Ethics Presentation Case VII - Gabriela Olivas BSN, SNNP
Ethics Presentation Case VII B Y: M A R I S S A H A M P T O N & G A B R I E L A O L I VA S GNRS 5633 NNP CONCEPTS AND PRACTICUM III 11/14/2014 Dr. Debra Armentrout PhD, RN, MSN, NNP-BC Dr. Leigh Ann Cates PhD, APRN, NNP-BC,RRT-NPS,CHSE Content Overview of the case Inherent ethical issues/dilemmas of the case Legal issues (if any)that may impact the decision made by The parents/family The healthcare team Advocacy Role of the NNP in managing the care of the infant and family
Overview of the case Case The VII: Johnsons are married and have given birth to their first child. Marsha had an unremarkable pregnancy and continued working until one week before the baby's birth. At birth, Al and Marsha's son appears to be perfectly normal. Within a few days of their discharge, the doctor calls the family at home and requests for them to bring the baby to the office for further testing. The
doctor asks that both the mother and father come along because he wants to talk to them. In his office, the doctor explains that a blood test was performed while the baby was in the hospital, as required by law. (Facts about Newborn Screening, 2014) Overview of the case continued The test reveals that the baby might have a genetic disease called phenylketonuria (PKU). However, more tests are needed to be sure. The Johnsons were told not to worry because there was a treatment for the condition. But neither Marsha nor Al has ever heard of the disease nor has anyone in their family. The infants parents express concern over a blood test being performed on their son without their consent and are now uncertain about consenting to further diagnostic studies.
Phenylketonuria (PKU) Multiple types of PKU Classic PKU Non- PKU hyperphenylalaninemia Both caused by defects in phenylalaninemia hydroxylase. Classic PKU requires diet modification. Restriction of phenylalanine life-long and within the first month of birth Variant PKU May cause early neurologic damage if not restricted.
Caused by defects of tetrahydrobiopterin (BH4) Defects of BH4 cause severe neurologic disorders if not identified early. Not diet restricted- must have cofactor in order for neurotransmitter processes to carry on. Transient hyperphenylalaninemia Caused by prematurity. Usually do not require treatment. (Zinn, 2006) History of PKU and Newborn screening 1934: Discovery by Asbjorn Folling revealed urine of children with intellectual disability had increased ferric chloride content
Identifies the presence of phenylpyruvic acid in those who lack the enzyme phenylypyruvic acid 1954: Reports identified that diets low in phenylalanine could reverse biochemical abnormalities. Therefore reducing intellectual defects associated with PKU 1957: Routine urine screening became available in California However, collection was not comprehensive and therefore deemed unsuitable. 1961: Blood testing on filter paper begins (Ross, 2010) Inherent ethical issues/dilemmas of the case
No informed consent. Obtaining blood samples without parental consent. Testing for genetically inherited diseases without parental consent. Failure to reveal all results of the newborn screen. Only revealing abnormal PKU results. Obtaining false positive results in initial screening may lead to unnecessary follow up testing. What happens to residual blood spots? Possibly used for further research and future testing modalities? Inherent ethical issues/dilemmas of the case No informed consent & obtaining blood samples without parental consent o
According to governmental regulations, state mandated newborn screening programs are justified by the ideals of protecting individualized child welfare. o o The child benefit model supports the addition of tests and/or mandatory screening panels under the argument that information gathered from newborns is used to directly benefit children. States support mandatory screening on the basis of parens patriae power o Parens patriae power gives the state inherent authority to act in a manner that promotes the overall welfare of children. This regulation protects states rights by overriding parental authority in cases which potential harm may be caused by acting against medical advice. (Tarini & Goldenberg, 2012)
Inherent ethical issues/dilemmas of the case Testing for genetically inherited diseases without parental consent. o An American Academy of Pediatrics (AAP) policy statement on genetic testing in pediatrics recommended that parental informed consent a standard procedure for Newborn screening (NBS) o o Some states have adopted a passive consent approach Passive consent: Entails that may parents may opt out of testing, by signed waiver. Written consent is not required before mandatory state testing. o The state of Texas has deemed NBS are medically necessary for all children. Parents may opt out of the screen only if it conflicts with their religious practices. Written consent to forego screening is then required. (Texas Health & Safety Code Sec. 33.012) (Gonzales, 2011)
(Texas Department of State Health Services, 2014) Inherent ethical issues/dilemmas of the case Failure to reveal all results of the newborn screen Newborn screening compromise 29 screens of metabolic diseases. In this case the family is only notified of one positive test result. The other 28 negative test results are not mentioned. These results may be misleading to the family because they may interpret that the PKU results is the only test on the NBS. The family should also be made aware that their child was tested for other metabolic, endocrine and blood
diseases, in which he does not have. Inherent ethical issues/dilemmas of the case Obtaining false positive results in initial screening may lead to unnecessary follow up testing. Obtaining false positive results due to incomplete or insufficient sample may cause: Increased hospitalization Increased parental stress Parent child dysfunction (Zinn, 2006) Legal issues (if any)that may impact the decision made
by the parents/family & the healthcare team What if I dont want my child to undergo a newborn screen? Preventative vs. Curative health care Newborn screens allow for early identification of genetically inherited diseases, and therefore provide preventative measures to keep the child healthy. Identification and differentiation of type of PKU will assist in managing the infants care. Dietary modifications Future follow up with appropriate specialist. State mandated
Currently 49 states require newborn screening Approximately 4 million newborns will have a newborn screen each year. The state of Texas requires each newborn to undergo a screen, unless written consent is given to forego screening due to religious beliefs. (Texas Health & Safety Code Sec. 33.012) (Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J., 2011) (Texas Department of State Health Services, 2014) Legal issues (if any)that may impact the decision made by the parents/family & the healthcare team What happens to residual blood spots? Is the Dried Blood Spot (DBS) possibly used for further research and testing modalities? Parental concerns for possible testing on blood samples for undisclosed research purposes led to multiple lawsuits at the state level.
March 18, 2009: Texas Civil Rights Project vs. Texas Dept. of State Health services Concern arose about the states ability to unlawfully collect blood samples shortly after birth and store the samples indefinitely for undisclosed research purposes, without plaintiffs knowledge or consent. Results of the lawsuit mandated state changes in authorizing the retention of DBS. Additionally, the state agreed to destroy 5 million DBS that were previously retained without parental consent. Currently, each DBS are retained by the state of Texas for 2 years, unless written consent is obtained by the parents to retain for a longer period. In their 2 years, the DBS is used for quality assurance testing and developing new studies on diseases that affect public health. After a 2 year time period the DBS is destroyed by the state. (Ross, 2010) (Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J., 2011) (Texas Department of State Health Services, 2014) Legal issues (if any)that may impact the decision made by the parents/family & the healthcare team What happens to residual blood spots? Possibly used for
further research and future testing modalities? Blood samples are genetic property of the individual and usage and storage is under the discretion of the provider March 19, 2009: Lawsuit filed against the Minnesota Department of Health and the State of Minnesota. Suit stated that the collection, storage and usage of newborn blood violated the states genetic privacy laws. 2006 genetic privacy laws dictates the specific laws that govern the collection, storage and use of the collection Written informed consent outlining a timeline is required for further testing and storage. 2008: New laws outlined the usage of residual newborn screens for quality control, assurance and new testing techniques. Mandates informed consent prior to obtaining initial newborn screen. Requiring informed consent on DBS used for further testing and the option to received additional results. Allows a time restraint of holding each DBS for a total of 25 months.
(Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J., 2011) (Minnesota Department of Health Fact Sheet, 2009) (Ross, 2010) Legal issues (if any)that may impact the decision made by the parents/family & the healthcare team What happens to residual DBS? American Academy of Pediatrics (2011) published an article evaluating state laws of the storage and use of newborn screens: Their research concluded that: 20 states currently have laws addressing retention of DBS 18 states have no regulations regarding retention of DBS In 10 states future use of the DBS is regulated by the department of health. In 4 states the DBS become property of the state
In 2 of these states, ownership of the DBS may be contested by the parents in writing. (Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J., 2011) Legal issues (if any)that may impact the decision made by the parents/family & the healthcare team Will the results of my infants NBS remain confidential? 26 states currently have restrictions on information related to newborn screens and their results. In 14 states, confidential information may be released with parental consent . (Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J., 2011)
Legal issues (if any)that may impact the decision made by the parents/family & the healthcare team Our baby has a positive PKU screen. What will happen if we decide against further testing for our infant? Failure of identification may prevent a specific diagnosis of the type of PKU Therefore, failure to identify exact treatment Preventing accurate treatment of PKU may cause irreversible neurologic damage. Further testing is not extremely invasive and should not be prolonged.
Advocacy Role of the NNP in managing the care of this infant/family First obligation of the provider is to inform the parents of the result. The provider should explain that the results are conditional, may be preliminary and that further confirmation is required to arrive at a diagnosis. Confirmatory testing should be initiated as soon as possible. Addressing the family with current results will allow for further decision making that guides the infants medical management. Rapid testing may initiate faster results and therefore treatment. Rapid and accurate testing will lead to a definitive diagnosis. This is especially
important since the clinical implications and therapies for various forms of hyperphenylalaninemia are different. A rapid diagnosis of the illness and leads to earlier introduction of appropriate therapy. Appropriate therapies lead to improved patient outcomes. Do not offer the parents false hope. It is key that the family understands the possibility of the diagnosis rather than focus on the probability of false positive results. (Zinn,2013) Advocacy Role of the NNP in managing the care of this infant/family The nurse practitioner should assess the infants clinical status. For a detected inborn error of metabolism, reassessment of the infants clinical status should be evaluated in order
to prevent further deterioration and for possible need for change in current medical management. Make proper referrals to metabolic disorder specialist. Further evaluation and care is necessary and should be handled under the guidance of a specialist. To make decisions about initiating and managing treatment. (Zinn, 2013) Advocacy Role of the NNP in managing the care of this infant/family Providing education to the caregivers to promote future wellbeing.
As the provider, providing accurate education is key for the parents to understand the severity and importance of dietary restrictions their child may need. Classic PKU disease requires lifelong phenylalanine restriction. Parents should be informed that: Dietary restrictions should begin within the first month of life. When initiated early, treatment is effective in preventing the long-term neurologic sequelae. (Zinn, 2013) Advocacy Role of the NNP in managing the care of this infant/family It is important to communicate clearly, be
empathetic and understanding. Explain the condition in terms the family will understand. This will allow the family an overall reason for further testing or why the provider is concerned. References Facts about Newborn Screening [Graphic]. (2014). Retrieved from http://www.babysfirsttest.org/newborn-screening/aboutnewborn-screening Gomella, T. L, Cunningham, M. D. & Eyal, F. G. (2013). Neonatology: Management, procedures, on-call problems, diseases and drugs (7th Ed.). New York: McGraw Hill Education Gonzales, J. L. (2011). Ethics for the Pediatrician Genetic Testing and Newborn Screening. Pediatrics in Review, 32(11), 490-493. Lewis, M., Goldenberg, A., Anderson, R., Rothwell, E., Botkin, J. (2011). State laws regarding the retention and use of residual newborn screening blood samples. Pediatrics, 127 (4), 703- 712. doi: 10.1542/peds.2010-1468
Minnesota Department of Health Fact Sheet. (2009) Newborn Screening Program. HF 1341 / SF 1478 Journal, 20(4), 299-328. References Ross, L. (2010). Mandatory vs. voluntary consent for newborn screening? Kennedy Institute of Ethics Journal, 20(4), 299-328. Tarini, B. A., & Goldenberg, A. J. (2012). Ethical issues with newborn screening in the genomics era. Annual review of genomics and human genetics, 13, 381. Texas Department of State Health Services. (2014). Newborn screening- Frequently asked questions. Retrieved from http://www.dshs.state.tx.us/lab/nbsFAQ.shtm Zinn. A.,B. (2013). Inborn errors of metabolism. In R. J. Martin, A. A. Fanaroff & M. C. Walsh (Eds.), NeonatalPerinatal Medicine: Diseases of the fetus and the infant (9th ed., pp.924-937). Philadelphia, PA: Mosby Elsevier.
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