PRINTER'S NO. 2362
No. 1944 Session of 1993
INTRODUCED BY STURLA, JOSEPHS, COY, FAJT, DeWEESE, ROEBUCK,
YEWCIC, PESCI, KUKOVICH, SCHULER, BATTISTO, ROONEY, COLAIZZO,
CLARK, MIHALICH, TIGUE, KREBS, BISHOP, STABACK, PISTELLA,
HARLEY, RAYMOND, GIGLIOTTI, MILLER, MELIO, TRELLO, BELFANTI,
VANCE, BAKER, STEELMAN, TOMLINSON, SCHEETZ, EGOLF, DeLUCA,
BLAUM, BELARDI, CAPPABIANCA, WOZNIAK AND SCRIMENTI,
JUNE 23, 1993
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, JUNE 23, 1993
AN ACT
1 Providing options for blood transfusions to persons undergoing
2 certain medical procedures; and further providing for duties
3 of attending physicians, duties of health care facilities,
4 duties of blood banks, disposal of blood and payment of
5 service fees.
6 The General Assembly of the Commonwealth of Pennsylvania
7 hereby enacts as follows:
8 Section 1. Short title.
9 This act shall be known and may be cited as the Blood Safety
10 Act.
11 Section 2. Definitions.
12 The following words and phrases when used in this act shall
13 have the meanings given to them in this section unless the
14 context clearly indicates otherwise:
15 "Allogeneic blood." Blood that is donated on a voluntary
16 basis without designating or knowing who the recipient is and
17 which complies with all the requirements of the United States
1 Food and Drug Administration.
2 "Attending physician." The physician who is designated by
3 the patient to perform a medical or surgical procedure.
4 "Autologous blood." Blood donated by a person for his own
5 use.
6 "Biohazardous blood product." A blood product which has
7 tested positive for one or more of the viral marker assays
8 performed by licensed blood collectors.
9 "Blood." This term shall include blood components and whole
10 blood.
11 "Blood bank." Any place, organization, institution or
12 establishment that is operated wholly or in part for the purpose
13 of obtaining, storing, processing, preparing for transfusing or
14 selling human blood products derived from single blood units,
15 whether such procedures are done for direct therapeutic use or
16 for storage for future use of such products and whether such a
17 place, organization, institution or establishment is operated on
18 a charitable, commercial or nonprofit basis.
19 "Blood components." Any part or fraction of single units of
20 whole blood or any material derived from single units of such
21 blood, excluding albumin, rhogam and gammo globulin or other
22 components which cannot transmit infectious agents.
23 "Department." The Department of Health of the Commonwealth.
24 "Designated blood." Blood donated for a specifically
25 indicated recipient of the donated blood other than the donor
26 and which complies with all the requirements of the Food and
27 Drug Administration.
28 "Health care facility."
29 (1) A general or special hospital, including
30 tuberculosis and psychiatric hospitals, rehabilitation
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1 facilities, skilled nursing facilities, kidney disease
2 treatment centers, including free-standing hemodialysis
3 units, intermediate care facilities and ambulatory surgical
4 facilities, both profit and nonprofit and including those
5 operated by an agency of State or local government, but shall
6 not include an office used exclusively for their private or
7 group practice by physicians or dentists, nor a program which
8 renders treatment or care for drug or alcohol abuse or
9 dependence, unless located within, by or through a health
10 care facility, a facility providing treatment solely on the
11 basis of prayer or spiritual means in accordance with the
12 tenets of any church or religious denomination, nor a
13 facility conducted by a religious organization for the
14 purpose of providing health care services exclusively to
15 clergymen or other persons in a religious profession who are
16 members of the religious denominations conducting the
17 facility.
18 (2) This definition shall exclude all health care
19 facilities as hereinabove defined that do not accept,
20 directly or indirectly, any Federal or State governmental
21 funds for capitalization, depreciation, interest, research or
22 reimbursement, unless the Secretary of Health, the Secretary
23 of Education and the Secretary of Public Welfare, pursuant to
24 Public Law 93-641, § 1523(a)(4)(B), concludes that this
25 exclusionary provision is unsatisfactory to the Department of
26 Health, the Department of Education and the Department of
27 Public Welfare.
28 "Informed consent." For the purposes of this act and of any
29 proceedings arising under this act, the consent of a patient to
30 the performance of health care services by a physician, provided
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1 that prior to the consent having been given, the physician has
2 informed the patient of the proposed procedure or treatment or
3 diagnosis that a reasonable patient would consider material to
4 that decision whether or not to undergo treatment or diagnosis.
5 No physician shall be liable for a failure to obtain an informed
6 consent in the event of an emergency which prevents consulting
7 the patient. No physician shall be liable for failure to obtain
8 an informed consent if it is established by a preponderance of
9 the evidence that furnishing the information in question to the
10 patient would have resulted in a seriously adverse effect on the
11 patient or on the therapeutic process to the material detriment
12 of the patient's health.
13 "Transfusion." The act of transferring blood into the body
14 of a person.
15 "Whole blood." The fluid that circulates in the heart,
16 arteries, capillaries and veins of a human body carrying
17 nourishment and oxygen to and bringing away waste products from
18 all parts of the body.
19 Section 3. Duties of attending physicians.
20 (a) Informed consent.--Whenever it is anticipated that a
21 transfusion may be necessary during a medical or surgical
22 procedure, the attending physician shall, prior to performing a
23 medical or surgical procedure, inform the patient or guardian or
24 designated surrogate that a blood transfusion may be necessary
25 during the procedure and of the options of predonating for
26 autologous blood transfusions, receiving allogeneic blood
27 transfusions or receiving designated blood transfusions, the
28 risks and benefits of each of these alternatives and the risks
29 of not receiving any transfusions if a transfusion becomes
30 necessary and shall obtain the patient's informed consent in
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1 writing.
2 (b) Documentation.--The attending physician shall note on
3 the patient's medical record, which shall be maintained in the
4 office of the attending physician, that the patient or guardian
5 or designated surrogate was advised of the opportunity to
6 receive an autologous, allogeneic or designated blood
7 transfusion, the risks of these alternatives and the risks of
8 not receiving the transfusion if a transfusion becomes
9 necessary.
10 (c) Predonation time.--If there are no medical
11 contraindications or the medical or surgical procedure is not
12 performed on an emergency basis, the attending physician shall
13 allow adequate time, prior to the medical or surgical procedure,
14 for predonation to occur.
15 (d) Waiver of predonation.--The patient or guardian or
16 designated surrogate may waive the option to predonate
17 autologous blood or have designated blood donated on his behalf.
18 This waiver shall be in writing and made a part of the patient's
19 record that is maintained in the office of the attending
20 physician. If the patient or guardian or designated surrogate
21 waives the option to predonate autologous blood or have
22 designated blood donated on his behalf, the attending physician
23 shall not incur any liability for failure to allow predonation
24 to occur.
25 Section 4. Duties of health care facilities.
26 (a) Option information.--All health care facilities shall
27 assist, when possible, with the facilitation, promulgation and
28 dissemination of information regarding the options available to
29 a patient regarding the predonation of autologous blood,
30 receiving allogeneic blood or receiving designated blood, the
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1 risks and benefits of each of these alternatives and the risks
2 of not receiving any transfusion if a transfusion becomes
3 necessary and shall obtain the patient's informed consent in
4 writing.
5 (b) Documentation.--The health care facility shall note on
6 the patient's record maintained at the facility as to whether
7 the patient was informed by his attending physician of the blood
8 transfusion options available. If the attending physician has
9 failed to advise the patient of these options, the health care
10 facility shall be responsible for advising the patient of these
11 options, the risks and benefits of these alternatives and the
12 risks of not receiving any transfusion if a transfusion becomes
13 necessary and shall obtain the patient's informed consent in
14 writing. The health care facility shall not incur any liability
15 for failure to allow the predonation to occur if the patient has
16 waived the option to predonate autologous blood or have
17 designated blood donated on his behalf. This waiver shall be in
18 writing.
19 (c) Acceptance of autologous or designated blood.--A health
20 care facility which performs a transfusion shall be required to
21 accept autologous or designated blood for a potential
22 transfusion to a patient if the blood meets the regulations of
23 the Food and Drug Administration and is received from a blood
24 bank located within this Commonwealth and duly licensed by the
25 department. Autologous or designated blood which is received
26 from a blood bank located outside this Commonwealth must be duly
27 licensed by the state in which it is located and must also meet
28 the regulations of the Food and Drug Administration. All
29 autologous and designated blood must be tested and prepared in
30 accordance with the standards approved by the department, except
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1 that autologous blood which is biohazardous may only be accepted
2 with the written permission of the attending physician and the
3 health care facility.
4 Section 5. Duties of blood banks.
5 (a) Option information.--All blood banks shall assist, when
6 possible, with the facilitation, promulgation and dissemination
7 of information regarding the options available to a patient
8 regarding the predonation of autologous blood, receiving
9 allogeneic blood or designated blood, the risks and benefits of
10 each of these alternatives and the risks of not receiving any
11 transfusion if a transfusion becomes necessary.
12 (b) Dissemination of information.--All blood banks shall
13 assist with the facilitation, promulgation and dissemination of
14 current information regarding the safety of available
15 transfusion options to the medical community.
16 (c) Fees.--A blood bank which collects autologous or
17 designated blood shall inform the donor of the blood or his
18 guardian or designated surrogate or the intended recipient of
19 the blood, in the case of a designated blood donation, of all
20 the fees that the blood bank charges to process, store,
21 transport or otherwise prepare the blood for transfusion.
22 Section 6. Disposal of unused autologous and designated blood.
23 In cases where a medical or surgical procedure is performed
24 and a transfusion was not performed or there is unused
25 autologous or designated blood, that blood shall be held for a
26 minimum of 21 days after the date of donation or a minimum of
27 seven days after the date the procedure was performed or was
28 scheduled to be performed for which the blood was originally
29 donated, for possible use, unless the useful life of the blood
30 has expired.
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1 Section 7. Payment of service fee by health care facilities.
2 A health care facility which accepts autologous or designated
3 blood and similar blood components shall pay a service fee to
4 the blood bank which provides the blood or blood components.
5 Insurance providers shall not deny payment of additional fees
6 for autologous blood costs if allogeneic blood transfusions are
7 covered in the policy. Any additional fees for designated blood
8 over and above allogeneic blood fees, unless medically
9 indicated, may be rejected for payment unless otherwise covered
10 in the policy.
11 Section 8. Exemptions.
12 The attending physician or the health care facility where the
13 medical or surgical procedure is to be performed shall not be
14 required to provide the patient or his guardian or designated
15 surrogate with an explanation of the transfusion options under
16 this act if medical contraindications exist or the medical or
17 surgical procedure is performed on an emergency basis.
18 Section 9. Effective date.
19 This act shall take effect in 60 days.
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