Swedish regulation requires that healthcare clinic write a patient safety report. The following is the English translation for the Carl von Linné Clinic, 2015:

Patient Safety Report for the calendar year 2015.


Healthcare function.  The Carl von Linné Clinic (CvLK) conducts gynecological outpatient care and outpatient IVF treatment (test tube fertilization).

Risk assessment and outcome: The risk of patient injury during outpatient visits must be considered negligible. No operational interventions are performed during visits. An elevator is available from the ground floor to the reception to eliminate the need for stairs. The landlord installed a new modern elevator in 2011 with minimal risk of getting stuck. The elevator doors are of a modern type to minimize the risk of getting caught in the doors. IVF treatment involves hormone stimulation of the ovaries and removal of the eggs via ultrasound puncture through the vagina. Risks may be ovarian hyperstimulation syndrome (OHSS) due to ovarian stimulation or possible bleeding or infection after puncture. All doctors at the clinic and other staff have many years of experience with IVF treatments, reducing the risk of complications. The risk of OHSS is reported in Sweden to be about 3-5% but can be largely prevented by individual assessment of hormone doses and careful control and dose adjustment during the stimulation period. The presence of OHSS at CvLK is below nationally reported levels. Six cases of OHSS with need for hospitalization have occurred during the year, one case of torsion of the ovary and three cases of infection occurred. None of the patients with complications are reported to have on-going problems. Bleeding complication after removal of eggs has been described historically to less than 1%. At CvLK, no case of complicated bleeding has occurred during the year. Infection following egg withdrawal is described in the literature and the risk of such is probably greatest in patients with chocolate cysts (endometrioma) or liquid-filled ovary (hydrosalpinx). The cases of infection that occurred through us had either endometriomas or hydrosalpinx. Routinely, we provide prophylaxis with antibiotics in these cases.



The safety efficiency: CvLK is certified according to ISO 9001 with annual audit by The Norwegian Veritas (DNV). The certification involves documented routines for working methods and routine for reporting any deviations. Written instructions with description of symptoms to be reported are given to each patient in connection with the removal of eggs. Review of deviations and remedial actions is made at recurring staff meetings.

CvLK has a permit from the Swedish National Board of Health and Welfare (Socialstyrelsen). Autumn 2015, a routine inspection was performed by the Health and Social Care Inspectorate (IVO, formerly Socialstyrelsen). Focus areas were safety and adherence to instruction manuals and job descriptions. No deviations were noted. The decision of January 11, emphasized:

"The reasons for the decision:
IVO assesses that this tissue bank (CvLK) has a well-functioning management system for quality and safety with ongoing monitoring and review of deviations. IVO bases its assessment on documents sent to the Authority as well as information obtained during the inspection.

Management
IVO assess that the tissue bank's management and operational support system, which is fully digitized with computer support from Fertsoft's various modules, is well implemented. Follow-up of results is done continuously through comparisons with expected results based on the prediction model built up with a number of parameters relevant to pregnancies. At start-up meetings (twice annually) where all staff participate, a summary of business monitoring and quality system is reviewed.

Side effects and adverse events
IVO estimates that adverse effects are adequately managed by a control system in the computer system to report if side effects have occurred, and if so which. The handling of discrepancies and improvement proposals, which are written by all personnel categories, reviewed by the chief executive officer and  addressed at staff - and start-up meetings, is considered satisfactory. "

Quality of care. The clinic reports annual results and follow-up to a national quality register, Q-IVF. This follow-up includes questionnaires where couples answer a number of questions such as satisfaction, quality of care, availability, etc. As in previous years, the evaluation showed high marks on the questions asked.

Summary During the calendar year 2015, no patient injuries have been reported. Nor have any serious bleeding complications or infections occurred. Few patients have had some form of OHSS. These have been handled according to routine without permanent injury to the patient.

Responsibility. The CEO is responsible for compliance with the Patient Safety Act and the preparation of a safety report.

Torbjörn Bergh