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Termination of tilsynssak – breach of spesialisthelsetjenesteloven section 2-2
Saksbehandlingsprosessen
the subject matter
Legal basis
the State’s helsetilsyns assessment
Conclusion
State board of health has found that XXXXXX university hospital, XXXXXX HF has broken forsvarlighetskravet in spesialisthelsetjenesteloven § 2-2, cf. internkontrollforskriften
section 4 as a result of inadequate routines for the preoperative assessment of patients for the operation.
Saksbehandlingsprosessen
the State board of health received by letter of XXXXXX from the County of XXXXXX submitted a tilsynssak concerning an operation performed the XXXXXX by XXXXXX universitetssjukehus (XXXXXX), XXXXXX HF, where XXXXXX was operated on the wrong side. The case began after a complaint dated XXXXXX from the health & social services ombudsman in XXXXXX on behalf of XXXXXX (hereinafter referred to as the patient).
In a letter dated XXXXXX-oriented State board of health XXXXXX about tilsynssaken. In the letter of the XXXXXX stated klinikkdirektør XXXXXX and klinikkoverlege XXXXXX themselves to the matter.
the Case also raises questions about the physician XXXXXX has given proper health care. This question is treated in a separate saksvurdering, which is enclosed to this letter. State board of health has concluded that the superior has broken under § 4, but we have not given her a warning.
Facts
the State board of health has considered the matter on the basis of the patient’s complaint, received the disclosures and other received documentation. We assume that the subject matter is known, and refers to the attached saksvurdering in tilsynssak against XXXXXX.
Legal basis
It is a fundamental requirement to the health service that the helsehjelpen provided is professionally prudent, cf. the law on specialist health services m.m. (spesialisthelsetjenesteloven) § 2-2, which reads:
Health care services that are offered or provided pursuant to this act shall be reasonable. The specialist shall organize their services so that personnel performing the services, are able to comply with their statutory duties, and so that the individual patient or user is given a comprehensive and coordinated service offerings.
the Claim to justifiability in tjenestelovgivningen imposes on business a duty to the organization and the establishment of routines and procedures that ensure proper health care services. The obligation also entails that the company’s owner and management have the responsibility to create the conditions so that the individual health workers can perform their tasks in a proper way.
We also refers to the regulations on internal control in health and omsorgstjenesten section 4.
Internal control is a management features and an aid for the management and development of the company’s daily operations. Internal control should contribute to professional sustainable health care, and is a tool to ensure that daily tasks are carried out, controlled and improved in accordance with the requirements of the law. This is particularly important in areas where failure could have serious repercussions.
State helsetilsyns assessment
the State board of health has considered whether the patient has received proper health care at XXXXXX.
In the concrete assessment of whether the patient has received a proper health care centre, taking the State board of health a starting point in what should be expected/what is “good practice” in accordance with recognized expert knowledge.
It is a requirement that the company makes a systematic review of its services and results to identify the activities or processes where there is danger of the failure or breach of the regulations. The goal of the survey is to get an overview of the areas where failures may have serious or unfortunate consequences for patients.
Surgery on the wrong side can have serious consequences for the patient. It is therefore important that the company implements measures/effective barriers against unwanted events such as the present one.
the World Health organization (WHO) has together with an international group of experts developed a checklist for “Safe surgery”, “Surgical Safety Checklist [1]“, which should be an aid to reduce the occurrence of injuries and complications in connection with surgical intervention. The checklist was tested in a multinational pilot study where a significant reduction of complications and death in connection with surgery was reported. It consists of three parts; the preparation before introduction of anesthesia, a “time-out” before operasjonsstart and shutdown before the main operator leaves the intended incision site.
the Checklist ensures the bl.a. right patient, right intervention, right to hire, review of risk factors and more. The written notification form along with the checklist “Safe surgery” is today a recognized method in Norway, in order to minimize the risk of failure of the surgical intervention.
the Company has accounted for the department’s procedures for the planning of surgical interventions, including specific procedures that are to ensure that we are operating on the correct page. This should be secured by review of the journal, as well as the examination of and conversation with the patient. This should also be reviewed/specified by pre-operative “time-out” to be done in the operating room.
the Department has in the aftermath of the event innskjerpet routine for it to be collected operasjonsbeskrivelse from the previous intervention from the referring departments. The department has introduced the routine for that operator to sidemerke the patient before the operation in those cases where it is possible with the right-left confusion.
the State board of health will point out that in the present case occurred a failure in multiple joints. There was confusion regarding the sidelokalisasjon already when pasientsøknaden was treated, by that the reference was not complete and operasjonsbeskrivelsen was not supplied with. However, this was not followed up when the reference was reviewed on XXXXXX HF. Outpatient control prior to the operation was undertaken by the LIS, which, after investigation, wrote a vague note with respect to which side the patient was to be operated on. Conversation with the patient the day before operasjonsdagen was conducted by a different physician than the operator. But there was no written record of this conversation, which could provide important information to the person who was to operate. The operator’s conversation with the patient took place at a time when the patient was under the influence of drugs and had limited opportunity to contribute with information. Pre-operative assessment should as a rule be terminated when operasjonsprogrammet completed, i.e. the day before the procedure will be carried out.
the State board of health finds that the clinic’s policies and procedures to specify which page of the patient it was to be operated, was flawed by the fact that the business had not routine for sidemerking of patients. In addition, the existing routines are inadequately implemented, or they were not followed by several involved in the case. The clinic secured thereby is not proper treatment of the patient in the planning of the operative procedure.
We find that there is a breach of the requirement to prudent health care by XXXXXX their routines/practices do not ensure that it conducted all appropriate preoperative investigations on the patient. Helseforetakets lack of management in this area is a violation of the specialist health service act § 2-2 and internkontrollforskriften section 4.
Conclusion
XXXXXX, XXXXXX HF has violated the requirement of proper treatment in the spesialisthelsetjenesteloven § 2-2 and internkontrollforskriften section 4.
the State board of health requires that the measures XXXXXX HF, XXXXXX has described, shall be taken, or is taken to rectify the conditions, and it is assumed that these are implemented and followed up.
Tilsynssaken ends with this.
regards,
XXXXXX
XXXXXX
Letter is approved electronically and sent therefore without a signature
Attachments:
a Copy of the decision in tilsynssak of d.d. against seksjonsoverlegen
Copy to:
the County in the XXXXXX
health & social services ombudsman in XXXXX
Seksjonsoverlege XXXXXX
Legal officer: XXXXXX
Medical officer: XXXXXX
[1] http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
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