Chapter 3725: PLASMAPHERESIS CENTERS

3725.01 Plasmapheresis center definitions.

As used in this chapter:

(A) "Plasma" means the fluid portion of blood that has been stabilized against clotting, and is collected by plasmapheresis:

(B) "Plasmapheresis" means a procedure in which blood is drawn from a donor, the plasma is separated from the formed elements, and the formed elements are returned to the donor during a single visit to the plasmapheresis center, but excludes such a procedure performed for the purpose of improving the health of the donor;

(C) "Plasmapheresis center" means a blood bank or other establishment except a hospital that collects plasma.

Cite as R.C. § 3725.01

Effective Date: 09-19-1975

3725.02 Plasma collection restrictions.

(A) No person other than a hospital shall collect plasma, regardless of the use for which the plasma is intended, except at a plasmapheresis center holding a current, valid certificate of approval issued by the director of health.

Whoever violates this division is guilty of a misdemeanor of the fourth degree.

(B) The director shall adopt such rules as are necessary to carry out this chapter.

Cite as R.C. § 3725.02

Amended by 129th General AssemblyFile No.127, HB 487, §101.01, eff. 9/10/2012.

Effective Date: 09-19-1975

3725.03 Application for certificate - inspection and certification of establishment.

Application for certificate shall be made to the director of health by the operator of each establishment desiring to operate as a plasmapheresis center. The director shall prescribe the application form.

The director or his representative shall inspect each establishment prior to certification, and thereafter at least once each year. Plasmapheresis facilities and operations shall be made available for inspection during normal working hours upon request of any authorized representative of the state department of health. If the director finds, upon inspection, that an establishment applying for certification complies with this chapter and the rules adopted thereunder, he shall issue a certificate of approval to the owner of the center. The owner shall annually apply for renewal of certification according to the standard renewal procedure under Chapter 4745. of the Revised Code.

The director may require the center at any time to send samples of any material collected or processed by the center, together with the results of applicable tests, to the department of health.

Cite as R.C. § 3725.03

Effective Date: 09-19-1975

3725.04 Certification denied, revoked or suspended.

Certification of a plasmapheresis center may be denied, revoked, or suspended if the director of health finds that the center is not in compliance with this chapter and the rules adopted thereunder, or if the examination of samples and test results submitted under section 3725.03 of the Revised Code reveals noncompliance with such rules. The director shall notify the owner of the center of the proposed action and the violation or information on which it is based. If the owner requests a hearing within seven working days of the receipt of notice, certification shall not be revoked or suspended prior to the hearing, except that certification may be temporarily suspended if the director finds that the public health and safety is in imminent danger.

Cite as R.C. § 3725.04

Effective Date: 09-19-1975

3725.05 Federal requirements for collection of plasma.

No plasmapheresis center shall be certified by the director of health unless all federal requirements for the collection of plasma by plasmapheresis under the "Public Health Service Act," 58 Stat. 682 (1944) 42 U.S.C. 201 , as amended, are met and:

(A) A test approved by the director of health for hepatitis B antigen is made on a sample of blood taken from the donor at the time of blood collection.

(B) No person who has ever shown a positive test for hepatitis B antigen or who has a history of hepatitis serves as a donor for plasma, with the exception of plasma intended for special purposes approved by the director of health;

(C) A qualified licensed physician, known as the medical director, is responsible for compliance with this chapter and rules adopted thereunder, and for maintaining the health and safety of participants in the plasmapheresis procedure.

(D) A licensed physician, a registered nurse, or a medical technologist approved by the director of health is in attendance at all times when a donor is undergoing plasmapheresis, and is responsible for supervising the procedure and the maintenance of sterile technique;

(E) Handwashing facilities are present in the room where the blood is drawn and in the room where the formed elements are separated from the plasma.

Cite as R.C. § 3725.05

Effective Date: 09-19-1975

3725.06 Monthly report to health commissioner.

Each plasmapheresis center shall report monthly to the health commissioner of the city or general health district or other administrator of public health appointed under Chapter 3709. of the Revised Code for the health district in which the center is located, the total number of plasma donations received, the total number of hepatitis B antigen positive donations received, and the names of all hepatitis B antigen positive donors. Each plasmapheresis center shall also report to such administrator the names of all personnel and donors who develop hepatitis or other diseases or serious reactions related to plasmapheresis, and shall report immediately the names of all donors testing positive for syphilis.

Cite as R.C. § 3725.06

Effective Date: 09-19-1975