10A NCAC 14C .3005. ADDITIONAL REQUIREMENTS FOR LIVER TRANSPLANTATION SERVICES

(a)  An applicant proposing to establish a new liver transplantation service shall project a cumulative minimum of 15 liver transplantation procedures by the end of the second full year of operation following the date on which the first liver transplant procedure is performed.

(b)  An applicant proposing to establish a new liver transplantation service or to expand an existing liver transplantation service shall demonstrate that it either:

(1)           operates an existing renal transplant service; or

(2)           has a written agreement with a renal transplant service that ensures that the professional expertise of the renal transplant service is readily available to the proposed liver transplantation service.

(c)  An applicant proposing to establish a new liver transplantation service or to expand an existing liver transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           anatomic and clinical pathology with an approved residency program;

(3)           24-hour angiography;

(4)           an intensive care unit with 24-hour per day resident coverage;

(5)           veno-venous bypass equipment that does not require heparin;

(6)           adult and pediatric (as appropriate) gastroenterologists and hepatologists on the active medical staff who meet UNOS criteria for transplant physicians and surgeons;

(7)           endoscopic retrograde cholangiopancreatography (ERCP) availability;

(8)           percutaneous cholangiogram availability;

(9)           a rapid blood infusion system;

(10)         percutaneous liver biopsy capability;

(11)         hemoperfusion;

(12)         a rapid red blood cell (RBC) saver system; and

(13)         duplex ultrasound.

(d)  The applicant shall establish and maintain all of the following:

(1)           nuclear HID biliary scan availability;

(2)           continuously available coagulation laboratory; and

(3)           a blood bank system capable of providing 200 units of blood or packed cells, 100 units of plasma on demand, 24 units (or four adult doses) of platelet concentrates and 30 units of cryoprecipate on demand.

 

History Note:        Filed as a Temporary Adoption Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996.