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RULE §117.33Sanitary Conditions and Hygienic Practices

(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.


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