IC 16-41-12
    Chapter 12. Communicable Disease: Precautionary Measures forUse of Human Tissues and Blood Products; Regulation of BloodCenters

IC 16-41-12-1
Autologous donation
    Sec. 1. As used in this chapter, "autologous donation" means theremoval and storage of blood or blood components from a donor orpatient for an intended transfusion to the same donor or patient.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-2
Bank
    Sec. 2. As used in this chapter, "bank" has the meaning set forthin IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.5.

IC 16-41-12-3
Blood center
    Sec. 3. As used in this chapter, "blood center" includes a bloodbank, a blood storage facility, a plasma center, a hospital, or otherfacility where blood or blood products are collected.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-4
Confirmatory test
    Sec. 4. As used in this chapter, "confirmatory test" means alaboratory test or a series of tests approved by the state departmentand used in conjunction with a screening test to confirm or refute theresults of the screening test for the human immunodeficiency virus(HIV) antigen or antibodies to the human immunodeficiency virus(HIV).
As added by P.L.2-1993, SEC.24.

IC 16-41-12-5
Directed donation
    Sec. 5. As used in this chapter, "directed donation" means adonation of whole blood or blood components collected from anindividual on behalf of an intended recipient of the transfusion.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-6
Hospital
    Sec. 6. As used in this chapter, "hospital" has the meaning setforth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.6.

IC 16-41-12-7
Physician    Sec. 7. As used in this chapter, "physician" has the meaning setforth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.7.

IC 16-41-12-8
Screening test
    Sec. 8. As used in this chapter, "screening test" means alaboratory screening test or a series of tests required by the statedepartment to be performed on blood or blood products collectedunder this chapter, including the following:
        (1) Tests for antibodies to the human immunodeficiency virus(HIV).
        (2) Other tests determined by the state department.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-9
Storage facility
    Sec. 9. As used in this chapter, "storage facility" has the meaningset forth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.8.

IC 16-41-12-10
Surgeon
    Sec. 10. As used in this chapter, "surgeon" has the meaning setforth in IC 29-2-16.1-1.
As added by P.L.2-1993, SEC.24. Amended by P.L.147-2007, SEC.9.

IC 16-41-12-11
Implied warranties; strict liability; screening tests; specification ofblood use; distributions by foreign blood centers
    Sec. 11. (a) The:
        (1) procurement, processing, distribution, or use of wholeblood, plasma, blood products, blood derivatives, or otherhuman tissue, such as corneas, bones, or organs, by a bank,storage facility, or hospital; and
        (2) injection, transfusion, or transplantation of any of the humantissue listed in subdivision (1) into the human body by ahospital, physician, or surgeon, whether or not anyremuneration is paid;
is the rendition of a service and not the sale of a product. Suchservices do not give rise to an implied warranty of merchantabilityor fitness for a particular purpose, nor do the services give rise tostrict liability in tort.
    (b) A hospital, physician, or other person is not required toperform another screening test on whole blood, plasma, bloodproducts, or blood derivatives that are provided by a blood center ifthe blood is labeled indicating that the blood has been tested asrequired under section 13 of this chapter.
    (c) An autologous blood donor may specify that the donor's bloodmust be used for the donor. Blood that is donated under this section

must be tested for the human immunodeficiency virus (HIV). Theblood center shall reserve the donor's blood for the purposesspecified by the donor and shall label the blood accordingly.
    (d) A directed blood donor may specify that the donor's blood isto be used for another person. The blood center shall consider themedical suitability and the wishes of the donor and recipient inmaking final distribution of the blood.
    (e) The blood center is subject to penalties under this chapter ifthe blood center knowingly fails to reserve the blood for the purposesspecified by the recipient under this section or if the blood centerfails to comply with subsections (c) through (d).
    (f) A blood center located outside Indiana may not distribute:
        (1) blood;
        (2) plasma;
        (3) a blood product; or
        (4) a blood derivative;
in Indiana unless the blood center has certified to the statedepartment that the blood has undergone a screening test under thischapter.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-12
Rules
    Sec. 12. The state department shall adopt rules under IC 4-22-2 tocarry out the purposes of this chapter. In formulating the rules, thestate department shall consider present medical and scientificpractices in the field and any other proper procedure that should befollowed to reasonably ensure the safety of the donor and recipientof whole blood, plasma, blood products, and blood derivatives.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-13
Screening tests; blood labeling; confirmatory tests; disposal ofblood; notification and referral of donors; records; violations
    Sec. 13. (a) A blood center shall perform a screening test on adonor's blood and obtain the results of the test before blood, plasma,a blood product, or a blood derivative is distributed for use.
    (b) The blood center shall label blood, plasma, a blood product,or a blood derivative before distribution by the blood center toindicate the results of the tests required by this chapter. The bloodcenter shall also label each blood sample according to the regulationsof the federal Food and Drug Administration.
    (c) The blood center shall perform a confirmatory test on a blooddonation from a donor when the screening test performed undersubsection (a) yields repeatedly reactive results.
    (d) Except for:
        (1) a sample retained to perform a confirmatory test; or
        (2) units used for research purposes or in the production ofpharmaceutical products if the blood center has obtainedapproval from the federal Food and Drug Administration;the blood center shall dispose of a blood donation after aninconclusive or repeatedly reactive screening test has beenperformed. The disposal must be made under rules adopted by thestate department under this chapter and IC 16-41-16.
    (e) A blood center shall report to the state department the resultsof each positive confirmatory test conducted under subsection (c).
    (f) A blood center shall attempt to notify a donor and refer thedonor to counseling when the confirmatory test on the donor's bloodis inconclusive or indicates the presence of antibodies to the humanimmunodeficiency virus (HIV).
    (g) Each health care provider that administers blood transfusionsshall keep a record of the following:
        (1) Blood center that furnished the blood.
        (2) Unit number assigned to the blood.
The records shall be made available to the state department forinspection.
    (h) An employee who is responsible for conducting the screeningtest required under this section who knowingly or intentionally failsto conduct the screening test commits a Class A misdemeanor.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-14
Confidentiality of information; violations
    Sec. 14. (a) A person may not disclose or be compelled to discloseinformation collected under this chapter or under rules adopted underthis chapter. This information may not be released or made publicupon subpoena or otherwise, except under the followingcircumstances:
        (1) For statistical purposes if done in a manner that does notidentify any individual.
        (2) With the written consent of all individuals identified in theinformation released.
        (3) To the extent necessary to enforce public health laws or toprotect the health or life of a named person.
    (b) Except as provided in subsection (a), a person responsible forrecording, reporting, or maintaining information required to bereported under this chapter who recklessly, knowingly, orintentionally discloses or fails to protect information classified asconfidential under this section commits a Class A misdemeanor.
    (c) In addition to subsection (b), a public employee who violatesthis section is subject to discharge or other disciplinary action underthe personnel rules of the agency that employs the employee.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-15
Donor information; informed consent
    Sec. 15. (a) A blood center shall require a blood donor to provideto the blood center the following information:
        (1) Name.
        (2) Address.        (3) Date of birth.
    (b) A blood center shall request a blood donor to provide theblood donor's Social Security number.
    (c) A blood center shall report the name and address of a blooddonor to the state department when a confirmatory test of the blooddonor's blood confirms the presence of antibodies to the humanimmunodeficiency virus (HIV).
    (d) A blood center shall provide to a blood donor information toenable the blood donor to give informed consent to the proceduresrequired by this chapter or IC 16-36. The information required bythis subsection must be in the following form:

NOTICE


        (1) This blood center performs a screening test for the humanimmunodeficiency virus (HIV) on every donor's blood.
        (2) This blood center reports to the state department of healththe name and address of a blood donor when a confirmatory testof the blood donor's blood confirms the presence of antibodiesto the human immunodeficiency virus (HIV).
        (3) A person who recklessly, knowingly, or intentionallydonates, sells, or transfers blood or a blood component thatcontains antibodies for the human immunodeficiency virus(HIV) commits transferring contaminated blood, a Class Cfelony. The offense is a Class A felony if the offense results inthe transmission of the virus to another person.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-16
Blood center licensing; inspections
    Sec. 16. (a) It is unlawful to operate a blood center in Indianawithout a license issued by the state department under this chapter.A blood center that applies for a license in Indiana must also belicensed or appropriately registered by the federal Food and DrugAdministration and remain in compliance with all applicable federalregulations.
    (b) An application for a license must be made on a formprescribed by the state department and must be accompanied by alicense fee established by the state department.
    (c) After inspection of an applicant's facility, if the statedepartment finds that the applicant has complied with this chapterand the rules adopted under this chapter, the state department shallissue a license to the applicant.
    (d) A license expires one (1) year after the date of issuance unlessthe license is renewed. A blood center may submit a renewalapplication on a form prescribed by the state department. Theprocedure and conditions for renewal are the same as the procedureand conditions established for the issuance of the original license.
    (e) A person who inspects an applicant's facility under this sectionmust have knowledge in blood banking and the nationally acceptedstandards of practice.
    (f) For the purposes of this chapter, a hospital licensed under

IC 16-21-2 that operates a blood center within the facility is subjectto the rules adopted under this chapter concerning the operation ofthe blood center. However, the hospital may be licensed only underIC 16-21-2 and shall be surveyed concurrently, for licensurepurposes, as a blood center and a hospital.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-17
Rules
    Sec. 17. The state department may adopt rules under IC 4-22-2,after considering the guidelines of the federal Food and DrugAdministration, for the minimum standards and specific requirementsfor operation of a blood center, including the following:
        (1) Physical facilities, including refrigeration, lighting,construction, and equipment of the blood center to ensure theoperation of the blood center in a manner that protects thepublic health.
        (2) Testing procedures for communicable diseases transmittedby blood.
        (3) Standards for collection, processing, storage, distribution,and proper conduct of the blood transfusion service of bloodand blood products.
        (4) Identification and screening of donors.
        (5) Qualifications for medical and laboratory personnelemployed in a blood center.
        (6) Restrictions on the use of blood and plasma donations.
        (7) System of identifying the donor of the blood at all times,including after the blood has been administered to the recipient.
        (8) Establishment of a system for determining the inventorylevel of blood in all blood centers and the coordination of thedistribution of blood and blood products.
        (9) Proficiency testing.
        (10) All sanitary conditions within the blood center and theblood center's surroundings needed to protect the public and theemployees.
        (11) A quality assurance program.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-18
Blood shortage emergencies
    Sec. 18. (a) This section does not apply to a blood center when theblood center declares a blood shortage emergency for a specific orunusual blood type for a specific patient.
    (b) A blood center must have written criteria for a blood shortageemergency before the blood center may declare a blood shortageemergency. The criteria required under this section must be based onquantitative factors within the geographic region served by the bloodcenter.
    (c) A blood center must file the written criteria required under thissection with the state department.    (d) Unless an emergency is declared by another regional bloodcenter, a blood center may not declare a blood shortage emergencyfor the sole purpose of selling or transferring blood to another center.
    (e) Whenever a blood center declares a blood shortage emergency,the blood center shall notify the state department and affirm that ablood shortage emergency exists.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-19
Transfusion records; financial information; proficiencydemonstrations; operation reports
    Sec. 19. (a) A health care provider that administers bloodtransfusions shall keep a record of the following:
        (1) Blood center that furnished the blood.
        (2) Unit number assigned to the blood.
The record must be made available to the state department forinspection.
    (b) The state department may require a blood center to submitfinancial information on allegations of financial improprietyinvolving the blood supply.
    (c) The state department may require the demonstration ofproficiency in the performance of the tests offered by the bloodcenter.
    (d) The state department may require the owner and director of ablood center to submit reports under oath that contain informationand data concerning the technical operation of the blood center.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-20
Blood center supervision; medical directors
    Sec. 20. (a) Except as provided in subsection (c), a responsiblehead (as defined in 21 CFR 600.10(a)) shall supervise the operationsof a blood center.
    (b) Except as provided in subsection (d), each blood center mustemploy a medical director who is a licensed physician and who:
        (1) is certified or eligible for certification in:
            (A) clinical pathology; or
            (B) the operation of a blood bank;
        by the American Board of Pathology; or
        (2) has:
            (A) received a minimum of one (1) year of specializedtraining in blood banking; or
            (B) equivalent experience and training.
    (c) The medical director shall supervise and is responsible for thefollowing:
        (1) The proper performance of all medical procedures in theblood center.
        (2) The continuous application of quality assurance proceduresin the blood center.
    (d) A blood center collecting blood products exclusively for

further manufacturing or research purposes under programs subjectto and licensed by the federal Food and Drug Administration mustemploy a medical director who is a licensed physician to supervisethe donor screening process. A blood center that utilizes bloodproducts for a purpose other than manufacturing or research underthis subsection is subject to the penalties described in section 21 ofthis chapter.
As added by P.L.2-1993, SEC.24.

IC 16-41-12-21
Inspections; violations
    Sec. 21. (a) The state department may designate an agent whomay, upon presentation of proper credentials, enter a facility toinspect for possible violations of this chapter or rules adopted underthis chapter.
    (b) The state department may commence an action underIC 4-21.5-3-6 or IC 4-21.5-4 for issuance of an order of complianceand civil penalty not to exceed ten thousand dollars ($10,000) perviolation per day against a person who:
        (1) fails to comply with this chapter or rules adopted under thischapter; or
        (2) interferes with or obstructs the state department or the statedepartment's designated agent in the performance of officialduties under this chapter.
    (c) The state department may commence an action to suspend orrevoke a blood center's license under IC 4-21.5-3-8 or IC 4-21.5-4 ifthe licensee has done any of the following:
        (1) Made false statements concerning material information onthe license application or any other document required by thestate department.
        (2) Permitted unauthorized persons to perform medical ortechnical procedures (as defined by the state department by ruleadopted under this chapter) when a licensed physician licensedto practice medicine in Indiana is not available for consultation.
        (3) Demonstrated incompetence in the performance of anyprocedure.
        (4) Performed a procedure for which approval was not granted.
        (5) Operated the center in a manner considered hazardous topublic health.
        (6) Violated this chapter or rules adopted under this chapter.
    (d) The state department may report to any other board or agencyresponsible for licensure, registration, or certification of health careproviders, facilities, or other health care workers an individual orfacility that is found to be operating in violation of this chapter orrules adopted under this chapter.
As added by P.L.2-1993, SEC.24.