Earlier this year, news revealed that over several years Unilabs had sent around 170,000 Norwegian X-rays to a clinic in Romania for examination. The practice took place in secret from the patients, Norwegian authorities and clients. The day after the agreement became known in the media, Unilabs terminated the agreement with the Romanian clinic. It happened after strong pressure from Health South-East, which reacted to the fact that Romanian doctors had participated in the work without Norwegian approval. Now a statement from Unilabs to the Norwegian Health Authority sheds new light on several sides of the story. After reading the report, the Norwegian Health Authority and the State Administrator in Oslo and Viken chose to close the case. It happened without considering whether it was illegal to send the surveys to Romania. Unilabs asked the Norwegian Health Authority not to share the report with the public. news has been given access to the entire report. Photo: Ronald Hole Fossåskaret / Ronald Hole Fossåskaret Won the tender – did not have enough people Why did Unilabs send tens of thousands of X-rays to Romania hidden from the public? According to the statement, the collaboration with the Romanian clinic was about capacity. In 2015, Unilabs won a tender to deliver X-ray images of patients to Helse Vest. The company was now to establish branches in Haugesund, Bergen and Stavanger. Unilabs had agreements in Helse Midt, Helse West and in all seven hospital areas in Helse South-East. The only problem was that they lacked radiologists to deliver on what they had promised. In 2016, Unilabs established itself in Bergen, Stavanger and Haugesund, after winning tenders the previous year. Facsimile: Bergens Tidende/Stavanger Aftenblad/Haugesunds Avis Without bringing in more radiologists, the company would have problems. In the agreement with Helse Vest and the other contract partners, there are requirements for time, expertise and staffing. But instead of talking about the complicated problem, Unilabs turned its nose towards Eastern Europe. Unilabs contacted the married couple Daria Arif and Khaled Arif, two experienced and highly productive radiologists. The married couple Daria Arif and Khaled Arif moved to Romania 17 years ago. She received Danish citizenship in 2002, while he became a Danish citizen in 1999. They both received Norwegian approval as radiologists in 2004. How? GPs across large parts of the country sent their patients to Unilabs in the belief that the X-rays were taken locally, and that the images were examined locally or, if necessary, elsewhere in Norway. Instead, the images and references were sent via at least three links and two languages through Romania. How? This is Unilabs’ version of what happened, and here you have to keep your tongue in your mouth: Step 1: A local secretary in Romania translates the text from the GP from Norwegian to English, and passes the text on to a local radiologist. This radiologist summarizes the text from the translator to prove that the content is understood. Step 2: The local radiologist examines, interprets and prepares a description in English. Step 3: The text is then sent back to a secretary, who translates from English to Norwegian. In Romania, the married couple Arif, a number of local radiologists and a bunch of translators were given access to thousands of Norwegian X-rays and patient histories. Illustration: Mari Grafsrønningen / news Step 4: This is where the married couple Daria Arif and Khaled Arif enter. One of the two radiologists with Norwegian authorization and specialist approval makes a complete re-examination of the X-rays. Step 5: Daria Arif or Khaled Arif signs, and is listed as medically responsible for the description. It is only the names of the Arif couple that appear when the GP reads the radiologist’s assessment. Why steps 1 to 3 were necessary, Unilabs does not write anything about in the report. The Romanian clinic was equipped with workstations from Norway, its own usernames and passwords, as well as an encrypted connection to the systems of Norwegian Unilabs. Photo: Rolv Christian Topdahl news has asked a number of questions to Unilabs and managing director Laila Aarseth in connection with this case. Read the questions and Unilabs’ answers further down in the article. Wrote that the Directorate of Health confirmed that the practice was legal – that was not true, Unilabs in any case believed itself that sending X-ray images to Romania in hiding from the Norwegian health authorities was not illegal. On the Directorate of Health’s website, Unilabs found support in a legal interpretation from 2007, which they believed supported their view. But when news questioned the practice, Unilabs contacted the Directorate of Health for the first time with questions about the legality. The answer from the Directorate of Health was clear (news’s emphases): The Health Personnel Act applies to health personnel who provide health care “in the kingdom”, and does not apply to personnel who provide health care from abroad. A solution with teleworking from abroad to Norway can be challenging in terms of Norwegian health legislation and patient rights. Only in special cases where, for example, the health personnel have a particularly strong connection to Norway and the specific patient relationship, can the health care, after a concrete assessment, be considered provided “in the kingdom”, wrote the Directorate of Health. The statement from the Directorate of Health triggered a number of questions from Unilabs, which for seven years had made use of health care from abroad. At the same time, the Directorate of Health wrote something that Unilabs stuck to: That it is the business, in this case Unilabs, which is responsible for ensuring that the health care complies with the requirements of the health legislation. Unilabs breathed a sigh of relief, and later wrote in its statement to the Norwegian Health Authority that the Directorate of Health vouched for such a practice: “In connection with the case in question, we have also obtained a confirmation from the Directorate of Health that indicates that the use of healthcare personnel abroad is legal”. with reference to the fact that Unilabs as a business was responsible. To news, the Directorate of Health denies that they exonerated Unilabs, even though Unilabs writes this to the Norwegian Health Authority. – The Directorate of Health does not have the authority to assess individual cases, and has not assessed whether Unilabs’ practice has been legal, the Directorate replies in an e-mail to news. news has asked Unilabs why the company has nevertheless written to the Norwegian Health Authority that the practice has been assessed as legal. We have not received an answer. Shared information with personnel without Norwegian approval Many readers have contacted news with questions about whether Unilabs was allowed to share health information with Romanian radiologists and Romanian secretaries. These do not have authorization or a license to provide health care in Norway. Unilabs has relied in several contexts on the fact that the law allows confidential information to be shared with so-called “collaborating personnel”: “The right to share patient information with cooperating healthcare personnel is not limited to applying within a business or within the country’s borders”, writes Unilabs to The Norwegian Health Authority. However, Helse Sør-Øst, Unilabs’ largest customer, believes that the practice may be in breach of the law. In a letter to Unilabs, Helse Sør-Øst wrote that the use of assistants presupposes necessity. “There is no need for a double assessment of the images as described and carried out by the subcontractor,” wrote Health South-East director Terje Rootwelt. Photo: Rolv Christian Topdahl / news Professor Henriette Sinding Aasen at the Faculty of Law at the University of Bergen (UiB) also believes that Unilabs is wrong. She points out that by law Unilabs should have obtained consent from the patients before their information was shared with doctors and secretaries in Romania. – The main rule in Norwegian law is that the patient has the right to object to the health information being passed on. This right is of course particularly important when it cannot be assumed that the patient would readily accept that the information is sent out of the country, and especially if the circumstances do not appear reassuring, says UiB professor Sinding Aasen to news. Concludes supervision – has not considered whether Unilabs broke the law In a letter to Unilabs, the Norwegian Health Authority writes that they register that there have been no deviations in the work carried out by the clinic in Romania. The inspectorate has also noted that the collaboration has ended, and that they will not follow up the case further. The state administrator in Oslo and Viken has also been involved in the case, and has ended the follow-up of Unilabs. The state administrator cites, among other things, meetings with Helse Sør-East about risk and vulnerability assessments and internal quality work as reasons. – In this case, we have considered it sufficient that the service itself has dealt with the case as part of its quality improvement work. We have not found it expedient to assess whether there is a breach of health legislation, writes Thea Marie Lindquist Belseth, assistant department director at the State Administrator in Oslo and Viken. It is not a goal in itself that supervision points to illegal conditions, writes Thea Marie Lindquist Belseth in an email. Photo: The State Administrator in Oslo and Viken The Danish Data Protection Authority established in April a letter control of Unilabs’ outsourcing of services to Romania. The outcome of the inspection is still not clear. Unilabs does not respond There are still many unanswered questions related to Unilabs’ deployment of services to Romania. In an e-mail sent to managing director Laila Aarseth, news asks: Laila Aarseth, managing director of Unilabs Norway. Photo: Unilabs What is the reason why Unilabs did not tell Helse Vest and Helse Sør-Öst that they had too few radiologists? Why didn’t Unilabs tell about the collaboration agreement with the Romanian clinic? Why was it necessary to use local translators and radiologists without Norwegian authorization? Why is Unilabs writing to the Norwegian Health Authority that they have obtained confirmation from the Norwegian Directorate of Health that the use of health personnel abroad has been legal? Instead of a reply from Unilab’s Norway director Aarseth, news receives an e-mail from Samuel Danofsky in Sweden. He has the title “Head of Communications Nordics” at Unilabs, and writes: – Thank you for your inquiry. Unilabs points out that the Norwegian Health Authority has reviewed and closed the case. We have nothing further to add.
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Unilabs secretly sent tens of thousands of X-rays to Romania – now the Norwegian Health Authority drops the case – Rogaland
