(a) General infection control measures.
  (1) Universal precautions.
    (A) Universal precautions shall be followed in the facility for all patient care activities in accordance with 29 Code of Federal Regulations, §1910.1030(d)(1) - (3) (concerning Bloodborne Pathogens) and the Health and Safety Code, Chapter 85, Subchapter I (concerning Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus by Health Care Workers).
    (B) The facility shall demonstrate that it follows standard infection control precautions by implementing the Recommended Infection Control Practices for Hemodialysis Units at a Glance, with the exception of screening for Hepatitis C, found in Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Morbidity and Mortality Weekly Report, Volume 50, Number RR - 5, April 27, 2001, pages 18 through 22, developed by the Centers for Disease Control and Prevention, to prevent and control cross-contamination and the spread of infectious agents.
    (C) Infection control precautions for all patients.
      (i) Disposable gloves shall be worn when caring for the patient or touching the patient's equipment or bloodlines at the dialysis station.
      (ii) Gloves shall be removed and hands shall be cleaned between each patient contact, as well as after touching blood, body fluids, secretions, excretions, and contaminated items or station. A sufficient number of sinks, with hands-free operable controls, with warm water and soap shall be available to facilitate hand washing. Provisions for hand drying shall be included at each hand washing sink.
      (iii) If hands are not visibly soiled, use of a waterless antiseptic hand rub can be substituted for handwashing.
      (iv) Staff members shall wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood).
      (v) Staff members shall not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
      (vi) Items taken to the dialysis station shall either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient.
      (vii) Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) shall be dedicated for use only on a single patient.
      (viii) Unused medications or supplies (syringes, alcohol swabs, etc.) taken to the patient's station shall be used only for that patient and shall not be returned to a common clean area or used on other patients.
      (ix) Clean areas shall be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Medications or clean supplies shall not be handled and stored in the same or an immediately adjacent area where used supplies, equipment, or blood samples are handled.
      (x) Contaminated areas where used supplies, equipment, or blood samples are handled shall be clearly designated.
      (xi) When multiple dose medication vials are used (including vials containing diluents), individual patient doses shall be prepared in a clean (centralized) area away from dialysis stations, and delivered separately to each patient.
      (xii) Multiple dose medications vials shall not be carried from station to station.
      (xiii) Common medication carts shall not be used to deliver medications to patients. If trays are used to deliver medications to individual patients, they shall be cleaned between each patient.
      (xiv) If a common supply cart is used to store clean supplies in the patient treatment area, this cart shall remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts shall not be moved between stations to distribute supplies.
      (xv) Medication vials, syringes, alcohol swabs or supplies shall not be carried in pockets.
    (D) Location and arrangement of hand washing sinks shall permit ease of access and proper use.
    (E) Facility staff shall explain the potential risks associated with blood and blood products to patients and family members and provide the indicated personal protective equipment to a patient or family member, if the patient or family member assists in procedures which could result in contact with blood or body fluids.
  (2) Documentation and coordination of infection control activities.
    (A) The facility shall designate a person to monitor and coordinate infection control activities.
    (B) A facility shall develop, maintain, and enforce a system to identify and track infections to allow identification of trends or patterns. This activity shall be reviewed as a part of the facility's quality assessment and performance improvement (QAPI) program described in §117.43 of this title (relating to Quality Assessment and Performance Improvement). The record shall include trends, corrective actions, and improvement actions taken.
(b) Physical environment.
  (1) General procedures.
    (A) A facility shall develop implement and enforce policies and procedures to provide and actively monitor a safe, functional, comfortable, and sanitary environment which minimizes or prevents transmission of infectious diseases for all patients and visitors, and the public.
      (i) Wall bases in patient treatment and other areas which are frequently subject to wet cleaning methods shall be tightly sealed to the floor and the wall, impervious to water, and constructed without voids that can harbor insects. Wall baseboard and floor tiles in all patient treatment care areas and bathrooms that are loose, torn, cracked, or not sealed shall be fixed or replaced. The maintenance safety occurrence shall be recorded in the safety report or maintenance log records and maintained in the facility.
      (ii) Wall finishes shall be washable and, in the immediate areas of plumbing fixtures, smooth and moisture resistant.
      (iii) All exposed ceilings and ceiling structures in areas normally occupied by patients, staff, and visitors shall be finished so as to be cleanable with equipment used in daily housekeeping activities, and shall be replaced if stained with blood. No portable or ceiling fans shall be utilized in patient treatment areas, or in the reprocessing room.
      (iv) Floors that are subject to traffic while wet shall have nonslip surfaces. Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. In all areas subject to wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions. Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed.
      (v) A facility shall utilize a ventilation system which provides adequate comfort to patients during treatment and which minimizes the potential of insect access.
      (vi) All storage areas shall be kept clean and orderly at all times, with a separate space designated for wheelchair storage.
    (B) Blood spills shall be cleaned immediately or as soon as is practical with a disposable cloth and an appropriate chemical disinfectant.
      (i) The surface shall be subjected to intermediate-level disinfection in accordance with the manufacturer's directions for use, if a commercial liquid chemical disinfectant is used.
      (ii) If a solution of chlorine bleach (sodium hypochlorite) is used, the solution shall be at least 1:100 sodium hypochlorite and mixed in accordance with the manufacturer's directions for use. The surface to be treated shall be compatible with this type of chemical treatment.
      (iii) The facility shall utilize dedicated cleaning supplies (i.e., mop, bucket) for the cleaning of blood spills.
  (2) Specific procedures for equipment and dialysis machines.
    (A) Routine disinfection of active and backup dialysis machines shall be performed according to facility defined protocol, accomplishing at least intermediate-level disinfection. The facility personnel responsible for the disinfection of the dialysis machines shall document the date, and the time of the disinfection, and verify that the dialysis machines were rinsed and that the disinfectant was removed.
    (B) Between patient shifts, facility staff shall clean machine exteriors, treatment chairs, tourniquets, blood pressure cuffs, facility individual television sets at each treatment station, and hemostats. Blood pressure cuffs which become contaminated with blood shall be removed from service, disinfected, and allowed to dry prior to being returned to use.
(c) Waste and waste disposal.
  (1) Special waste and liquid/sewage waste management.
Cont'd...
(A) The ESRD facility shall comply with the requirements set forth by the department in §§1.131-1.137 of this title (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities) and the Texas Commission on Environmental Quality (TCEQ) requirements in 30 Texas Administrative Code, §330.1207 (relating to Generators of Medical Waste).
    (B) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with Title 30, Texas Administrative Code, Chapter 285 (relating to On-Site Sewage Facilities).
  (2) Waste containers.
    (A) Waste containers shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location(s) into closed containers.
    (B) Waste containers shall be cleaned and properly maintained and free of visible residue.
    (C) All containers for other municipal solid waste shall be leak-resistant, have covers, be rodent-proof, and comply with local sanitation requirements.
    (D) Nonreusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations.
(d) Hepatitis B prevention.
  (1) The facility shall offer hepatitis B vaccination to previously unvaccinated, susceptible new staff members in accordance with 29 Code of Federal Regulations, §1910.1030(f)(1) - (2) (concerning Bloodborne Pathogens). Staff vaccination records shall be maintained in each staff member's health record.
  (2) Prevention requirements concerning patients.
    (A) Hepatitis B vaccination.
      (i) With an order from the patient's nephrologist, facility staff shall make the hepatitis B vaccine available to a patient who is susceptible to hepatitis B, provided that the patient has coverage or is willing to pay for vaccination.
      (ii) The facility shall make available to patients literature describing the risks and benefits of the hepatitis B vaccination.
    (B) Serologic screening of patients.
      (i) The Hepatitis B virus (HBV) serological status to include Hepatitis B surface antigen (HBsAg), total anti-Hepatitis B core antibody (anti-HBc), and antibody to Hepatitis B surface antigen (anti-HBs) of all patients should be known before admission to the hemodialysis unit. The anti-HBc results obtained previously or on admission shall be maintained in the clinical record and repeated only if clinically indicated.
      (ii) A patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer shall have been screened for hepatitis B surface antigen (HBsAg) within one month before or at the time of admission to the facility or have a known hepatitis B surface antibody (anti-HBs) status of at least 10 milli-international units per milliliter no more than 12 months prior to admission. The facility shall document how this screening requirement is met.
      (iii) Repeated serologic screening shall be based on the antigen or antibody status of the patient.
        (I) Monthly screening for HBsAg is required for patients whose previous test results are negative for anti-HBs.
        (II) Screening of HBsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis, but must be performed at least annually.
    (C) Isolation procedures for the HBsAg-positive patient.
      (i) An ESRD facility which was licensed prior to the effective date of these rules shall comply with §117.101 of this title (relating to Construction Requirements for an Existing End Stage Renal Disease Facility). An ESRD facility which is licensed after the effective date of these rules shall treat patients positive for HBsAg in a separate treatment room which complies with §117.102(d)(4) of this title (relating to Construction Requirements for a New End Stage Renal Disease Facility).
      (ii) Separate dedicated supplies and equipment, including blood glucose monitors, shall be used to provide care to the Hepatitis B positive patients. All supplies used in the isolation area/room, such as clamps, blood pressure cuffs, testing reagents, etc., shall be labeled "isolation" and not routinely removed from the isolation area/room.
      (iii) Refillable concentrate containers shall be surface disinfected at the completion of each treatment. Refillable acid concentrate containers shall be kept in the isolation area/room and refilled at the door. Refillable bicarbonate concentrate containers shall be removed for cleaning and disinfection. In the disinfection area, containers labeled "isolation" container(s) and pick-up tube(s) shall be segregated in a dedicated, designated area away from all other containers and pick-up tubes.
      (iv) Separate gowns shall be used in the isolation area/room and removed before leaving the isolation area/room. Any one entering the isolation area/room during the patient's treatment must wear a protective gown.
      (v) Dedicated cleaning supplies (i.e., mop, bucket) for the cleaning of the isolation area/room and blood spills shall be utilized and labeled "isolation."
      (vi) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for an HBsAg-positive patient's use only.
      (vii) When a direct patient care staff member is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping shall be Hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and be assigned to the same staff member who is caring for the HBsAg-positive patient.
      (viii) If an HBsAg-positive patient is discharged, the equipment which had been reserved for that patient shall be given intermediate-level disinfection prior to use for a patient testing negative for HBsAg.
      (ix) In the case of patients new to dialysis or a patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer, if these patients are admitted for treatment before results of HBsAg or anti-HBs testing are known, these patients shall undergo treatment as if the HBsAg test results were potentially positive, except that they shall not be treated in the HBsAg isolation room, area, or machine.
        (I) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area which is outside of traffic patterns and may not reuse the dialyzer until the HBsAg test results are known.
        (II) The dialysis machine used by this patient shall be given intermediate-level disinfection prior to its use by another patient.
        (III) The facility shall obtain HBsAg status results of the patient no later than three days from admission.
(e) Tuberculosis prevention.
  (1) The facility's direct care staff shall be screened for tuberculosis upon employment prior to patient contact, or provide documentation of negative tuberculosis status.
  (2) Subsequent screening of facility staff shall be performed after any potential exposure to laryngeal or pulmonary tuberculosis.
  (3) Respiratory isolation procedures and precautions developed by the facility shall be employed by facility staff providing treatment to patients with pulmonary tuberculosis.
  (4) The facility shall screen patients for tuberculosis when indicated by the presence of risk factors for, or the signs and symptoms of tuberculosis. Screening shall be performed after potential exposure to active laryngeal or pulmonary tuberculosis.
(f) The facility shall adopt, implement, and enforce a policy for offering and providing pneumococcal and influenza vaccines for elderly persons. The policy shall:
  (1) establish that an elderly person, defined as 65 years of age or older, who receives ongoing care at the facility, is offered, to the extent possible as determined by the facility, the opportunity to receive the pneumococcal and influenza vaccines, if a physician, or an advanced practice registered nurse or physician assistant on behalf of a physician, determines that the vaccine is in the person's best interest. If the facility decides it is not feasible to offer the vaccine, the facility shall provide the person with information on other options for obtaining the vaccine;
  (2) include provisions that the influenza vaccine shall be offered according to the Centers for Disease Control annual recommendations, and the pneumococcal vaccine shall be offered throughout the year;
  (3) require that the person administering the vaccine ask the elderly patient if they are currently vaccinated against influenza or pneumococcal disease, assess potential contraindications, and then, if appropriate, administer the vaccine under approved facility protocols;
  (4) address required documentation of the vaccination in the patient clinical record; and
  (5) include that the department may waive requirements related to the administration of the vaccines based on established shortages of the vaccines.

Source Note: The provisions of this §117.33 adopted to be effective July 6, 2010, 35 TexReg 5835