When does a center become “medical”? In conversations with staff from a number of pregnancy centers, one question and one statement keep resurfacing. Let’s see if they sound familiar to you:
Let’s look at this from a strictly legal angle first. In October of 1989, the Right to Life League of Southern California was ordered by a Los Angeles Superior Court judge to stop providing pregnancy testing. The League was also forbidden from advertising in the “clinic” section of telephone books because it was not a licensed medical facility.
According to an article covering the court case in the Los Angeles Times:
Superior Court Judge Miriam Vogel granted the permanent injunction in response to a civil suit, which accused the centers of practicing medicine without a license…
Vogel ruled that telling the clients whether they are pregnant or not constitutes a diagnosis and is forbidden because the counselors are not licensed medical professionals. The centers, she said, cannot administer the pregnancy tests, interpret laboratory results or give the results to the clients…
Vogel added that the centers, under the order, could do pregnancy testing only if they became licensed medical facilities and hired medical professionals… It also allows them to give them (clients) pregnancy tests kits to take home and administer themselves.
As a result of this lawsuit, non-medical pregnancy centers should use the self-testing model for performing pregnancy tests. Performing a pregnancy test on a client, reading the result, and giving the result to the client is determined to be a medical procedure based on the California judges ruling. Those centers who offer pregnancy testing performed by a staff member should have a standing order from their medical director, and a medically licensed professional (e.g. a registered nurse) who performs the test or delegates and oversees the performance of the test before advertising pregnancy testing. Non-medical centers should use the self-testing model, and should only advertise that they offer pregnancy tests (which the clients will then use), not testing.
Remember, the judge ruled in the aforementioned case that administering prgnancy tests, interpreting or reading the results, or giving the results to the clients constituted the practice of medicine. In a pregnancy help center, an ultrasound is performed for the following:
In other words, a test is being performed, a result is obtained, and the result is given to the client, suggesting a diagnostic procedure is being performed. In essence, there is no such thing as a non-diagnostic ultrasound. Even if you are using an ultrasound machine for the singular purpose of showing the client her baby, you are likely conducting a diagnostic test that suggests a medical procedure. Because of this, you are functioning as a medical facility when you perform an ultrasound.
So, if you are performing ultrasound tests on your clients, you must have a medical director who issues the standing order for the ultrasounds, and who reads or oversees the reading of the scans and gives a signed report that becomes a part of the client’s medical records. Your medical director must approve of any staff performing the tests. Excellent practice also requires that you have the appropriate policies and procedures in place.
Does that mean you have to become a state licensed medical clinic? Not necessarily. Pregnancy centers are required to go through specific licensing in just four states: California, New York, Massachusetts, and New Jersey. All other states require only the medical personnel within the clinics to be licensed (e.g. MD, RN, LPN, RDMS).
In response to a center who questioned as to whether or not having a client sign a disclaimer form stating the client understood the ultrasound was not a diagnostic procedure, it is the opinion of Heartbeat legal counsel that a center release form signed by the client stating that this is a non-diagnostic ultrasound will afford the center little or no legal protection.
The FDA states: "Ultrasound imaging is a common diagnostic medical procedure (emphasis added) that uses high-frequency sound waves to produce dynamic images (sonograms) of organs, tissues, or blood flow inside the body."
AWHONN Ultrasound Examination: Clinical Competencies and Education Guide states:
Fetal ultrasound should be performed only when there is a valid medical reason (American College of Obstetricians and Gynecologists [ACOG], 2009; American Institute of Ultrasound in Medicine [AIUM], 2005, 2007b). Performing an obstetric ultrasound primarily for keepsake images or to determine fetal gender without a medical indication is not recommended (ACOG, 2009; AIUM, 2005, 2007b; Rados, 2004). The U.S. Food and Drug Administration states that the use of ultrasound equipment for these purposes is an unapproved use of a medical device. This practice may violate state or local laws regarding use of such devices without a prescription (Rados, 2004).
In its handbook, titled, “AIUM Practice Guideline for the Performance of Obstetric Ultrasound Examinations,” the American Institute of Ultrasound in Medicine cautions against using ultrasound imaging for non-medical reasons:
Diagnostic ultrasound studies of the fetus are generally considered safe during pregnancy. This diagnostic procedure should be performed only when there is a valid medical indication, and the lowest possible ultrasonic exposure setting should be used to gain the necessary diagnostic information under the as low as reasonably achievable (ALARA) principle.
The promotion, selling, or leasing of ultrasound equipment for making “keepsake fetal videos” is considered by the US Food and Drug Administration to be an unapproved use of a medical device. Use of a diagnostic ultrasound system for these purposes, without a physician’s order, may be in violation of state laws or regulations.
The FDA Consumer Health Information article, Avoid Fetal “Keepsake Images,” Heartbeat Monitors says:
The use of ultrasound imaging devices for producing fetal keepsake videos is viewed as an unapproved use by the Food and Drug Administration (FDA). Doppler ultrasound heartbeat monitors are not intended for over-the-counter (OTC) use. Both products are approved for use only with a prescription … Using ultrasound equipment only through a prescription ensures that pregnant women will receive professional care that contributes to their health and to the health of their babies, and that ultrasound will be used when medically indicated.
Until a center is able to satisfy all five of these components, it should not begin to offer ultrasound services.
If you are considering adding ultrasound, or if you already have ultrasound in your center but are not currently considering yourselves a medical clinic, please examine your current practices in light of the parameters discussed above. Heartbeat recommends this issue be examined and addressed by your board.
To both provide optimal client/patient care and to avoid being found practicing medicine without a license, the question, “Are we medical?” must be accurately answered.
by Ellen Foell, Heartbeat International Legal Counsel
“A patient-physician relationship is generally formed when a physician affirmatively acts in a patient’s case by examining, diagnosing, treating, or agreeing to do so.
"Once the physician consensually enters into a relationship with a patient in any of these ways, a legal contract is formed in which the physician owes a duty to that patient to continue to treat or properly terminate the relationship.”
- Valarie Blake
This sounds like a trick question a Pharisee might ask to entrap Jesus.
The answer seems fairly straightforward. The patient is anyone who receives medical services from a physician. But then, there is a follow-up question: "When is my patient no longer my patient?" In other words, when does the legal obligation to the patient end?
The physician and the clients who walk through the center’s doors are indispensable to its existence as a medical pregnancy clinic. Without the client-patients, there would be no need for the medical center to exist. Without the medical director, the center has no legal authority to provide any of its critical life-changing medical services, including ultrasounds and sexually transmitted infection and disease testing.
The medical director’s presence in name, policy-setting, procedure, and writing standing orders creates a patient-physician relationship. It runs between the physician and every client who walks through your doors to receive medical service.
However, much like ambulatory care clinics, the relationship between the physician in a medical pregnancy center and patient is limited in time and treatment, so the center must set distinct parameters to avoid confusion for the patient and liability for the center. Failure of the center to be clear in setting and communicating those parameters to the patient can create liability-laden situations.
The best way for centers to avoid liability issues is to be up-front in communicating the parameters of the patient-physician relationship with each client. In the eyes of the law, the physician-patient relationship continues if the following three factors are present, with the third factor posing the most relevance for pregnancy help centers:
It is easy to see how a client-patient could leave a center with the impression that she and the medical director have now established a continuous patient-physician relationship. Treatment and care for a pregnant woman typically involves multiple doctor visits, additional ultrasounds, and can include additional procedures as well.
Further, since many of the women coming to a medical pregnancy clinic may not have an existing relationship with a physician, a client-patient might naturally conclude that the relationship would continue beyond the parameters of that place (the center) and time (the appointment).
That is, the client-patient might have a reasonable expectation of continued services because she clearly requires continued treatment. The question is, “From whom?” That question can and must be addressed in the context of clear and explicit communication to the client that the patient-physician relationship is terminated upon her leaving the pregnancy medical clinic, and—if needed—receipt of referrals for obstetrician-gynecologists, in keeping with standard pregnancy medical center practice.
If the client is clearly and explicitly informed—verbally and in writing—that no continuing patient-physician relationship continues after the verification of pregnancy and/or ultrasound, then the center and its medical director will have fulfilled their legal duty to the client. In fact, most pregnancy medical centers have a Consent and Release Form for the client to sign, indicating this agreement.
Heartbeat International was recently asked whether giving a regimen of prenatal vitamins or prescribing prenatal vitamins constituted a continuation of the patient-physician relationship, possibly exposing the center to liability. The question was raised for obvious reasons: Prenatal vitamins tend to be something pregnant women take throughout the course of their pregnancy, implying continuing treatment.
Arguably, prescribing the vitamins could be interpreted to constitute action taken pursuant to the patient-physician relationship. Thus, a center will want to ensure that its Consent and Release Form is broad enough to encompass the prescription for vitamins.
Pregnancy help medical clinics daily provide excellent and caring life-saving services. In the event that a client-patient is pregnant, she should be given referrals for other service providers.
Centers should have an attorney draft a Consent and Release Form, which should be given and explained to the client-patient. This paperwork should clearly state that no follow-up care will be provided, and that the patient-physician relationship is terminated.
That form must be signed by both center staff and the client-patient, with a signed copy given to the client-patient and a copy kept in the client-patient’s medical file. In following these guidelines, a center will have fulfilled its obligation to the client-patient, and to the law.
Go and do likewise!
What would you do if a client contacted you and said she had taken the first dose of the RU-486 regimen and now regretted it?
There is help!
Because of the critical time factor involved in attempting a reversal, Dr. George Delgado and Culture of Life Family Services have launched AbortionPillReversal.com.
This website and its associated hotline (877-558-0333) will serve as a means to rapidly connect women who have taken mifepristone (brand name Mifeprex, a.k.a. RU-486) to a nationwide network of medical providers who can attempt reversal of the drug with progesterone.
In a recent presentation to the American Association of Prolife Obstetricians and Gynecologists (AAPLOG), Dr. George Delgado described a series of seven patients where a reversal of RU-486 was attempted. The majority of the babies survived, and were born full-term with no apparent anomalies.
Mifepristone causes abortion because it is a progesterone receptor blocker. Progesterone is an essential hormone during pregnancy, which allows the placenta to grow, flourish, and nourish the baby. Blocking the action of progesterone (as mifepristone does) causes placental failure, which in turn, leads to the death of the unborn baby.
Supplemental progesterone, if given early enough, can out-compete the mifepristone and prevent the progesterone receptor-blocking action. By out-competing the mifepristone on a molecular and receptor level, the progesterone serves as an antidote to the mifepristone.
Since Ella and other “morning after pills” are also progesterone blockers like mifepristone, they also have the potential to be reversed by an emergency progesterone intervention.
The fact is that many women regret their choice to abort their babies. After a surgical abortion, of course, there is no going back. But, when a woman begins the process of a medical abortion and changes her mind, there is a window of opportunity to reverse the effects of an abortion-causing agent.
Please take a look at this website, and keep this information handy, should one of your clients come looking for help.
By Kimela Hardy, MA, RT(R), RDMS
Available literature states the fetal heart beat begins its lifelong work at approximately six weeks, and depending on the sonographer’s skills, ultrasound system, and maternal body habitus, the heart beating may be visualized at this time. There are several factors that can be used to not only see this little miracle at work, but also improve general images.
Thermal Index is the heating of tissue as ultrasound is absorbed by tissue, measured by ratio of power used to produce a temperature increase of 1°C. This is measured in soft tissue (TIS), bone (TIB), and in the cranium (TIC).
The Mechanical Index is an ultrasound measurement used as estimation of the risk of non thermal effects and the degree of bio-effects a given set of ultrasound parameters will induce; Higher MI means a larger bio-effect. These can include cavitation, the formation of transient or stable bubbles, which can damage tissues. The current Federal Drug Administration has set the maximum MI at 1.9
MI = PNP Peak Negative Pressure of the ultrasound wave √Fc The Center Frequency of the ultrasound wave (MHz)
Before a specific organ, for example the fetal heart, image can be improved on, first obtain the best image possible. To begin any ultrasound study, but especially in Obstetrical scanning, the correct manufacturer’s Preset must be selected. Presets are essentially a “recipe” set for the ultrasound system. These parameters may include depth, gain, frequency, and focus among other factors. Using the OB Preset sets the Thermal Index (TI) and Mechanical Index (MI) which are generally lower for obstetric ultrasound examinations. In general, the TI and MI are not deliberately manipulated during routine ultrasound examinations.
Which Knobs Can Improve Your Picture?
Once the Preset is selected, consider the overall gain in the image on the monitor. Is it all black, all white, or a combination with many grays? Adjust the overall gain, often a large dial easily accessible, so it is easiest to identify the landmarks and in general is appealing to one’s eye and interpretation. This may differ somewhat with each sonographer, but not to an extreme.
The importance of correctly interpreting the landmarks cannot be over stressed, know the anatomy well.
Be sure the size of your image, or depth, allow demonstration of the area of interest. On some machines, this is either a dial knob or toggle switch labeled Depth, Size, or a combination of these. There is a scale on either side of the image that registers this depth in either centimeters or millimeters, and changes as the dial/toggle is adjusted.
Most transducers/probes are multi-herz, which means they offer more than one frequency, usually 2, 4, and 6 MHz. Once the landmarks have been identified and the overall gain is satisfactory, try each frequency with a simple adjustment and determine which provides the best penetration and resolution.
This means images of a patient with Large Maternal Body Habitus (LMBH) most often improves with the lowest frequency, and our smaller, more athletic patients can use the higher frequency for better resolution images. The frequency is often displayed at the top of the image where the TI and MI are located.
The optimal area of the ultrasound beam is the focus, demonstrated by a triangle or karat along the depth scale. Place this at the area of interest at the correct depth. On some systems, the focus makes a significant difference in clarity, but in other systems, there does not appear to be much change.
After the above have been set to optimize the image, the slide pods or TGC/STC can be used to fine tune the image even more. These are a step alteration in the gain, with the slides on the top affecting the top of the image and vice versa. Most often the “slope” is a gradual downward slope to the right.
Manufacturers frequently have specific image enhancing features under proprietary names which reduce haze, clutter, and artifacts allowing for improved clarity of images. These harmonic features may allow for increased penetration without details lost. Simply turning this feature on and determining its benefit (or not) is required.
Looking at the Heart
Once the optimal image has been achieved by using the features discussed above, there are additional tips to see that small fetal heart. Some systems have a Field of View (FOV) which has the effect of “coning down” and creating a smaller field visible and increases image clarification. This is the consequence of taking only a portion of the available area to scan instead of the entire area seen prior to using this option. Often, a pie-shaped icon is on the image top to illustrate and highlight the FOV area.
Using the Zoom option will increase the image size, which also can make it easier to visualize the fetal heart. In addition, most of the Zoom also has a feature which allows the size of the area, or box, to be increased/decreased. Another key to using a zoom option is to be certain the item of interest is directly in the center of the box.
When viewing the small fetal heart, another gain adjustment making the image brighter aids in recognizing the wave form during Motion-mode (M-mode). This gain is sometimes located by turning the M-mode dial. The brighter the image, the more likely the wave form is visualized. Also, the wave form will be in direct relationship to the location of the heart in the 2 Dimensional (2 D) image. For example, if the heart is in the center, the q, r, s, etc. waves will be in the center of the strip. If the heart is at the bottom of the image, the wave form will be at the bottom of the strip.
Oftentimes, maternal respirations interfere with achieving a well demonstrated strip. To overcome this, ask the patient/client to suspend breathing or hold her breath. Be aware, if she takes in a deep breath, the fetal heart may move out of the image, and you will need to make the necessary adjustments.
All of these discussed options to improve ultrasound images pertain to both Transabdominal and Transvaginal imaging. However, it is reasonable to anticipate that Transvaginal images will be larger and therefore improve the ability to obtain a fetal heart rate.
Using these tips should increase the skill set and confidence for the nurse sonographer and show this little miracle to his or her maximum potential. The tips prior to the “M-mode” can be used for general imaging as well.
By Connie Ambrecht RDMS, CMB
Heartbeat International has a heart for international ministry. If you would like to join in the international ultrasound ministry, there are a couple of resources of which you should be aware:
Have you wondered how much impact ultrasound could have internationally? What does it take? Who is qualified to go? Who would you train in those countries?
It almost sounds glamorous to travel to exotic places like Haiti and Ecuador or Ukraine and Romania. Hope Imaging and its teams have been to all of these countries and more, taking life-affirming sonography training to physicians, midwives, and nurses in these foreign lands.
If traveling internationally to address life issues doesn’t interest you, read no further. Hope Imaging is all about the God possibilities, and exotic travel and intrigue are all part of His itinerary to get the job done well.
You may already be interested and eagerly have your hand raised saying “Send me Lord, send me!”
What does it take to go internationally?
Flexibility, agenda-free thinking, funding, immunizations, peanut butter, and “just in case” medicines make international outreach travel all that you imagine and then some.
Who’s qualified to go?
Those He’s called.
Hope Imaging recommends taking a team; two registered sonographers, one prayer partner, and one intern. The registered sonographers can rotate with the training and translation. The prayer partner is one who can be trusted with difficult situations – team members, participants, safety, health, technical translations, clinic needs, medical needs…the prayer needs can be endless.
An intern, as defined by Hope Imaging, is one of the following:
Any of these members can be combined. For example, a registered nurse/sonographer might also serve as prayer partner, or a registered sonographer may be prayer warrior. You get the idea; it’s that flexible thing again!
Who do we teach internationally? The simple answer is primarily physicians. Physicians are quick learners so keep that in mind as you walk them through the steps to a good image. Be patient and work with them. Remember, they want to learn. That machine has been sitting idle for too long. Let’s get it in use!The reality is, however, that we teach everyone we cross paths with.
Our teams need people with a heart for international missions, who are flexible, and who are willing to raise their hand and say, “Send me Lord, send me!”
Connie Ambrecht serves as International Team Coordinator as well as Team Leader for Hope Imaging. She and her husband have been involved with Hope Imaging since its birth in 2005.
If you have a heart for integrating medical services or expanding medical services in existing programs your pregnancy help organization offers, we are here to assist you in making that transition.
Many organizations today offer, are adding, or at least are contemplating medical services. Other established medical organizations are taking the basic model a step further, by adding STD/STI testing, Abortion Pill Reversal, natural family planning, prenatal care, birthing centers, and well-woman care. Some are becoming “hub” pregnancy help medical clinics and are encouraging others to refer clients to them for ultrasounds among other medical services. The medical community represents natural contacts with our pregnancy help organizations, as we partner to bring a more positive, life-affirming, and holistic approach to the care women need.
Before adding medical services, your pregnancy help organization must first lay the groundwork. The Medical Director (a D.O. and/or M.D) and other healthcare professionals are necessary for this transformation. In most cases, the organization would operate under the licensure of the Medical Director. In some states, pregnancy help organizations are included within the types of facilities that must obtain licensure.
In most states, there is a designated agency such as a state department of health that is given the authority and responsibility for regulating health care facilities. You should contact this agency in your state to determine what specific licensure requirements are in place and whether they pertain to the type of facility you intend to operate. In states where licensing is required, a pregnancy help organization must comply with applicable regulations and must submit to periodic agency inspections. The scope and substance of applicable regulations differ from state to state.
An ultrasound tech, a trained nurse, or other trained health professional as approved by your state regulations and your Medical Director would perform the ultrasounds.
One thing is clear: offering relevant medical services increases the number of clients served. Only a medical diagnosis of pregnancy can truly answer the question, “Am I pregnant?”
As a pregnancy help medical clinic, you can provide on-site immediate services that will empower women to choose life. Primary among these services is ultrasound confirmation of pregnancy.
Often when supporters understand the impact of adding medical services they are enthused and increase their giving. Further, adding medical services can be appealing to new donors as they see the effectiveness and positive client outcomes. Some organizations have reported dramatic increases in their revenue over the years as they add medical services and communicate to their supporters the successes in doing so.
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