Chapter 59A-7, Florida Administrative Code, is being amended to update and clarify clinical laboratory licensure requirements to reflect recent advances in clinical laboratory technology, delete requirements that are duplicative of the federal ...

Health Facility and Agency Licensing

RULE CHAPTER NO.: RULE CHAPTER TITLE:

59A-7 Clinical Laboratories

RULE NOS.: RULE TITLES:

59A-7.020 Definitions

59A-7.029 General Quality Control Requirements for Non-waived Testing

59A-7.030 Special Requirements for Licensure – Specialties and Subspecialties.

PURPOSE AND EFFECT: Chapter 59A-7, Florida Administrative Code, is being amended to update and clarify clinical laboratory licensure requirements to reflect recent advances in clinical laboratory technology, delete requirements that are duplicative of the federal Clinical Laboratory Improvement Amendments (CLIA) and require licensed laboratories to be in compliance with CLIA.

SUMMARY: The amendments to this rule update the existing clinical laboratory requirements to reflect recent advancements in clinical laboratory technology, deletes language duplicative of the existing federal Clinical Laboratory Improvement Amendments (CLIA), and requires licensed laboratories to be in compliance with CLIA.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No statement of estimated regulatory cost has beenwas prepared.

Any person who wishes to provide information regarding the statement of estimated regulatory costs or to provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

SPECIFIC AUTHORITY: 483.051 FS.

LAW IMPLEMENTED: Chapter 483, Part I, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW. (IF NO HEARING IS REQUESTED, NO HEARING WILL BE HELD.)

DATE AND TIME: April 18, 2006, 1:00 p.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room B, Tallahassee, FL 32308

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULES IS: Patricia L. James, Health Services and Facilities Consultant Supervisor, Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee, Florida 32308, [phone]

 

THE FULL TEXT OF THE PROPOSED RULES IS:

 

59A-7.020 Definitions.

In addition to definitions set forth in Section 483.041, F.S., as used in this chapter the following terms shall mean:

(1) through (5) No change.

(6) Clinical and Laboratory Standards Institute or CLSI – the voluntary consensus organization that develops and disseminates standards, guidelines and best practices for clinical laboratories and the healthcare community. This organization was formerly known as the National Committee for Clinical Laboratory Standards (NCCLS).

(7)(6) Clinical Laboratory Improvement Amendments of 1988 and Federal Rules Adopted Thereunder – shall mean Section 353 of the Public Health Service Act known as the Clinical Laboratory Improvement Amendments of 1988 and Part 493, 42 Code of Federal Regulations, 1993, as amended in the Federal Register, Volume 68, Number 16, Friday, January 24, 2003 Volume 60, Number 78, 1995, each incorporated by reference and referred to as CLIA, herein.

(7) through (11) renumbered (8) through (12) No change.

(13) Free-standing Histology and Cytology Center – any location outside a clinical laboratory licensed under Chapter 483, Part I, F.S., which is engaged in and limits its activities to the preparation of human cellular material for microscopic interpretation by laboratories licensed in the specialty and subspecialties of pathology and cytology.

(12) through (15) renumbered (14) through (17) No change.

(18)(16) Licensure Certificate – evidence of current licensure issued to a clinical laboratory upon application and qualification as required in this Rule and Chapter 483, Part I, F.S. Such license shall be issued for testing for one or more of the following specialties or subspecialties:

(a) Histocompatibility.

(b) Microbiology composed of the subspecialties of Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, or Microbiology (Other).

(c) Diagnostic Immunology composed of the subspecialties of Syphilis Serology or General Immunology.

(d) Chemistry composed of the subspecialties of Routine Chemistry, Urinalysis, Endocrinology, Toxicology or Chemistry (Other).

(e) Hematology.

(f) Immunohematology composed of the subspecialties of ABO Group & Rh Group, Antibody Detection (Transfusion), Antibody Detection (Non-Transfusion), Antibody Identification, Compatibility Testing or Immunohematology (Other).

(g) Pathology composed of the subspecialties of Histopathology, Oral Pathology or Cytology.

(h) Clinical Cytogenetics.

(i) Radiobioassay.

(j) Free-standing histology center limited to those activities described in subsection 59A-7.020(12), F.A.C.

(k) Provider-performed microscopy tests limited to the CLIA category of Provider-Performed Microscopy tests found in 42 CFR 493.19(c)(1-9).

(17) through (32) renumbered (19) through (34) No change.

Specific Authority 483.051 FS. Law Implemented 483.035 FS., 483.041 FS., 483.051 FS., 483.106 FS., 483.191 FS. History–New 11-20-94, Amended 8-13-95, 12-27-95, Amended_________.

 

(Substantial rewording of Rule 59A-7.029 follows. See Florida Administrative Code for present text.)

 

59A-7.029 General Quality Control Requirements for Non-waived Testing.

(1) The laboratory shall establish and follow written quality control procedures for monitoring and evaluating the quality of the testing process of each method to assure the accuracy and reliability of patient test results and reports in accordance with CLIA requirements. The laboratory shall follow the manufacturers’ instructions and recommendations for instrument or test system operation and test performance if such instructions exceed requirements specified in this rule. In the event of a conflict between these rules and CLIA requirements, the more stringent requirement(s) shall prevail.

(2) The laboratory must utilize test methods, equipment, instrumentation, reagents, materials, and supplies that provide accurate and reliable test results and test reports as required by CLIA.

(a) Methodologies and equipment must be selected and testing must be performed in a manner that provides test results within the laboratory’s stated performance specifications for each test method and reflect procedures that are generally accepted by leading authorities such as the Centers for Disease Control and Prevention (CDC), CLIA recognized accreditation organizations, the American Association of Blood Banks (AABB) or other nationally recognized organizations. Documentation that the test methodologies and equipment meet the requirements of this rule must be maintained by the laboratory and available for review by the agency.

(b) The laboratory must have equipment, instruments, reagents, materials, and supplies for the type and volume of services provided during the preanalytic, analytic, and postanalytic phases of testing.

(c) All equipment and supplies shall be in good working order, checked and calibrated for the proper performance of tests and services offered in accordance with this rule and CLIA requirements. The laboratory must, at a minimum, follow the manufacturers’ recommendations and instructions for equipment operation and document all such activities required for maintenance and operation of such equipment.

(d) The manufacturers’ instructions and documentation of maintenance and operation of equipment must be maintained by the laboratory and available for review by the agency.

(e) Out-of-service equipment and supplies shall be clearly labeled to indicate their status.

(f) Expired, substandard or unusable supplies shall be promptly removed from use and clearly labeled to indicate their status. Such supplies shall be isolated from usable supplies until they are removed from the premises.

(g) Procedures must be approved, signed, and dated by the current laboratory director both initially and biennially thereafter.

(3) Quality Control Procedures. In accordance with CLIA requirements and any additional provisions of this Rule, the laboratory shall perform control procedures to monitor the ability of the method or test system to give accurate, precise and reliable patient test results.

(a) Quantitative controls shall be of different concentrations that approximate the analytical range of that analyte, e.g. normal and abnormal patient values.

(b) No daily quality control testing is required for those tests listed as Provider-Performed Microscopy tests in 42 CFR 493.19(c)(1-9), provided the laboratory has instituted a quality assessment program containing the elements found in Rule 59A-7.031, F.A.C., Quality Assessment, to verify the accuracy of those tests at least every 6 months.

(c) All control procedures required above shall be documented and available to the agency upon request.

(d) Use of Equivalent Quality Control (EQC).

1. A laboratory is permitted to use equivalent quality control testing pursuant to 42 CFR 493.1256(d) provided that those electronic, procedural or internal controls or combinations thereof are met; and the following requirements are met:

a. The process evaluates each step in the testing process;

b. The process evaluates the potential sources of error;

c. The process evaluation includes specific assessment and documentation of how each step of the testing process is evaluated by the EQC process; and evaluates potential sources of error.

d. The implications of reducing the frequency of the use of external controls and the possibility of providing inaccurate and unreliable test results are evaluated and found acceptable by the clinical consultant and approved in writing by the laboratory director;

e. The choice of EQC options described in 42 CFR 493.1256(d) is consistent with the extent to which the electronic, procedural or internal controls or combinations thereof ensure that the provisions of this rule are met;

f. All EQC studies shall be composed of no less than 20 consecutive different test samples;

g. All EQC evaluations, reevaluations, assessments, actions or other such EQC studies shall be documented and available for review by the agency.

2. After an acceptable EQC evaluation has been completed in accordance with these Rules, the laboratory is permitted to institute EQC in lieu of external quality control requirements of 42 CFR 493.1256(d). However, if any of the following conditions occur, the laboratory shall reinstitute the external quality control provisions of 42 CFR 493.1256(d):

a. A proficiency testing score of less than 80% is obtained for any of the last three proficiency testing events;

b. Personnel competency problems are identified;

c. Major preventive maintenance or replacement of critical parts occurs;

d. Any EQC result that was repeatedly outside acceptable limits as specified in 42 CFR 493.1256(d);

e. When there is any indicator that inaccurate, imprecise or unreliable patient testing is being reported.

3. Before EQC can be resumed, the laboratory must repeat the EQC evaluation in accordance with the requirements of this Rule. External quality control procedures in accordance with 42 CFR 493.1256(d) shall be performed until the subsequent EQC evaluation meets the requirements of this rule.

4. When an EQC failure occurs, the laboratory’s clinical consultant must examine all patient test results reported during the time that the EQC evaluation was used to determine if there was any clinical impact on the patients tested during that time. Appropriate action shall be taken if such patient impact is found.

Specific Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended_______.

 

(Substantial rewording of Rule 59A-7.030 follows. See Florida Administrative Code for present text.)

 

59A-7.030 Special Requirements for Licensure – Specialties and Subspecialties.

The laboratory must establish and follow written quality control procedures for monitoring and evaluating the quality of the analytical testing process of each specialty and subspecialty in which it performs tests to assure the accuracy and reliability of patient test results and reports. The laboratory must meet the applicable quality systems requirements specified in CLIA in addition to Rule 59A-7.029, F.A.C., and the applicable requirements of Rule 59A-7.030, F.A.C., indicated below:

(1) Microbiology. The laboratory must maintain records that reflect the systems used and the reactions, measurements and observations for the specialty of microbiology and the subspecialties, analytes and tests included thereunder.

(a) Bacteriology.

1. Each shipment, batch or lot of bacitracin, catalase, cefinase, coagulase plasma, OPNG, Optochin, oxidase, spot indole, X,V, and XV reagents shall be checked with a positive control before being put into use and each week of use thereafter.

2. Each batch of media(prepared in-house), lot number (commercially prepared media that is not listed on NCCLS M22-A3 as exempt), and shipment of antisera shall be checked with a positive and negative control before being put into use and each month of use thereafter.

3. Antibiotic sensitivity tests shall be performed in accordance with CLIA requirements.

(b) Mycobacteriology.

1. General requirements for mycobacteriology testing. Each laboratory accepting specimens for the staining, isolation, identification or susceptibility testing of mycobacteria is required to:

a. Ensure that all specimens for mycobacteria are handled in a manner that minimizes the potential for cross contamination.

b. Ensure that any specimen, isolate or other material requiring transportation to other laboratories for testing or storage is transported in an appropriate and timely manner in accordance with these rules.

c. Use a biological safety cabinet for all manipulations of mycobacterial isolates. The cabinet shall be tested, certified, and used according to the recommendations of the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention and National Institutes of Health set forth in the publication, “Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets”, U.S. Government Printing Office, Washington: 2000. This publication is incorporated by reference. This publication is available from the United States Government Printing Office, 732 North Capitol Street, N.W., Washington, D.C. or www.gpo.gov. Certification shall be conducted after the initial installation in the laboratory and any time the cabinet is moved, and at least annually thereafter. The laboratory must follow the manufacturer’s instructions for the operation of the cabinet if they exceed the requirements of these rules. The manufacturer’s instructions must be maintained by the laboratory and be available for review by the agency.

d. Aerosol-free centrifuge cups are required if the laboratory uses a centrifuge for mycobacteriology testing.

e. Each laboratory shall notify its respective county health department of all specimens positive for mycobacteria pursuant to Sections 381.003(2), 392.53(2) and Rule 64D-3.023, F.A.C.

f. Examination of smears, isolation, identification and susceptibility testing shall be done by methods that are generally accepted by leading authorities such as the Centers for Disease Control and Prevention (CDC).

g. Testing of all mycobacteriology specimens shall begin no later than 24 hours after receipt in the laboratory.

h. The laboratory shall report the receipt of unsatisfactory specimens to the authorized person ordering the test within 36 hours of receipt of that specimen in the laboratory.

2. Smears; performance and reporting.

a. An appropriately stained smear shall be examined microscopically for all sputum mycobacteriology specimens.

b. The reactivity of all stains for mycobacteria shall be tested with at least one organism that produces the expected staining reaction (positive) and one organism that shows the expected staining reaction does not occur (negative).

c. The laboratory must check fluorochrome stains for positive and negative reactivity each day of use.

d. The laboratory must check all other mycobacteria stains for positive and negative reactivity each week of use.

e. Reports of smears for mycobacteria shall indicate:

I. An estimate of the number of mycobacteria seen per microscopic field.

II. That smear results should be used as an adjunct in evaluating a patient’s tuberculosis status; and

III. That examination by culture is recommended for the primary diagnosis of M. tuberculosis.

IV. If the laboratory has referred the specimen to another laboratory for further testing, the name and location of the laboratory to which the specimen was sent, and the date the specimen was sent to that laboratory.

f. If the smear results indicate the presence of mycobacteria, the report results shall be communicated by telephone or electronic transmission to the person authorized to use the test results within 48 hours of receipt of the specimen.

g. Stained slides that are positive for mycobacteria shall be retained for at least one year from the date that the specimen is received in the laboratory.

h. Stained slides that are negative for mycobacteria must be retained for no less than 90 days.

i. If the laboratory performs only smears for mycobacteria, any specimen whose smear results indicate the presence of mycobacteria or that requires additional testing for M. tuberculosis complex must be shipped by courier or overnight mail to a laboratory capable of performing additional isolation, identification and susceptibility testing.

3. Isolation of mycobacteria; performance and reporting.

a. All digested, decontaminated, or concentrated specimens for the primary isolation of mycobacteria shall be inoculated to a suitable liquid medium. In addition to the inoculation of a liquid media, at least one suitable selective solid medium shall be inoculated at the same time. Solid media inoculation is not required for blood specimens processed with a radiometric broth or other rapid growth systems.

b. The laboratory that identifies M. tuberculosis complex is responsible for assuring that susceptibility testing is performed on all initial patient isolates. If the laboratory cannot determine if the specimen is an initial isolate, the laboratory is responsible for assuring that susceptibility testing is performed on that specimen. If such testing cannot be done in the laboratory that isolates the M. tuberculosis complex, the specimen shall be shipped by courier or overnight mail to a Florida licensed laboratory capable of such testing. The laboratory shall retain a subculture of the isolate for newly diagnosed or relapsed patients on a suitable medium for at least one year after receipt of the specimen in the laboratory. In lieu of retaining this subculture, the laboratory is permitted to send the subculture to the State of Florida Department of Health Central Laboratory. The laboratory shall retain a record indicating the date that the subculture was transported to the Department of Health Central laboratory:

c. If the laboratory presumptively isolates but does not identify M.tuberculosis complex:

I. The specimen must be shipped by courier or overnight mail to a laboratory capable of performing identification and susceptibility testing;

II. The laboratory must issue a report indicating the presumptive isolation of M. tuberculosis complex that includes the name and location of the laboratory to which the specimen was sent.

4. Identification of mycobacteria; performance and reporting.

a. The laboratory must use a rapid method, such as but not limited to, nucleic acid probes or high pressure liquid chromatography (HPLC) to presumptively or specifically identify M. tuberculosis complex. If such testing cannot be done in the laboratory, the culture shall be shipped by overnight courier or overnight mail in a timely and appropriate manner to a Florida licensed laboratory capable of such testing.

b. Each shipment or each new lot number of commercial test system or test reagent(s) must be tested with at least one organism that produces the expected reaction (positive) and one organism that shows the expected reaction does not occur (negative).

5. Susceptibility testing of mycobacteria.

a. Antimycobacterial sensitivity tests shall be performed in accordance with CLSI specifications contained in NCCLS M24-A (ISBN 1-56238-536-4), Volume 24, Number 19 “Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard”, incorporated by reference herein. This document is available from Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 or www.clsi.org.

b. Laboratories performing susceptibility testing must identify M. tuberculosis. If an isolate received is identified as Mycobacterium tuberculosis or Mycobacterium tuberculosis complex, the laboratory performing susceptibility testing must ensure that the identification is confirmed before susceptibility testing is reported.

c. For susceptibility tests performed on M. tuberculosis complex isolates, the laboratory must check the procedure each week of use with a strain of M. tuberculosis susceptible to all antimycobacterial agents tested.

d. All initial isolates of M. tuberculosis complex must be tested using a rapid method against the following first-line tuberculosis drugs:

I. Rifampin

II. Isoniazid

III. Ethambutol

IV. Streptomycin

e. If a laboratory does not have the capability to perform any of the susceptibility testing for these first-line drugs, the isolate must be sent by overnight courier or overnight mail to a laboratory capable of performing such testing.

f. Susceptibility tests of all initial isolates of M. tuberculosis complex that show resistance to one or more first-line drugs are required to be confirmed either by a different susceptibility method or by another laboratory capable of performing such testing.

g. For all initial isolates of M. tuberculosis complex, if resistance is found to one or more first-line drugs, additional susceptibility testing must be performed using second-line drugs. If this additional susceptibility testing is not performed in-house, isolates must be shipped via overnight courier or overnight mail to a laboratory capable of performing such testing.

h. For susceptibility tests performed on Mycobacterium tuberculosis isolates, the laboratory must check the procedure each week of use with a strain of Mycobacterium tuberculosis susceptible to all antimycobacterial agents tested.

i. Reports confirming the identification of initial isolates of M. tuberculosis complex shall be communicated to the person authorized to use the test results as soon as they are available to the laboratory.

(2) General immunology and syphilis serology. In addition to the CLIA requirements for General immunology, and syphilis serology, the laboratory shall ensure that confirmatory testing of all HIV positive test results is conducted before any positive test result is reported as required in Section 381.004, F.S., Section 381.0041(5),(6), F.S., and rules promulgated thereunder. The confirmatory test must use a methodology different from the original positive test and have sensitivity and specificity equal to or greater than the original test used.

(4) Hematology. In addition to the CLIA requirements for Hematology, the laboratory shall meet the following requirments:

(a) Prothrombin time. Prothrombin time shall be reported in seconds and incorporate the use of International Normalized Ratio (INR) calculations for patient reporting.

(b) Blood Smears for Manual Differential. Smears of blood, bone marrow or their components shall be prepared for examination and examined in accordance with recognized practice in the specialty of hematology. The uniformity and staining of smears shall be of diagnostic quality. Morphologic abnormalities of red blood cells, white blood cells, or platelets shall be recorded and reported. Whenever possible, manual differential cell counts are to be performed on no less than 100 individual cells. When fewer than 100 cells are examined, the report shall indicate the actual number of cells counted. The laboratory shall maintain for a minimum of two years documentation that initial smears that are interpreted as suspicious for malignant cells are reviewed and confirmed by a laboratory director qualified under Chapter 483, Part III, F.S., according to the limitations described in Section 483.111, F.S.

(5) Cytology. In addition to the CLIA requirements for Cytology, the laboratory shall:

(a) Review no less than 10% of all gynecological smears reported as negative; and

(b) This review shall be performed by a cytology director or supervisor licensed in cytology under Chapter 483, Part III, F.S. The same individual who originally screened the slide shall not conduct this review.

(6) Pathology, cytology, histopathology, and free-standing histology and cytology centers. In addition to the CLIA requirements for Pathology, Cytology and Histopathology, the laboratory or center shall meet the following requirements:

(a) Each facility performing histology and cytology preparation must employ and maintain a system that provides for proper preparation, identification, preservation, transportation, and processing of all specimens, slides, blocks, and associated materials. This system must assure patient specimen integrity and positive identification throughout the entire preparation process.

(b) Procedures for specimen submission and handling. The laboratory must have available and follow written policies and procedures for methods used for specimen acceptance, specimen labeling, specimen preservation, conditions for specimen transportation and specimen processing. Such policies and procedures must assure positive identification and integrity of patient specimens from the time the facility takes possession of the specimen(s) until processing has been completed and the product received by the interpreting laboratory.

(c) A positive control slide of known reactivity must be included with each slide or group of slides stained together for differential and special stains. Fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. Each facility shall develop a mechanism whereby interpreters of the slide have access to a visual representation of the stained control slide for its respective slides.

(d) All patient and control stained slides or their visual representation shall be maintained by the entity that interpreted the specimen for at least ten years from the date of examination. All specimen blocks shall be maintained by the entity that interpreted the specimen for at least two years from the date of examination.

(e) Tissue remnants shall be maintained in a manner that assures proper preservation until the portions submitted for microscopic examination have been examined and a diagnosis reported by the individual qualified to interpret such materials provided under the applicable portions of rule subsection 59A-7.035(1), F.A.C.

(f) Provisions shall be made for the handling and storage of tissues, blocks, slides and records in accordance with CLIA requirements. The laboratory is permitted to store these items off the immediate laboratory premises so long as they are available to the laboratory within twenty-four hours.

(g) All stains and solutions shall be changed at intervals to assure quality staining, but no less than that recommended by the manufacturer.

(h) Paraffin baths temperature shall be documented each day of use.

(i) All automated and semi-automated slide reading devices are subject to the provisions of these rules.

(j) Additional requirements for free-standing histology centers:

1. A free-standing histology center is permitted to prepare slides only for entities that are licensed pursuant to Chapter 483, Part I, F.S., and certified by CLIA to perform histopathology or oral pathology.

2. A free-standing histology center shall comply with all the provisions of this Rule as they apply to the activities performed.

3. A free-standing histology center is not required to meet the proficiency testing provisions of Rules 59A-7.025 and 59A-7.027, F.A.C.

4. A free-standing center shall participate at least twice annually in an external program, such as proficiency testing, to evaluate the quality of its special stains.

5. Each free-standing histology center shall have a valid contract or agreement with each entity for which it prepares slides. At a minimum this document shall contain the following:

a. Services to be provided;

b. Provisions for the transport of unprocessed tissue and other specimens from the laboratory or healthcare provider;

c. Provisions for the transport of slides, embedded material and any non-embedded material from the slide preparation facility to the clinical laboratory where the slides will be read; and

d. Contact information for personnel in the free-standing histology center and the clinical laboratory interpreting the slide who are responsible for transportation of materials.

6. Any tissue, portion of tissue or other specimen not embedded shall not be stored in the slide preparation facility and shall be returned to the clinical laboratory interpreting the slides as soon as practical, but no more than 14 days after the specimen has been reported by the interpreting laboratory.

7. The free standing histology center shall establish, implement and maintain a tracking system that is capable of identifying each specimen received the status of that specimen within the facility and its transportation system; and the disposition of slides, blocks, and tissue remnants. At a minimum, the tracking system must include:

a. Patient name;

b. Unique identification number;

c. Date the specimen was received by common carrier or date the specimen was accepted by facility transportation personnel;

d. Condition received (acceptable, unacceptable, etc.);

e. Date processing began;

f. Date slides were completed and released for transportation to the interpreting clinical laboratory;

g. Date transported to the interpreting laboratory; and

h. Any applicable notations regarding the receipt, processing, or transportation of the specimen.

(7) Immunohematology/Blood Banking.

(a) In addition to the CLIA requirements for Immunohematology/Blood Banking, the laboratory shall meet the following requirements:

1. Employ a control system capable of detecting false positive D(Rho) test results.

2. Establish and follow a policy specifying when testing for weak D(Du) must be performed.

3. Employ a control system using red blood cells sensitized with IgG which must be applied to each antiglobulin test interpreted as negative.

4. Ensure that the ABO group of any uncrossmatched unit to be used for emergency transfusion has been confirmed and matches the ABO group indicated on the unit label prior to its administration.

(b) Laboratories that provide blood and blood products storage facilities shall develop and implement policies and procedures for:

1. The issue and re-issue of blood and blood products;

2. The return of blood after it has been issued;

3. Positive identification for patients;

4. The isolation of untested or potentially infectious blood or blood products;

5. Power failure protection for temperature controlled areas containing blood or blood products, including audible alarms; and

6. Response to alarms.

(8) Clinical Cytogenetics and Fluorescence in situ Hybridization (FISH) Testing for Medical Genetics. In addition to the CLIA requirements for cytogenetics, the laboratory shall meet the following requirements:

(a) Laboratories shall ensure that the type of banding and banding resolution shall be applicable to the case when an appropriate clinical diagnosis is provided, and to the type of tissue studied. A minimum of two adequately banded karyotypes must be prepared. Certain tissue types having abnormalities may require additional karyotypes. A sufficient number of metaphases must be counted and analyzed to ensure that a band-by-band comparison of all homologous chromosomes has been accomplished and has been documented. Clinical diagnoses and/or initial laboratory findings shall be assessed by the laboratory to indicate the need to count or analyze additional metaphases, create additional karyotypes, perform special banding techniques, or perform special hybridization techniques. It is the responsibility of the testing laboratory to identify and perform these additional analyses when needed, as current standards of medical care might dictate.

(b) The sole use of interphase nuclear observations for the purposes of determining the chromosomal status of a patient both for constitutional and acquired chromosome abnormalities shall be limited to those circumstances where these technologies have demonstrated a clear superiority to full chromosome analysis for clinical diagnostic purposes. Only full chromosome analysis shall be permitted, other than under those circumstances where limitations might be imposed by specimen quality and quantity. All other techniques shall be adjunctive only and the patient report shall so indicate.

(c) For lymphocyte and constitutional fibroblast cultures, a total of 20 metaphase spreads from two different cultures should be counted, and a minimum of five metaphases analyzed. When high resolution analysis is requested on constitutional peripheral blood samples, only focused high resolution analysis shall be performed. If non-focused, full high resolution analysis is requested and an attempt made to perform such testing, a statement regarding the limitations of this type of testing must be provided on the final report. Requests for non-focused full high resolution analysis shall be discouraged by the laboratory.

(d) For amniotic fluid and chorionic villus cultures, a minimum of two culture vessels should be employed. A minimum total of 15 colonies and 15 metaphase spreads, or a total of 20 metaphase spreads should be counted. For chorionic villus specimens, a total of 20 metaphase spreads should be counted. For both types of specimens, a minimum of five metaphase spreads must be analyzed.

(e) For oncology specimens (e.g., bone marrow, leukemic blood, lymph node, solid tumor), a total of 20 metaphase spreads from two different cultures should be counted and analyzed.

(f) Laboratory records shall include media utilized, cell culture handling steps, dates of processing, number of cells examined (counted and analyzed), and number of karyotypes produced.

(g) Laboratory testing records and reports shall document and clearly distinguish any communication with the authorized person requesting the test when specimens are so inadequate that the uniform application of these rules cannot be applied. The reason(s) for the specimen inadequacy, when known, are to be included in the testing records and final patient report. In those cases where some aspect of specimen inadequacy leads to the inability to apply uniform or complete application of standards, specimens should still be processed whenever there is a reasonable possibility of achieving some success from a partial analysis.

(h) The laboratory must compare clinical information, when available, with the cytogenetic report and if discrepancies are found, attempt to determine the causes of those discrepancies.

(i) Accurate and correct nomenclature endorsed by the International System for Human Cytogenetic Nomenclature, 1995, Report of the Standing Committee on Human Cytogenetic Nomenclature, incorporated by reference, shall be used in the final report. The final report shall also include clinical recommendations for follow-up or further studies, the number of metaphases counted and analyzed, the number of karyotypes prepared, the date of specimen reception, and date of reporting.

(j) Fluorescence in situ Hybridization (FISH) Testing.

1. Manufacturing source and specific identification of probe(s) employed, as well as number of cells evaluated and hybridization results obtained, shall be reported.

2. The following specific disclaimer must be included in the report: “This test was developed and its performance characteristics determined by (laboratory name). This test may not be cleared or approved for specific uses by the U.S. Food and Drug Administration.”

3. The reporting of preliminary normal results is prohibited; normal results will be reported only after a complete analysis has been performed.

(k) Final reports, photographic negatives, and computer image storage media shall be retained for a minimum of five years. Microscope slides employed for counting and analyzing, and other laboratory and accessioning documents shall be retained for two years. For FISH studies, photographic or digitized images must be retained for a minimum of five years. At least one cell image for normal findings, two cell images for abnormal results, and one cell image for each target where more than 2 chromosomal loci are targets in a single test must be retained.

(l) Both commercially available and in-house developed FISH probes must be validated in two ways, both including sensitivity and specificity: probe validation/chromosome localization, and assay validation. Comparable analytic sensitivity and specificity must be established for each new lot of FISH probe.

(m) Reference ranges for all FISH probes must be monitored either through biannual review or continuous quality monitoring of test results.

(n) Internal or external controls must be run for each FISH assay.

(9) Chemistry, and Histocompatability.

The quality control requirements for the specialties of chemistry, cytogenetics and histocompatability shall meet the CLIA requirements and the requirements of Rule 59A-7.029, F.A.C.

Specific Authority 483.051 FS. Law Implemented 483.051 FS. History–New 11-20-94, Amended 12-27-95,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Patricia L. James

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Alan Levine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 9, 2006

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: June 3, 2005