FLORIDA - BLOOD (DRAWING OF BLOOD) - PART 2

January 1, 2008

Florida state laws and regulations that affect your medical practice

1. What are the requirements necessary for licensed practical nurses to administer intravenous therapy?

A licensed practical nurse's intravenous therapy education must contain the following components:

(a) Policies and procedures of both the Nurse Practice Act and the employing agency in regard to intravenous therapy. This includes legalities of both the Licensed Practical Nurse role and the administration of safe care. Principles of charting are also included.

(c) Site and function of the peripheral veins used for veinpuncture.

(d) Procedure for veinpuncture, including physical and psychological preparation, site selection, skin preparation, palpation of veins, and collection of equipment.

(e) Relationship between intravenous therapy and the body's homeostatic and regulatory functions, with attention to the clinical manifestations of fluid and electrolyte imbalance.

(f) Signs and symptoms of local and systemic complications in the delivery of fluids and medications and the preventive and treatment measures for these complications.

(g) Identification of various types of equipment used in administering intravenous therapy with content related to criteria for use of each and means of troubleshooting for malfunction.

(h) Formulas used to calculate fluid and drug administration rate.

(i) Methods of administering drugs intravenously and advantages and disadvantages of each.

(j) Principles of compatibility and incompatibility of drugs and solutions.

(k) Nursing management of the patient receiving drug therapy, including principles of chemotherapy, protocols, actions, and side effects.

(l) Nursing management of the patient receiving blood and blood components, following institutional protocol. Include indications and contraindications for use; identification of adverse reactions.

(m) Nursing management of the patient receiving parenteral nutrition, including principles of metabolism, potential complications, and physical and psychological measures to ensure the desired therapeutic effect.

(n) Principles of infection control in IV therapy, including aseptic technique and prevention and treatment of iatrogenic infection.

(o) Nursing management of special IV therapy procedures that are commonly used in the clinical setting, such as heparin lock, central lines, and arterial lines.

(p) Glossary of common terminology pertinent to IV fluid therapy.

(q) Performance check list by which to evaluate clinical application of knowledge and skills.

Central Lines:

The Board recognizes that through appropriate education and training, a Licensed Practical Nurse is capable of performing intravenous therapy via central lines under the direction of a registered professional nurse. Appropriate education and training requires a minimum of four (4) hours of instruction. The requisite four (4) hours of instruction may be included as part of the thirty (30) hours required for intravenous therapy education. The education and training required in this subsection shall include, at a minimum, didactic and clinical practicum instruction in the following areas:

(a) Central venous anatomy and physiology;

(b) CVL site assessment;

(c) CVL dressing and cap changes;

(d) CVL flushing;

(e) CVL medication and fluid administration;

(f) CVL blood drawing; and

(g) CVL complications and remedial measures.

Upon completion of the intravenous therapy training via central lines, the Licensed Practical Nurse shall be assessed on both theoretical knowledge and practice, as well as clinical practice and competence. The clinical practice assessment must be witnesses by a Registered Nurse who shall file a proficiency statement regarding the Licensed Practical Nurse's ability to perform intravenous therapy via central lines. The proficiency statement shall be kept in the Licensed Practical Nurse's personnel file.

Providers:

The LPN/IV education must be sponsored by a provider of continuing education courses approved by the Board pursuant to Rule 64B9-5.005. To be qualified to teach any such course, the instructor must be a currently licensed registered nurse in good standing in this state, have teaching experience, and have professional nursing experience, including IV therapy. The provider will be responsible for issuing a certificate verifying completion of the requisite number of hours and course content.

Educational Alternatives. The cognitive training shall include one or more of the following:

(a) Post-graduate Level Course. In recognition that the curriculum requirements mandated by Rule 64B9-2.006(3) for practical nursing programs are extensive and that every licensed practical nurse will not administer IV Therapy, the course necessary to qualify a licensed practical nurse to administer IV therapy shall be not less than a thirty (30) hour post-graduate level course teaching aspects of IV therapy containing the components enumerated in 64B9-12.005(1).

(b) Credit for Previous Education. The continuing education provider may credit the licensed practical nurse for previous IV therapy education on a post-graduate level, providing each component of the course content of 64B9- 12.005(1) is tested by and competency demonstrated to the provider.

(c) Nontraditional Education. Continuing education providers may select nontraditional education alternatives for acquisition of cognitive content outlined in 64B9-12.005. Such alternatives include

1. Interactive videos;

2. Self study;

3. Other nontraditional education that may be submitted to the Board for consideration and possible approval. Any continuing education providers using nontraditional education must make provisions for demonstration of and verification of knowledge.

Clinical Competence:

The course must be followed by supervised clinical practice in intravenous therapy as needed to demonstrate clinical competence. Verification of clinical competence shall be the responsibility of each institution employing a licensed practical nurse based on institutional protocol. Such verification shall be given through a signed statement of a Florida licensed registered nurse.

64 FL ADC 64B9-12.005

2. What are the personnel requirements for alternate-site testing (laboratory tests performed in a hospital facility out of the physical or administrative confines of the central laboratory)?

(a) Testing personnel shall have a high school diploma, or its equivalent, and have met the HIV/AIDS educational requirements. In addition, all testing personnel in the alternate-test site locations shall meet one of the following requirements:

1. Is licensed as a registered nurse or licensed practical nurse.

2. Is licensed as a radiologic technologist.

3. Is licensed as a respiratory care practitioner certified in critical care services or a respiratory therapist.

4. Is a phlebotomist certified by the American Society of Clinical Pathologists (ASCP), National Certification Agency for Medical Laboratory Personnel (NCA), American Society of Phlebotomy Technicians (ASPT) or American Medical Technologists (AMT).

5. Is licensed as a physician assistant.

6. Is a perfusionist certified by the American Board of Cardiovascular Perfusionists.

7. Is a cardiovascular technician certified by the American Board of Cardiovascular Perfusion, or

8. Is licensed as a director, supervisor, technologist or technician.

(b) The laboratory director shall, in consultation with medical staff designated by the hospital, establish the training needs for the test methods used at each site. This training at a minimum must ensure that alternate-site testing personnel have had instruction in the following areas:

1. Specimen collection, handling and storage including infection control procedures.

2. Instrument procedures including skills required to perform preventive maintenance, calibration and troubleshooting.

3. Skills required to implement quality control procedures and evaluate quality control results.

4. Skills required to perform specific test procedures.

5. Result reporting and documentation techniques including knowledge of reporting procedures for life threatening results.

6. Awareness of the factors that influence test results including the skills required to assess and verify the validity of patient test results through the assessment and correlation of pre-analytical and post-analytical phases of testing with laboratory data generated during the analytical phase of testing as they relate to common physiological conditions and quality control, and

7. Monitoring of systems and results for errors including instruction on corrective action including whether or not results can be reported.

(c) Successful completion of a training program approved by the Board of Clinical Laboratory Personnel shall meet the minimum training requirements specified in (b), above.

Responsibilities of the laboratory director pertaining to the alternate-test site.

(a) The laboratory director shall:

1. Ensure that testing personnel are limited to those who meet the requirements of Rule 59A-7.034(5)(a); and

2. Establish methods for the evaluation of competency to verify that alternate-site testing personnel perform procedures and report test results promptly and accurately. Evaluation of competency shall include:

a. Sample handling skills;

b. Skills required to perform the test method;

c. Skills required to perform preventive maintenance, troubleshooting, and calibration procedures, applicable to the test methodologies;

d. Demonstration of knowledge of reagent stability and storage applicable to the test system in use;

e. Skills required to implement quality control policies and procedures and evaluate quality control results;

f. An awareness of the factors that influence test results;

g. Skills required to assess and verify the validity of patient test results through the assessment of quality control results;

h. Demonstration of knowledge of patient preparation for each test performed;

i. Demonstration of knowledge of infection control procedures; and

j. Demonstration of knowledge of reporting procedures for life threatening results.

(b) Validation of personnel competency shall include review of test results, quality control records, proficiency testing results and preventive maintenance records; direct observation of test performance and instrument maintenance; and assessment of performance through testing previously analyzed specimens, internal blind samples, or proficiency testing samples.

(c) Evaluation of competency for alternate-site testing personnel must be performed prior to initiation of patient testing and at least annually thereafter.

(d) Documentation of licensure or certification, as applicable, pursuant to Rule 59A-7.034(5), and competency evaluations must be maintained during the tenure of all testing personnel and for a minimum of two years thereafter and made available to the agency at the time of inspection.

(7) Tests performed. Only test procedures approved by the laboratory director and documented in the internal needs assessment in accordance with Rule 59A-7.034, shall be performed at the alternate-test site.

(a) Tests performed at these sites shall not exceed moderately complex test procedures and must:

1. Employ whole blood specimens that require no specimen or reagent manipulation, treatment, extraction, separation or any other processing of any kind; and

2. Utilize automated test systems in which a specimen is directly introduced into the system. Such instrumentation shall automatically provide for instrument calibration without access by the operator to modify or adjust calibration limits.

(b) Alternate-test sites are also permitted to perform waived tests, activated clotting times, gastric occult blood, gastric pH and urine specific gravity by refractometer.

(c) Data output must be directly reportable in the final units of measurement needed for patient care without need for data conversion or other manipulation.

(d) Electronic instrumentation must have a mechanism whereby the operator is alerted when patient results exceed the reportable operating range of the test method and when calibration is not acceptable; such results shall not be used for the diagnosis, treatment, management or monitoring of patients as required under Rule 59A-7.029, and shall be validated through the central laboratory.

(e) Notwithstanding (b), above, waived tests are permitted to be performed under a certificate of exemption. Such testing shall meet the requirements specified for a certificate of exemption.

(8) The agency shall take administrative action up to and including revocation of the approval for operation of any or all alternate-testing sites where the agency determines that said sites have operated in violation of applicable statutes. In the event of such a violation, the agency shall take administrative action up to and including revocation of the laboratory license of the laboratory maintaining the alternate-testing site.

59 FL ADC 59A-7.034

3. What are the requirements for collecting blood samples for law enforcement purposes?

(1) Before collecting a sample of blood, the skin puncture area must be cleansed with an antiseptic that does not contain alcohol.

(2) Blood samples must be collected in a glass evacuation tube that contains a preservative such as sodium fluoride and an anticoagulant such as potassium oxalate or EDTA (ethylenediaminetetraacetic acid). Compliance with this section can be established by the stopper or label on the collection tube, documentation from the manufacturer or distributor, or other evidence.

(3) Immediately after collection, the tube must be inverted several times to mix the blood with the preservative and anticoagulant.

(4) Blood collection tubes must be labeled with the following information: name of person tested, date and time sample was collected, and initials of the person who collected the sample.

(5) Blood samples need not be refrigerated if submitted for analysis within seven days of collection, or during transportation, examination or analysis. Blood samples must be otherwise refrigerated, except that refrigeration is not required subsequent to the initial analysis.

(6) Blood samples must be hand-delivered or mailed for initial analysis within thirty days of collection, and must be initially analyzed within sixty days of receipt by the facility conducting the analysis. Blood samples which are not hand-delivered must be sent by priority mail, overnight delivery service, or other equivalent delivery service.

(7) Any blood analysis results obtained, notwithstanding any other requirements, shall be acceptable as a valid blood alcohol level.

11 FL ADC 11D-8.012

2. What procedures must be followed to comply with drug-free workplace standards?

(1) Designation of Collection Sites. For urine and blood specimen collection, each laboratory that has a contract or agreement for testing services with an employer, shall provide collection sites under contract and training for collectors, or shall provide a trained collector to collect specimens for the employer at any time designated by the employer in his contract or agreement with the laboratory. The collector shall be responsible to the laboratory for implementing collection procedures and chain of custody procedures. The laboratory shall provide to the collection site, or collector, specimen collection kits which, as applicable, shall contain chain of custody forms, mailing boxes or containers, specimen identification labels, laboratory address labels, urine specimen bottles, external temperature strips, tamper-proof plastic sealable bags and forensic tamper-proof tape to seal the specimen containers(s). Kits for alcohol testing must have a 7ml blood vial that contains an anticoagulant and a preservative of sodium fluoride. Employers who do not use hair testing for their drug-free workplace program shall not be required to maintain collection facilities and personnel for hair testing.

(2) Chain of Custody Form and Procedures. Chain of custody refers to the methodology of documenting the tracking of specified materials or substances for the purpose of maintaining control and accountability from initial collection to final disposition of all such materials or substances and providing for accountability at each stage in handling, testing, storing and reporting of the test results. The agency chain of custody forms shall be utilized for this purpose. These forms will be available from each laboratory licensed under these rules. Each laboratory shall be responsible for obtaining these forms from a vendor of their choosing. The agency shall provide one camera-ready copy of this form to each laboratory upon request.

(a) A chain of custody form shall be completed for each donor tested.

(b) Each laboratory licensed under these rules shall provide legally defensible chain-of-custody forms to be used for each donor.

(c) All chain of custody forms shall provide a unique identifier which shall not be used to identify any other Florida Drug Free Workplace specimen. The employer is permitted to assign an employee identification number for use with each donor tested.

(d) The design of the chain of custody forms shall meet the following requirements:

1. Prominently indicate the name and address of the laboratory performing the drug test(s).

2. A section to be completed by the collector or employer representative that solicits the following information:

a. Employer name and address;

b. Medical review officer name and address;

c. Employee identification number;

d. Reason for the test(s); and

e. Tests to be performed.

3. A section which indicates the temperature of urine specimens taken within 4 minutes of collection. This shall not be required for chain-of-custody forms for hair specimens.

4. A section to be completed by the collector that indicates the following:

a. The collection facility name, address and telephone number;

b. A designation that a split sample was or was not collected;

c. A remarks section;

d. A statement for the collector to sign incorporating the following language:

I certify that the specimen identified on this form is the specimen presented to me or collected by me from the donor providing certification on Copy 4 of this form, that it bears the same identification number as set forth above, and that it has been collected, labeled and sealed in accordance with the Florida Drug-Free Workplace as found in Section 112.0455, F.S., and Chapter 59A-24, F.A.C.; and

e. A place for the collector to print his name, a place for the collector's signature and the date and time.

5. A section to be initiated by the collector and completed as necessary thereafter that documents the transfer of the specimen for the purpose of maintaining control and accountability for the specimen. At a minimum, this section shall indicate:

a. Date of transfer;

b. Signature and name of the person releasing the specimen;

c. Signature and name of the person receiving the specimen; and

d. Purpose of the transfer.

6. A section to be completed by the laboratory which indicates the following:

a. An indication as to whether the specimen was received with intact specimen seals;

b. The test results;

c. Contains the following statement for the certifying scientist to sign: I certify that the specimen identified by the laboratory accession number on this form is the same specimen identification number set forth above, that the specimen has been examined upon receipt, handled and analyzed in accordance with the Florida Drug-Free Workplace Program requirements as found in Section 112.0455, F.S. and Chapter 59A-24, F.A.C., and that the results set forth are for that specimen; and

d. A place for the certifying scientist to print his name, the signature of the certifying scientist and the date.

7. A section to be completed by the Medical Review Officer including the following:

a. The statement: I have reviewed the laboratory test(s) for the specimen identified by this form in accordance with the Florida Drug-Free Workplace Program as found in Section 112.0455, F.S., and Chapter 59A-24, F.A.C.;

b. A space for determination of test results as one of the following:

I. Negative;

II. Positive;

III. Test not performed; and

IV. Test canceled.

c. A place for remarks;

d. The signature of the Medical Review Officer; and

e. The name of the Medical Review Officer and the date.

8. The chain of custody form shall be comprised of the following copies for distribution:

a. Original laboratory copy (Copy 1) which shall be routed to the laboratory with the specimen; the laboratory will retain upon the completion of testing.

b. Second Original Laboratory copy (Copy 2) which shall be routed to the laboratory with the specimen; as a means or reporting the test result, the laboratory will forward the copy to the Medical Review Officer.

c. Split specimen copy (Copy 3) which must accompany the split portion to the laboratory. Split sample testing is optional.

d. Medical Review Officer copy (Copy 4) which shall be routed directly to the MRO by the collection site personnel; this form copy is not to be sent to the laboratory.

e. Donor copy (Copy 5) which shall be given to the donor by the collector. Do not send to the laboratory.

f. Collector copy (Copy 6) which shall be retained by the collector. Do not send to the laboratory.

g. Employer copy (Copy 7) which shall be forwarded to the employer.

(e) Forms are permitted to be modified to indicate specialized specimen identification numbering systems, laboratory identification information and logos, and specimen labels provided that:

1. The content of each section of the form is not altered.

2. The instructions are not altered.

3. The sequence, number and color of the copies are not altered.

4. The drugs listed in the reverse of Copy 5 are not altered.

(f) The form shall contain no information which can be traceable to the donor except the unique identifier, the employee identification number, if used, and the laboratory's specimen identification number.

(g) The form shall also contain the following list of over-the-counter and prescription drugs which could alter or affect a test result. Due to the large number of obscure brand names and constant marketing of new products, this list, as follows, is not intended to be all-inclusive:

Alcohol All liquid medications containing ethyl alcohol (ethanol). Please read the label for alcohol content. As an example, Vick's Nyquil is 25% (50 proof) ethyl alcohol. Comtrex is 20% (40 proof), Contact Severe Cold Formula Night Strength is 25% (50 proof) and Listerine is 26.9% (54 proof).

Amphetamines Obetrol, Biphetamine, Desoxyn, Dexedrine, Didrex, Ionamine, Fastin

Cannabinoids Marinol (Dronabinol, THC)

Cocaine Cocaine HCl topical solution (Roxanne)

Phencyclidine Not legal by prescription

Methaqualone Not legal by prescription

Opiates Paregoric, Parepecolin, Donnagel PG, Morphine, Tylenol with Codeine, Empirin with Codeine, APAP with Codeine, Aspirin with Codeine, Robitussin AC, Guiatuss AC, Novahistine DH, Novahistine Expectorant, Dilaudid (Hydromorphone), M-S Contin and Roxanol (morphine sulfate), Percodan, Vicodin, Tussi-organidin, etc.

Barbiturates Phenobarbital, Tuinal, Amytal, Nembutal, Seconal, Lotusate, Fiorinal, Fioricet, Esgic, Butisol, Mebaral, Butabarbital, Butalbital, Phrenilin, Triad, etc.

Benzodiazepines Ativan, Azene, Clonopin, Dalmane, Diazepam, Librium, Xanax, Serax, Tranxene, Valium, Verstran, Halcion, Paxipam, Restoril, Centrax

Methadone Dolophine, Metadose

Propoxyphene Darvocet, Darvon N, Dolene, etc.

(h) Handling and transportation of a specimen from one authorized individual or place to another shall always be accomplished through the chain of custody form and procedures. The chain of custody form shall be used for maintaining control and accountability of each specimen from the point of collection to final disposition of the specimen at the laboratory. The purpose of the transfer of possession, the name and signature of the person releasing and receiving the specimen, and the date shall be documented on the form each time a specimen is handled or transferred and every individual in the chain shall be identified. Since the specimen and the chain of custody form are sealed in tamper-proof sealable plastic bags that would indicate any tampering during transit to the laboratory, and since couriers, express carriers and postal service personnel do not have access to the chain of custody forms, there is no requirement that such personnel document chain of custody for the shipping container during transit. Nor is there a requirement that there be a chain of custody entry when a specimen which is sealed in such a shipping container is placed in or taken out of secure storage at the collection site prior to pickup by such personnel. A test shall not be canceled because couriers, express carriers, postal service personnel or other persons involved solely with the transportation of a specimen to a laboratory have not documented their participation in the chain of custody or because the chain of custody does not contain entries related to placing the specimen in or removing it from secure temporary storage at the collection site.

(i) Once the specimen has arrived at the laboratory, an internal chain of custody form shall be used by the laboratory until the laboratory has finalized the test results.

(j) Every effort shall be made to minimize the number of persons handling the specimens.

(3) Security Procedures and Specimen Collection. Collection site security and specimen collection security are the responsibility of the collector through contract with the licensed laboratory. Security procedures shall provide for the designated collection site to be secure including the providing of privacy for the donor and the integrity of the specimen.

(a) Access to Authorized Personnel Only. No unauthorized personnel shall be permitted in any part of the designated collection site when specimens are collected or stored.

(b) Privacy. Procedures for collecting urine specimens shall allow individual privacy unless there is reason to believe that a particular individual intends to alter or has altered or substituted the specimen to be provided.

(c) Integrity and Identity of Specimen. The collection site person shall take precautions to ensure that a specimen not be adulterated or diluted during the collection procedure and that information on the collection bottle and on the chain of custody form can identify the individual from whom the specimen was collected. The following minimum precautions shall be taken to ensure that unadulterated specimens are obtained and correctly identified.

1. Blood alcohol specimens shall be collected using aseptic venipuncture technique. The venipuncture site for blood alcohol shall be cleansed with a non-alcoholic antiseptic substance prior to collection. Blood specimens shall contain 7 ml of blood which shall be collected in one tube containing an anticoagulant and a preservative of sodium fluoride. Immediately after collection, the collection site person shall rock the tube gently to mix the anticoagulant and preservative substance with the blood.

9. While any part of the above chain of custody procedures is being performed, it is essential that the specimen and the chain of custody form be under the control of the collection site person. If the collection site person leaves his or her work station momentarily, the specimen and the chain of custody form shall be taken with him or her or shall be secured in a locked room, drawer, file cabinet, etc. After the collection site person returns to the work station, the chain of custody process will continue. If the collection site person is leaving for an extended period of time, the specimen shall be packaged for shipment before he or she leaves the site.

10. The collection site person shall arrange to send the collected specimens by express shipment, courier, or U.S. Mail to the drug testing laboratory which is designated by the employer. The specimens shall be placed in containers designed to minimize the possibility of damage during shipment. Prior to shipping or storage, the collection site person shall ensure that:

a. The specimen container is sealed with forensic tamper-proof tape;

b. The forensic tamper-proof tape contains the initials of the donor, the date the specimen was sealed in the specimen container; and

c. The completed chain of custody form and specimen container is enclosed and sealed in a tamper-proof sealable plastic bag before packaging for shipment to the drug testing laboratory.

59 FL ADC 59A-24.005

3. What procedures must be followed with respect to metabolic screening of newborn infants?

(1) Each live born infant shall be screened for phenylketonuria, hypothyroidism, galactosemia, and designated disorders unless the parent or guardian objects to the screening.

(2) The infant's blood shall be collected on a specimen slip. The form may be obtained through any DOH County Health Department. The slip with blood and completed data must be inserted into the protective envelope and mailed to an approved laboratory within 24 hours after collection.

(3) The infant's blood for these tests shall be collected not earlier than 48 hours after birth and not before the infant has been on a protein diet for at least 24 hours, except as stated in (4) and (5), and no later than 5 days after birth.

(4) When a live birth occurs in a hospital, the responsible physician shall obtain a satisfactory blood specimen prior to the infant's discharge from the hospital. If the infant is discharged from the hospital before 48 hours after birth, or before being on a protein diet for 24 hours, a blood specimen shall be collected regardless, but collection shall be repeated after 48 hours and no later than 5 days after birth. At or before discharge, the hospital administrator or a designated representative shall provide a written notice to the parents, guardian, or other legally responsible person of the requirements for such newborn to be tested again prior to 5 days after birth. The primary responsibility for assuring repeat testing remains with the hospital.

(5) When a live birth occurs in a facility other than a licensed hospital, the professional person in attendance at the birth shall obtain a satisfactory blood specimen prior to the infant's discharge from the facility. If the infant is discharged from the facility before 48 hours after birth, or before being on a protein diet for 24 hours, a blood specimen shall be collected regardless, but collection shall be repeated after 48 hours and no later than 5 days after birth. At or before discharge, the facility administrator or a designated representative shall provide a written notice to the parents, guardian or other legally responsible person of the requirements for such newborn to be tested again prior to 5 days after birth.

64 FL ADC 64C-7.002

4. What is included in blood bank transfusion services?

A blood bank transfusion service shall include the collection of blood and blood components, performance of therapeutic collection or pheresis, preparation of red blood cells and the recovery of human plasma.

59 FL ADC 59A-7.020

Blood banks offering only transfusion services shall not be required to obtain a license.

59 FL ADC 59A-7.019

5. For what procedures is a license required?

Facilities where crossmatching, prenatal immunohematology procedures, donor processing or other procedures required for therapeutic administration or collection of blood or blood products are performed shall be considered a clinical laboratory and shall be required to obtain a license.

59 FL ADC 59A-7.019

6. What is the scope of practice for clinical laboratory personnel relative to particular specialties?

The following rules are not intended to prevent collection and storage of specimens or the performance of manual pretesting procedures by persons who are exempt by statute or statutorily authorized within their scope of practice. Clinical laboratory personnel qualified as a physician director, supervisor, technologist or technician in the specialty or specialties indicated can perform testing identified as being within the specialty.

(1) The scope of practice for licensed clinical laboratory personnel includes specimen collecting, processing, storing, shipping and performing manual pretesting procedures.

(2) The scope of practice for licensed clinical laboratory technologists, supervisors and directors includes interpretation of clinical laboratory test results.

(3) The purpose of the specialty of microbiology is to provide diagnostic testing for and optimum management of infectious disease in patients and to prevent the spread of infection to other individuals. Testing shall include procedures performed to culture, isolate, identify and determine the susceptibility of microbes. Testing also encompasses direct examination and microbial antigen detection methods. The term microbes includes bacteria, fungi, mycobacteria, viruses, rickettsia, parasites and emerging, unclassified infectious agents. Directors, supervisors and technologists licensed in the specialty may provide consultation in the areas of infection control and epidemiology and administer intra-dermal skin tests and vaccines.

(4) The purpose of the special of serology/immunology is to detect and quantitate antibodies to infectious agents as well as microbial and non-microbial antigens. The specialty encompasses all the serological techniques (except those specific to immunohematology) used to detect the interaction of antigens with antibodies for evaluation of the consequences of the immune response. The specialty also encompasses all laboratory procedures performed in the specialty of histocompatability as defined in subsection (15).

(5) The purpose of the specialty of hematology is to quantitatively and qualitatively evaluate cells in peripheral blood and bone marrow, their production, maturation and release; their morphology, chemistry and function; and diagnostic testing for optimum management of primary and secondary hematological disorders. Testing in this specialty also encompasses all the routine and special procedures, except those specific to cytology, performed to evaluate the numbers, morphology and function of cells in body fluids including urine and the evaluation of hemostatis and thrombosis and the management of anticoagulant therapy. Testing in this specialty may also encompass urine chemistries specific to routine urinalysis.

(6) The purpose of the specialty of immunohematology is to insure the best possible outcomes of blood or blood component and apheresis by the accurate performance of all pre-transfusion testing; to prevent transfusion transmitted infections; and to investigate and evaluate post-transfusion reactions. The specialty also encompasses all laboratory procedures performed in the specialty of histocompatibility as defined in subsection (15).

(7) The purpose of the specialty of clinical chemistry is to perform qualitative and quantitative analyses on body fluids such as blood, urine, spinal fluid, feces, tissue, calculi and other materials to measure the chemical constituents including but not limited to carbohydrates, proteins, lipids, enzymes, non-protein nitrogenous substances, electrolytes, blood gases, trace elements, inorganic compounds, therapeutic and drugs of abuse, hormones, vitamins, tumor markers, other automated immunoassays and other analyses. The specialty also encompasses urine microscopics and the chemical evaluation of liver, renal, lung, cardiac, neuromuscular, reproductive, bone, endocrine and other organ function and pathology and all testing included in the specialties of radioassay as defined in subsection (9) and blood gas analysis as defined in subsection (10). Individuals employed in plasmapheresis centers who perform only total protein by refractometer are not required to hold a license in clinical chemistry if they meet the requirements of 42 CFR 493.1423 and can document appropriate training.

(8) The purpose of the specialty of blood banking is to perform all testing identified as being within the scope of the specialty of immunohematology as well as testing within the scope of clinical chemistry, hematology and serology/immunology that pertains strictly to the processing of donor blood and blood products. Clinical laboratory personnel who are licensed in the specialties of immunohematology, clinical chemistry, hematology and serology/immunology may perform all testing identified as being within the scope of the specialty of blood banking.

(9) The purpose of the specialty of radioassay is to perform qualitative and quantitative analyses on body fluids such as blood, urine, and other materials to measure certain chemical constituents using radionuclides as part of the assay. The scope of practice in this specialty is limited to radioassay procedures and is also contained in the scope of clinical chemistry.

(10) The purpose of the specialty of blood gas analysis is to evaluate pulmonary function by measuring pCO2, pO2, pH, and hemoglobin in arterial blood by automated techniques. Instrument calculated values such as base excess, P50, oxygen content, oxygen saturation and associated parameters are also encompassed in this specialty. The scope of practice in this specialty is limited to blood gas analysis and is also contained in the scope of clinical chemistry.

(11) The purpose of the specialty of histology is to process cellular and tissue components through methods of fixation, dehydration, embedding, microtomy, frozen sectioning, staining, and other related procedures and techniques employed in the preparation of smears, slides, and tissues. This specialty also encompasses methods for antigen detection and other molecular hybridization testing methods where the purpose is analysis and/or quantification of cellular and tissue components for interpretation by a qualified physician. Technicians licensed in histology are limited to the performance of specimen processing, embedding, cutting, routine and special histologic staining, frozen sectioning and mounting of preparations under the general supervision of a director, supervisor, or technologist.

(12) The purpose of the specialty of cytology is to process and interpret cellular material derived from the human body delineating data regarding human cytopathological disease. Cytology includes:

(a) Review and interpretation of gynecological cytology preparations;

(b) Screening of non-gynecological cytology preparations where final review and interpretation is the responsibility of a qualified physician; and

(c) Process, perform, review and correlate diagnostic techniques ancillary to liquid based cytology.

(13) The purpose of the specialty of cytogenetics is to determine the presence or absence of quantitative (numerical) and qualitative (structural) chromosome abnormalities relating to constitutional and acquired disorders. Laboratory personnel providing counseling associated with the results of cytogenetics testing shall be licensed in cytogenetics at the director level.

(14) The purpose of the specialty of molecular pathology is the use of molecular techniques for the characterization of gene expression (protein, RNA), genetic lesions ((DNA) in cells, gene products (proteomics) and analysis on human DNA< RNA and chromosomes to detect heritable or acquired disease-related genotypes, mutations, and phenotypes. It includes the study of how the changes found lead to the disease process, monitoring of the effectiveness of therapy, and detection of residual disease. Techniques included are but are not limited to immunohistochemistry, in situ hybridization, mutational analysis, protein analysis, polymerase chain reactions, cell culture and isolation, expression profiling, blotting and microarrays.

(15) The purpose of the specialty of histocompatibility is to insure the best possible results of the determination of tissue compatibility, prevent transmitted infections, and to investigate and evaluate post-transplant problems. The specialty encompasses blood typing, HLA typing, HLA antibody screening, disease markers, Cluster Designation specific to tissue compatibility, flow cytometry, crossmatching, HLA antibody identification, lymphocyte immunophenotyping, immunosuppressive drug assays, allogenic, isogenic and autologous bone marrow processing and storage, mixed lymphocyte culture, stem cell culture, cell mediate assays, and assays for the presence of cytokines.

(16) In the specialties of clinical chemistry, hematology, immunohematology, microbiology and serology/immunology, clinical laboratory personnel licensed at the technician level may perform testing identified within the scope of each specialty, in any specialty for which they hold licensure if the tests are classified as highly complex, only when under the direct supervision of a licensed technologist, supervisor or director unless the technician meets minimum qualifications and requirements.

(17) There is no technician license available in radioassay, blood gases, cytogenetics, or histocompatibility. However, clinical laboratory technicians licensed in the specialties of radioassay, blood gas analysis and cytogenetics prior to March 28, 1995, may continue to perform such testing , under direct supervision.

(18) Inidividuals using flow cytometry or molecular detection techniques must be able to demonstrate training or experience in this procedure, and must hold licensure in the specific discipline for which they are using flow cytometry and molecular detection techniques.

(19) The purpose of the specialities of andrology and embryology is to quantitatively and qualitatively evaluate gametes and embryos as well as their associated fluids and tissues, their production, maturation and release, their morphology, numbers and motility, chemistry and function, cellular development, and diagnostic testing for optimum management of primary and secondary infertility, fertility assessment, and fertility preservation. This would encompass all testing and procedures involved in the production and storage of gametes and embryos, including micro-techniques and cryopreservation of gametes, embryos, associated fluids and tissues. Simple sperm count and motility could be excluded from the category of andrology.

64 FL ADC 64B3-10.005

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.