends or shifts or any other special cause signals in the data? Why or why not? What do they mean and how can you reconstruct the graph to create a hypothesis?
37. If you compare the situation of Turkey with Germany’s figures of confirmed cases equaling 100.132 and deaths of 1.584 people are the mortality rates of these countries the same or different?
38. What is the power of the test that you have just done to compare Turkey’s and Germany’s death rates?

Case Study
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Part 5
The Medical Director of your hospital wants you to investigate the biodistribution of the virus among different tissues of patients confirmed with COVID-19 disease diagnosed based on symptoms and radiology. Based on clinical indications, from January 1 through February 17, patients are chosen and their specimens are collected. There were 1070 specimens collected from 205 patients with COVID-19 who were a mean age of 44 years (range, 5-67 years) and 68% male. Most of the patients presented with fever, dry cough, and fatigue; 19% of patients had severe illness. As given in the table below, bronchoalveolar lavage fluid specimens showed the highest positive rates (14 of 15; 93%), followed bysputum (72 of 104; 72%), nasal swabs (5 of 8; 63%), fibrobronchoscope brush biopsy (6 of 13; 46%), pharyngeal swabs (126 of 398; 32%), feces (44 of 153; 29%), and blood (3 of 307; 1%). None of the 72 urine specimens tested positive.
Additionally, bronchoalveolar lavage fluid and fibrobronchoscope brush biopsy were sampled from patients with severe illness or undergoing mechanical ventilation. RNA was from clinical specimens and determined by rRT-PCR. The cycle threshold values of rRT-PCR were used as indicators of the copy number of COVID-19 in specimens with lower cycle threshold values corresponding to higher viral copy numbers. A cycle threshold value less than 40 is interpreted as positive for COVID-19 RNA.

39. Using the data from the table, design and analyze the comparison table for bronchoalveolar lavage fluid, sputum, nasal swabs, fibrobronchoscope brush biopsy, pharyngeal swabs, feces, blood and urine specimens. Is there a significant difference
 

Case Study
Sensitivity: Public between the specimens for measurement accuracy? State your hypotheses and comment using p-values.
40. Is there a difference in the average of the cycle thresholds of different specimens? State your hypotheses, graphically express the findings and comment.
41. Since the cycle threshold value less than 40 is interpreted as positive for COVID-19 RNA, which specimen will you continue to use in the future? Why?
42. Using the specimen you have identified in question 41, calculate the sigma level and report the expected ppm outside the limit.
 

Case Study
Sensitivity: Public

Part 6
As human-to-human transmissions have been described with incubation times between 2-10 days, facilitating its spread via droplets, contaminated hands or surfaces. The analysis of past studies reveals that human coronaviruses such as Severe Acute Respiratory Syndrome (SARS) coronavirus, Middle East Respiratory Syndrome (MERS) coronavirus or endemic human coronaviruses (HCoV) can persist on inanimate surfaces like metal, glass or plastic but can be possibly inactivated by surface disinfection procedures with 62-71% ethanol (cologne), 0.5% hydrogen peroxide (bleach) or 0.1% sodium hypochlorite and other biocidal agents such as 0.05-0.2% benzalkonium chloride or 0.02% chlorhexidine digluconate. As the Quality Director, you want to determine the most effective way of cleaning all the hospital floors and recommend a method of application of the chemical disinfectants as well.

• Inputs Levels Values Surface 3 glass; metal; plastic Cleaning_agent 5 ethanol; hydrogen peroxide; sodium
• hypochlorite; benzalkonium chloride; chlorhexidine digluconate
• Cleaning_duration 2 20; 30 Cleaning_method 2 manual; automatic
• Temperature continuous measurement
• Humidity continuous measurement

Output: % reduction in viral activity (objective is maximization)
The related data is given in cleaning.mtw. of the project file.
43. Analyze the relationship between the inputs and output and create your model. Write down the relationship equation.
44. How much of the variation in the output is explained by the model? Is this a satisfactory level?
45. Are the assumptions of the model fulfilled? Do you see any peculiarities?
46. How can you show the results of your study to your management team and that will be the suggestion that you will issue to the hospital staff and also the public in general?
47. What is the optimal factor setting and what is the best level that you will be able to get with the optimal values of the inputs?
48. If the LSL for virus removal is 90%, what will be the Cpk at the optimal settings? Is this a satisfactory level?
49. By taking into consideration your optimal cleaning agent, design an Acceptance Sampling plan and prepare a work instruction that you can send to your Purchasing Department .
50. You want to design an FMEA study for the cleaning process of the hospital. Please indicate potential risks, their severity and probability of occurrence and prioritize the risks based on RPN calculation.
 

Case Study

Part 7
Previous studies have supported an epidemiological hypothesis that cold and dry (low absolute humidity) environments facilitate the survival and spread of droplet-mediated viral diseases, and warm and humid environments see attenuated viral transmission. However, the role of absolute humidity in transmission of COVID-19 has not yet been established. As the Quality Director and a reputable disease expert, you will be asked for an interview on TV. You have a week before the interview and want to design a laboratory experiment to test the effect of ambient temperature and humidity on the transmission activity of the virus. This study is critically important in order to estimate the magnitude of the outbreak as spring and summer months will be soon arriving in the North Hemisphere..
51. Elaborate on the procedure and checklist for designing such an experiment Hoew di you decide on the inputs and their range of the levels?
52. Design your fictitious experiment, create a dataset yourself and analyze using Minitab. Report your findings as you will do on the TV show. Submit your worksheet and analysis in a separate Minitab project file.
53. Create an activity flowchart for your interns to follow if they are to repeat a similar experiment.
54. What are the values you have specified for Type I error and Type II error and why?
55. During the times of a contagious outbreak, what will be a typical Kano Model that you need to draw taking into requirements of all stakeholders such as the hospitalized patients, caretakers of hospitalized patients, regular incoming patients, doctors, nurses, public and state health officials.
56. As the Quality Director, what will be the key elements of a Quality System that you should have applied during “normal” times and how should you adjust them to handle the times of crisis?

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