(1) Open heart surgery means a specialized surgical procedure (excluding organ transplantation) which utilizes a heart-lung bypass machine and is intended to correct congenital and acquired cardiac and coronary artery disease.

(2) Open heart surgery is a tertiary service as listed in WAC 246-310-020. To be granted a certificate of need, an open heart surgery program shall meet the standards in this section in addition to applicable review criteria in WAC 246-310-210, 246-310-220, 246-310-230, and 246-310-240.

(3) Standards.

(a) A minimum of two hundred fifty open heart surgery procedures per year shall be performed at institutions with an open heart surgery program.

(b) Hospitals applying for a certificate of need shall demonstrate that they can meet one hundred ten percent of the minimum volume standard. To do so, the applicant hospital must provide written documentation, which is verifiable, of open heart surgeries performed on patients referred by active medical staff of the hospital. The volume of surgeries counted must be appropriate for the proposed program (i.e., pediatric and recognized complicated cases would be excluded).

(c) No new program shall be established which will reduce an existing program below the minimum volume standard.

(d) Open heart surgery programs shall have at least two board certified cardiac surgeons, one of whom shall be available for emergency surgery twenty-four hours a day. The practice of these surgeons shall be concentrated in a single institution and arranged so that each surgeon performs a minimum of one hundred twenty-five open heart surgery procedures per year at that institution.

(e) Institutions with open heart surgery programs shall have plans for facilitating emergency access to open heart surgery services at all times for the population they serve. These plans should, at minimum, include arrangements for addressing peak volume periods (such as joint agreements with other programs, the capacity to temporarily increase staffing, etc.), and the maintenance of or affiliation with emergency transportation services (including contingency plans for poor weather and known traffic congestion problems).

(f) In the event two or more hospitals are competing to meet the same forecasted net need, the department shall consider the following factors when determining which proposal best meets forecasted need:

(i) The most appropriate improvement in geographic access;

(ii) The most cost efficient service;

(iii) Minimizing impact on existing programs;

(iv) Providing the greatest breadth and depth of cardiovascular and support services; and

(v) Facilitating emergency access to care.

(g) Hospitals granted a certificate of need have three years from the date the program is initiated to establish the program and meet these standards.

(h) These standards should be reevaluated in at least three years.

(4) Steps in the need forecasting method. The department will develop a forecast of need for open heart surgery every year using the following procedures.

(a) Step 1. Based upon the most recent three years volumes reported for the hospitals within each planning area, compute the planning area's current capacity and the percent of out-of-state use of the area's hospitals. In those planning areas where a new program is being established, the assumed volume of that institution will be the greater of either the minimum volume standard or the estimated volume described in the approved application and adjusted by the department in the course of review and approval.

(b) Step 2. Patient origin adjust the three years of open heart surgery data, and compute each planning area's age-specific use rates and market shares.

(c) Step 3. Multiply the planning area's age-specific use rates by the area's corresponding forecast year population. The sum of these figures equals the forecasted number of surgeries expected to be performed on the residents of each planning area.

(d) Step 4. Apportion the forecasted surgeries among the planning areas in accordance with each area's average market share for the last three years of the four planning areas. This figure equals the forecasted number of state residents' surgeries expected to occur within the hospitals in each planning area. In those areas where a newly approved program is being established, an adjustment will be made to reflect anticipated market share shifts consistent with the approved application.

(e) Step 5. Increase the number of surgeries expected to occur within the hospitals in each planning area in accordance with the percent of surgeries calculated as occurring in those hospitals on out-of-state residents, based on the average of the last three years. This figure equals the total forecasted number of surgeries expected to occur within the hospitals in each planning area.

(f) Step 6. Calculate the net need for additional open heart surgery services by subtracting the current capacity from the total forecasted surgeries.

(g) Step 7. If the net need is less than the minimum volume standard, no new programs shall be assumed to be needed in the planning area. However, hospitals may be granted certificate of need approval even if the forecasted need is less than the minimum volume standard, provided:

(i) The applying hospital can meet all the other certificate of need criteria for an open heart surgery program (including documented evidence of capability of achieving the minimum volume standard); and

(ii) There is documented evidence that at least eighty percent of the patients referred for open heart surgery by the medical staff of the applying hospital are referred to institutions more than seventy-five miles away.

(5) For the purposes of the forecasting method in this section, the following terms have the following specific meanings:

(a) Age-specific categories. The categories used in computing age-specific values will be fifteen to forty-four year olds, forty-five to sixty-four year olds, sixty-five to seventy-four year olds, and seventy-five and older.

(b) Current capacity. A planning area's current capacity for open heart surgeries equals the sum of the highest reported annual volume for each hospital within the planning area during the most recent available three years data.

(c) Forecast year. Open heart surgery service needs shall be based on forecasts for the fourth year after the certificate of need open heart surgery concurrent review process. The 1992 reviews will be based on forecasts for 1996.

(d) Market share. The market share of a planning area represents the percent of a planning area's total patient origin adjusted surgeries that were performed in hospitals located in that planning area. The most recent available three years data will be used to compute the age-specific market shares for each planning area.

(e) Open heart surgeries. Open heart surgeries are defined as DRGs 104 through 108, inclusive. All pediatric surgeries (ages fourteen and under) are excluded.

(f) Out-of-state use of planning area hospitals. The percent of out-of-state use of hospitals within a planning area will equal the percent of total surgeries occurring within the planning area's hospitals that were performed on patients from out-of-state (or on patients whose reported zip codes are invalid). The most recent available three years data will be used to compute out-of-state use of planning area hospitals.

(g) Patient origin adjustment. A patient origin adjustment of open heart surgeries provides a count of surgeries performed on the residents of a planning area regardless of which planning area the surgeries were performed in. (Surgeries can be patient origin adjusted by using the patient's zip code reported in the CHARS database.)

(h) Planning areas. Four regional health service areas will be used as planning areas for forecasting open heart surgery service needs.

(i) Health service area "one" includes the following counties: Clallam, Island, Jefferson, King, Kitsap, Pierce, San Juan, Snohomish, Skagit, and Whatcom.

(ii) Health service area "two" includes the following counties: Cowlitz, Clark, Grays Harbor, Klickitat, Lewis, Mason, Pacific, Skamania, Thurston, and Wahkiakum.

(iii) Health service area "three" includes the following counties: Benton, Chelan, Douglas, Franklin, Grant, Kittitas, Okanogan, and Yakima.

(iv) Health service area "four" includes Adams, Asotin, Columbia, Ferry, Garfield, Lincoln, Pend Oreille, Stevens, Spokane, Walla Walla, and Whitman.

(v) Use rate. The open heart surgery use rate equals the number of surgeries performed on the residents of a planning area divided by the population of that planning area. The most recent available three years data is used to compute an averaged annual age-specific use rate for the residents of each of the four planning areas.

(6) The data source for open heart surgeries is the comprehensive hospital abstract reporting system (CHARS), office of hospital and patient data, department of health.

(7) The data source for population estimates and forecasts is the office of financial management population trends reports.