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INDT1170 Introduction To Total Quality Management

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INDT1170 Introduction To Total Quality Management

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Course Code: INDT1170
University: Northeast Community College

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Country: United States


You will begin an in-depth evaluation of a serious lapse in patient safety and organizational quality. As you read the case and dig deeper into the case through your own research, you will learn of lapses that occurred. In M5A1, you will focus on the facts of the case to learn what went wrong in terms of quality processes and requirements, and probable reasons why things went so wrong.  You will conclude your paper in M7A1 by sharing evidence-based recommendations for quality improvement so that this situation never occurs again at this organization.
Review the story of the medical error Dennis and Kimberly Quaid’s infant twins experienced at Cedars-Sinai Hospital in 2007. This 60 Minutes video should get you started in your exploration.

First, in your own words, describe what happened .
Next, apply the focus Model (found in your text) to investigate and determine what went wrong. Note that this week, you will only apply the F, O, C, and U. In Module 7, you will focus exclusively on the S or selection of a process improvement.
Find 3 related breakdowns in processes, requirements, regulations, or policy that highlight need for improvement.
Organizeor choose your team that could help you in your work. Who in that organization would know what happened and how to fix it?
Clarify your knowledge at the time of the case. What were the existing processes at the time of the error? 
Understand what variables broke down within each of the 3 processes you chose. Here you will do a brief literature search around these three processes to inform your understanding.

Total Quality Management : Dennis and Kimberly Quaid’s infant twins Medical Error
Having stayed for quite some time without having children due to miscarriages, Dennis and Kimberly Quaid could not have felt more blessed on finally having twins, Thomas Boone and Zoe Grace, through surrogacy. However, their happiness turned into sorrow and anguish following wrong medication at the Cedars-Sinai hospital which almost cost the infants’ lives. A few days after the parents and the infants arrived home, Thomas and Zoe contracted Staph infection and the family doctor recommends that they are taken to Cedars-Sinai hospital for treatment. The infants were treated with intravenous antibiotics and they seemed to respond well to treatment to the extent that the parents felt that they were in safe hands and went home to rest. Back at the hospital, the nurse on duty mistakenly injected the twins with an overdose of a blood thinner. Instead of HEP-LOCK, the blood thinner for infants, the twins were given Heparin, the adult version of the chemical which is a thousand times stronger. Heparin is usually given during the administration of medications through IV and its main function is to prevent blood clotting and keep the IV lines clear (Keers, Williams, Cooke, & Ashcroft, 2013). Given that the children were given two doses of the adult drug, they were essentially massively overdosed. The doctors were able to stabilize the children and they were later discharged. The drug administration era was not unique as it happens often across the globe (Yin, Dreyer, Moreira, van Schaick, Rodriguez, Boettger, et al., 2014).
Various actors bear responsibility for the overdose of the infants. First, the company that manufactures the drug, Baxter, packs the two drugs in almost similar packs with the only differentiating features being the labeling and a slight difference in the color of the cap and the wrapper. The similarity of the two medications lends it to easy confusion. Second, the pharmacy technician was negligent in that she or he did not do due diligence in the sorting of the drugs and placed the two in the same container. Finally, the nurse in a hurry picked one of the containers and proceeded to administer the drug, in total disregard of the cardinal rule in drug administration which is a careful reading of the labels (Kroft, Rosen, & CBS News, 2008). However, the pharmacy technician and the nurse on duty bear the greatest responsibility in the drug overdose of the twins.
F (Find)
There were various breakdowns in the process that culminated with the Quaid tins receiving the wrong dosage.

The first breakdown in the process was the pharmacy technician’s inability to and separate the two drugs (the one for the adults and the one for infants). The drug’s packaging appeared to resemble each other in almost every aspect including similar size and closely related color of the labels. These factors may have contributed to the drugs confusion, and the pharmacy technician trusting his/her familiarity with the medicines did not carefully read the labels on the drugs. The two different drugs, therefore, found their way into the same bin.
The second breakdown in the medical administration process occurred when the nurse in charge of administering the drugs failed to carefully read the labels on the medicine pack and match the same with the patients to be given the medication. The nurse was confident that the drugs were correct as they were in the right bin and by and large looked similar. However, the drugs confusion by the intern is no excuse for the nurse’s failure in the job. The nurse was supposed to read the label carefully and compare the same with the doctor’s prescription and the patient’s name before going ahead to administer the drugs to the Quaid twins.  
The third breakdown in the process is that the nurse did not communicate with the parents on the drugs that twins were receiving. It is possible that while communicating with the parents, the nurse could have checked the labels on the package and realize the mistake before administering it, or before giving the second dose.         

O (Organize)
The quality assurance team that would ensure proper drug administration process would include a pharmacy technician, a nurse, senior nurse, and the senior administrators. These are the people who are in a position to know what went wrong in the process and, therefore, can be depended on to come up with relevant ideas that can help prevent such future occurrences.   
C (Clarify)
At the point of the occurrence of the mistake, the hospital, like all other hospitals, had procedures and processes in place to ensure that such mistakes do not occur. In drug administrations, the procedure to be followed in the safe administration of medication involves ensuring that the five Rs are taken into consideration. The first R deals with the issue of ensuring that it is the right patient that the medication is aimed at. It is a common procedure to employ a three-factor procedure to identify the right person. In Sinai-Cedars hospital, they used the name and age of the patient and the name of the medication to ensure they have the right patient.  After identifying the right person, the second R deals with ensuring that it is the right medication. The nurse confirms the information from the doctor’s prescription form before proceeding with the process. While confirming the correctness of the medication, the nurse makes sure that it is the right time and the right dosage. Finally, the nurse ensures that the process of delivery for the medication is right, also known as the right route (Pham, Story, Hicks, et al., 2011).  These were the existing processes at the time the medical overdose error occurred and because the nurses had performed hundreds of these checks before, they felt confident enough to administer the heparin to the without carefully scrutinizing the medicine.
The manufacturers of the drugs were at fault for the similarity of the vials, and the pharmacy technician was also at fault for mixing the two vials at the bin. However, if the nurse had not assumed some issues in the process like failure to make actual reading of the labelling and comparing the same with the doctor’s prescription, the current situation could not have occurred.
U (Understand)
The breakdown in the drug administration occurred at three places: at the point of placing the drugs at the drug trays; at the point of confirming that it was the right medication; and finally during the administration of the medication. Under normal circumstances, the process would have right from the point the administering nurse came into contact with the drug to the final route used to administer the same to the twins. However, the nurse made some assumptions at the point of identifying the right patient for the right medication, which culminated in the wrong medication being administered to the twins.
The rule of the thumb in drugs administration is to ensure that before the nurse takes the medication from the bin, he or she is clearly not on the colour of the vial, but on the labelling. The concerned nurse must check the patient’s file and make sure that he or she has the right name of the drug to be administered. On picking the medication, he or she should make sure that the labelling clearly matches the name of the medication prescribed by the doctor in the file. It is important to double or triple check the medication with the file to make sure that there is a perfect match between the two. In such a case scenario, the nurse would have noticed the problem as the names of the two drugs that were confused differ significantly. The important issue in the drug administration should be the name of the medicine and not the size or colour of the vial or the color or consistency of the drug (Chua, Tea, Rahman, 2009).
When all is said and done even perfect processes are prone to human errors making it difficult to eliminate all mistakes that might occur during a drug administration. In most cases perfect human beings can only be able to prevent 99.9% of errors which seems impressive on the face of it but has significant implications in the healthcare sector (Institute for Safe Medication Practices (ISMP), (2011). For instance, in a hospital like Cedars-Sinai hospital catering for an average of 40,000 patients per year, 99.9% accuracy means that there will be 400 hundred mistakes, with some of the fatal or calling for further treatment. In the medical profession, therefore, the point is to lower the risks of making mistakes to the lowest level possible and not to eliminate them as it is virtually impossible (Perras et al., 2009). Reading the vial labels and correctly matching the same with the information on the patient’s files is the most effective way of ensuring that there is wrong medication for the patients, thus improving the patient’s care (Smeulers et al., 2015).
In the process of placement of the wrong drugs in the bins/cabinets, the variables that broke down were lack of careful reading and crosschecking the medications and assumptions that the drugs were the correct ones based on size and color of the vials. The pharmacy technician simply depended on experience with the drugs without taking due diligence to ensure that the medicines were the right ones (Keers, Williams, Cooke, Ashcroft, 2013). The pharmacy technician probably checked the vials and color and probably assumed that the color differences were probably as a result of either the storage or the company manufacturing new labels for their drugs.
The person charged with ensuring that the bins and cabinets contain the right medicines did not check the labels on the vials to make sure that they were the right medicines ordered by the physician. The variable of failure to cross-check information to ensure that the process is done right introduced mistakes in the whole drug administration process leading to near-fatal consequences. The pharmacy physician needs to always double check the medicines he/she places on the bins to ensure that they are the correct ones regarding the manufacture, type, and dosage, irrespective of the color or size of the vial (Guido, 2010). Any inconsistency between the drugs requested and the ones available should be reported immediately to the relevant department to ensure that the errors do not trickle down to the patients. The pharmacy technician would have noticed the slight differences in color which would have led to further inquiry on the suitability of the medication ending up with the realization that there was nothing wrong with the medicines as it was a completely different one from the one needed at the specific bins (Agarwal & Joshi, 2011). Information technology is one of the most effective means of dealing with the issues of errors in drug administration (McKibbon, et al., 2011).
The variables breakdown at the process of the nurse picking the drug and administering the same to the neonates involved almost similar scenario to one of the pharmacy technicians. The nurse did not strictly adhere to the quality processes of double checking the medication to ensure it was the right one prescribed by the doctor (Berdot, et al., 2012).  Probably due to fatigue and assumptions, the nurse simply picked the drug available at the bin which vaguely resembled the correct one and proceeded to use it on the infants.  
The third process failure involved the breakdown in communication between the nurse and the guardians, in this case, the parents. It is common practice to talk to the patients or the guardians before administering medication informing them of the drugs administered and the reasons behind the need for the medication (Agarwal & Joshi, 2011). Communicating with the patients serves as another safety measure for the nurse to cross-check and ensure the right medication is offered to the right patient (Westbrook, Rob, Woods, Parry, 2011).   
The case of wrong medication of the Quaid’s twins resulted from a failure in the drug administration process. The problem started with the pharmacy technician who placed two different medicines within the same container and culminated with the nurse who did not double check to confirm that the label on the vial matched the written the prescription on the patients’ file. The pharmacy technician made a mistake in placing the two different drugs together, but the nurse bears the greatest responsibility in the incident. If she had strictly followed the five Rs (Right medication, right time, right dosage, right patient, and right route), she would have noticed the problem and avoided administering the wrong medicine to the twins.      
Agarwal, S., Joshi, M. C., A. (2011). Study of medication errors associated with prescription drug ordering, Rev Glob Med Healthc Res.
Berdot, S., Sabatier, B., Gillaizeau, F., Caruba, T., Prognon, P., Durieux, P. (2012). Evaluation of drug administration errors in a teaching hospital. BMC Health Serv Res. 12:60.
Chua, S.S., Tea, M.H., Rahman, M.H. (2009). An observational study of drug administration errors in a Malaysian hospital, J Clin Pharm Ther 34: 215-223. doi:https://doi.org/10.1111/j.1365-2710.2008.00997.x.
Guido, G. W., (2010). Legal & ethical issues in nursing. Boston: Pearson.
Institute for Safe Medication Practices (ISMP). (2011). Acute Care Guidelines for Timely Administration of Scheduled Medications. Available at Available: https://www.ismp.org/tools/guidelines/acutecare/tasm.pdf. Accessed 9 November 2018)         
 Keers, R.N., Williams, S.D., Cooke, J., Ashcroft, D.M. (2013). Prevalence and nature of medication administration errors in health care settings: A systematic review of direct observational evidence. Ann Pharmacother 2013:47:237-56.
Keers, R.N., Williams, S.D., Cooke, J., Ashcroft, D.M. (2013).. Relias Media, Available at:  https://www.reliasmedia.com/articles/9928-drug-safety-lapses-at-cedars-sinai (Accessed 9 November 2018)
Kroft, S., Rosen, I., & CBS News. (2008), 60 minutes. New York, NY: Columbia Broadcasting System.
McKibbon, K., Lokker, C., Handler, S., Dolovich, L., Holbrook, A., et al. (2011). Enabling medication management through health information technology. Evid Rep/Technol Assess No. 201. AHRQ Publication No 11-E008-EF. Rockville MD: Agency for Healthcare Research and Quality.
Perras, C., Jacobs, P., Boucher, M., Murphy, G., Hope, J., et al. (2009). Technologies to reduce errors in dispensing and administration of medication in hospitals: Clinical and economic analyses [Technology report number 121]. Ottawa: Canadian Agency for Drugs and Technologies in Health.
Pham, J.C., Story, J.L., Hicks, R.W., et al. (2011). National study on the frequency, types, causes, and consequences of voluntarily reported emergency department medication errors. J Emerg Med. 40(5):485–492
Smeulers, M., Verweij, L., Maaskant, J. M., de Boer, M., Krediet, C. T., Nieveen van Dijkum, E. J., & Vermeulen, H. (2015). Quality indicators for safe medication preparation and administration: a systematic review. PloS one, 10(4), e0122695. doi:10.1371/journal.pone.0122695
Westbrook, J.I., Rob, M.I., Woods, A, Parry, D., (2011). Errors in the administration of intravenous medications in hospital and the role of correct procedures and nurse experience. Bmj Qual Saf 20: 1027–1034. doi:https://doi.org/10.1136/bmjqs-2011-000089.
Yin, H., Dreyer, B.P, Moreira, H., van Schaick, L., Rodriguez. L., Boettger, S., et al. (2014) Liquid medication dosing errors in children: role of provider counseling strategies. Acad Pediatr. 2014;14:262.

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