WHOLE BLOOD (HUMAN)

New Orleans City Code ch. 82, art. XI, div. 5

in effect

New Orleans City Code § 82-576 Proper name.

Sec. 82-576. - Proper name. The proper name of the product shall be "whole blood (human)." Whole blood (human) is defined as blood collected from human donors for transfusion to human recipients. (Code 1956, § 29-123)

New Orleans City Code § 82-577 Processing responsibility.

Sec. 82-577. - Processing responsibility. All collection of whole blood (human), including donor examination, blood collection, laboratory tests, labeling, storage and issue, shall be done under the supervision and control of the same licensed establishment except that the director may approve specific joint processing operations at the request of two or more licensed establishments, which he finds are of such a nature as to assure compliance otherwise with the provisions of this article. (Code 1956, § 29-124(a))

New Orleans City Code § 82-578 Periodic check on sterile technique.

Sec. 82-578. - Periodic check on sterile technique. (a) Where blood is collected in an open system, that is, where the blood container is entered, at least one container of such blood that upon visual examination appears normal shall be tested each month between the 18th and 24th day after collection, as a continuing check on technique of blood collection as follows: (1) The test shall be performed with a total sample of no less than ten milliliters of blood and a total volume of fluid thioglycollate or thioglycollate broth medium ten times the volume of the sample of blood. (2) The test sample shall be inoculated into one or more test vessels in a ratio of blood to medium of one-to-ten for each vessel, mixed thoroughly, incubated for seven to nine days at a temperature of 30 degrees to 32 degrees Celsius, and examined for evidence of growth of microorganisms every workday throughout the test period. (3) On the third, fourth or fifth day at least one milliliter of material from each test vessel shall be subcultured in additional test vessels containing the same culture medium and in such proportion as will permit significant visual inspection, mixed thoroughly, incubated for seven to nine days at a temperature of 30 degrees to 32 degrees Celsius and examined for evidence of growth of microorganisms every workday throughout the test period. (4) If growth is observed in any test vessel, the test shall be repeated to rule out faulty test procedure, using another sample of blood from either: a. The container from which the initial test sample was taken; b. The residual cells or plasma from that blood; or c. Two different containers of blood, each 18 to 24 days old and each tested separately. (5) The formula for fluid thioglycollate medium shall be as prescribed in this chapter and the formula for thioglycollate broth medium shall be as prescribed in this chapter. (6) Media and design of container shall meet the requirements prescribed in this chapter. (7) In lieu of performing one test using an incubation temperature of 30 degrees to 32 degrees Celsius, two tests may be performed, each in all respects as prescribed in this subsection, one at an incubation temperature of 18 degrees to 22 degrees Celsius and one at an incubation temperature of 35 degrees to 37 degrees Celsius. (8) A different test may be performed provided that prior to the performance of such test a processor submits data which the director finds adequate to establish that the different test is equal or superior to the test herein prescribed as a check on sterile technique and makes the finding a matter of official record. (Code 1956, § 29-124(b))

New Orleans City Code § 82-579 Final container.

Sec. 82-579. - Final container. The original blood container shall be the final container and shall not be entered prior to issue for any purpose except for blood collection. Such container shall be uncolored and transparent to permit visual inspection of the contents and any closure shall be such as will maintain an hermetic seal and prevent contamination of the contents. The container material shall not interact with the contents under the customary conditions of storage and use, in such a manner as to have an adverse effect upon the safety, purity or potency of the blood. (Code 1956, § 29-124(c))

New Orleans City Code § 82-580 Reissue of blood.

Sec. 82-580. - Reissue of blood. Blood that has been removed from storage controlled by a licensed establishment shall not be reissued by a licensed establishment unless the following conditions are observed: (1) The container has a tamperproof seal when originally issued and this seal remains unbroken; (2) An original pilot sample is properly attached and has not been removed, except that blood lacking a pilot sample may be reissued in an emergency provided it is accompanied by instructions for sampling and for use within six hours after entering the container for sampling; (3) The blood has been maintained continuously at one degree to ten degrees Celsius; (4) The blood is held for observation until a significant inspection consistent with the requirements of section 82-584(5) can be made. (Code 1956, § 29-124(e))

New Orleans City Code § 82-581 Issue prior to determination of test results.

Sec. 82-581. - Issue prior to determination of test results. Notwithstanding the provisions of section 82-476, blood may be issued by the licensee on the request of a physician, hospital or other medical facility, before results of all tests prescribed in section 82-584 and the test for hepatitis associated (Australia) antigen prescribed in this chapter have been determined where such issue is essential to allow time for transportation to assure arrival of the blood by the time when needed for transfusion of such blood provided: (1) The blood is shipped directly to such physician or medical facility; (2) The records of the licensee contain a full explanation of the need for such issue; (3) The label on each container of such blood bears the information required by section 82-585(5); (4) The label does not bear results of tests other than those made on pilot samples of the blood to be shipped, taken at the time of its collection; and (5) The label does not bear the name or any other identification of the intended recipient. (Code 1956, § 29-124(f))

New Orleans City Code § 82-582 Suitability of donor.

Sec. 82-582. - Suitability of donor. (a) Method of determining. The suitability of a donor as a source of whole blood (human) shall be determined by a qualified physician or by persons under his supervision and trained in determining suitability. Such determination shall be made on the day of collection from the donor by means of medical history, a test for hemoglobin level, and such physical examination as appears necessary to a physician who shall be present on the premises when examinations are made, except that the suitability of donors may be determined when a physician is not present on the premises, provided the establishment maintains records indicating the name and qualifications of the person immediately in charge of the employees who determine the suitability of donors when a physician is not present on the premises. (b) Qualifications of donor. Except as provided in subsection (f) of this section, a person may not serve as a source of whole blood (human) more than once in eight weeks. In addition, donors shall be in good health, as indicated in part by: (1) Oral temperature not to exceed 99.6 degrees Fahrenheit; (2) Demonstration that the systolic blood pressure is between 100 and 200 millimeters of mercury, and the diastolic is between 50 and 100 millimeters of mercury, unless the examining physician is satisfied that an individual with blood pressures outside these limits is a qualified donor under the provisions of this section; (3) A blood hemoglobin level which shall be demonstrated to be no less than 12.5 grams of hemoglobin per 100 milliliters of blood; (4) Freedom from acute respiratory diseases; (5) Freedom from any infectious skin disease at the site of phlebotomy and from any such disease generalized to such an extent as to create a risk of contamination of the blood; (6) Freedom from any disease transmissible by blood transfusion, insofar as can be determined by history and examinations indicated above; and (7) Freedom of the arms and forearms from skin punctures or scars indicative of addiction to self-injected narcotics. (c) Prohibited donors. No individual shall be used as a source of whole blood (human) if he has: (1) A history of viral hepatitis; (2) A history of close contact within six months of donation with an individual having viral hepatitis; (3) A history of having received within six months human blood, or any derivative of human blood which the department of health has advised the licensed establishment is a possible source of viral hepatitis. (d) Therapeutic bleedings. Blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of this section, shall not be used as a source of whole blood (human) unless the container label conspicuously indicates the donor's disease that necessitated withdrawal of blood. (e) Immunized donors. Blood withdrawn from donors known to have been immunized to human blood cell antigens shall not be used for whole blood (human) unless the container label conspicuously indicates such information. (f) Qualifications; donations within less than eight weeks. A person may serve as a source of whole blood (human) more than once in eight weeks only if at the time of donation the person is examined and certified by a physician to be medically acceptable for this donation. (g) Pregnancy. No female may donate if she is pregnant with a child and her pregnancy is beyond or more advanced than 90 days. (Code 1956, § 29-125)

New Orleans City Code § 82-583 Collection of the blood.

Sec. 82-583. - Collection of the blood. (a) Supervision. Blood shall be drawn from the donor by a qualified physician or under his supervision by assistants trained in the procedure. A physician shall be present on the premises when blood is being collected, except that blood may be collected when a physician is not present on the premises, provided the establishment: (1) Maintains on the premises a manual of standard procedures and methods, specifically developed for that institution and approved yearly by the medical director of that institution, that shall be followed by employees who collect blood; and (2) Maintains records indicating the name and qualifications of the person immediately in charge of the employees who collect blood when a physician is not present on the premises. A copy of this manual must be provided to the director of health upon request. (b) The donor clinic. The pertinent requirements of sections 82-511 through 82-519 shall apply at both the licensed establishment and at any other place where the bleeding is performed. (c) Blood containers. Blood containers and donor sets shall be pyrogen-free, sterile and identified by lot number. The amount of anticoagulant required for the quantity of blood to be collected shall be in the blood container when it is sterilized. In addition, all container and donor set surfaces that come in contact with blood used in the processing of Heparinized whole blood (human) shall be water repellant. (d) The anticoagulant solution. The anticoagulant solution shall be sterile and pyrogen-free. One of the following formulae shall be used in the indicated volumes: (1) Anticoagulant acid citrate dextrose solution (ACD). Solution A | Solution B Tri-sodium citrate (Na 3 c 6 H 5 O 7 2H 2 O) | 22.0 gm. | 13.2 gm. Citric acid (C 6 H 8 O 7 H 2 O) | 8.0 gm. | 4.8 gm. Dextrose (C 6 H 12 O 5 H 2 O) | 24.5 gm. | 14.7 gm. Water for injection (U.S.P.) to make | 1,000 ml. | 1,000 ml. Volume per 100 ml. blood | 15 ml. | 25 ml. (2) Anticoagulant heparin solution. Heparin sodium (U.S.P.) .....75,000 units Sodium chloride injection (U.S.P.) to make .....1,000 ml. Volume per 100 ml. blood .....6 ml. A buffer to maintain stability shall be added if necessary. (3) Anticoagulant citrate phosphate dextrose solution (CPD). Tri-sodium citrate (Na 3 c 6 H 5 O 7 2H 2 O) .....26.3 gm. Citric acid (C 6 H 8 O 7 H 2 O) .....3.27 gm. Dextrose (C 6 H 12 O 6 H 2 O) .....25.5 gm. Monobasic sodium phosphate (NaH 2 PO 4 H 2 O) .....2.22 gm. Water for injection (U.S.P.) to make .....1,000 ml. Volume per 100 ml. blood .....14 ml. (e) Donor identification. Each unit of blood shall be so marked or identified by number or other symbol as to relate it to the individual donor whose identity shall be established to the extent necessary for compliance with section 82-582. (f) Prevention of contamination of the blood. The skin of the donor at the site of phlebotomy shall be prepared thoroughly and carefully by a method that gives maximum assurance of a sterile container of blood. The blood shall be collected by aseptic methods in a sterile system which may be closed or may be vented if the vent protects the blood against contamination. (g) Pilot samples for laboratory tests. Pilot samples for laboratory tests shall meet the following standards: (1) One or more pilot samples shall be provided with each unit of blood when issued or reissued except as provided in section 82-580 and all pilot samples shall be from the donor who is the source of the unit of blood. (2) All samples for laboratory tests performed by the processor and all pilot samples accompanying a unit of blood shall be collected at the time of filling the final container by the person who collects the unit of blood. (3) All containers for all samples shall bear the donor's identification before collecting the samples. (4) All containers for pilot samples accompanying a unit of blood shall be attached to the whole blood container before blood collection, in a tamperproof manner that will conspicuously indicate removal and reattachment. (h) Phlebotomy for Heparinized whole blood (human). Heparinized whole blood (human) shall be collected with minimal damage to and minimal manipulation of the donor's tissue. (i) Storage. Immediately after collection, the blood shall be placed in storage within a two degree range between one degree and six degrees Celsius, unless it must be transported from the donor clinic to the processing laboratory. In the latter case the blood shall be placed in temporary storage having sufficient refrigeration capacity to cool the blood continuously toward a two degree range between one degree and six degrees Celsius until it arrives at the processing laboratory where it shall be stored within a two degree range between one degree and six degrees Celsius. (Code 1956, § 29-126)

New Orleans City Code § 82-584 Testing the blood.

Sec. 82-584. - Testing the blood. All laboratory tests shall be made on a pilot sample specimen of blood taken from the donor at the time of collecting the unit of blood, and these tests shall include the following: (1) Serological test for syphilis. Whole blood (human) shall be negative to a serological test for syphilis. Positive diagnosis of disease must be reported to the director and in accordance with the state sanitary code. (2) Determination of blood group. Each container of whole blood (human) shall be classified as to ABO blood group. At least two blood group tests shall be made and the unit shall not be issued until grouping tests by different methods or with different lots of antiserums are in agreement. Only those Anti-A and Anti-B Blood Grouping Serums licensed under, or that otherwise meet the requirements of the regulations of this article shall be used, and the technique used shall be that for which the serum is specifically designed to be effective. (3) Determination of the Rh factors. Each container of whole blood (human) shall be classified as to Rh type on the basis of tests done on the pilot sample. The label shall indicate the extent of typing and the results of all tests performed. If the test, using Anti-Rh o (Anti-D) Typing Serum, is positive, the container may be labeled "Rh Positive". If this test is negative, the results shall be confirmed by further testing which may include tests for the Rh o variant (D u ) and for other Rh-Hr factors. Blood may be labeled "Rh Negative" if negative to tests for the Rh o (D) and Rh o variant (D u ) factors. If the test using Anti-Rh o (Anti-D) Typing Serum is negative, but not tested for the Rh o variant (D u ), the label must indicate that this test was not done. Only Anti-Rh Typing Serums licensed under, or that otherwise meet the requirements of, the regulations of this article shall be used, and the technique used shall be that for which the serum is specifically designed to be effective. (4) Sterility test. Whole blood (human) intended for transfusion shall not be tested for sterility by a method that entails entering the final container before the blood is used for transfusion. (5) Inspection. Whole blood (human) shall be inspected visually during storage and immediately prior to issue. If the color or physical appearance is abnormal or there is any indication or suspicion of microbial contamination the unit of whole blood (human) shall not be issued for transfusion. (Code 1956, § 29-127)

New Orleans City Code § 82-585 Labeling.

Sec. 82-585. - Labeling. In addition to all other applicable labeling requirements, the following shall appear on the label of each container: (1) Anticoagulant. a. Name. The name of the anticoagulant immediately preceding and of no less prominence than the proper name, expressed as follows: 1. Either "ACD", or "acid citrate dextrose solution"; 2. Either "Heparinized" or "heparin solution"; 3. Either "CPD" or "citrate phosphate dextrose solution". b. Quantity. The quantity and kind of anticoagulant used and the volume of blood corresponding with the formula prescribed under section 82-583(d). (2) Serological test and test for hepatitis associated (Australia) antigen. Indication of the method used for serological test for syphilis and the test for hepatitis associated (Australia) antigen, and the results. (3) Blood group and type. Designation of blood group and Rh factors: a. The blood group and the Rh factors shall be designated conspicuously. b. If a color scheme for differentiating the ABO blood groups is used, the color used to designate each blood group on the container shall be: Blood Group A: Yellow. Blood Group B: Pink. Blood Group O: Blue. Blood Group AB: White. (4) Additional information for labels of Group "O" bloods. Each Group "O" blood shall be labeled with a statement indicating whether or not isoagglutinin titers or other tests to exclude so-called "dangerous" Group "O" bloods were performed, and indicating the classification based on such tests. (5) Issue prior to determination of test results. The label on each container of blood that is issued pursuant to the provisions of section 82-581 shall bear the following information and instructions in lieu of the information specified in subsections (2), (3), and (4) of this section. EMERGENCY SHIPMENT FOR USE ONLY BY (Name of physician, hospital or other medical facility.) CAUTION BEFORE TRANSFUSION (1) Do not use until test results received from (name of licensee). (2) Perform crossmatch. (Code 1956, § 29-128)

Source: City of New Orleans, Code of Ordinances and Home Rule Charter (Municode Library, library.municode.com)URL: https://library.municode.com/la/new_orleans/codes/code_of_ordinances?nodeId=PTIICO_CH82HESA_ARTXISTOPBLBAPLCE_DIV5WHBLHUFetched: 10/28/2026