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Decision in supervision – breach of Specialized Health Services Act
Report after serious incident
Norwegian Board of Health has concluded that XXXX XXXX born, did not get proper health care by XXXX, XXXX.
XXXX has not adapted that healthcare providers can fulfill their statutory duties with regard to the proper treatment of and information to risk pregnant women offered outpatient balloon induction. Moreover, the business is not facilitated good control of women’s bladder control after childbirth.
There has been a breach of the duty to provide adequate health services, cf. Specialized Health Services Act §§ 2-2 and 3-11, ref. the Health §§ 4 and 10.
Introduction
Norwegian Board of Health conducted a site inspection by XXXX after warning of a serious incident on XXXX. We sent a report after the event the XXXX. On-site inspections we also received information about the health care given at XXXX, XXXX in XXXX. This concerned supervision of XXXX (hereinafter woman) XXXX pregnancies. The information was of such a nature that the Norwegian Board of Health found no grounds to establish a supervision against XXXX in its letter of XXXX.
XXXX In a letter dated XXXX given an account of the matter and has forwarded the relevant documentation. XXXX and XXXX has received a copy of the letter, and was also given an opportunity to respond to this.
We apologize for the long processing time.
The subject matter
Initially follows a review of patient care. Then follows a description of the relevant governing documents for business, the opinion of XXXX and statement of operations.
Patient Treatment
Background
the case concerns a former fresh XXXX pregnant with ultrasound futures (TUL) XXXX. In gestation XXXX she was referred to the gynecological department XXXX on suspicion of gestational diabetes. Glucose Load had shown a slightly elevated two hours value of 8.2 mmol / l. She was admitted for investigation, and it was proven satisfactory blood glucose values. There was not indication for insulin therapy. She received dietary and blood glucose meters for self-monitoring, and it was agreed further action in primary care. It was not documented elevated blood glucose levels later in the pregnancy.
The induction
The XXXX was the woman outpatient control by the gynecological department XXXX when pregnancy had passed forward. It was normal findings except for some small head circumference. When new control two days after targets were repeated and found normal. It was normal amount of amniotic fluid and Doppler examination showed normal values pulsativ index in umbilical artery.
The XXXX was decided induction consecutive day due to over future pregnancies. By Journal stated that the cervix was immature with Bishop score 2, and balloon catheter was chosen as the induction method. Fetal weight was estimated at 3.5 kg. Amniotic fluid index (AFI) was measured at 11 cm and CTG was also designated as normal. The balloon catheter was placed XXXX kl. XXXX (gestational XXXX).
In the journal it is stated that “ because of immature cervix commencing induction with COOK catheter Bishop score 2. Patients are notified of it and get to go home with the catheter” . the woman and XXXX testified before the State Board of Health that after insertion of the balloon catheter, was sent home with instructions to return if the catheter fell out. They believe that they did not receive information about potential risks, or how to deal with if it occurred complications.
Return to the maternity ward
On the night of the XXXX woman had severe pain, and there was an unusual amount of activity of the child. On the morning of XXXX ca. kl. XXXX called the woman to the maternity ward and expressed concern about this. She was told to take it easy, eat, shower and go to the hospital eventually. There is no information in the patient record about this phone call.
XXXX arrived at the hospital at. XXXX. It was conducted investigation with CTG and abdominal ultrasound. There were no cardiac activity in the fetus, and diagnosis utero were posed. The balloon catheter was removed. Cervix were five cm open, and it was made amniotomi without observed amniotic fluid.
There was a need to stimulate contractions, and because of the long utdrivningstid was placed vacuo. The child was a stillborn XXXX children born XXXX kl. XXXX. Epidural anesthesia ended at. XXXX.
XXXX consented to an autopsy, and it was also decided that the placenta should be submitted for histology.
Follow-up of bladder function in postnatal period
the woman was catheterized urine several times during labor, most recently at. XXXX. It is described in the journal that the woman was in the toilet the first time after giving birth before kl. XXXX. Exact time was not documented in the records. Responsible midwife journaled after the night watchman was finally: “Peeing spontaneously do. Uterus little rind palperad because obesity, but would fall to be well contra council, Scanty bleeding. Interest heard anything från pair after 05 o’clock. “
Midwives have noted in Partus that woman again was the toilet XXXX kl. XXXX, but it then just got a little urine. The project involved a bladder scan. She was tapped for 600 ml urine ca. kl. XXXX, then 1300 ml of urine at. XXXX. At this time, it was not put into open permanent urinary catheter. The reason this was not done, should, according to the business have been that it was laid plans for a memorial service shortly thereafter. Urinary catheter was inserted at. XXXX.
The woman was discharged from hospital XXXX with inlaid urinary catheter that she should have a week’s time. It appears in the journal that she received instruction about bladder training and the catheter should be one week. She got a prescription for Furadantin against urinary tract infection that she would spend up to XXXX. She got along written instructions about removing urinary catheter. Although not of the exit note or of discharge summary after stay how bladder training would be followed up. The further development of the woman when leaving XXXX was delegated to a midwife in XXXX.
The catheter was attempted removed after only five days. There was yet another episode with crowded bladder during this time period.
It was according to patient laid plans for follow-up by a midwife at the health clinic in XXXX. It was also planned that XXXX would receive notice within six weeks of follow-up at the gynecological department XXXX for conversation and review of test results by stillbirth occur.
Of Patient Record states the medical record by gynecological department XXXX, that there has been a telephone conversation between XXXX and doctor. It appears in the journal paper that the woman together with the midwife removed the catheter, but that she was unable to empty their bladder afterward. They agreed that she would continue to have a permanent catheter, and the catheter should be fully open. She would then come to the gynecological department XXXX XXXX in order to remove the catheter, alternatively learn self-catheterization. It was noted that bladder training had not been optimal, since it had been a further episode of residual urine ca. 1500 ml.
The woman was hospitalized in the gynecological department XXXX. She still could not urinate, despite a total of eleven days of permanent urinary catheter. She received during our training in engangskateterisering. She stated that she produced 400-500 ml urine at two hours and 1000 ml during the night. She got recommendation to empty the bladder every two hours.
The night of XXXX woman had catheterized himself on three occasions at. XXXX, at. XXXX and noon. XXXX. There had been little urine, and what came was bloody. Nurse Note dated XXXX showed that the woman had catheterized himself for another 150 ml kl. XXXX. It follows nurse note that she would go home the next morning and did not need further training in self-catheterization. In medical note emerges that the woman wanted to be in the department further one day to become quite sure even catheterization. The doctor had a long conversation with the woman about bladder problems and how she would regulate catheterization. It was decided that she would catheterize every 4 hours, but not at night.
Later monitoring of bladder function
was made an agreement on new controls on XXXX. This was done by a gynecologist at the gynecological department XXXX. It appears in the journal paper that the woman still had urination problems with residual urine 300ml. It was made a new agreement on follow-XXXX. The woman had at this time still no urgency, and she still had to catheterize themselves. Plans were made for new consultations with further investigation after two to three months if the bladder function had improved. At this consultation should also autopsy results are reviewed.
The patient met for consultation by the gynecological outpatient clinic on XXXX. At the consultation the woman was also supervised by an anesthesiologist who concluded that epidural anesthesia during labor had led briefly reduced sensitivity Bladder. This had further led to a lack of urgency after birth, requiring bladder scanning and catheterization as a result. There is a full medical record of the consultation, which the entire patient care is reviewed. The note also contains a reference to XXXX for monitoring new pregnancy.
Clinical autopsy of the stillborn child
The conclusion after clinical autopsy was that it was an intrauterine fetal death in week XXXX. Underlying cause of death was perceived as acute chorioamnionitt and chronic maternal circulatory disturbance. There was extensive intracranial pathology (bleeding in the brain tissue). It was believed that this was due to placental insufficiency. Pictures of radiological examinations were sent for “second opinion” to XXXX. There they were considered normal, which XXXX was briefed on XXXX.
Relevant governing documents
The company has submitted a copy of the relevant governing documents along with a statement in letter of XXXX. Several of the written procedures have been revised / updated after the event.
Procedures for induction
– Doc. No. PR 0949 version 2 came from XXXX
– Doc. no. PR 0949 version 3 that came from XXXX
It appears that induction with Foley Catheter is the first choice when unripe cervix. Procedure must ensure that there is clear indication for induction, and apply to midwives and gynecologists. Different methods of induction are described, and a description of the actual execution.
Procedures for urinary retention after childbirth
It is not submitted written procedures for monitoring of patients with urinary retention after childbirth. The company has stated that it is the earth mother’s responsibility to control her bladder function.
The company has not written procedure describing what midwife should observe and control in women who have given birth, with regard to urination. There is no description of which patients are especially prone to urinary retention. It is not disclosed procedures for the patients with severe urinary retention should be treated or followed up.
Litigation death in utero
– Id. no. PR0964
The procedure specifies the research to be done on admission, as well as the information that must be given to XXXX. It also tells you who is responsible for the different areas of treatment and information on admission, after abortion / birth and the general assessment. Midwives are responsible for the placenta and storing it. Midwives are also responsible for procedures relating to the autopsy of the fetus.
Statement from the woman and XXXX
In a letter dated XXXX has XXXX given a written statement on the matter. It is also sent claim form to the Norwegian pasientskadeerstatning.
XXXX was concerned that the child was not born at term, as they believed that the woman had gestational diabetes. They requested that the birth should be started XXXX, over a week after installment. The woman did not granted this, and it was reasoned that XXXX (maternity ward) had the capacity to do so. An attempt was made to initiate birth several times by “stripping”. XXXX believed that it was not done any research to assess amniotic fluid quantity or infection, nor by inserting balloon catheter.
They ask further questions about why the woman’s gestational diabetes was not taken seriously. They wonder also why the hospital did not follow up the reduction in weight of the child, as it emerged the health card. XXXX brought this up several times towards the end of pregnancy. They ask if not birth should have been initiated earlier and whether it should have been investigated how much amniotic fluid that existed before induction with balloon catheter.
Statement by XXXX
XXXX has issued a statement in a letter of XXXX. It is here accounted for patient care and the procedures and practices applicable to that area.
The company has a procedure for induction with balloon catheter. It appears that induction with Foley Catheter is the first choice when unripe cervix. The business has stated that they considered that close monitoring was not necessary and that the pregnancy was not considered a risk pregnancies. After their review, the procedure for balloon induction followed.
The Company believes that the patient’s bladder at no time was left out.
Legal basis
Specialist health § 2-2 says something about which requirements apply to health care is provided in hospital:
“ healthcare offered or provided under this Act shall be reasonable.
Specialist health shall prepare their services so that personnel performing services, being able to comply with their statutory duties, and so that each patient or user is given an overall and coordinated care. “
the requirement for prudence is a legal standard. This means that the content is determined by norms outside the law. This requirement is rooted in recognized expertise, professional guidelines and social ethical norms. Healthcare offered and rendered to be justifiable. This means that the standard of health services should be at a certain level.
Specialized Health Services Act § 2-2 must be seen in conjunction with the Health § 4 which requires health professionals to exercise their functions in a professional manner. Soundness norm in Specialized Health Services Act, however, a more comprehensive basis than prudence provision in the Health.
There is a close link between the requirement to soundness and the need for internal controls and systematic program to ensure patient safety, cf. Act on Supervision of Health Services § 3 and regulations regarding internal controls in the health and social services (internal regulation § 4).
Specialized health Services Act § 3-11er a provision on the hospital’s responsibility to provide good information:
“Healthcare facilities covered by this law, are obliged to ensure the provision of such information as the patient is entitled to receive for patient and user rights Act § 3-2. The same applies for information to the patient’s next of kin for patient and user Rights Act § 3-3 third paragraph. “
The Health § 4, first paragraph reads as follows:
” Health personnel shall conduct their work in accordance with the requirements to professional responsibility and diligent care that can be expected based on their qualifications, the nature of work and the situation in general. “
the Health § 10 reads:
Information for patients etc.
“The health health services, should provide information to the person entitled to it under the rules of patient and user Rights Act §§ 3-2 to 3-4. In health institutions information under the first sentence given by the person whom the institution designates. “
The Health § 39 reads:
” The health care provider shall record or record information as mentioned in § 40 in a record for the individual patient. The obligation to keep records does not apply to cooperative personnel providing care for instruction or guidance from other health professionals. “
Norwegian Board of Health review
The overall assessment subject is the woman got proper health care by XXXX. We will also consider whether the company’s practices and procedures in this area was acceptable.
Review themes of the matter is structured in these key points:
- on the election of outpatient balloon induction in the female and further review was proper and whether the woman received information after the induction in accordance with the information requirement
- the woman’s bladder function was properly followed up after birth
We will also consider whether the business by its management has facilitated the treatment was justifiable on the above points, and this is included in the overall assessments below.
Ratings of enkeltpersonells actions included in the assessment of the overall follow-up the patient received.
on the choice of outpatient balloon induction in women and further action was justifiable, and whether the woman received information after induction into line with information obligation
Birth care during pregnancy passing forward, and guidelines for the time of induction, has been changing in recent years. Pending the revision of the Guidelines in obstetrics from 2008 prepared Directorate of Health recommendations for handling postterm pregnancy 7th July 2011. A further specification of the recommendations was sent as a circular to all the regional health authorities, dated 29 June 2012. According to recommendations in the circular should all pregnant will be offered control in the specialist seven to nine days after ultrasound term. If this investigation are particular risk factors, the woman should be advised induction over further action.
Supervisor in obstetrics specifies insertion of balloon catheter as one of several methods for labor induction at immature os,. The method is mentioned both in the edition of the guide from Norwegian gynecological association which came in 2014 and in previous edition of 2008. In the latest release it is stated that women do not necessarily need hospitalization or monitoring of the fetus, if there are no signs of pathology otherwise in pregnancy.
A summary of knowledge in “UpToDate” concludes that there is enough research in this area to recommend induction by outpatient treatment.
Norwegian health authorities have different practices in this area. Whether the choice of outpatient treatment using balloon catheter could be considered justifiable, must depend on a concrete assessment of each case. Assessments must be taken into consideration risk assessments made by induction time and the situation in general. The management of the business must facilitate proper practice for which women should be offered outpatient induction, and what women should be discouraged this.
When installing balloon will cervix ripen by extracting prostaglandins from the tissue locally where the balloon is placed. This causes contractions of the uterus, and may even lead to rupture. Contractions leads to increased stress on the fetus by reduced circulation in the placenta. This causes stress healthy fetuses usually tolerate well. In case of future pregnancies may however be different. Prolonged pregnancy is considered a risk pregnancies.
During the delivery shall fetus carefully monitored because there is a risk of complications. This must be part of the overall assessment made by decision induction and monitoring after the treatment. In cases where the business chooses to send the pregnant home after induction with balloon catheter, provide information about both normal stream, and about possible complications of treatment.
Norwegian Board assumes that outpatient induction balloon catheter may be considered if the risk of complications is minimal. It may be appropriate where there is no doubt about the fetal condition, and there are no risk factors of importance. It is also a condition that the patient receives appropriate information. Both the supervisor for obstetrics 2008 and 2014, it pointed out that it is important that the pregnant prior to getting information about the treatment and what is expected proceeding by induction of labor. In the new supervisor recommended that the maternity ward stock writing patient information that is adapted to hospital routines.
Assessment of the health care
According to the woman’s health cards for pregnant women, there were XXXX with the woman even before she became pregnant. She gained well XXXX kg during pregnancy. In addition, pregnancy over future. There was thus more risk factors at the time of induction. None of these were, however, absolute contraindications for choice of balloon catheter induction method by immature cervix.
Good practice would be to keep the patient in the ward for observation after insertion. Upon investigation by ultrasound and CTG embryo prior to induction, it was found normal values. The fetus was growth estimated XXXX and XXXX and the average large. Amniotic fluid amount was assessed and it was normal both by decision induction XXXX and the induction day. CTG recordings were taken both days and they were normal. It is debatable whether the woman pregravide XXXX, major weight gain and glucose intolerance were risk factors of such a nature as outpatient induction in this case should not have been offered. The business did in this case a specific assessment, and concluded that this was proper.
Despite that good practice would be to keep the woman for monitoring, find Norwegian Board that outpatient treatment could be carried out with the proviso that it was given sufficient information about how the woman would relate, including when she should contact the hospital, and if the risks were associated with outpatient follow-up.
In this case, should the woman learned that she immediately had to turn to the hospital when contractions or rupture of membranes, if she was unwell or unsure if the child was all right. There is conflicting information about such information was provided. The woman believes that such information was not given, while the entity believes XXXX was informed. The medical records contain no such information was provided. Norwegian Board considers it likely that such information was not given. We therefore assume that the woman had not been given enough information about how she should deal with after the induction.
Norwegian Board finds that it was indefensible that the woman was offered outpatient induction, without the enterprise simultaneously ensured that the woman had been given the necessary information about risk, and how she should proceed. This was violation of the requirement for proper health care in Specialized Health Services Act § 2-2, ref. The requirement for information in Specialized Health Services Act § 3-11, ref. The Health §§ 4 and 10.
In addition, we note that the phone call when she contacted the hospital and expressed his concern, should have been recorded in the patient record. That it was not recorded are not in line with the requirements of good practice, but the discrepancy is not regarded as so big that it violates the Health § 39; see. Journal Regulation.
Review of business facilitation responsibility
the agency shall facilitate proper treatment of pregnant women with increased risk of complications. Norwegian Board notes that the business has not provided any guidance on which women should be offered outpatient treatment. It is then up to the individual doctor to evaluate this from time to time. This will result in varying managing risk mothers, thus increasing the risk of complications and unwanted outcomes in at-risk pregnant women. Moreover, the business is not routines of good information for women who are offered outpatient balloon induction. This applies to both the method’s nature, potential complications and precautions for symptoms of complications.
Norwegian Board of Health found that the company has not been made for the proper care of, and information to risk pregnant women offered outpatient balloon induction. This violates the Specialized Health Services Act § 2-2, ref. Internal regulation.
About the control of bladder function after birth
bladder capacity decreases and sensitivity to over stretch reduced in during pregnancy. During birth the bladder being exposed to a mechanical stress, which can lead to nerve damage in the bladder wall. After birth, many women have increased diuresis due to redistribution of extracellular fluid, which can also contribute to crowded bladder.
The result of a severe urinary retention may be permanent damage of the urinary bladder.
Risk Factors which can lead to urinary retention after childbirth, prolonged birth, operative intervention, edema, hematoma and abrasions, especially fortilrifter, epidural / spinalanalgesi and large amounts of intravenous fluid.
According to supervisor in obstetrics 2008 Chapter 43 on urinary retention after birth, it should be documented in all nyforløste women that urination is settled in within three hours after birth. For residual urine between 150 ml and 1000 ml, the woman engangskateteriseres every 2 to 4 hours to spontaneous urination has begun. She should be catheterized so often that she avoids residual urine of more than 400-500 ml. Plan for catheterization should be noted in the flowchart in the nursing report. For residual urine over 1000 ml should be inserted indwelling catheter from two to three days and up to one week. Upon discontinuation of urinary catheter, the woman should be closely monitored.
It is important to measure the residual urine. If there is residual urine at & gt; 150 ml, the patient should be trained in regular self-catheterization to prevent new urinary retention that may cause the bladder wall further damage. It is important to investigate whether there is a urinary tract infection and by positive findings should such an infection is always treated. The women who need regular catheterization over time, should always be referred to a competent gynecologist or urologist for further control of bladder function and possible treatment.
Women who have recently given birth should be encouraged to urinate within two hours birth. If the woman fails this, midwife assessing whether it can wait another hour. The assessment must be made concrete in the individual case. Degree of observations and measures should be adapted to the situation and any risk factors, so that it is clarified and documented whether urination has come in order within three hours.
Although the woman has passed urine within two hours, the midwife at palpation ensure that there are no signs of filled bladder. If the uterus is high or to either side, this may be a sign of full bladder. Another sign is that the urine comes by palpation of the uterus or symphysis. Good practice is such that monitoring of bladder function occurs concurrently with a clinical assessment of uterine contraction after birth. The woman should also be informed that it is important to follow through on urination.
If health workers suspect incomplete emptying of the bladder, should be examined with bladder scanning or by catheterization. The timing of the survey and the quantity of residual urine documented in the records. By unrest or indefinable pain should urinary retention assessed as the cause. It may be difficult by clinical examination to assess whether a nyforløst woman has urinary retention or not. It should therefore be a low threshold for investigating bladder scanning. Alternatively it can be done engangskateterisering to investigate whether there is urinary retention.
Knowledge of how the midwife will monitor the bladder function after birth, the basic knowledge a midwife should have. Enterprises must ensure practices that underpin good practice in this area. They must ensure that there is an established practice that ensures that women with conditions particularly predisposes to retention, should receive special attention.
At unsatisfactory urination after childbirth should be clearly responsible treats the measures to be implemented, and how this will be monitored and documented. Necessary information on follow-up at discharge should be clear both for the woman and for personnel who have treats responsibility in the future course. This is especially important in cases where the task is delegated to another qualified midwife or GP.
Assessment of the health care
In this incident there were several risk factors for incomplete bladder emptying. The woman was catheterized several times during labor. However, there is insufficient documentation on how voiding occurred after birth, except that she had spontaneous urination once before at. XXXX.
