Exempt from public disclosure pursuant to offline a. § 13 cf. PAA. § 13, first paragraph. 1
The public demands for transparency in individual cases are handled through that anyone can request access to individual documents, based on publicly available mailing lists.
Decisions warning
Norwegian Board of Health has decided to give you a warning under the Health § 56 first paragraph. We have concluded that you have violated the acceptability requirements of the same Act § 4 by your treatment of two patients. We have also concluded that you have violated the disclosure requirements of § 10.
You can appeal the decision within three – 3 – weeks of receiving this letter.
Procedural process
Norwegian Board of Health received by letter dated XXXXXX and XXXXXX XXXXXX from the county governor sent two audits matters concerning your activities as a doctor. Supervision cases concerning your treatment of patient XXXXXX (case XXXXXX, hereinafter patient 1) and patient XXXXXX (case XXXXXX, hereinafter patient 2).
In a letter of XXXXXX to XXXXXX HF, we asked for information on the occasion of patient 1 . After reminders we received responses from XXXXXX by letter of XXXXXX.
We forwarded information from XXXXXX to you by letter of XXXXXX. You submitted a statement on the matter in a letter dated XXXXXX.
In a letter dated XXXXXX XXXXXX to dermatologists, we prayed that XXXXXX submitted patient 1′s journal. We received journal in a letter dated XXXXXX.
We oriented you by letter dated XXXXXX that we would consider giving you a warning. In e-mail of XXXXXX, you asked for deferred deadline to XXXXXX. We confirmed postponed deadline in the e-mail of XXXXXX.
In the e-mail of XXXXXX submitted a statement in the case.
County of XXXXXX has forwarded additional supervision to you, our Case XXXXXX. This was concluded in the letter of XXXXXX. We stated in the letter that our assessments and conclusions in the case, will be taken into consideration whether you will be given an administrative sanction.
The subject matter
You are a graduate of the University of XXXXXX in XXXXXX and you got Norwegian authorization as a doctor the XXXXXX, HPR no. XXXXXX. You are a specialist in skin and venereal diseases from XXXXXX. At the time of the relevant events were you employed at XXXXXX XXXXXX in.
Norwegian Board has considered the matter on the basis of case documents. Below is a discussion of the factors that have had an impact on our rating.
Patient 1
The patient is a woman who at the time of the events was XXXXXX years.
The patient complaint
In his complaint to the County dated XXXXXX, informs the patient that she fall XXXXXX consulted about getting examined moles. She was told that she had moles were not dangerous, but that she had solar keratoses, which you said was the precursor to cancer. You suggested that you should treat this with a strong TCA peel. You should have explained that the treatment was going to be somewhat painful, and the skin would exfoliate (peeling) during about 10 days.
The patient states that she received the XXXXXX XXXXXX treatment. She indicates that the treatment after a while it became very painful. She learned that her skin would first be white and then, in a matter of hours, red. She got a prescription for an ointment that would prevent skin infection and Valtrex for preventing herpes. The patient noted after the treatment, the skin of the nose and forehead remained white.
The 1st and 2nd day after surgery patient clinic contacted telephonically because of facial swelling. She writes that she spoke with you at these inquiries. At the first call, she learned that it was not unusual to be slightly swollen after this type of treatment, and the day after she’d take Zyrtec. Three days after the treatment she got a high fever. Over the next few days evolved bubbles of pus in the face, and the XXXXXX, 7 days after treatment was the face covered by this. She then called the clinic again. This time she got to talk to you. She said she thought she had received infection and you sent her an e-prescription for Ery-Max (because of penicillin allergy) and more Valtrex, and you agreed that she would come to control with you the next day.
The patient writes that she thereafter was with you twice, the XXXXXX and XXXXXX, where you cleaned and scraped skin of the face. You gave her permission to continue with antibiotics. In connection with the last purification bled she pretty much. The following day she would to her doctor in another occasion. When the family doctor saw the patient she phoned XXXXXXs Department of Dermatology and ensured that the patient did get there the same day. She got here changed antibiotics to Dalacin and it was started treatment with Betnovate with Chiniform. On XXXXXX gave one expression of concern for the patient’s forehead and nose.
The patient was under treatment at XXXXXX weeks. In XXXXXX, at the time the complaint was written, she was still not recovered, but had red, ugly scar and infiltrates in the face.
Concern Message from XXXXXX
In concern of XXXXXX by dermatologist and head of section, it must be questioned whether there was indication for such a potent therapy, and about other treatment options were considered. It also questions whether trichloroacetic was too strong or whether it seemed for a long time and it noted that photos taken at the Department of Dermatology the XXXXXX showed uneven application of TCA with some recessed areas. Likewise, it must be questioned whether or not the patient should have been followed closely by the treating physician (you) when it tilstøtte complications.
Your journal
You write in the journal after the first consultation the XXXXXX:
leveled PDT beh. Åter after sun holidays. advice solskydd + BCC + AK + seb. Keratosis + PDT.
About the previous and current skin diseases, type:
atopiker as a child, Inga hudoperationer .
In connection with processing the XXXXXX stated in the record that the patient received Emla and nerve blockage in the face, and you then swabbed TCA 30%
2-3 stock tills Equalize frozen effect happens, Grade 2 . Zimmer cooling hela time decisively helped against smertor .
Of your journal also stated that the patient took telephonic contact with you XXXXXX because she thought she had gotten an infection in the skin. You journaled she
Got tecken on hudinfektion, hot and tender. Given treatment .
The next day, the patient to control with you, and you journaled that
Sekundära hudinfektioner in face by TCA peeling with gula skorpor. Ery-Max 2×2 dagligt has hjälpt .
You journaled also that you cleaned up in “ mugs seats “, and that the patient should set up new control after 6 days . At the next control you have in the journal described debridement of the wound in the same way.
The XXXXXX have recorded that the patient has canceled his hour because she had been referred to XXXXXX.
Your statement to the County
In the statement let you by written information that includes medium-deep peeling. In this it says about the side effects of exfoliation that after treatment will be red, slightly swollen and slightly annoyed, and the skin after a few days will be slightly darker in color, and that the top layer of skin will exfoliate.
Concern Message to the County from the patient’s GP
The patient’s general practitioner states in its concern to the County that the patient came to her with crust coated wounds all over his face except periorbital area after deep TCA peel with you. The patient was referred XXXXXX immediate help.
Your statement to the Norwegian Board of Health
You allege in the statement that the information in the assessment from XXXXXX, exclusively seems to be based on the patient’s own statements. You mean patient information is misleading in relation to the facts when it ia applies timeline of the case as well as indication for the treatment you gave her. You also write that the specified error indication for treatment were lines, wrinkles and benign hyper pigmentation, and not solar keratoses.
When it comes to the treatment itself shows you that there was steady frost effect to grade 2. You wrote out a prescription for Microcid cream and Valtrex tablets. You also tried to prescribe Dalacin capsules for 10 days, but the patient reported that she was allergic and she promised to take Ery-Max that she still had at home. You represent that you explained that the patient had to take antibiotics to protect itself against infection, because you made a powerful chemical peeling, and she accepted this. You write in the statement that “Debatable hygien again and ulcer” .
You further submits that the patient contacted XXXXXX the XXXXXX and XXXXXX and that she at last contact was asked to get to control. The patient should then have said that it was urgent so very, that she had fever and that there was only very swollen. It was also, questions from the patient, provided advice on the need to take antibiotics.
You show the patient the XXXXXX was new consultation with you. You did when mechanical cleaning and application of Betnovate with Chinoform. Patients should be informed to you that she took Ery-Max. You printed a new prescription for this.
The XXXXXX, 6 days later, the patient was again to consultation with you. Again performed to mechanical cleaning and application of Betnovate with Chinoform. You wrote out a prescription for Fucidin-hydrocortisone cream. You recommended Dalacin instead Ery-Max, but it would not have the patient in that she was allergic. The patient was afebrile during the consultation.
You also write, in the same statement, that you had not received any drug list from the patient’s doctor, and the patient gave wrong information about their medications and their health status. She said nothing about serious Staphylococcus aureus infections that she had had, and whether XXXXXX, but presented himself as a fully healthy person.
You also notes that the patient was referred XXXXXX the XXXXXX by her doctor.
You also shows that patient, phone the XXXXXX, reported that she had received Dalacin by XXXXXX, something you were surprised, ref. the patient’s allergy.
You’ve also added by copies of your educations and courses completed.
Patient 2
The patient, a day XXXXXX year-old man, sought on the XXXXXX because of two skin changes at the top of the forehead at the hairline. You measured size of 12 x 7, 8 x 6 mm. You have rated skin lesions clinically and you thought it was about plateepithelkarsinom (squamous cell carcinoma, SCC). You did not biopsy. The patient was set up to operation the XXXXXX, and it was done excisjon and patch plastic (double H-flap).
Postoperative went patches in total necrosis and the patient was 16 days after the operation referred by you to Department of Plastic Surgery at XXXXXX. The XXXXXX was there made Debridement and delhudstransplantasjon. The wound healed up sequelae as a 2×10 cm long hollow in the forehead.
Histology of the removed skin showed changes with seboroisk keratosis with no evidence of malignancy in one composition. The second formulation could not be evaluated because of a mistake made by the pathologist during the handling of this.
The patient was referred from Department of Plastic Surgery Section for dermatitis XXXXXX. On the basis of the assessment which sent the management of the department concern to the County.
The patient appealed the case to the NPE and was invited by letter of XXXXXX informed that he was entitled to compensation under the Patient Injury Act. The decision was based partly on the expert opinion of the dermatologist XXXXXX.
Concern Message from the Section for skin diseases, XXXXXX
Officials at Division for skin diseases have on the basis of relevant incident sent concern, dated XXXXXX, XXXXXX to about your business. It noted the concern message that the Section for skin disorders find it reprehensible that you did biopsies before it relatively extensive procedure, and that it is questionable whether you have the knowledge it takes to do this kind of surgery.
Statement of NPE from an expert dermatologist XXXXXX
XXXXXX writes in his statement that you, even though one might suspect that there existed a squamous cell carcinoma alone out from the clinical picture, should have secured diagnosed microscopically, particularly when localization was on such a prominent place in the pan. Unless biopsy within operation had shown seborrheic keratosis, one would could have avoided surgery with H-flap, and instead treated with less invasive treatments such as superficial abrasion (curettage) or freezing with liquid nitrogen.
Your journal
For the first memorandum states that the patient got frozen akiniske keratoses on forehead x 2 in XXXXXX, and that skin lesions had recidivert after courses. You have recorded that the patient has two well-defined skin tumors in the middle of the forehead at the hairline as clinically SCC. You enter last in the note that you informed the patient about skin cancer.
In the operation description contends that you gave local anesthesia containing epinephrine, and that you did 3 ashore flaps in double H-flap technique. You write that you moved one piece of the skin of the right proximal side without rotation and one from the left proximal side without rotation and a third from the left lateral side without rotation.
At first control two days after surgery, you found according to the Journal that the two piece of skin laterally had good signs of circulation, but that piece of skin in the middle was light faded, and that it was not certain that it came to the “ that binds ” . By the third control 7th postoperative day, you described mechanical purification by necrosis as “Corresponds to 25% of skin grafts.” Direct Command wrote you in controlling the XXXXXX “Poor adoption by skin grafts. The requirements kirugisk cleansing and ånyo hudtransplantation “. You referred when patient XXXXXX for this purpose.
Your statement to the Norwegian Patients (NPE)
In a letter to NPE including stated that your decision to take biopsies of lesions were influenced by patient XXXXXX and that he would not come to more consultations than necessary.
Your statement to the Norwegian Board of Health
You said that you have operated more patients with this treatment with good results and without complications. You write that you made
on spets of the implant, it is important for adoption of the implant and I used fine threads on suturing as not traumatize the skin .
You write that the patient had no serious complications such as nerve damage, blefaroptose, ophthalmic complications, bleeding or damage of major blood vessels, and that this demonstrates that the technique was good. Unfortunately had the complication of necrosis in parts of the graft, which was not adapted well by the surrounding tissue.
Legal basis for assessment
The information in supervision by the case to consider whether you have acted contrary to the requirement of proper business in Health § 4.
The Health § 4 contains provisions for soundness. The first and second paragraph reads:
health professionals must perform their work in accordance with the requirements of professional responsibility and diligent care that can be expected based on their qualifications, the nature of work and the situation in general.
Health professionals should abide by their professional qualifications, and shall obtain assistance or refer patients further where necessary and possible. If the patient needs dictate, the profession shall be by collaboration and cooperation with other qualified personnel. Health professionals have an obligation to participate in developing individual plans, when a patient or user is entitled to such a plan for patient and user Rights Act § 2-5.
The Health § 4 is a central provision. The provision requires professional responsibility and diligent care and health professionals’ professional practice.
What is justifiable is determined by an assessment of each case, and how health workers ideally should have acted.
A key provision in cosmetic surgery without medical indication is the Health § 10 for information. The first paragraph reads:
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 designated by.
Norwegian Board of Health review
Norwegian Board has considered whether your assessment, treatment and monitoring of patient 1 and 2 have been prudent. In this connection, we have considered the following:
Patient 1:
- information to patients
- choice of treatment method
- performing processing
- monitoring of the patient
Patient 2:
- of treatment method
- missing biopsy
- performing the operation
Patient 1
Good Practice – Information
In any medical professional practice, communication with the patient basic, and it is essential that the patient receives the necessary information before a medical procedure to be conducted. This applies in particular when there is cosmetic and not medically indicated for surgery. The doctor must explain to the patient why he / she believes the treatment you have chosen is the right one for the patient. Furthermore, the doctor must inform thoroughly about possible side effects and complications and what result the patient can expect to achieve.
The information must be sufficient for the patient to exercise his right to participation, including participate in the choice of health care where there is more than one option.
Review
Norwegian Board notes that it is not stated in the record or your statements that you have informed the patient about the risk of infection, or if you have enlightened patient about the importance of a possible infection treated quickly because of the risk of scarring. Nor does it appear whether you had any agreement concerning the control of any problems that may arise along the way. Norwegian Board On the basis of an individual case basis that this was not done.
In the information sheet about TCA treatment that you have submitted, mentioned side effects of treatment such as flushing, light swelling and some irritation of the skin. There is no mention of severe complications / side effects such as infection, scarring or hyper / hypopigmentation.
We assume that you have not informed the patient to such an extent that she could exercise its right to participate, and that you have broken Health § 10.
Good Practice – investigation and review
The study and evaluation of the patient involves taking a detailed medical history and do a comprehensive lens examination. History shall include at least familial disposition, previous and current diseases allergies, medications (taken regularly / on daily bais) and social conditions. Specifically, prior to a chemical peel, it should also be asked about contraindications to treatment.
Review
Norwegian Board notes that it is not stated in the record if you asked the patient about allergies at the first consultation. We put on the basis of an individual case on the assumption that you are not asked about this at the first consultation.
In our opinion would clarify the patient’s allergies and mapped the way health status. As the patient’s physician is the one who is responsible for relevant aspects pertaining to the patient’s health are clarified. We note that the patient’s primary doctor does not have the responsibility to transmit health information unless it is he / she who has referred the patient, which was not the case in this matter.
When it comes to patient hypersensitivity to penicillin, you should Having clarified this before starting TCA treatment. In our opinion you should also have revealed that the patient had previously had infections with Staphyllococcus aureus.
Norwegian Board has come to the conclusion that your assessment / evaluation of the patient prior to TCA treatment was incomplete in that you do not cut allergies, medication use and health condition before the treatment.
Good practice – treatment
In chemical peeling of the skin applied a chemical substance of defined strength resulting in rejection ( exfoliation) of the skin followed by regeneration of new skin. Chemical peels are classified by the depth of the impact into three groups, overflatiske-, medium and deep peels dype-.
TCA 30% characterized the international literature as a superficial peeling (superficiell, ligth) and TCA 35% as medium deep peel.
Superficielle peels, which only penetrates the epidermis, can be used to increase the efficacy of treatment of various conditions such as melasma, dyschromia, sun damage and akiniske keratoses. Medium deep peels penetrate pappilære dermis and for the treatment of multiple solar keratoses (including precankrøse akiniske keratoses), superficielle scars and pigment changes. All types of peels can be used in cosmetic indication.
Superficielle peels are very safe when used properly, but can cause itching, increased sensitivity of the skin, epidermiolyse, allergisk- and contact dermatitis. Scarring and post-inflammatory hyperpigmentation seen somehow infection rarely with superficial peels. Complications to medium deep peels can be divided into two groups based on the time they occur. Immediate complications occur within minutes to hours after the commencement of treatment consists of irritation (burning sensation, itching, pain), persistent redness, swelling, and vesicle formation. Delayed complications occur within days to weeks and consists of infections, scarring, delayed healing, milia, hyper- and hypopigmentation, demarcation line, degradation of the cutaneous barrier with deeper tissue damage, allergic reactions.
Infections can cause scarring in the skin and must be treated as soon as possible to prevent / minimize this. In the passage of some peeling, patients must be monitored closely for signs that may indicate incipient infection. Erythema and prolonged healing time is early warning signs that should give rise to treatment with local antibiotic and a potent topical corticosteroid.
To obtain a uniform penetration of the mixture during treatment, careful purification (antibacterial cleaning agent) of the skin and hereinafter degreasing prior to application of the active substance is essential in. After a single application of the chemical substance clinician must wait 3-4 minutes. to ensure that the frost has reached its peak before a new application is considered.
Exfoliering skin takes 1-3 days for a superficial peel, and the regeneration usually takes 3-5 days. At medium deep peels take exfolieringen usually 4-5 days, and one can expect epithelialisering of skin for 7-10 days.
Review
Norwegian Board of Health notes that it appears from the register that you used TCA 30%. Multiple notes stated, however, that treatment is carried out as if it were a medium deep peeling. In a letter to the Norwegian Board of Health writes also that you perform a deep peeling on the patient, and in the information circular from the clinic that you have forwarded to the County, also stated that the treatment the patient would get was a medium deep peel.
Government Health assumes that you performed a medium deep peeling on the patient. Of the patient record stated that you did not follow the usual guidelines for medium deep peeling with cleansing and degreasing of the skin prior to treatment, and we can not see that you have been waiting 3-4 minutes max frost effect between applications of trichloroacetic. Norwegian Board of Health has thus concluded that you are not performing the treatment for recommended guidelines.
Good practice – monitoring
Follow up of patients who have received made TCA peel , attention must be directed at those points in the postoperative course where one can expect complications. In a medium deep peel is rejection of the skin often complete after 4-5 days, but a complication of surgery is Prolonged rejection (7- 10 days) and Prolonged blush. Erythema associated with pain, should lead to immediate investigation with respect to the infection as early as possible to put into treatment.
Review
Norwegian Board of Health shows that you should have taken the patient to review the same day that she called and informed about the infection. You should have done a clinical assessment and included viral and bacterial tests to identify them. You should put into Dalacin (covering betlactamaseproduserende microorganisms and do not cross react with penicillins) instead of Ery-Max, and you should have put the patient on a potent topical corticosteroid.
In our opinion you should also followed the patient closer In this acute phase, and taken her to the new control already after a few days, then fast and adequate treatment of the infection is essential to prevent scarring.
Overall assessment
Norwegian Board of Health has concluded that the patient was not adequately informed about the side effects of the intervention. We have further found that your study, assessment, treatment and monitoring of the patient has not been in accordance with good practice.
Norwegian Board of Health has overall concluded that your treatment and monitoring of patient 1 was indefensible, cf. . Health § 4. We have also concluded that you have violated the disclosure requirements of § 10.
Patient 2
Good Practice – Information
We refer to good practice on information above, which will also apply to this patient.
Review
Norwegian Board notes that it is not stated in the record that you informed the patient of the potential risks of the operation. Nor does it appear that the patient was informed about the possibility of less invasive alternative treatments than surgery if by a biopsy would prove to be SCC. The only thing you have journaled concerning information is that you have informed the patient about skin cancer. We assume that this is the only thing you have informed.
After the State Board of Health assessment should have informed the patient about the risks of the procedure, especially considering that the interference was in a conspicuous place and that the diagnosis was not confirmed by biopsy. If you had informed the patient about this, he would have been in far better able to contribute to the treatment. Norwegian Board of Health has concluded that you have violated the disclosure requirements Health
§ 10.
Good practice – assessment / review
squamous cell carcinoma (SCC ) is a malignant tumor of the skin especially on sun exposed areas of the skin occurs. It is the second most common type of skin cancer and occurs approximately 1,500 new cases per year. Common localization is the face. The tumor metastasize in
about 5% of cases. Differential diagnosis of SCC is partly a different type of skin cancer, basocellulært carcinoma (BCC), and partly more benign conditions (keratoacanthoma, actinic keratosis, warts, warts seboroiske). The most common treatment for SCC is surgery.
Patients to be subjected to a surgical procedure must have a diagnosis that underlies the procedure to be performed. The diagnosis is also crucial for the intervention character, when, upon an unsightly, benign skin lesion as the patient would like to have removed have completely different approach than the removal of a malignant change.
The basic principle of all surgery that one should strive to do the simplest procedure that ensures patient adequate treatment. Thus one should always ensure to confirm or deny a malignant diagnosis before an intervention is planned. When skin lesions of unknown malignant potential take easily and without risk to the patient a 3 mm stoppage biopsy sent to histologic evaluation.
Review
Norwegian Board of Health notes that you undertook a surgical procedure on the patient without having a clear diagnosis. You undertook a large and potentially mutilating surgery without assure you that this was a necessary treatment. This is irresponsible.
Good practice – treatment
When clinical suspicion of SCC at small skin lesions can, in areas where this is cosmetically acceptable and the patient wishes change removed, preferably make a excisjonsbiopsi, i.e. that the entire lesion is removed and sent for histological examination. For larger lesions where treatment requires more extensive surgery should be done a diagnostic biopsy of the lesion before excisjonen.
By excisjon by a skin cancer, it must always be removed one brim of healthy skin outside the area that the clinical assessment represents the limit of the cancer (macroscopic free margin).
At the surgery of hudcancere potentially metastatic which SCC and malignant melanoma, it is important to know which one has the area for the malignant cells if histology did not show free edge . One must therefore always make simple interventions when removing the tumor, so around this, where the remaining cancer cells are located, can be found.
Lapp tuck face
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