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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 1MISCELLANEOUS PROVISIONS
SUBCHAPTER KDEFINITION, TREATMENT, AND DISPOSITION OF SPECIAL WASTE FROM HEALTH CARE-RELATED FACILITIES
RULE §1.132Definitions

The following words and terms, when used in this undesignated head, shall have the following meanings unless the context clearly indicates otherwise.

  (1) Anatomical remains--The remains of a human body donated for the purposes of teaching or research to a medical school, a teaching hospital, or a medical research facility, after the completion of the activities for which the body was donated.

  (2) Animal waste--Animal waste includes:

    (A) carcasses of animals intentionally exposed to pathogens;

    (B) body parts of animals intentionally exposed to pathogens;

    (C) whole bulk blood and blood products, serum, plasma, and other blood components from animals intentionally exposed to pathogens; and

    (D) bedding of animals intentionally exposed to pathogens.

  (3) Approved alternate treatment process--A process for waste treatment which has been approved by the Texas Department of Health in accordance with §1.135 of this title (relating to Performance Standards for Commercially-Available Alternate Treatment Technologies for Special Waste from Health Care-Related Facilities).

  (4) Biological indicators--Commercially-available microorganisms (e.g., United States Food and Drug Administration-approved strips or vials of Bacillus species endospores) which can be used to verify the performance of waste treatment equipment and/or processes.

  (5) Blood and blood products--All waste bulk human blood, serum, plasma, and other blood components.

  (6) Body fluids--Those free-flowing body substances other than blood, plasma, or serum identified under universal precautions as recommended by the United States Centers for Disease Control and Prevention, and includes, but are not limited to:

    (A) semen;

    (B) vaginal secretions;

    (C) any body fluid containing visible blood;

    (D) saliva in dental settings;

    (E) amniotic fluid;

    (F) cerebrospinal fluid;

    (G) peritoneal fluid;

    (H) pleural fluid;

    (I) pericardial fluid; and

    (J) synovial fluid.

  (7) Bulk--A containerized, aggregate volume of 100 milliliters (mL) or more.

  (8) Bulk human blood, bulk human blood products, and bulk human body fluids--All free-flowing waste: human blood; serum; plasma; other blood components; and body fluids; including disposable items saturated with blood or body fluids.

  (9) Burial--The act of depositing a pathological waste in a grave, a crypt, vault, or tomb, or at sea.

  (10) Burial park--A tract of land that is used or intended to be used for the interment of pathological waste in graves.

  (11) Cemetery--A tract of land that is used or intended to be used for the permanent interment of pathological waste, and includes:

    (A) a burial park for earth interments;

    (B) a mausoleum for crypt or vault interments;

    (C) a columbarium for cinerary interments; or

    (D) a combination of one or more thereof.

  (12) Challenge waste load--A surrogate waste load assembled for use during waste treatment protocols to evaluate the efficacy of microbial inactivation processes. The composition of the challenge waste load will vary depending on the technology being evaluated.

  (13) Chemical disinfection--The use of a chemical agent to reduce significantly the numbers of active microorganisms, but not necessarily their endospores, from the surfaces of inanimate objects.

  (14) Chlorine disinfection/maceration--The process of shredding waste in the presence of a chlorine solution under negative pressure.

  (15) Columbarium--A structure or room or other space in a building or structure of most durable and lasting fireproof construction; or a plot of earth, containing niches, used, or intended to be used, to contain cremated pathological waste.

  (16) Contagious--Capable of transmission from human or animal to human.

  (17) Contaminated--The presence or the reasonably anticipated presence of blood or those body fluids as defined elsewhere in this section.

  (18) Cremated remains--The bone fragments remaining after the cremation process, which may include the residue of any foreign materials that were cremated with the pathological waste.

  (19) Crematory--A building or structure containing one or more furnaces used, or intended to be used, for the reduction (by burning) of pathological waste to cremated remains.

  (20) Crypt or vault--The chamber in a mausoleum of sufficient size to inter the uncremated pathological waste.

  (21) Department--The Texas Department of Health.

  (22) Deposition in a sanitary landfill--Deposition in a sanitary landfill in accordance with 30 TAC Chapter 330.

  (23) Discharge to sanitary sewer system--A discharge or flushing of waste into a sanitary sewer system which is done in accordance with provisions of local sewage discharge ordinances.

  (24) Disinfection--A somewhat less lethal process compared to sterilization which destroys or inactivates viruses, fungi, and bacteria (but not necessarily their endospores) on inanimate surfaces.

  (25) Encapsulation--The treatment of waste using materials which, when fully reacted, will encase such waste in a solid protective matrix.

  (26) Entombment--The permanent interment of pathological waste in a crypt or vault.

  (27) Grave--A space of ground in a burial park that is used, or intended to be used for the permanent interment in the ground of pathological waste.

  (28) Grinding--That physical process which pulverizes materials, thereby rendering them as unrecognizable, and for sharps, reduces the potential for the material to cause injuries such as puncture wounds.

  (29) Immersed--A process in which waste is submerged fully into a liquid chemical agent in a container, or that a sufficient volume of liquid chemical agent is poured over a containerized waste, such that the liquid completely surrounds and covers the waste item(s) in the container.

  (30) Incineration--That process of burning SWFHCRF in an incinerator as defined in 30 TAC Chapter 101 under conditions in conformance with standards prescribed in 30 TAC Chapter 111 by the Texas Natural Resource Conservation Commission.

  (31) Interment--The disposition of pathological waste by cremation, entombment, burial, or placement in a niche.

  (32) Log[sub]10[/sub]--Logarithm to the base ten.

  (33) Log[sub]10[/sub] reduction--A mathematically defined unit used in reference to level or degree of microbial inactivation. A 4 log[sub]10[/sub] reduction represents a 99.99% reduction in the numbers of active microorganisms, while a 6 log[sub]10[/sub] reduction represents a 99.9999% reduction in the numbers of active microorganisms.

  (34) Mausoleum--A structure or building of most durable and lasting fireproof construction used, or intended to be used, for the entombment pathological waste.

  (35) Microbial inactivation--Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log[sub]10[/sub] reduction or greater; and inactivation of Bacillus subtilis endospores or Bacillus stearothermophilus endospores at a 4 log[sub]10[/sub] reduction or greater.

  (36) Microbiological waste--Microbiological waste includes:

    (A) discarded cultures and stocks of infectious agents and associated biologicals;

    (B) discarded cultures of specimens from medical, pathological, pharmaceutical, research, clinical, commercial, and industrial laboratories;

    (C) discarded live and attenuated vaccines, but excluding the empty containers thereof;

    (D) discarded, used disposable culture dishes; and

    (E) discarded, used disposable devices used to transfer, inoculate or mix cultures.

  (37) Moist heat disinfection--The subjection of:

    (A) internally shredded waste to moist heat, assisted by microwave radiation under those conditions which effect disinfection; or

    (B) unshredded waste in sealed containers to moist heat, assisted by low-frequency radiowaves under those conditions which effect disinfection, followed by shredding of the waste to the extent that the identity of the waste is unrecognizable.

  (38) Niche--A recess or space in a columbarium used, or intended to be used, for the permanent interment of the cremated remains of pathological waste.

  (39) Parametric controls--Measurable standards of equipment operation appropriate to the treatment equipment including, but not limited to pressure, cycle time, temperature, irradiation dosage, pH, chemical concentrations, or feed rates.

  (40) Pathological waste--Pathological waste includes but is not limited to:

    (A) human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy, including:

      (i) body parts;

      (ii) tissues or fetuses;

      (iii) organs; and

      (iv) bulk blood and body fluids;

    (B) products of spontaneous or induced human abortions, regardless of the period of gestation, including:

      (i) body parts;

      (ii) tissues or fetuses;

      (iii) organs; and

      (iv) bulk blood and body fluids;

    (C) laboratory specimens of blood and tissue after completion of laboratory examination; and

    (D) anatomical remains.

  (41) Saturated--Thoroughly wet such that liquid or fluid flows freely from an item or surface without compression.

  (42) Sharps--Sharps include, but are not limited to the following materials:

    (A) when contaminated:

      (i) hypodermic needles;

      (ii) hypodermic syringes with attached needles;

      (iii) scalpel blades;

      (iv) razor blades, disposable razors, and disposable scissors used in surgery, labor and delivery, or other medical procedures;

      (v) intravenous stylets and rigid introducers (e.g., J wires);

      (vi) glass pasteur pipettes, glass pipettes, specimen tubes, blood culture bottles, and microscope slides;

      (vii) broken glass from laboratories; and

      (viii) tattoo needles, acupuncture needles, and electrolysis needles;

    (B) regardless of contamination:

      (i) hypodermic needles; and

      (ii) hypodermic syringes with attached needles.

  (43) Shredding--That physical process which cuts, slices, or tears materials into small pieces.

  (44) Special waste from health care-related facilities--A solid waste which if improperly treated or handled may serve to transmit an infectious disease(s) and which is comprised of the following:

    (A) animal waste;

    (B) bulk blood, bulk human blood products, and bulk human body fluids;

    (C) microbiological waste;

    (D) pathological waste; and

    (E) sharps.

  (45) Steam disinfection--The act of subjecting waste to steam under pressure under those conditions which effect disinfection. This was previously called steam sterilization.

  (46) Thermal inactivation--The act of subjecting waste to dry heat under those conditions which effect disinfection.

  (47) Unrecognizable--The original appearance of the waste item has been altered such that neither the waste nor its source can be identified.


Source Note: The provisions of this §1.132 adopted to be effective April 4, 1989, 14 TexReg 1457; amended to be effective November 21, 1991, 16 TexReg 6482; amended to be effective December 21, 1994, 19 TexReg 9599.

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