In Re Mansfield General Hospital

Interpreting one subsection of Ohio Adm. Code 3701-12-25, the majority concludes that, because appellant's CON application did not propose physical construction of a new cardiac catheterization laboratory or the addition of another cardiac catheterization laboratory to its existing facility, appellant's CON application was not reviewable under Ohio Adm. Code3701-12-25, so that the CONRB erred in denying appellant a CON. *Page 140

I dissent because the majority focuses only upon the definition of "cardiac catheterization service" as a cardiac catheterization laboratory, and defines "cardiac catheterization laboratory" as merely a room or suite of rooms in a hospital. By that definition, any room or suite of rooms could be used for cardiac catheterizations, and the performance of cardiac catheterization procedures upon high-risk patients would only be reviewable if a new room or suite of rooms were constructed or dedicated to that purpose. The majority's reading not only fails to "sustain the spirit" of Ohio Adm. Code 3701-12-25, it also misreads the Administrative Code section.

Ohio Adm. Code 3701-12-25(B)(4) reads, in its entirety:

"`Cardiac catheterization laboratory' or `laboratory' means a room or suite of rooms in a hospital, freestanding cardiac catheterization facility, or mobile diangostic [sic] imaging center which has the equipment, staff, and support services to function as an integrated unit for the purposes of performing cardiac catheterization procedures for a single patient at a given time and which is used to perform cardiac catheterization procedures."

Ohio Adm. Code 3701-12-25(B)(5) reads, in full:

"`Cardiac catheterization procedure' or `procedure' means an angiographic study or physiologic study performed within a cardiac catheterization laboratory. For the purposes of the utilization criteria in this rule, all activities performed during one clinical session, including angiocardiography, coronary arteriography, pulmonary arteriography, coronary angioplasty, other diagnostic or therapeutic measures, and physiologic studies shall be considered one procedure."

The definition of "cardiac catheterization laboratory" expressly requires the room or rooms in a hospital to have "the equipment, staff, and support services to function as an integrated unit for the purposes of performing cardiaccatheterization procedures" (emphasis added), Ohio Adm. Code3701-12-25(B)(4), and to be used for that purpose. In addition, the definition of "cardiac catheterization procedure," which includes the high-risk procedures proposed by appellant, includes such procedures as those performed within a cardiac catheterization laboratory. Thus, cardiac catheterization service is not simply defined in terms of its physical facilities as the majority concludes, but is defined in terms of the procedures conducted therein.

By the majority's reasoning, because appellant is proposing new procedures upon a new class of patients but wishes to use its existing cardiac catheterization laboratory, no establishment of a new cardiac catheterization service has been proposed. Inevitably, however, a cardiac catheterization laboratory must be defined by the procedures conducted therein, and is never merely a room or suite of rooms in a hospital. The cardiac catheterization laboratory and the procedures *Page 141 conducted there are inextricably bound, and the definitions of both "cardiac catheterization service" and "cardiac catheterization laboratory" must be read to reflect the procedures performed within that room or suite of rooms in a hospital.

I also dissent because I find Ohio Adm. Code 3701-12-25 to be consistent with R.C. Chapter 3702 and pertinent to appellant's proposed upgrade from the nonreviewable cardiac catheterization procedures it currently offers to low-risk patients to the reviewable high-risk procedures for which an accompanying open-heart surgery capability is mandated.

Whether appellant would alter its physical facilities, appellant's CON application clearly seeks to establish or add a new cardiac catheterization service because appellant does not require a CON in order to conduct the low-risk procedures it presently conducts, and does require a CON in order to perform any high-risk procedure, pursuant to Ohio Adm. Code3701-12-25(L)(1).2 Thus, appellant's proposed cardiac catheterization service is new so far as the CON review process is concerned.

Ohio Adm. Code 3701-12-25(L)(1) reads, in part:

"The director shall not grant a certificate of need under this rule relating to a cardiac catheterization service in which * * * high-risk procedures will be performed or high-risk or pediatric patients are or will be served unless:

"(a) The service is or will be located in a hospital which has the capability for emergency coronary artery surgery, including having:

"(i) An established on-site open-heart surgery program located in close proximity to the relevant laboratory or laboratories. * * *" (Emphasis added.)

R.C. 3702.51(R)(3)(b) includes within those activities listed as reviewable a "cardiac catheterization service or the addition of another cardiac catheterization laboratory to an existing service, when the service treats or will treat high-risk patients."

Both the statute and the regulation contemplate that a cardiac catheterization service may already be serving high-risk patients without a CON, and allow the director to deny a CON to such a facility unless open-heart surgery capabilities are already on-site. Thus, R.C. 3702.51(R)(3)(b) and Ohio Adm. Code3701-12-25, read in their entirety, indicate that a hospital need not propose adding a new physical facility in order to establish a new cardiac catheterization service. *Page 142

The majority apparently finds that the statute and the rule are incompatible, and so invalidates the rule. "[W]here a potential conflict exists between an administrative rule and a statute, an administrative rule is not inconsistent with a statute unless the rule contravenes or is in derogation of some express provision of the statute." Kelly v. Accountancy Bd. ofOhio (1993), 88 Ohio App.3d 453, 459, 624 N.E.2d 292, 296, citing McAninch v. Crumbley (1981), 65 Ohio St.2d 31, 34, 19 O.O.3d 225, 226-227, 417 N.E.2d 1252, 1253. Here, Ohio Adm. Code3701-12-25 is not in derogation of R.C. 3702.51(R)(3)(b). The statute generally requires that the addition of a cardiac catheterization service which treats or will treat high-risk patients is a reviewable activity, while the code indicates that the director shall use relevant criteria in reviewing the establishment of a new "cardiac catheterization service," which is defined as a laboratory in which certain cardiac catheterization procedures, including high-risk procedures, are or will be conducted.

Appellant proposes its current cardiac catheterization service, in which it conducts cardiac catheterizations upon low-risk patients and for which it does not require a CON, be replaced with a new cardiac catheterization service in which appellant would conduct cardiac catheterization procedures upon both low-risk and high-risk patients. Appellant's proposed change in the procedures it offers is reviewable pursuant to R.C. 3702.51(R)(3)(b), and Ohio Adm. Code 3701-12-25, since appellant is seeking to establish or add a cardiac catheterization service which will accommodate high-risk patients. What appellant does with its old cardiac catheterization service, in which it conducted low-risk cardiac catheterizations, is a matter not subject to ODH review, and not relevant to whether the new procedures sought to be performed, and which are reviewable, merit the issuance of a CON.

Finally, although the majority's decision concludes that appellant's application is not reviewable under Ohio Adm. Code3701-12-25, it leaves unanswered the question of whether appellant's application is reviewable under some other criteria contained within the Administrative Code. Although the majority expressly remands this matter to the CONRB for a determination of appellant's CON application using the appropriate statutory and regulatory provisions, it is foreseeable that the CONRB will conclude that this court is ordering it to find appellant's proposal to perform cardiac catheterization procedures upon high-risk patients is not a reviewable activity, as there would appear to be no other applicable statutory or regulatory provision.

Because appellant's proposal that it be permitted to perform cardiac catheterization procedures upon high-risk patients without an open-heart surgery capability is a reviewable activity for which appellant is not entitled to a CON under Ohio *Page 143 Adm. Code 3701-12-25, or any other code provision, the decision of the CONRB denying appellant a CON should be affirmed.

2 Thus, although appellant's CON application evades the issue of what type of procedures it proposes to conduct, the CONRB properly assumed appellant sought permission to conduct cardiac catheterization procedures upon high-risk patients, since only such a proposal would require a CON.