11.68.010 Title.
11.68.020 Purpose.
11.68.030 Guidelines adopted.
11.68.040 Definitions.
11.68.050 Blood or plasma vendor registration-identification card.
11.68.060 Recordkeeping.
11.68.070 Breath analysis.
11.68.080 Reporting of communicable disease.
11.68.090 Prohibited acts.
11.68.100 Enforcement and inspection.
11.68.110 Denial, suspension or revocation of registration-identification card.
11.68.120 Appeals.
11.68.130 Penalty for violation.

11.68.010 Title.

This chapter shall be known and may be cited and referred to as the "Commercial Blood or Plasma Vendor Registration-Identification Ordinance."
(Ord. 59751 § 1, 1986.)

11.68.020 Purpose.

The purpose of this chapter is to provide a system for the registration and identification of and the reporting of medical data applicable to commercial blood or plasma vendors as being in the common interest of the health of the people of the City.
(Ord. 59751 § 2, 1986.)

11.68.030 Guidelines adopted.

Parts 600, 601, 606, 607, 610, 640, as amended (including the relevant guidelines and memoranda published by the Food and Drug Administration pursuant to such parts) Title 21 of the Code of Federal Regulations governing standards for human blood and blood products, a copy of which is filed of record with the Register of the City and set forth in Appendix A hereof, is hereby adopted by the City and incorporated herein by reference as part of the chapter and it shall become the law of this City in the same manner as if it were fully set forth herein. If there is a conflict between the federal regulations and the provisions of this chapter, the provisions of this chapter shall prevail.
(Ord. 59751 § 3, 1986.)

11.68.040 Definitions.

For the purposes of this chapter, the following words, terms and phrases shall have the following respective meanings, unless otherwise specifically provided:

A. "Blood collection facility" is defined as any facility, laboratory, or place of business where commercial blood vendors participate in the whole blood extraction process.

B. "Commercial blood vendor" is defined as an individual who sells, barter, or exchanges for monetary consideration, whole blood.

C. "Commercial plasma vendor" is defined as an individual who sells, barters, or exchanges for monetary consideration his or her blood plasma through the plasmapheresis process.

D. "Division" is defined as the St. Louis City Health Division.

E. "Health Commissioner" shall mean the Health Commissioner of the City or his designated representative in the Health Division of the City.

F. "Plasmapheresis" is defined as the procedure whereby whole blood is removed from a commercial plasma vendor by venipuncture (or phlebotomy), the plasma is separated therefrom, and the blood cells returned to the plasma vendor.

G. "Plasmapheresis facility" is defined as any facility, laboratory, or place of business where commercial plasma vendors participate in the plasmapheresis process.
(Ord. 59751 § 4, 1986.)

11.68.050 Blood or plasma vendor registration-identification card.

All commercial blood collection facilities and plasmapheresis facilities doing business within the City shall prepare a blood or plasma vendor registration-identification card for each commercial blood vendor or plasma vendor. The card shall contain identifying information, as shall be required by the Division, including a photograph and number of the vendor. The card shall identify the facility which prepared the card. Only one (1) card and one (1) number shall be issued to each vendor. The registration-identification card shall be good for one (1) blood collection facility or one (1) plasmapheresis facility only. A copy of the registration-identification card shall be filed with the Division.
(Ord. 59751 § 5, 1986.)

11.68.060 Recordkeeping.

A. No blood collection facility or plasmapheresis facility within the City may remove whole blood or perform the plasmapheresis process on a commercial blood or plasma vendor until said vendor presents the facility with a valid vendor registration-identification card issued as required by Section 11.68.050. The blood collection or plasmapheresis facility shall keep accurate records of each whole blood extraction or plasmapheresis procedure performed by it, which shall include:

1. The date of the whole blood extraction or plasmapheresis procedure;

2. The name, address, age, weight, height and sex of the vendor;

3. A photograph and identification number of the vendor;

4. The results of breath analysis of the vendor as required by Section 11.68.070;

5. The amount of whole blood, not including anticoagulant, removed from the vendor during the plasmapheresis procedure;

6. The proportion of the blood cells successfully returned to the vendor at the time of each plasmapheresis procedure;

7. The results of testing for hepatitis;

8. The results of testing for HTLV-III antibody;

9. The current hematocrit value;

10. Any other identifying information as the division may deem necessary.

B. All said facilities within the City shall provide access to the aforementioned records to the Division during all normal hours of operation for purpose of determining compliance with all applicable laws and regulations.

C. Prior to beginning the plasmapheresis procedure upon any commercial blood or plasma vendor, the plasmapheresis facility shall ascertain that said vendor has not participated in the plasmapheresis procedure in excess of the amounts listed below within the times indicated:

1. The amount of whole blood, not including anticoagulant, removed from a vendor during the plasmapheresis procedure in any forty-eight (48) hour period shall not exceed one thousand (1,000) milliliters unless the vendor's weight is one hundred seventy-five (175) pounds or greater, in which case the amount of whole blood, not including anticoagulant removed from the vendor during the plasmapheresis procedure, in any forty-eight (48) hour period shall not exceed one thousand two hundred (1,200) milliliters.

2. The amount of whole blood, not including anticoagulant, removed from a vendor during the plasmapheresis procedure, within a seven (7) day period shall not exceed two thousand (2,000) milliliters, unless the vendor's weight is one hundred seventy-five (175) pounds or greater, in which case the amount of whole blood, not including anticoagulant, removed from the vendor during the plasmapheresis procedure, within a seven (7) day period shall not exceed two thousand four hundred (2,400) milliliters.

3. During the plasmapheresis procedure, no more than five hundred (500) milliliters of whole blood shall be removed from a vendor at one time unless the vendor's weight is one hundred seventy-five (175) pounds or greater, in which case no more than six hundred (600) milliliters of whole blood shall be removed from the vendor at one time.

D. No plasmapheresis facility within the City may perform the plasmapheresis process on a commercial plasma vendor until said vendor has been examined and issued a certificate of good health as required by the regulations of the Food and Drug Administration (FDA), of the United States Department of Health and Human Services.

E. Prior to beginning the whole blood extraction process upon any commercial blood vendor, the facility shall ascertain that said vendor has not participated in the whole blood extraction procedure in excess of the amounts listed below within the time indicated:

1. The amount of whole blood, not including anticoagulant, removed from a vendor during the whole blood extraction procedure in any eight (8) week period shall not exceed four hundred fifty (450) milliliters, providing that the vendor's weight is one hundred ten (110) pounds or greater.

F. No whole blood extraction facility within the City may extract whole blood from a commercial blood vendor until said vendor has been examined and issued a certificate of good health as required by the regulations of the Food and Drug Administration (FDA), of the United States Department of Health and Human Services.

G. The Division shall keep all records in a manner which protect the rights of individuals to the confidentiality of their medical records. The disclosure of the identity of, or other information relating to commercial blood or plasma vendors is expressly prohibited, except as such disclosure is directly related to and necessary for enforcement of this chapter or as is required by law.
(Ord. 59751 § 6, 1986.)

11.68.070 Breath analysis.

It shall be unlawful for any said facility in the City to extract whole blood or plasma from a commercial blood or plasma vendor unless, immediately prior to said extraction, the facility shall analyze the breath of the commercial blood or plasma vendor and determine from such analysis that the blood of the commercial blood or plasma vendor does not contain alcohol in excess of 0.07 percent, weight per volume or its equivalent by other measure. For the purpose of performing the required breath analysis, each facility in the City shall maintain upon the premises thereof such testing materials, equipment, supplies, and personnel as are approved by the Division.
(Ord. 59751 § 7, 1986.)

11.68.080 Reporting of communicable disease.

Any blood collection or plasmapheresis facility which shall discover that the vendor evidences venereal disease, or other communicable disease shall immediately submit to the Division a confidential report setting forth the evidence of the disease and the vendor's name, address, registration-identification number and other information sufficient to identify and locate the vendor. The Health Commissioner shall establish written procedures for reporting the above information.
(Ord. 59751 § 8, 1986.)

11.68.090 Prohibited acts.

It shall be unlawful for any person to obtain or attempt to obtain or possess more than one (1) vendor registration-identification card or more than one (1) vendor identification number within the prescribed time, or for any person to attempt to utilize a vendor registration-identification card or vendor identification number of another individual, or for any person to provide false information to any said facility or to the St. Louis Health Division in connection with the application for a vendor identification number or in connection with any procedure.
(Ord. 59751 § 9, 1986.)

11.68.100 Enforcement and inspection.

It shall be the responsibility of the Health Commission of the St. Louis City Health Division or his duly authorized representative to enforce the provisions of this chapter throughout the City and the Health Commissioner may promulgate rules and regulations necessary to carry out the provisions of this chapter. The St. Louis City Health Division may make periodic inspections of each said facility of the City for the purpose of determining the existence of any violation of this chapter.
(Ord. 59751 § 10, 1986.)

11.68.110 Denial, suspension or revocation of registration-identification card.

A. If the Health Commissioner of the St. Louis City Health Division determines that an individual has violated a provision of this chapter, he may deny, suspend or revoke any vendor registration-identification card or identification number, according to the following criteria:

1. For a violation by a person who is not a registered commercial blood or plasma vendor, a disqualification of that person from becoming a registered vendor for a period not exceeding ninety (90) days for each violation;

2. For the first violation by a registered commercial blood or plasma vendor, suspension of the vendor registration-identification card and number and all the privileges incident thereto for a period not exceeding ninety (90) days;

3. For the second violation by a registered commercial blood or plasma vendor, suspension of the vendor registration-identification card and number and all privileges incident thereto for a period not exceeding one (1) year;

4. For the third violation by a registered commercial blood or plasma vendor, suspension of the vendor registration-identification card and number and all the privileges incident thereto for a period not exceeding five (5) years, or permanent revocation of the vendor registration-identification card and registration number and all the privileges incident thereto.

B. If the Health Commissioner of the St. Louis City Health Division or his designee shall determine that a violation of this chapter or any regulation promulgated hereunder has occurred, the Health Commissioner may take one or more of the following actions:

1. Service upon the person or facility in violation of a citation setting forth the violation and establishing a time within which such violation must be corrected;

2. Initiation of a procedure for the denial, revocation, suspension, limitation of any commercial blood or plasma vendor registration-identification card;

3. The initiation of a judicial procedure for injunctive action against any individual or organization violating this chapter, it being hereby declared that the performance of whole blood extraction and/or the plasmapheresis procedure on any commercial blood or plasma vendor in violation of this chapter or any regulation promulgated hereunder is a nuisance inimical to the public health, welfare and safety;

4. Whenever the Health Commissioner of the Division shall have determined the existence of a violation of this chapter which constituted an immediate threat to the health, safety or welfare of a commercial blood or plasma vendor, a potential recipient of blood or plasma or the public, and such condition cannot or will not be immediately corrected, the Health Commissioner may order the immediate closing of such facility and request the City Counselor to initiate judicial proceedings seeking injunctive relief to accomplish said purpose until such time as the threat is found no longer to exist;

5. The Health Commissioner may also refer any violation of this chapter to the City Counselor's Office for prosecution in the City Courts.

C. Whenever the Health Commissioner of the St. Louis City Health Division or his duly authorized representative believes there has been a violation of the provisions of this chapter, he shall serve notice of such violation in writing to the party responsible for such violation. The notice shall specify the violation and shall be deemed to be properly served and binding upon the party responsible, if a copy is served personally or served by certified mail at the address reported under Section 11.68.060. Such notice shall inform the party to whom it is directed of the right to apply to the Board of Public Service for a hearing and review of the matters specified in the notice.
(Ord. 59751 § 11, 1986.)

11.68.120 Appeals.

Any person aggrieved by a decision of the Division made under the provisions of this chapter shall have the right to appeal such decision to the Board of Public Service (Board). Said appeal must be in writing and received by the Board no later than ten (10) days from the date of the decision to be reviewed. The Board shall set such appeal for hearing at the earliest possible date, and cause notice thereof to be given to the appellant and the Health Commissioner of the St. Louis City Health Division. The Board shall hear and consider all facts material to the appeal and render a decision promptly. The Board may affirm, reverse, or modify the action or decision appealed from providing that the Board shall not take any action which conflicts or nullifies any of the provisions of this chapter. The Board shall specifically state in its decision the date by which compliance must be made. The decision of the Board shall be final, and no rehearing or reconsideration shall be considered. Any party aggrieved by any decision of the Board on appeal taken to it, may apply to the Circuit Court of the City for a review.
(Ord. 59751 § 12, 1986.)

11.68.130 Penalty for violation.

A conviction for violation of the provisions of this chapter shall be punishable by a fine not to exceed five hundred dollars ($500.00) or by imprisonment in the City jail for a term not to exceed ninety (90) days or both such fine and imprisonment.
(Ord. 59751 § 13, 1986.)