PRINTER'S NO. 2487
No. 2006 Session of 1995
INTRODUCED BY STURLA, VANCE, KUKOVICH, CAPPABIANCA, COY, KREBS,
CLARK, ROEBUCK, DALEY, ROONEY, STABACK, LAUGHLIN, TIGUE,
MELIO, BATTISTO, RAYMOND, ITKIN, HENNESSEY, READSHAW, STERN,
BAKER, JOSEPHS, CURRY, MILLER, ZIMMERMAN, MIHALICH,
RICHARDSON, TRELLO, SCHULER, DeLUCA, WOZNIAK, YOUNGBLOOD,
STEELMAN, BOSCOLA AND BELFANTI, SEPTEMBER 20, 1995
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
SEPTEMBER 20, 1995
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 United
27 States Food and Drug Administration.
28 "Health care facility." A general or special hospital,
29 including tuberculosis and psychiatric hospitals, rehabilitation
30 facilities, skilled nursing facilities, kidney disease treatment
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1 centers, including free-standing hemodialysis units,
2 intermediate care facilities and ambulatory surgical facilities,
3 both profit and nonprofit and including those operated by an
4 agency of State or local government, but shall not include an
5 office used exclusively for private or group practice by
6 physicians or dentists, nor a program which renders treatment or
7 care for drug or alcohol abuse or dependence, unless located
8 within, by or through a health care facility, a facility
9 providing treatment solely on the basis of prayer or spiritual
10 means in accordance with the tenets of any church or religious
11 denomination, nor a facility operated by a religious
12 organization for the purpose of providing health care services
13 exclusively to clergymen or other persons in a religious
14 profession who are members of the religious denominations
15 operating the facility.
16 "Informed consent." For the purposes of this act and of any
17 proceedings arising under this act, the consent of a patient to
18 the performance of health care services by a physician if, prior
19 to consent having been given, the physician provided information
20 to the patient about the proposed procedure, treatment or
21 diagnosis that a reasonable patient would consider material to
22 that decision whether or not to undergo the procedure or
23 treatment.
24 "Transfusion." The act of transferring blood into the body
25 of a person.
26 "Whole blood." The fluid that circulates in the heart,
27 arteries, capillaries and veins of a human body carrying
28 nourishment and oxygen to and bringing away waste products from
29 all parts of the body.
30 Section 3. Duties of attending physicians.
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1 (a) Informed consent.--Whenever it is anticipated that a
2 transfusion may be necessary during a medical or surgical
3 procedure, the attending physician shall, prior to performing a
4 medical or surgical procedure, inform the patient or guardian or
5 designated surrogate that a blood transfusion may be necessary
6 during the procedure and of the options of predonating for
7 autologous blood transfusions, receiving allogeneic blood
8 transfusions or receiving designated blood transfusions, the
9 risks and benefits of each of these alternatives and the risks
10 of not receiving any transfusions if a transfusion becomes
11 necessary and shall obtain the patient's informed consent in
12 writing.
13 (b) Documentation.--The attending physician shall note on
14 the patient's medical record, which shall be maintained in the
15 office of the attending physician, that the patient or guardian
16 or designated surrogate was advised of the opportunity to
17 receive an autologous, allogeneic or designated blood
18 transfusion, the risks of these alternatives and the risks of
19 not receiving the transfusion if a transfusion becomes
20 necessary.
21 (c) Predonation time.--If there are no medical
22 contraindications or the medical or surgical procedure is not
23 performed on an emergency basis, the attending physician shall
24 allow adequate time, prior to the medical or surgical procedure,
25 for predonation to occur.
26 (d) Waiver of predonation.--The patient or guardian or
27 designated surrogate may waive the option to predonate
28 autologous blood or have designated blood donated on his behalf.
29 This waiver shall be in writing and made a part of the patient's
30 record that is maintained in the office of the attending
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1 physician. If the patient or guardian or designated surrogate
2 waives the option to predonate autologous blood or have
3 designated blood donated on his behalf, the attending physician
4 shall not incur any liability for failure to allow predonation
5 to occur.
6 Section 4. Duties of health care facilities.
7 (a) Option information.--All health care facilities shall
8 assist, when possible, with the facilitation, promulgation and
9 dissemination of information regarding the options available to
10 a patient regarding the predonation of autologous blood,
11 receiving allogeneic blood or receiving designated blood, the
12 risks and benefits of each of these alternatives and the risks
13 of not receiving any transfusion if a transfusion becomes
14 necessary and shall obtain the patient's informed consent in
15 writing.
16 (b) Documentation.--The health care facility shall note on
17 the patient's record maintained at the facility as to whether
18 the patient was informed by his attending physician of the blood
19 transfusion options available. If the attending physician has
20 failed to advise the patient of these options, the health care
21 facility shall be responsible for advising the patient of these
22 options, the risks and benefits of these alternatives and the
23 risks of not receiving any transfusion if a transfusion becomes
24 necessary and shall obtain the patient's informed consent in
25 writing. The health care facility shall not incur any liability
26 for failure to allow the predonation to occur if the patient has
27 waived the option to predonate autologous blood or have
28 designated blood donated on his behalf. This waiver shall be in
29 writing.
30 (c) Acceptance of autologous or designated blood.--A health
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1 care facility which performs a transfusion shall be required to
2 accept autologous or designated blood for a potential
3 transfusion to a patient if the blood meets the regulations of
4 the United States Food and Drug Administration and is received
5 from a blood bank located within this Commonwealth and licensed
6 by the department. Autologous or designated blood which is
7 received from a blood bank located outside this Commonwealth
8 must be licensed by the state in which it is located and must
9 also meet the regulations of the United States Food and Drug
10 Administration. All autologous and designated blood must be
11 tested and prepared in accordance with the standards approved by
12 the department, except that autologous blood which is
13 biohazardous may only be accepted with the written permission of
14 the attending physician and the health care facility.
15 Section 5. Duties of blood banks.
16 (a) Option information.--All blood banks shall assist, when
17 possible, with the facilitation, promulgation and dissemination
18 of information regarding the options available to a patient
19 regarding the predonation of autologous blood, receiving
20 allogeneic blood or designated blood, the risks and benefits of
21 each of these alternatives and the risks of not receiving any
22 transfusion if a transfusion becomes necessary.
23 (b) Dissemination of information.--All blood banks shall
24 assist with the facilitation, promulgation and dissemination of
25 current information regarding the safety of available
26 transfusion options to the medical community.
27 (c) Fees.--A blood bank which collects autologous or
28 designated blood shall inform the donor of the blood or his
29 guardian or designated surrogate or the intended recipient of
30 the blood, in the case of a designated blood donation, of all
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1 the fees that the blood bank charges to process, store,
2 transport or otherwise prepare the blood for transfusion.
3 Section 6. Disposal of unused autologous and designated blood.
4 In cases where a medical or surgical procedure is performed
5 and a transfusion was not performed or there is unused
6 autologous or designated blood, that blood shall be held for a
7 minimum of 21 days after the date of donation or a minimum of
8 seven days after the date the procedure was performed or was
9 scheduled to be performed for which the blood was originally
10 donated, for possible use, unless the useful life of the blood
11 has expired.
12 Section 7. Payment of service fee by health care facilities.
13 A health care facility which accepts autologous or designated
14 blood and similar blood components shall pay a service fee to
15 the blood bank which provides the blood or blood components.
16 Insurance providers shall not deny payment of additional fees
17 for autologous blood costs if allogeneic blood transfusions are
18 covered in the policy. Any additional fees for designated blood
19 over and above allogeneic blood fees, unless medically
20 indicated, may be rejected for payment unless otherwise covered
21 in the policy.
22 Section 8. Exemptions.
23 The attending physician or the health care facility where the
24 medical or surgical procedure is to be performed shall not be
25 required to provide the patient or his guardian or designated
26 surrogate with an explanation of the transfusion options under
27 this act if medical contraindications exist or the medical or
28 surgical procedure is performed on an emergency basis.
29 Section 9. Liability.
30 No physician shall be liable for a failure to obtain an
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1 informed consent in the event of an emergency which prevents
2 consulting the patient. No physician shall be liable for failure
3 to obtain an informed consent if it is established by a
4 preponderance of the evidence that furnishing the information in
5 question to the patient would have resulted in a seriously
6 adverse effect on the patient or on the therapeutic process to
7 the material detriment of the patient's health.
8 Section 10. Effective date.
9 This act shall take effect in 60 days.
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