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Subject 111-8-10 LICENSURE OF CLINICAL LABORATORIES
Rule 111-8-10-.01 Legal Authority
The legal authority for this chapter is found in Chapters 2, 7 and 22 of Title 31 of the Official Code of Georgia Annotated.
Rule 111-8-10-.02 Purpose
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.
Rule 111-8-10-.03 Definitions
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:
|Analyte means a substance or constituent for which the laboratory conducts testing;
|Board means the Board of Community Health of the State of Georgia;
|Clinical Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis of, recommendation of, treatment of, or for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings; the term "Clinical Laboratory" shall include specimen collection stations and blood banks which provide through their ownership or operation a system for the collection, processing, or storage of human blood and its component parts unless such human blood and its component parts are intended as source material for the manufacture of biological products and regulated by the Center for Biologics Evaluation and Research (CBER) within the federal Food and Drug Administration; the term "Clinical Laboratory" shall include tissue banks which procure, store, or process human or animal tissues designed to be used for medical purposes in human beings. The term 'clinical laboratory' shall not include laboratories which are nondiagnostic only and regulated pursuant to the federal Clinical Laboratory Improvement Amendments (CLIA) whose sole function is to perform examination of human blood or blood components intended as source material for the manufacture of biological products.
|CLIA-exempt state means a state where the Centers for Medicare & Medicaid Services (CMS) has determined that the state has enacted laws/rules relating to laboratory requirements that are equal to or more stringent than CLIA requirements. All laboratories subject to state licensure will be considered as "CLIA exempt" where the state has been determined to be CLIA exempt;
|Commissioner means the Commissioner of the Department of Community Health of the State of Georgia;
|Department means the Georgia Department of Community Health;
|Director means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures for testing and the reporting of results;
|Evaluation Program means a state-conducted or state-approved proficiency testing program;
|Facility means a building, structure, institution, place, or entity, which may be fixed or mobile;
|Laboratory Advisory Council means the Clinical Laboratory, Blood Bank and Tissue Bank Committee authorized and required by law and appointed by the Board;
|Laboratory Test means any examination and/or manipulation performed on a specimen produced by the human body, by procedures such as phlebotomy or blood diverted from a normal or life-sustaining circulatory path, or in vivo testing of body fluids for the purpose of diagnosis, treatment, monitoring or the assessment of the health of human beings;
|Limited specialty laboratory or limited laboratory specialty means a clinical laboratory, or part of a clinical laboratory, in which testing is restricted (limited) to a designated category or subcategory, including but not necessarily limited to the following examples: cytology, histology, tissue banking, special chemistries (radio bioassay, blood gases, toxicology, etc.), cytogenetics and histocompatibility;
|Other Personnel means non-technical personnel who may be employed in the laboratory such as aides, clerks, etc. These persons may assist laboratory technical staff, but do not themselves qualify as technical staff or perform tests;
|Person means any individual, firm, partnership, association, corporation, the State or any municipality or other subdivision thereof, or any other entity whether organized for profit or not;
|Pertinent Laboratory Experience means full time or equivalent work in a clinical laboratory, directing, supervising or performing tests in all categories, or, when limited to laboratory specialty(ies), work is restricted to that category/subcategory;
|Plan of Correction means a written plan submitted by the laboratory director, owner, or other controlling authority, for approval by the Department. The plan shall identify the existing noncompliance of the laboratory and the proposed procedures, methods, means and reasonable period of time needed to correct the noncompliance;
|Point of Care Technician means a medical professional person subject to these rules, who has received special training in point of care testing as defined by these rules. Medical professional staff authorized to perform point of care testing are limited to registered professional nurses, certified nurse practitioners, licensed practical nurses, certified respiratory care professionals, physician assistants, certified paramedics, certified emergency medical technicians, perfusionists, laboratory technologists, laboratory technicians and certified cardiovascular technologists, radiologic technologists certified by a professional credentialing organization approved by the Department, and phlebotomists, certified by a professional credentialing organization approved by the Department;
|Point of Care Testing means testing performed in the immediate proximity of the patient. All point of care testing must be approved by and under the supervision of a Georgia-licensed laboratory, unless the test site meets the requirements for exemption. All such point of care testing shall be approved only in the specialties for which the laboratory holds a license. Testing shall be limited to procedures which meet all current Georgia rules for quality control, quality assurance and Point of Care Testing personnel requirements. Point of Care Testing is exclusive of screening and monitoring tests;
|Quality Assurance means a comprehensive process used by the laboratory to prevent and control errors that may occur at any interval from the time a test is ordered until it is reported and charted;
|Quality Control Program means those quality control requirements established for clinical laboratories as provided in applicable federal law and regulations and in Georgia law and regulations;
|Screening and Monitoring Tests. Screening tests mean those simple laboratory tests, approved by the Board as screening tests, used to aid in the detection of previously undiagnosed conditions. Monitoring tests mean those simple laboratory tests, approved by the Board as monitoring tests, with performance characteristics (accuracy and precision) that allow the tests to be used for evaluation of the status of previously diagnosed conditions and/or for evaluation of response to medical management;
|Specimen Collection Station means a place or entity, without regard to location, that either collects specimens directly from patients or brings specimens together after collection for the purpose of forwarding them either intrastate or interstate to a licensed/certified clinical laboratory for examination;
|Specimen Collector and/or Phlebotomist means any person who has been trained in procedures requiring understanding and skills in the procurement of specimens for clinical laboratory analysis in Clinical Chemistry, Hematology, Immunohematology, Microbiology, and Immunology/Serology and who works under the general supervision of the laboratory director, supervisor or technologist;
|Supervisor means an assistant to the director and a person with special scientific skills, who, under the general supervision of a clinical laboratory director, supervises technical personnel;
|Technician means any person other than the clinical laboratory
director, supervisor, technologist, or trainee who functions under the
supervision of a clinical laboratory director, supervisor, or technologist and
performs only those clinical laboratory procedures which require limited skill
and responsibility and a minimal exercise of independent judgment as described
The degree of supervision by the clinical laboratory director, supervisor, or
technologist of a technician shall be determined by the director, supervisor,
or technologist based on:
|Technologist means a person who performs clinical laboratory procedures which require the exercise of independent judgment and responsibility, with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which they are qualified by education, training, experience, and certification.
|Trainee means 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 available, trains under the supervision of a director, supervisor, or technologist qualified in the specialty(ies), but does not report actual patient test results without prior supervisory approval.
Rule 111-8-10-.04 License
| Clinical
Laboratory License.
|Director's License.
Rule 111-8-10-.05 Fees
|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 monitoring approval shall pay a non-refundable processing and inspection fee as set by the Board.
|A non-refundable fee set by the Board shall accompany each application and renewal for licensure as a clinical laboratory director. Each license or renewal shall be valid for two years, unless suspended or revoked, or voluntarily terminated.
|Changes in fees and/or development of additional fee schedules may be established by the Board, without formal change in the rules and regulations.
Rule 111-8-10-.06 Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records
|Laboratory Personnel
|Licensed Laboratory
|Laboratory Supervisor.
|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.
|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.
|Point of Care Technician.
|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.
Rule 111-8-10-.07 Application
| 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:
|If a facility provides any laboratory testing services it must apply for and obtain one or more appropriate laboratory licenses (or screening and monitoring approvals) as needed to cover all laboratory services provided and must meet all requirements of these regulations. Where testing beyond the scope of authorized laboratory services is performed, these additional tests must be obtained from a duly licensed laboratory that meets all requirements of these regulations or from an out-of-state laboratory holding a current federal certificate for laboratory testing.
|The application for licensure in the category of specimen collection station shall be made on forms provided by the Department, and shall indicate the name and address of the laboratory or laboratories to which specimens are submitted for testing.
|Application for screening and monitoring approvals shall be made on forms provided by the Department and shall provide pertinent information as deemed necessary by the Department.
Rule 111-8-10-.08 Sanitation and Safety
|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 and state sanitation and safety regulations:
|Sanitary Facilities. All laboratories shall have suitable sanitary facilities, including toilet and hand washing facilities, within the premises. New installations and major renovations completed after the effective date of these rules shall include hand washing and toilet facilities for visitors and patients, separate from those provided for employees.
|Garbage and Rubbish Disposal. All laboratories shall provide facilities for maintaining sanitary standards, including water supply, sewage, garbage and refuse disposal, throughout the laboratory structure and premises. Such facilities shall meet local and state regulations, and shall be maintained in a clean and orderly manner. Cultures and specimens shall be discarded in an appropriate manner.
|Safety. Laboratory locations and facilities must conform to local
and state building and safety and fire codes and ordinances where applicable.
There shall be sufficient space, equipment and facilities to perform the
services provided by the laboratory with reasonable accuracy and safety:
Rule 111-8-10-.09 General Quality Control Requirements
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 collection to reporting of test results. The program shall identify and correct problems, assure the accurate, reliable and prompt reporting of test results and assure adequacy and competency of laboratory staff. Written procedures shall be revised when evaluation results indicate the need. There must be documentation of the ongoing quality assurance program as well as corrective action taken when necessary. The laboratory director is responsible for ensuring that the following quality controls are employed for all clinical testing authorized under the laboratory's license:
|Preventive maintenance, periodic inspection or testing for proper operation of equipment and instruments, based on but not limited to manufacturers' instructions. The laboratory must confirm the effectiveness of its preventive maintenance program;
|Each quantitative method shall be validated prior to placing into routine use. Such validation shall include reportable range, sensitivity, specificity, accuracy and precision. Documentation of validation shall be maintained for the period the method is used, or for at least two years, whichever is longer;
|Evaluation of reagents and volumetric equipment;
|Maintenance of documentation verifying that test systems perform according to laboratory specification; such documentation must be available to the authorized persons ordering or receiving test results, and to the Department; the laboratory must establish its reference range for each method before reporting patient test results;
|Establishment and employment of policies/procedures for remedial action to be taken in response to quality control outside acceptable limits, equipment or methodology performance outside established operating limits, test results outside acceptable limits, tests not performed within laboratory established time frames, proficiency test results outside acceptable limits or errors detected in reported patient results;
|Adequacy of space, ventilation, facilities, equipment, instruments, and methods of performance of the procedures or categories of procedures for which a license application is filed or granted; proper lighting for accuracy and precision; convenient location of essential utilities; monitoring of temperature controlled spaces and equipment to assure proper performance of equipment and storage of specimens, tissues, reagents and supplies; the evaluation of analytical measuring devices, with respect to all critical operating characteristics, and the laboratory shall not report test results unless such operating characteristics are within defined acceptable ranges;
|Labeling of all reagents and solutions to indicate identity, and when significant, titer, strength or concentration, recommended storage and preparation or expiration date, and other pertinent information. Material of substandard reactivity, expired, or deteriorated materials may not be used;
|Availability at all times, in the immediate bench area of personnel engaged in examining specimens and performing related procedures within a category, of laboratory manuals or other complete written descriptions and instructions (properly designated and dated to reflect an initial and periodic review by the current director) relating to the current analytical methods, specimen processing procedures, reagents, control and calibration procedures, microscopic examinations, remedial action procedures, limitations in methodologies, pertinent literature references and the date each procedure was placed into use. Textbooks may be used as supplements to such written descriptions but may not be used in lieu thereof;
|Written approval by the director of any and all changes in laboratory procedures; a copy of each procedure must be retained for two years after the procedure has been discontinued;
|Maintenance and availability to laboratory personnel, and to the Department, of records, reflecting dates, and where appropriate, the nature of inspection, validation, remedial action, monitoring, evaluation, and alternative test methods;
|Written materials designed to provide instruction for proper collection, labeling, preservation and transportation of specimens to assure accurate results suitable for clinical interpretation.
Rule 111-8-10-.10 Quality Control for Microbiology
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 approved reference organisms.
|Bacteriology, Mycobacteriology and Mycology. Staining material shall be tested for intended reactivity by weekly application to smears of microorganisms with predictable staining characteristics, with the exception of fluorochrome acid fast stains, which must be checked each day of use. Each batch of media shall be tested before or concurrently with use with selected organisms to confirm required growth characteristics selectivity, enrichment, and biochemical response. The laboratory may use commercial manufacturers' quality control checks of media if the laboratory has documentation to verify that the manufacturer meets the National Committee for Clinical Laboratory Standards (NCCLS) requirements for media quality control. Each day of use the laboratory must test direct antigen detection systems using positive and negative control organisms that evaluate both the extraction and reaction phases.
|Parasitology. A reference collection of slides, photographs, or gross specimens of identified parasites shall be available in the laboratory for the appropriate comparison with diagnostic specimens. A calibrated ocular micrometer shall be used for determining the size of ova and parasites, if size is a critical factor. Staining material shall be tested for intended reactivity, using a fecal sample control that will demonstrate staining characteristics, whenever a new lot number of reagent is opened or once a month, whichever comes first;
Rule 111-8-10-.11 Quality Control for Serology/Immunology
|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.
|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.
|Equipment, glassware, reagents, controls and techniques for tests for syphilis shall conform to manufacturers' specifications, where applicable.
Rule 111-8-10-.12 Quality Control for Clinical Chemistry
|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.
| Calibration,
or calibration verification must be performed:
|Each quantitative assay procedure shall be rechecked at least once each day of testing (24-hour period) except for blood gases, which must be rechecked each shift (see (7) below); rechecks must be conducted using two levels of calibrators, controls, standards, or a combination of these materials.
|Limits for standards and reference samples shall be recorded and shall include the course of action to be instituted when the results are outside the acceptable limits for each lot number of controls. Manufacturer's limits may be used only if they are verified by the laboratory.
|For urinalysis, the laboratory shall use a positive control each day of patient testing, which checks the reactivity of each constituent for which qualitative tests are reported.
|Counting equipment used for in vitro radioassay determination shall be checked for stability at least once each day of use with radioactive standards or reference sources. Records which document the routine precision of each method, automated or manual, and its recalibration scheduled, shall be maintained. At least one standard and one reference sample (control) shall be included with each run (ad defined by guidelines) of unknown specimens.
|For blood gas analysis, a two point calibration must be performed and documented each shift; a third point verification must be run using a separate material from that used in the two point check; for blood gas analyzers which include other chemistries (electrolytes, glucose, bun, etc.) the quality control requirements are outlined under Rule 111-8-10-.09 and .09(5).
|For co-oximetry, preventive maintenance shall follow manufacturer's guide lines except where regulations are more stringent; a hemoglobin control shall be performed each day of testing. The calibration of the instrument shall be checked weekly unless required more frequently by the manufacturer.
|Drug screens for medical purposes must contain a standard which contains all drugs to be identified by the method used, or for which the laboratory reports, per each plate or run. The control must go through all phases of testing including extraction, unless technology that is more current has been approved by the Department. Positive qualitative tests must be confirmed by a quantitative method, if required or recommended by the manufacturer.
Rule 111-8-10-.13 Quality Control for Immunohematology
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:
|Selection of donor:
|Donor deferral:
|Donor Information. Potential donors must be informed and sign a consent form. This information/form must contain, at least, information relative to the potential danger of donation, the significance of blood-borne pathogens, and post-phlebotomy care. The donor must be given the opportunity to confidentially request that his/ her donation not be used for transfusion. A physician associated with the collecting facility must establish a means to notify donors of any significant abnormality detected during predonation evaluation or laboratory test results.
|Autologous donor blood. If a
donation is only for autologous purposes, the donor requirements may be
reduced, however, no donation shall be collected for an individual with a
systemic infection. The unit must be labeled "autologous use only". Autologous
units must be stored under the same requirements as banked blood. However, the
autologous units must be segregated from the regular banked blood and blood
components. The facility must be licensed by the FDA for the collection and
storage of autologous donations.
|Reagent quality control. All reagents must conform to FDA
regulations and manufacturer's instructions must be followed.
|Transfusion services. It is the responsibility of the laboratory director to assure that the needs of the physicians responsible for the diagnosis, management, and treatment of patients are met in reference to blood, blood components, blood products and blood bank testing services.
|Preparation of blood components.
The process of component preparation must be sterile and a closed system
is preferred.
|Testing of donor blood. Prior to transfusion, the testing
laboratory must perform, at a minimum, the following tests on donor blood:
labeling. The label on a unit of blood or blood component must identify
the original unit and any component, or component modification; the label must
be clear, eye-readable, and may be machine readable; handwritten labels must be
legible and in permanent ink; prior to labeling, a review to reveal units not
to be issued shall be completed; the labeling process must include a second
check to determine if an error has occurred in the labeling; this check must
verify ABO, expiration date, and other appropriate labels on the unit as well
as components. An appropriate label must be affixed, should modification be
made to the component.
Refrigerators in which blood and blood components are stored must
provide a uniform temperature. Blood and blood components must be stored within
an acceptable temperature range.
|Expiration of blood and blood components. Provided that FDA approved collection methods, solutions, labeling practices, storage, transportation and equipment are used, the expiration date that appears on the label must be followed under ordinary situations. In order to consider this the expiration date, the closed system under which the unit was collected must not have been compromised; dating periods must follow FDA regulations ( 21 CFR 610.5B ).
At a minimum, the following policies and procedures must be available
and followed when blood or a blood component is to be returned to the donor in
a timely manner to assure that only the donor's blood or blood component is re
infused to the donor:
|Plasmapheresis. The donor criteria for an occasional (not to
exceed one donation in a four-week period) donation shall be the same as those
for a whole blood donor.
|Compatibility Testing.
Requests for transfusion and samples from the recipient must contain
sufficient information for positive identification of the recipient; the
facility must establish policies to determine minimum criteria for recipient
identification; these policies and procedures must contain provisions for
emergency situations; the minimum acceptable information must be the patient's
name (first and last) and an identification number, if not addressed in the
emergency policy; any discrepancy must be resolved prior to testing. The
facility must do the following as appropriate:
|Selection of blood and blood components for transfusion:
|Issuance and transfusion of blood
and blood components. At the time of release for transfusion, the donor
unit must be labeled as specified in the facility's policy. The information
must include, at a minimum, the recipient's name (first and last),
identification number, donor unit number, and compatibility test
interpretation, if performed. There must be a mechanism to identify the
intended recipient and requested blood component at the time of issue. The
transfusion record for each unit of blood, blood component or pooled component
must contain the intended recipient's name, identification number, ABO group,
and if required, the Rh type, the interpretation of the compatibility tests, if
performed, and the date of transfusion. Following the transfusion, the record
must be made part of the patient's medical record. A sealed specimen from the
recipient and the donor must be maintained at 1- 6ºC for a period of seven
days post transfusion.
|Transfusion complications. The facility must establish policies and procedures to assure that any transfusion complication is investigated. These policies and procedures must have a mechanism to detect errors in reporting, and evaluation of suspected complications of transfusion. All such investigations must be evaluated with a written interpretation by the laboratory director. The collection facility must be notified, if the complication appears to be attributed to the donor or the processing of the unit. Fatal transfusion reactions must be reported to the FDA, the collecting facility, and the Department.
Rule 111-8-10-.14 Quality Control for Hematology
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.
Rule 111-8-10-.15 Quality Control for Exfoliative Cytology; Histopathology; and oral Pathology
|Exfoliative Cytology.
|Histopathology and Oral Pathology. Special stains on tissue sections must be checked for intended reactivity by use of positive preparations, and results of reactions must be documented. Stained slides and tissue blocks shall be retained as long as required by applicable federal law and regulations, but not less than ten years for slides or two years for tissue blocks. Remnants of tissue specimens shall be retained in a fixative solution until those portions submitted for microscopy have been examined and a diagnosis made by a pathologist.
Rule 111-8-10-.16 Quality Control for Tissue Banks
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:
|Each step in collection, preparation, testing, storage and distribution of the tissue must be documented concurrent with the performance of each step.
|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.
|Donor identification and documentation of the pathological and microbiological evaluation of the donor shall be recorded.
|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.
| 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.
|Air drains, surfaces and water faucets shall include periodic sampling to ensure the tissue bank environment is maintained.
|The tissue bank shall have a system to prevent unauthorized entry either by physical configuration and/or an adequate security system.
|Procedures for recruiting donors shall be established and approved by appropriate officials.
|Permission to obtain tissues from living or non-living donors shall be documented through informed consent. Tissue banks must comply with Georgia Rules and Regulations for Anatomical Gifts, Chapter 111-8-5, as may be applicable.
|Tissues shall be processed by procedures which are appropriate for the type of tissue and the manner in which it is retrieved. Processing shall not change the physical properties of the tissues.
|Tissue preservation and types of storage containers shall ensure that the biological and biochemical properties are retained.
| Tissues shall be sent only to licensed
and approved facilities that have accepted responsibility for proper handling
and use. There shall be an agreement for notifications of the tissue bank if
tissues are received in defective packaging, have been removed from sterile
containers but not used, or have been lost. The following criteria for
distribution must be met:
| Records must be retained
indefinitely to permit tracing of any tissue from the donor to all recipients
or other final dispositions. Records must include the following:
|Storage temperature records must be retained for five years.
Container labels must include:
| Package labels must include:
|Final container shall be packaged in a manner that ensures the integrity and sterility of the contents.
|A product insert must accompany all tissues.
|There shall be written procedures for tissue recall and notification of recipient centers of possible tissue contamination, errors detected in the processing, preparation or distribution process or other factors which may render the tissue unsuitable for its intended application.
|Standard nomenclature and units of measure shall be used to describe tissues and the processing they have undergone.
Rule 111-8-10-.17 Quality Control for Sperm Banks/Embryology and Assisted Reproductive
Banks. Facilities collecting semen specimens shall comply with the
|Assisted Reproductive Technology
(ART). Facilities providing ART shall comply with the following:
Rule 111-8-10-.18 Quality Control for Specimen Collection Stations
|A laboratory supervisor or designated supervisory qualified staff must make monthly on-site visits to specimen collection stations.
|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.
| Procedure manuals for specimen collection
stations must include procedures for:
| Accession records for specimen
collection stations shall indicate the following:
Rule 111-8-10-.19 Quality Control for Cytogenetics
|Each laboratory performing cytogenetics procedures shall engage the services of a sufficient number of testing personnel who meet the requirements as noted in Rule 111-8-10-.06. In addition, the laboratory must document the competency of testing personnel in the areas of collection, handling, preparation and processing of various specimens, appropriate culture techniques for specimens submitted, proper techniques for setting up cell cultures and harvesting specimens, proper techniques of chromosome banding and staining, maintenance and use of microscopes, photographic and computer-generated imaging techniques and equipment, chromosome analysis including knowledge of normal and abnormal morphology, general laboratory skills, quality control, and understanding of general principles of genetics.
| Each
cytogenetics laboratory must comply, at a minimum, with ma nfacturers'
instructions except where applicable regulations are more stringent, when using
reagents and equipment and must document all quality control activities.
|The laboratory must maintain records that indicate the media used, reactions observed, number of chromosomes counted for each metaphase spread, quality of banding, and resolution to support the final results and number of karyotypes for each individual. Records must also be maintained of confirmatory testing on all atypical results, of at least two cells karotyped for each use, and two cultures for each specimen type.
|The laboratory must establish guidelines, based on appropriate standards for setting time limits on signing out final reports. Preliminary reports must be submitted within a reasonable length of time as established by the laboratory. Laboratory reports must include type of banding used, number of cells counted and analyzed microscopically, number of cells from which photographic or computerized karotypes were prepared, band resolution, preliminary report results, a narrative report of clinical pathology interpretation of the laboratory findings, diagnosis and identification of testing personnel. The current International System of Human Cytogenetic Nomenclature (ISCN) or other standard nomenclature recognized industrywide, must be used correctly in the final report. The results of tests performed must be reviewed and signed out by the director.
Rule 111-8-10-.20 Quality Control for Screening and Monitoring Tests
|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.
|Quality control procedures for screening and monitoring tests shall be performed for each test, if available. Controls and control frequency shall be according to published guidelines. Only tests approved by the Department may be performed; a list of approved tests shall be available from the Department. Proficiency testing is required for all tests, where such is available and graded.
|Results of exempt screening and monitoring tests, including all quality control records, shall be maintained separate from the patient's medical record for two years. The records must include the test date, time, patient's first and last name or unique identifier, test site, control/calibration results, lot numbers of reagents/controls, and identification of testing personnel.
|Reports of test results provided to non-physicians shall contain a statement which recommends that the results of the test be reviewed by a physician or that medical advice be obtained.
|The results of the tests shall be clearly identified as being performed by a nonlicensed facility and shall be displayed in a manner which will clearly differentiate them from results of a licensed laboratory.
|Screening test results which indicate abnormal conditions shall be noted with a recommendation that the abnormal results be confirmed by a definitive laboratory test performed in a licensed laboratory.
|Safety instruction using CDC's universal precaution guide lines for handling blood and instructions for packaging, labeling and disposal of potentially infectious waste materials and sharps, must be available to and practiced by the facility personnel.
| Each facility,
performing whole blood cholesterol, HDL or other approved screening procedures,
shall establish a training program with written guidelines and retain
documentation of the training of those personnel designated for performing
these procedures. The training shall include all areas of the testing process
including the use of the instrument.
Rule 111-8-10-.21 Quality Control for Histocompatibility
|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.
| The laboratory must
have available and follow written policies and procedures regarding specimen
The laboratory must maintain a system to ensure reliable specimen
identification and document each step in the processing and testing of patient
specimens. If "chain of custody" is a requirement, the laboratory must maintain
records of the "chain of custody" of the sample, the phlebotomist who collected
the sample, documentation to identify each specimen, and a signature to verify
information submitted.
| Records of the results for each
individual must be maintained for a minimum of two (2) years. In addition, the
laboratory must participate in at least one national or regional cell exchange
program, if available, or develop an exchange system with another licensed/
certified laboratory in order to validate interlaboratory reproducibility.
| Renal and Bone Marrow
Transplantation. The laboratory must have established policies for selecting
appropriate patient samples for crossmatching, preparing donor lymphocytes for
crossmatching, and reporting crossmatch results; having available results of
final crossmatches before an organ or tissue is transplanted, documenting
efforts to obtain specimens for all potential transplant recipients at initial
typing, for periodic screening, for pre-transplantation crossmatch and
following sensitizing events such as transfusion and transplant loss. If
transplantation is deferred, a new serum sample must be obtained from the
patient at monthly intervals, screened for antibodies and stored in the frozen
state for possible use in crossmatch tests. Serum used for crossmatching must
be tested undiluted and with one or more dilutions. Crossmatching must use
techniques documented to have increased sensitivity in comparison with the
basic microlymphocytotoxicity test such as prolonged incubation, washing or
augmentation with antiglobulin or flow cytometry. Final crossmatches performed
prior to transplantation must utilize a serum sample collected within the past
48 hours before transplant if the recipient has class I lymphocytotoxic
antibodies or has had a recent sensitizing event, otherwise, a serum collected
within seven days may be used. Donors and recipients must be ABO and Rh typed
according to blood bank standards.
|Potential transplant sera must be screened for HLA-A, B and DR antibodies with a suitable lymphocyte panel on sera collected, at the time of the recipient's initial HLA typing and thereafter, following sensitizing events and upon request. A suitable cell panel, which contains all the major HLA specificities and common splits for screening patient sera, must be used.
| Transfusion and Non-Renal
Transplantation. All requirements specified in (5)(a) must be met.
|Non-Renal Solid Organ Transplantation. The results of final crossmatches must be available before transplantation when the recipient has demonstrated presensitization by prior screening, except for emergency situations. The laboratory must document the circumstances, if known, under which emergency transplants are performed, and records must reflect any information concerning the transplant provide d by the patient's physician to the laboratory.
Rule 111-8-10-.22 Quality Control for Flow Cytometry
|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/ alignment must be recorded each day.
|A threshold value for acceptable optical standardization shall be established for all relevant signals for each instrument and the focusing procedure repeated until these values are achieved or surpassed. If a particular threshold value cannot be attained, a written protocol for instituting corrective action must be available and used.
|A fluorescent standard, for each fluorochrome to be used, shall be run to insure adequate amplification of the fluorescent signal(s) each day of use and after any maintenance or adjustment of the instrument. This standard may be incorporated in the beads or other particles used for optical standardization or may be a separate bead of fixed cell preparation. If acceptable fluorescence separation cannot be attained, a written protocol instituting corrective action must be available and used.
|When performing analyses using two or more fluorochromes simultaneously, an appropriate procedure must be used to compensate for "spill over" into the other fluorescence detectors.
|For laser based instruments, the current input (amps) and laser light output (milliwatts), at the normal operating wavelength measured after the laser is peaked and normal operating power set, must be recorded as part of a daily quality control record.
|The use time of instruments with mercury fluorescent lamps must be recorded. Lamps must be replaced when the allowable use limit has been reached.
|The laboratory must run a positive and negative control each day of patient testing. The negative controls should include normal serum from a healthy individual. The positive control (using appropriate dilutions) should react with cells representing all HLA types (i.e., pulled high PRA sera).
|Each laboratory must establish and document its own threshold with multiple normal sera for discriminating positive crossmatches. For significant change in protocol, instrumentation, or software, the characterization of the positive threshold must be repeated.
|For internal labeling, the method used to allow fluorochrome labeled antibodies to penetrate the cell membrane must be documented as effective.
|Whether analyzed directly or fixed prior to analysis, labeled cells must be analyzed within a time period demonstrated by the laboratory to avoid significant loss of any cell sub-population or total cell numbers. Test samples must be analyzed within the same period, after staining, as the control samples.
|If analysis will be based on a population of cells selected by flow cytometry "gating" on size or density parameters, or selected depletion or enrichment techniques, control stains must be run for each test individual to detect the presence of contaminating cells in the selected population (i.e., monocyte contamination of lymphocytes gated by forward angle or forward angle vs. 90 degree light scatter must be detected with a monocyte specific marker antibody). For cell surface labeling, a method must be used to determine the proportion of viable cells in the population of counted cells (i.e., thidium bromide staining, CD45 staining). If this value falls below an established laboratory threshold, an appropriate reanalysis of specific measurements must be done.
|Conclusions about abnormal proportions of abnormal cell surface marker shall only be drawn in comparison with local control data obtained with the same instrument, reagents and techniques. Conclusions about leukemia/lymphoma classification shall be based on local or published reference data. Determination of percent positives must take into consideration the results of the negative control reagent.
|The specificity of monoclonal antibodies shall be verified by the published and/or manufacturer's documentation and, whenever possible, verified locally through tests with appropriate control cells prepared and tested by the same analysis. The quantities of reagents used for each test sample must be determined by the manufacturers from published data and, whenever possible, should be verified locally by appropriate titration procedures.
|Terminology used must be defined and/or must conform to nomenclature recommended/approved by the most recent International Workshop of Differentiation Antigens of Human Leukocytes or other appropriate scientific organizations.
Rule 111-8-10-.23 Evaluation
The Department shall conduct a clinical laboratory performance evaluation (proficiency testing) program with the following requirements:
|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.
|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.
|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.
|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.
|Proficiency testing performance standards must be consistent with current federal requirements unless the Department elects to require more stringent standards.
Rule 111-8-10-.24 Specimens Examined
|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.
|All specimens accepted by a licensed laboratory shall be tested on the premises, unless forwarded to another licensed clinical laboratory.
Rule 111-8-10-.25 Reporting
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.
Rule 111-8-10-.26 Records
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:
|For general laboratory records and quality control records, kept at least two (2) years,
|For records of immunohematology and cytology, kept at least five (5) years, and
|For records of surgical pathology, kept at least ten (10) years.
Rule 111-8-10-.27 Reports to the Department
|Clinical laboratories shall report to the Department evidence of selected infectious diseases on forms provided by the Department.
|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.
| Reports of Serious
Incidents/Events. The laboratory shall report to the Department the following
| The laboratory shall make the initial
report of the serious incident/ event within twenty-four (24) hours or by the
next regular business day from when the reportable event occurred, or from when
the laboratory has reasonable cause to believe that the reportable event has
occurred. The initial report shall be received by the Department in confidence
and shall include at least the following:
|Within forty-five (45) days following the resolution of the event, the laboratory shall prepare a written report which includes a root cause analysis on systems and processes associated with the event to identify those improvements that are within the control of the laboratory that will be made to help prevent similar occurrences. The complete report shall be available to the Department for inspection at the facility. The laboratory is not required to complete a written report or a root cause analysis on interruptions in service for which the laboratory did nothing that contributed to the interruption in service.
|The Department will hold the initial self-report concerning the reportable serious incident/event in confidence and not release it to the public. However, where the Department determines that a rule violation related to the reported serious incident/event has occurred, the Department will initiate a separate complaint investigation of the incident. The separate complaint investigation report and survey results concerning the serious incident/event will not be kept confidential.
|Where a licensed laboratory is operated as an organized service of the licensed hospital, the laboratory may comply with the requirements for reporting serious incidents/events set forth in this rule by submitting its reports to the Department through the hospital- wide peer review committee, so long as the reports are made in a timely manner. Only one self-report of each serious incident/event is required to be made for the licensed laboratory that is operating within a licensed hospital.
Rule 111-8-10-.28 Plasmapheresis and Whole Blood Donor Centers
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.
Special Personnel Requirements. In addition to the general personnel
requirements outlined elsewhere in these Rules and Regulations, the following
special personnel requirements are established:
|Proficiency Testing Requirements. Rule 111-8-10-.23 outlines proficiency testing requirements for hematology, immunohematology, syphilis serology, HIV testing and hepatitis testing. External proficiency testing is not required for blood, tissue and/or plasmapheresis donor screening procedures such as specific gravity, hematocrits, dipstick tests and serum proteins. This exemption from external proficiency testing does not, however, exempt such facilities from quality control requirements, inspection and licensure.
|Documentation of Reactions. The records system of the facility must maintain documentation of all reactions. Adequate reporting and recording forms must be available and used.
|Blood Labeling and Associated Records. In addition to labeling required as a part of good laboratory practices, it shall be the responsibility of the licensed laboratory director to comply with Chapter 24 of Title 31 of the Official Code of Georgia Annotated and Rules and Regulations for Blood Labeling, Chapter 111-8-9.
Rule 111-8-10-.29 Exemption of Specific Screening and Monitoring Tests
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.
|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.
|Screening and monitoring approvals shall be issued by the Department and shall be valid for one year or a limited and specified time.
|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.
Rule 111-8-10-.30 Inspection and Plans of Correction
|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.
|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.
|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.
|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.
|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.
|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.
|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.
Rule 111-8-10-.31 Exemptions
These rules and regulations shall not apply to:
|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;
|Clinical laboratories operated and maintained exclusively for research and teaching purposes involving no patient or public health services;
|Clinical laboratories operated by duly licensed physicians exclusively in connection with the diagnosis and treatment of their own patients; or
|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.
Rule 111-8-10-.32 Variances and Waivers
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.
Rule 111-8-10-.33 Enforcement
|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.
A Clinical Laboratory and/or Clinical Laboratory Director License may be
denied, revoked, suspended, limited or renewal denied for:
| Upon
being notified of a conviction, plea, or first offender treatment of a licensed
laboratory director involving the manufacture, distribution, trafficking, sale,
or possession of a controlled substance or marijuana, the Department shall
suspend or revoke the license of such individual as follows:
|The operation or maintenance of an unlicensed clinical laboratory in violation of Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules may be declared a nuisance, inimical to the public health, welfare, and safety. The Commissioner may bring an action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such clinical laboratory until compliance with Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules has been demonstrated to the satisfaction of the Department. (5) Any person who violates any provision of Chapter 22 of Title 31 of the Official Code of Georgia Annotated or any of the rules and regulations promulgated thereto shall be guilty of a misdemeanor.
Rule 111-8-10-.34 Severability
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.


text:
ibis Jaipur Civil Lines has reimagined itself its unique design concept, interiors and dining for the new-age traveller in line with the global ibis rebrand. Located in close proximity to the Jaipur railway station and Civil Lines metro station, ibis Jaipur Civil Lines features a vibrant and colourful lobby with traditional Pichwai artwork that connects to the ethic charm of the Pink city. The lobby also showcases a visual abstract of the Jaipur city designed by renowned architect Vidyadhar Bhattacharya in 1727. Guests can use it as a map or even innovate and play a map game with their friends. For our avid readers, there is cosy corner with an interesting collection of books from different genres and a web corner with high speed WIFI to meet your quick business and travel needs.
"Jaipur has become one of India's key markets for leisure, destination weddings and is an emerging commercial hub. With our commitment to deliver best-in-class services, we decided to refurbish our ibis property." said Shwetank Singh – Vice President of Development & Asset Management, InterGlobe Hotels. "The completion of the project has far exceeded expectations of what we had envisioned which is in line with our 'New Generation' Design and we are excited about the new look and feel of the hotel. The culinary offerings along with the vibrant and colourful public area bring about a great amount of energy to the place and it fits in well with the Rajasthani art and architecture. I would like to congratulate the operations team and our projects team whose tireless efforts resulted in the completion of the project within timelines and budget whilst the property was still operational."
The hotel boasts of guest rooms, especially for the family travellers, 22 new premium rooms that feature three beds along with newly designed interiors with geo-contextual art. The guest lounge located on the seventh floor serves light snacks, tea, coffee along with other beverages. The multi cuisine restaurant Spice It offers both local and international delicacies like Lal Maas, Gatta Curry, Papad Paneer Bhurji, signature 'Spice It' burgers and more. For an evening wind down, the lobby bar offers a selection of mocktails, cocktails and wines from different regions. You can bring your guitar and jam with friends or dance to the amazing music being played in the hotel; you can be yourself at the ibis.

subset: commoncrawl


text: Product Description Beautiful white mop-like balls of blooms appear in Summer. Lush green foliage and striking black stems give this deciduous shrub extra impact. Great for any border, easy to grow. Striking black stem gives contrast against foliage. Large white mophead flowers. Strong roots give added reliability and performance. Hardy.


text:
What Size of Home Can I Build in Promontory? | Real Estate In Park City
Posted by Derrik Carlson on Friday, October 30th, 2015 at 10:23am
I recently had a client ask me "Derrik can we go look at this property and what is the smallest home I can build in Promontory?" I did a bit of research and I've outlined Section 4.1 Building size for Promontory's Design Guidelines (By the time you read this the guidelines could have changed so make sure you have the most recent information). It's best to make sure you check the most recent subdivision guidelines in every neighborhood you are considering before you begin going out to preview at properties.
"Section 4.1 Building Size: The County's zoning requirements have designated (as noted on the applicable Recorded Subdivision Plats) certain Lots within Promontory as Estate Lots which require custom homes to have a minimum building size of 3,500 square feet of Enclosed Livable Space. If not designated as such, then custom residences in Promontory shall have a minimum of 2,500 square feet of Enclosed Livable Space. Within the villages of West View and on other Plats where indicated, certain lots which are less than one (1) acre in size will be designated as Incentive Density Lots and will be subject to a maximum size limit of 4,000 square feet of Enclosed Livable Space. All residences on Estate Lots and on Incentive Density Lots of one (1) acre or larger in size have a maximum size requirement of 8,000 square feet of Enclosed Livable Space."
Source: http://www.promontoryclub.com/pdf/Final_Design_Guidelines_June_2008.pdf
If you are curious as to building costs in Promontory please contact me and I can put you in contact with a Park City luxury builder.
Derrik Carlson | (435)200-5478 | email@example.com


text: dogs4eva Posted October 8, 2019 · Report post Hi I am looking to do titre testing for my dog rather than annual vaccinations and was wondering where this was available in Sydney. Do DOLers have any recommendations? I am on the north shore. TIA I also wanted to check when to start titre testing. I have a 9 week old puppy and from what I can gather, it is recommended that she still continues with the standard puppy shots at 10-12 weeks and then at 14-16 weeks before starting titre testing after 1 year. Is my understanding right? Share this post Link to post Share on other sites


text:
Poet Laureate of Kansas: May Our Voices Ring True
Poetry is a lens that can be both microscopic and telescopic representing the "…clear expression of mixed feelings," as poet W.H. Auden suggests. Poetry creates space where we can discover ourselves, find our place and revel in beauty and truth. But through poetry we can also find connection with one another. Poet Mahmoud Darwish said … Read more Poet Laureate of Kansas: May Our Voices Ring True


text:
Senate confirms Amul Thapar to key judicial post
Amul Thapar, an Indian-American legal luminary and US President Donald Trump's first nominee to a powerful appeals court, has been confirmed by the US Senate to the key judicial position. Thapar, the first Indian-American to be nominated by Trump for the 6th US Circuit Court of Appeals, was confirmed by the Senate 52-44 in a vote on party lines.
With this, 48-year-old Thapar becomes the second South Asian judge to be on the US Circuit Court of Appeals, which hears appeals from Kentucky, Tennessee, Ohio and Michigan. "Judge Thapar will make an outstanding addition to the US Appeals Court for the Sixth Circuit," said Senate Majority Leader Mitch McConnell on Thursday.Thapar, currently a US District Court Judge, was nominated by Trump on March 21.
The South Asian Bar Association of North America also congratulated Thapar.
Next Story


text:
Research Assistant / Research Associate in Medical Statistics (2 posts)
- Recruiter
- Location
- London (Central), London (Greater) (GB)
- Salary
- RA: £32,676 to £37,297 or RAssoc: £38,304 to £45,026 per annum, inclusive of £3,500 London Allowance
- Posted
- 05 Jun 2020
- End of advertisement period
- 07 Jul 2020
- Ref
- Academic Discipline
- Clinical, Pre-clinical & Health, Other Health & Social Care
- Contract Type
- Fixed Term
- Hours
- Full Time
The School of Population Health & Environmental Sciences (https://www.kcl.ac.uk/sphes/index) is looking to recruit two posts of either Research Assistant or Research Associate grade in Medical Statistics. The main duties of the postholders will be to take day-to-day responsibility for the statistical aspects of specific studies such as clinical trials and/or other clinical studies and registry projects. This will include project planning and protocol development, study conduct, plans for all statistical analyses and liaising with the appropriate multidisciplinary teams to represent the statistics view and role. In addition, the postholders will contribute to statistical consultancy as part of UMS. All work will be supervised by a senior member of UMS.
The post holders will be medical statisticians with a strong interest in clinical trials and epidemiological studies. For the Research Associate post, the postholder will have a PhD in medical statistics (or extensive equivalent industry experience in medical statistics research) and experience of conducting collaborative health research.
The post holders will be members of the Unit for Medical Statistics and will be the study statistician for some of our wider portfolio of trials, clinical studies and registries
This post will be offered on a fixed-term contract for 2 years
This is a full-time post - 100% full time equivalent
The selection process will include a presentation and a panel interview.
Candidates are strongly encouraged to specifically address the essential criteria outlined in the Person Specification in their covering letter.
To apply, please register with the King's College London application portal and complete your application online.


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The girlfriend of Baste Duterte just proves that she is truly a former beauty queen and a model.
Presidential son Sebastian "Baste" Duterte's longtime girlfriend Darrela Kate Necessario recently unveiled her oh-so-pretty looks on her social media post. The triathlete shared her photo of her clad in a pink, embroidered top.
Darela Kate, a former FHM model, is a good artist and painter. She is currently based in Davao and is often spotted in Duterte – Zimmerman family gatherings. She also has a close relationship to Davao City Mayor Inday Sara Duterte.


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I haven't been able to stop thinking about the panel with Elizabeth Wurtzel and her article in The Cut, where she tells what it's like to discover that your father was actually a close family friend, which her mom never told her.
So this morning when the Wall Street Journal published Two Sisters Bought DNA Kits. The Results Blew Apart Their Family, I got engrossed again. Oh my God, the secrets families keep. The mysteries behind why a child doesn't seem to have similar interests to the rest of her family. The emotional shock of staring at a DNA test and asking, WHAT?
Doing a google search turns up some fascinating other articles and books, like this one I'm trying to resist:
Anyone else know anyone who went through this shock?


text: Laura DAndrea Tyson is dean of the Haas School of Business at the University of California at Berkeley. Dr. Tyson served in the Clinton Administration from January 1993 through December 1996. Between February 1995 and December 1996 she served as the Presidents National Economic Adviser and was the highest ranking woman in the Clinton White House. Dr. Tyson was a key architect of President Clintons domestic and international policy agenda during his first term in office. As the Administration's top economic adviser, she managed all economic policy-making throughout the executive branch, serving as head of the National Economic Council. Dr. Tyson previously served as the sixteenth chair of the White House Council of Economic Advisers, the first woman to hold that post. Before joining the Clinton Administration, Dr. Tyson published a number of books and articles on industrial competitiveness and trade, including the highly acclaimed Who's Bashing Whom? Trade Conflict in High Technology Industries. She is a columnist for Business Week magazine and a commentator for Nightly Business Report. Dr. Tyson received a Ph.D. degree in economics from the Massachusetts Institute of Technology.


text:
Altered Images
Required Supplies
Do you have all your supplies? Use this checklist to be sure you're not missing anything you'll need!
Paint & Brushes Grab some acrylic paint! I prefer artist grade paints, but craft paint will work, too. Also have a variety of brushes on hand - I'll be using flats and rounds in class.
Painting Knives You'll need a palette knife or scraper of some sort.
Found Images I use Found Relative Cards by Idea-Ology, but old photos, magazine images, or rejects from photo shoots are all great choices.
Paper or Substrate You'll want something that will stand up to your paint technique, like 140 lb. or higher watercolor apper, Strathmore mixed media paper pad or journals, Dylusions journals, or painting panels. I work on cradled wood panels by Art Alternatives in my demonstrations.
Liquitex Matte Medium This is my collage glue of choice, but there are several options out there, including Mod Podge, Collage Pauge, etc.
Liquitex Clear Gesso This makes drawing on top of found images a breeze. I'm not sure how it will work on modern photos, so make sure to test it first!
Drawing Implements Some of my favorites are General Pencil Co. 9XXB graphite pencils, Caran d'Ache Neocolor II crayons, Portfolio water-soluble oil pastels, Prismacolor pencils and Faber-Castel PITT pens.
Patterned Paper, Stamps, Stencils, Rub Ons & Embellishments Pull together items from your stash that make your heart shout, "Let me create!"


text:
Café Rouge – Classic Afternoon Tea Hen Party in London
What to Look Forward to on a London Café Rouge Classic Afternoon Tea Hen Party?
Hoping to bring something a bit different to your day? Make sure the bride-to-be feels special by arranging a Café Rouge classic afternoon tea hen party in London. Not only is this a fantastic chance to spoil all the girls in your group, but it's an opportunity to take some time off the busy streets of the capital for some delicious food with the ladies! As you tuck into your cakes, sandwiches and scones, you'll each get a cup of Twinings tea each with your food.
What's Included
- Spoil yourself to a delicious afternoon tea experience
- Held within Café Rouge, a popular French bistro chain
- Variety of cakes, scones with cream and jam
- Delicious croque monsieur
- Gluten-free, non-dairy and vegan menus are also available
- Afternoon tea comes with a Twinings tea
- Upgrade to include a glass of prosecco – ask for price
There are no reviews yet.


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Every player in the 10U, 12U, 14U, 16U and 18U age groups should be taking the Mental Skills Training lessons as the training is a key element of being part of the Sno-King program. We have been receiving great feedback from participants in the program! A total of 8 lessons will be provided for this season. We monitor participation in the lessons and we encourage you to complete them on a timely basis.
Lesson # 3 of the Mental Skills Training program on TEAMWORK will be available tonight so you will be receiving an email today from Jordan Burt, founder of Pro Performance, to provide you with access. If you have any questions please contact your team manager or Stephanie Stiegler at email@example.com or Andrew Birnbrich at email@example.com.
The first two lessons may still be accessed if you have not participated yet. Players 8U and up can also access the program by requesting such access through Andrew Birnbrich at firstname.lastname@example.com or the program coordinator Stephanie Stiegler at email@example.com.
The Sno-King Staff
Tag(s): Home Teams 8U 10U 12U 14U 18U 18U A1 16U AAA 16U A2 14U A2 14U A3 10U A (Cooke) 10U A (Rodgers) 10U B (Grudzien) 10U B (Anderson) 10U B (Breen) 10U B (Lee) 12U A1 12U A2 12U A3 (White) 12U A3 (Chakrabarti) 18U C (Ansley) 18U C (Leung) 14U C (York) 14U C (Wilkinson) 14U C (Colar) 12U C (Stillwell) 12U C (Guthrie) 12U C (Norman) 12U C (Longfellow) 12U C (Townsend) 10U C1 (Perkins) 10U C2 (Bicksler) 10U C3 (McFadden) 10U C4 (Trotter) 10U C5 (Heinz) 10U C6 (Levin) 8U Major Navy 8U Major Silver 8U Major Maroon 8U Major Orange 8U Major Gold 8U Major Green 8U Major Purple 8U Major Light Blue 8U Minor Green 8U Minor JPC Blue 8U Minor Orange 8U Minor Silver 8U Minor Navy 8U Minor Maroon 16U 14U C (Philip) 8U Girls Misc Teams Hockey 2


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Indian Government's new initiative to stop crime against women
Soon the Indian government is launching a website to provide information about sex offender and other crime against women. This is indeed a move to make the concerned parents, employers, relatives of the country's women population aware about the sex offenders residing or working in their vicinity. Only charge-sheeted records of criminals will be updated in the website.
This step is a part of Crimes and Criminals Tracking Network and Systems (CCTNS). Information of Charge-sheeted criminals, wanted and most wanted criminals will be published. This online initiative also extends its service in publishing the data about missing persons, human trafficking and easy access to legal services to help not only women of the country but also the general masses in tracking or knowing about criminals.
In USA there is a similar website called National Sex Offender Public Website which helps the people of their country in knowing the current location of the criminals, sex offenders and other crime information.
Delhi police has recently launched a mobile application called "Himmat†to help women in distress. The app acts like an alarm raiser for women in distress. Once the aap is on distress signals will be transmitted to the police and in 5-7 mins the police would be there to act against the criminal.
Department of telecommunication in line with home ministry has set-up a nation-wide emergency response system through the emergency number 112. The best thing about 112 is it can be reached via all tele-communication mediums such as landline telephone, mobile phones as well as their sms, chat, voip, app services.
112 is one of grand government project which would cost the Government 312 crore but its objective a way important than the money involved to stop crime and punish offenders. 112 services will have a capability to handle 10 lakh calls per day while roughly 3,500 call attenders will be deployed to handle the emergency calling service.
By : | Category : Sensitive News for over 18 year| Date : August 13,2015


text: Aeoshattr 679 Report post Posted June 28, 2015 (edited) When, Where? Check here. [spoiler] I will do my best to update both topics, but the Avatar of Pain one takes priority over this one, in case I for some reason forget to post date/time here too. For clarity: Date&Time will coincide with The Sixth. They are the same. I will decide the date/time for this when the roles have been satisfactorily taken. [/spoiler] Why? [spoiler] In order to make The Sixth more entertaining, as it is the second most important "face" of Aeo, I thought I could organise an impromptu quest and get people more involved. [/spoiler] What? [spoiler] As the title says, this is a roleplaying quest. In a nutshell, I will make a series of "roles" available. I will decide an actual setting to put all the roles in, which I will communicate to the players. Then we spend 1-2 hrs playing the little story! Please apply to occupy (and therefore play those roles) in this topic, using the following template: Role: Player name: Player ID: I will expect those that apply to be punctual and also notify me if they cannot make it anymore ahead of time, please :) [/spoiler] ROLES: [spoiler] I will cross out the roles that are taken. I am playing The Mirror myself, and the rest will be given on a first come first served basis. Please, however, apply within your limits of RP experience and knowledge. No specific role will grant you more chances to win, but the way you play the role will. Any role that is not filled by the time of the quest will be filled in by myself. The Mirror : The one that will guide the story accordingly. The Man: Main character. Introspective, always in a conflict with himself, torn between monologues and pseudo-dialogues, speaking with different faces of himself. The Man hates the mirror for never showing a truthful reflection, tries to suppress and avoid the Taint and is openly fighting The Witch. The Taint: Secondary "evil" character; this refers to Granos' Taint, a collection of maddening voices and minds overwhelming the mind of The Man. Erratic, chaotic, but with a purpose and few considerations for the means to reach the said purpose. The Witch: She is the one who initially Taints the Man; though he openly dislikes and fights against her, her aim is to teach him the truth which he does not want to see. The Reflections: They inhabit the mirror and change constantly. Only The Man can see them, and while neither good nor evil, their purpose is usually to protect the man regardless of the means needed to achieve that. The Friend: Tries to get the best from the man by pushing him to being a better person. However, his methods can sometimes get questionable and soon the question rises: is he truly a friend? I might add more roles, if there is a tremendous demand for participation. Anyway, please post here if you want to take a role, and then I will PM you with a few additional details! There will be turns taken in a predetermined order, and each has a maximum of 3 posts / turn; each must signal the end of their turn. I will provide details to each participant. [/spoiler] REWARDS: [spoiler] I will provide some rewards myself. Any sponsors are more than welcome, please let me know in this topic or in PM if you are willing to help sponsor the quest! Judges are also more than welcome, since I am forced to participate in the quest as well, I would like to have enough judges for my opinion to not be needed. Please contact me privately, not in this topic, if you want to judge! 1st Prize: 1hr Nightmode access + 3SC 2nd Prize: Movelock or locate stone 3rd Prize: whichever stone is left [/spoiler] Edited August 9, 2015 by Aeoshattr 2 Eagle Eye and Myth reacted to this Quote Share this post Link to post Share on other sites


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Tag: Restaurants
Street food vendors in Montreal
In keeping with an exploding North American trend, the appetite for truck grub is increasing in Montreal, where the city is now considering allowing food trucks and street food vendors to sell their delicacies downtown. Since the beginning of summer, a few vendors have been allowed in selected areas, apparently with great success. At the […]
Danish restaurant crowned the world's best… yet again!
Danish restaurant Noma was crowned the world's best restaurant for the 3rd year in a row in the World's 50 Best Restaurants listing, produced by Britain's 'Restaurant Magazine'. The voting was done by a panel of more than 800 chefs, restaurateurs, journalists and food experts.
A dinner-concert for your Valentine
If you're looking for somethig special for your Valentine (and for yourself) and happen to be in Montreal next Friday, Feb 10th, here's a suggestion: A dinner-concert with opera music and love songs at the TribuTerre bistro 2590 Jarry Est*.


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Sponsored by SynQuest Laboratories and Honeywell
Although most of Henry Selig's career has been devoted to fluorine chemistry, he is, in fact, something of an accidental fluorine chemist.
Selig, 81, was born in Germany, but in 1939, when he was just 11, he and his family were forced to flee the country. They ended up in Chicago, where Selig attended Herzl Junior College and the University of Chicago, earning bachelor's degrees in chemistry and mathematics.
After completing a master's in chemistry at the University of Chicago, Selig went on to what is now Carnegie Mellon University to earn a Ph.D. in nuclear chemistry under Truman P. Kohman. His next stop was a logical destination for an up-and-coming young nuclear chemist: Argonne National Laboratory.
At Argonne, Selig worked for six years on a classified project for the Atomic Energy Commission. On the side, he embarked on the study of rhenium-187, an isotope he expected to have an extremely long half-life. "To study the radioactivity, we had to convert it to a gas," he recalls. The possibilities were few, so after one false start with an organorhenium compound, Re(CH3)3, Selig and his colleagues settled on the synthesis of the volatile ReF6.
Something seemed fishy, however, and they soon discovered that in the process they had also made ReF7, a previously unknown compound. Inauspiciously, in late 1959, Selig's life in fluorine chemistry had begun.
For the next 35 years, Selig was a leader in the field. His many accomplishments include the 1962 synthesis of XeF4, just months after chemist Neil Bartlett created one of the first noble gas compounds. Selig also helped pioneer the field of intercalation chemistry with breakthroughs such as the discovery that AsF5 can intercalate into graphite, resulting in a compound with phenomenal electrical conductivity.
At the urging of his Israeli wife, Selig left Argonne in 1967 and moved to Hebrew University of Jerusalem. There, he continued his groundbreaking work in fluorine chemistry, reacting oxides in anhydrous hydrogen fluoride and creating synthetic metals. His later work included the fluorination of buckminsterfullerene in pursuit of the elusive C60F60.
Selig retired in 1995 at the age of 68, in keeping with Hebrew University policy, but he continued to work in the lab on his own for a number of years. Even today, he still stops by the chemistry department to keep up with the literature.
Karl O. Christe, a professor at Loker Research Institute at University of Southern California, in Los Angeles, has known Selig for 40 years and considers him "one of the most underrated scientists and the most underrated fluorine chemist I know."
Another colleague, Gary J. Schrobilgen, a chemistry professor at McMaster University, in Hamilton, Ontario, says Selig's accomplishments are all the more impressive because his research group at Hebrew University was always relatively small. Schrobilgen calls Selig "not only the real chemical thinker behind the first synthesis of XeF4 but a guiding chemical mind" behind much of the other fluorine work that came out of Argonne in the late 1950s and early 1960s.
Indeed, although Selig accomplished much in the subsequent years, he looks back fondly on those early days at Argonne when fluorine chemistry was seen as a dangerous field that few would venture into. "It was a great job," he recalls. "You did what you liked and even got paid for it."
Selig will present the award address before the Division of Fluorine Chemistry.


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Washington Brewers Festival
Jun 14, 2019 - Jun 16, 2019TBD
Raise a glass with us on Father's Day weekend as the Washington Beer Commission presents the 13th Annual Washington Brewer's Festival at King County's Marymoor Park! The Washington Brewer's Festival is a unique all-ages beer festival (Sat & Sun) where thousands of beer aficionados can sample more than 500 beers from 100 Washington breweries. In addition, the festival great food trucks, a live music stage, wine/cider and all-ages
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Acworth Wedding - The Conservatory at Waterstone
October 16, 2017
Shon and Deirdre married at The Conservatory at Waterstone this past weekend and it was an absolutely beautiful wedding! The couple wanted to spend some time together after their reception and they traveled to nearby Acworth Lake. It was a beautiful calm night and was a great way for them to spend a few moments together after the busy day.
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