reglab/statecodes huggingface dataset:
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-.11 - Quality Control for Serology/Immunology

Current through Rules and Regulations filed through June 27, 2024
(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 employed to ensure reactivity and uniform dosage. Test results shall
				not be reported unless the redetermined pattern of the control is
				obtained.
(2) Each new lot of
				reagent shall be tested with one of known acceptable reactivity, or with known
				control sera before or concurrent with the new lot of reagent being placed into
				routine use.
(3) Equipment,
				glassware, reagents, controls and techniques for tests for syphilis shall
				conform to manufacturers' specifications, where applicable.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.12 - Quality Control for Clinical Chemistry

Current through Rules and Regulations filed through June 27, 2024
(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
				methodology; a laboratory may not report test results beyond or below its own
				established range.
(2) Calibration,
				or calibration verification must be performed:
(a) According to manufacturer specifications,
				or every six months, whichever is sooner;
(b) When a complete change of reagents
				(except where all reagents are packaged together) occurs;
(c) When major preventive maintenance or
				replacement of a critical part occurs;
(d) When controls begin to reflect an unusual
				trend or are consistently outside acceptable ranges; or
(e) At least every six months.
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-.13 - Quality Control for Immunohematology

Current through Rules and Regulations filed through June 27, 2024
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 components, and shall
				  ensure that the blood and component donation will not be detrimental to the
				  donor and also protect, as far as possible, the recipient of the human blood or
				  any of its components from infectious disease known to be transmissible by
				  blood. The methods used shall conform to the following:
(a)
Selection of donor:
1. On the day of donation, the donor shall be
				evaluated in order to protect the donor and the recipient of the donation. At a
				minimum, the following shall be used in the evaluation of the donor and records
				shall be retained.
2. The minimum
				age for donation is seventeen (17) years; the maximum age for a donor is left
				to the discretion of the director of the facility providing the donor is in
				good health.
3. Minimum weight for
				routine donation shall not be less than 110 lbs. (50 kg) with a maximum of 525
				ml. of blood removed per donation; individuals weighing less than 110 lb. (50
				kg) may donate relative to the volume collected; in this event, the volume of
				anticoagulant must be considered. Any recent unexplained weight loss (e.g.,
				more than 4.5 gk. or 10 lbs) should be evaluated by the donor's
				physician.
4. The volume of
				donation shall not exceed 545 ml in an eight week period; donation of whole
				blood must be deferred for at least 48 hours after apheresis.
5. The systolic blood pressure shall be no
				higher than 180mm of mercury, and the diastolic blood pressure must be no
				higher than 90 mm of mercury.
6.
				Pulse rate shall be between 50 and 100 beats per minute. Prospective donors
				with pathogenic cardiac irregularities must be deferred.
7. Donor hemogoblin or hematocrit must be
				determined prior to donation by a method acceptable to the Department; donors
				with a hemoglobin less than 12,5g/dL or a hematocrit less than 38% must not be
				considered for donation.
8.
				Prospective donors with chronic or acute illness must be evaluated by a
				physician prior to donation.
9.
				Routine donation must be deferred for six months after the conclusion of a
				pregnancy.
10. Prospective donors
				on therapeutic drugs must be evaluated by a physician prior to donation to
				protect the donor and the recipient.
11. The donor temperature (oral) shall not
				exceed 37.5 degrees C. (99.6 degrees F.).
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-.14 - Quality Control for Hematology

Current through Rules and Regulations filed through June 27, 2024
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, unless
				  required more frequently by the manufacturer or federal laboratory regulations.
				  Tests such as the hematocrit and one-stage prothrombin time test shall be run
				  in duplicate except as specified in published guidelines. Standard deviation,
				  coefficient of variation, or other statistical estimates of precision shall be
				  determined by the laboratory. All control materials used to satisfy the control
				  requirement must have documented established limits.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.16 - Quality Control for Tissue Banks

Current through Rules and Regulations filed through June 27, 2024
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 records and
				  communications. These records must be retained for not less than seven years
				  after the distribution of the tissue material. These records shall be evaluated
				  and reviewed by the director to ensure the suitability of the donated tissue
				  for its intended use. Records must include the following:
(a) Each step in collection, preparation,
				testing, storage and distribution of the tissue must be documented concurrent
				with the performance of each step.
(b) Records must be legible and indelible and
				must include dates of testing, testing results, interpretations, assigned
				expiration date, if applicable, and the identity of the person performing the
				work.
(c) Donor identification and
				documentation of the pathological and microbiological evaluation of the donor
				shall be recorded.
(d) Each tissue
				and any component must be given a generic designation and a unique
				identification number which shall be used as the lot number throughout the
				collection, processing, distribution and utilization processes.
(e) All records concerning donor history,
				tissue processing and any other details deemed necessary (within the bounds of
				medical-legal and donor confidentiality) shall be available to authorized
				personnel upon request.
1. An adverse reaction
				file must be maintained.
2. An
				accurate inventory of all tissues (unprocessed, processed, and distributed)
				must be maintained.
3. There must
				be verification of step by step procedures under which tissue is procured,
				processed, tested and stored. Final disposition of the transplanted tissue must
				be recorded.
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-.17 - Quality Control for Sperm Banks/Embryology and Assisted Reproductive Technology (ART)

Current through Rules and Regulations filed through June 27, 2024
(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 release and
				a complete history.
(c) Donor semen
				shall have specific identification codes for use during the freezing and
				storage processes. Codes shall in no way be linked to the donor or the
				recipient.
(d) Donor history shall
				include the following:
1. Interview;
2. Examination including personal, physical,
				sexual and genetic histories;
3.
				Examination of semen to ensure viability and motility, freedom from infection
				and/or foreign cells and freezing survival capabilities.
(e) Semen specimens shall be collected at the
				sperm bank and processing shall be initiated within one hour of collection.
				Test results and measurements shall be initiated within one hour of collection.
				Test results and measurements shall be documented concurrent with
				evaluation.
(f) An appropriate
				method of cryopreservation shall be chosen which ensures maximum viability and
				freedom from contamination. Documentation shall be available which validates
				the method chosen.
(g) Storage and
				handling instructions shall be made available to the requesting physician. Such
				instructions shall include handling and disposition of unused specimen. Donor
				semen shall not be refrozen or redistributed.
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-.18 - Quality Control for Specimen Collection Stations

Current through Rules and Regulations filed through June 27, 2024
(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 to be available/on call during all hours of specimen
				collection.
(3) Procedure manuals
				for specimen collection stations must include procedures for:
(a) Proper collection of specimen;
(b) Types of specimens collected;
(c) Storage and handling of
				specimens;
(d) Proper
				identification and labeling of specimens;
(e) Instructing facilities forwarding
				specimens to the collection station, including criteria for unsatisfactory
				specimens; and
(f) Forwarding
				reports to the appropriate physician when reports are returned to the
				collection station.
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-.21 - Quality Control for Histocompatibility

Current through Rules and Regulations filed through June 27, 2024
(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 reagents must be stored at an acceptable temperature range. Reagents,
				solutions, culture media, controls, calibrators or other materials must be
				labeled to indicate identity and when significant, titer, strength or
				concentration, recommended storage requirements, preparation and expiration
				date and other pertinent information. Reagents typing area (locally constructed
				trays) must indicate source, bleeding date, identification number and volume
				remaining.
(2) The laboratory must
				have available and follow written policies and procedures regarding specimen
				collection:
(a) Requisitions must include
				patient's first and last name or unique identifier, name and address of the
				authorized person who ordered the test, date and time of specimen collection
				and source of specimen.
(b) All
				specimens must be properly identified and easily retrievable. Blood samples
				must be labeled with the patient's first and last name or unique identifier,
				date of collection, and must be obtained in a manner which does not compromise
				aseptic techniques.
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-.23 - Evaluation

Current through Rules and Regulations filed through June 27, 2024
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 testing areas shall be enrolled or
				participate in approved proficiency testing programs subscribed to by the
				responsible laboratory. No proficiency testing agency will be
				Department-approved unless it meets current requirements found in Title
				42 U.S.C. Section
				263 a.
(b) In addition, the Department may require
				the clinical laboratory to analyze test samples submitted or authorized by the
				Department and to report on the results of such analysis.
(c) Laboratories shall enroll in one or more
				representative segments of approved proficiency testing programs, if available,
				based upon the categories, subcategories and/or procedures for which a license
				is issued, and shall have copies of the results sent to the Department.
				External proficiency testing is not required for blood, tissue, and/or
				plasmapheresis donor screening procedures.
(d) Proficiency testing must be conducted in
				the laboratory being evaluated, by regular employees of that laboratory and in
				the same manner as patient testing. If a laboratory is found to have
				intentionally sent proficiency testing samples to another laboratory for
				analysis prior to receiving results back from the testing agency, it shall have
				its license revoked for a minimum of one year or a period that is equal to or
				more stringent than current federal law and regulations and, shall be subject
				to other appropriate sanctions as provided for in Chapter 111-8-25 of the
				Georgia Rules and Regulations for General Licensing and Enforcement
				Requirements; all records of proficiency testing must be retained and available
				for inspection for a period of not less than two years.
(e) Proficiency testing performance standards
				must be consistent with current federal requirements unless the Department
				elects to require more stringent standards.
O.C.G.A. §§
										31-2-8 and
				  31-22-1
et
				  seq.
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-.24 - Specimens Examined

Current through Rules and Regulations filed through June 27, 2024
(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 premises, unless
				forwarded to another licensed clinical laboratory.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.25 - Reporting

Current through Rules and Regulations filed through June 27, 2024
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 the
				  clinical laboratory in which the test was performed. When a test is performed
				  in a reference laboratory, the director, name and address of the laboratory
				  performing the test must be clearly identified in the report.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.26 - Records

Current through Rules and Regulations filed through June 27, 2024
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 two (2) years,
(b) For records of immunohematology and
				cytology, kept at least five (5) years, and
(c) For records of surgical pathology, kept
				at least ten (10) years.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.27 - Reports to the Department

Current through Rules and Regulations filed through June 27, 2024
(1) Clinical laboratories shall report to the
				Department evidence of selected infectious diseases on forms provided by the
				Department.
(2) Clinical
				laboratories making such reports concerning infectious diseases shall not be
				held liable for having violated a trust or confidential relationship. The
				reports shall be deemed confidential and not subject to public
				inspection.
(3) Reports of Serious
				Incidents/Events. The laboratory shall report to the Department the following
				incidents:
(a) Fatal transfusion reactions or
				transfusion complications affecting the patients;
(b) Laboratory testing errors which have
				resulted in the death or serious injury to a patient or employee;
(c) Significant interruptions in service
				vital to the continued safe operation of the facility, such as the loss of
				electricity, gas or water services.
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

Current through Rules and Regulations filed through June 27, 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.
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-.29 - Exemption of Specific Screening and Monitoring Tests

Current through Rules and Regulations filed through June 27, 2024
A facility or part of a facility in which laboratory testing
				  is performed may apply and qualify for exemption from personnel requirements
				  for specific screening and monitoring tests or techniques, as approved and
				  published by the Board.
(a) The
				Department shall establish guidelines for the exempted screening and monitoring
				tests, which shall include adequate provisions for (1) personnel, (2) quality
				control, (3) reporting, (4) record keeping and (5) safety. The guidelines and
				list of tests or techniques will be periodically reviewed and published by the
				Department.
(b) Screening and
				monitoring approvals shall be issued by the Department and shall be valid for
				one year or a limited and specified time.
(c) Approvals, renewal of approvals or
				continuation of approvals are subject to continued conformance with the
				published guidelines, as determined by the Department. If approval is not
				granted, the laboratory testing is subject to clinical laboratory
				licensure.
O.C.G.A. §§
										31-2-7 and
				  31-22-1
et
				  seq.
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-.30 - Inspection and Plans of Correction

Current through Rules and Regulations filed through June 27, 2024
(1) Employees and agents of the Department
				shall have the right of entry into the premises of the laboratory during all
				hours of operation and full access to all records, reports and documents
				relevant to the licensure status of the laboratory as determined by the
				Department.
(2) Licensed
				laboratories shall submit to inspection by CMS or CMS agents as a condition of
				licensure, and failure to submit to such inspection shall constitute grounds
				for suspension or denial of the State license.
(3) A laboratory subject to CMS inspection is
				authorized and required by the Department to release to CMS or CMS agents all
				records and information required by CMS in the course of the
				inspection.
(4) The Department
				shall make periodic inspections of every clinical laboratory, at its
				discretion. The frequency of inspection shall take into consideration the
				compliance record of the laboratories, e.g., the laboratory personnel,
				proficiency testing performance, and the number or seriousness of deficiencies
				reported on or since the last on-site inspection.
(5) The director or the laboratory supervisor
				in charge of the laboratory in the director's absence shall be present during
				each inspection of the laboratory. In the case of hospital laboratories, the
				hospital administrator or the administrator's designee shall be available for
				interview at the opening and close of inspection.
(6) None of the inspections performed by the
				Department nor any reports generated by the Department shall relieve the
				licensee from its duty to maintain the safety of its equipment, the work place,
				or to ensure safe and accurate laboratory testing.
(7)
Plan of Correction.
If as a
				result of an inspection, violations of these licensing rules are identified;
				the laboratory will be given a written report of the inspection which
				identifies the rules violated. The laboratory shall submit to the Department a
				written plan of correction in response to the report of inspection, which
				states what the laboratory will do, and when, to correct each of the violations
				identified. The laboratory may offer an explanation or dispute the findings or
				violations in the written plan of correction, so long as an acceptable plan of
				correction is submitted within ten days of the facility's receipt of the
				written report of inspection. The laboratory shall comply with its plan of
				correction.
O.C.G.A. §
										31-22-1
et
				  seq.
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-.31 - Exemptions

Current through Rules and Regulations filed through June 27, 2024
These rules and regulations shall not apply to:
(a) Clinical laboratories operated by the
				Medical College of Georgia, the Emory University School of Medicine, Mercer
				University School of Medicine, Morehouse School of Medicine, or any other
				medical schools in Georgia, or the United States Government;
(b) Clinical laboratories operated and
				maintained exclusively for research and teaching purposes involving no patient
				or public health services;
(c)
				Clinical laboratories operated by duly licensed physicians exclusively in
				connection with the diagnosis and treatment of their own patients; or
(d) Pharmacists duly licensed in Georgia
				practicing in accordance with O.C.G.A. §
									26-4-4 as it pertains to the
				performing or capillary blood tests and the interpretation of the results of
				those tests as a means to screen for or monitor disease risk factors and
				facilitate patient education. The capillary blood tests allowed under this
				exemption shall be limited to those capillary blood tests available to and for
				use by the public without licensure of the user of the test.
O.C.G.A. §§
										26-4-4 and
				  31-22-9.
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-.32 - Variances and Waivers

Current through Rules and Regulations filed through June 27, 2024
The Department, upon application or petition, may grant
				  variances and waivers to these rules and regulations (after review and advice
				  of Laboratory Advisory Council) when it is shown that the rule and regulation
				  should not be applied as written, because strict application would cause undue
				  hardship and that adequate standards affording protection of health, safety and
				  care exist and will be met in lieu of the exact requirements, or that the
				  purpose of the rule is met through equivalent standards affording equivalent
				  protection of health, safety and care, or to allow experimentation or
				  demonstration of new and innovative approaches to delivery of services, where
				  the approach has the potential to improve service delivery and the intended
				  protections afforded by the rule are being met.
O.C.G.A. §
										31-2-7.
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-.33 - Enforcement

Current through Rules and Regulations filed through June 27, 2024
(1) The
				administration and enforcement of these rules and regulations shall be in
				accordance with Chapters 2, 5 and 22 of Title 31 of the Official Code of
				Georgia Annotated and Chapter 13 of Title 50 of the Official Code of Georgia
				Annotated and the Rules and Regulations General Licensing and Enforcement
				Requirements, Chapter 111-8-25.
(2)
				A Clinical Laboratory and/or Clinical Laboratory Director License may be
				denied, revoked, suspended, limited or renewal denied for:
(a) Making false statements of material
				information on an application for a license or any other documents required by
				the Department;
(b) Permitting
				unauthorized persons to perform technical procedures or to issue or sign
				reports;
(c) Demonstrating
				incompetence in the performance or reporting of clinical laboratory examination
				and procedures;
(d) Performing a
				test for or rendering a report to a person not authorized by law to receive
				such services;
(e) Referring a
				specimen for examination to a clinical laboratory in this state which has not
				been licensed or exempted under Chapter 22 of Title 31 of the Official Code of
				Georgia Annotated or, if not in this state, certified under all applicable
				federal law and associated rules and regulations;
(f) Making a report on clinical laboratory
				work actually performed in another clinical laboratory without designating the
				director and the name and address of the clinical laboratory in which the test
				was performed.
(g) Lending the use
				of the name of the licensed clinical laboratory or its personnel to an
				unlicensed clinical laboratory;
(h)
				Violating or aiding in the violation of any provision of Chapter 22 of Title 31
				of the Official Code of Georgia Annotated, or these rules and
				regulations;
(i) Violating any
				other provisions of law applicable to the proper operation of a clinical
				laboratory.
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-.34 - Severability

Current through Rules and Regulations filed through June 27, 2024
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
				  remaining rules or portions thereof and such remaining rules or portions
				  thereof shall remain in full force and effect, as if such rule or portions
				  thereof so determined, declared or adjudged invalid or unconstitutional were
				  not originally a part thereof.
O.C.G.A. §
										31-22-1
et
				  seq.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.01 - Legal Authority

Current through Rules and Regulations filed through June 27, 2024
These rules are adopted and published pursuant to the
				  Official Code of Georgia Annotated (O.C.G.A.) §
									31-7-350 et seq. (effective Oct. 1,
				  2019).
O.C.G.A.
				  §§
											31-2-5,
				  31-2-7,
				  31-7-360.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.02 - Title and Purpose

Current through Rules and Regulations filed through June 27, 2024
These rules, known as the Rules and Regulations for Criminal
				  Background Checks, establish the minimum standards for the Georgia Long-term
				  Care Background Check Program for conducting criminal background checks of
				  owners, applicants for employment, administrators, onsite managers, directors
				  and direct access employees at certain facilities.
O.C.G.A. §
											31-7-350 et
				  seq.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.03 - Definitions

Current through Rules and Regulations filed through June 27, 2024
In these rules, unless the context otherwise requires, the
				  terms set forth herein shall mean the following:
(1) "Abuse" means the willful infliction of
				injury, unreasonable confinement, intimidation, or punishment with resulting
				physical harm, pain, or mental anguish. Such term includes the deprivation by
				an individual of goods or services that are necessary to attain or maintain
				physical, mental, and psychosocial well-being. Such term includes verbal abuse,
				sexual abuse, physical abuse, and mental abuse, including abuse facilitated or
				enabled through the use of technology.
(2) "Conviction" means a finding or verdict
				of guilty or a plea of guilty regardless of whether an appeal of the conviction
				has been sought.
(3) "Crime" means
				commission of:
(a) Any of the following
				offenses:
1. A violation of O.C.G.A. §
											16-5-70;
2. A violation of O.C.G.A. §
											16-5-101;
3. A violation of O.C.G.A. §
											16-5-102;
4. A violation of O.C.G.A. §
											16-6-4;
5. A violation of O.C.G.A. §
											16-6-5;
6. A violation of O.C.G.A. §
											16-6-5.1; or
7. A violation of O.C.G.A. §
											30-5-8;
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.04 - Registry and Professional Licensing Board Checks

Current through Rules and Regulations filed through June 27, 2024
(1) Prior to a
				criminal background check required by these rules, the facility shall perform a
				registry check of the owner, administrator, onsite manager, director, and
				employees. If an individual has not resided in this state for at least two
				years, the facility shall conduct registry checks of each state in which the
				individual resided for the previous two years, as represented by such
				individual or as otherwise determined by the facility.
(2) If the subject of the criminal background
				check is a licensed healthcare professional or is required to hold a
				professional license as a qualification for the position, a query of available
				information maintained by the Georgia Composite Medical Board, the Secretary of
				State, or other applicable licensing boards shall be conducted prior to a
				criminal background check to determine that such individual has a professional
				license and is in good standing.
(3) If the individual appears on a registry
				or has a professional license that is not in good standing, the facility must
				comply with the Rule
				111-8-12-.06.
(4) Except as provided in subsection (c) of
				O.C.G.A. §
									31-7-359, nothing in these rules
				shall be construed to limit the responsibility or ability of a facility to
				screen owners, applicants for employment, administrators, onsite managers,
				directors or employees through additional methods.
O.C.G.A.
				  §§
											31-7-352,
				  31-7-354.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.05 - Records Check Application

Current through Rules and Regulations filed through June 27, 2024
(1) A records check application shall be
				required:
(a) For each owner, upon application
				for a new license;
(b) For each
				owner, upon application for a change of ownership;
(c) For each administrator, onsite manager or
				director of a facility, upon application for employment or prior to placement
				in the position;
(d) For each
				direct access employee, upon application for employment or prior to placement
				in the position; and
(e) For
				existing owners, administrators, onsite managers, directors and direct access
				employees, on or before January 1, 2021.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.06 - Employment Prohibition; Grace Period; Personnel Files; Notice

Current through Rules and Regulations filed through June 27, 2024
(1) Except for the
				Grace Period described in paragraph (3) below, an individual required to submit
				to a registry check and criminal background check shall not be employed by,
				contracted with, or allowed to work as an employee at a facility, or to serve
				as an administrator, onsite manager or director of the facility, if:
(a) The individual appears on a registry
				check;
(b) There is a substantiated
				finding of neglect, abuse, or misappropriation of property by a state or
				federal agency pursuant to an investigation conducted in accordance with
				42 U.S.C. Section
				1395i-3 or
				1396r as it existed on February 1,
				2018;
(c) The individual's
				professional license, if applicable, is not in good standing; or
(d) The facility receives notice from the
				department that the individual has been found to have an unsatisfactory
				determination as a result of a criminal background check.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.07 - Ownership Prohibition

Current through Rules and Regulations filed through June 27, 2024
When the department determines that an owner has an
				  unsatisfactory determination as a result of a criminal background check or has
				  appeared on a registry check, the department shall notify such owner of the
				  ineligible status for ownership and shall take the necessary steps to revoke
				  the facility's license or refuse to issue a license if an application is
				  pending.
O.C.G.A. §
											31-7-358.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.08 - Background Checks Initiated by the Department

Current through Rules and Regulations filed through June 27, 2024
The department may require a criminal background check on any
				  facility owner, administrator, onsite manager, director or employee during the
				  course of an abuse investigation involving such individual or if the department
				  receives information that such individual was arrested for a crime. In such
				  instances, the department shall require the owner or employee to furnish two
				  full sets of fingerprints which the department shall submit to GCIC together
				  with appropriate fees collected from the owner or employee.
O.C.G.A. §
											31-7-355.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.09 - Enforcement and Penalties

Current through Rules and Regulations filed through June 27, 2024
The department shall impose a civil monetary penalty fine in
				  the amount of the lesser of $10,000.00 or $500.00 for each day that a violation
				  of these rules occurs. The daily civil monetary penalty fine shall be imposed
				  only from the time the facility knew or should have known that it employed an
				  individual with a criminal record and until the date such individual's
				  employment is terminated.
O.C.G.A. §
											31-7-356.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.10 - Contested Results and Appeals

Current through Rules and Regulations filed through June 27, 2024
(1) An owner, applicant for employment,
				employee, administrator, onsite manager or director may:
(a) Obtain information concerning the
				accuracy of his or her criminal record, and the department shall refer such
				individual to the appropriate state or federal law enforcement agency that was
				involved in the arrest or conviction;
(b) Challenge the finding that he or she is
				the true subject of the results from a registry check, and the department shall
				refer such individual to the agency responsible for maintaining such registry;
				and
(c) Appeal his or her
				disqualifying unsatisfactory determination pursuant to O.C.G.A §
										31-7-358.
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 111-8-12 - RULES AND REGULATIONS FOR CRIMINAL BACKGROUND CHECKS › Rule 111-8-12-.11 - Severability

Current through Rules and Regulations filed through June 27, 2024
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
				  remaining rules or portions thereof. The remaining rules or portions thereof
				  shall remain in full force and effect as if such rule or portions thereof so
				  determined, declared or adjudicated invalid or unconstitutional were not
				  originally part of these rules.
O.C.G.A.
				  §§
											31-2-5,
				  31-2-7,
				  31-7-360.
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 111-8-13 - RULES AND REGULATIONS FOR THE GEORGIA CAREGIVER REGISTRY › Rule 111-8-13-.01 - Legal Authority

Current through Rules and Regulations filed through June 27, 2024
These rules are adopted and published pursuant to the
				  Official Code of Georgia Annotated §§
									31-7-380 et seq.
O.C.G.A. §§
											31-7-380 et
				  seq.
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 111-8-13 - RULES AND REGULATIONS FOR THE GEORGIA CAREGIVER REGISTRY › Rule 111-8-13-.02 - Title and Purpose

Current through Rules and Regulations filed through June 27, 2024
These rules, known as the Rules and Regulations for the
				  Georgia Caregiver Registry, establish the minimum standards for the Georgia
				  Caregiver Registry which allows employers who are family members or guardians
				  of elderly persons to conduct an employment eligibility determination for an
				  applicant or employee who will provide personal care services for the
				  employer's family members or wards.
O.C.G.A. §
											31-7-380.
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 111-8-13 - RULES AND REGULATIONS FOR THE GEORGIA CAREGIVER REGISTRY › Rule 111-8-13-.03 - Definitions

Current through Rules and Regulations filed through June 27, 2024
In these rules, unless the context otherwise requires, the
				  terms set forth herein shall mean the following:
(a) "Applicant" means an individual applying
				to provide personal care services to an elderly person in a residence or
				location not licensed by the Department.
(b) "Caregiver Registry" means the database
				established by the Department to provide private family employers with access
				to employee or applicant eligibility determinations.
(c) "Criminal Background Check" means a
				search of the criminal records maintained by the Georgia Crime Information
				Center (GCIC) and the Federal Bureau of Investigation to determine whether an
				applicant or employee has a criminal record.
(d) "Department" means the Department of
				Community Health.
(e) "Elderly
				Person" means an individual who is 65 years of age or older.
(f) "Employee" means any individual who is
				providing personal care services to an elderly person in a residence or
				location not licensed by the Department.
(g) "Employer" means an individual who is
				considering an applicant or has hired an employee for a family member or
				ward.
(h) "Family Member" means an
				individual with a close familial relationship, including, but not limited to, a
				spouse, parent, sibling, or grandparent.
(i) "Personal care services" means home care,
				health care, companionship, or transportation and includes, but is not limited
				to, providing assistance with bathing, eating, dressing, walking, shopping,
				fixing meals, and housework.
(j)
				"Records Check Application" means fingerprints in such form and of such quality
				as prescribed by GCIC under standards adopted by the FBI and a records search
				fee, payable in such form as the Department may direct to cover the cost of
				obtaining a criminal background check.
(k) "Registry Check" means a review of the
				nurse aide registry provided in O.C.G.A §
									31-2-14, the state sexual offender
				registry, and the List of Excluded Individuals and Entities as authorized in
				Sections 1128 and 1156 of the federal Social Security Act, as it existed on
				February 1, 2018, or other registry useful for the administration of these
				rules as specified by the Department.
(l) "Ward" means an elderly person for whom a
				guardian has been appointed pursuant to O.C.G.A. §
									29-1-1 et seq.
O.C.G.A
				  §§
											31-7-381,
				  31-7-386.