Pennsylvania state laws and regulations that affect your medical practice
1. What is Pennsylvania's public policy with respect to the use of blood and blood products?
The public policy of this Commonwealth is to safeguard the health and well-being of the citizens of this State with reference to the use of blood and blood products in the treatment of many human diseases, as well as its use in the treatment of injuries resulting from casualties or disasters. Use of blood and blood products in this manner has increased to such proportions that, in the public interest, there is need for establishing Statewide minimum standards for the control and licensing of the activities of blood banks. It is declared that the purpose of this act is to provide for the better protection of public health (i) through the development, establishment, and enforcement of standards to establish, equip, maintain and conduct a suitable program to collect, process, store and distribute whole human blood, and the various human blood derivatives prepared from single units of whole blood by the licensing of blood banks, (ii) by providing qualifications for the personnel of such blood banks, (iii) by insuring that the procedures performed by blood banks are performed with a high degree of scientific and professional competency and (iv) by providing that no person will be denied blood or blood products that can be made reasonably available. This act shall be liberally construed to carry out these objects and purposes.
35 P.S. § 6502
"Blood bank" means any place, organization, institution or establishment that it operated wholly or in part for the purpose of obtaining, storing, processing, preparing for transfusing, or selling human blood or parts or fractions of single blood units or products derived from single blood units, whether such procedures are done for direct therapeutic use or for storage for future use of such products, and whether a place, organization, institution, or establishment is operated on a charitable, commercial, or nonprofit basis.
35 P.S. § 6503
3. What exactly constitutes a "blood product?"
"Blood product" means any part or fraction of single units of whole human blood, or any material derived from single units of such blood which is subsequently administered to human subjects.
35 P.S. § 6503
4. What procedures are used to collect blood?
"Collection" means the obtaining of blood by the bleeding of donors by a phlebotomy or plasmapheresis.
35 P.S. § 6503
5. What are the requirements for blood bank facilities?
The premises and equipment used by any blood bank shall meet minimal requirements determined by the secretary. This shall include storage provisions, temperature controls, laboratory testing and controls for the proper examination and evaluation of blood and blood products, conditions of obtaining and administering blood and blood products, and safety factors such as construction, and preservation of sterile operating procedures where essential.
35 P.S. § 6504
6. What sort of records must be kept at blood banks?
(a) All records and files shall be maintained in a standardized manner designated by the department. The department will make every effort to insure that they do not require duplicate records of blood banks. Coordination shall be made with existing programs requiring records.
(b) The department shall establish a central registry of blood donors who have a history of hepatitis or have tested positive for Australian antigen.
( c ) A copy of the blood donor registry shall be sent to every blood bank within two months of their licensing and each blood bank shall be notified periodically to update this list, at least once a year.
35 P.S. § 6505
7. What are the qualifications required of a blood bank director?
A blood bank must be under the direction of a qualified person who has specific experience in the field of blood bank operations, hematology and immunohematology.
Any procedures involving the service of transfusing or injecting of blood or blood products into humans must be under the supervision of a medical director who has experience and/or training which is acceptable to the department. The medical director may also serve as the director of the blood bank if qualifications are suitable. Any time blood is being obtained from a human donor, a physician must be available who is licensed to practice medicine in the Commonwealth of Pennsylvania.
35 P.S. § 6506
8. What procedures must be followed to obtain a license for a blood bank?
All persons now operating or hereafter desiring to operate a blood bank shall make written application to the department for a license to operate, which application shall be accompanied by a fee. For a blood bank participating in a voluntary inspection program outlined in section 13, the fee shall be fifty dollars ($50) per year. For all blood banks not participating in a voluntary inspection program approved by the department the fee shall be two hundred dollars ($200). A separate fee shall be charged for each permanent blood bank location.
35 P.S. § 6507
9. What information must be included on an application?
The application shall contain at least the following:
(1) The name and location of the blood bank.
(2) Name and address of the person owning the blood bank.
(3) Name and address of the person operating the blood bank.
(4) Education and experience of all persons having directoral, supervisory, or technical duties in the blood bank.
(5) Description of physical facilities, location, equipment, sources of materials, and methods of storage and distribution of products.
(6) Description of all technical procedures in the routine operations for which license is to be issued.
(7) Such additional information as the department may require by rule and regulation.
A standard form shall be established by the department for the application.
35 P.S. § 6508
10. Will the Department conduct an investigation following the filing of an application?
Yes. Upon filing of application for license, the department shall investigate all facts set forth in the application.
35 P.S. § 6509
The department shall also inspect the premises and facilities of all applicants before issuance of license, and at any subsequent time deemed necessary, such inspection to include all matters pertaining to the operation of the blood bank as defined by this act.
No notice shall be given to the blood banks prior to inspections that follow the initial licensing inspection. All blood banks shall be inspected at least annually by the department. This annual inspection can be waived by the department when the blood bank is complying with section 13 of this act.
35 P.S. § 6510
11. May a blood bank be operated without a license?
(a) No person shall hereafter operate or conduct a blood bank in this Commonwealth unless duly licensed by the secretary under the provisions of this act. The license required by this act shall be in addition to any other license or permit required by any local board of health or other body exercising the powers of such a board in this Commonwealth.
(b) The department shall issue a license to the applicant to operate a blood bank to provide the service and program described in the application if the department is satisfied that the applicant has complied with the provisions of this act and the rules and regulations adopted by the department pursuant to this act. Any person who has conducted or maintained a blood bank prior to the effective date of this act may, until action has been taken on such application by the department, continue in operation if applications are made for a license within one hundred eighty days after the effective date of this act.
( c ) A license shall expire one year after the date of issuance unless renewed. Licenses may be renewed in the same manner and subject to the same conditions as the issuance of the original license and upon payment of a renewal application fee.
(d) If any major change in the program or services, including the discontinuance of substantial services of the blood bank are made, the changes shall be registered with the department within thirty days.
(e) Each blood bank must have a license. A single license must be obtained for each location of a blood bank even though several blood banks or locations may be supervised by the same director. A license shall be valid only in the hands of the person to whom it is issued and shall not be a subject of sale, assignment, or transfer, voluntary or involuntary, nor shall a license be valid for any premises other than that for which issued. However, a new license may be secured for a new location, or owner prior to the actual change, provided that the contemplated change is in compliance with the provisions of this act and the rules and regulations adopted by the department pursuant to this act.
35 P.S. § 6511
12. What information is included on a blood bank license?
The license shall contain at least the following:
(1) Name and address of the blood bank.
(2) Name and address of owner.
(3) Name and address of the person responsible for operation of blood bank.
(4) Any specific limitations of permit as may be determined by rule and regulation.
(5) Signature of the secretary.
Any person maintaining a blood bank shall display in a prominent place in his establishment the current license issued to him by the department.
35 P.S. § 6512
13. What are the other requirements for operating a blood bank?
Each blood bank shall meet one or more of the following requirements once each year:
(1) Hold a currently valid Federal license to operate a blood bank and meet any additional requirements determined by the department.
(2) Participate in and be accredited under an evaluation program as conducted by agencies, approved by the department, providing the results of such evaluation are on file with the department, and meet any additional requirements determined by the department.
(3) Participate in an evaluation by the department according to provision to be established by rule and regulation.
35 P.S.§ 6513
14. What are the regulations concerning the exchange of blood and blood components?
(a) No individual shall be denied blood or blood components for any reason unrelated to the medical needs of that individual provided that the blood or blood components are reasonably available.
(b) An individual who receives blood or blood components from a facility charging a nonreplacement fee shall not be responsible for the replacement of blood or blood components so received or a nonreplacement fee if a blood bank offers to and within seven days of the offer is able to replace the blood or blood components so received.
( c ) All blood banks shall agree to the reciprocal exchange of blood as required by patient needs without regard for geographical location or blood bank affiliation. The various blood banks in the Commonwealth will begin the immediate implementation of the reciprocal exchange of blood in such a manner as not to jeopardize local blood supplies or cause misallocations of blood supplies. The receiving facility shall remit to the shipping facility the standard blood processing fee of said shipping facility for units received. Blood replacement requests may not be accumulated for more than sixty days from the date of transfusion.
(d) Blood components shall be exchanged on a one-for-one basis and a kind-for-kind basis unless otherwise agreed to by the parties transferring and receiving blood components.
(e) Effective January 1, 1980, any person charging a nonreplacement fee shall establish an upper limit on that fee, not to exceed the greater of:
(1) one thousand dollars ($1,000) per individual per period of hospitalization; or
(2) one thousand five hundred dollars ($1,500) per individual per calendar year.
(f) No portion of a nonreplacement fee shall be assignable to any person and no unpaid nonreplacement fee may be forwarded to any person for collection other than to an attorney for the purpose of instituting collection litigation in the name of the person imposing the nonreplacement fee.
35 P.S. § 6514-1
15. What recourse does an applicant have if refused a license?
If an applicant is refused a license, as provided in section 15 of this act, the applicant may request and receive a hearing before the secretary, if such request is made within thirty days after receiving notice of denial.
35 P.S. § 6516
16. For what reasons may a license be revoked?
Any license issued in accordance with the provisions of this act may be suspended or revoked by the department for a violation of any of the provisions of this act or of the rules and regulations adopted by the department pursuant to this act. Before the department suspends or revokes a license, it shall provide written notification to the licensee or applicant. Such notification shall specify the reason for revocation or suspension, and indicate a time and place for a hearing on the matter, to be held within thirty days of notification.
The department shall have the power and authority and it shall be its duty to enter and inspect, with no prior notice, any blood bank and to make such investigations of the premises and the books and records as is reasonably necessary to carry out the provisions of this act and the regulations adopted pursuant to this act.
35 P.S. § 6517
17. What will happen if a blood bank continues to operate without a license?
(a) Whenever the department shall have refused to grant or renew a license, or shall have revoked or suspended a license required under this act to operate or conduct a blood bank, or shall have ordered the person to refrain from conduct violating the rules and regulations of the department and the person deeming himself aggrieved by such refusal or revocation or order shall have appealed the action of the department, the court may during pendency of such appeal, issue a restraining order or injunction upon proof that the operation of the private institution or its failure to comply with the order of the department is dangerous to the public health.
(b) Should a person, who is refused a license or the renewal of a license to operate or conduct a blood bank or whose license to operate or conduct a blood bank is revoked or who has been ordered to refrain from conduct or activity which violates the rules and regulations of the department, fail to appeal or should such appeal be decided finally favorably to the department, then the court shall issue a permanent injunction upon proof that the person is operating or conducting a blood bank without a license as required by law, or has continued to violate the rules and regulations of the department.
35 P.S. § 6518
18. Do the Pennsylvania regulations apply to blood banks operated by the Federal Government?
This act shall not include or apply to any blood bank operated by the Federal Government, or any blood bank operated purely for research or teaching purposes: Provided, that the blood and blood products are not injected into humans. Nor shall it include any commercial establishment which obtains and processes blood and blood products which are never transfused or injected into humans.
35 P.S. § 6519
19. What are the penalties for operating a blood bank without a license?
Any person operating a blood bank without first obtaining a license from the department or operating a blood bank after suspension or revocation of license has become effective shall, upon conviction thereof, be sentenced to pay a fine of one thousand dollars ($1,000). Each day's violation shall constitute a separate offense.
35 P.S. § 6522
20. What are the liability issues associated with transfusions?
(a) No person shall be held liable for death, disease or injury resulting from the lawful transfusion of blood, blood components or plasma derivatives, or from the lawful transplantation or insertion of tissue, bone or organs, except upon a showing of negligence on the part of such person. Specifically excluded hereunder is any liability by reason of any rule of strict liability or implied warranty or any other warrant not expressly undertaken by the party to be charged.
(b) As used in this section the term "negligence" shall include but not be limited to any failure to observe accepted standards in the collection, testing, processing, handling, storage, transportation, classification, labeling, transfusion, injection, transplantation or other preparation or use of any such blood, blood components, plasma derivatives, tissue, bone or organs.
42 Pa. C.S.A. § 8333
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.