N.J. Admin. Code § 8:8-1.3 - Licensure

(a) Application for an initial license to conduct a blood bank, as required under the provisions of 26:2A-2 et seq., commonly known as the Blood Bank Licensing Act and this chapter, shall be made on forms provided for that purpose by the Department.

(b) A blood bank license shall be obtained whenever any function related to the collection, processing, storage, distribution or the administration of blood and blood components is performed.

(c) A separate blood bank license shall be obtained for each permanent location of a blood bank even if the location is owned and operated by the same licensee. No more than one blood bank license shall be issued for each location. However, a licensed blood bank may permit representatives of another licensed blood bank to provide services within its facility that are within the scope and consistent with the provisions of this chapter provided that the licensed blood bank director has reviewed and approved the SOP for that service.

(d) Renewal of the license shall be on an annual basis on or before November 10th of each year on forms provided for that purpose by the Department.

(e) Amendments to the license shall be as follows:

1. A license renewal shall be obtained 30 days prior to a change in the location or the name of the blood bank.

2. The Department shall be notified in writing, 30 days prior to a change, whenever the ownership, corporate structure, director, and/or services of a blood bank change.

(f) The blood bank shall perform only those services, related to this chapter for which they specifically request and receive licensure. In the case of new services, written approval shall be received from the Department prior to initiating the new service.

(g) Blood and blood components for therapeutic purposes shall only be distributed to a New Jersey licensed blood bank unless a nonsurgical situation exists which could not be anticipated and blood and blood components are necessary on an emergency basis to treat a life-threatening situation as specified in 8:8-12.3(c).

(h) Pursuant to 26:2A-4, the following blood bank licensure fees shall be effective November 1, 1992:

1. Transfusion Services:

Number of Transfusions	Fee
0-1,000	$200.00
1,001-2,000	300.00
2,001-3,000	400.00
3,001-4,000	500.00
4,001-5,000	600.00
5,001-+	700.00

2. Collection Centers:

Number of Transfusions	Fee
0-200	$250.00
201-1,500	500.00
1,501-3,000	750.00
3,001-5,000	1,000.00
5,001-10,000	1,250.00
10,001-15,000	1,500.00
15,001-25,000	1,600.00
25,001-35,000	1,700.00
35,001-50,000	1,800.00
50,000-+	1,900.00

3. Other Blood Bank Services:

Type	Fee
Collection Site	$100.00
Broker	200.00
Industrial Blood Bank	200.00
Home Transfusion Service	200.00

Notes

N.J. Admin. Code § 8:8-1.3

Amended by R.1989 d.246, effective 5/15/1989.
See: 21 N.J.R. 407(a), 21 N.J.R. 1412(a).
License requirement for subsidiary blood bank added; service requirements amended.
Amended by R.1992 d.427, effective 10/19/1992.
See: 24 N.J.R. 2508(a), 24 N.J.R. 3725(c).
Blood bank licensure fee scheduled added at (f).
Amended by R.1994 d.350, effective 8/1/1994.
See: 26 N.J.R. 1057(a), 26 N.J.R. 3171(a).
Amended by R.2005 d.283, effective 10/3/2005.
See: 36 N.J.R. 4261(a), 37 N.J.R. 3815(a).
In (a) and (d), substituted "Department" for "State of New Jersey" following "purpose by the"; rewrote (c); in (d), substituted "shall" for "will" following "license" and substituted "Department" for "State of New Jersey" at the end.
Administrative correction.
See: 38 N.J.R. 2800(b).