Compilation of Rules and Regulations of the State of Georgia
Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH
Chapter 111-8 - HEALTHCARE FACILITY REGULATION
Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES
Rule 111-8-10-.28 - Plasmapheresis and Whole Blood Donor Centers

Universal Citation: GA Rules and Regs r 111-8-10-.28

Current through Rules and Regulations filed through September 23, 2024

Clinical laboratories, including independent plasmapheresis and whole blood donor centers, which provide a system for the collection, processing or storage of human blood and/or its components shall provide methods for the selection of donors as well as methods for the collection, storage, processing, and transfusion, which shall ensure that the donation will not be detrimental to the donor and also protect (as far as possible) the recipient of human blood or any of its components from infectious disease known to be transmissible by blood.

(a) Special Personnel Requirements. In addition to the general personnel requirements outlined elsewhere in these Rules and Regulations, the following special personnel requirements are established:

1. Requirements for Directors and/or Physicians:
(i) In a whole blood, plasmapheresis or other blood component donor center, the director shall meet at least the requirements of Rule 111-8-10-.06(2)(b)1.

(ii) In a whole blood, plasmapheresis or other blood component donor center, the director and any other physician employed must be licensed in the State of Georgia and comply with all provisions of the Georgia Laboratory Licensure Law and associated regulations, and with all applicable federal regulations, specifically those provisions regarding physician requirements. The director shall be responsible, at all times, for all phases of operation.

2. Requirements for Other Personnel:
(i) Donor Selection (Screening) Area. The donor screening area shall be staffed with trained personnel with no lesser qualification than that of Licensed practical Nurse (LPN), Clinical Laboratory Technician or an equivalent level of training or experience. Every screener must be trained to recognize abnormalities, (i.e., blood pressure, pulse, etc.). Careful evaluation must be conducted by a skilled interviewer (based on the outline for donor selection published by the American Association of Blood Banks) to eliminate most donor reactions. A Clinical Laboratory Technologist or a licensed Registered Nurse (RN) must be assigned responsibility for supervision of the screening area, including such procedures as total protein, hemoglobin and hematocrit testing performed there.

(ii) Blood Collection (Phlebotomy) Area.
(I) The supervisors in the phlebotomy area must be persons who have a minimum of three months training and experience in a plasmapheresis or blood donor center and who are qualified as either a Registered Nurse or a Clinical Laboratory Technologist, Licensed Practical Nurse, or a Certified Physician's Assistant. One person of such qualifications must be employed for one (1) to twelve (12) donors being processed at one time.

(II) The phlebotomists in the phlebotomy area must be persons who have a minimum of one month training in a plasmapheresis or blood donor center and who meet no lesser qualifications in phlebotomy and/or reinfusion than that of Licensed Practical Nurse (LPN), Clinical Laboratory Technician, or equivalent level of training and/or experience. A phlebotomist must be employed for one to six donors being processed on automated equipment, for manual processing there must be one phlebotomist for one to four donors being processed at a time, with a minimum of two phlebotomists in the phlebotomy area whenever any donors are processed. (The phlebotomy supervisors may also serve as phlebotomists).

(iii) Laboratory Testing Area. Personnel in the laboratory area of all whole blood, plasmapheresis or other blood component donor centers must meet qualifications required for any licensed clinical laboratory.

(iv) Other Personnel. Other personnel may be employed or used in the center, such as aides, clerks, volunteer workers, etc. These persons may assist technical staff, but shall not themselves perform technical laboratory duties.

(b) Proficiency Testing Requirements. Rule 111-8-10-.23 outlines proficiency testing requirements for hematology, immunohematology, syphilis serology, HIV testing and hepatitis testing. External proficiency testing is not required for blood, tissue and/or plasmapheresis donor screening procedures such as specific gravity, hematocrits, dipstick tests and serum proteins. This exemption from external proficiency testing does not, however, exempt such facilities from quality control requirements, inspection and licensure.

(c) Documentation of Reactions. The records system of the facility must maintain documentation of all reactions. Adequate reporting and recording forms must be available and used.

(d) Blood Labeling and Associated Records. In addition to labeling required as a part of good laboratory practices, it shall be the responsibility of the licensed laboratory director to comply with Chapter 24 of Title 31 of the Official Code of Georgia Annotated and Rules and Regulations for Blood Labeling, Chapter 111-8-9.

O.C.G.A. § 31-22-1et seq.

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