Ga. Comp. R. & Regs. R. 111-8-10-.06 - Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records

(1) Laboratory Personnel Requirements:

(a) General. The laboratory shall perform tests in only those categories, subcategories or procedures for which it is licensed and for which there is either a director, supervisor, or technologist having minimum qualifications as outlined for Clinical Laboratory Technologists in Rule 111-8-10-.06(4). (Special personnel requirements for donor screening and plasmapheresis and whole blood donor centers are outlined in Rule 111-8-10-.28). In addition, the following criteria shall be minimum personnel qualifications for the supervision of the categories and subcategories below:

1. Clinical Chemistry, Hematology, Immunohematology, Microbiology, Clinical Immunology and Serology: Supervisory requirements for these categories are those requirements for Clinical Laboratory Supervisor, outlined in Rule 111-8-10-.06(3).

2. Exfoliative Cytology. For the purpose of these rules, exfoliative cytology is defined as that part of laboratory science dealing with the examination of cells obtained from human body fluids, surfaces, tissues, and other sources. This service must be provided by either a licensed physician who is certified or eligible for certification in anatomic pathology or cytopathology by the American Board of Pathology or the American Osteopathic Board of Pathology or by applicants who have a doctoral degree and whose special field is cytology. Unless the physician/Ph.D. also serves as cytology general supervisor, the supervisor must meet the minimum qualifications outlined in Rule 111-8-10-.06(3)(b)5 or current federal regulations of § 353 of the Public Health Service Act and Title 42 U.S.C. 263 a, whichever is more stringent.

3. Anatomic Pathology. For the purpose of these rules, anatomic pathology is defined as the examination and diagnosis of human tissues whether removed during life or after death. It deals with the morphologic study of normal or abnormal structure of tissues. For the purpose of these rules, this definition includes performance of all autopsies including medical-legal, and forensic autopsies. The laboratory director, if not so qualified, shall engage the services of a licensed physician who is certified or eligible for certification in an anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

4. Oral Pathology. For the purpose of these rules, oral pathology is defined as a branch of anatomic pathology (see (a)3. above). The laboratory director, if not qualified in oral pathology, shall engage the services of a licensed physician who is certified or eligible for certification in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or those of a dentist, licensed in the State of Georgia, who is certified or eligible for certification by the American Board of Oral Pathology.

5. Radiobioassay. For the purposes of these rules, radiobioassay is defined as the diagnostic in vivo study involving administration of radioactive materials to a human subject (with the exclusion of organ scanning). Laboratories performing tests in radiobioassay must have a director or supervisor who is a physician working in Georgia in the field of radiobioassay at the time of the adoption of these rules and regulations or is qualified and trained in nuclear medicine or radioisotopic pathology and/or is certified or eligible for certification by the American Board of Nuclear Medicine or the subspecialty of radioisotopic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. If not so qualified, the laboratory must engage the services of one so qualified:

(i) In vitro studies of organs, tissues, or fluids, using radioactive materials are considered in the licensed category of Clinical Chemistry (special) and may be handled by those appropriately qualified in this area.

(ii) For both in vivo and in vitro studies, all users of radioactive material must comply with Georgia "Rules and Regulations for Radioactive Material", Chapter 290-5-23.

6. Qualifications for test areas not included in above general categories may be established as Department policy.

(b) Directors. Each licensed laboratory shall be under the direction of a licensed laboratory director whose responsibilities and qualifications are outlined in Rule 111-8-10-.06(2). The director may delegate Point of Care Testing oversight to qualified laboratory supervisors; however, such delegation must be in writing. In addition, delegation of authority does not relieve director of responsibilities as outlined in these regulations regarding Point of Care Testing.

(c) Supervisors. With the exception of a laboratory in which the director also qualifies and serves as supervisor, each laboratory shall have one or more supervisors who serve as assistants to the laboratory director and whose responsibilities are outlined in Rule 111-8-10-.06(3). Such personnel must spend an adequate amount of time in the laboratory to supervise the performance of the work in the laboratory and must be readily available at other times for on-site or telephone consultation.

(d) Technologists and Technicians. Each laboratory shall engage the services of a sufficient number of clinical laboratory technologists, and/or clinical laboratory technicians to meet the workload demands including prompt performance, reporting and record-keeping of test results, quality control and proficiency testing.

(e) Point of Care Technicians. Each point of care testing site subject to state licensure shall utilize medical professional staff, as defined in these rules to perform such testing.

(f) Specimen Collectors and Phlebotomists. A laboratory may employ specimen collectors and/or phlebotomists whose responsibilities are outlined in Rule 111-8-10-.06(7).

(g) Other Personnel. No person may perform laboratory tests within a licensed laboratory unless they qualify as a trainee, technician, technologist, supervisor, or director as defined in these rules. Other personnel may be employed in the laboratory such as aides, clerks, etc. These persons may assist the laboratory technical staff, but do not themselves qualify as technical staff, perform patient testing or operate clinical analyzers.

(h) Personnel Records:

1. Personnel records shall be kept current. They shall include a complete resume of each employee's training, experience, duties, competency evaluation and date or dates of employment. Personnel forms shall be submitted to the Department in a timely manner.

2. The laboratory is responsible for maintaining written documentation (in the personnel file of each employee performing testing) which demonstrates that the employee meets the personnel qualifications as set forth in these rules.

(2) Licensed Laboratory Directors.

(a) Responsibilities and general requirements:

1. Each licensed clinical laboratory shall be under the direction of a licensed laboratory director who is responsible for the operation of the laboratory at all times, who must spend an adequate amount of time in the laboratory to administer the technical and scientific operation of the laboratory, is responsible for the proper performance and reporting of laboratory findings, and is responsible for adequate staffing by qualified laboratory personnel, their in-service training and work assignment.

(i) There must be documentation completed by the laboratory director or supervisor, of competency to perform testing by an individual initially before patient testing is performed and not less than annually, thereafter, unless test methods or instruments change, in which case the director or supervisor is responsible for completing a new competency validation on the individual(s) before test results can be reported. Competency is to be measured against an established performance standard as defined by the laboratory director. Methods for validation of competency for each procedure must include:

(I) Direct observation of test performance through the testing of previously analyzed specimens and internal blind samples or external proficiency testing samples previously run and recorded. Testing samples may not be labeled as competency evaluation material, but must be treated as patient samples for routine processing;

(II) Review of test results from tests performed as a part of the competency assessment;

(III) Assessment of response to problems or situations related to the procedure;

(IV) Review of documentation of critical incidents related to the individual's performance of the procedure;

(V) Response to written or oral questions related to the procedures and, if applicable to the individual's responsibilities;

(VI) Assessment of the performance of calibration, and review of records pertaining to quality control and instrument maintenance.

(ii) The laboratory director may delegate the responsibility for competency assessment to other directors or supervisors in the laboratory meeting the qualifications described in 111-8-10-.06(2) and 111-8-10-.06(3).

(iii) The licensed laboratory director shall ensure that no individual performs any laboratory procedure independently without first having demonstrated competency for the procedure as described above in 111-8-10-.06(2)(a)1. (i).

(iv) When a director will be continuously absent for more than four weeks, arrangements must be made for a qualified substitute licensed director.

2. In addition to responsibilities outlined at 111-8-10-.06(8)(a) and (b) of these rules, the director is responsible for ensuring that all testing is instituted and conducted in a manner that complies with all applicable rules. The director, in consultation with appropriate medical staff, shall prepare an internal needs assessment for point of care testing which shall include evaluation of patient benefits and criteria for establishing the necessity of such testing. The assessment shall also include an evaluation of proposed methodologies for tests to be performed. The director is responsible for terminating testing in cases where there is consistent non-compliance with applicable rules or substandard performance.

3. There must be a written plan of action for how patient testing and reporting is handled when either laboratory or point of care testing fails. The director must ensure that, when recommended by the manufacturer, all screening tests performed must have confirmatory tests performed in a timely manner. The director must also ensure that the laboratory is enrolled and successfully participates in an approved proficiency testing program and that each Point of Care Testing area either enroll and successfully participate in an approved proficiency testing program or successfully participate in an approved program subscribed to by the responsible laboratory. Point of Care Testing methods, analyzers, or test areas must be challenged the number of times a year as is consistent with the requirement for clinical laboratories under state and/or current federal regulations. The director may delegate his or her authority, to assure that all applicable state regulations are met, to a supervisor that is qualified as defined in these rules and regulations.

4. Each licensed clinical laboratory must be served by a licensed clinical laboratory director, (permitted to direct no more than five clinical laboratories at a given time), on a full time or regular part-time basis. However, no licensed clinical director (Restricted) shall be permitted to direct more than one clinical laboratory at a given time.

(b) Qualifications:

1. Each licensed clinical laboratory in Georgia shall be directed by a licensed clinical laboratory director who qualifies under either (i), (ii), (iii), (iv), or (v) below, and whose practice is to be restricted according to the subparagraph under which he/she qualifies.

(i) Licensed Clinical Laboratory Director. A licensed clinical laboratory director must hold a license to practice medicine and surgery pursuant to Chapter 34 of Title 43 of the Official Code of Georgia Annotated, or a Georgia license to practice dentistry, or hold an earned doctoral degree in biology, microbiology, chemistry or related fields, and must either be certified or eligible for certification by one of the following:

(I) The American Board of Pathology or the American Board of Osteopathic Pathology in Clinical and/or Anatomic Pathology;

(II) The American Board of Oral Pathology;

(III) The American Board of Medical Microbiology;

(IV) The American Board of Clinical Chemistry;

(V) The American Board of Bioanalysists [Clinical Laboratory Director (CLD) and/or Bioanalyst Clinical Laboratory Director (BCLD)]; or

(VI) The American Board of Medical Laboratory Immunology; or

(VII) Qualified by other combinations of pertinent laboratory training and experience, in one or more of limited laboratory specialties, which are acceptable to the Department.

(ii) Licensed Clinical Laboratory Director (Restricted). In recognition that certain laboratories, due to varying circumstances, have difficulty providing a laboratory director qualified under the requirements above, the clinical laboratory director's license (restricted) is authorized for issuance to new applicants who are physicians or possess an earned doctoral degree and who are qualified as laboratory supervisors under Rule 111-8-10-.06(3)(b)1. or (b)2., and who meet the following requirements:

(I) The person will serve as director of only one laboratory at a given time;

(II) The served laboratory employs not more than ten full-time technical employees (supervisors, technologists, and technicians) or equivalent number of part-time technical employees; and

(III) The laboratory must also employ a qualified full-time or regular part-time clinical laboratory supervisor or pathologist.

(iii) Licensed Clinical Laboratory Director (Plasmapheresis and/or Whole Blood Donor Centers). The director of a plasmapheresis and/or whole blood donor center shall be a physician licensed in Georgia, who is qualified by training and/or experience in blood banking and/or plasmapheresis procedures and who shall be responsible for the medical, technical and clerical services, including special services such as phlebotomy for autologous transfusion, and special pheresis technique.

(iv) Licensed Clinical Laboratory Director (Specimen Collection Station). Each specimen collection station which is not a part of a parent clinical laboratory that is licensed by the State of Georgia must have a licensed clinical laboratory director. The director of a Specimen Collection Station shall be a person who is licensed to practice medicine in Georgia, or who holds an earned doctoral degree in biology, microbiology, chemistry or a related field and have pertinent clinical laboratory experience related to specimen collection.

(v) A person, who at the time of adoption of these regulations holds a current Georgia license as a clinical laboratory director, may renew the license and continue to function with same or similar duties and responsibilities upon application and payment of license fee. Persons who qualify under this provision but who are inactive for two (2) consecutive years must meet current requirements. Provided, further, that individuals and laboratories so concerned must meet all other standards of performance required by law and accompanying rules and regulations.

2. In addition to the directorship of the clinical laboratory, the director may participate in actual laboratory work only in those areas in which qualified by training and experience. For those categories in which the director is not qualified, a supervisor must be employed who is qualified in accordance with Rule 111-8-10-.06(3) to perform and/or supervise those procedures independently.

3. The person serving as a hospital laboratory director must be a member of the hospital medical staff.

(3) Laboratory Supervisor.

(a) Responsibilities and general requirements. With the exception of a laboratory in which the director also serves as supervisor, each laboratory must have an adequate number of qualified personnel who are assistants to the director, and who, under his/her general direction may function as supervisors, depending upon the size of the laboratory and diversity of the laboratory testing. A supervisor must be available for two-way communication within 30 minutes during all hours of operation, for the purpose of supervising technical personnel. For Point of Care Testing areas, the responsible supervisor must be qualified at a minimum under subparagraph (3)(b)4 of this rule. In addition, the supervisor of the testing area must be available for two-way communication within 30 minutes during all hours of operation. The supervisor is responsible for developing a quality control and quality assurance program for each test area that is equal to or more stringent than current federal and applicable state requirements. No Point of Care Testing area may be operated without a qualified supervisor.

(b) Qualifications. A supervisor shall meet one of the following minimum requirements:

1. Hold a license to practice medicine and surgery pursuant to Chapter 34 of Title 43 of the Official Code of Georgia Annotated and have at least two years of pertinent laboratory experience; or

2. Hold a doctoral degree from an accredited institution with a chemical, physical, or biological science as the major subject and have at least two years of pertinent laboratory experience; or

3. Hold a master's degree from an accredited institution with a major in one of the chemical, physical or biological sciences, allied health science or laboratory management, and have at least three years of pertinent laboratory experience as a technologist as outlined in Rule 111-8-10-.06(4)(b) of these rules and regulations; or

4. Qualify as a clinical laboratory technologist under Rules 111-8-10-.06(4)(b)1., 2., 3. or 4. and have at least four years of pertinent laboratory experience as a technologist as outlined in Rule 111-8-10-.06(4)(b); or

5. In the limited specialty laboratory or limited laboratory specialty(ies), the supervisor must meet one of the above conditions or, if restricted to the category or subcategory, must meet one of the following:

(i) Hold a master's degree with a major in a chemical, physical, or biological science, allied health science, or laboratory management; be a graduate of an accredited program in the specialty and have at least two years pertinent laboratory experience in the specialty as technologist; or

(ii) Hold a bachelor's degree in the specialty; or a degree with a major in chemical, physical, or biological sciences and be a graduate of a program in the specialty accredited by an agency accepted by the Department, or have one year of training in a clinical laboratory environment; and have at least three years of pertinent laboratory experience in the specialty as a technologist; or

(iii) Qualify as a technologist under Rule 111-8-10-.06(4)(b)6. (i) and have at least four years of pertinent laboratory experience in the specialty as a technologist.

(iv) A cytology supervisor must be a physician licensed to practice medicine in Georgia, and be certified in anatomic pathology by the American Board of Pathology, or the American Osteopathic Board of Pathology, and be licensed by the Department as a laboratory director.

(v) A cytotechnologist general supervisor must meet the requirements of Rule 111-8-10-4(b)6. (iii) and have 3 years full time experience as a cytotechnologist in a clinical laboratory.

(vi) A histocompatibility supervisor must be a pathologist who is board certified in anatomical and clinical pathology, a licensed physician or doctor of osteopathy with four years experience in histocompatibility, or a Ph.D. with two years general immunology and two years histocompatibility experience.

(vii) The histopathology supervisor must be a licensed physician or doctor of osteopathy, and be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, and licensed by the Department as a laboratory director.

(viii) The histotechnologist general supervisor must have formal training, be certified by an approved crediting agency and have two years of pertinent experience.

6. Persons who have been continuously engaged as laboratory supervisors in Georgia since July 1, 1970, are exempt from the personnel qualifications listed above. Persons who initially qualified under this provision and who become inactive for two (2) consecutive years for any reason must meet current requirements. Provided, further, individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(4) Technologist.

(a) Responsibilities and general requirements. Technologists, under general supervision, exercise independent judgment to perform and report findings proficiently for clinical laboratory tests. In the case of technologists who are qualified only in limited laboratory specialties, work as a technologist shall be limited to those respective specialties in which qualified.

(b) Qualifications. Each technologist shall successfully complete a certification examination from the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), the National Credentialing Agency for Laboratory Personnel (NCA), the American Association of Bioanalysts (AAB), or another agency approved by the Department, and shall meet one of the following requirements, listed in 1. through 7. below:

1. Successful completion of a full course of study which meets all academic requirements for a bachelor's degree in medical technology from an accredited college or university; or

2. Successful completion of three years of academic study (a minimum of 135 quarter hours or equivalent) in an accredited college or university and the successful completion of a course of training of at least 12 months in a school of medical technology accredited by an agency recognized by the Council for Higher Education Accreditation (CHEA) or the U.S. Department of Education; or

3. Successful completion in an accredited college or university of a course of study which meets all academic requirements for a bachelor's degree in one of the chemical, physical, or biological sciences, and have at least one year of pertinent laboratory experience or training accepted by the Department; or

4. Successful completion of 135 quarter hours in an accredited college or university, including 24 quarter hours of chemistry, 24 quarter hours of biology, and 5 quarter hours of mathematics, (thirty quarter hours of the total, with a minimum of fifteen in science, must be at the third or fourth year level), and have at least two years of pertinent laboratory experience; or

5. Successful completion of a full course of study which meets all academic requirements for an associate's degree in medical technology from an accredited college or university, or successful completion of two years of academic study (a minimum of 90 quarter hours or equivalent) in an accredited college or university which included at least 20 quarter hours of lecture and laboratory courses in chemical, physical, or biological sciences acceptable toward a major in science, with at least three years of pertinent laboratory experience; or graduation from high school and successful completion of a formal technician training course which is accredited by an accrediting agency accepted by the Department with at least four years of pertinent laboratory experience; or

6. In the limited specialty laboratory or limited laboratory specialty(ies), a technologist is restricted to the category or subcategory of testing authorized to be performed in the limited laboratory, and must have satisfactorily completed either:

(i) Ninety (90) quarter hours in an accredited college or university with at least 20 quarter hours in science and one year of pertinent laboratory experience or training accepted by the Department; or

(ii) At least two years of pertinent laboratory experience as a technician under the supervision of a director qualified in the specialty, or a one-year formal training program accepted by the Department in the specialty; or

(iii) Cytotechnologists must be certified by specialty examination by the American Society for Clinical Pathology (ASCP), or another agency approved by the Department; or

(iv) Histotechnologists must have formal training and specialty certification by the American Society for Clinical Pathology (ASCP) or another agency acceptable to the Department.

7. Persons who possess the technologist qualifications under provisions (b)1. through 6. above and have recently moved into the state or have recently completed the academic and training/experience requirements may be temporarily classified once as technologists for eighteen (18) months to afford the persons an opportunity to successfully complete an approved qualifying examination.

8. Persons who have been continuously engaged as technologists in Georgia since July 1, 1970, are exempt from the personnel qualifications listed above. Persons who initially qualified under this provision but become inactive for two consecutive years must meet current requirements. Provided further, that individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(c) Technologist allowable testing. Technologists shall be permitted to independently perform all laboratory procedures for which the technologist has been trained and demonstrated competency as described under 111-8-10-.06(2)(a)1. (i). Where the technologist chooses to delegate the performance of any test requiring more than limited skill and responsibility and exercise of independent judgment as described in 111-8-10-.06(5)(c):

1. The delegating technologist shall ensure that the individual to whom the testing has been delegated meets at a minimum the qualifications described in 111-8-10-.06(5)(b) and has documented competency for performance of the test as described in 111-8-10-.06(2)(a)1. (i);

2. The delegating technologist shall be responsible for the accuracy of the test results; and

3. The delegating technologist shall ensure that a qualified technologist is available onsite or by telephone for consultation regarding the testing or for review of results; and

4. In those cases where a qualified technologist is not available on site during the performance of the delegated test, but is only available on call, the performance of those tests shall only be delegated to an individual who has completed a technician-level certification test approved by the Department, has completed a full course of study which meets all academic requirements for an associate's degree in medical technology from an accredited college or university, and has completed a minimum of two years of pertinent full time laboratory experience, one year of which experience has been obtained in the laboratory where they will be performing the delegated test.

(5) Technician.

(a) Responsibilities and general requirements. The laboratory must employ a sufficient number of qualified technicians to meet the workload demands, and they must function under the direct supervision of a technologist, supervisor or director. The decision regarding the degree of supervision necessary shall be determined by consideration of the complexity of the procedure, the training and capability of the technician, and the demonstrated competency of the technician in the procedure to be performed. The determination of the degree of supervision under which the technician performs any type of laboratory testing must be documented in the technician's job description and personnel record. In the case of technicians who are qualified only in limited laboratory specialties, work as a technician shall be limited to those respective specialties in which qualified.

1. For any testing performed by a technician, there must be documentation in the technician's personnel record of training and competency testing of the technician to perform the test.

2. Documentation of the test and reporting of results must be retained, for the purpose of supervisory review, for all testing performed independently by a technician.

(b) Qualifications. Each technician shall successfully complete a certification examination from the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), the National Credentialing Agency for Laboratory Personnel (NCA), the American Association of Bioanalysts (ABB), or another agency approved by the Department and shall meet one of the following requirements listed in 1. through 4. below:

1. Has earned an associate's degree in medical laboratory technology; or successful completion of two years of academic study (a minimum of 90 quarter hours or equivalent) in an accredited college or university which included at least 20 quarter hours of lecture and laboratory courses in chemical, physical, or biological sciences acceptable toward a major in science and have at least one year of pertinent laboratory experience or training accepted by the Department; or

2. Graduation from high school and successful completion of a formal technician training course which is accredited by an accrediting agency accepted by the Department; or

3. Graduation from high school and subsequent to graduation has obtained two years of pertinent laboratory experience in a clinical laboratory of a hospital, a health department, university, or in an independent clinical laboratory; or

4. For persons who possess the technician qualifications under provisions above and have recently moved into the state or completed the academic and/or training requirements, they may be temporarily classified once as technicians for eighteen (18) months to afford them an opportunity to successfully complete an approved qualifying examination.

5. Persons who have been continuously engaged as technicians in Georgia since July 1, 1970 are exempt from personnel qualifications listed above. Persons who initially qualified under this provision but become inactive for two consecutive years for any reason must meet current requirements. Provided, further, individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(c) Technician allowable testing. Technicians shall be permitted to perform tests requiring limited skill and responsibility and a minimal exercise of independent judgment, and for which the technician has demonstrated competency as described in 111-8-10-.06(2)(a)1. (i), to include:

1. CLIA waived tests;

2. Complete blood count (CBC) utilizing automated/semi-automated methods with internal support systems;

3. Routine chemistries utilizing automated/semi-automated methods with internal support systems; and

4. Coagulation studies utilizing automated methods.

(6) Trainee. A trainee is a person who is enrolled in an accredited training program, or who, in a limited laboratory specialty(ies) for which there is no accredited training program, works and trains under the direct supervision of a qualified director, supervisor, or technologist qualified in the specialty(ies), but does not report actual patient test results without prior supervisory review. A person may function as a trainee for the duration of the formal approved training program or for a maximum period of 24 months.

(7) Specimen Collector and/or Phlebotomist. The laboratory may employ specimen collectors, qualified by training and/or experience approved by the laboratory director, to perform, under general supervision, collection procedures requiring understanding and skills in the procurement of specimens for clinical laboratory analysis. Documentation of qualifying training and/or experience must be available in the laboratory's personnel files. The collector may also perform exempt screening and monitoring tests as outlined in Rule 111-8-10-.16 of these regulations. Phlebotomists certified by the American Society for Clinical Pathologists (ASCP), the American Medical Technologists (AMT), the National Healthcareer Association (NHA), the National Center for Competency Testing (NCCT), the American Association of Bioanalysts (ABB), or another professional credentialing organization that has been approved by the Department, may perform Point of Care Testing in accordance with these rules.

(8) Point of Care Technician.

(a) Responsibilities and general requirements. Point of Care technicians must function under the supervision of a laboratory director and/or supervisor appointed by the director. These technicians must complete all training requirements as outlined in subparagraph (b) of this rule.

(b) Qualifications:

1. Professional background. Point of Care technicians must have one of the following medical professional backgrounds: licensed registered nurse, certified nurse practitioner, licensed practical nurse, certified respiratory care professional, physician assistant, perfusionist, certified paramedic or certified emergency medical technician, radiologic technologist, certified cardiovascular technologist certified by a professional credentialing organization approved by the Department, medical technologist and medical technician qualified by these rules, or a phlebotomist certified by a professional credentialing organization approved by the Department.

2. Training. The laboratory director is responsible for determining and maintaining documentation of an individual's credentials which qualify him or her to perform Point of Care Testing. The director may delegate this responsibility to a qualified supervisor. The documentation of qualifications to perform point of care testing must include the following: training, licensure, certification or other medical professional background information as well as competency certification documentation. In all cases, an individual must be trained and his or her competency verified prior to the director or supervisor allowing the individual to perform patient testing. Such training must include, at a minimum, proper specimen collection and handling, proper use of test instruments, proper storage, handling and preparation of test kits/reagents, quality control, quality assurance, remedial action and record keeping. Training must also include troubleshooting to the extent that results will not be reported when instrument or quality control problems arise.

(9) Other Personnel. Other personnel may be employed in the laboratory, such as aides, clerks, etc. These persons may assist laboratory technical staff in the performance of non-clinical tasks, but do not qualify as technical staff, perform technical tests or operate testing devices.

Notes

Ga. Comp. R. & Regs. R. 111-8-10-.06

O.C.G.A. § 31-22-1 et seq.

Original Rule entitled "Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013. Amended: F. Jan. 27, 2017; eff. Feb. 16, 2017.