Corneal transplant (CT) surgery remains the most common

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1 Efficacy of Routine Notification and Request on reducing corneal transplantation wait times in Canada Mahta Rasouli,* MD; Valerie B. Caraiscos, MD, PhD; Allan R. Slomovic, MA, MD, FRCSC ABSTRACT RÉSUMÉ Objective: To determine whether the implementation of Routine Notification and Request (RNR) has been effective in increasing the amount of donor corneal tissue available and reducing wait times for corneal transplant (CT) surgeries. Design: Survey of the CT surgeons and eye banks in Canada. Participants: CT surgeons and representatives of the 10 eye banks in Canada. Methods: Voluntary, anonymous questionnaires were distributed between May 1 and September 30, Results: Following the implementation of RNR, 3 eye banks had an increase in the amount of corneal tissue available: Manitoba, 81% (from 42 tissues in 2004 to 76 tissues in 2006); Ontario, 25% (from 1304 tissues in 2005 to 1626 tissues in 2006); New Brunswick, 129% (from 86 tissues in 2005 to 197 tissues in 2006). British Columbia, where RNR was implemented in 1999, had a 6% increase (from 766 in 2005 to 812 in 2006). There has been a significant decrease in wait times from the time of diagnosis by CT surgeons to the time of surgery in British Columbia (from 48±18 weeks in 2004 to 39±20 weeks in 2006), Manitoba (from 82±56 weeks in 2004 to 32±23 weeks in 2006), Ontario (from 82±56 weeks in 2004 to 31±34 weeks in 2006), and Nova Scotia (from 44±12 weeks in 2004 to 32±28 weeks in 2006). Conclusions: RNR has been effective in increasing corneal tissue availability and decreasing wait times in provinces where it has been implemented. We recommend similar legislative changes to be considered in those provinces where corneal tissue shortage is delaying the availability of CT surgery. Objet : Définir l efficacité du recours à la formule de Notice et demande régulières (NDR) (Routine Notification and Request) pour augmenter les dons de tissus cornéens et réduire le temps d attente des chirurgies de transplantation de la cornée (TC). Nature : Sondage auprès des chirurgiens de la TC et des banques d yeux du Canada. Participants : Chirurgiens de la TC et représentants de 10 banques d yeux du Canada. Méthodes : Distribution de questionnaires anonymes et facultatifs entre le 1 mai et le 30 septembre Résultats : Après la mise en œuvre de la NDR, 3 banques d yeux ont vu augmenter la quantité de tissus cornéens disponibles : au Manitoba, la hausse a été de 81 % (de 42 tissus en 2004 à 76 tissus en 2006); en Ontario, 25 % (de 1304 tissus en 2005 à 1626 tissus en 2006); et au Nouveau-Brunswick, 129 % (de 86 tissus en 2005 à 197 tissus en 2006). La Colombie-Britannique, qui a mis en œuvre la formule NDR en 1999, a connu une hausse de 6 % (de 766 tissus en 2005 à 812 tissus en 2006). Il y a eu une importante baisse du délai d attente entre la pose du diagnostic par le chirurgien et le moment de la chirurgie en Colombie-Britannique (de 48±18 semaines en 2004 à 39±20 semaines en 2006), au Manitoba (de 82±56 semaines en 2004 à 32±23 semaines en 2006), en Ontario (de 82±56 semaines en 2004 à 31±34 semaines en 2006) et en Nouvelle-Écosse (de 44±12 semaines en 2004 à 32±28 semaines en 2006). Conclusions : La formule NDR est efficace en ce qu elle accroît la disponibilité du tissu cornéen et réduit les délais d attente dans les provinces où elle a été mise en œuvre. Nous recommandons que l on considère des modifications législatives semblables dans les provinces où le manque de tissu cornéen retarde l accès à la TC. Corneal transplant (CT) surgery remains the most common human transplant surgery performed. It has a high success rate and has been documented to improve patients quality of life. Since CT surgery is a frequent procedure, it is necessary for both physicians and legislative bodies to have a clear understanding of the supply and demand status of corneal tissue across Canada. Our current report is a follow-up of our previous study, in which we assessed From *the School of Medicine, Faculty of Health Sciences, Queen s University, Kingston, Ont.; the School of Medicine, University of Toronto, Toronto, Ont.; and the Department of Ophthalmology, University of Toronto and Toronto Western Hospital, Toronto, Ont. Presented at the University of Toronto Department of Ophthalmology and Vision Sciences Annual Research Day in Toronto, Ont., June 15, 2007, and as a poster presentation at the Canadian Ophthalmological Society Annual Meeting and Exhibition in Montreal, Que., June 20 23, 2007 the supply and demand of corneal tissue by analyzing its availability in all Canadian eye banks as well as patient wait times and CT surgeon availability in each province. 1 Based on that study, it was determined that long waiting lists were leading to suboptimal care for Canadian patients in 2004, with an average wait time of 51±32 weeks from the time of diagnosis to CT surgery. The main limiting factor contributing to the long wait times across Canada was the lack Correspondence to Mahta Rasouli, MD, Department of Ophthalmology, University of Alberta, 2319, Kingsway Ave. NW, Edmonton AB T5H 3V9; mrasouli@ualberta.ca Originally received Oct. 25, Revised May 28, 2008 Accepted for publication July 8, 2008 Published online Jan. 23, 2009 Can J Ophthalmol 2009;44:31 5 doi: /i CAN J OPHTHALMOL VOL. 44, NO. 1,

2 of donor corneal tissue, followed by operating room (OR) time shortages. In 2004, Routine Notification and Request (RNR) was introduced to the existing tissue donation legislation in several provinces across Canada. Upon implementation of RNR within a province, central bodies are appointed to bring the new legislation into effect. These central bodies designate facilities that are eligible for tissue retrieval and can be contacted by health care professionals to report expected deaths. Expected deaths are deaths that are foreseeable due to the nature of the patient s injury or illness. The designated facilities determine patient eligibility and obtain informed consent from the patient or the next of kin as to tissue donation. If required, the patient is kept on ventilation support until tissue retrieval. An auditing system is in place for each province to ensure that the number of reported deaths matches the actual number of deaths in each hospital. RNR legislation was passed in Manitoba in December 2004, New Brunswick in April 2005, and Ontario in January At the time of our survey, due to the lack of CT surgeons in New Brunswick, all of the corneal tissue obtained in that province was sent to Nova Scotia. British Columbia was the first province to implement RNR in 1999 and the long-term sustainability of RNR in the province was further examined. Alberta implemented similar legislation in May 2005, however, the act had not been proclaimed at the time of our study. In Ontario, Although RNR was passed in Ontario as a proclamation of Part 2 of the Trillium Gift of Life Network (TGLN) Act in 2000, RNR was not implemented until 2006 in order to allow the hospitals and TGLN to set up the necessary facilities for its implementation. RNR requires Type A and B hospitals to notify the Networks as soon as possible when a patient at the facility has died or a physician is of the opinion that the death of a patient at the facility is imminent by reason of injury or disease. 2 Type A hospitals are defined as those with trauma and neurosurgical services, while Type B hospitals include those with ventilation units and those that can facilitate donations and make a neurological determination of death. Networks are designated as central bodies, such as the Trillium Gift of Life Network in Ontario, that promote, support and coordinate activities related to tissue donation. 2 Similarly, the Human Tissue Gift Act in New Brunswick, the Human Tissue Gift Act of British Columbia, the Human Tissue Gift Act in Manitoba, and the Human Tissue and Organ Donation Act in Alberta require hospital staff to report deaths to an organ donation agency such that the agency, in conjunction with the hospital, may determine the suitability of tissue for donation. 3 6 Since 2004, there have been several advancements in CT surgeries, where partial-thickness transplants are gaining favour over full-thickness. They include deep lamellar endothelial keratoplasty (DLEK), deep anterior lamellar keratoplasty (DALK), Descemet s stripping endothelial keratoplasty (DSEK), and lamellar keratoplasty (LK). The results presented in this paper include data collected for both partial- and fullthickness transplant surgeries. The objectives of our study were to (i) obtain updated demographics as to CT surgeons and their practice patterns with respect to full- and partialthickness CT surgeries, (ii) determine whether RNR has had an effect on corneal tissue availability, and (iii) examine the effect of RNR on wait times for CT surgeries. Me t h o d s The study consisted of 2 concurrent questionnaires, with data collected from June to September The first questionnaire was based on a previous survey by Cao et al., 1 which was used when a comparison was needed (such as wait times and number of CT surgeries). A section was added to deal with the more recent types of CT surgery (DLEK, DALK, DSEK). This first questionnaire was anonymous and voluntary and was directed to Canadian CT surgeons. The contact information of the surgeons was obtained by the voluntary reply of eye banks and the Canadian Ophthalmological Society (COS) contact list. Any ophthalmologist in Canada who performs CT surgeries and had obtained donor corneal tissue from an eye bank was eligible to complete this questionnaire. The survey was distributed via fax and and was subsequently followed by 2 reminders by phone, 2 reminders by fax, 3 reminders by , and a reminder by mail that included stamped return envelopes. The second survey was also voluntary and was faxed to the 10 eye banks across Canada. This was followed by 3 reminders by , 3 reminders by phone, and 2 reminders by fax. An information sheet was attached to each survey, describing the objectives of our research study. Re s u lt s Survey of eye banks All 10 of the Canadian eye banks responded to the survey. Following the implementation of RNR, eye banks reported an increase in available corneal tissues: Manitoba, 81% (from 42 tissues in January December 2004 to 76 tissues in the same time period in 2006), Ontario, 25% (from 1304 tissues in January June 2005 to 1626 tissues in the same period in 2006), and New Brunswick, 129% (from 86 tissues in January June 2005 to 197 tissues in the same time period in 2006) (Fig. 1). British Columbia had a 6% increase in the number of corneal tissues received (from 766 in January June 2005 to 812 in the same time period in 2006), likely due to better enforcement and more vigorous education in regards to RNR (Fig. 2).Upon implementation of RNR, an increase in the number of CT surgeries performed was also observed: Manitoba, 142% (from 38 in January December 2004 to 92 in the same time period in 2006), Ontario, 14% (from 592 in January June 2005 to 675 in the same time period in 2006), and Nova Scotia, 18% (from 85 in January June 2005 to 100 in the same time period in 2006) (Fig. 3). In British Columbia, an increase of 19% in the number of CT surgeries performed was observed (from 32 CAN J OPHTHALMOL VOL. 44, NO. 1, 2009

3 359 in January June 2005 to 428 in the same time period in 2006). Based on our results, the Ontario eye bank is the main exporter of tissue to other Canadian provinces as well as to foreign eye banks. The largest importer of corneal tissue in Canada is Banque d yeux du Québec, followed by Lions Eye Bank Alberta. When eye banks were asked about the creation of a national registry for the purpose of coordinating import, export, and distribution of corneal tissue as well as maintaining a database for current wait times, 6/8 (75%) were in favour of such initiatives. Survey of CT surgeons The 77 CT surgeons currently working in Canada were contacted, with a response rate of 58% (45/77). The majority of respondents were male, with a male-to-female response ratio of 34 to 9. The average age of CT surgeons in Canada was 50±8 years at the time of our survey. CT surgeons reported practising for 18±9 years and their preferred age of retirement from performing CT surgeries was 62±7 years. The distribution of surgeons in each province and the surgeon to population ratio is listed in Table 1, with Manitoba having the highest and Quebec having the lowest CT surgeon-to-population ratio. Of note, there were no CT surgeons in the Northwest Territories, Yukon, Nunavut, Newfoundland and Labrador, New Brunswick, and Prince Edward Island at the time of the survey. With respect to practice patterns of partial-thickness CT surgery in Canada, 4% (2/45), 24% (11/45), and 13% (6/46) of CT surgeons were performing DLEK, DALK, and DSEK, respectively, in Based on the self-reported pattern of CT surgeries, 64% (27/45), 60% (21/45), and 76% (35/46) of surgeons reported that they will be incorporating DLEK, DALK, or DSEK, respectively, into their practice within the next 5 years (Fig. 4). CT surgeons performed on average 1.8±1.5 CT surgeries per surgeon per week and 44±40 CT surgeries per surgeon per year, with an average of 7±11 operations cancelled per surgeon per year. Factors resulting in cancellation of surgeries from the most to the least frequent in all provinces were tissue availability (75%; 21/28), development of a medical condition in patients (32%; 9/28), and (or) time shortage (14%; 4/28). Across Canada, the average wait time in each province from the date of referral to initial appointment with a CT surgeon was 11±7 weeks, and the wait time from the time of diagnosis by the CT surgeon to the date of surgery was 49±46 weeks. In provinces where RNR was implemented, a major decrease in wait time from the time of diagnosis by the CT surgeon to Fig. 1 Increase in amount of available corneal tissue following the implementation of Routine Notification and Request (RNR) in Ontario (ON), Manitoba (MB), and New Brunswick (NB). Fig. 3 Increase in the number of corneal transplant (CT) surgeries performed after implementation of Routine Notification and Request (RNR), in Ontario (ON), Manitoba (MB), and Nova Scotia (NS). Fig. 2 Increase in amount of available corneal tissue in British Columbia (BC). Note that BC passed the Routine Notification and Request (RNR) in The program was revived after a period of decline by better enforcement and education of RNR in Table 1 Corneal transplant (CT) surgeon distribution and CT surgeon to population ratio in Canadian provinces Province Population (thousands) CT surgeons, n CT surgeon : population ratio British Columbia Alberta Saskatchewan Manitoba Ontario Quebec Nova Scotia New Brunswick Newfoundland and Labrador Prince Edward Island Nunavut Northwest Territories Yukon CAN J OPHTHALMOL VOL. 44, NO. 1,

4 surgery was observed from 2004 to 2006: Manitoba, 61% (from 82±56 weeks in 2004 to 32±23 weeks in 2006), Ontario, 62% (from 82±56 weeks in 2004 to 31±34 weeks in 2006), and Nova Scotia, 27% (from 44±12 weeks in 2004 to 32±28 weeks in 2006). In British Columbia, a 19% decrease in wait time was observed (from 48±18 weeks in 2004 to 39±20 weeks in 2006), following more vigorous enforcement and education in regards to RNR legislation starting in 2005 (Table 2). Interestingly, in provinces without RNR, there has been an increase in the wait times from 2004 to 2006: Saskatchewan, 17% (from 78±37 weeks in 2004 to 91±18 weeks in 2006) and Quebec, 49% (from 76±24 weeks in 2004 to 113±48 weeks in 2006) (Table 3). This does not apply to Alberta, however, as this province has had a decrease of 19% in its wait time (from 48±18 weeks in 2004 to 39±20 weeks in 2006), partly due to its import of corneal tissue from other provinces. The average wait time in provinces with RNR was 33±4 weeks in 2006 compared to 81±38 weeks in provinces without RNR in the same year. At the time of our survey, 95% (21/22) of CT surgeons in all provinces reported corneal tissue shortage being the most important factor contributing to the long wait times, followed by OR time shortage (64%; 9/14) and OR nurse shortage (31%; 4/13), with the exception of Ontario, where OR time shortage continued to be the main problem (50%; 11/22), followed by tissue shortage (38%; 8/21) and shortage of CT surgeons (29%; 6/21). Co n c l u s i o n s Based on our data, the new legislative changes on RNR have been effective in increasing the amount of corneal tissues obtained and utilized. This is likely due to increased availability of corneal tissue and enhanced awareness of the possibility of tissue donation. The increase in available tissue has led to shorter wait times in all provinces with RNR. Given that tissue shortage is the main limiting factor determining wait times across Canada, we recommend similar legislative changes in other provinces. However, in order to fully utilize the increased number of tissues available and further decrease wait times, other limiting factors, such as OR time shortage, CT surgeon shortage, and OR nurse shortage, should be considered. As corneal tissue is greatly needed in all Canadian provinces, establishing a more unified definition of eligible donors by the eye banks across the country would be beneficial. At this point, despite the presence of the Safety of human cells, tissue, and organs for transplantation regulations act, there are still inconsistencies in the definition of donor eligibility between provinces, which impede the transfer of all available corneal tissues among Canadian eye banks. It is crucial to emphasize the importance of education, enforcement, and compliance for the long-term success of RNR programs. This has been demonstrated by the Eye Bank of British Columbia. The government of British Columbia was the first in Canada to pass RNR legislation, in The province reported a 40% increase in tissue supply over the first 2 years, followed by a reduction in supply over the next 3 years. This was attributed to the lack of ongoing education and enforcement of RNR. However, since 2005, an intensive education program has been initiated, which has resulted in an increase in the availability of corneal tissue from 2004 to 2006 as was demonstrated by our results. This experience will serve as a valuable guideline to provinces that have implemented or plan to implement RNR legislation. Future studies will examine the long-term sustainability of RNR in provinces where it has been legislated and the impact of recently established hospital-affiliated cataract surgical centres (such as the Kensington Eye Institute in Toronto) on CT surgery wait times. Table 2 Wait times for corneal transplant (CT) surgery in Canadian provinces where Routine Notification and Request (RNR) was introduced. Average wait time from diagnosis by CT surgeon to time of surgery (weeks) Decrease in wait times Province from , % Canada 51±32 49±46 British Columbia* 48±18 39±20 19 Manitoba 82±56 32±23 61 Ontario 82±56 31±34 62 Nova Scotia 44±12 32±28 27 *In British Columbia, RNR was established in 1999, however, measures have been taken for proper enforcement and education of RNR since Note: Average wait time in 2006 was 33±4 weeks; average wait time decreased by 32% compared with the national average. Fig. 4 Self-reported current and future patterns of utilizing partial thickness corneal transplant surgery among Canadian corneal transplant surgeons. (DLEK, deep lamellar endothelial keratoplasty; DALK, deep anterior lamellar keratoplasty; DSEK, Descemet s stripping endothelial keratoplasty.) Table 3 Wait times for corneal transplant (CT) surgery in Canadian provinces where Routine Notification and Request has not yet been introduced. Average wait time from diagnosis by CT surgeon to time of surgery (weeks) Change in wait times Province from , % Canada 51±32 49±46 Saskatchewan 78±37 91± Quebec 76±24 113± Alberta 48±18 39±20 19 Note: Average wait time in 2006 was 81±38 weeks; average wait time increased by 65% compared with the national average. 34 CAN J OPHTHALMOL VOL. 44, NO. 1, 2009

5 The authors thank Dr. M. McCarthy (Eye Bank of British Columbia), Dr. G. Rocha (Lions Eye Bank of Manitoba and NW Ontario), Dr. C. Seamone (Regional Tissue Bank, Nova Scotia), Ms. Linda Sharpen (Director, Eye Bank of Canada, Ontario Division), and Ms. Fides Coloma (Regional Director, Trillium Gift of Life Network), as well as the CT surgeons and eye bank representatives for their helpful comments and suggestions in designing the surveys. The authors have no financial interest, personal relationships, or conflicts of interest associated with this paper. Re f e r e n c e s 1. Cao KY, Dorrepaal SJ, Seamone C, Slomovic AR. Demographics of Corneal Transplantation in Canada in Can J Ophthalmol 2006;41: Government of Ontario. Trillium Gift of Life Network Act. R.S.O. 1990, c. H.20. Consolidated July 25, Available at: statutes_90h20_e.htm. 3. Government of New Brunswick. Human Tissue Gift Act. S.N.B. 2004, c. H Consolidated June 22, Available at: Government of British Columbia. Human Tissue Gift Act. R.S.B.C. 1996, c Available at: statreg/stat/h/96211_01.htm. 5. Government of Manitoba. The Human Tissue Gift Act. C.C.S.M. 2004, c. H180. Available at: mb/laws/sta/h-180/ /whole.html. 6. Government of Alberta. Human Tissue and Organ Donation Act. S.A. 2006, c. H Available at: ab.ca/documents/acts/h14p5.cfm?frm_isbn= Keywords: corneal transplantation, legislation, Canada CAN J OPHTHALMOL VOL. 44, NO. 1,