3701-84-26. Facilities/safety standards - bone marrow transplantation service

(A) The hospital at which the bone marrow transplant service is located shall provide all of the following on site:

(1) A designated bone marrow transplant unit with a sufficient number of beds to meet the needs of the bone marrow transplant service;

(2) Active departments or sections in hematology/oncology, immunology and infectious diseases;

(3) Laboratories;

(4) Adequate intensive care facilities;

(5) Protective reverse isolation rooms with appropriate air handling characteristics (i.e., hepa-filtered positive pressure patient rooms);

(6) Radiologic services including, but not limited to, tomography, computed tomography (CT) scans and/or magnetic resonance imaging (MRI) scans;

(7) Radionuclide scans and ultrasonography;

(8) Immunopathology and hepatopathology;

(9) Histopathology;

(10) Microbiology laboratory;

(11) Blood banking services capable of routinely providing irradiated blood products appropriate for cytomegalovirus (CMV) seronegative patients;

(12) Clinical pharmacology services with a pharmacist familiar with antineoplastic agents;

(13) Modern radiotherapy capabilities including the ability to provide total body irradiation either on-site or through agreement or contract with another hospital;

(14) Operating room facilities; and

(15) Echocardiography or multigated blood-pool imaging (MUGA) scan capability.

(B) The provider of a bone marrow transplant service shall have the following readily available:

(1) Tissue-typing laboratory;

(2) Apheresis capability with adequate blood cell component therapy and routine access to a blood irradiator; and

(3) Facilities to cryopreserve hematopoietic stem cells for transplantation and which additionally may be used to manipulate hematopoietic stem cells ex-vivo.

Effective: 8/1/2017
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 6/21/12