Patients who took sleep tests in Kelowna between 2007 and 2011 may need to be re-tested or re-diagnosed, says Interior Health Authority (IHA) review released this week.
Interior Health contacted 13 patients who underwent polysomnography testing at the Kelowna General Hospital (KGH) Sleep Lab and will be reviewing a further 980 cases given potential concern about the interpretation of these test results. The polysomnography tests, also known as sleep studies, are used in the diagnosis and treatment of sleep disorders and occurred between August 29, 2007 and September 8, 2011.
“It’s important to note that the physicians doing the interpretation did have the required training or credentials required to perform this service,” said Dr. Michael Murray, IHA’s senior medical director. “We need to review our systems, ensuring we have the right checks and balances in place – including mentoring and peer review for our staff and physicians – which will enhance patient safety. That is our priority.”
This situation was discovered during a recent quality assurance review put in place to protect patients. A medical surveyor from the Diagnostic Accreditation Program conducted a site visit to the KGH Sleep Lab at the end of May and identified concerns related to the quality of the readings of a small, random sampling of sleep studies conducted at the lab.
The surveyor recommended a retrospective audit by an independent, external reviewer. That review took place in late July and confirmed the surveyor’s original concerns with some studies.
The two physicians involved have voluntarily agreed to no longer interpret sleep studies. This was a service they provided in addition to their regular specialty. Interior Health has not had concerns with their practice in those other areas.
Interior Health is in the process of reviewing which patients may require further support such as a change in their care plans and follow-up with their referring physician. For others, there may be no change at all. All patients will be notified of this review by Interior Health in the interest of full disclosure and transparency.
“We believe that patients would want to have this information even if the expert reviewer determines there is little or no risk involved. Additionally, we have an ethical responsibility to inform them,” said Dr. Murray.
Interior Health operates two Sleep Labs, one at KGH and one at Royal Inland Hospital (RIH) in Kamloops, and patients are referred by their physicians from throughout the health region. There are no issues associated with the lab at RIH which just recently received full accreditation by the provincial Diagnostic Accreditation Program.
Interior Health recognizes some patients may have questions and has established a phone line for this purpose. Staff will be answering calls Monday to Friday from 8 a.m. to 4:30 p.m. and monitoring voicemail messages after hours. The number to call is
In addition, further information is available through Interior Health’s website, at www.interiorhealth.ca
Sleep Studies at the Kelowna General Hospital Sleep Lab
Sleep Studies (polysomnograms)
A Sleep study is a diagnostic tool focusing on the breathing disorders of sleep (obstructive sleep apnea, snoring, insomnia, narcolepsy, parasomnias and other problems including sleep walking, night terrors, and night seizures). Physicians refer their patients with sleep issues to a sleep lab, where their sleep is monitored by a trained technologist.
Polysomnography records various physiological parameters including brain activity, breathing patterns, oxygen levels, heart rate and movements of the extremities such as legs and arms. Studies are interpreted and sent back to the referring physician for determination of treatment.
The KGH Sleep Lab sees approximately 350 clients a year from across Interior Health.
Medical Professional Involvement in Sleep Studies
Qualified physicians provide interpretations of sleep studies conducted at Interior Health’s two sleep labs. This is a service they provide in addition to their regular specialty. Physicians must be trained and Board Certified in sleep medicine or have taken specialized sleep medicine education through a recognized university centre. Physicians interpreting sleep studies at KGH are specialists in one of the following: internal medicine, respiratory medicine, neurology or psychiatry.
Number of Studies under Review
The number of sleep studies conducted from August 29, 2007 and September 8, 2011 was 1291. Of those, 994 are being reviewed (this includes the 14 that have already been re-read).
Risk to Patients
Sleep disorders are chronic diseases and the sleep study is only one aspect in the overall management of patients. In general patients with chronic diseases including sleep disorders are regularly reviewed by their treating physician.
Although there is the potential the previous sleep study interpretation could affect a patient’s management and health status, there have been no reports of this occurring to date. However, in some cases, patients may require a change in their treatment plan, while for others there may be no change.
This will be dependent on each individual circumstance and known more fully as the sleep studies are reviewed.
Why weren’t patients notified sooner?
The May 25, 2011 accreditation review identified a potential problem that required further investigation. At the recommendation of the surveyor, an external audit was conducted by a sleep study expert in late July, with a final report in late August. This confirmed concerns with the interpretation of test results. Subsequently, Interior Health began the process of confirming information, identifying the sleep studies and the patients potentially impacted in order for communication to begin with both patients as well as their physicians.
What is the Diagnostic Accreditation Program (DAP)?
Interior Health participates in the BC College of Physician and Surgeons sponsored Diagnostic Accreditation Program (DAP), which evaluates all aspects of various laboratories and diagnostic facilities within the province.