Alabama Administrative Code
Title 420 - ALABAMA STATE BOARD OF HEALTH
Chapter 420-5-8 - INDEPENDENT CLINICAL LABORATORIES
Section 420-5-8-.04 - Management
Universal Citation: AL Admin Code R 420-5-8-.04
Current through Register Vol. 42, No. 5, February 29, 2024
(1) Personnel.
(a) The laboratory shall be under the
direction of a director and shall provide the number of other qualified
personnel commensurate with the volume and type of tests performed.
(b) The laboratory shall perform only those
laboratory procedures and tests that are within the specialties or
subspecialties in which the laboratory director, supervisors, or persons
engaged to perform tests are qualified.
(c) The laboratory may perform laboratory
procedures and tests in all specialties provided that the director or
supervisor is a pathologist certified or eligible for certification in both
anatomical and clinical pathology by the American Board of Pathology or
American Osteopathic Board of Pathology.
(d) In circumstances where AAC Rule
420-5-8.04(1) (c) is not met, the following criteria shall be used to establish
qualifications of laboratory personnel to perform each specialty:
1. Microbiology, including serology - The
laboratory engages the services of an individual who holds an earned doctoral
degree or master's degree in microbiology from an accredited institution or is
a licensed practitioner of the healing arts with two years of experience in
microbiology.
2. Hematology - The
laboratory engages the services of an individual who holds a master's or
bachelor's degree in biology, immunology or microbiology from an accredited
institution and has had at least four years experience in hematology or is a
licensed practitioner of the healing arts with pertinent experience.
3. Immunohematology - The laboratory engages
the services of a licensed physician with specific experience in this field or
an individual with a master's or bachelor's degree in biology, immunology or
microbiology from an accredited institution and has four years of experience in
immunohematology.
4. Chemistry -
The laboratory engages the services of an individual who holds an earned
doctoral degree or master's degree in chemistry or biochemistry from an
accredited institution or is a licensed practitioner of the healing arts with
two years experience in clinical chemistry.
5. Histopathology - The laboratory engages
the services of a licensed practitioner in the healing arts who is certified in
anatomic pathology or is eligible for certification by the American Board of
Pathology or the American Board of Osteopathic Pathology or possesses
qualifications which are equivalent to those required for certification by
these Boards.
6. Cytotechnology -
The laboratory engages the services of a licensed practitioner of the healing
arts who is certified in anatomic pathology or is eligible for certification by
the American Board of Pathology or the American Osteopathic Board of Pathology
or is certified by the American Society of Cytology to practice cytopathology
or who possesses qualifications which are equivalent to those required for
certification by these Boards.
(2) Operation.
(a) Equipment shall be provided and
maintained for the proper performance of the specialties and volume of service
offered.
(b) The laboratory shall
be in compliance with all state and local laws and regulations including those
relating to construction and sanitary conditions and also including the
handling and disposal of specimens.
(3) Administration and Organization.
(a) The director shall serve the laboratory
full time or on a regular part-time basis and shall be readily available for
personal or telephone consultations.
(b) If the director is not in attendance
throughout normal periods of operation, at least one clinical laboratory
supervisor shall be available and on the premises.
(c) The licensee shall be responsible for the
proper maintenance and conduct of the laboratory.
(4) Procedures and Equipment.
(a) All technical procedures employed in the
laboratory shall be the standard procedures which are generally accepted by
leading authorities in microbiology, serology, chemistry, hematology,
immunohematology, biophysics, cytotechnology, and histopathology as applicable
or are equivalents approved by the Alabama Department of Public
Health.
(b) There shall be quality
control procedures in effect, including the use of reference and control sera
and other biological samples, calibrating standards, and control
charts.
(c) All equipment shall be
in good working order, routinely checked and calibrated, and documentation of
checks and calibrations shall be maintained.
(d) Syringes, needles, lancets, or other
blood-letting devices capable of transmitting infection from one person to
another shall be cleaned and sterilized prior to each use. Each sterilizing
cycle shall contain an indicator device which assures proper
sterilization.
(e) A specimen
received by a laboratory shall not be tested or reported if:
1. The apparent condition of the specimen
indicates that it is unsatisfactory for testing or that it is inappropriate for
the test requested.
2. It has been
collected, labeled, preserved, or otherwise handled in such a manner that it
has become unsatisfactory or unreliable as a test specimen.
3. It is perishable and the time lapse
between the collection of the specimen and its receipt by the laboratory is of
such duration that the test finding may no longer be reliable.
4. When a specimen is not tested for any of
the reasons specified in AAC Rule 420-5-8.04(4)(e), the laboratory shall
promptly notify the sender and give the reason therefore.
(f) Notebooks or manuals containing
appropriate current laboratory methods shall be maintained.
(5) Records and Reports.
(a) All changes in clinical laboratory
personnel shall be reported to the Alabama Department of Public Health
initially and annually at time of licensing.
(b) Modifications of facilities or services
affecting the operation of the laboratory shall be reported to the Alabama
Department of Public Health annually at the time of licensing.
(c) The laboratory shall participate in one
or more of the proficiency testing programs offered by state or private
organizations approved by the Alabama Department of Public Health. The results
of such programs shall be made available to the Alabama Department of Public
Health for review upon request. Proficiency testing is not required for CLIA
waived tests as published by the U.S. Food and Drug Administration at
http://www.fda.gov.
(d) Records shall be maintained on each
specimen received for testing and shall contain the following information:
1. Laboratory number or other identification
of the specimen.
2. Name and other
identification of the person from whom the specimen was taken.
3. Name and address of the licensed
practitioner of the healing arts or other authorized person or clinical
laboratory that submitted the specimen.
4. Date the specimen was collected.
5. Condition of unsatisfactory specimens when
received (e.g., broken, leaked, hemolyzed, turbid).
6. Date the specimen was received.
7. Date the specimen was tested.
8. Type of test performed.
9. Complete information as to the disposition
of the specimen when it has been referred to another laboratory for
examination.
10. Result of test and
date of reporting.
(e)
The laboratory director is responsible for laboratory reports and the following
records shall be maintained:
1. Tissue
pathology reports utilizing acceptable terminology of a recognized system of
disease nomenclature.
2. Duplicate
copies of laboratory reports shall be filed in the laboratory or stored in a
readily accessible location for at least two years.
3. Records and reports of examinations of all
specimens shall be treated as confidential information.
(6) Collection Stations.
(a) Clinical laboratories operating
collection stations within this state shall obtain a license from the Alabama
Department of Public Health for each collection station. Such collection
stations shall be maintained in accordance with the following requirements:
1. A refrigerator which maintains a
temperature of 40-50 degrees F. shall be available on the premises for storage
of specimens.
2. Syringes, needles,
lancets, or other blood-letting devices capable of transmitting infection from
one person to another shall be clean and sterile prior to use. Each sterilizing
cycle shall contain an indicator device which assures proper
sterilization.
3. Laboratory tests
shall not be performed at collection stations.
4. Records shall be maintained indicating the
daily accession of specimens containing the following information:
(i) Name and other identification of the
person from whom specimen was obtained.
(ii) Name and address of the licensed
practitioner of the healing arts or other authorized person or clinical
laboratory who submitted the specimen.
(iii) Date the specimen was
collected.
(iv) Date the specimen
was received.
(v) Type of test
requested.
(vi) Name and address of
referring laboratory or authorized person.
(b) Procedure manuals relating to the
procedures performed by the collection station shall be maintained in
laboratories and collection stations.
(7) Plasmapheresis and Whole Blood Donor Centers.
(a) Methods shall be provided for
the selection of donors and for the collection, storage, processing and
transfusion, which shall ensure as far as possible that: 1) the donation is not
detrimental to the donor, and, 2) the recipient of the donated human blood or
any of its components is protected from exposure to infectious diseases known
to be transmissible by blood.
(b)
Written policies and procedures shall conform to the current edition of the
American Association of Blood Banks' Standards for Blood Banks and Transfusion
Services. Copies of this reference may be purchased from: American Association
of Blood Banks, 1117 North 19th Street, Suite 600, Arlington, Virginia 22209,
telephone number 1-703-528-8200, or may be inspected at the office of the
Alabama Department of Public Health, Division of Licensure and Certification,
Laboratory Section, Montgomery, Alabama.
(c) Personnel Requirements.
1. Director shall meet at least the
requirements specified in AAC Rule 420-5-8.03(1)(a)(1) and shall be responsible
at all times for all phases of operation.
2. Donor Selection (Screening Area).
(i) This area shall be staffed with at least
one person with no lesser qualifications than that of a Licensed Practical
Nurse (LPN), Clinical Laboratory Technician (MLT), or equivalent level of
training or experience (approved by the Alabama Department of Public Health).
Said qualified person shall be assigned the responsibility for supervision of
all activities of the donor screening area (including such laboratory
procedures as total serum protein, urine dipstick tests, hemoglobin and
hematocrit testing).
(ii) Every
person employed in the screening area shall receive ongoing continuing or
in-service education to enable him to recognize abnormalities that could make
it detrimental to the donor to donate (i.e., problem with blood pressure,
pulse, etc.) and to conduct careful evaluations of donor suitability in
accordance with the outline for donor selection published by the American
Association of Blood Banks. Documentation of the continuing or in-service
education for each donor screening employee shall be available for review by
the Alabama Department of Public Health.
3. Phlebotomy Area.
(i) Phlebotomists shall be persons who have a
minimum of one month's training in a plasmapheresis or blood donor
center.
(ii) A phlebotomist shall
be employed for the care of each four (or fraction of four) donors being
processed at one time.
(iii) The
phlebotomy area shall be supervised by a person with no lesser qualifications
than that of a Licensed Practical Nurse (LPN), Clinical Laboratory Technician
(MLT), or equivalent level of training and/or experience (approved by the
Alabama Department of Public Health). Said supervisor shall be certified in
cardiopulmonary resuscitation (CPR) annually. It is permissible for one
qualified person to supervise both the donor screening area and the phlebotomy
area.
4. Plasmapheresis
or Whole Blood Donor Testing Centers. Plasmapheresis or Whole Blood Donor
Centers that perform any laboratory procedures other than screening procedures
such as total serum protein, urine dipstick, hemoglobin and hematocrit testing,
must comply with all provisions of the Alabama Administrative Code (AAC),
Chapter 420-5-8, Rules of the Alabama State Board of Health for Independent
Clinical Laboratories and Independent Physiological Laboratories.
5. Other Personnel. Aides, clerks, volunteer
workers, etc., may be employed in the center but shall not perform technical
duties.
(d) Proficiency
Testing Requirements. The center shall participate in one or more of the
proficiency testing programs approved by the Alabama Department of Public
Health. The results of such programs shall be made available to the Alabama
Department of Public Health for review.
(e) Quality Control Requirements. Quality
control requirements shall be in accordance with AAC
420-5-8.04(4)(b).
(f) Documentation
of Reactions.
1. The facility shall maintain
a records system documenting all reactions.
2. Adequate reporting and recording forms
shall be available and utilized.
Authors: L. O'Neal Green, Patricia E. Ivie, Rick Harris, W. T. Geary, Jr., M.D.
Statutory Authority: Code of Ala. 1975, §§ 22-21-20, et seq.
Disclaimer: These regulations may not be the most recent version. Alabama may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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