State laws and regulations that affect your medical practice
1. How does Texas define "blood bank?"
"Blood bank" means a facility that obtains blood from voluntary donors, as that term is defined by the United States Food and Drug Administration, the American Association of Blood Banks, and the American Red Cross Blood Services and that is registered or licensed by the Office of Biologics of the United States Food and Drug Administration and accredited by the American Association of Blood Banks or the American Red Cross Blood Services, or is qualified for membership in the American Association of Tissue Banks. The term includes a blood center, regional collection center, tissue bank, and transfusion service.
2. What sort of testing must be done on donated blood?
(a) For each donation of blood, a blood bank shall require the donor to submit to tests for infectious diseases, including tests for AIDS, HIV, or hepatitis, and serological tests for contagious venereal diseases.
(b) A blood bank is not required to obtain the donor's informed consent before administering tests for infectious diseases and is not required to provide counseling concerning the test results.
V.T.S.C.A. § 162.002
3. Are donor records confidential?
Yes. The medical and donor records of a blood bank are confidential and may not be disclosed except as provided by this chapter.
V.T.S.C.A. § 162.003
4. What information is required to be disclosed by law?
A blood bank shall disclose all information required by law, including HIV test results, to:
(1) The department and a local health authority as required under Chapter 81 (Communicable Disease Prevention and Control Act);
(2) The Centers for Disease Control of the United States Public Health Service, as required by federal law or regulation; or
(3) Any other local, state, or federal entity, as required by law, rule, or regulation.
V.T.S.C.A. § 162.004
5. To whom should blood test results and the name of the person tested be reported?
A blood bank shall disclose blood test results and the name of the person tested to:
(1) The physician or other person authorized by law who ordered the test;
(2) The physician attending the person tested; or
(3) The person tested or a person legally authorized to consent to the test on behalf of the person tested.
V.T.S.C.A. § 162.005
6. What kind of information can be disclosed to other blood banks?
(a) A blood bank may report to other blood banks the name of a donor with a possible infectious disease according to positive blood test results.
(b) A blood bank that reports a donor's name to other blood banks under this section may not disclose the infectious disease that the donor has or is suspected of having.
( c ) A blood bank that reports as provided by this section does not breach a confidence arising out of any confidential relationship.
V.T.S.C.A. § 162.006
7. What information may be disclosed to other blood banks?
(a) A blood bank shall report blood test results for blood confirmed as HIV positive by the normal procedures blood banks presently use or found to be contaminated by any other infectious disease to:
(1) the hospital or other facility in which the blood was transfused or provided;
(2) the physician who transfused the infected blood; or
(3) the recipient of the blood.
(b) A blood bank may report blood test results for statistical purposes.
( c ) A blood bank that reports test results under this section may not disclose the name of the donor or person tested or any other information that could result in the disclosure of the donor's or person's identity, including an address, social security number, designated recipient, or replacement donation information.
V.T.S.C.A. § 162.007
8. What procedures must be followed in notifying blood recipients?
Each hospital, physician, health agency, and other transfuser of blood shall strictly follow the official "Operation Look-Back" procedure of the American Association of Blood Banks or the American Red Cross Blood Services in notifying past and future recipients of blood. The only exception to notifying a recipient of blood is if the recipient is dead or cannot be located.
V.T.S.C.A. § 162.008
9. Must blood banks provide samples for testing?
On request, a blood bank shall provide blood samples to hospitals, laboratories, and other blood banks for additional, repetitive, or different testing.
V.T.S.C.A. § 162.009
10. May courts order blood banks to provide test results to recipients?
(a) After notice and hearing, a court of competent jurisdiction may require a blood bank to provide a recipient of blood from the blood bank with the results of tests of the blood of each donor of blood transfused into the recipient. The court may also require the test results to be given to an heir, parent, or guardian of the recipient, or a personal representative of the recipient's estate. The test results must be given in accordance with Section 162.007.
(b) If a blood bank fails to or cannot provide the test results as required under Subsection (a), the court may require the blood bank to use every reasonable effort, including any effort directed by the court, to locate any donor of the blood in question. The court may require the blood bank to obtain from that donor a blood sample for testing and may direct the blood bank to provide blood test results, samples of the blood, or both, to an independent laboratory designated by the court for testing. The results of the independent laboratory test must be made available to the recipient, an heir, parent, or guardian of the recipient, or the personal representative of the recipient's estate.
( c ) Section 162.002 applies if a blood bank requires a donor to provide a blood sample for testing under Subsection (b).
(d) If a blood test result is positive or if the blood bank fails to or cannot provide a blood test result or blood sample as required under Subsection (b), the court may require the blood bank to provide any information that the court determines is necessary to satisfy the court that the blood bank has complied in all respects with this section and the court's order or has demonstrated every reasonable effort to comply. The blood bank must provide the information to the judge of the court in camera and under seal.
(e) The court may not disclose to any other person the name of a donor or any other information that could result in the disclosure of a donor's identity, including an address, social security number, designated recipient, or replacement donation information. However, on the motion of any party, the court shall order the taking of the donor's deposition at a specified time and in a manner that maintains the donor's anonymity.
(f) The court may not deny a party's attorney the right to orally cross-examine the donor.
V.T.S.C.A. § 162.010
11. What are the discovery powers of the court?
(a) A court of competent jurisdiction shall exercise the discovery powers granted in this section on the motion of any party. The court shall exercise the powers to the extent reasonably necessary to obtain information from or relating to a donor if that information:
(1) Is reasonably calculated to lead to the discovery of admissible evidence regarding any matter relevant to the subject matter of a pending proceeding; and
(2) Cannot otherwise be obtained without threatening the disclosure of the name of a donor or other information that could result in the disclosure of a donor's identity, including an address, social security number, designated recipient, or replacement donation information.
(b) This section does not apply to information obtainable under Section 162.010.
( c ) The court may:
(1) Order the deposition of any witness, including a donor, orally, on written questions and cross-questions propounded by the parties, or both; and
(2) Compel the production of documents and things.
(d) A subpoena issued to a donor under this section may be served only in person at the donor's residence address. On a showing that service in person cannot be made at the donor's residence despite diligent efforts to do so, the court may order service on the donor at other places as directed by the court.
(e) The court shall deliver to the parties all discoverable information obtained through the exercise of powers provided by this section, including testimony, documents, or things. The court shall first delete from that information the name of any donor or any other information that could result in the disclosure of a donor's identity, including information described by Subsection (a)(2). The court may substitute fictitious names, such as "John Doe," or make other changes as necessary to protect the confidentiality of the donor's identity in the information made available to the parties.
(f) The court may not disclose confidential donor information to any person other than a person acting under Section 162.010(e) or (f). That person may not disclose the information to others.
(g) The exercise of the court's powers under this section is governed by the Texas Rules of Civil Procedure, except to the extent of any conflict with this section.
V.T.S.C.A. § 162.011
12. Do blood banks have any immunity from liability?
(a) A donor who provides information or blood samples under Section 162.010 is immune from all liability arising out of the donation of the blood transfused into a recipient.
(b) A blood bank is not liable for the disclosure of information to a court in accordance with an order issued under Sections 162.010(b)-(f).
( c ) A presumption of negligence or causation does not attach to a donor's positive test result if the test result is obtained after the donation of blood or blood components that is the subject of discovery as provided under Section 162.011.
(d) Except as provided by Section 162.013 or 162.014, a person who negligently or intentionally discloses blood bank records in violation of this chapter is liable only for actual damages resulting from the negligent or intentional disclosure.
(e) This chapter does not give rise to any liability under Subchapter E, Chapter 17, Business & Commerce Code (Deceptive Trade Practices-Consumer Protection Act).
V.T.S.C.A. § 162.012
13. What are the civil penalties for violations of blood bank regulations?
(a) A person who is injured by a violation of Section 162.006, 162.007, 162.010, or 162.011 may bring a civil action for damages. In addition, any person may bring an action to restrain such a violation or threatened violation.
(b If it is found in a civil action that a person has violated a section listed in Subsection (a), that person is liable for:
(1) actual damages;
(2) a civil penalty of not more than $1,000; and
(3) court costs and reasonable attorney's fees incurred by the person bringing the action.
V.T.S.C.A. § 162.013
14. Under what circumstances may a blood bank face criminal charges?
(a) A person commits an offense if the person discloses information in violation of Section 162.006, 162.007, 162.010, or 162.011.
(b) An offense under this section is a Class C misdemeanor.
( c ) Each disclosure made in violation of Section 162.006 or 162.007 constitutes a separate offense.
V.T.S.C.A. § 162.014
15. May a minor donate blood?
A person who is 17 years of age may consent to the donation of the person's blood or blood components. A person younger than 18 years of age may not receive any compensation from a blood bank for a donation of the person's blood or blood components.
V.T.S.C.A. § 162.015
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.