Georgia Administrative Code

(1) In a format provided by the Department, each center shall complete and submit for approval a disaster preparedness plan that contains a set of procedures for responding to internal and external disasters or emergency situations. (2) The disaster preparedness plan shall identi…

(1) General. The adult day center shall be constructed, arranged, and maintained so as to provide adequately for the health, safety, access, and well-being of the participants. (a) Each center shall have a standard telephone, not a pay telephone or cellular telephone, on the prem…

(1) Each center shall supply soap at the sinks, toilet tissue at each commode, and single use towels or mechanical hand dryers in each bathroom. (2) Each center shall stock and maintain in a single location first aid supplies to treat minor burns, cuts, abrasions, and accidental …

(1) The scope of services provided or arranged by the center shall be based on the written description of the program. (a) Adult day centers may provide a social model adult day care program or a medical model adult day health care program, which are differentiated by the intensi…

(1) Core Requirements. Each adult day center shall have as many staff and/or volunteers on duty at all times as may be needed to properly safeguard the health, safety and welfare of the participants, as required by these regulations. At a minimum the following shall be observed: …

(1) All adult day centers shall maintain written personnel policies and procedures which address at least the following: (a) The hiring, training, and supervising of staff members; and (b) The use, nature and extent of volunteer services, including a screening procedure to select…

(1) Admission. Each adult day center shall admit individuals based on the center's comprehensive description of the types of services to be provided by the center and shall only admit individuals for whom the center can meet the participant's needs. (2) Prior to the provision of …

(1) Participant Records. An individual file for each participant shall be established and maintained at the adult day center and shall include the following: (a) The participant's full name, address, telephone number, date of birth, marital status, and living arrangement; (b) At …

(1) The following rights shall be guaranteed and cannot be waived by the participant or his or her representative: (a) The right to be treated as an adult, with respect and dignity; (b) The right to participate in a program of services and activities that promotes positive attitu…

(1) All adult day centers operating for more than four (4) hours a day and/or operating during regularly scheduled mealtimes shall ensure that a nutritious meal is provided to each participant in attendance. (2) Snacks and fluids shall be available and offered to meet the partici…

(1) All medications required by a participant in an adult day center that does not employ a licensed RN, LPN or proxy caregiver shall be self-administered by the participant. (2) Centers that provide assistance with medication without employing a licensed RN, LPN or proxy caregiv…

(1) The center may provide transportation and/or assist in arranging transportation services for participants. (2) When transportation is provided to participants through center-operated vehicles, the operation of each vehicle shall comply with all applicable state and federal re…

(1) In case of an accident or adverse change in a participant's condition or adjustment, the center shall immediately obtain needed care and notify the representative or emergency contact. (2) The center shall immediately investigate the cause of an accident or injury involving a…

(1) Immediate Transfer. In case of emergency, such as acute illness, if family or the participant's representative cannot be reached, a signed release shall be on file stating that the participant may be sent to the nearest hospital emergency room for treatment. (2) Discharge. Ea…

(1) Serious Incidents. All adult day centers shall maintain records and submit on a timely basis reports required by the Department. (2) On forms provided by the Department, no later than the next business day, the adult day center shall report whenever any of the following serio…

(1) Adult day centers shall develop and implement an annual quality improvement plan to evaluate and improve the effectiveness of the program's operation and services to ensure continuous improvement in service delivery. The plan shall include the parties to be involved and the a…

(1) Each adult day center shall develop and implement policies and procedures that address infection control issues in all components of the adult day center. These policies and procedures shall be based on accepted standards of infection control and shall address at least the fo…

(1) The Department is authorized and empowered to conduct complaint investigations and periodic on-site inspections of any center when determined necessary. (2) Prior to licensure and periodically thereafter, the Department shall inspect each adult day center to ensure that the c…

(1) A center may request a waiver or variance of a specific rule by application on forms provided by the Department. The Department may grant or deny the request for waiver or variance at its discretion. If the waiver or variance is granted, the Department may establish condition…

An adult day center that fails to comply with licensing requirements contained in these rules, the Rules and Regulations for the Use of Proxy Caregivers, Chapter 111-8-100 as applicable and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-…

In the event that any rule, sentence, clause, or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect…

The legal authority for this chapter is found in Chapters 2, 7 and 22 of Title 31 of the Official Code of Georgia Annotated.

The purpose of these rules is to implement the requirements of Chapter 22 of Title 31 of the Official Code of Georgia Annotated pertaining to the licensure of clinical laboratories and the qualifications and performances of laboratory personnel.

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning here in after respectively ascribed to them: (a) Analyte means a substance or constituent for which the laboratory conducts testing; (b) Board …

(1) Clinical Laboratory License. (a) No clinical laboratory shall be operated without a license issued pursuant to these rules and regulations and without a licensed director. All laboratory activities, which are not specifically exempted by these regulations, must be performed i…

(1) Each original application for licensure and each application for annual renewal for a clinical laboratory shall be accompanied by the non-refundable fee set by the Board. These fees as determined by the Board shall be applicable to a ll laboratories. Each screening and monito…

(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 fo…

(1) Applications for licensure of clinical laboratories shall be made on forms provided by the Department and shall indicate from the following list, those categories, subcategories and/or procedures for which the facility requests licensure: (a) Clinical Chemistry; 1. Routine; 2…

(1) General. All laboratories shall be well lighted, maintained in a clean, neat, orderly and professional manner, and operated in a manner which will prevent undue physical, chemical, or biological hazards to its employees or other members of the community, and shall meet local …

Each laboratory shall establish and follow written policies and procedures for a quality assurance program, comprehensive in scope and specific to that laboratory. The program shall monitor and evaluate the ongoing and overall quality of the total testing process from specimen co…

Chemical or biological solutions, reagents, and antiserum shall be tested and inspected as prescribed by the Department for reactivity and deterioration. Discs and systems used in antibiotic susceptibility testing are checked for deterioration and proper reactivity, using approve…

(1) Serologic and immunologic tests on unknown specimens shall be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels. Controls for all test components shall be e…

(1) The laboratory must verify (validate) that each method or testing system functions in the laboratory as specified by the manufacturer. Verification includes reportable range, accuracy, sensitivity and specificity. Verification studies must be done upon introduction of a new m…

Those clinical laboratories which provide for the collection, processing or storage of human blood and its components shall provide methods for the selection of blood and component donors as well as for the collection, storage, processing and transfusion of blood and its componen…

Instruments used in hematological examination of specimens shall be recalibrated, retested or reinspected, as appropriate, each day of use. Each procedure shall be recalibrated or rechecked each shift of use with standards or controls covering the entire range of expected values,…

(1) Exfoliative Cytology. (a) The laboratory must establish and document an annual evaluation of the number of cytology cases examined, the number of specimens processed by type, the number of cases reported by diagnosis, including the number of cases reported as unsatisfactory f…

Tissue banks which procure, store, or process human or animal tissue designed to be used for medical purposes in human beings shall conform to the procurement, storage and processing requirements listed in this section. The tissue bank must maintain donor and patient recipient re…

(1) Sperm Banks. Facilities collecting semen specimens shall comply with the following: (a) Sperm banks shall be staffed with personnel trained in the most current methods of cryobanking and who meet the personnel requirements of these rules. (b) Records must contain a donor rele…

(1) A laboratory supervisor or designated supervisory qualified staff must make monthly on-site visits to specimen collection stations. (2) Collection stations drawing specimens must have a written agreement with a designated person possessing medical emergency treatment skills t…

(1) Each laboratory performing cytogenetics procedures shall engage the services of a sufficient number of testing personnel who meet the requirements as noted in Rule . In addition, the laboratory must document the competency of testing personnel in the areas of collection, hand…

(1) Facilities performing only screening and monitoring tests shall establish a training program with written guidelines and must keep documentation of the training of those personnel designated for performance of specific tests. (2) Quality control procedures for screening and m…

(1) Mechanical refrigerators and freezers with recording thermometers must have an audible alarm that is monitored 24 hours a day. If liquid nitrogen is used for storage of frozen cells, the level of liquid nitrogen in the cell freezers must be monitored periodically. Sera and re…

(1) A standard, consisting of latex beads or other uniform particles, shall be run to insure proper focusing and alignment of all lenses in the path, and for both the existing light source and signal (light scatter, fluorescence, etc.) detectors. The results of optical focusing/ …

The Department shall conduct a clinical laboratory performance evaluation (proficiency testing) program with the following requirements: (a) All clinical laboratories shall enroll and successfully participate in a Department approved proficiency testing program. Point of Care tes…

(1) A licensed clinical laboratory shall examine human specimens only at the request of a licensed physician, dentist or other person authorized by law to use the findings of laboratory examinations. (2) All specimens accepted by a licensed laboratory shall be tested on the premi…

The results of a test performed by a licensed clinical laboratory shall be reported only to (or as directed by) a licensed physician, dentist, or other authorized person requesting the test. Such reports shall include the name of the director and the name and street address of th…

Records of all clinical laboratory services, including records of laboratory test requests and reports, shall be retained by the laboratory for as long as required by federal law and regulations, and: (a) For general laboratory records and quality control records, kept at least t…