Texas Register, Volume 33, Number 51, Pages 10253-10386, December 19, 2008 Page: 10,288
10253-10386 p. ; 28 cm.View a full description of this periodical.
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(1) A licensed abortion facility shall develop, implement,
and enforce written policies and procedures on cleaning the procedure
room(s).
(2) A licensed abortion facility shall develop, implement,
and enforce written policies and procedures for the handling, process-
ing, storing, and transporting of clean and dirty laundry.
(3) A licensed abortion facility may provide cleaning and
laundry services directly or by contract in accordance with Occupa-
tional Safety and Health Administration's Standards, 29 Code of Fed-
eral Regulations, Subpart Z. Bloodborne Pathogens.
(d) Policies and procedures for decontamination, disinfection,
sterilization, and storage of sterile supplies. A licensed abortion facility
shall have written policies covering its procedures for the decontami-
nation and sterilization activities performed. Policies shall include, but
not be limited to, the receiving, cleaning, decontaminating, disinfect-
ing, preparing and sterilization of critical items (reusable items), as well
as those for the assembly, wrapping, storage, distribution, and the mon-
itoring and control of sterile items and equipment.
(1) Supervision. The decontamination, disinfection, and
sterilization of all supplies and equipment shall be under the supervi-
sion of a person qualified by education, training, or experience.
(2) Quantity of sterile surgical instruments. The facility
shall ensure that surgical instruments are sufficient in number to permit
sterilization of the instrument(s) used for each procedure and adequate
to perform conventional cervical dilatation and curettage.
(3) Inspection of surgical instruments.
(A) All instruments shall undergo inspection before be-
ing packaged for reuse or storage. Routine inspection of instruments
shall be made to assure clean locks, crevices, and serrations.
(B) Inspection procedures shall be thorough and in-
clude visual and manual inspection for condition and function.
(i) Cutting edges shall be checked for sharpness; tips
shall be properly aligned, and box locks shall be clean and free from
buildup of soap, detergent, dried blood, or tissue.
(ii) There shall be no evident cracks or fissures in the
box locks, and the hinges shall work freely.
(iii) Ratchets shall hold and be routinely tested.
(iv) There shall be no corrosion or pitting of the fin-
ish.
(C) Instruments needing maintenance shall be taken out
of service and repaired by someone qualified to repair surgical instru-
ments.
(D) To protect the instrument and its protective finish,
impact markers or electric engravers shall not be used for instrument
identification. Instrument identification shall be accomplished by the
instrument manufacturer, employing methods which shall not damage
the instrument or its protective finish.
(4) Items to be disinfected and sterilized.
(A) Critical items.
(i) Critical items include all surgical instruments and
objects that are introduced directly into the bloodstream or into other
normally sterile areas of the body and shall be sterilized in accordance
with this subsection.
(ii) All items that come in contact with the sterile
field during the operative procedure shall be sterile.(B) Semicritical items.
(i) Semicritical items include items that come in
contact with nonintact skin or mucous membranes. Semicritical items
shall be free of microorganisms, except bacterial spores. Semicritical
items may include respiratory therapy equipment, anesthesia equip-
ment, bronchoscopes, and thermometers.
(ii) High-level disinfection shall be used for semi-
critical items.
(C) Noncritical items.
(i) Noncritical items include items that come in con-
tact with intact skin.
(ii) Intermediate-level or low-level disinfection
shall be used for noncritical items.
(5) Equipment and sterilization procedures. Effective
sterilization of instruments depends on performing correct methods
of cleaning, packaging, arrangement of items in the sterilizer, and
storage. The following procedures shall be included in the written
policies as required in this subsection to provide effective sterilization
measures.
(A) Equipment. A licensed abortion facility shall pro-
vide sterilization equipment adequate to meet the requirements of this
paragraph for sterilization of critical items. Equipment shall be main-
tained and operated to perform, with accuracy, the sterilization of crit-
ical items.
(B) Environmental requirements. Where cleaning,
preparation, and sterilization functions are performed in the same room
or unit, the physical facilities, equipment, and the written policies and
procedures for their use shall be such as to effectively separate soiled
or contaminated supplies and equipment from the clean or sterilized
supplies and equipment.
(i) A facility shall have a sink for hand washing.
This sink shall not be used for cleaning instruments or disposal of liq-
uid waste.
(ii) A facility shall have a separate sink for cleaning
instruments and disposal of liquid waste. Hand washing shall only be
performed at this sink after it has been disinfected.
(C) Preparation for sterilization.
(i) All items to be sterilized shall be prepared to re-
duce the bioburden. All items shall be thoroughly cleaned, decontami-
nated and prepared in a clean, controlled environment. Cleaning is the
removal of all adherent visible soil from the surfaces, crevices, joints,
and lumens of instruments. Decontamination is the physical/chemical
process that renders an inanimate object safe for further handling.
(ii) One of the following methods of cleaning and
decontamination shall be used as appropriate.
(I) Manual cleaning. Manual cleaning of instru-
ments at the sink is permitted.
(II) Ultrasonic cleaning. Ultrasonic cleaning of
instruments cleans by cavitation and reduces the need for hand scrub-
bing. When grossly soiled items are placed in the ultrasonic cleaner
the water shall be changed more than once a shift. If using this method
for cleaning, chambers shall be covered to prevent potential hazards to
personnel from aerosolization of the contents.
(III) Washer-sterilizers. Washer-sterilizers clean
by using rotating spray arms to create water jets that clean by im-33 TexReg 10288 December 19, 2008 Texas Register
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Texas. Secretary of State. Texas Register, Volume 33, Number 51, Pages 10253-10386, December 19, 2008, periodical, December 19, 2008; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth90820/m1/34/: accessed May 21, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.