In the United States, clinical testing is monitored by the federal and state governments, held to standards to ensure the safety and efficacy of these tests, as well as maintaining privacy for patients receiving a test. In order for the ABCTL to lawfully operate in the state of Arizona, it had to meet various legal criteria. These major legal considerations, in no particular order, are: Clinical Laboratory Improvement Amendments compliance; FDA Emergency Use Authorization (EUA); Health Insurance Portability and Accountability Act compliance; state licensure; patient, state, and federal result reporting; and liability. <br/>In this paper, the EUA pathway will be examined and contextualized in relation to the ABCTL. This will include an examination of the FDA regulations and policies that affect the laboratory during its operations, as well as a look at the different authorization pathways for diagnostic tests present during the COVID-19 pandemic.

In 1997, physicians and researchers Ambre Olsen, Virginia Smith, John Bergstrom, Joyce Colling, and Amanda Clark published, “Epidemiology of Surgically Managed Pelvic Organ Prolapse and Urinary Incontinence,” in the journal Obstetrics and Gynecology. In their article, the authors retrospectively analyzed data from patients who underwent surgery for pelvic organ prolapse or urinary incontinence two years prior in 1995. Often due to a weakening of or damage to their pelvic muscles, women with pelvic organ prolapse can experience a descent of pelvic organs into the lower pelvis and vagina. People with urinary incontinence can experience bladder control issues and urinary leaks. According to the authors, an estimated fifty percent of women who have previously given birth have had a prolapse. In their article, Olsen and colleagues analyze factors such as race, age, and weight in women who had surgery to treat pelvic organ prolapse and ultimately advocate for a standard assessment for the severity of those conditions.

In 1996, a team of researchers associated with the International Continence Society published “The Standardization of Terminology of Female Pelvic Organ Prolapse and Pelvic Floor Dysfunction” in American Journal of Obstetrics and Gynecology. Pelvic organ prolapse is characterized by the descent of the pelvic organs into the lower portion of the pelvis and is often caused by a weakening of the muscles and ligaments that normally hold the organs in place. The authors concluded that physicians and researchers needed to develop a system of standardized terms to use to describe the anatomical position of pelvic organ prolapse in women. They propose using terms that emphasize the location of the prolapse rather than just the involved organ. They also suggest that the system utilizes a series of examinations and imaging to uniformly describe and quantify pelvic organ prolapse. The article by Bump and colleagues was one of the first to call for a standardized system using specific terms to communicate findings about pelvic organ prolapse systematically across clinical and academic research settings.

Hans Peter Dietz and Judy Simpson published, “Levator Trauma is Associated with Pelvic Organ Prolapse,” in the journal BJOG: An International Journal of Obstetrics and Gynecology in 2008. In their article, Dietz and Simpson estimated the risk of pelvic organ prolapse in women who attained injuries to the pelvic levator muscles. The levator muscles, also known as the levator ani, are a major muscle group that comprise the pelvic floor. Along with other muscles, the pelvic floor supports organs in a woman’s pelvis, such as the bladder, uterus, and rectum. Vaginal childbirth can cause a weakening of the pelvic muscles. That can lead to pelvic organ prolapse, which results in the descent of the pelvic organs towards a woman’s vaginal opening. In, “Levator Trauma is Associated with Pelvic Organ Prolapse,” Dietz and Simpson found that women were more likely to have pelvic organ prolapse if they had levator trauma, and called for further research to understand the relationship between levator ani trauma and pelvic organ prolapse.

William Thornton Mustard was a surgeon in Canada during the twentieth century who developed surgical techniques to treat children who had congenital heart defects. Mustard has two surgeries named after him, both of which he helped to develop. The first of these surgeries replaces damaged or paralyzed muscles in individuals who have polio, a virus that can cause paralysis. The other technique corrects a condition called the transposition of the great arteries (TGA) that is noticed at birth. Surgeons worldwide adopted that technique, leading to increased survival rates in infants afflicted with the condition. Mustard also published over 100 articles on congenital heart defects, surgical techniques, and the preparation of an artificial heart lung machine. Mustard helped perform the first blood transfusion of a newborn whose red blood cells (RBCs) had degraded, a condition called hemolytic anemia. Throughout his career, Mustard developed surgical techniques that increased the survival rates of infants and children with congenital and developmental disorders.

The Mustard Operation is a surgical technique to correct a heart condition called the transposition of the great arteries (TGA). TGA is a birth defect in which the placement of the two arteries, the pulmonary artery, which supplies deoxygenated blood to the lungs, and the aorta, which takes oxygenated blood to the body are switched. William Thornton Mustard developed the operation later named for him and in 1963 operated on an infant with TGA, and ameliorated the condition, at the Hospital for Sick Children in Toronto, Canada. Afterwards, the Mustard Operation became the primary form of corrective surgery for TGA, until the arterial switch operation largely replaced the Mustard Operation by the late 1990s. The Mustard Operation enabled surgeons to correct TGA in infants born with the life-threatening anomaly, increasing their life spans and quality of life.

In 2007, physicians John Jelovsek, Christopher Maher, and Matthew Barber published, “Pelvic Organ Prolapse,” in The Lancet. In their article, Jelovsek and colleagues provided an overview of pelvic organ prolapse in women and described the epidemiology, risk factors, symptoms, and management of the condition. Pelvic organ prolapse occurs when a woman’s pelvic floor is weakened or damaged from stress or trauma such as vaginal childbirth. The pelvic floor is a group of muscles that provides support to organs within the lower abdominal region of the body, including the bladder, uterus, and rectum. Disorders of the pelvic floor disrupt its normal function, often causing a feeling of uncomfortable pressure or pain, and incontinence, which is involuntary leakage of urine or feces. In their article, Jelovsek and colleagues reviewed the known information about pelvic organ prolapse as of 2007 and research teams who further studied the causes and management of pelvic organ prolapse in women later used the article as a reference.

Pelvic organ prolapse is a common condition in women that causes the pelvic organs to descend, often resulting from a weakened pelvic floor. Pelvic organs supported by the pelvic floor, such as the bladder, bowel, or uterus, can descend to such a degree that they project out from a woman’s body typically via the vagina. Pelvic floor stress or trauma, like vaginal childbirth, can cause pelvic organ prolapse. Women with pelvic organ prolapse also often experience other conditions, such as incontinence or the involuntary leakage of urine or fecal matter. As a result, while many women experience pressure or fullness from the prolapse itself, other common symptoms of pelvic organ prolapse are those involving the bladder or the bowel. Treatments for prolapse depend on the woman’s symptoms, and include pessaries, surgery, and pelvic floor exercises. As of 2021, researchers and physicians continue to study pelvic organ prolapse to determine how different treatments can be tailored to specific causes or symptoms.

In 1981, Frank Addiego and colleagues published “Female Ejaculation: A Case Study” in The Journal of Sex Research. In the article, the authors find that female ejaculation, or the expulsion of fluid from a female’s urethra during or before orgasm, is a legitimate phenomenon that can occur when one stimulates an area in the vaginal wall that the team names the Gräfenberg-spot. According to the authors, at the time of publication, many individuals believed that if a female expelled fluid during orgasm, the fluid was urine and, thus, improper bladder control caused the expulsions. However, in “Female Ejaculation: A Case Study,” the researchers explain that they collected samples of one woman’s orgasmic fluid and compared its chemical composition to that of her urine, and they found that the two fluids were different. In their case study, Addiego and colleagues not only provide evidence that female ejaculation is a legitimate physiological response, but they also support the idea that females who experience it are not defective, which helped to shape social views and future research on the female orgasm.